1. Name of the medicinal product

Verapamil Hydrochloride ER Tablets 120mg Taj Pharma

Verapamil Hydrochloride ER Tablets 180mg Taj Pharma

Verapamil Hydrochloride ER Tablets 240mg Taj Pharma

Verapamil Hydrochloride ER Tablets 360mg Taj Pharma

  1. Qualitative and quantitative composition

a) Verapamil Hydrochloride ER Tablets 120mg Taj Pharma
Each Extended-release tablet contains:
Verapamil Hydrochloride USP 120mg
Excipients: Q.S.

b) Verapamil Hydrochloride ER Tablets 180mg Taj Pharma
Each Extended-release tablet contains:
Verapamil Hydrochloride USP 180mg
Excipients: Q.S.

c) Verapamil Hydrochloride ER Tablets 240mg Taj Pharma
Each Extended-release tablet contains:
Verapamil Hydrochloride USP 240mg
Excipients: Q.S.

d) Verapamil Hydrochloride ER Tablets 360mg Taj Pharma
Each Extended-release tablet contains:
Verapamil Hydrochloride USP 360mg
Excipients: Q.S.

  1. Pharmaceutical form

Extended-release Tablets

  1. Clinical particulars
    • Therapeutic indications

Verapamil Hydrochloride ER Taj Pharma is indicated for:

The treatment of mild to moderate hypertension.

The treatment and prophylaxis of angina pectoris.

Secondary prevention of reinfarction after an acute myocardial infarction in patients without heart failure, and not receiving diuretics (apart from low-dose diuretics when used for indications other than heart failure), and where beta-blockers are not appropriate. Treatment is to be started at least one week after an acute myocardial infarction.

  • Posology and method of administration

For oral use only.

Verapamil Hydrochloride ER Taj Pharma Tablets should be taken without sucking or chewing, with sufficient liquid, preferably with or shortly after meals.

Verapamil Hydrochloride ER Taj Pharma Tablets are scored and may be halved without damaging the modified-release formulation.

Adults

Hypertension: One Tablets of Verapamil Hydrochloride ER Taj Pharma daily. For patients new to verapamil therapy, the physician should consider halving the initial dose to 120mg (one Tablets Half Verapamil Hydrochloride ER Taj Pharma). Most patients respond to 240mg daily (one Tablets Verapamil Hydrochloride ER Taj Pharma) given as a single dose. If control is not achieved after a period of at least one week, the dosage may be increased to a maximum of two Verapamil Hydrochloride ER Taj Pharma Tablets daily (one in the morning and one in the evening at an interval of about twelve hours). A further reduction in blood pressure may be achieved by combining Verapamil Hydrochloride ER Taj Pharma with other antihypertensive agents, in particular diuretics. Half Verapamil Hydrochloride ER Taj Pharma may be used for dose titration purposes.

Angina pectoris: One Tablets of Verapamil Hydrochloride ER Taj Pharma twice daily. A small number of patients respond to a lower dose and where indicated, adjustment down to one Tablets of Verapamil Hydrochloride ER Taj Pharma daily could be made. Half Verapamil Hydrochloride ER Taj Pharma may be used for dose titration purposes.

Secondary prevention of reinfarction after an acute myocardial infarction in patients without heart failure, and not receiving diuretics (apart from low-dose diuretics when used for indications other than heart failure), and where beta-blockers are not appropriate: Treatment is to be started at least one week after an acute myocardial infarction. 360mg/day in divided doses, to be taken either as one Half Verapamil Hydrochloride ER Taj Pharma (120mg) Tablets three times daily, or as one Verapamil Hydrochloride ER Taj Pharma (240mg) Tablets in the morning and one Half Verapamil Hydrochloride ER Taj Pharma (120mg) Tablets in the evening, on a daily basis.

Elderly patients

The adult dose is recommended unless renal or hepatic function is impaired (see Section 4.4, ‘Special Warnings and Precautions for Use’).

Children

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma are not recommended for children.

