Amiodarone Tablets USP 200mg Taj Pharma

  1. Name of the medicinal product

Amiodarone Tablets USP 100mg Taj Pharma
Amiodarone Tablets USP 200mg Taj Pharma
Amiodarone Tablets USP 400mg Taj Pharma

  1. Qualitative and quantitative composition

a) Amiodarone Tablets USP 100mg Taj Pharma
Each uncoated tablet contains:
Amiodarone hydrochloride 100mg
Excipients: Q.S.

b) Amiodarone Tablets USP 200mg Taj Pharma
Each uncoated tablet contains:
Amiodarone hydrochloride 200mg
Excipients: Q.S.

c) Amiodarone Tablets USP 400mg Taj Pharma
Each uncoated tablet contains:
Amiodarone hydrochloride 400mg
Excipients: Q.S.

For a full list of excipients, see section 6.1.

  1. Pharmaceutical form

Uncoated Tablets

  1. Clinical particulars
    • Therapeutic indications

Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Amiodarone Taj Pharma is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatment cannot be used.

Tachyarrhythmias associated with Wolff-Parkinson-White syndrome.

Atrial flutter and fibrillation when other drugs cannot be used.

All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias. ventricular fibrillation; when other drugs cannot be used.

  • Posology and method of administration

Adults:

It is particularly important that the minimum effective dose be used. In all cases the patient’s management must be judged on the individual response and well-being. The following dosage regiment is generally effective:

Initial stabilization:

Treatment should be started with 200mg, three times a day and may be continued for 1 week.

The dosage should then be reduced to 200mg twice daily for a further week.

Maintenance:

After the initial period the dosage should be reduced to 200mg daily, or less if appropriate.

Rarely, the patient may require a higher maintenance dose. The scored 100mg tablet should be used to titrate the minimum dosage required to maintain control of the arrhythmia. The maintenance dose should be regularly reviewed, especially where this exceeds 200mg daily.

General considerations

Initial dosing:

A high dose is needed in order to achieve adequate tissue levels rapidly.

Maintenance:

Too high a dose during maintenance therapy can cause side effects which are believed to be related to high tissue levels of Amiodarone Taj Pharma and its metabolites.

Amiodarone Taj Pharma is strongly protein bound and has an average plasma half-life of 50 days (reported range 20 to 100days). It follows that sufficient time must be allowed for new distribution equilibrium to be achieved between adjustments of dosage. In patients with potentially lethal arrhythmias the long half-life is a valuable safeguard, as omission of occasional doses does not significantly influence the overall therapeutic effect. It is particularly important that the minimum effective dosage is used and the patient is monitored regularly to detect the clinical features of excess Amiodarone Taj Pharma dosage. Therapy may then be adjusted accordingly.

Dosage reduction/withdrawal

Side effects slowly disappear as tissue levels fall. Following drug withdrawal, residual tissue bound Amiodarone Taj Pharma may protect the patient for up to a month. However, the likelihood of recurrence of arrhythmia during this period should be considered.

Paediatric population

The safety and efficacy of Amiodarone Taj Pharma in children has not been established.

Currently available data are described in sections 5.1 and 5.2.

Elderly:

As with all patients it is important that the minimum effective dose is used. Whilst there is no evidence that dosage requirements are different for this group of patients they may be more susceptible to bradycardia and conduction defects if too high a dose is employed. Particular attention should be paid to monitoring thyroid function. (See Sections 4.3,4.4 and 4.8).

Amiodarone Taj Pharma is for oral administration.

  • Contraindications

Sinus bradycardia and sino-atrial heart block: In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Amiodarone Taj Pharma should be used only in conjunction with a pacemaker.

Evidence of history of thyroid dysfunction: Thyroid function tests should be performed prior to therapy in all patients.

Known hypersensitivity to iodine or to Amiodarone Taj Pharma (one 100mg tablet contains approximately 37.5mg iodine), or to any of the excipients listed in section 6.1.

The combination of Amiodarone Taj Pharma with drugs which may induce Torsades de Pointes is contra- indicated (see section 4.5).

Pregnancy – except in exceptional circumstances (see section 4.6)

Lactation (see section 4.6).

  • Special warnings and precautions for use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Amiodarone Taj Pharma can cause serious adverse reactions affecting the eyes, heart, lung, liver, thyroid gland, skin and peripheral nervous system (see section 4.8.). Because these reactions may be delayed, patients on long-term treatment should be carefully supervised. As undesirable effects are usually dose-related, the minimum effective maintenance dose should be given.

Before surgery, the anaesthetist should be informed that the patient is taking Amiodarone Taj Pharma (see sections 4.5 and 4.8).

Cardiac disorders (see section 4.8):

Too high a dosage may lead to severe bradycardia and to conduction disturbances with the appearance of an idioventricular rhythm, particularly in elderly patients or during digitalis therapy. In these circumstances, Amiodarone Taj Pharma treatment should be withdrawn. If necessary, beta-adrenostimulants or glucagon may be given. Because of the long half-life of Amiodarone Taj Pharma, if bradycardia is severe and symptomatic the insertion of a pacemaker should be considered.

Oral Amiodarone Taj Pharma is not contraindicated in patients with latent or manifest heart failure but caution should be exercised as, occasionally, existing heart failure may be worsened. In such cases, Amiodarone Taj Pharma may be used with other appropriate therapies.

