Verapamil Tablets USP 120mg Taj Pharma

Name of the medicinal product

Verapamil Tablets USP 40mg Taj Pharma
Verapamil Tablets USP 120mg Taj Pharma
Verapamil Tablets USP 160mg Taj Pharma
Verapamil Tablets USP 180mg Taj Pharma

Qualitative and quantitative composition

a) Verapamil Tablets USP 40mg Taj Pharma
Each film-coated tablet contains:
Verapamil Hydrochloride USP 40mg
Excipients: Q.S.

b) Verapamil Tablets USP 120mg Taj Pharma
Each film-coated tablet contains:
Verapamil Hydrochloride USP 120mg
Excipients: Q.S.

c) Verapamil Tablets USP 160mg Taj Pharma
Each film-coated tablet contains:
Verapamil Hydrochloride USP 160mg
Excipients: Q.S.

d) Verapamil Tablets USP 180mg Taj Pharma
Each film-coated tablet contains:
Verapamil Hydrochloride USP 180mg
Excipients: Q.S.

Excipient with known effect

Sunset yellow aluminium lake

For the full list of excipients, see section 6.1

Pharmaceutical form

Yellow film-coated tablets.

Yellow, circular, biconvex film-coated tablets,

Clinical particulars
- Therapeutic indications

1) The management of mild to moderate hypertension and renal hypertension, used alone or in combination with other antihypertensive therapy (see section 4.3 for warning regarding concomitant administration with beta-blockers).

2) For the management and prophylaxis of angina pectoris (including variant angina).

3) The treatment and prophylaxis of paroxysmal supraventricular tachycardia and the reduction of the ventricular rate in atrial fibrillation/flutter. Verapamil Taj Pharma should not be used for atrial fibrillation/flutter in patients with Wolff-Parkinson-White syndrome (see section 4.4).

Posology and method of administration

Posology

Adults:

Hypertension: initially 120mg twice daily increasing to 160mg twice daily where necessary. In some cases doses of up to 480mg daily, in divided doses, have been used. A further reduction in blood pressure may be obtained by combining Verapamil Taj Pharma with other antihypertensive agents, in particular diuretics. For concomitant administration with beta-blockers, see section 4.4.

Angina: 120mg three times daily is recommended. 80mg three times daily may be completely satisfactory in some patients with angina of effort. Less than 120mg three times daily is unlikely to be effective in variant angina.

Supraventricular tachycardias: 40-120mg three times daily depending on the severity of the condition.

Paediatric population:

A paradoxical increase in the rate of arrhythmias in children has been noted. Therefore, Verapamil Taj Pharma should only be used under expert supervision.

Up to 2 years: 20mg 2-3 times a day.

2 years and above: 40-120mg 2-3 times a day according to age and effectiveness.

Elderly: The adult dose is recommended unless liver or renal function is impaired (see section 4.4).

Method of Administration

For oral administration.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypotension (of less than 90mmHg systolic)
Second or third degree atrioventricular block; sick sinus syndrome (except in patients with a functioning artifical pacemaker); uncompensated heart failure; marked bradycardia (less than 50 beats/minute).
Combination with beta-blockers is contraindicated in patients with poor ventricular function.
Wolff-Parkinson-White syndrome.
Concomitant ingestion of grapefruit juice is contraindicated.
Acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure.
Combination with ivabradine (see section 4.5)
- Special warnings and precautions for use

Verapamil Taj Pharma may affect left ventricular contractility as a result of its mode of action. The effect is small and not normally important. However, cardiac failure may be aggravated or precipitated if it exists. In cases with poor ventricular function, Verapamil Taj Pharma should therefore only be administered after appropriate therapy for cardiac failure such as digitalis, etc.

Verapamil Taj Pharma may affect impulse conduction and should be administered with caution in patients with first degree atrioventricular block. The effects of Verapamil Taj Pharma and beta-blockers or other drugs may be additive both in respect of conduction and contraction, therefore care should be exercised when these are administered concurrently or closely together. This is especially true when either drug is administered intravenously.