Liver impairment

In patients with impaired liver function, metabolism of the drug is delayed to a greater or lesser extent depending on the severity of hepatic dysfunction, thus potentiating and prolonging the effects of verapamil hydrochloride. Therefore, the dosage needs to be adjusted with special caution in patients with impaired liver function and low doses should be given initially (see Special Warnings and Precautions for Use Section).

  • Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or third degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker); sino-atrial block; sick sinus syndrome (except in patients with a functioning artificial pacemaker); uncompensated heart failure; bradycardia of less than 50 beats/minute; hypotension of less than 90 mmHg systolic.

Patients with atrial flutter/fibrillation in the presence of an accessory pathway (e.g. WPW syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated.

Combination with ivabradine (see section Interactions with other medicinal products and other forms of interaction).

  • Special warnings and precautions for use

Since verapamil is extensively metabolised in the liver, careful dose titration is required in patients with liver disease. Although the pharmacokinetics of verapamil in patients with renal impairment are not affected, caution should be exercised and careful patient monitoring is recommended. Verapamil is not removed during dialysis.

Verapamil may affect impulse conduction and should therefore be used with caution in patients with bradycardia or first degree AV block. Verapamil may affect left ventricular contractility; this effect is small and normally not important but cardiac failure may be precipitated or aggravated. In patients with incipient cardiac failure, therefore, verapamil should be given only after such cardiac failure has been controlled with appropriate therapy, e.g. digitalis.

When treating hypertension with verapamil, monitoring of the patient’s blood pressure at regular intervals is required.

Caution should be exercised in treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started at the lowest possible dose of verapamil and titrated upwards. If verapamil treatment is to be added to patients already taking an HMG CoA reductase inhibitor (e.g., simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information.

Use with caution in the presence of diseases in which neuromuscular transmission is affected (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy)

  • Interaction with other medicinal products and other forms of interaction

In vitro metabolic studies indicate that verapamil hydrochloride is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil 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 hydrochloride while inducers of CYP3A4 have caused a lowering of plasma levels of verapamil hydrochloride, therefore, patients should be monitored for drug interactions.

The following are potential drug interactions associated with verapamil:

Acetylsalicylic acid

Concomitant use of verapamil with aspirin may increase the risk of bleeding

Alcohol

Increase in blood alcohol has been reported.

Alpha blockers

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

Antiarrhythmics

Verapamil may slightly decrease the plasma clearance of flecainide whereas flecainide has no effect on the verapamil plasma clearance.

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

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

Anticonvulsants

Verapamil may increase the plasma concentrations of carbamazepine. This may produce side effects such as diplopia, headache, ataxia or dizziness. Verapamil may also increase the plasma concentrations of phenytoin.

Antidepressants

Verapamil may increase the plasma concentrations of imipramine.

Antidiabetics

Verapamil may increase the plasma concentrations of glibenclamide (glyburide).

Antihypertensives, diuretics, vasodilators

Potentiation of the hypotensive effect.

Anti-infectives

Rifampicin may reduce the plasma concentrations of verapamil which may produce a reduced blood pressure lowering effect. Erythromycin, clarithromycin and telithromycin may increase the plasma concentrations of verapamil.

Antineoplastics

Verapamil may increase the plasma concentrations of doxorubicin.

Barbiturates

Phenobarbital may reduce the plasma concentrations of verapamil.

Benzodiazepines and other anxiolytics

Verapamil may increase the plasma concentrations of buspirone and midazolam.

Beta blockers

Verapamil 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.

Cardiac glycosides

Verapamil may increase the plasma concentrations of digitoxin and digoxin. Verapamil has been shown to increase the serum concentration of digoxin and caution should be exercised with regard to digitalis toxicity. The digitalis level should be determined and the glycoside dose reduced, if required.

Colchicine

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

H2 Receptor antagonists

Cimetidine may increase the plasma concentrations of verapamil.

HIV antiviral agents

Due to the metabolic inhibitory potential of some of the HIV antiviral agents, such as ritonavir, plasma concentrations of verapamil may increase. Caution should be used or dose of verapamil may be decreased.

Immunosuppressants

Verapamil may increase the plasma concentrations of ciclosporineverolimus, sirolimus and tacrolimus.

