Eden Atenolol Tablets

Eden Atenolol 50 mg
(Atenolol Tablets BP 50mg)

For the use of a Registered Medical Practitioner or Hospital or a Laboratory only

 

COMPOSITION

Each uncoated tablet contains

Atenolol BP 50mg

 

CLINICAL PHARMACOLOGY

Pharmacological Action

Beta- adrenoceptor antagonists complete with beta-adrenergic agonists for available beta-receptor sites. Unselective beta-blockers inhibit the beta1 receptors (located chiefly in cardiac muscle) and beta2 receptors (located chiefly in the bronchial and vascular musculature) inhibiting the chronotropic, inotroptic and vasodilator responses to beta-adrenergic stimulation. Atenolol is cardioselective and preferentially inhibits beta1 adrenoceptors. Beta1 selectively has been confirmed by the inability of atenolol to reverse the beta2 mediated vasodilating effects of adrenaline or isoprenaline. This contrasts with the effect of nonselective beta-blockers which completely reverse the vasodilating effects of adrenaline. Atenolol does not have membrane stabilizing effects, little direct myocardial depressant activity and little or no intrinsic sympathomimetic activity.

Clinical response to beta-blockage includes slowing of the sinus heart rate, depressed AV conduction, decreased cardiac output at rest and on exercise, reduction of systolic blood pressure on exercise, reduction of both supine and standing blood pressure, inhibition of isoprenaline-induced tachycardia amid reduction of reflex orthostatic tachycardia.

 

Pharmacokinetics

Absorption: Atenolol is consistently absorbed when administered orally; with approximately 50-60% of the dose administered being absorbed. After an oral dose of 100 mg a mean peak serum level of 880ng/ml was reached in approximately 3 hours, declining to approximately 63 ng/ml in 24 hours.

Distribution: Atenolol is widely distributed throughout the body, but only a small amount of the drug reaches the brain. Atenolol is not significantly bound to serum proteins. In pregnancy atenolol readily crosses the placenta, the umbilical and maternal serum being approximately equal at birth.

Metabolism: Metabolism of atenolol in man is minimal. In animal studies, hydroxilated compound, with minor beta-blocking activity, has been identified as a minor metabolite of atenolol, but atenolol does not appear to be metabolised to any significant extent in man.

Excretion: Atenolol is excreted unchanged, mainly through the kidneys. About 40-50% of a single oral dose is excreted in the urine of healthy subjects. The elimination half life of atenolol is approximately 6-7 hours.

In renal dysfunction, the elimination of atenolol is closely related to the glomerular-filtration rate, although important accumulation probably only occurs if the glomerular filtration is less than 30 ml/min.

 

INDICATION AND USAGE

• In the management of hypertension

• In the management of angina pectoris

• In the management of cardiac dysrhythmias

• In the management of myocardial infarction: early intervention in the acute phase and long term prophylaxis after recovery from myocardia infarction.

 

CONTRAINDICATION

As with other beta-adrenoceptor blocking drugs, atenolol should not be used in the following circumstances

• Patients with second degree or third degree hearth block.

• Patients with severe bradycardia.

• Uncontrolled or digitalis/diuretic-refractory heart failure.

• Patients with cardiogenic shock.

• Patients with sick sinus syndrome.

• Patients with untreated phaeochromocytoma.

• Patients with hypersensitivity to Atenolol or to any other ingredients of the preparation.

• Patients with severe peripheral circulatory disturbances.

• Patients with metabolic acidiosis.

• Patients with hypotension.

 

INTERACTION

• The beta-blocker should only he used with great caution in patients who are receiving concomitant myocardial depressants such as chloroform, lignocaine, procainamide, beta-adrenoceptor stimulants such as isoprenaline, or verapamil or alpha-adrenoceptor stimulants such as noradrenaline, adrenaline (which reverse the hypotensive effects and increase the vasoconstrictor activities).

• Neurotic blocking agents such as guanethidine, reserpine, diuretics and other antihypertensive agents, including the vasodilator group, will have an additive effect on the hypotensive action of the drug.

• The beta-blocker may mask the symptoms of thyrotoxicosis.

• Caution should be exercised when transferring patients from clonidine to beta-adrenoceptor blocking drugs. If the beta-blocker and clonidine are given concurrently, the clonidine should not be discontinued until several days after withdrawal of the beta-blocker.

