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PATIENT INFORMATION LEAFLET

Labetalol Tablets 100mg and 200mg

(Labetalol hydrochloride 100mg or 200mg)

□ What this medicine is and what it is used for

Labetalol Tablets belong to a group of medicines called beta-blockers, which help slow the heart beat and relax the blood vessels. This reduces blood pressure and the heart's demand for oxygen.

Labetalol Tablets are used to treat the following:

■    High blood pressure

■    High blood pressure during pregnancy

■    High blood in patients with chest pain (angina)

Before you take

Do not take Labetalol Tablets if:

■    you have a history of breathing difficulties, wheezing or asthma. Ask your doctor or pharmacist if you should take this medicine.

■    you are allergic (hypersensitive) to labetalol hydrochloride or any of the other ingredients (see 'Important information about some of the ingredients', Section 2 and list of ingredients, Section 6)

■    you have very low blood pressure 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)

■    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)

Take special care with Labetalol Tablets 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

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

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

■    you    have any allergies

■    you    have diabetes

■    you are to have an anaesthetic or laboratory test (see 'Having an anaesthetic or laboratory test', Section 2)

If any of the conditions listed under Do not take' or

Take special care' apply to you, please contact your

doctor or pharmacist.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Medicines which should not be taken with Labetalol Tablets: ■ 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 (cardiac glycosides)

■    Medicines for depression, such as moclobemide (monoamine oxidase inhibitors - MAOIs)

Special care should be taken with Clonidine:

■    Clonidine is for high blood pressure and migraine. If you are taking Labetalol Tablets with Clonidine you should take special care when you stop therapy. Labetalol Tablets should be stopped several days before you stop taking Clonidine.

Other medicines which may interact with or be affect by Labetalol Tablets, if taken together include:

■    Medicines for irregular heart beat, such as disopyramide and amiodarone

■    Oral medicines for diabetes, such as metformin and insulin.

Labetalol Tablets may increase the effects of low levels of sugar in your blood (hypoglycaemia) and hide the warning signs, such as shaking (tremors) and faster heart beat

■    Cimetidine, for stomach ulcers and indigestion

■    Hydralazine, for high blood pressure

■    Other medicines for high blood pressure or chest pains (angina) known as 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)

■    Tricyclic antidepressants for depression, such as amitriptyline, barbiturates for epilepsy, sleeping disorders and Parkinson's disease, such as phenobarbital and phenothiazines for anxiety, mental disorders, nausea and vomiting, such as trifluoperazine. These groups of medicines may increase the frequency of shaking and the blood pressure lowering effect of Labetalol Tablets

Having an anaesthetic or a laboratory test

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

■    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 tumor in the adrenal glands)

Alcohol

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

Pregnancy and breast-feeding

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

If you are pregnant or think you may be pregnant you should only take Labetalol tablets if told to do so by your doctor. This medicine should not be taken during the first 3 months of pregnancy unless your doctor thinks the benefits outweigh the risks.

If you are breast-feeding, you should not take Labetalol tablets.

Driving or using machinery

Labetalol Tablets may make you feel tired or dizzy. If this happens, do not drive or operate machinery and consult your doctor or pharmacist.

Important Information about some of the ingredients

These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product.

These tablets contain the colouring agent sunset yellow FCF (E110). It may cause allergic reactions.

continued....

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|3| How to take

You should always take this medicine as prescribed by your doctor. Do not take more than the doctor told you to. Read and follow the instructions on the pharmacist's label.

■    These tablets are to be taken orally.

■    The tablets should be taken with food

Normal starting doses

The doses stated below are guidelines only. You should always take this medicine as prescribed by your doctor.

High blood pressure with or without chest pain (angina)

The usual staring dose is 100mg twice a day.

If your high blood pressure is not controlled by the starting dose, your doctor may increase this dose by 100mg twice a day about every 14 days. For severe high blood pressure a daily dose of 2,400mg may be prescribed.

Daily doses higher than 400mg should be taken in three or four divided doses.

High blood pressure in pregnancy

The usual starting dose is 100mg twice a day.

This may be increased each week by 100mg twice a day during the second and third trimesters (months 4 - 9).

The maximum dose is 2,400mg a day. Higher doses should be taken three times a day. If a rapid reduction in blood pressure is required, you may be given Labetalol by injection. If admitted to hospital the dose may be increased daily, if required.

Elderly

The usual starting dose is 50mg twice a day.

Patients with liver or kidney problems

A lower dose may be given

Children

Children should not take these tablets.