Inhaled anaesthetics

When used concomitantly, inhalation anaesthetics and calcium antagonists, such as verapamil hydrochloride, should each be titrated carefully to avoid additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Lipid lowering agents

Verapamil 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 should be started at the lowest possible dose and titrated upwards. If verapamil 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 levels. Although there is no direct in vivo clinical evidence, there is strong potential for verapamil to significantly affect atorvastatin pharmacokinetics in a similar manner to simvastatin or lovastatin. Consider using caution when atorvastatin and verapamil are concomitantly administered.

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

Lithium

Serum levels of lithium may be reduced. However, there may be increased sensitivity to lithium causing enhanced neurotoxicity.

Neuromuscular blocking agents employed in anaesthesia

The effects may be potentiated.

Serotonin receptor agonists

Verapamil may increase the plasma concentrations of almotriptan.

Theophylline

Verapamil may increase the plasma concentrations of theophylline.

Uricosurics

Sulfinpyrazone may reduce the plasma concentrations of verapamil which may produce a reduced blood pressure lowering effect.

Anticoagulants

When oral verapamil was co-administered with dabigatran 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. Co- administration of verapamil 240mg Extended-release at the same time as dabigatran etexilate resulted in increased dabigatran exposure (increase of Cmax by about 90 % and AUC by about 70 %).

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

Other Cardiac therapy

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

Other

St. John’s Wort may reduce the plasma concentrations of verapamil, whereas grapefruit juice may increase the plasma concentrations of verapamil.

  • Pregnancy and lactation

Although animal studies have not shown any teratogenic effects, verapamil should not be given during the first trimester of pregnancy unless, in the clinician’s judgement, it is essential for the welfare of the patient.

Verapamil hydrochloride is excreted in human breast milk. Limited human data from oral administration has shown that the infant relative dose of verapamil is low (0.1 – 1% of the mother’s oral dose) and that verapamil use may be compatible with breastfeeding. Due to the potential for serious adverse reactions in nursing infants, verapamil should only be used during lactation if it is essential for the welfare of the mother.

  • Effects on ability to drive and use machines

Depending on individual susceptibility, the patient’s ability to drive a vehicle, operate machinery or work under hazardous conditions may be impaired. This is particularly true in the initial stages of treatment, when changing over from another drug or when the dose is raised. Like many other common medicines, verapamil has been shown to increase the blood levels of alcohol and slow its elimination. Therefore, the effects of alcohol may be exaggerated.

  • Undesirable effects

Reactions from Postmarketing Surveillance or Phase IV Clinical Trials

The following adverse events reported with verapamil are listed below by system organ class:

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

Nervous system disorders: headache, dizziness, paresthesia, tremor and extrapyramidal syndrome.

Ear and labyrinth disorders: vertigo and tinnitus.

Cardiac disorders/vascular disorders: bradycardic arrhythmias such as sinus bradycardia, sinus arrest with asystole, 2nd and 3rd degree AV block, bradyarrhythmia in atrial fibrillation, peripheral oedema, palpitations, tachycardia, development or aggravation of heart failure and hypotension. There have been rare reports of flushing.

Gastrointestinal disorders: nausea, vomiting, constipation, ileus and abdominal pain/discomfort. Gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods, and is fully reversible when the drug is discontinued.

Skin and subcutaneous tissue disorders: ankle oedema, Quincke’s oedema, Steven-Johnson syndrome, erythema multiforme, erythromelalgia, alopecia and 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. On very rare occasions, gynaecomastia has been observed in elderly male patients under long-term verapamil treatment, and is fully reversible in all cases when the drug was discontinued.

General disorders and administration site conditions: fatigue.

Investigations: A reversible impairment of liver function characterized by an increase of transaminase and/or alkaline phosphatase may occur on very rare occasions during verapamil treatment and is most probably a hypersensitivity reaction. Rises in blood prolactin levels have been reported.