• Combined use of beta-adrenoceptor blocking drugs and calcium channel blockers with negative inotropic effects e.g. verapamil, dilitiazem, can lead to an exaggeration of these effects, particularly in patients with impaired ventricular function and /or sino-atrial or antrio-ventricular conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-adrenoceptor blocking drug nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

• Digitalis glycosides, in association with beta-adrenoceptor-blocking drugs, may increase atrio-ventricular conduction time.

• Caution must be exercised when prescribing a beta-adrenoceptor blocking drug with Class1 antiarrythmic agents such as disopyramide.

• Beta-blockers may have hypoglyaemic or hyperglycaemic actions and may decrease or increase the patient’s requirements for insulin or oral antidiabetic agents. Beta-blockers may mask some of the symptoms of hypoglycaemia.

• Plasma concentrations of beta-adrenoceptor blocking drugs may be increased by cimetidine, which is believed to impair beta-blocker metabolism.

• Reduction in first-pass metabolism of oral beta-adrenoceptor blocking drugs may occur in patients also receiving hydralazine.

• Plasma clearance of beta-adrenoceptor blocking drugs can be affected by alcohol intake.

• Concomitant use of prostaglandin synthetase inhibiting drug e.g. ibuprofen or indomethacin may decrease the hypotensive effects of beta-adrenoceptor blocking drugs.

• Plasma concentrations of some beta-adrenoceptor blocking drugs may be reduced by barbiturates.

• Concomitant use of phenothiazines and beta-adrenoceptor blocking drugs may cause increased plasma concentrations and bioavailability and reduced
metabolism.

 

WARNINGS AND PRECAUTIONS

• Sudden withdrawal of beta-adrenoceptor blocking agents in patients with ischaemic heart disease may result in the appearance of anginal attacks of increased frequency or severity or deterioration in cardiac state. Discontinuation of therapy should be gradual.

• In Anaesthesia: Care should be taken when using anaesthetic agents with atenolol. The anaesthetist should be informed to enable the necessary precautions to be taken.

• If a beta-blocker is withdrawn prior to surgery it should be discontinued for at least 24 hours.

• Atenolol should only be used with caution in patients with controlled congestive cardiac failure. Evidence of development of this condition should be regarded as a signal to discontinue therapy.

• Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease, unless no alternative treatment is available. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken.

• The initial treatment of severe malignant hypertension should be designed as to avoid sudden reduction in diastolic blood pressure with impairment of autoregulatory mechanisms.

• Patients with psoriasis should take beta-blockers only after careful consideration.

• Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

• Atenolol may increase the number and duration of angina attacks in patients with Prinzmetal’s angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Atenolol is a beta1 selective beta adrenoceptor-blocking drug; consequently, its use maybe considered although utmost caution must be exercised.

• Although contraindicated in severe peripheral arterial circulatory disturbance, atenolol may also aggravate less severe peripheral arterial circulatory disturbances.

• Due to atenolol’s negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block.

 

PREGNANCY

The safety of amlodipine in human pregnancy has not been established. In animal studies, re-productive toxicity was observed at high doses. Use in pregnancy is only recomnmended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.

Breast-Feeding: It is not known whether amlodipine is excreted in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breast-feeding to the child and the benefit of amlodipine therapy to the mother.

Fertility: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility.

 

ADVERSE REACTION

Atenolol is generally well-tolerated and side effects associated with it are infrequent and generally mild. These can include: coldness of the extremities and muscular fatigue may occur and, in isolated cases, bradycardia. Sleep disturbances which are associated with some other beta-blocking preparations are rare.

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment is withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy with a beta- blocker should be gradual.

Beta-adrenergic blocking drugs can cause dry mouth and gastrointestinal disturbances including nausea and vomiting, diarrhea, constipation and abdominal cramping. The signs of thyrotoxicosis maybe masked by atenolol treatment.

Bronchospasm may occur in patients with bronchial asthma or history of asthmatic complaints.

An increase in ANA(antinuclear antibodies) has been observed, however, the clinical relevance of this is not clear.

 

DRUG ABUSE AND DEPENDENCE

None

 

SYMPTOMS OF OVERDOSAGE AND PARTICULAR TREATMENT

Symptoms: Signs of overdosage are bradycardia, severe hypotension, bronchospasm, hypoglycaemia, acute cardiac insufficiency and heart failure.