The pharmacological action of Amiodarone Taj Pharma induces ECG changes: QT prolongation (related to prolonged repolarisation) with the possible development of U-waves and deformed T-waves; these changes do not reflect toxicity.

In the elderly, heart rate may decrease markedly.

Treatment should be discontinued in case of onset of 2nd or 3rd degree A-V block, sino-atrial block or bifascicular block.

Amiodarone Taj Pharma has a low pro-arrhythmic effect. Onsets of new arrhythmias or worsening of treated arrhythmias, sometimes fatal, have been reported. It is important, but difficult, to differentiate a lack of efficacy of the drug from a proarrhythmic effect, whether or not this is associated with a worsening of the cardiac condition. Proarrhythmic effects generally occur in the context of drug interactions and/or electrolytic disorders (see sections 4.5. and 4.8). Despite QT interval prolongation, Amiodarone Taj Pharma exhibits a low torsadogenic activity.

Before starting Amiodarone Taj Pharma, it is recommended to perform an ECG and serum potassium measurement. Monitoring of ECG is recommended during treatment.

Amiodarone Taj Pharma may increase the defibrillation threshold and/or pacing threshold in patients with an implantable cardioverter defibrillator or a pacemaker, which may adversely affect the efficacy of the device. Regular tests are recommended to ensure the proper function of the device after initiation of treatment or change in posology.

Severe Bradycardia (see section 4.5):

Cases of severe, potentially life-threatening bradycardia and heart block have been observed when Amiodarone Taj Pharma is used in combination with sofosbuvir in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA), such as daclatasvir, simeprevir, or ledipasvir. Therefore, coadministration of these agents with Amiodarone Taj Pharma is not recommended.

If concomitant use with Amiodarone Taj Pharma cannot be avoided, it is recommended that patients are closely monitored when initiating sofosbuvir in combination with other DAAs. Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for at least 48 hours in an appropriate clinical setting after initiation of the concomitant treatment with sofosbuvir.

Patients receiving these hepatitis C medicines with Amiodarone Taj Pharma, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.

Endocrine disorders (see section 4.8)

Amiodarone Taj Pharma may induce hypothyroidism or hyperthyroidism, particularly in patients with a personal history of thyroid disorders. Clinical and biological [including ultrasensitive TSH (usTSH)] monitoring should be performed prior to therapy in all patients. Monitoring should be carried out during treatment, at six-monthly intervals, and for several months following its discontinuation. This is particularly important in the elderly. In patients whose history indicates an increased risk of thyroid dysfunction, regular assessment is recommended. Serum usTSH level should be measured when thyroid dysfunction is suspected.

Amiodarone Taj Pharma contains iodine and thus may interfere with radio-iodine uptake. However, thyroid function tests (free-T3, free-T4, usTSH) remain interpretable. Amiodarone Taj Pharma inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, free-T3 being slightly decreased or even normal) in clinically euthyroid patients. There is no reason in such cases to discontinue Amiodarone Taj Pharma treatment if there is no clinical or further biological (usTSH) evidence of thyroid disease.

Hypothyroidism

Hypothyroidism should be suspected if the following clinical signs occur: weight gain, cold intolerance, reduced activity, excessive bradycardia. The diagnosis is supported by an increase in serum usTSH and an exaggerated TSH response to TRH. Tand T4 levels may be low. Euthyroidism is usually obtained within 3 months following the discontinuation of treatment. In life-threatening situations, Amiodarone Taj Pharma therapy can be continued, in combination with levothyroxine. The dose of levothyroxine is adjusted according to TSH levels.

Hyperthyroidism

Hyperthyroidism may occur during Amiodarone Taj Pharma treatment, or, up to several months after discontinuation. Clinical features, such as weight loss, asthenia, restlessness, increase in heart rate, onset of arrhythmia, angina, congestive heart failure should alert the physician. The diagnosis is supported by a decrease in serum usTSH level, an elevated Tand a reduced TSH response to thyrotropin releasing hormone. Elevation of reverse T3 (rT3) may also be found.

In the case of hyperthyroidism, therapy should be withdrawn. Clinical recovery usually occurs within a few months, although severe cases, sometimes resulting in fatalities, have been reported. Clinical recovery precedes the normalisation of thyroid function tests.

Courses of anti-thyroid drugs have been used for the treatment of severe thyroid hyperactivity; large doses may be required initially. These may not always be effective and concomitant high dose corticosteroid therapy (e.g. 1mg/kg prednisolone) may be required for several weeks.

Eye disorders (see section 4.8)

If blurred or decreased vision occurs, complete ophthalmologic examination including fundoscopy should be promptly performed. Appearance of optic neuropathy and/or optic neuritis requires Amiodarone Taj Pharma withdrawal due to the potential progression to blindness. Unless blurred or decreased vision occurs, opthamological examination is recommended annually.

Hepato-biliary disorders (see section 4.8):

Amiodarone Taj Pharma may be associated with a variety of hepatic effects, including cirrhosis, hepatitis, jaundice and hepatic failure. Some fatalities have been reported, mainly following long-term therapy, although rarely they have occurred soon after starting treatment particularly after Amiodarone Taj Pharma intravenous. It is advisable to monitor liver function particularly transaminases before treatment and six monthly thereafter. Amiodarone Taj Pharma dose should be reduced or the treatment discontinued if the transaminases increase exceeds three times the normal range.

At the beginning of therapy, elevation of serum transaminases which can be in isolation (1.5 to 3 times normal) may occur. These may return to normal with dose reduction, or sometimes spontaneously.