Caution should be observed in the acute stage of myocardial infarction.

Patients with atrial fibrillation/flutter and an accessory pathway (eg Wolff-Parkinson-White syndrome) may rarely develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated.

Since Verapamil Taj Pharma is extensively metabolised in the liver, careful dose titration of Verapamil Taj Pharma is required in patients with liver disease. The disposition of Verapamil Taj Pharma in patients with renal impairment has not been fully established and therefore careful patient monitoring is recommended. Verapamil Taj Pharma is not removed during dialysis.

Interaction with other medicinal products and other forms of interaction

In vitro metabolic studies indicate that Verapamil Taj Pharma hydrochloride is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil Taj Pharma has been shown to be an inhibitor of CYP3A4 enzymes and P-glycoprotein (P-gp). Clinically significant interactions have been reported with inhibitors of CYP3A4 causing elevation of plasma levels of Verapamil Taj Pharma hydrochloride while inducers of CYP3A4 have caused a lowering of plasma levels of Verapamil Taj Pharma hydrochloride, therefore, patients should be monitored for drug interactions.

H₂ Receptor antagonists

Cimetidine increases serum levels of Verapamil Taj Pharma.

Anticonvulsants:

Increased serum levels of carbamazepine which could lead to increased side-effects.

Reduced serum levels of Verapamil Taj Pharma when taken with phenytoin.

Barbiturates:

Reduced serum levels of Verapamil Taj Pharma when taken with Phenobarbital.

Lithium:

Serum levels of lithium may be reduced (pharmacokinetic effect). There may be increased sensitivity to lithium causing enhanced neurotoxicity (pharmacodynamic effect).

Alcohol:

Verapamil Taj Pharma has been shown to increase the blood levels of alcohol and slow its elimination. Therefore, the effects of alcohol may be exaggerated.

Antihypertensive drugs:

Verapamil Taj Pharma may have an additive effect with other antihypertensive drugs; thus, in many cases with Verapamil Taj Pharma, a reduction in the dosage of the other antihypertensive drug may be possible:

Beta blockers:

Verapamil Taj Pharma may increase the plasma concentrations of metoprolol and propranolol which may lead to additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Intravenous beta-blockers should not be given to patients under treatment with Verapamil Taj Pharma.

Alpha blockers:

Verapamil Taj Pharma may increase the plasma concentrations of prazosin and terazosin which may have an additive hypotensive effect.

Antiarrhythmics:

Verapamil Taj Pharma may increase the plasma concentrations of quinidine. Pulmonary oedema may occur in patients with hypertrophic cardiomyopathy.

The combination of Verapamil Taj Pharma and antiarrhythmic agents may lead to additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Benzodiazepines and anxiolytics:

Verapamil Taj Pharma may increase the plasma concentrations of midazolam.

Lipid lowering agents:

Verapamil Taj Pharma may increase the plasma concentrations atorvastatin, lovastatin and simvastatin.

Treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin) in a patient taking Verapamil Taj Pharma should be started at the lowest possible dose and titrated upwards. If Verapamil Taj Pharma treatment is to be added to patients already taking an HMG CoA reductase inhibitor (e.g., simvastatin, atorvastatin or lovastatin), consider a reduction in the statin dose and retitrate against serum cholesterol concentrations.

Atorvastatin has been shown to increase Verapamil Taj Pharma levels. Although there is no direct in vivo clinical evidence, there is strong potential for Verapamil Taj Pharma to significantly affect atorvastatin pharmacokinetics in a similar manner to simvastatin or lovastatin. Consider using caution when atorvastatin and Verapamil Taj Pharma are concomitantly administered.

Fluvastatin, pravastatin and rosuvastatin are not metabolized by CYP3A4 and are less likely to interact with Verapamil Taj Pharma.

Acetylsalicylic acid

Concomitant use of Verapamil Taj Pharma with aspirin may increase the risk of bleeding.