Treatment: General treatment should include: close supervision: treatment in an intensive care ward, if ingestion is recent, the stomach should be emptied by aspiration and lavage; activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract; the use of plasma or plasma substitutes to treat hypotension and shock. The possible uses of haemodialysis or haemoperfusion may be considered.

From first principles, excessive bradycardia may be countered by atropine 1-2mg intravenously and/or a cardiac pacemaker, followed, if necessary, by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as prenalterol 5 mg intravenously, followed if necessary by an intravenous infusion of 5 mg/hour or dobutamine 2.5 to 10 microgram/kg/minute by intravenous infusion may be given. Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blocker blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.
Any risk of hypotension occurring following the use of beta-adrenoceptor agonists will be reduced by the use of the more selective agents. e.g. prenalterol and dobutamine. Bronchospasm can usually be reversed by bronchodilators.

 

DOSAGE AND ADMINISTRATION

Posology

Adults

Hypertension: One tablet daily. Most patients respond to 100 mg daily given as a single dose. Some patients, however, will respond to 50 mg given as a single daily dose. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents. For example, co-administration of atenolol with a diuretic provides a highly effective and convenient antihypertensive therapy.

Angina: Most patients with angina pectoris will respond to 100mg given orally once daily or 50mg given twice daily: It is unlikely that additional benefit will be gained by increasing the dose.

Dysrhythmias: Having controlled the dysrhythmias with intravenous atenlol a suitable maintenance dosage is 50mg – 100mg daily, given as a single dose.

Myocardial Infarction: 15 minutes after the administration of the intravenous dose an oral dose of 50mg may be given provided that no untoward effects occur from the intravenous dose.

This should be followed by a further 50mg orally 12 hours after the intravenous dose and then 12 hours later by 100mg orally to be given once daily for up to ten days. If bradycardia and/or hypotension require treatment, or may other untoward effects occur, atenolol should be discontinued.

 

Special Populations

Renal Failure: Atenolol is excreted via the kidneys, dosage adjustment should therefore be considered in patients with severe impairment of renal function. As a guide, for patients with a serum creatinine of 300- 600 µmol/L, the atenolol oral dose should be 50mg daily or 100mg once every two days, for patients with a serum creatinine of >600 µmol/L, the oral dose of atenolol should be 50mg on alternate days or 100mg once every four days.

Patients on haemodialysis should be given 50mg atenolol orally following each dialysis. Because of the possibility of marked falls in blood pressure: this should be carried out under hospital supervision.

Elderly: Dosage requirements may be reduced, especially in patients with impaired renal function.

Children: There is no paediatric experience with atenolol and for this reason it is not recommended for use in children.

 

Method of Administration

For oral administration.

 

THE PREPARATION FOR USE

Take the whole Tablet with a glass of water.

 

PRESENTATION: 2 x 14 Tablets packed in Alu-PVC Blister Pack.

 

STORAGE CONDITION: Store at temperature not exceeding 30oC in a dry place. Protect from light.

 

KEEP OUT OF REACH AND SIGHT OF CHILDREN

 

SHELF LIFE: 36 Months

 

Manufactured by

Scott- Edil Pharmacia Ltd.

56,EPIPP, Phase1, Jharmajri 173205,

Distt. Solan (H.P.), India.

 

Imported and distributed by

Eden U.K Pharmaceutical Ltd

J116, Daminja Avenue, Housing Estate,

Fegge, Anambram State, Nigeria.

Clopidogrel Teva Film Coated Tablets

Clopidogrel Teva 75 mg film-coated tablets

Package leaflet: Information for the user

 

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

– Keep this leaflet. You may need to read it again.

– If you have any further questions, ask your doctor 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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

 

What is in this leaflet

1 What Clopidogrel Teva is and what it is used for

2 What you need to know before you take Clopidogrel Teva

3 How to take Clopidogrel Teva

4 Possible side effects

5 How to store Clopidogrel Teva

6 Contents of the pack and other information

 

1 What Clopidogrel Teva is and what it is used for

Clopidogrel Teva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Clopidogrel Teva is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel Teva to help prevent blood clots and reduce the risk of these severe events because:

– You have a condition of hardening of arteries (also known as atherosclerosis), and

– You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or

– You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

– You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel Teva and acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

 

2 What you need to know before you take Clopidogrel Teva

Do not take Clopidogrel Teva

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).

• If you have a medical condition that is currently causing bleeding such as a
stomach ulcer or bleeding within the brain.

