1. Name of the medicinal product

Diltiazem Hydrochloride Tablets USP 30mg Taj Pharma
Diltiazem Hydrochloride Tablets USP 60mg Taj Pharma
Diltiazem Hydrochloride Tablets USP 90mg Taj Pharma
Diltiazem Hydrochloride Tablets USP 120mg Taj Pharma

  1. Qualitative and quantitative composition

a) Diltiazem Hydrochloride Tablets 30mg Taj Pharma
Each uncoated tablet contains:
Diltiazem Hydrochloride USP 30mg
Excipients: Q.S.

b) Diltiazem Hydrochloride Tablets 60mg Taj Pharma
Each uncoated tablet contains:
Diltiazem Hydrochloride USP 60mg
Excipients: Q.S.

c) Diltiazem Hydrochloride Tablets 90mg Taj Pharma
Each uncoated tablet contains:
Diltiazem Hydrochloride USP 90mg
Excipients: Q.S.

d) Diltiazem Hydrochloride Tablets 120mg Taj Pharma
Each uncoated tablet contains:
Diltiazem Hydrochloride USP 120mg
Excipients: Q.S.

Excipient(s) with known effect: Each tablet contains 111.50mg lactose and 42.00mg hydrogenated castor oil.

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

White uncoated modified-release tablets.

  1. Clinical particulars
    • Therapeutic indications

1) Prevention and long term treatment of angina pectoris. NOT indicated for acute attacks of angina.

2) Treatment of mild to moderate arterial hypertension.

  • Posology and method of administration

Posology

Adults:

The usual maintenance dose is one tablet (60mg) three times daily. However, patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the dosage may be increased to 360mg/daily. Higher doses of up to 480mg/daily have been used with benefit in some patients, especially in unstable angina. There is no evidence of any decrease in efficacy at these high doses.

Elderly and patients with impaired renal function:

The recommended starting dose is one tablet (60mg) twice daily. The heart rate should be measured regularly in these groups of patients and the dose should not be increased if the heart rate falls below 50 beats/minute.

Paediatric population:

Not recommended.

Method of Administration

For oral administration. Tablets should be swallowed whole with a little water.

  • Contraindications
  • Hypersensitivity to Diltiazem Taj Pharma or to any of the excipients listed in section 6.1
  • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker
  • pregnancy; women of child-bearing potential
  • Breast-feeding
  • congestive heart failure
  • severe aortic stenosis
  • cardiogenic shock
  • severe hypotension (systolic Blood Pressure less than 90mmHg)
  • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker
  • Severe bradycardia (less than 50 beats per minute)
  • Left ventricular failure with pulmonary congestion
  • Concomitant use of dantrolene infusion (see section 4.5)
  • Combination with ivabradine (see section 4.5)Acute porphyria.

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.

Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) prolonged PR interval, or with a first degree AV block detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).

Prior to general anaesthesia, the anaesthesist must be informed of ongoing Diltiazem Taj Pharma treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.

Increase of plasma concentrations of Diltiazem Taj Pharma may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.

Treatment with Diltiazem Taj Pharma may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.

Diltiazem Taj Pharma has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk of developing an intestinal obstruction. Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose.

The use of Diltiazem Taj Pharma may induce bronchospasm, including asthma aggravation, especially in patients with pre-existing bronchial hyper-reactivity. Cases have also been reported after dose increase. Patients should be monitored for signs and symptoms of respiratory impairment during Diltiazem Taj Pharma therapy. Tablet residues from slow release formulations of the product may pass into the patient’s stools; however, this finding has no clinical relevance.

  • Interaction with other medicinal products and other forms of interaction

Concomitant use contraindicated:

  • Dantrolene (infusion): Lethal ventricular fibrillation is regularly observed in animals when intravenous verapamil and dantrolene are administered concomitantly. The combination of a calcium antagonist and dantrolene is therefore potentially dangerous (see section 4.3).
  • Concomitant use with ivabradine is contraindicated due to the additional heart rate lowering effect of Diltiazem Taj Pharma to ivabradine (see section 4.3)

Concomitant use requiring caution:

  • Lithium: Risk of increase in lithium-induced neurotoxicity
  • Nitrate derivatives: Increased hypotensive effects and faintness (additive vasodilatating effects): In all the patients treated with calcium antagonists, the prescription of nitrate derivatives should only be carried out at gradually increasing doses.
  • Theophylline: Increase in circulating theophylline levels.
  • Alpha-antagonists: Increased antihypertensive effects: concomitant treatment with alpha-antagonists may produce or aggravate hypotension. The combination of Diltiazem Taj Pharma with an alpha-antagonist should be considered only with the strict monitoring of the blood pressure.
  • Amiodarone, digoxin: Increased risk of bradycardia: caution is required when these are combined with Diltiazem Taj Pharma, particularly in elderly subjects and when high doses are used. In common with other calcium antagonists Diltiazem Taj Pharma may cause small increases in plasma levels of digoxin.
  • Beta-blockers: Possibility of rhythm disturbances (pronounced bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure (synergistic effect). Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment.
  • The blood levels of beta blockers with a low bioavailability (egpropranolol) may be increased and small increases in the plasma levels of digitalis glycosides have been observed.
  • Other antiarrhythmic agents: since Diltiazem Taj Pharma has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended (additive risk of increased cardiac adverse effects). This combination should only be used under close clinical and ECG monitoring.
  • Carbamazepine: Increase in circulating carbamazepine levels: It is recommended that the plasma carbamazepine concentrations be assayed and that the dose should be adjusted if necessary.
  • Rifampicin: Risk of decrease of Diltiazem Taj Pharma plasma levels after initiating therapy with rifampicin: The patient should be carefully monitored when initiating or discontinuing rifampicin treatment.
  • Anti-H2agents (cimetidine, ranitidine): Increase in plasma Diltiazem Taj Pharma concentrations. Patients currently receiving Diltiazem Taj Pharma therapy should be carefully monitored when initiating or discontinuing therapy with H2 An adjustment in Diltiazem Taj Pharma daily dose may be necessary.
  • Ciclosporin: Increase in circulating ciclosporin levels: It is recommended that the ciclosporin dose be reduced, renal function be monitored, circulating ciclosporin levels be assayed and that the dose should be adjusted during combined therapy and after its discontinuation.

General information to be taken into account:

  • Due to the potential for additive effects, caution and careful titration are necessary in patients receiving Diltiazem Taj Pharma concomitantly with other agents known to affect cardiac contractility and/or conduction.
  • Diltiazem Taj Pharma is metabolized by CYP3A4. A moderate (less than 2-fold) increase of Diltiazem Taj Pharma plasma concentration in cases of co-administration with a stronger CYP3A4 inhibitor has been documented. Diltiazem Taj Pharma is also a CYP3A4 isoform inhibitor. Co-administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co-administered drug. Co-administration of Diltiazem Taj Pharma with a CYP3A4 inducer may result in a decrease of Diltiazem Taj Pharma plasma concentrations.
  • Benzodiazepines (midazolam, triazolam): Diltiazem Taj Pharma significantly increases plasma concentrations of midazolam and triazolam and prolongs their half-life. Special care should be taken when prescribing short-acting benzodiazepines metabolized by the CYP3A4 pathway in patients using Diltiazem Taj Pharma.
  • Corticosteroids (methylprednisolone): Inhibition of methylprednisolone metabolism (CYP3A4) and inhibition of P-glycoprotein: The patient should be monitored when initiating methylprednisolone treatment. An adjustment in the dose of methylprednisolone may be necessary.
  • Statins: Diltiazem Taj Pharma is an inhibitor of CYP3A4 and has been shown to significantly increase the AUC of some statins. The risk of myopathy and rhabdomyolysis due to statins metabolised by CYP3A4 may be increased with concomitant use of Diltiazem Taj Pharma. When possible, a non CYP3A4-metabolised statin should be used together with Diltiazem Taj Pharma, otherwise close monitoring for signs and symptoms of a potential statin toxicity is required.
  • Diltiazem Taj Pharma increases plasma concentration of imipramine and possibly other tricyclic antidepressants.
  • Drugs that increase hepatic microsomal activity (egphenobarbital) lead to decreased plasma Diltiazem Taj Pharma levels.
  • Diltiazem Taj Pharma has been used safely in combination with diuretics. It is recommended that patients receiving these combinations should be regularly monitored.
  • Diltiazem Taj Pharma hydrochloride treatment has been continued without problem during anaesthesia, but the anaesthetist should be informed that the patient is receiving a calcium antagonist. (see section 4.4)
  • There is a possibility that calcium channel blockers may occasionally impair glucose tolerance.
  • Phenytoin: When co-administered with phenytoin, Diltiazem Taj Pharma may increase phenytoin plasma concentration. It is recommended that the phenytoin plasma concentrations be monitored.
  • X-Ray contrast Media: Cardiovscular effects of an intravenous bolus of an ionic X-ray contrast media, such as hypotension, may be increased in patireds treated with Diltiazem Taj Pharma. Special caution is required in paitents who concomitantly receive Diltiazem Taj Pharma and X-ray contrast media.
  • Antiplatelet drugs: In a pharmacodynamics study, Diltiazem Taj Pharma was shown to inhibit platelet aggregation. Although the clinical significance of this finding is unknown, potential additive effects when used with antiplatelet drugs should be considered.
    • Pregnancy and lactation

Pregnancy

There is very limited data from the use of Diltiazem Taj Pharma in pregnant patients. Diltiazem Taj Pharma has been shown to have reproductive toxicity in certain animal species (rat, mice, rabbit). Diltiazem Taj Pharma is therefore not recommended during pregnancy, as well as in women of childbearing potential not using effective contraception.