Isolated cases of acute liver disorders with elevated serum transaminases and/or jaundice may occur; in such cases treatment should be discontinued.

There have been reports of chronic liver disease. Alteration of laboratory tests which may be minimal (transaminases elevated 1.5 to 5 times normal) or clinical signs (possible hepatomegaly) during treatment for longer than 6 months should suggest this diagnosis. Routine monitoring of liver function tests is therefore advised. Abnormal clinical and laboratory test results usually regress upon cessation of treatment, but fatal cases have been reported. Histological findings may resemble pseudo-alcoholic hepatitis, but they can be variable and include cirrhosis.

Although there have been no literature reports on the potentiation of hepatic adverse effects of alcohol, patients should be advised to moderate their alcohol intake while taking Amiodarone Taj Pharma tablets.

Nervous system disorders (see section 4.8):

Amiodarone Taj Pharma may induce peripheral sensorimotor neuropathy and/or myopathy. Both these conditions may be severe, although recovery usually occurs within several months after Amiodarone Taj Pharma withdrawal, but may sometimes be incomplete.

Respiratory, thoracic and mediastinal disorders (see section 4.8):

Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity (hypersensitivity pneumonitis, alveolar/interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonitis. Presenting features can include dyspnoea (which may be severe and unexplained by the current cardiac status), non-productive cough and deterioration in general health (fatigue, weight loss and fever). The onset is usually slow but may be rapidly progressive. Whilst the majority of cases have been reported with long term therapy, a few have occurred soon after starting treatment.

Patients should be carefully evaluated clinically and consideration given to chest X-rays before starting therapy. During treatment, if pulmonary toxicity is suspected, this should be repeated and associated with lung function testing including, where possible, measurement of transfer factor. Initial radiological changes may be difficult to distinguish from pulmonary venous congestion. Pulmonary toxicity has usually been reversible following early withdrawal of Amiodarone Taj Pharma therapy, with or without corticosteroid therapy. Clinical symptoms often resolve within a few weeks followed by slower radiological and lung function improvement. Some patients can deteriorate despite discontinuing Amiodarone Taj Pharma tablets.

Skin and subcutaneous tissue disorders (see section 4.8)

Patients should be instructed to avoid exposure to sun and to use protective measures during therapy as patients taking Amiodarone Taj Pharma tablets can become unduly sensitive to sunlight, which may persist after several months of discontinuation of Amiodarone Taj Pharma tablets. In most cases symptoms are limited to tingling, burning and erythema of sun-exposed skin but severe phototoxic reactions with blistering may be seen.

Severe bullous reactions:

Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (see section 4.8). If symptoms or signs of SJS, TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present Amiodarone Taj Pharma treatment should be discontinued immediately.

Drug interactions (see section 4.5)

Concomitant use of Amiodarone Taj Pharma is not recommended with the following drugs: beta-blockers, heart rate lowering calcium channel inhibitors (verapamil, diltiazem), stimulant laxative agents which may cause hypokalaemia.

Increased plasma levels of flecainide have been reported with co-administration of Amiodarone Taj Pharma. The flecainide dose should be reduced accordingly and the patient closely monitored.

.

Excipient warnings

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

  • Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

  • Drugs inducing Torsade de Pointes or prolonging QT
    • Drugs inducing Torsade de Pointes

Combined therapy with the following drugs which prolong the QT interval is contra-indicated (see section 4.3) due to the increased risk of torsades de pointes; for example:

  • Class Ia anti-arrhythmic drugs e.g. quinidine, procainamide, disopyramide
  • Class III anti-arrhythmic drugs e.g. sotalol, bretylium
  • intravenous erythromycin, co-trimoxazole or pentamidine injection
  • some anti-psychotics e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpiride and sertindole
  • lithium and tricyclic anti-depressants e.g. doxepin, maprotiline, amitriptyline
  • certain antihistamines e.g. terfenadine, astemizole, mizolastine
  • anti-malarials e.g. quinine, mefloquine, chloroquine, halofantrine.
  • Moxifloxacin
    • Drugs prolonging QT interval

Co-administration of Amiodarone Taj Pharma with drugs known to prolong the QT interval (such as clarithromycin) must be based on a careful assessment of the potential risks and benefits for each patient since the risk of torsade de pointes may increase and patients should be monitored for QT prolongation.

Concomitant use of Amiodarone Taj Pharma with fluoroquinolones should be avoided (concomitant use with moxifloxacin is contraindicated).

There have been rare reports of QTc interval prolongation, with or without torsades de pointes, in patients taking amiodrone with fluoroquinolones (see section 4.3).

  • Drugs lowering heart rate or causing automaticity or conduction disorders

Combined therapy with the following drugs is not recommended:

  • Beta blockers and heart rate lowering calcium channel inhibitors (diltiazem, verapamil); potentiation of negative chronotropic properties and conduction slowing effects may occur.
  • Agents which may induce hypokalaemia

Combined therapy with the following drugs is not recommended:

  • Stimulant laxatives, which may cause hypokalaemia thus increasing the risk of torsades de pointes; other types of laxatives should be used.

Caution should be exercised over combined therapy with the following drugs which may also cause hypokalaemia and/or hypomagnesaemia, e.g. diuretics, systemi corticosteroids, tetracosactide, intravenous amphotericin.

In cases of hypokalaemia, corrective action should be taken and QT interval monitored. In case of torsades de pointes antiarrhythmic agents should not be given; pacing may be instituted and IV magnesium may be used.