• If you suffer from severe liver disease.

If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva.

 

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva:

• If you have a risk of bleeding such as

– A medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).

– A blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).

– A recent serious injury.

– A recent surgery (including dental).

– A planned surgery (including dental) in the next seven days.

• If you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.

• If you have kidney or liver disease.

• If you have had an allergy or reaction to any medicine used to treat your disease.

 

While you are taking Clopidogrel Teva:

• You should tell your doctor if surgery (including dental) is planned

• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).

• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).

• Your doctor may order blood tests.

 

Children and adolescents

Do not give this medicine to children because it does not work.

 

Other medicines and Clopidogrel Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some other medicines may influence the use of Clopidogrel Teva or vice versa.

You should specifically tell your doctor if you take

– Medicines that may increase your risk of bleeding such as:

o Oral anticoagulants, medicines used to reduce blood clotting,

o A non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

o Heparin or any other injectable medicine used to reduce blood clotting,

o Ticlopidine, other antiplatelet agent,

o A selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

– Omeprazole or esomeprazole, medicines to treat upset stomach,

– Fluconazole or voriconazole, medicines to treat fungal infections,

– Efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,

– Carbamazepine, a medicine to treat some forms of epilepsy,

– Moclobemide, medicine to treat depression,

– Repaglinide, medicine to treat diabetes,

– Paclitaxel, medicine to treat cancer.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

 

Pregnancy and breast-feeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva. If you become pregnant while taking Clopidogrel Teva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breast-feed while taking this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

 

Driving and using machines

Clopidogrel Teva is unlikely to affect your ability to drive or to use machines.

 

Clopidogrel Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

 

3 How to take Clopidogrel Teva

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

The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Teva per day as described above.

You should take Clopidogrel Teva for as long as your doctor continues to prescribe it.

 

If you take more Clopidogrel Teva than you should

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

 

If you forget to take Clopidogrel Teva

If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of usual time, take your tablet straightaway and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time.

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

For the 28 x 1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel Teva by referring to the calendar printed on the blister.

 

If you stop taking ClopidogrelTeva

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

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.

 

Contact your doctor immediately if you experience

• Fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells

• Signs of liver problems such as yellowing of the skin and/ or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions’).

• Swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.

These may be the signs of an allergic reaction.

The most common side effect reported with Clopidogrel Teva is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

 

If you experience prolonged bleeding when taking Clopidogrel Teva

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form.

For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.

However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).

 

Other side effects include

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

Diarrhoea, abdominal pain, indigestion or heartburn.

 

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

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

 

Rare side effect (may affect up to 1 in 1000 people):

Vertigo, enlarged breasts in males.

 

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

Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.

In addition, your doctor may identify changes in your blood or urine test results.

 

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. You can also report side effects directly via the national reporting system listed via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

 

5 How to store Clopidogrel Teva

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

Do not use this medicine after the expiry date which is stated on the outer carton, bottle or blister, after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice any visible sign of deterioration.

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

 

6 Contents of the pack and other information

What Clopidogrel Teva contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

• The other ingredients are (see section 2 ‘Clopidogrel Teva contains lactose’):

– Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463),crospovidone (type A), hydrogenated vegetable oil and sodium laurilsulfate.

– Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132).

 

What ClopidogrelTeva looks like and contents of the pack

• The film-coated tablets are light pink to pink, film coated, capsule shaped tablets. One side of the tablet is debossed with the number “93’’ The other side of the tablet is debossed with the number “7314’’.

• Clopidogrel Teva is supplied in:

– Peelable perforated blisters of aluminium/aluminium containing 14×1, 28×1, 30×1, 50×1, 84×1, 90×1 or 100×1 tablets.

– Perforated blisters of aluminium/aluminium containing 14×1, 28×1, 30×1, 50×1, 84×1, 90×1 or 100×1 tablets.

– HDPE bottles with polypropylene closures or child resistant polypropylene
closures and silica gel desiccant containing 30 or 100 tablets.

– Calendar pack of perforated blisters of aluminium/aluminium containing 28×1
tablets.

Not all pack sizes may be marketed.

Please note that instructions on how to remove the tablet from the blister strip
are given on the outer carton of the peelable blisters.

