Diltiazem Hydrochloride Extended-release Capsules USP 300mg Taj Pharma

1. Name of the medicinal product
2. Diltiazem Hydrochloride Extended-release Capsules USP 60mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 90mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 120mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 180mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 240mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 300mg Taj Pharma
   Diltiazem Hydrochloride Extended-release Capsules USP 360mg Taj Pharma
   2. Qualitative and quantitative composition

   a) Diltiazem Hydrochloride Extended-release Capsules USP 60mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 60mg
   Excipients: Q.S.

   b) Diltiazem Hydrochloride Extended-release Capsules USP 90mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 90mg
   Excipients: Q.S.

   c) Diltiazem Hydrochloride Extended-release Capsules USP 120mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 120mg
   Excipients: Q.S.

   d) Diltiazem Hydrochloride Extended-release Capsules USP 180mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 180mg
   Excipients: Q.S.

   e) Diltiazem Hydrochloride Extended-release Capsules USP 240mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 240mg
   Excipients: Q.S.

   f) Diltiazem Hydrochloride Extended-release Capsules USP 300mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 300mg
   Excipients: Q.S.

   g) Diltiazem Hydrochloride Extended-release Capsules USP 360mg Taj Pharma
   Each Hard gelatin capsule contains:
   Diltiazem hydrochloride USP 360mg
   Excipients: Q.S.

   For the full list of excipients see section 6.1.

3. Pharmaceutical form

Extended-release capsule, hard

4. Clinical particulars

• Therapeutic indications

The treatment of angina pectoris.
The treatment of mild to moderate hypertension.
Diltiazem Taj Pharmacapsules are indicated for use in adults only.

• Posology and method of administration

Posology

Angina

Adults: the usual initial dose is 90mg twice daily. Dosage may be increased gradually to 120mg twice daily or 180mg twice daily if required. Patients’ responses may vary and dosage requirements can differ significantly between individual patients.

Hypertension

Adults: the usual dose is 120mg once or twice daily. Patients may benefit by titrating from a lower total daily dose.

Paediatric population

The safety and efficacy in children has not been established. Therefore Diltiazem Taj Pharma is not recommended for use in children.

Dosage in the elderly and patients with impaired hepatic or renal function

Angina

Dosage should commence at 60mg twice daily and the dose carefully titrated as required.

Hypertension

Dosage should commence at the lower level of 60mg twice daily and be increased slowly in order to achieve the required level of control. The daily dose should not exceed 90mg twice daily. Do not increase the dose if the heart rate falls below 50 beats per minute.

Method of administration

For oral use.

Capsules should be swallowed whole with water and should not be sucked, chewed or crushed.

Contraindications

•  Hypersensitivity to Diltiazem Taj Pharma hydrochloride or to any of the excipients listed in section 6.1
•  Pregnancy and in women of child bearing potential
•  Severe bradycardia (below 40 bpm)
•  Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker
•  Sick sinus syndrome except in the presence of a functioning ventricular pacemaker
• Cardiac failure after myocardial infarction
•  Left ventricular failure with pulmonary congestion
•  Concomitant administration of dantrolene infusion (see section 4.5)
•  Combination with ivabradine (see section 4.5)

Special warnings and precautions for use

Rare instances of hyperglycaemia have been reported in association with Diltiazem Taj Pharma hydrochloride. The use of Diltiazem Taj Pharma in diabetic patients may require adjustment of their control.

Precaution should be taken in patients with reduced left ventricular function. Patients should be observed closely if they have bradycardia (risk of exacerbation), first degree AV block detected on the electrocardiogram (risk of exacerbation and rarely, of complete block) or prolonged PR interval.

Diltiazem Taj Pharma is considered unsafe in patients with acute porphyria.

Prior to general anaesthesia, the anaesthetist 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.

Calcium channel blocking agents, such as Diltiazem Taj Pharma, may be associated with mood changes, including depression.