  • General anaesthesia

Caution is advised in patients undergoing general anaesthesia, or receiving high dose oxygen therapy.

Potentially severe complications have been reported in patients taking Amiodarone Taj Pharma undergoing general anaesthesia: bradycardia unresponsive to atropine, hypotension, disturbances of conduction, decreased cardiac output.

A few cases of adult respiratory distress syndrome, sometimes fatal, most often in the period immediately after surgery, have been observed. A possible interaction with a high oxygen concentration may be implicated.

Effect of Amiodarone Taj Pharma on other medicinal products

Amiodarone Taj Pharma and/or its metabolite, desethylAmiodarone Taj Pharma, inhibit CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6 and Pglycoprotein and may increase exposure of their substrates.

Due to the long half-life of Amiodarone Taj Pharma, interactions may be observed for several months after discontinuation of Amiodarone Taj Pharma

  • PgP substrates

Amiodarone Taj Pharma is a P-gp inhibitor. Co administration with P-gp substrates is expected to result in an increase of their exposure:

  • Digitalis: administration of Amiodarone Taj Pharma to a patient already receiving digoxin will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with high digoxin levels. Clinical, ECG and biological monitoring is recommended and digoxin dosage should be halved. A synergistic effect on heart rate and atrioventricular conduction is also possible.
  • Dabigatran: caution should be exercised when Amiodarone Taj Pharma is co administered with dabigatran due to the risk of bleeding. It may be necessary to adjust the dosage of dabigatran as per its label.
  • CYP 2C9 substrates

Amiodarone Taj Pharma raises the plasma concentrations of oral anticoagulants (warfarin) and phenytoin by inhibition of CYP 2C9:

  • Warfarin: the dose of warfarin should be reduced accordingly. More frequent monitoring of prothrombin time both during and after Amiodarone Taj Pharma treatment is recommended.
  • Phenytoin: phenytoin dosage should be reduced if signs of overdosage appear (resulting in neurological signs), and plasma levels may be measured.
  • CYP P450 3A4 substrates

When such drugs are co-administered with Amiodarone Taj Pharma, an inhibitor of CYP 3A4, this may result in a higher level of their plasma concentrations, which may lead to a possible increase in their toxicity:

  • Ciclosporin: plasma levels of ciclosporin may increase as much as 2-fold when used in combination. A reduction in the dose of ciclosporin may be necessary to maintain the plasma concentration within the therapeutic range.
  • Statins: the risk of muscular toxicity (e.g.rhabdomyolysis) is increased by concomitant administration of Amiodarone Taj Pharma with statins metabolised by CYP 3A4 such as simvastatin, atorvastatin and lovastatin. It is recommended to use a statin not metabolised by CYP 3A4 when given with Amiodarone Taj Pharma.
  • Other drugs metabolised by cytochrome P450 3A4: examples of such drugs are lidocaine, tacrolimus, sildenafil, fentanyl, midazolam, triazolam, dihydroergotamine, ergotamine and colchicine.
  • CYP 2D6 substrates
    • Flecainide: given that flecainide is mainly metabolised by CYP 2D6, by inhibiting this isoenzyme, Amiodarone Taj Pharma may increase flecainide plasma levels; it is advised to reduce the flecainide dose by 50% and to monitor the patient closely for adverse effects. Monitoring of flecainide plasma levels is strongly recommended in such circumstances.

Effect of other products on Amiodarone Taj Pharma

CYP3A4 inhibitors and CYP2C8 inhibitors may have a potential to inhibit Amiodarone Taj Pharma metabolism and to increase its exposure.

It is recommended to avoid CYP 3A4 inhibitors during treatment with Amiodarone Taj Pharma.

Grapefruit juice inhibits cytochrome P450 3A4 and may increase the plasma concentration of Amiodarone Taj Pharma. Grapefruit juice should be avoided during treatment with oral Amiodarone Taj Pharma.

Other drug interactions with Amiodarone Taj Pharma (see section 4.4)

Coadministration of Amiodarone Taj Pharma with sofosbuvir in combination with another HCV direct acting antiviral (such as daclatasvir, simeprevir, or ledipasvir) is not recommended as it may lead to serious symptomatic bradycardia. The mechanism for this bradycardia effect is unknown.

If coadministration cannot be avoided, cardiac monitoring is recommended (see section 4.4).

  • Fertility, pregnancy and lactation

Pregnancy:

There are insufficient data on the use of Amiodarone Taj Pharma during pregnancy in humans to judge any possible toxicity.

However, in view of its effect on the foetal thyroid gland, Amiodarone Taj Pharma is contraindicated during pregnancy, except in exceptional circumstances.

If, because of the long half life of Amiodarone Taj Pharma, discontinuation of the drug is considered prior to planned conception, the real risk of reoccurrence of life threatening arrhythmias should be weighed against the possible hazard for the foetus.

Breast-feeding;

Amiodarone Taj Pharma is excreted into the breast milk in significant quantities and breast-feeding is contraindicated.

  • Effects on ability to drive and use machines

The ability to drive or operate machinery may be impaired in patients with clinical symptoms of Amiodarone Taj Pharma-induced eye disorders.

  • Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

  • Very rare:
    • haemolytic anemia
    • aplastic anaemia

In patients taking Amiodarone Taj Pharma there have been incidental findings of bone marrow granulomas. The clinical significance of this is unknown.

