PATIENT INFORMATION LEAFLET

Sotacor 80 mg Tablets

Sotalol hydrochloride

In this leaflet:

1.    What Sotacor tablets are and what they are used for

2.    Before you take your medicine

3.    Taking your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Further Information

1. What SOTACOR tablets are and what they are used for

The name of this medicine is Sotacor tablets. Each tablet contains 80mg of sotalol hydrochloride as the active ingredient.

Sotacor tablets belong to a group of drugs called beta-adrenergic blocking agents or “Beta-Blockers.” Sotacor tablets are used to treat irregular heartbeats.

2. Before you take your medicine

Do not take this medicine if you: . Are allergic to any of the ingredients in Sotacor.

. Suffer from asthma, attacks of wheezing or any other lung disease.

. Have a very slow heart beat or low blood pressure.

. Suffer from a condition causing discoloration (white or purple) of the hands and feet (Raynaud’s syndrome).

. Suffer from any severe circulation disorders.

. Have suffered from heart disease (such as untreated heart failure) or had a recent heart attack that your doctor does not know about.

. Suffer from a condition called metabolic acidosis.

. Suffer from an untreated tumour of the adrenal gland . Suffer from kidney failure.

If you are affected by any of the above you should tell your doctor before taking this medicine. Your doctor may wish to check the level of potassium and magnesium in your blood before you start taking Sotacor. Patients with low levels should not take Sotacor tablets.

Regular blood tests may be required during your treatment with Sotacor.

Sotacor is not recommended for use in children.

You must tell your doctor if you:

. Are pregnant, planning to become pregnant or are breastfeeding.

. Have any kidney problems, as your dose of Sotacor may need to be changed.

. Suffer from diabetes, as it may be necessary to change the dose of insulin or any other medicines you take to treat your diabetes. Sotacor may also hide or reduce the warning signs of low levels of sugar in your blood (hypoglycaemia).

. Have an overactive thyroid, as Sotacor can hide the symptoms or make them worse if treatment with Sotacor is stopped suddenly.

. Suffer from, or have recently suffered from diarrhoea, or if you have recently had severe diarrhoea, or an attack that lasted a long time. This is because it can affect the levels of potassium and magnesium in the body, and you may not be able to take Sotacor.

. Suffer from psoriasis (a skin disease that causes itchy, red, sore patches of skin).

If any of the above applies to you, tell your doctor before you take the tablets.

If you are due to have surgery

You should tell the doctor or anaesthetist that you are taking Sotacor as it can affect anaesthetics. You may have to stop taking Sotacor before surgery and it should be gradually stopped over a period of one week. Your doctor will tell you if this is necessary.

Taking Sotacor tablets with other medicines

Always tell your doctor about other medicines you may be taking or have recently taken including those obtained without a prescription. Some medicines can have an effect on each others action.

It is especially important that you tell your doctor if you are taking medicines for:

. High blood pressure, heart failure or an irregular heartbeat (eg digoxin, amiodarone, verapamil)

. Diabetes (eg metformin or insulin)

. Asthma and other diseases of the lung (eg ventolin inhalers)

. Depression, anxiety, nervous disorders and mental disturbances (eg methyldopa)

. Allergies such as hayfever (eg antihistamines)

Or if you are taking:

. A medicine called clonidine (sometimes used to treat hot flushes or headaches).

. Steroids . Laxatives . Antibiotics

. Water tablets (diuretics)

Pregnancy and Breastfeeding

Make sure you tell your doctor if you are pregnant or planning to become pregnant. You should not be given Sotacor tablets during pregnancy unless your doctor thinks it is essential.

You should not breastfeed while you are being treated with Sotacor tablets.

Taking with Food and Drink

Moderate amounts of alcohol will not affect Sotacor, however you should check with your doctor first to see if drinking is advisable for you.

Driving or operating machinery

Sotacor does not usually affect your ability to drive. However, if you feel light-headed or dizzy, do not drive or operate machinery.

Important information about some of the ingredients in Sotacor

This medicine contains 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 your medicine

Always take Sotacor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not stop taking Sotacor without consulting your doctor.

The usual daily dose is between 80 mg and 320mg. Some patients may need up to 640mg a day or sometimes the doctor may prescribe a different dose from these. Lower doses are often used for elderly patients or those with kidney disease.

Tablets should be swallowed whole with a glass of water and can be taken with or without food.

The dose may be taken either as a single dose or in two divided doses. You can check with the doctor or pharmacist if you are not sure.

For the first few weeks after you start your Sotacor treatment your doctor will need to see you regularly to check on your response and may need to adjust the dose to one that suits you.

Sotacor is not recommended for use in children.

If you take more Sotacor than you should

If you take too many tablets contact your doctor or go to your nearest hospital emergency department immediately and take the tablets and leaflet with you.

If you forget to take Sotacor

If you forget to take a dose, do not worry, just take it as soon as you remember unless it is nearly time for your next dose then you should miss the forgotten dose and continue as before. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines Sotacor can cause unwanted effects, although not everybody gets them.

Tell your doctor immediately if you get any of the following symptoms swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. These may be signs of an allergic reaction and the tablets will be stopped.

Side effects seen with Sotacor tablets (affecting more than 1 in 100 patients) include the following:

. Irregular heartbeat, slow heart beat, heart failure, chest pain, low blood pressure, difficulty in breathing, swelling, fainting and palpitations.

. Nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhoea, cramps.

. Anxiety depression, mood changes, headache, light-headedness, dizziness, general weakness, tiredness, problems with vision, sleeping, tingling in feet and hands (pins and needles).

. Sexual dysfunction, fever, rash, hearing problems, problems with vision, changes in the way things taste. Patients taking this type of medicine have complained of cold and/or blue fingers and toes, worsening of aches in their legs when walking, skin rash or dry eyes.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately. It will help if you make a note of what you experienced, when it started and how long it lasted.

5. How to store your medicine

Do not store the tablets above 25°C.

Store in the original packaging to protect from light.

Please check the expiry date of the product, shown on the blister foil and carton and do not use after the month stated.

Keep your medicines out of the reach and sight of children.

If you are told to stop taking this medicine, return any unused tablets to your pharmacist.

6. Further Information

What Sotacor tablets contain

The active ingredient in Sotacor tablets is sotalol hydrochloride 80 mg. The other ingredients are:

colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose

and stearic acid.

What Sotacor tablets look like and contents of the pack

Sotacor 80mg tablets are white in colour, round, biconvex, with a break bar on each side. The tablets are supplied in blister packs of 14 a strip, or 10 a strip, and come in packs containing 28 0r 30 tablets, respectively.

Marketing Authorisation Holder and Manufacturer Manufactured by:

FARMEA

10 rue Bouche Thomas ZAC d’Orgemont 49007 Angers France ;

Haupt Pharma Wolfratshausen GmbH Pfaffenrieder StraBe 5 82515 Wolfratshausen Germany

Marketing Authorisation Holder:

UK

Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Uxbridge Business Park Sanderson Road, Uxbridge Middlesex UB8 1DH, United Kingdom

DATE OF LAST REVISION: February 2014

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