Like other calcium channel antagonists, Diltiazem Taj Pharma has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. Tablet residues from slow release formulations of the product may pass into the patient’s stools; however, this finding has no clinical relevance.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• 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 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. Diltiazem Taj Pharma hydrochloride may cause small increases in plasma levels of digoxin, requiring careful monitoring of AV conduction.

Beta-blockers: Possibility of rhythm disturbances (pronounced bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure (synergistic effect). Patients with pre-existing conduction defects should not receive the combination of Diltiazem Taj Pharma and beta-blockers.Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment.

Other hypertensive drugs: Enhanced antihypertensive effect may occur with concomitant use of other hypertensive drugs (e.g. beta-blockers, diuretics, ACE-inhibitors) or drugs that cause hypotension such as aldesleukin and antipsychotics.

Combination with beta-adrenoceptor blockers having significant “first pass” loss, e.g. propranolol, may require a decrease in their dose. Diltiazem Taj Pharma will not protect against effects of withdrawal of beta-adrenoceptor blocking agents, nor the rebound effects seen with various antihypertensives.

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-H₂ agents (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 anti-H₂ agents. An adjustment in Diltiazem Taj Pharma daily dose may be necessary.

Protease inhibitors (e.g. atazanavir, ritonavir): Increase in plasma Diltiazem Taj Pharma concentrations.

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:

Diltiazem Taj Pharma has been continued in anaesthesia without problems, but the anaesthetist should be made aware that the patient is taking this medication because of the potential for synergism or interactions with other agents used in anaesthesia (see section 4.4).

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 (e.g. cilostazol, ivabradine, sirolimus, tacrolimus). Care should be exercised in patients taking these drugs. Concomitant use of Diltiazem Taj Pharma with cilostazol should be avoided. Co-administration of Diltiazem Taj Pharma with a CYP3A4 inducer may result in a decrease of Diltiazem Taj Pharma plasma concentrations.

Concomitant use of Diltiazem Taj Pharma with ivabradine is contraindicated due to the additional heart rate lowering effect of Diltiazem Taj Pharma to ivabradine (see section 4.3).

Barbiturates (phenobarbital, primidone) serum levels of Diltiazem Taj Pharma may be decreased by concomitant usage of CYP34A inducers.

Phenytoin: serum levels of Diltiazem Taj Pharma may be decreased by concomitant use of CYP34A inducers. Diltiazem Taj Pharma may increase serum levels of phenytoin.

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 metabolised by the CYP3A4 pathway in patients using Diltiazem Taj Pharma.

Diltiazem Taj Pharma may increase bioavailability of tricyclic antidepressants.

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 (simvastatin, atorvastatin, lovastatin): 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 Pharmacapsules should not be taken at the same time as alcohol, as it may increase the rate of release of Diltiazem Taj Pharma from the prolonged release preparation. In addition the combination of alcohol and Diltiazem Taj Pharma may have an additive vasodilatory effect.

• Fertility, 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 contraindicated during pregnancy (see section 4.3), as well as in women of child-bearing 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.

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, and atrioventricular conduction disturbances. It is recommended that patients with suspected overdose should be placed under observation in a coronary care unit.

Most patients suffering from overdosage of Diltiazem Taj Pharma become hypotensive within 8 hours of ingestion. With bradycardia and first to third degree atrioventricular block also developing, cardiac arrest may ensue. Hyperglycaemia is also a recognised complication. The elimination half-life of Diltiazem Taj Pharma after overdosage is estimated to be about 5.5-10.2 hours.

The following may be linked to renal impairment in patients; polyuri, pollakiuria, nocturia, acute kidney injury, acute interstitiel nephritis.

Management

Treatment, in a hospital setting, will include gastric lavage with administration of activated charcoal to reduce Diltiazem Taj Pharma absorption and/or osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing. Proposed corrective treatments: Hypotension should be corrected with plasma expanders, vasopressors, glucagon, calcium gluconate infusion and inotropic agents (e.g. dopamine, dobutamine or isoprenaline). Symptomatic bradycardia and high grade AV block may respond to atropine, isoprenaline or occasionally cardiac pacing which may be useful if cardiac standstill occurs.