Cardiac disorders:

  • Common: bradycardia, generally moderate and dose-related.
  • Uncommon:
    • onset or worsening of arrhythmia, sometimes followed by cardiac arrest (see sections 4.4 and 4.5.)
    • conduction disturbances (sinoatrial block, AV block of various degrees) (see section 4.4)
  • Very rare: marked bradycardia or sinus arrest in patients with sinus node dysfunction and/or in elderly patients.
  • Not known: Torsade de pointes (see sections 4.4 and 4.5.)

Endocrine disorders (see section 4.4):

  • Common:
    • hypothyroidism
    • hyperthyroidism, sometimes fatal
  • Very rare
    • syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Eye disorders:

  • Very common: corneal microdeposits usually limited to the area under the pupil, which are usually only discernable by slit-lamp examinations. They may be associated with colored halos in dazzling light or blurred vision. Corneal micro-deposits consist of complex lipid deposits and are reversible following discontinuation of treatment. The deposits are considered essentially benign and do not require discontinuation of Amiodarone Taj Pharma.
  • Very rare: optic neuropathy/neuritis that may progress to blindness (see section 4.4).

Gastrointestinal disorders:

  • Very common: benign gastrointestinal disorders (nausea, vomiting, dysgeusia) usually occurring with loading dosage and resolving with dose reduction.
  • Common: Constipation
  • Uncommon: Dry mouth
  • Unknown: pancreatitis/acute pancreatitis

General Disorders:

  • Not known: Granuloma, including bone marrow granuloma

Hepato-biliary disorders: (see section 4.4).

  • Very common: isolated increase in serum transaminases, which is usually moderate (1.5 to 3 times normal range), occurring at the beginning of therapy. It may return to normal with dose reduction or even spontaneously.
  • Common: acute liver disorders with high serum transaminases and/or jaundice, including hepatic failure, which are sometimes fatal
  • Very rare: chronic liver disease (pseudo alcoholic hepatitis, cirrhosis), sometimes fatal.

Immune system disorders:

Not known:

  • Angioneurotic oedema (Quincke’s Oedema)
  • Anaphylactic shock/anaphylactoid reaction including shock

Investigations:

Very rare:

  • increase in blood creatinine.

Metabolic and nutrition disorders

Not known:

  • decreased appetite

Musculoskeletal and connective tissue disorders:

Not known:

  • lupus like syndrome

Nervous system disorders:

  • Common:
    • extrapyramidal tremor, for which regression usually occurs after reduction of dose or withdrawal
    • nightmares
    • Sleep disorders.
  • Uncommon: peripheral sensorimotor neuropathy and/or myopathy, usually reversible on withdrawal of the drug (see section 4.4).
  • Very rare:
    • cerebellar ataxia, for which regression usually occurs after reduction of dose or withdrawal
    • benign intracranial hypertension (pseudo- tumor cerebri)
    • headache

Not known:

  • parkinsonism
  • parosmia

Psychiatric disorders:

Not known:

  • confusional state/delirium

Reproductive system and breast disorders:

  • Very rare:
    • epididymo-orchitis

Respiratory, thoracic and mediastinal disorders:

  • Common: pulmonary toxicity [hypersensitivity pneumonitis, alveolar/interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonia (BOOP)], sometimes fatal (see section 4.4).
  • Very rare:
    • bronchospasm in patients with severe respiratory failure and especially in asthmatic patients
    • surgery (possible interaction with a high oxygen concentration) (see sections 4.4 and 4.5).

Pulmonary haemorrhage (there have been some reports of pulmonary haemorrhage, although exact frequencies are not known)

Skin and subcutaneous tissue disorders:

  • Very common: photosensitivity (see section 4.4).
  • Common:
    • eczema,
    • slate grey or bluish pigmentations of light-exposed skin, particularly the face, in case of prolonged treatment with high daily dosages; such pigmentations slowly disappear following treatment discontinuation
  • Very rare:
    • erythema during the course of radiotherapy
    • skin rashes, usually non- specific
    • exfoliative dermatitis
  • Unknown/ Not known:
    • urticarial,
    • severe skin reactions sometimes fatal including toxic epidermal necrolysis (TEN)/ Stevens- Johnson syndrome (SJS),
  • -bullous dermatitis, Drug reaction with eosinophilia and systematic symptoms (DRESS).

Vascular disorders:

  • Very rare: vasculitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Little information is available regarding acute overdosage with Amiodarone Taj Pharma. Few cases of sinus bradycardia, heart block, attacks of ventricular tachycardia, torsades de pointes, circulatory failure and hepatic injury have been reported.

In the event of overdose treatment should be symptomatic, gastric lavage may be employed to reduce absorption in addition to general supportive measures. The patient should be monitored and if bradycardia occurs beta-adrenostimulants or glucagon may be given. Spontaneously resolving attacks of ventricular tachycardia may also occur. Due to the pharmacokinetics of Amiodarone Taj Pharma, adequate and prolonged surveillance of the patient, particularly cardiac status, is recommended. Neither Amiodarone Taj Pharma nor its metabolites are dialysable.

  1. Pharmacological properties
    • Pharmacodynamic properties

Pharmacotherapeutic group: Amiodarone Taj Pharma hydrochloride is an antiarrhythmic.

Paediatric population

No controlled paediatric studies have been undertaken.

In published studies the safety of Amiodarone Taj Pharma was evaluated in 1118 paediatric patients with various arrhythmias. The following doses were used in paediatric clinical trials.