  • Overdose

The course of symptoms in verapamil 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 was taken and the type and severity of intoxication symptoms. In intoxications with large amounts of slow-release preparations (Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma), it should be noted that the release of the active drug and the absorption in the intestine may take more than 48 hours. Verapamil 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 Verapamil Hydrochloride ER Taj Pharma or Half Verapamil Hydrochloride ER Taj Pharma 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 -20 ml of a 10% calcium gluconate solution administered intravenously (2.25 – 4.5 mmol), repeated if necessary or given as a continuous drip infusion (e.g. 5 mmol/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. If there are signs of continuing myocardial failure – dopamine, dobutamine, if necessary repeated calcium injections.

  1. Pharmacological properties
    • Pharmacodynamic properties

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

Verapamil, a phenylalkylamine calcium antagonist, has a balanced profile of cardiac and peripheral effects. It lowers heart rate, increases myocardial perfusion and reduces coronary spasm. In a clinical study in patients after myocardial infarction, verapamil reduced total mortality, sudden cardiac death and reinfarction rate.

Verapamil reduces total peripheral resistance and lowers high blood pressure by vasodilation, without reflex tachycardia. Because of its use-dependent action on the voltage-operated calcium channel, the effects of verapamil are more pronounced on high than on normal blood pressure.

As early as day one of treatment, blood pressure falls; the effect is found to persist also in long-term therapy. Verapamil is suitable for the treatment of all types of hypertension: for monotherapy in mild to moderate hypertension; combined with other antihypertensives (in particular with diuretics and, according to more recent findings, with ACE inhibitors) in more severe types of hypertension. In hypertensive diabetic patients with nephropathy, verapamil in combination with ACE inhibitors led to a marked reduction of albuminuria and to an improvement of creatinine clearance.

  • Pharmacokinetic properties

Verapamil hydrochloride is a racemic mixture consisting of equal portions of the R-enantiomer and the S-enantiomer. Verapamil is extensively metabolized. Norverapamil is one of 12 metabolites identified in urine, has 10 to 20% of the pharmacologic activity of verapamil and accounts for 6% of excreted drug. The steady-state plasma concentrations of norverapamil and verapamil are similar.

Steady state after multiple once daily dosing is reached after three to four days.

Absorption

Greater than 90% of verapamil is rapidly absorbed from the small intestine after oral administration. Mean systemic availability of the unchanged compound after a single dose of ER verapamil is approximately 33%, owing to an extensive hepatic first-pass metabolism. Bioavailability is about two times higher with repeated administration. Peak verapamil plasma levels are reached four to five hours after ER administration. The peak plasma concentration of norverapamil is attained approximately five hours after ER administration. The presence of food has no effect on the bioavailability of verapamil.

Distribution

Verapamil is widely distributed throughout the body tissues, the volume of distribution ranging from 1.8–6.8 L/kg in healthy subjects. Plasma protein binding of verapamil is approximately 90%.

Metabolism

Verapamil is extensively metabolized. In vitro metabolic studies indicate that verapamil is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. In healthy men, orally administered verapamil hydrochloride undergoes extensive metabolism in the liver, with 12 metabolites having been identified, most in only trace amounts. The major metabolites have been identified as various N and O-dealkylated products of verapamil. Of these metabolites, only norverapamil has any appreciable pharmacological effect (approximately 20% that of the parent compound), which was observed in a study with dogs.

Elimination

Following oral administration, the elimination half-life is three to seven hours. Approximately 50% of an administered dose is eliminated renally within 24 hours, 70% within five days. Up to 16% of a dose is excreted in the feces. About 3% to 4% of renally excreted drug is excreted as unchanged drug. The total clearance of verapamil is nearly as high as the hepatic blood flow, approximately 1 L/h/kg (range: 0.7-1.3 L/h/kg).

Special Populations

Geriatric:

Aging may affect the pharmacokinetics of verapamil given to hypertensive patients. Elimination half-life may be prolonged in the elderly. The antihypertensive effect of verapamil was found not to be age-related.

Renal insufficiency:

Impaired renal function has no effect on verapamil pharmacokinetics, as shown by comparative studies in patients with end-stage renal failure and subjects with healthy kidneys. Verapamil and norverapamil are not significantly removed by hemodialysis.