Diltiazem Taj Pharmacapsules are prolonged release capsules and effects may be slow in onset and prolonged, therefore, monitoring should be carried out for longer periods than following overdose with immediate-release dosage forms.

5. Pharmacological properties
   • Pharmacodynamic properties

Pharmacotherapeutic group: Selective calcium channel blockers with direct cardiac effects:

Diltiazem Taj Pharma hydrochloride is a calcium-channel blocking agent. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem Taj Pharma inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. It is used in the management of classical and vasospastic angina pectoris and it is also used in the treatment of essential hypertension.

• Pharmacokinetic properties

Absorption

Diltiazem Taj Pharma is rapidly and almost completely absorbed from the gastro-intestinal tract following oral administration, but undergoes extensive first-pass hepatic metabolism. The bioavailability has been reported to be about 40%, although there is considerable inter-individual variation in plasma concentrations.

Distribution

Diltiazem Taj Pharma is about 80% bound to plasma proteins.

Biotransformation

It is extensively metabolised in the liver; one of the metabolites, desacetyl Diltiazem Taj Pharma has been reported to have 25 to 50% of the activity of the parent compound. The half-life is reported to be about 3 to 4 hours.

Elimination

Approximately 60% of the dose is excreted in the bile and 35 to 40% in the urine, and 2 to 4% as unchanged Diltiazem Taj Pharma.

The prolonged-release formulation is designed for twice daily dosage.

• Preclinical safety data

There are no additional data of relevance to the prescriber.

6. Pharmaceutical particulars

• List of excipients

Capsule contents

Sugar spheres (up to 92 % sucrose), Povidone, Methacrylic acid – ethyl acrylate copolymer, Ethylcellulose, Diethyl phthalate

Talc

Capsule shell, Gelatin, Titanium dioxide, Red iron oxide

Yellow iron oxide (90mg and 120mg capsules only)

Ink

Shellac, Iron oxide black, Propylene glycol

Ammonium hydroxide/Strong ammonia solution and may also contain potassium hydroxide

• Incompatibilities

Not applicable.

• Shelf life

4 years

• Special precautions for storage

Store below 25°C. Store in the original package in order to protect from moisture.

• Nature and contents of container

PVC/aluminium foils blister strips

These all capsules are supplied in blister packs containing 30, 40, 50, 56, 60, 90 or 100 capsules or in plastic containers containing 100 capsules..

Polyethylene containers with polypropylene caps containing 100 capsules.

• 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

Diltiazem Hydrochloride Extended-release Capsules USP 300mg Taj Pharma

Package leaflet: Information for the patient

(diltiazem hydrochloride)

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 or pharmacist.
• 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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Diltiazem Taj Pharma is and what it is used for
2. Before you take Diltiazem Taj Pharma ER
3. How to take Diltiazem Taj Pharma ER
4. Possible side effects
5. How to store Diltiazem Taj Pharma ER
6. Contents of the pack and other information

1.What Diltiazem Taj Pharma is and what it is used for

Diltiazem Taj Pharma contains diltiazem hydrochloride which belongs to a group of medicines called calcium channel blockers. Diltiazem acts by relaxing the muscles around the blood vessels and so relaxes and widens the blood vessels. This makes it easier for the heart to do its work and allows more blood to flow to the heart, relieving angina (chest pain due to an inadequate blood supply to the heart) and reducing blood pressure. Diltiazem also has an effect on the heart muscle itself, helping the heart to slow down and reduce the amount of work it is doing.

Diltiazem Taj Pharma can be used to treat:

• High blood pressure (hypertension)
• Chest pain (angina).