  • Oral
  • Loading dose: 10 to 20mg/kg/day for 7 to 10 days (or 500mg/m2/day if expressed per square meter)
  • Maintenance dose: the minimum effective dosage should be used; according to individual response, it may range between 5 to 10mg/kg/day (or 250mg/m2/day if expressed per square meter)
  • Intravenous
    • Loading dose: 5mg/kg body weight over 20 minutes to 2 hours
    • Maintenance dose: 10 to 15mg/kg/day from a few hours to several days

If needed, oral therapy may be initiated concomitantly at the usual loading dose.

  • Pharmacokinetic properties

Amiodarone Taj Pharma is strongly protein bound and the plasma half-life is usually of the order of 50 days. However there may be considerable inter-patient variation; in individual patients a half life of less than 20 days and a half life of more than 100 days has been reported. High doses of Amiodarone Taj Pharma, for example 600mg / day should be given initially to achieve effective tissue levels as rapidly as possible. Owing to the long half-life of the drug, a maintenance dose of only 200mg / day, or less is usually necessary. Sufficient time must be allowed for a new distribution equilibrium to be achieved between adjustments of dose.

The long half-life is a valuable safeguard for patients with potentially lethal arrhythmias as omission of occasional doses does not significantly influence the protection afforded by Amiodarone Taj Pharma.

No controlled paediatric studies have been undertaken. In the limited published data available in paediatric patients, there were no differences noted compared to adults.

Amiodarone Taj Pharma is metabolised mainly by CYP3A4, and also by CYP2C8. Amiodarone Taj Pharma and its metabolite, desethylAmiodarone Taj Pharma, exhibit a potential in vitro to inhibit CYP1A1, CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP2A6, CYP2B6 and 2C8. Amiodarone Taj Pharma and desethylAmiodarone Taj Pharma have also a potential to inhibit some transporters such as Pgp and organic cation transporter (OCT2) (One study shows a 1.1% increase in concentration of creatine (a OCT 2 substrate). In vivo data describe Amiodarone Taj Pharma interactions on CYP3A4, CYP2C9, CYP2D6 and Pgp substrates.

  • Preclinical safety data

In a 2-years carcinogenicity study in rats, Amiodarone Taj Pharma caused an increase in thyroid follicular tumours (adenomas and/or carcinomas) in both sexes at clinical relevant exposures. Since mutagenicity findings were negative, an epigenic rather than genotoxic mechanism is proposed for this type of tumour induction. In the mouse, carcinomas were not observed, but a dose-dependent thyroid follicular hyperplasia was seen. These effects on the thyroid in rats and mice are most likely due to effects of Amiodarone Taj Pharma on the synthesis and/or release of thyroid gland hormones. The relevance of these findings to man is low.

  1. Pharmaceutical particulars
    • List of excipients

Lactose Monohydrate, Povidone K 90, Colloidal Anhydrous Silica, Magnesium Stearate, Pregelatinised Starch

  • Incompatibilities

Not applicable

  • Shelf life

36 months

  • Special precautions for storage

Do not store above 25°C. Store in the original package.

  • Nature and contents of container

Amiodarone Taj Pharma tablets are packed in blister composed of clear transparent or opaque white PVC (250 micron) and backing aluminium foil of 20 micron or 25 micron

  • Special precautions for disposal and other handling

No special requirements

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Amiodarone Tablets USP 200mg Taj Pharma
(Amiodarone Hydrochloride)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Amiodarone Taj Pharma Tablets are and what they are used for
  2. What you need to know before you take Amiodarone Taj Pharma Tablets
  3. How to take Amiodarone Taj Pharma Tablets
  4. Possible side effects
  5. How to store Amiodarone Taj Pharma Tablets
  6. Contents of the pack and other information

1. WHAT AMIODARONE TAJ PHARMA TABLETS ARE AND WHAT THEY ARE USED FOR

Amiodarone Taj Pharma 100mg or 200mg Tablets (called Amiodarone Taj Pharma Tablets in this leaflet) contain a medicine called Amiodarone Taj Pharma hydrochloride. This belongs to a group of medicines called anti-arrhythmics.

It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablets helps your heartbeat to return to normal.

Amiodarone Taj Pharma Tablets can be used to:

  • Treat uneven heartbeats where other medicines either have not worked or cannot be used
  • Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast
  • Treat other types of fast or uneven heartbeats known as ”atrial flutter” or ”atrial fibrillation”.
  • Amiodarone Taj Pharma Tablets are used only when other medicines can not be used.
    • Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Taj Pharma Tablets are used only when other medicines cannot be used.
  1. What you need to know before you take Amiodarone Taj Pharma Tablets

Do not take Amiodarone Taj Pharma Tablets if

  • you are allergic (hypersensitive) to iodine , Amiodarone Taj Pharma hydrochloride or any of the other ingredients of Amiodarone Taj Pharma Tablets ( see section 6 ).Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • you have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sinoatrial’ heart block
  • you have any other problems with your heartbeat and do not have a pacemaker fitted
  • you have ever had thyroid problems. Your doctor should test your thyroid before giving you this medicine
  • you are taking certain other medicines which could affect your heartbeat (see ‘Taking other medicines’ below)
  • you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)

Do not take this medicine if any of the above applies to you.