Breast-feeding

Diltiazem Taj Pharma is excreted in breast milk at low concentrations. Breast-feeding while taking this drug should be avoided. If use of Diltiazem Taj Pharma is considered medically essential, an alternative method of infant feeding should be instituted.

  • Effects on ability to drive and use machines

On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.

  • Undesirable effects

The following CIOMS frequency rating is used, when applicable: 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).

Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Very commonCommonUncommonRareNot known
Blood and lymphatic system disordersThrombocytopenia
Psychiatric disordersNervousness, insomniaMood changes (including depression)
Nervous system disordersHeadache, dizzinessExtrapyramidal syndrome
Cardiac disordersAtrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitationsBradycardiaSinoatrial block, congestive heart failure, sinus arrest, cardiac arrest (asystole)
Vascular disordersFlushingOrthostatic hypotensionVasculitis (including leukocytoclastic vasculitis)
Gastrointestinal disordersConstipation, dyspepsia, gastric pain, nauseaVomiting, diarrhoeaDry mouthGingival hyperplasia
Hepatobiliary disordersHepatic enzymes increase (AST, ALT, LDH, ALP increase)Hepatitis
Skin and subcutaneous tissue disordersErythemaUrticariaPhotosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson’s syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever
Reproductive system and breast disordersGynecomastia
General disorders and administration site conditionsPeripheral oedemaMalaise

The current literature suggests that the effects of vasodilation particularly ankle oedema are dose dependent and are more frequent in the elderly.

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

Symptoms

The clinical effects of acute overdose can involve pronounced hypotension possibly leading to collapse, sinus bradycardia with or without isorhythmic dissociation, sinus arrest, atrioventricular conduction disturbances and cardiac arrest.

Treatment

Treatment, in a hospital setting, will include gastric lavage and/or osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing. Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Calcium channel blockers; Benzothdiazepine derivatives, Diltiazem Taj Pharma is a calcium antagonist. It restricts the slow channel entry of calcium into the cell and so reduces the liberation of calcium from stores in the sarcoplasmic reticulum. This results in a reduction of the amount of available intracellular calcium reducing myocardial oxygen consumption. It increases exercise capacity and improves all indices of myocardial ischaemia in the angina patient.

Diltiazem Taj Pharma relaxes large and small coronary arteries and relieves the spasm of vasospastic (prinzmetals) angina and the response to catecholamines but has little effect on the peripheral vasculature. There is therefore no possibility of reflex tachycardia. A small reduction in heart rate occurs which is accompanied by an increase in cardiac output, improved myocardial perfusion and reduction of ventricular work.

In animal studies, Diltiazem Taj Pharma protects the myocardium against the effects of ischaemia and reduces the damage produced by excessive entry of calcium into the myocardial cell during reperfusion.

  • Pharmacokinetic properties

Diltiazem Taj Pharma hydrochloride is effective in angina, protecting the heart against ischaemia, vasodilating coronary arteries and reducing myocardial oxygen requirements. It is well tolerated and does not generally give rise to side effects associated with peripheral vasodilators, nor cause significant myocardial depression.

Diltiazem Taj Pharma is well absorbed (90%) in healthy volunteers following oral administration.

Peak plasma concentrations occur 3 to 4 hours after dosing.

Due to a first pass effect, the bioavailability of the 60mg tablet is about 40 %. The mean apparent plasma half-life is 4- 8 hours.

Diltiazem Taj Pharma is 80 to 85% bound to plasma proteins. It is extensively metabolised by the liver.

The major circulating metabolite, N-monodesmethyl Diltiazem Taj Pharma accounts for approximately 35% of the circulating Diltiazem Taj Pharma.

Less than 5% of Diltiazem Taj Pharma is excreted unchanged in the urine.

There is a linear relationship between dose and plasma concentration. During long term administration to any one patient, plasma concentrations of Diltiazem Taj Pharma remain constant.

Mean plasma concentrations in elderly subjects and patients with renal and hepatic insufficiency are higher than in young subjects.

Diltiazem Taj Pharma and its metabolites are poorly dialysed.