2. What you need to know before you take Diltiazem Taj Pharma SR

Do not take  Diltiazem Taj Pharma if you:

• are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6)
• are pregnant or might become pregnant
• suffer from a very slow beating heart (less than 40 beats per minute)
• have been told by your doctor that you suffer from heart block or sick sinus syndrome (disorders of the heart’s rhythm), and do not have a pacemaker fitted
• have recently had a heart attack and are suffering from heart failure
• have been given an infusion of a drug called dantrolene (muscle relaxant)
• are already taking a medicine containing ivabradine for the treatment of certain heart diseases

Warnings and precautions

Talk to your doctor before taking this medicine if you:

• suffer from a slow beating heart
• have heart disease or changes in the electrical activity of the heart
• have liver or kidney problems as your doctor may monitor you more closely
• are 65 or over
• have diabetes
• suffer from constipation or a history of blockages in the bowel
• have porphyria (a rare disease of the blood pigments)

Medicines like  Diltiazem Taj Pharma can cause mood changes, including depression, especially in patients prone to episodes of depression or low mood. If you think you may be affected, talk to your doctor or pharmacist.

Other medicines and  Diltiazem Taj Pharma ER

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, especially any of the following:

• dantrolene (a muscle relaxant) (See section ‘Do not take’ above);
• antidepressants known as tricyclic antidepressants (e.g. amitriptyline or imipramine) or lithium;
• nitrate derivatives, usually used to treat angina e.g. glyceryl trinitrate;
• alpha-blockers, used to treat prostate problems or high blood pressure e.g. prazosin;
• any medicines which may cause low blood pressure or slow heart beat (for example aldesleukin to treat cancer of the kidneys, or antipsychotics to treat mental and behavioural disorders);
• ivabradine to treat angina;
• medicines used to treat a heart rhythm condition e.g. digoxin, amiodarone;
• cilostazol to treat intermittent claudication (a condition that causes leg pain due to a restriction in blood supply to the muscles);
• beta-blockers, water tablets (diuretics) or ACE inhibitors, used to treat high blood pressure and heart conditions e.g. propranolol, furosemide or lisinopril;
• rifampicin, used to treat an infection;
• ciclosporin, tacrolimus or sirolimus, usually used after an organ or bone marrow transplant;
• a specific type of medicine known as a protease inhibitor to treat HIV (examples include atazanavir or ritonavir);
• theophylline (to prevent shortness of breath or difficulty breathing);
• barbiturates e.g. phenobarbital or primidone, carbamazepine or phenytoin ( antiepileptics, to treat seizures, fits or convulsions);
• cimetidine or ranitidine, for heartburn or stomach ulcers;
• benzodiazepines, used to treat anxiety or sleep disturbances e.g. midazolam or triazolam;
• methylprednisolone, a corticosteroid (normally used to treat inflammation or allergy);
• statins, used to lower blood cholesterol levels e.g. simvastatin.

If you need to have an operation and will require an anaesthetic, tell your doctor or dentist you are taking this medicine.

 Diltiazem Taj Pharma with alcohol

Do not take  Diltiazem Taj Pharma at the same time as an alcoholic drink.

Pregnancy and breast-feeding

Do not take  Diltiazem Taj Pharma if you are pregnant or planning to become pregnant.

If you are a woman of child bearing age or have not gone through the menopause, and your doctor recommends you take this medicine, you must use an effective form of contraception  Diltiazem Taj Pharma should not be taken if you are breast-feeding.

Driving and using machines

Diltiazem Taj Pharma may cause side effects such as dizziness or feeling generally unwell. If you are affected you should not drive or use machines.

Diltiazem Taj Pharma contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.

3. How to take Diltiazem Taj Pharma SR

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

• This medicine should not be sucked or chewed
• Swallow the capsule whole with a glass of water
• Allow 12 hours between each dose

Angina

Adults: the recommended dose is 90mg twice daily. If necessary, your doctor may be gradually increased to a dose of 180mg twice daily.

Hypertension

Adults: the recommended dose is 120mg once or twice daily. Your doctor may give you a lower starting dose and gradually increase the dosage.

Older people or patients with liver or kidney problems

Angina

Your doctor may prescribe a lower dose of 60mg twice daily which may be increased as required.

Hypertension

Your doctor may prescribe a lower dose of 60mg twice a day which may be increased to up to a maximum of 90mg twice a day if required.

Use in children and adolescents

Diltiazem Taj Pharma is not suitable for children and adolescents.