Dabigatran etexilate

When oral Verapamil Taj Pharma was co-administered with dabigitran etexilate (150mg), a P-gp substrate, the Cmax and AUC of dabigatran were increased but magnitude of this change differs depending on time between administration and the formulation of Verapamil Taj Pharma. When Verapamil Taj Pharma 120mg immediate-release was co-administered one hour before a single dose of dabigatran etexilate, the dabigatran Cmax was increased by about 180% and AUC by about 150%. No meaningful interaction was observed when Verapamil Taj Pharma was administered 2 hours after dabigatran etexilate (increase of Cmax by about 10% and AUC by about 20%).

Close clinical surveillance is recommended when Verapamil Taj Pharma is combined with dabigatran etexilate and particularly in the occurrence of bleeding, notably in patients having a mild to moderate renal impairment.

Anti-infectives

Reduced serum levels of Verapamil Taj Pharma when taken with rifampicin.

Erythromycin, clarithromycin and telithromycin may increase the plasma concentrations of Verapamil Taj Pharma.

Anaesthesia:

Long-term Verapamil Taj Pharma therapy may give rise to potentiation of neuromuscular blocking agents during anaesthesia.

Interactions have been reported during the concomitant use of Verapamil Taj Pharma and the following medications:

Theophylline:

Increased serum levels of theophylline which could lead to increased side-effects.

Immunosuppressants

Verapamil Taj Pharma may increase the plasma concentrations of ciclosporin, everolimus, sirolimus and tacrolimus which could lead to increased side-effects.

Digoxin:

Verapamil Taj Pharma has been shown to increase the serum concentration of digoxin and caution should therefore be exercised with regard to digitalis toxicity.

Dantrolene

Concomitant use of Verapamil Taj Pharma with intravenous dantrolene may cause hypotension, myocardial depression, and hyperkalaemia. This combination should be avoided.

Colchicine

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (P-gp). Verapamil Taj Pharma is known to inhibit CYP3A and P-gp. When Verapamil Taj Pharma and colchicine are administered together, inhibition of P-gp and/or CYP3A by Verapamil Taj Pharma may lead to increased exposure to colchicine. Combined use is not recommended.

Other:

An increase in Verapamil Taj Pharma serum level has been reported when taken with grapefruit juice.

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

Fertility, pregnancy and lactation

Animal studies have shown no teratogenic effect. Verapamil Taj Pharma should not be administered during pregnancy unless, in the clinicians judgement, it is essential for the welfare of the patient. The possibility that Verapamil Taj Pharma can cause relaxation of the uterine muscle should be considered at term.

Verapamil Taj Pharma is excreted in breast milk at concentrations approximately equal to 0.5-1.0 times that coexisting in maternal plasma. However, the amount ingested in such circumstances is less than 1% of the recommended therapeutic infant dose, assuming normal suckling rates.

Effects on ability to drive and use machines

Depending on individual susceptibility, the patient’s ability to drive or operate machines may be impaired due to feelings of drowsiness. This is particularly true in the initial stages of treatment, or when changing over from another drug. Verapamil Taj Pharma has been shown to increase the blood levels of alcohol and slow its elimination. Therefore, the effects of alcohol may be exaggerated.

Undesirable effects

Immune system disorders: allergic reactions (e.g. erythema, pruritus, urticaria) are very rarely seen.

Nervous system disorders: headaches occur rarely, dizziness, paraesthesia, tremor, extrapyramidal syndrome (e.g. parkinsonism), dystonia.

Ear and labyrinth disorders: vertigo, tinnitus.

Cardiac disorders: bradycardic arrhythmias such as sinus bradycardia, sinus arrest with asystole, 2nd and 3rd degree AV block, bradyarrhythmia in atrial fibrillation, palpitations, tachycardia, development or aggravation of heart failure, hypotension.

Vascular disorders: flushing, peripheral oedema.

Gastrointestinal disorders: nausea, vomiting, constipation is not uncommon, ileus and abdominal pain/discomfort. Gingival hyperplasia may very rarely occur when the drug is administered over prolonged periods. This is fully reversible when the drug is discontinued.

Skin and subcutaneous tissue disorders: alopecia, ankle oedema, Quincke’s oedema, Steven-Johnson syndrome, erythema multiforme, erythromelalgia, purpura.