  • Preclinical safety data

Pregnancy: Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials (480mg q.d. or 8mg/kg q.d. for a 60-kg patient) resulted in embryo and fetal lethality. These studies revealed, in one species or another, a propensity to cause fetal abnormalities of the skeleton, heart, retina, and tongue. Also observed were reductions in early individual pup weights, pup survival, as well as prolonged delivery times and an increased incidence of stillbirths.

  1. Pharmaceutical particulars
    • List of excipients

Also contains: castor oil, lactose, magnesium stearate, polyethylene glycol.

  • Incompatibilities

None known.

  • Shelf life

Three years from the date of manufacture.

  • Special precautions for storage

Blister packs:

Do not store above 25°C.
Store in the original package.
Keep container in the outer carton

Polypropylene containers, polyethylene containers and amber glass bottles:

Do not store above 25°C.
Store in the original container.
Keep the container tightly closed

  • Nature and contents of container

The product may supplied in blister packs and cartons:

  1. a) Carton:
  2. b) Blister PVC Pack

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s

Not all pack sizes may be marketed

Special precautions for disposal and other handling

Not applicable.

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

Diltiazem Hydrochloride Tablets USP 30mg Taj Pharma

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 symptoms are the same as yours.
  • If you get any side effects, talk to your 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 Diltiazem Taj Pharma Hydrochloride tablets are and what they are used for
  2. What you need to know before you take Diltiazem Taj Pharma Hydrochloride tablets
  3. How to take Diltiazem Taj Pharma Hydrochloride tablets
  4. Possible side effects
  5. How to store Diltiazem Taj Pharma Hydrochloride tablets
  6. Contents of the pack and other information

1.What Diltiazem Taj Pharma Hydrochloride tablets are and what they are used for

Diltiazem Taj Pharma Hydrochloride tablets belong to a group of medicines called calcium channel blockers.
Diltiazem Taj Pharma Hydrochloride tablets are used to:

  • treat (long-term) and prevent angina pectoris
  • treat mild to moderate high blood pressure.
  1. What you need to know before you take Diltiazem Taj Pharma Hydrochloride tablets

Do not take Diltiazem Taj Pharma Hydrochloride tablets if you

  • are allergic (hypersensitive) to Diltiazem Taj Pharma hydrochloride or any of the other ingredients in Diltiazem Taj Pharma Hydrochloride tablets (see section 6).
  • are pregnant, are a woman of child bearing age or you are breast-feeding.
  • have severe low blood pressure.
  • have a heart condition such as; a severe slow heart beat (bradycardia), disturbances in heart rhythm causing palpitations or fainting (sick sinus syndrome) not requiring a pacemaker, heart failure with reduced blood flow, congestive heart failure, second or third degree heart block without a functioning pacemaker, narrowing of the opening of the aortic valve in the heart (aortic stenosis), shock caused by heart problems (cardiogenic shock),
  • have an inherited disorder of the red blood pigment haemoglobin, causing skin blisters, abdominal pain and nervous system disorders (porphyria).
  • are already taking a medicine containing ivabradine for the treatment of certain heart diseases
Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Diltiazem Taj Pharma Hydrochloride tablets if you:

  • have impaired liver function.
  • have impaired kidney function
  • have depression
  • are likely to have surgery which requires a general anaesthetic
  • have problems with your stomach or intestines
  • have heart problems including a slow heartbeat, first degree heart block, a change in the electrical activity of the heart (prolonged PR interval).
  • have diabetes. The treatment for your diabetes may need to be adjusted, as Diltiazem Taj Pharma Hydrochloride tablets may impair glucose tolerance.

Other medicines and Diltiazem Taj Pharma Hydrochloride tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,

Especially:

  • dantrolene infusion (a muscle relaxant)
  • antiarrhythmic drugs such as amiodarone (used to treat an irregular heart beat)
  • antihypertensives (used to lower blood pressure)
  • lithium (used for mental health problems)
  • nitrates such as glyceryl trinitrate or isosorbide mononitrate (used to treat angina)
  • midazolam or triazolam (used for sedation and anaesthesia)
  • rifampicin (used to treat tuberculosis)
  • imipramine and other tricyclic antidepressants (used for depression)
  • phenobarbital, phenytoin or carbamazepine (to treat epilepsy)
  • ciclosporin (used to suppress immune system e.g. after organ transplantation)
  • theophylline (used in breathing problems such as asthma)
  • digitalis glycosides e.g. digoxin (used for some heart conditions)
  • beta blockers such as propranolol (used for some heart problems)
  • H2 antagonists e.g. cimetidine (used to treat conditions caused by excess acid such as stomach ulcers)
  • diuretics (water tablets)
  • alpha blockers such as prazosin
  • anaesthetics
  • aspirin or clopidogrel (anti platelet medicines used to reduce the chance of blood clots forming)
  • Iodinated contrast media (used for tests involving x-rays)
  • statins, e.g. simvastatin (used to treat high cholesterol)
  • corticosteroids (used to treat inflammation).