If you take more  Diltiazem Taj Pharma than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. Signs of overdose include low blood pressure possibly leading to collapse,

slow heart beat or changes in heart rhythm and/or abnormal blood sugar levels.

If you forget to take  Diltiazem Taj Pharma ER

If you have forgotten to take a dose at the scheduled time, take it as soon as possible. If it is less than 6 hours until you are due to take your next dose, do not double the dose, just carry on as before. Do not

take a double dose to make up for forgotten individual doses.

If you stop taking  Diltiazem Taj Pharma

Take the medicine for as long as the doctor has prescribed it. Do not discontinue treatment without prior discussion with your doctor or pharmacist.

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

4. Possible side effects

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

If any of the following happen, stop taking  Diltiazem Taj Pharma and tell your doctor immediately or go to your nearest hospital emergency department:

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

• allergic reactions such as swollen skin or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
• liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes
• severe skin reactions including blistering of the skin, mouth, eyes and genitals, and swollen blood vessels in the skin.

These side effects are serious. You may need medical attention.
Tell your doctor straight away if you notice any of the following side effects:

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

• mood changes, including depression
• uncontrollable movements, including trembling or shaking of the hands and fingers
• trembling, muscle stiffness or spasms, slowing of movement (Parkinsonian syndrome)
• shortness of breath, swelling of the feet or legs (congestive heart failure)
• abnormal heart rhythm, slow or uneven heartbeat (sinoatrial block).

Other side effects include:

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

• swelling of the ankles, feet and fingers

Common side effects (may affect up to 1 in 10 people):

• abnormal heart rhythm (AV block)
• headache
• feeling dizzy
• palpitations
• flushing
• constipation
• indigestion
• stomach pain
• feeling sick
• redness of the skin
• itching
• feeling generally unwell
• tiredness

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reaction
• feeling nervous
• difficulty sleeping
• slower heart beat
• dizziness, light-headedness or fainting on standing up
• being sick
• diarrhoea
• increase in liver enzymes (these may show up in blood tests)

Rare side effects (may affect up to 1 in 1,000 people)

• dry mouth
• a nettle-like rash or hives

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

• reduction in blood platelets which increase risk of bleeding or bruising
• loss of appetite
• pins and needles or tingling
• bleeding, tender or enlarged gums
• skin problems such as an increased sensitivity to light, rash, dark areas, severe flaking or peeling
• sweating
• breast enlargement in men
• inflammation of blood vessels (often with skin rash)
• gastrointestinal disorders (e.g. upset stomach)
• low blood pressure

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.

5. How to store Diltiazem Taj Pharma SR

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store below 25⁰C. Store in the original package in order to protect from moisture.

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

6. Contents of the pack and other information

What Diltiazem Taj Pharma contains

The active substance is diltiazem hydrochloride.
Each prolonged-release capsule contains 60mg, 90mg or 120mg diltiazem hydrochloride.

The other ingredients are sucrose (see section 2, ‘Diltiazem Taj Pharma contains sucrose’), maize starch,

povidone, methacrylic acid – ethyl acrylate copolymer, ethylcellulose, diethyl phthalate, and talc. The capsule also contains gelatin, titanium dioxide, red iron oxide and the 90mg and 120mg capsules also contain yellow iron oxide. The printing ink contains shellac, black iron oxide, propylene glycol, ammonium hydroxide/strong ammonia solution and may also contain potassium hydroxide.

What Diltiazem Taj Pharma looks like and contents of the pack

Your medicine comes in the form of a capsule.

Diltiazem Taj Pharma 60mg Extended release Capsules, Hard
Diltiazem Taj Pharma 90mg Extended release Capsules, Hard
Diltiazem Taj Pharma 120mg Extended release Capsules, Hard
Diltiazem Taj Pharma 240mg Extended release Capsules, Hard
Diltiazem Taj Pharma 300mg Extended release Capsules, Hard
Diltiazem Taj Pharma 360mg Extended release Capsules, Hard

They are supplied in blister packs containing 30, 40, 50, 56, 60, 90 or 100 capsules or in plastic containers containing 100 capsules.

Not all pack sizes 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