If you forget to take your Labetalol Tablets

Take the normal dose as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before. Do not take a double dose to make up for the missed dose.

If you have taken more Labetalol Tablets than recommended

You should immediately call your doctor or go to the nearest hospital casualty department. Take with you any remaining medicine, the original carton and the label so that the medicine can be identified.

Do not stop taking Labetalol Tablets without your doctor's advice

It could be dangerous. Continue to take this medicine for as long as the doctor has told you to. Your doctor will gradually reduce your dose before you stop taking this medicine. If you do not gradually reduce your dose you may develop high blood pressure and an irregular heart beat

Possible side effects

Like all medicines, Labetalol Tablets can cause side effects although not everybody gets them. Most side effects occur when treatment is first started and they are usually short lived.

If you have any of the following side effects, stop taking

Labetalol Tablets and see your doctor immediately:

■    Allergic reaction such as rash, itching, swelling of the face or throat and breathlessness

■    Difficulty breathing (in patients with asthma or a history of asthma)

■    Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)

■    Inflammation of liver (hepatitis). Symptoms include tiredness, pains in abdomen, muscle and joint aches

Side effects on starting treatment (usually short lived)

■    Headache    ■    Feeling sluggish

■    Tiredness    ■    Depressed

■    Dizziness    ■    Stuffy nose

■    Sweating    ■    Tingling scalp

Rare side effects

■    Swollen ankles ■ Slower heart beat

■    Positive autoimmune blood tests

■    Irregular or slower heart beat than normal (heart block)

■    Joint pain, skin rashes and fever due to an allergic condition (systemic lupus erythematosus)

■    Liver damage, which is usually reversible when treatment stops. Symptoms may include feeling tired, weak, vague stomach pain and loss of appetite.

■    Increase in liver enzymes (detected through blood test)

Very rare side effects

■    Sharp rise in body temperature with shivering (drug fever)

■    Pain or weakness in muscles (toxic myopathy)

Other side effects

■    Feeling or being sick    ■    Stomach pains

■    Blurred or poor vision    ■    Dry or itchy eyes

■    Confusion    ■    Sleep disturbances

■    Nightmares    ■    Diarrhoea

■    Cold or blue extremities

■    Feeling light-headed and dizzy when you get up from sitting or lying down (usually due to the initial dose being too high or increases in doses being too rapid)

■    Unable or difficult to urinate

■    Shaking (during pregnancy)

■    Difficult for men to have an erection

■    Heart failure, which can cause shortness of breath or ankle swelling

■    Poor blood circulation which makes the toes and fingers numb and pale

■    Tingling or numbness in the hands or feet

■    Seeing or hearing things that are not real (halluciniations)

■    Personality changes or thought disorders (psychosis)

■    Hiding the symptoms of too much thyroid hormone (thyrotoxicosis), such as rapid heart rate, weight loss, tremor, anxiety, unable to cope with heat

■    Hiding the symptoms of low blood sugar levels (hypoglycaemia), such as shaking (tremors) and faster heart beat

■    Increase of existing cramping pain in the calf, thigh or buttocks (intermittent claudication)

If any of the side effects get serious or if you notice any

not listed, please contact your doctor or pharmacist.

How to store

Keep out of reach and sight of children. Store in a cool, dry place.

Store in the original package.

Do not use Labetalol Tablets

after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.

16 Further information

What Labetalol Tablets contain:

■    Active ingredient: Labetalol Hydrochloride 100mg or 200mg

■    Other ingredients:lactose, starch, povidone, isopropanol, sodium starch glycollate, magnesium stearate

■    Coating: hydroxypropyl methylcellulose, sunset yellow (E110) and triacetin.

(See Important information about some of the

ingredients' section 2, page 1)

What Labetalol Tablets look like and the contents of the pack:

■    Labetalol Tablets 100mg are orange coded LTL 100 and break line one side, twin triangle logo on reverse.

■    Labetalol Tablets 200mg are orange coded LTL 200 and break line one side, twin triangle logo on reverse.

Labetalol Tablets come in containers of 7, 14, 21,28, 30,

50, 56, 60, 84, 90, 100, 112, 120, 250, 500 or 1000 tablets Or, in blister packs of 7, 14, 21,28, 30, 50, 56, 60, 84, 90, 100, 112 or 120 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road,

Eaton Socon,

St. Neots,

Cambs.PE19 8ET UK.

Product licence number:

Labetalol Tablets 100mg: PL 11311/0375 Labetalol Tablets 200mg: PL 11311/0376

Date of last revision January 2010

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