Hepatic insufficiency:

The half-life of verapamil is prolonged in patients with impaired liver function owing to lower oral clearance and a higher volume of distribution.

  • Preclinical safety data

Reproduction studies have been performed in rabbits and rats at oral verapamil doses up to 0.6 and 1.2 times respectively the maximum recommended human oral daily dose based on a body surface area comparison (mg/m2) and have revealed no evidence of teratogenicity. In the rat, however, a dose similar to the clinical dose was embryocidal and retarded fetal growth and development. These effects occurred in the presence of maternal toxicity (reflected by reduced food consumption and reduced weight gain of dams). This oral dose has also been shown to cause hypotension in rats.

  1. Pharmaceutical particulars
    • List of excipients

Microcrystalline cellulose,

Sodium alginate,

Povidone K30,

Magnesium stearate,

Purified water,

Hypromellose 2910,

Macrogol 400,

Macrogol 6000,

Talc,

Titanium dioxide,

L-green lake [quinoline yellow and indigo carmine aluminium lacquer],

Montan glycol wax.

  • Incompatibilities

None stated.

  • Shelf life

36 months.

  • Special precautions for storage

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

  • Nature and contents of container

Calendar pack consisting of a PVC/PVDC blister in a cardboard outer container.

Pack size:

Each pack contains 10, 14, 20, 28, 30, 40, 50, 560, 60, 80, 100, 120, 240, 360 and 500 Extended Release Tablets.

Not all pack size may be marketed to another country.

  • Special precautions for disposal and other handling

No special requirements. The Tablets should not be chewed or sucked, but may be halved without affecting the modified-release form.

Any unused medicinal product or waste material should be disposed of in accordance with local 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

Verapamil Hydrochloride ER Tablets 360mg Taj Pharma

PATIENT INFORMATION LEAFLET

Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma Tablets

Extended release

Verapamil hydrochloride USP

IMPORTANT INFORMATION

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet as you may need to read it again
  • This leaflet provides a summary of the information currently available about Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma
  • For further information or advice ask your doctor or pharmacist
  • This medicine is for you only and should never been given to anyone else, even if they appear to have the same symptoms as you
  • Tell your doctor or pharmacist if you experience any side effects

What is in this leaflet

  1. What Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma is and what is it used for
  2. What you need to know before you take Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma
  3. How to take Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma
  4. Possible side effects
  5. How to store Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma
  6. Contents of the pack and other information
  1. What Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma is and what is it used for

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma Tablets belong to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cells in your heart and blood vessels. This can change the strength and speed with which your heart beats. It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure.

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma Tablets are used to treat hypertension (high blood pressure) and to prevent angina (chest pain) attacks. The Tablets may also be prescribed following a heart attack, to prevent another attack occuring.

The active ingredient in Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma Tablets is verapamil hydrochloride.

  1. What you need to know before you take Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma

If the answer to any of the following questions is ‘YES’ please tell your doctor or pharmacist BEFORE taking any Tablets:

  • Are you are sensitive (allergic) to verapamil or any of the other ingredients in the Tablets? (See section 6)
  • Are you pregnant or planning to become pregnant, or are you breast feeding?
  • Do you have very low blood pressure?
  • Do you have or have you ever suffered from heart problems such as heart failure?
  • Do you have an abnormally slow or irregular heart beat?
  • Have you recently had a heart attack?
  • Do you have liver or kidney problems?
  • Do you have or have you ever suffered from heart problems such as heart failure or the heart condition called Wolff-Parkinson-White syndrome?
  • Do you have a condition where the nerve to muscle transmission is affected e.g. myasthemia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy?
  • Are you being treated with ivabradine (for heart conditions)?

Taking other medicines.