 

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva B.V.,

Swensweg 5

2031 GA Haarlem

The Netherlands

 

Manufacturer

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG,

United Kingdom

Teva Metoprolol Tartrate Tablets

METOPROLOL TARTRATE 50 mg AND 100 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

 

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

• Keep this Ieaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1 What Metoprolol is and what it is used for

2 What you need to know before you take Metoprolol

3 How to take Metoprolol

4 Possible side effects

5 How to store Metoprolol

6 Contents of the pack and other information

 

1 What Metoprolol is and what it is used for

Metoprolol belongs to a group of drugs called beta-blockers, which affect the heart and circulation.

Metoprolol tablets are used to:

• Manage high blood pressure

• Manage angina pectoris (chest pain) and heartbeat irregularities, and may also be given after a heart attack

• Prevent recurrent migraines

• Treat hyperthyroidism (an overactive thyroid gland).

 

2 What you need to know before you take Metoprolol

Do NOT take Metoprolol if you

• Are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6)

• Are allergic to any other beta-blocker drugs

• Have severe asthma or severe attacks of wheezing

• Have heart failure, severe slow heart beat, irregular heart beat, narrowing of the arteries or had a heart attack with complications

• Have second or third degree heart block (a condition which may be treated by a
pacemaker)

• Have low blood pressure

• Have poor circulation

• You been told that you have high blood pressure due to a tumour near your kidney (phaeochromocytoma)

• Are pregnant or breast-feeding

• Have metabolic acidosis (a condition where there is a change in the acid/base balance of the body).

 

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Metoprolol. If you:

• Have a history of or suffer from allergies

• Have any other heart problems, in particular, a slow heartbeat

• Have poor blood circulation or controlled heart failure

• Suffer from psoriasis (patches of thickened and sore skin)

• Are diabetic. Your treatment for diabetes may need to be adjusted

• Have any liver problems

• Have a history of asthma or wheezing or any similar lung disorder

• Have recently suffered a severe allergic reaction

• Have a tumour of the adrenal gland (phaeochromocytoma)

• Have a type of chest pain (angina) called prinzmetal’s angina

• Have first degree heart block

• Have thyrotoxicosis (a condition caused by an overactive thyroid gland).Your medicine may hide the symptoms of thyrotoxicosis.

• Suffer from eye disorders.

If you are about to undergo surgery requiring anaesthetic, tell your doctor or dentist that you are taking Metoprolol.

 

Other medicines and Metoprolol

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

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and metoprolol together, do not stop taking clonidine unless your doctor has told you to do so. If you have to stop taking clonidine or metoprolol, your doctor will give you careful instructions about how to do it.

• Other drugs for your heart or to reduce blood pressure, e.g. prazosin

• Other beta blockers, e.g. timolol, for glaucoma

• Monoamine-oxidase inhibitors, for depression, e.g. phenelzine

• Verapamil, diltiazem, hydralazine, nifedipine (used to treat heart problems)

• Quinidine, amiodarone (for heart problems)

• Cimetidine (used to treat heartburn)

• Cardiac glycosides e.g. digoxin (used to treat heart failure)

• Rifampicin (used to treat tuberculosis)

• Lidocaine (used as a local anaesthetic to relieve pain)

• Ergotamine (used to treat migraine)

• Medicines to treat other mental illnesses (such as phenothiazines)

• Antiretroviral drugs (e.g. ritonavir) used to treat AIDS and some other conditions

• Drugs to prevent malaria

• Medicines to treat fungal infections

• Adrenaline (used in emergency treatment e.g. allergic reactions)

• Indometacin and celecoxib (used to treat inflammation of the joints, gout and period pain) medicines for the treatment of diabetes (including insulin).Your doctor may need to adjust your dose of these medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines, including medicines obtained without a prescription.

 

Taking Metoprolol with food, drink and alcohol

You should keep your alcohol intake to a minimum while you are taking Metoprolol, as alcohol may increase the effect of this drug.

 

Pregnancy, breast-feeding and fertility

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

 

Driving and using machines

Metoprolol may cause dizziness and tiredness, if affected do not drive or operate machinery.

 

Metoprolol contains Lactose monohydrate

Patients who are intolerant to lactose should note that Metoprolol Tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

3 How to take Metoprolol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure. The tablets should be swallowed preferably with a glass of water. Metoprolol can be taken with or without food.

The recommended dose is:

Adults

High blood pressure

Initially 100 mg/day in the morning, which may be increased to a maximum of 400 mg daily.