Pregnancy, breast-feeding and fertility

Do not take Diltiazem Taj Pharma Hydrochloride tablets if you are pregnant, planning to become pregnant, are a woman of child bearing age or if you are breast-feeding. Speak to your doctor before taking any medicine.

Driving and using machines

Diltiazem Taj Pharma tablets may cause dizziness or tiredness, therefore make sure you are not affected before driving or operating machinery

Diltiazem Taj Pharma Hydrochloride tablets contain lactose

If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Diltiazem Taj Pharma Hydrochloride tablets contain hydrogenated castor oil

Hydrogenated castor oil may cause stomach upset and diarrhoea.

Tests

If you have impaired kidney or liver function, your doctor may want to monitor you by carrying out tests.

3. How to take Diltiazem Taj Pharma Hydrochloride tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adult

The maintenance dose is one tablet (60mg) three times a day. Up to 8 tablets (480mg) a day may be used. Your doctor will decide on the best dose for you.

Elderly and those with impaired kidney function

Initially one tablet (60mg) twice a day. Your doctor may adjust the dose according to your response.

Use in children

Not recommended.

Taking the tablets

  • Swallow the tablets whole with a little water.
  • After all the drug has been released from the tablet, the empty shell may pass into the stools. This is normal and does not affect the action of the product.

If you take more Diltiazem Taj Pharma Hydrochloride tablets than you should

Do not take more tablets than your doctor tells you to. If you take too many go to the nearest hospital casualty department or tell your doctor at once. Take the container and any remaining tablets with you. An overdose may lead to severe low blood pressure leading to collapse, and a slow heart beat which may be accompanied by changes in heart rhythm and conduction.

If you forget to take Diltiazem Taj Pharma Hydrochloride tablets

If you forget to take a dose, take one as soon as you remember.
Then go on as before. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor at once, if you have an allergic reaction such as swelling of the face, lips, tongue, mouth or throat, which may cause shortness of breath or difficulty swallowing.

Tell your doctor if you notice any of the following side effects.

Very common: may affect more than 1 in 10 people: water retention causing swelling.

Common: may affect up to 1 in 10 people: headache, dizziness, heart block, palpitations, flushing, constipation, indigestion,stomach pain, feeling sick, skin redness, feeling of general discomfort or illness.

Uncommon: may affect up to 1 in 100 people: nervousness, difficulty sleeping, slow heart beat, feeling faint when getting up due to low blood pressure, being sick, diarrhoea, increase in liver enzymes (as seen in blood tests).

Rare: may affect up to 1 in 1,000 people: dry mouth, itchy skin rash with pale or red irregular raised patches.

Not known: frequency cannot be estimated from the available data: lowered number of platelets in the blood (as seen in blood tests), changes in mood (including depression), inflammation of the liver causing yellowing of the skin or eyes (hepatitis), heart failure, heart attack, inflammation of the blood vessels, enlargement of the gums, sensitivity to light, sweating, enlarged breasts in men, tremor, slurred speech, restlessness, muscle spasm of neck, shoulders and body, anxiety, distress (extrapyramidal syndrome).

Rash and other severe skin reactions including – circular, severe skin rash (toxic epidermal necrolysis), severe form of skin rash with flushing, fever, blisters or ulcers (Steven-Johnson’s syndrome), inflammation and scaling of skin (exfoliative dermatitis), irregular red patches of the skin of the hands and arms (erythema multiforme), boil-like inflammation of the skin (exanthematous pustulosis).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.
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.

5. How to store Diltiazem Taj Pharma Hydrochloride tablets

Keep out of the sight and reach of children.

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

Keep the container tightly closed.

Do not use Diltiazem Taj Pharma Hydrochloride tablets after the expiry date stated on the label/carton/bottle.

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

6. Contents of the pack and other information

What Diltiazem Taj Pharma Hydrochloride tablets contain

  • the active substance (the ingredient that makes the tablets work) is Diltiazem Taj Pharma hydrochloride. Each tablet contains 60mg of the active substance.
  • the other ingredients are castor oil, lactose, magnesium stearate, polyethylene glycol.

What Diltiazem Taj Pharma Hydrochloride tablets look like and contents of the pack

Diltiazem Taj Pharma Hydrochloride tablets are white, uncoated, modified-release tablets. Pack size is 84.

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