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Labetalol Tablets Bp 100 Mg

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT


Labetalol belongs to a group of medicines called beta-blockers, which help slow the heartbeat and relax the blood vessels. This reduces blood pressure.

Labetalol is used to treat the following:

■    High blood pressure (hypertension)

■    High blood pressure during pregnancy

■    High blood in patients with chest pain (angina)

What you need to know before you take Labetalol

Do not take Labetalol if:

You have a history of breathing difficulties, wheezing or asthma.

You are allergic (hypersensitive) to Labetalol, other beta-blockers or any of the other ingredients of this medicine (listed in section 6)

You have very low blood pressure (hypotension) or you have had this condition for a long time e.g. due to a weakened heart (cardiogenic shock)

You have a slow heart rate (less than 45 - 50 beats per minute) (bradycardia)

You have an irregular or slower heart beat than normal (2nd or 3rd degree heart block)

You have shortness of breath, feel tired or ankle swelling (heart failure), which is not controlled by medicine or does not respond to treatment with digitalis You have an irregular heart beat (sick sinus syndrome) or had dizziness, weakness or confusion (sino-atrial block)

You have chest pains when at rest (Prinzmetal's angina)

You have severe circulation problems, which make the toes and fingers go numb You have an untreated rare tumour of the adrenal gland (phaechromoytoma)

You have more acid than normal in your blood (metabolic acidosis)

Warnings and precautions

Talk to your doctor before taking Labetalol if:

Your heart has difficulty pumping blood around your body (low cardiac reserve) or you suffer from shortness of breath or ankle swelling (heart failure) Your heart beat slows to less than 50-55 beats per minute whilst resting (bradycardia)

You have circulatory problems such as your toes and fingers go numb and pale (Raynaud's syndrome) or you sometimes limp (intermittent claudication)

You have irregular heart beat (first degree heart block)

You have a poor flow of blood to your heart (ichaemic heart disease)

You have liver or kidney problems You are elderly, particularly if you have kidney problems

You have a skin disease which causes scaly pink patches (psoriasis)

You have any allergies

You are due to have an anaesthetic or laboratory test (see 'Having an anaesthetic or a laboratory test' section)

Other medicines and Labetalol

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

Medicines which should not be taken with Labetalol:

■    Calcium channel blockers for high blood pressure or chest pain (angina), such as verapamil and, to a lesser extent, diltiazem

■    Medicines for heart failure or irregular heart beat, such as digoxin (digitalis glycosides)

■    Medicines for depression, such as moclobemide (Monoamine Oxidase Inhibitors - MAOIs)

■    Clonidine, used to treat high blood pressure and migraine. Labetalol should be stopped several days before you stop taking Clonidine.

Other medicines which may interact with or be affected

by Labetalol:

■    Medicines for irregular heartbeat, such as disopyramide, quinidine and amiodarone (class I antiarrhythmics)

■    Medicines for diabetes, such as metformin and insulin. Labetalol may increase the effects of

■    Cimetidine, for stomach ulcers and indigestion

■    Hydralazine, for high blood pressure

■    The following groups of medicines may increase the blood pressure lowering effect of Labetalol:

o    ACE inhibitors, angiotensin-II

antagonists and alpha blockers, used to treat high blood pressure o Aldesleukin, used to treat some cancers

o Alprostadil, used to treat sexual disorders such as impotence o Medicines used to treat anxiety e.g. diazepam (anxiolytics)

o    Medicines used to treat sleep problems

e.g. zolpidem (hypnotics) o    Moxisylyte, used to treat poor

circulation

o    Medicines used to increase frequency

of urination e.g. furosemide (diuretics)

■    The following groups of medicines may decrease the blood pressure lowering effect of Labetalol:

o    Non-Steroidal Anti-Inflammatory Drugs

(NSAIDS), and corticosteroids, used to treat pain and inflammation such as ibuprofen

o    Hormones such as oestrogen and

progesterone, used as contraceptives or Hormone Replacement Therapy (HRT)

■    Other medicines for high blood pressure or chest pains (angina), including calcium antagonists, such as nifedipine

■    Medicines for reducing inflammation, relieving pain, swelling and stiffness in the joints and muscles, such as indomethacin (prostaglandin synthetase inhibitors)

■    Medicines used to treat severe allergic reactions such as adrenaline (sympathomimetics)

■    The following groups of medicines may increase the frequency of shaking (tremor) and the blood pressure lowering effect of Labetalol:

o    Tricyclic antidepressants for depression,

such as amitriptyline o    Barbiturates for epilepsy, sleeping

disorders and Parkinson's disease such as phenobarbital

o    Phenothiazines for anxiety, mental

disorders, feeling and/or being sick (nausea, vomiting) such as trifluoperazine o Other medicines used to treat high blood pressure (antihypertensives)

■    Anti-malarial medicines such as mefloquine or quinine

■    Medicines used to treat migraine such as ergotamine

Having an anaesthetic or a laboratory test

You must tell the medical staff that you are taking Labetalol if you are going to have surgery under anaesthetic or a laboratory test.

   Anaesthetics - Anaesthetics may interfere with this medicine, in particular anaesthetics such as cyclopropane, trichloroethylene and halothane

   Laboratory test - This medicine is known to interfere with the results of catecholmine testing and MIBG scans (tests for diagnosing a tumour in the adrenal glands)

Taking Labetalol with food and drink and alcohol

■    These tablets should be taken with food

■    It is recommended that you do not drink alcohol whilst being treated with Labetalol

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 for advice before taking this medicine.

Pregnancy

This medicine should not be taken during the first 3 months of pregnancy (first trimester) unless your doctor thinks the benefits outweigh the risks.

Breast-feeding

If you are breast-feeding, you should not take Labetalol as it is passed into breast milk.

Driving and using machines

Labetalol may make you feel tired or dizzy. If this happens, do not drive or operate machinery.

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