Your doctor may combine this dose with a diuretic (water tablet) or another blood
pressure-lowering drug.

 

Angina

50 to 100 mg two or three times daily.

 

Irregular heartbeat

50 mg two or three times daily. If necessary this may be increased to 300 mg/day in divided doses.

 

Hyperthyroidism

50 mg four times daily. Your doctor may reduce the dosage as your condition improves.

 

Heart attack

The usual maintenance dose following a heart attack is 200 mg daily.

 

Migraine prevention

100 to 200 mg/day in divided doses.

 

Patients with liver problems

A reduced dose may be necessary.

 

Older people

A reduced dose may be necessary.

 

Use in children and adolescents

Metoprolol tablets are not recommended for use in children.

 

If you take more Metoprolol than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause low blood pressure (feeling dizzy or faint), a slow heartbeat, your heart may suddenly stop, difficulty breathing, reduced consciousness, feeling sick, being sick, blue discolouration of skin and coma. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

 

If you forget to take Metoprolol

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet dose.

Take the remaining doses at the correct time.

 

If you stop taking Metoprolol

You should continue to take these tablets for as long as your doctor tells you to.

DO NOT stop taking your medicine without talking to your doctor first, even if you feel better. Your treatment with Metoprolol must not be stopped suddenly. If it is necessary to stop treatment, your doctor should reduce your dose gradually.

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

 

4 Possible side effects

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

 

The side effects listed below have been reported.

Common (may affect up to 1 in 10 people)

• Headache, dizziness, or unusual tiredness

• Slow heart beat

• Low blood pressure which might make you faint or dizzy

• Feeling short of breath when exercising

• Feeling or being sick, stomach ache

 

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

• Depression

• Sleep disorders such as sleepiness, difficulty in sleeping or nightmares

• Feeling less alert

• Coldness, numbness or tingling in your hands and feet

• Muscle cramps

• Heart problems which can cause shortness of breath or ankle swelling (heart failure) or irregular heart beat or a very fast, uneven or forceful heartbeat

• Water retention (oedema)

• Poor blood circulation which makes the toes and fingers numb and pale (Raynaud’s phenomenon)

• Breathlessness or wheeziness (bronchospasm)

• Diarrhoea or constipation

• Skin rash (including nettle rash, patches of thickened and sore skin) and/or itching.

 

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

• Reduction in blood platelets, which increases risk of bleeding or bruising

• Weight gain

• Hallucinations or personality disorders

• Dry or sore eyes or problems with vision

• Ringing in the ears (tinnitus) or partial loss of hearing or deafness (hearing problems)

• Gangrene

• Runny and itchy nose (rhinitis), dry mouth

• Changes in the results of liver function tests

• Bruising or increased sensitivity of the skin to sunlight, worsening of patches of thickened and sore skin (psoriasis)

• Increased sweating, loss of hair (alopecia)

• Impotence or loss of libido

• Painful joints

• Chest pain.

 

Frequency not known (cannot be estimated from the available data)

• Confusion

• Abnormal levels of certain types of fats such as cholesterol or triglycerides in the blood

• Abnormal curvature of the penis with painful erections (known as Peyronie’s disease)

• Retroperitoneal fibrosis where abnormal scar tissue occurs behind the membrane that lines the cavity of the abdomen. This may present with pain in the back, groin or the lower abdomen

• Hepatitis

• Positive anti-nuclear antibodies (an indicator of autoimmune disease where the body attacks its own tissues)

• Memory loss, nervousness, anxiety, taste disturbance

• Conjunctivitis

• An increase in intermittent claudication (a cramp-like pain brought on by exercise).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this Ieaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

 

5 How to store Metoprolol

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the outer packaging. 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 to protect the environment.

 

6 Contents of the pack and other information

What Metoprolol Tablets contain

• The active ingredient is metoprolol tartrate.

• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate, colloidal anhydrous silica and magnesium stearate.

 

What Metoprolol Tablets look like and contents of the pack

• The 50 mg tablets are round, biconvex white tablets, engraved ‘4A5’ with a breakline on the reverse.

• The 100 mg tablets are round, biconvex white tablets, engraved ‘4A6’ with a breakline on the reverse.

• The product is available in pack sizes of 28, 30, 56, 60, 100, 500 tablets.

Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:

TE VA UK Limited, Eastbourne, BN22 9AG

 

This leaflet was last revised: January 2015
PL 00289/0743-0744