Musculoskeletal and connective tissue disorders: muscular weakness, myalgia and arthralgia.

Reproductive system and breast disorders: impotence (erectile dysfunction) has been rarely reported and isolated cases of galactorrhoea. Gynaecomastia was observed on very rare occasions in elderly male patients under longer term Verapamil Taj Pharma treatment which was fully reversible in all cases when the drug was discontinued.

General disorders and administration site conditions: fatigue.

Investigations: On very rare occasions, a reversible impairment of liver function characterised by an increase in transaminases and/or alkaline phosphatase, may occur during Verapamil Taj Pharma treatment and is most probably a hypersensitivity reaction.

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

The course of symptoms in Verapamil Taj Pharma intoxication depends on the amount taken, the point in time at which detoxification measures are taken and myocardial contractility (age-related). The main symptoms are as follows: blood pressure fall (at times to values not detectable), shock symptoms, loss of consciousness, 1st and 2nd degree AV block (frequently as Wenckebach’s phenomenon with or without escape rhythms), total AV block with total AV dissociation, escape rhythm, asystole, bradycardia up to high degree AV block and, sinus arrest, hyperglycaemia, stupor and metabolic acidosis. Fatalities have occurred as a result of overdose.

The therapeutic measures to be taken depend on the point in time at which Verapamil Taj Pharma was taken and the type and severity of intoxication symptoms. In intoxications with large amounts of slow-release preparations, it should be noted that the release of the active drug and the absorption in the intestine may take more than 48 hours. Verapamil Taj Pharma hydrochloride cannot be removed by haemodialysis. Depending on the time of ingestion, it should be taken into account that there may be some lumps of incompletely dissolved tablets along the entire length of the gastrointestinal tract, which function as active drug depots.

General measures to be taken: Gastric lavage with the usual precautions, even later than 12 hours after ingestion, if no gastrointestinal motility (peristaltic sounds) is detectable. Where intoxication by a modified release preparation is suspected, extensive elimination measures are indicated, such as induced vomiting, removal of the contents of the stomach and the small intestine under endoscopy, intestinal lavage, laxative, high enemas. The usual intensive resuscitation measures apply, such as extrathoracic heart massage, respiration, defibrillation and/or pacemaker therapy.

Specific measures to be taken: Elimination of cardiodepressive effects, hypotension or bradycardia. The specific antidote is calcium, e.g. 10 20ml of a 10% calcium gluconate solution administered intravenously (2.25 – 4.5mmol), repeated if necessary or given as a continuous drip infusion (e.g. 5mmol/hour).

The following measures may also be necessary: In case of 2nd or 3rd degree AV block, sinus bradycardia, asystole – atropine, isoprenaline, orciprenaline or pacemaker therapy. In case of hypotension – dopamine, dobutamine, noradrenaline (norepinephrine). If there are signs of continuing myocardial failure – dopamine, dobutamine, if necessary repeated calcium injections.

Pharmacological properties
- Pharmacodynamic properties

Pharmacotherapeutic group: Selective calcium channel blockers with direct cardiac effects, phenylalkylamine derivatives.

Verapamil Taj Pharma hydrochloride is a calcium channel blocker and is classified as a class IV anti-arrhythmic agent.

Mechanism of action

Verapamil Taj Pharma inhibits the entry of calcium into smooth muscle cells of the systemic and coronary arteries and in the cells of cardiac muscle and the intracardiac conduction system.

Verapamil Taj Pharma lowers peripheral vascular resistance with little or no reflex tachycardia. Its efficacy in reducing both raised systolic and diastolic blood pressure is thought to be primarily due to this mode of action.

The decrease in systemic and coronary vascular resistance and the sparing effect on intracellular oxygen consumption appear to explain the anti-anginal properties of the product.

Due to the effect on the movement of calcium in the intracardiac conduction system, Verapamil Taj Pharma reduces automaticity, decreases conduction velocity and increases the refractory period.

Pharmacokinetic properties

Absorption

Verapamil Taj Pharma is approximately 90% absorbed from the gastrointestinal tract.