If you are not sure, talk to your doctor or pharmacist before taking Amiodarone Taj Pharma Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Amiodarone Taj Pharma Tablets if:

  • you have heart failure
  • you have liver problems
  • you have any problems with your lungs or have asthma
  • you have any problems with your eyesight. This includes an illness called ‘optic neuritis’
  • you are about to have an operation
  • you are elderly (over 65 years of age). The doctor will need to monitor you more carefully
  • you have a pacemaker or implantable cardioverter defibrillator (ICD). Your doctor will check that your device is working properly shortly after you start taking the tablets or if your dose is changed.
  • You have blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome
  • You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles
  • (Toxic Epidermal Necrolysis)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiodarone Taj Pharma Tablets.

Other medicines and Amiodarone Taj Pharma Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Amiodarone Taj Pharma Tablets can affect the way some other medicines work. Also some medicines can affect the way Amiodarone Taj Pharma Tablets works.

In particular, do not take this medicine and tell your doctor, if you are taking:

  • Other medicines for an uneven heartbeat (such as sotalol, quinidine, procainamide,
  • disopyramide or bretylium).
  • Medicines for infections (such as injectable erythromycin, co-trimoxazole, moxifloxacin or
  • pentamidine)
  • Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpiride or sertindole)
  • Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline)
  • Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine)
  • Medicines used for hay fever, rashes or other allergies called antihistamines (such as
  • terfenadine, astemizole or mizolastine)
  • Medicines for hepatitis C treatment (such as sofosbuvir, daclatasvir, simeprevir or ledispasvir)

Tell your doctor if you are taking any of the following medicines:

  • Medicines that lengthen your heart beat (the QT interval) such as medicines for infection (such as clarithromycin, ciprofloxacin, ofloxacin or levofloxacin)
  • Medicines for heart problems called beta-blockers (such as propranolol)
  • Medicines called calcium channel blockers – for chest pain (angina) or high blood pressure (such as diltiazem or verapamil)
  • Medicines for constipation (laxatives) such as bisacodyl or senna
  • Medicines for high cholesterol (statins) such as simvastatin or atorvastatin
    • The following medicines can increase the chance of you getting side effects, when taken with Amiodarone Taj Pharma Tablets :
  • Amphotericin (when given directly into a vein) – used for fungal infections
  • Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone
  • Water tablets (diuretics)
  • General anaesthetics or high dose oxygen – used during surgery
  • Tetracosactide – used to test some hormone problems
    • Amiodarone Taj Pharma Tablets may increase the effect of the following medicines:
  • Ciclosporin and tacrolimus – used to help prevent rejection of transplants
  • Medicines for impotence such as sildenafil, tadalafil or vardenafil
  • Fentanyl – used for pain relief
  • Ergotamine – used for migraines
  • Midazolam – used to relieve anxiety or to help you relax before surgery
  • Colchicine – used for the treatment of gout
  • Flecainide – another medicine used for uneven heartbeats. Your doctor should monitor your treatment and may half your dose of Flecainide
    • Lidocaine – used as an anaesthetic
    • Warfarin – used to stop your blood from clotting
    • Digitalis – used for some heart conditions
    • Dabigatran- used to thin the blood

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiodarone Taj Pharma Tablets.

Amiodarone Taj Pharma Tablets with food,drink and alcohol

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking Amiodarone Taj Pharma Tablets can increase your chance of getting side effects.

Limit the amount of alcohol you drink while taking this medicine. This is because drinking alcohol while taking this medicine will increase the chance of you having problems with your liver.

Talk to your doctor or pharmacist about the amount of alcohol you can drink.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for a few months after you have finished taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

  • Make sure you use high factor sun cream
  • Always wear a hat and clothes which cover your arms and legs

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • Amiodarone Taj Pharma Tablets are normally not given during pregnancy
  • Do not take if you are breast-feeding or plan to breast-feed. This is because small amounts of this medicine may pass into the mother’s milk
  • Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

You may have blurred eyesight after taking this medicine. If this happens, do not drive or use any tools or machines.

Amiodarone Taj Pharma Tablets contains Lactose and Iodine

This medicine contains:

  • Lactose (a type of sugar): If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine
  • Iodine: Amiodarone Taj Pharma Tablets contain 37.5mg of iodine in a 100mg tablet and 75mg of iodine in a 200mg tablet. Iodine is present in Amiodarone Taj Pharma hydrochloride, the medicine your tablets contain. Iodine can cause problems to your thyroid (see ‘Tests’ below)
  1. How to take Amiodarone Taj Pharma tablets

Always take Amiodarone Taj Pharma Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • Take this medicine by mouth
  • Swallow the tablets whole. Do not crush or chew your tablets
  • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

How much to take

Adults

  • The usual starting dose is 200mg (one 200mg or two 100mg Amiodarone Taj Pharma Tablets ) three times each day for one week
  • The dose will then be lowered to 200mg twice each day for one week
  • The dose will then be lowered to 200mg once each day, until you are told otherwise
  • In some cases, your doctor may then decide to either increase or lower the amount you take each day. This will depend on how you react to this medicine

Use in children and adolescents

  • Amiodarone Taj Pharma tablets should not be given to children and adolescents.

Elderly

  • The doctor may give you a lower dose of Amiodarone Taj Pharma Tablets . Also, the doctor should check your blood pressure and thyroid function regularly

If you take more Amiodarone Taj Pharma Tablets than you should

If you take more Amiodarone Taj Pharma Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor will know what you have taken.

The following effects may happen: feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.

If you forget to take Amiodarone Taj Pharma Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Amiodarone Taj Pharma Tablets

Keep taking Amiodarone Taj Pharma Tablets until your doctor tells you to stop. Do not stop taking Amiodarone Taj Pharma Tablets just because you feel better. If you stop taking this medicine the uneven heartbeats may come back. This could be dangerous.