Please tell your doctor or pharmacist if you are taking any medicines with or without a prescription or have recently taken any of the following medicines:

  • beta-blockers used to treat high blood pressure and heart conditions (these include atenolol, propranolol and metoprolol)
  • alpha blockers used to treat high blood pressure and heart conditions (these include prazosin and terazosin)
  • diuretics (also called ‘water pills’)
  • medicines known as “statins” such as atorvastatin, lovastatin, simvastatin used to lower cholesterol levels
  • any other medicine for high blood pressure or an abnormal heart beat (arrhythmia) such as quinidine, flecainide, disopyramide, digoxin and digitoxin
  • dabigatran (medicine to prevent the formation of blood clots)
  • medicines containing ivabradine for the treatment of certain heart diseases
  • medicines used to treat depression (including the herbal product St John’s Wort), anxiety or psychosis. These may include imipramine, buspirone and lithium
  • medicines known as immunosuppressants such as ciclosporin, sirolimus, everolimus and tacrolimus. These are used to prevent organ transplant rejection
  • glibenclamide, used to treat certain types of diabetes
  • aspirin, a non-steroidal anti-inflammatory painkiller (NSAID) used to relieve pain and reduce fever
  • almotriptan, used to treat migraine
  • midazolam, used as a sedative or anaesthetic
  • theophylline, used to treat asthma
  • doxorubicin, an anti-cancer medicine
  • cimetidine, used to treat indigestion or stomach ulcers
  • rifampicin, used to treat tuberculosis and other types of infection
  • carbamazepine, phenytoin or phenobarbital (phenobarbitone). These medicines are used as anti-convulsants.
  • ritonavir, used to treat HIV
  • erythromycin, clarithromycin and telithromycin, used to treat types of infection
  • colchicine or sulfinpyrazone, used to treat gout.

Tell your surgeon or dentist that you are taking Verapamil Hydrochloride ER Taj Pharma or Half Verapamil Hydrochloride ER Taj Pharma if surgery is planned as it may affect the anaesthetic used.

Driving and operating machines

Do NOT drive, operate machinery or do anything that requires you to be alert, until you know how the Tablets affect you.

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma can make some people feel dizzy, especially when they first start to take the Tablets.

Other important information

Do NOT drink grapefruit juice whilst taking your Tablets as it can affect the absorption of this medicine. This does not occur with other fruit juices such as orange, apple or tomato juice.

Drinking alcohol

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma will increase the time your body takes to get rid of alcohol. This means that you may not have to drink as much for your blood alcohol levels to be above the legal limit to drive. It will also take you longer to sober up.

Pregnancy and breast feeding

Please discuss with your doctor if you are pregnant, planning to become pregnant or are breast feeding.

  1. How to take Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma

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

TAKE YOUR TABLETS with a glass of water. You should swallow the Tablets without chewing or crushing them. It does not matter if you have not eaten.

The number of Tablets that you will need to take will depend on what you are being treated for:

ADULTS:

Hypertension (high blood pressure)

The recommended dose is one Verapamil Hydrochloride ER Taj Pharma 240mg Tablets a day. If you have not taken Verapamil Hydrochloride ER Taj Pharma 240mg before, your doctor may prescribe a lower dose such as a Half Verapamil Hydrochloride ER Taj Pharma 120mg Tablets each day. The maximum dose to treat high blood pressure is 480mg each day. This is usually taken as one Securon 240mg Tablets in the morning and one in the evening, leaving a gap of about 12 hours between each dose.

Angina (chest pain)

The usual starting dose for angina is one Verapamil Hydrochloride ER Taj Pharma 240mg Tablets taken twice a day. You should take one Tablets in the morning and one in the evening, with a gap of about 12 hours in between them. Your doctor may prescribe a lower dose according to your symptoms.

Following a heart attack

The usual dose following a heart attack is 360mg each day. This may be taken as one Verapamil Hydrochloride ER Taj Pharma 240mg Tablets in the morning and a Half Verapamil Hydrochloride ER Taj Pharma 120mg Tablets in the evening or as one Half Verapamil Hydrochloride ER Taj Pharma 120mg Tablets taken three times a day. The doctor will usually wait at least a week after your heart attack before prescribing these Tablets.

CHILDREN:

Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma are NOT recommended for children under 12 years of age.

Elderly

The dose will be the same as that for adults. If you have kidney or liver problem, your doctor may lower your dose.

