• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Labetalol is and what it is used for
2. What you need to know before you take Labetalol
3. How to take Labetalol
4. Possible side effects
5. How to store Labetalol
6. Contents of the pack and other information

• You have a history of breathing difficulties, wheezing or asthma
• You are allergic 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 heartbeat 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 heartbeat (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)

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 heartbeat 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 heartbeat (first degree heart block)
• You have a poor flow of blood to your heart (ischaemic 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 cataract surgery (see ’Having an anaesthetic or cataract surgery’ section)

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 heartbeat, 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 low levels of sugar in your blood (hypoglycaemia) and hide the warning signs such as shaking (tremors) and faster heartbeat (tachycardia)
• 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:
  • ACE inhibitors, angiotensin-II antagonists and alpha blockers, used to treat high blood pressure
  • Aldesleukin, used to treat some cancers
  • Alprostadil, used to treat sexual disorders such as impotence
  • Medicines used to treat anxiety e.g. diazepam (anxiolytics)
  • Medicines used to treat sleep problems e.g. zolpidem (hypnotics)
  • Moxisylyte, used to treat poor circulation
  • 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:
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), and corticosteroids, used to treat pain and inflammation such as ibuprofen
  • 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:
  • Tricyclic antidepressants for depression, such as amitriptyline
  • Barbiturates for epilepsy, sleeping disorders and Parkinson’s disease such as phenobarbital
  • Phenothiazines for anxiety, mental disorders, feeling and/or being sick (nausea, vomiting) such as trifluoperazine
  • 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

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

Anaesthetics may interfere with this medicine, in particular anaesthetics such as cyclopropane, trichloroethylene.

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

• These tablets should be taken with food
• It is recommended that you do not drink alcohol whilst being treated with Labetalol.

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 passes into breast milk.

Nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4).

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

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

It may cause allergic reactions.

• The usual starting dose is 100mg twice daily.
• Your doctor may increase this dose by 100mg twice daily every 14 days.
• For severely high blood pressure, a daily dose of 2400mg may be prescribed, to be taken in three or four divided doses.

• The usual starting dose is 100mg twice daily.
• This may be increased each week by 100mg twice daily.
• During the second and third trimesters (months 4 − 9), the dose may be increased further ranging from 100mg-400mg three times daily.
• The maximum dose is 2400mg daily, to be taken in three or four divided doses.
• If admitted to hospital, the dose may be increased daily, if required.

• If a rapid reduction in blood pressure is required, you may be given Labetalol by injection.

The usual starting dose is 50mg twice a day.

Children should not take Labetalol.

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you, Symptoms of overdose include: low blood pressure (hypotension), slower heartbeat (bradycardia), difficulty in breathing or wheezing (bronchospasm) and sudden heart failure (acute cardiac insufficiency)

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

It is important that you keep taking Labetalol for as long as your 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 heartbeat

• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
• Difficulty breathing (if you have asthma or a history of asthma)
• Hypersensitivity (rash, severe itching [pruritus], swelling of the deeper layers of the skin caused by a build-up of fluid [angioedema], shortness of breath or difficulty in breathing [dyspnoea])

• Headache
• A lack of energy (lethargy)
• Tiredness
• Depression
• Dizziness
• Blocked nose
• Sweating
• Tingling scalp
• Swollen ankles
• Slower heartbeat (bradycardia)
• Positive autoimmune blood tests
• Irregular or slower heartbeat than normal (heart block)
• Long-term inflammation of skin and/or intestines (Systemic Lupus Erythematosus [SLE])
• Liver failure or damage (hepatic necrosis)
• Increase in liver enzymes (detected through blood test)
• Yellowing of the skin or whites of the eyes (jaundice)
• Inflammation of the liver (hepatitis)
• Medicine-induced fever
• Pain or weakness in the muscles (toxic myopathy)
• Feeling (nausea) or being sick (vomiting)
• Stomach pain
• Poor vision
• Dry eyes
• Confusion
• Sleep disturbances
• Nightmares
• Diarrhoea
• Feeling light−headed and dizzy when you get up from sitting or lying down (postural hypotension) (usually due to the initial dose being too high or increases in doses being too rapid)
• Unable or difficult to urinate
• Shaking (tremor) during pregnancy
• Difficulty for men to ejaculate
• Heart failure
• Poor blood circulation leading to nipple pain, cold or blue extremities with numbness or tingling in your finger and toes
• Seeing or hearing things that are not real (hallucinations)
• Mental illness (psychoses)
• Hiding the symptoms of high levels of thyroid hormones in the blood (thyrotoxicosis)
• Hiding the symptoms of low blood sugar levels (hypoglycaemia)
• Increase of existing cramping pain in the calf, thigh or buttocks (intermittent claudication)
• Abnormally high levels of potassium in blood (hyperkalaemia)
• A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Low blood pressure (hypotension)
• Inflammation of the lungs (interstitial lung disease)
• (Reversible) non-infectious, itchy rash that can affect many areas of the body (lichenoid rash)
• Worsening of psoriasis (skin disease causing scaly pink patches)
• Cramps
• (Reversible) hair loss (alopecia)

Not known (cannot be estimated from the available data)

• Nipple pain
• Intermittent decrease in blood flow to your nipples, which may cause your nipples to go numb, pale, and painful (Raynaud's phenomenon)

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• Each 100mg tablet contains Labetalol Hydrochloride 100mg
• Each 200mg tablet contains Labetalol Hydrochloride 200mg

The other ingredients are: lactose, starch, povidone, isopropanol, sodium starch glycollate, magnesium stearate. Coating: hydroxypropyl methylcellulose, sunset yellow (E110), triacetin, water, IMS.

• Labetalol 100mg are orange, round, biconvex, film-coated tablets coded ‘LTL 100’ on one side
• Labetalol 200mg are orange, round, biconvex, film-coated tablets coded ‘LTL 200’ on one side

Labetalol is available in:

Labetalol Tablets are available in containers or blister packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500 or 1000 tablets

Not all pack sizes or pack types may be marketed.

Product Licence Numbers:

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