Tests

  • Your doctor may do regular thyroid tests while you are taking this medicine. This is because
  • Amiodarone Taj Pharma Tablets contain iodine which can cause problems to your thyroid.
  • Your doctor may also do other regular tests such as blood tests, chest X-rays, ECG (electrical test of your heartbeat) and eye tests both before and while you are taking Amiodarone Taj Pharma Tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, Amiodarone Taj Pharma Tablets can cause side effects, although not everybody gets them.

The active ingredient in Amiodarone Taj Pharma Tablets may stay in your blood for up to a month after stopping treatment.

You may still get side effects in this time.

Stop taking Amiodarone Taj Pharma Tablets and see a doctor or go to a hospital straight away if:

  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swollen eyelids, face, lips, throat or tongue
  • You have blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome
  • You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles
  • (Toxic Epidermal Necrolysis)
  • You have inflammation of the skin characterised by fluid filled blisters (bullous dermatitis)
  • You have flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS)

Common (may affect up to 1 in 10 people)

  • You get yellowing of the skin or eyes (jaundice) feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous
  • Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous

Uncommon (may affect up to 1 in 100 people)

  • Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away
  • Very rare (may affect up to 1 in 10,000 people)
  • You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy or neuritis’
  • Your heartbeat becomes very slow or stops beating. If this happens, go to hospital straight away

Stop taking Amiodarone Taj Pharma Tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

  • Feeling numb or weak, tingling or burning feelings in any part of your body

Very rare (may affect up to 1 in 10,000 people)

  • Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)
  • Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea) fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain.
  • Moving unsteadily or staggering, slurred or slow speech
  • Feeling faint, dizzy, unusually tired and short of breath. These could be signs of a very slow heartbeat (especially in people over 65 years old) or other problems with your heart’s natural beat

Not Known (frequency cannot be estimated from the available data):

  • Chest pain and shortness of breath and irregular heartbeat. These could be signs of a condition called “Torsade de pointes”

Some cases of bleeding in the lungs have been reported in patients taking Amiodarone Taj Pharma Tablets. You should tell your doctor straight away if you cough up any blood.

Tell your doctor as soon as possible if you have any of the following side effects:

Very common (may affect more than 1 in 10 people)

  • Blurred eyesight or seeing a coloured halo in dazzling light
    • Common (may affect up to 1 in 10 people)
  • Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called ‘hyper-thyroidism’
  • Feeling extremely tired, weak or ‘run-down’, weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called ‘hypo-thyroidism’
  • Trembling when you move your arms or legs
  • Blue or grey marks on parts of your skin exposed to sunlight, especially the face

Uncommon (may affect up to 1 in 100 people)

  • Muscle cramps, stiffness or spasm
  • Very rare (may affect up to 1 in 10,000 people)
  • Swelling of the testicles
  • Red, scaly patches of skin, loss of hair or loosening of nails (called ‘exfoliative dermatitis’)
  • Feeling tired, faint, dizzy or having pale skin. These could be signs of anaemia
  • You may bleed or bruise more easily than usual. This could be because of a blood disorder (called‘thrombocytopenia’)
  • Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)

Not known (frequency cannot be estimated from the available data)

  • Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (may affect more than 1 in 10 people).

  • Feeling sick (nausea) or being sick (vomiting)
  • Change in the way things taste
  • Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests
  • Burning more easily in the sun (see ‘Protect your skin from sunlight’ in Section 2)

Common (may affect up to 1 in 10 people)

  • Slightly slower heart beat
  • Nightmares
  • Problems sleeping
  • Constipation
  • Scaly and itchy rash (eczema)

Uncommon (may affect up to 1 in 100 people)

  • Dry mouth

Very rare (may affect up to 1 in 10,000 people)

  • Headache
  • Balance problems, feeling dizzy (vertigo)
  • Difficulty in getting or maintaining an erection or in ejaculating
  • Hair loss, balding
  • Skin rash
  • Skin redness during radio-therapy

Not known (frequency cannot be estimated from the available data)

  • Hives (itchy, lumpy rash)
  • Granulomas, small red lumps on the skin or inside the body which are seen by X-ray
  • Feeling less hungry
  • Movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs (Parkinsonism)
  • Feeling confused or seeing or hearing things that are not there
  • A distorted sense of smell (parosmia)
  • Joint pain and muscle pain , fatigue, inflammation of the tissues lining the heart and lungs (Lupus like syndrome)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects, you can help provide more information on the safety of this medicine.

  1. How to store Amiodarone Taj Pharma Tablets

Do not store above 25°C. Store in the original package.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton.The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Amiodarone Taj Pharma Tablet contain

  • The active substance is Amiodarone Taj Pharma hydrochloride .
  • The other ingredients are lactose monohydrate, povidone K 90, pregelatinised starch, colloidal anhydrous silica and magnesium stearate (see section 2 for Important information about some of the ingredients of Amiodarone Taj Pharma Tablets).

What Amiodarone Taj Pharma Tablets look like and contents of the pack

Amiodarone Taj Pharma 100mg, 200mg and 400mg Tablets are white to off white, uncoated tablets with Amiodarone Taj Pharma 100mg, 200mg and 400mg tablets are available in Alu-Alu and blister pack of 10, 15, 30,  tablets.

Not all pack size may be marketed.

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

 

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