Distribution

Verapamil Taj Pharma acts within 1-2 hours after oral administration with a peak plasma concentration after 1-2 hours. There is considerable interindividual variation in plasma concentrations. Verapamil Taj Pharma is about 90% bound to plasma proteins.

Biotransformation

Verapamil Taj Pharma is subject to very considerable first-pass metabolism in the liver and the bioavailability is only about 20%. It is extensively metabolised in the liver to at least 12 metabolites of which norVerapamil Taj Pharma has been shown to have some activity.

Elimination

Verapamil Taj Pharma exhibits bi- or tri-phasic elimination kinetics and is reported to have a terminal plasma half-life of 2-8 hours following a single oral dose. After repeated oral doses this increases to 4.5-12 hours. About 70% of a dose is excreted by the kidneys in the form of its metabolites but about 16% is also excreted in the bile into the faeces. Less than 4% is excreted unchanged.

Pregnancy and breast-feeding

Verapamil Taj Pharma crosses the placenta and is excreted in breast milk (see section 4.6).

Preclinical safety data

Not applicable.

Pharmaceutical particulars
- List of excipients

Also contains: croscarmellose sodium, magnesium stearate, maize starch, propylene glycol, sunset yellow aluminium lake, quinoline yellow aluminium lake, titanium dioxide, microcrystalline cellulose, hydroxypropylcellulose, methylhydroxypropylcellulose, purified talc.

Incompatibilities

None known.

Shelf life

Three years from the date of manufacture.

Special precautions for storage

Store below 25°C in a dry place.

Nature and contents of container

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack size: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 1000.

Not all pack size may be marketed in another country.

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

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

What Verapamil Taj Pharma tablets are and what they are used for
What you need to know before you take Verapamil Taj Pharma tablets
How to take Verapamil Taj Pharma tablets
Possible side effects
How to store Verapamil Taj Pharma tablets
Contents of the pack and other information

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

Verapamil Taj Pharma belongs to a group of medicines called calciumchannel blockers which interfere with the electrical signals in the heart muscle and blood vessels. It is used to:

manage high blood pressure (hypertension), used alone or with other drugs for high blood pressure.

manage and prevent angina.
treat and prevent certain types of abnormal heart beats.

What you need to know before you take Verapamil Taj Pharma tablets

Do not take Verapamil Taj Pharma tablets if you:

are allergic to Verapamil Taj Pharma hydrochloride or any of the other ingredients of this medicine (listed in section 6)
have heartfailure or severe problems with the impulses and rhythms of the heart (second or third degree atrioventricular block or sick sinus syndrome) unless you have a pacemaker
have heart failure and are taking beta blockers
have recently suffered a heart attack
suffer from a slow heart rate (bradycardia)
have low blood pressure (hypotension)
have Wolff-Parkinson-White syndrome (rapid heart rate sometimes associated with dizziness or faintness).
are already taking a medicine containing ivabradine for the treatment of certain heart diseases

Warnings and precautions

Talk to your doctor or pharmacist before taking Verapamil Taj Pharma tablets if you have:

had a heart attack or have problems with the impulses of the heart (first degree atrioventricular block)
liver disease
kidney failure.

Surgery

You should tell your doctor you are taking Verapamil Taj Pharma tablets if you are having an operation or anaesthetic.

Other medicines and Verapamil Taj Pharma tablets

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

ivabradine (for heart disease)
alpha or beta blockers (particularly important if having a beta blocker by injection) and other drugs to treat high blood pressure e.g. prazosin
cimetidine (to treat stomach ulcers)
phenobarbital, carbamazepine or phenytoin (to treat epilepsy)
rifampicin (to treat infections)
lithium (to treat depression)
theophylline (to treat asthma)
digoxin (to treat certain heart conditions)
midazolam (used as sedative or anaesthetic)
statins e.g. simvastatin, atorvastatin (to lower cholesterol levels)
erythromycin, clarithromycin (to treat infections)
aspirin (for pain, fever or to prevent blood clots)
dabigatran (medicine to prevent the formation of blood clots)
quinidine (to treat arrhythmias)
colchicine (for gout)
immunosupressants such as ciclosporin, sirolimus, everolimus and tacrolimus (to prevent organ transplant rejection)
dantrolene (to control muscle spasms)
if you are about to receive surgery where an anaesthetic will be used (including dentistry).