If you take more Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma than you should

If you take more Tablets than prescribed (an overdose) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your Tablets with you.

If you forget to take Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma

If you forget to take your Tablets take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Do not take double dose to make up for a forgotten Tablets.

If you stop taking Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma

If you stop taking your Tablets your condition may get worse. It is important that you keep taking these Tablets until your doctor tells you to stop. Do NOT stop just because you feel better.

Other things to remember about Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma

  • Verapamil Hydrochloride ER Taj Pharma 240mg Tablets may be broken in half if your doctor advises you to do so (e.g. if a lower dose has been prescribed).
  • The Tablets should NOTbe crushed, chewed or sucked, as this will affect the Extended release formulation of the product.

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

  1. Possible side effects

As with all medicines, Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma can cause side effects, although not everyone will suffer from them. If you experience any other unusual symptoms whilst taking your Tablets, tell your doctor or pharmacist.

Tell your doctor IMMEDIATELY if you experience any of the following side effects:

  • Yellowing of the skin or eyes, a fever or tenderness around the middle. These are signs that your liver may not be functioning as well as usual
  • Palpitations, chest pains for the first time or chest pains becoming more frequent, swollen ankles, hot and painful hands or feet
  • Swelling of the limbs
  • Unexpected wheezing, difficulty breathing, swelling of the mouth, lips or tongue or severe skin rash

The most common side effect is constipation. Other side effects include abnormal heart beat, flushing of the face or neck, headaches, feeling or being sick, abdominal pain or discomfort, dizziness, vertigo, tinnitus (ringing or buzzing in the ears), tiredness, tremor, movement disorders, muscle weakness, aches and pains in the joints and/or muscles, skin rash or itching, a tingling or prickling feeling on the skin, numbness and hair loss. Impotence may occur rarely.

Other side effects might occur if Verapamil Hydrochloride ER Taj Pharma or Half Verapamil Hydrochloride ER Taj Pharma are used for a long time. Tell your doctor if you develop swollen gums which start to spread over your teeth, or if your breasts swell (males) or start to produce milk (males and females). These effects are rare and are resolved upon stopping taking the Tablets.

  1. How to store Verapamil Hydrochloride ER Taj Pharma / Half Verapamil Hydrochloride ER Taj Pharma

Do NOT take your Tablets after the ‘use by’ date shown on the carton. Keep them in the original pack, at normal room temperature (do not store them above 25 °C).

Your Tablets should be stored in a safe place out of the reach and sight of children, your medicine could harm them.

If your doctor decides to stop treatment, return any leftover Tablets to your pharmacist. Only keep the Tablets if your doctor tells you to. Do NOT dispose of leftover Tablets carelessly (e.g. down the toilet or in with your general rubbish).

  1. Contents of the pack and other information

What Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma contains

  • The active substance is verapamil hydrochloride, in a Extended release (slow release) formulation.
  • Each Verapamil Hydrochloride ER Taj Pharma Tablets contains 120mg, 180mg, 240mg and 360mg of verapamil hydrochloride.
  • Each Half Verapamil Hydrochloride ER Taj Pharma Tablets contains 180mg of verapamil hydrochloride.
  • The other ingredients are sodium alginate, microcrystalline cellulose, povidone K30, purified water, talc, titanium dioxide, hypromellose 2910, magnesium stearate, macrogol 400, macrogol 6000, and montan glycol wax. In addition, Verapamil Hydrochloride ER Taj Pharma (240mg) Tablets contain I-green lake (quinoline yellow and indigo carmine aluminium lacquer.

What Verapamil Hydrochloride ER Taj Pharma and Half Verapamil Hydrochloride ER Taj Pharma look like and contents of the pack:

Verapamil Hydrochloride ER Taj Pharma Tablets are pale green, oblong in shape,

Calendar pack consisting of a PVC/PVDC blister in a cardboard outer container.

Pack size:

Each pack contains 10, 14, 20, 28, 30, 40, 50, 560, 60, 80, 100, 120, 240, 360 and 500 Extended Release Tablets.

Not all pack size may be marketed to another country.

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