Verapamil Taj Pharma tablets and alcohol

Verapamil Taj Pharma may increase the amount of alcohol in the body and the time it takes for alcohol to leave the body. You should avoid excessive amounts of alcohol whilst taking Verapamil Taj Pharma tablets.

Verapamil Taj Pharma tablets and Grapefruit juice

Do not eat or drink products containing grapefruit juice whilst taking Verapamil Taj Pharma, as grapefruit juice increases the effects of Verapamil Taj Pharma.

Pregnancy and breast-feeding

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.

Driving and using machines

Verapamil Taj Pharma tablets may make you feel drowsy, particularly when you first start the treatment and when changing over from another medicine. Make sure you are not affected before you drive or operate machinery, especially if taken with alcohol.

Verapamil Taj Pharma tablets contains sunset yellow aluminium lake

Sunset yellow aluminium lake may cause allergic reactions.

How to take Verapamil Taj Pharma tablets

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults

High blood pressure: Initially 120mg twice a day increasing to 160mg twice a day. In some cases up to a maximum of 480mg a day can be taken in divided doses.
Angina: Usually 120mg three times a day. For some patients 80mg three times a day may be sufficient.
Abnormal heart beats: 40-120mg three times a day. Elderly with heart or liver problems: you may be given a different dose.

Use in children and adolescents

Up to 2 years: 20mg two or three times a day.
2 years and over: 40-120mg two or three times a day.

Swallow the tablets with water.

If you take more Verapamil Taj Pharma tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

Overdose can lead to low blood pressure and in rare cases heart failure.

If you forget to take Verapamil Taj Pharma tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose and take the next dose at the right time.

If you stop taking Verapamil Taj Pharma tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

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

Possible side effects

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

Contact your doctor at once if any of the following symptoms occur:

allergic reaction: itching, rashes, difficulty breathing and swelling of the face lips or tongue
palpitations, chest pains for the first time or chest pains becoming more frequent.

Tell your doctor if you notice any of the following side effects, they get worse or you notice any other effects not listed:

Nervous system – headaches, dizziness, ‘pins and needles’, involuntary shaking or spasm

Ears – spinning sensation, ‘ringing in the ears’

Heart /blood vessels – fast, slow or irregular heart beat, low blood pressure, flushing/reddening of the skin, swelling of the ankles, hands or feet

Stomach – constipation, feeling or being sick, pain or discomfort in the stomach, swelling of the gums

Skin – hair loss, skin rash or itching, discolouring, tingling or prickling feeling, blisters, ulcers, numbness

Muscles – weakness, aches, pains in the joints and/or muscles

Reproductive system – impotence, enlarged breasts in men (reversible when treatment is stopped)

Other – tiredness, liver problems which can be detected by blood tests done by your doctor.

Reporting of side effects

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

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

How to store Verapamil Taj Pharma tablets

Keep out of the sight and reach of children.

Store below 25°C in a dry place.

Do not use this medicine after the expiry date stated on the 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.

Contents of the pack and other information

What Verapamil Taj Pharma tablets contain

The active substance is Verapamil Taj Pharma hydrochloride. Each tablet contains either 40mg, 80mg, 120mg or 160mg of Verapamil Taj Pharma hydrochloride.
The other ingredients are Croscarmellose Sodium, Magnesium Stearate, Maize Starch, Propylene Glycol, Sunset Yellow Aluminium Lake, Quinoline Yellow Aluminium Lake, Titanium Dioxide, Microcrystalline Cellulose, Hydroxypropylcellulose, Methylhydroxypropylcellulose, Purified Talc.

What Verapamil Taj Pharma tablets look like and contents of the pack

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack size: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Maximum size of bulk packs: 1000.

Not all pack size may be marketed in another country.