TEVA UK Ref: 231-30-85697-V LEA SOTALOL A/S TAB TUK Version: 2 07 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

SOTALOL 80 mg AND 160 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

IN THIS LEAFLET

1.    What Sotalol is and what it is used for

2.    Before you take Sotalol

3.    How to take Sotalol

4.    Possible side effects

5.    How to store Sotalol

6.    Further information

OWHAT SOTALOL IS AND WHAT IT IS USED FOR

• Sotalol belongs to a group of medicines called beta-blockers, which slow the heart beat, so the heart beats more efficiently.

• Sotalol is used to prevent a recurrence of serious heart beat problems.

BEFORE YOU TAKE SOTALOL

DO NOT take Sotalol if you:

•    are allergic (hypersensitive) to sotalol or any of the other ingredients of this medicine

•    are sensitive to sulphonamides e.g. co-trimoxazole, sulfadiazine

•    have any heart problems, other than those for which your medicine has been prescribed, in particular:

•    abnormal heart rhythms called 'long QT syndrome'

•    torsades de pointes

•    atrioventricular (AV) block

•    sick sinus syndrome (without a pacemaker)

•    if your heart beats less than 50 times per minute

•    if you suffer from uncontrolled heart failure

•    if you are in shock due to heart problems (a condition which may be associated with low blood pressure, cold skin, a weak pulse, mental confusion and anxiety)

•    suffer from any of the following conditions:

•    asthma or any other breathing difficulties

•    Prinzmetal's angina (chest pain and palpitations at rest, usually during sleep)

•    problems with your circulation (e.g. Raynaud's phenomenon or pain in the calf muscles on walking)

•    phaeochromocytoma (a benign adrenal tumour) which is not being treated

•    low blood pressure (which is not due to an irregular heartbeat)

•    severe kidney problems

•    metabolic acidosis (acidification of the blood)

•    are due to have a general anaesthetic

•    are also taking other medicines to correct an abnormal heart rhythm, e.g. quinidine, hydroquinidine or disopyramide (called class Ia antiarrhythmic agents) or amiodarone, dofetilide or ibutilide (called class III antiarrhythmic agents)

•    are also taking medicines used to treat schizophrenia and other serious mental disorders e.g. sulpiride, sultopride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, tiapride, pimozide, haloperidol, droperidol (called neuroleptics)

• are also receiving injections of erythromycin (an antibiotic) or vincamine (which may be used to treat some forms of brain disease, notably dementia), or if you are taking bepridil (used to treat angina), cisapride (used to treat certain gastrointestinal problems), diphenamil (which may be used to treat a slow heart beat), mizolastine (used to treat hayfever), moxifloxacin (an antibiotic) or floctafenine (used to treat pain).

If you are elderly, it is especially important for you not to take Sotalol if any of the above applies to you.

Take special care with Sotalol:

Sotalol may sometimes make an abnormal heart beat worse or cause new heart rhythm problems.

Tell your doctor before you start to take this

medicine if you have:

•    heart failure which is being treated or a heart rhythm disorder called 'first degree atrioventricular (AV) block', or you have recently had a heart attack

•    an electrolyte imbalance (low levels of potassium and magnesium in your blood)

•    severe or prolonged diarrhoea

•    frequent allergic reactions

•    an over-active thyroid gland

•    psoriasis (patches of thickened and sore skin)

•    diabetes, treated with insulin or sulphonylureas, as warning signs of low blood sugar may be less obvious than usual

•    kidney disease.

Other precautions you should take:

•    Tell the hospital staff or dentist you are taking Sotalol if you are to have an operation requiring an anaesthetic or need X-rays.

•    Never stop taking Sotalol abruptly (see 3. How to take Sotalol).

Athletes should note that sotalol can cause positive results in drug tests.

Taking other medicines:

Some medicines must not be taken at the same time as sotalol. These are listed above, under the heading 'Do not take Sotalol if you'.

Talk to your doctor if you are taking any of the medicines listed below.

Sotalol should not generally be taken at the same time as the following medicines because of the risk of further heart problems:

•    halofantrine (used to treat malaria)

•    pentamidine (used to treat pneumonia)

•    sparfloxacin (an antibiotic)

•    methadone (which may be used to treat cough, pain and heroin addiction)

•    diltiazem or verapamil (called calcium channel blockers or antagonists, used to treat abnormal heart beats)

•    medicines that can cause high blood pressure such as monoamine oxidase inhibitors (MAOIs) e.g. moclobemide, phenelzine, isocarboxazid.

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice. Your doctor may prescribe Sotalol during pregnancy if it is clearly necessary. Do not take Sotalol unless your doctor tells you to and always take it exactly as prescribed.

Breast-feeding is not recommended during treatment with Sotalol.

Driving and using machines

Sotalol may affect your eyesight or make you feel dizzy.

Do not drive or operate any tools or machines if you are affected.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Important information about some of the ingredients of Sotalol

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

^ HOW TO TAKE SOTALOL

Always take Sotalol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults (including the elderly):

The initial dose is 80 mg of Sotalol taken once daily or in two divided doses at 12 hour intervals. Your doctor will then gradually increase this according to your needs.

The usual dose is between 160 mg and 320 mg of Sotalol taken in two or three divided doses each day.

For certain patients who have a life-threatening irregular heart beat, the dose can be increased up to 480 mg or 640 mg of Sotalol daily.

Patients with kidney problems may require a lower dose.

Children:

Due to a lack of data Sotalol is not recommended for use in children. Please check with your doctor.

Method of administration

You should swallow Sotalol whole with a full

glass of water.

If you take more Sotalol 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. 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 Sotalol If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

If you stop taking Sotalol

You must not stop taking Sotalol suddenly, as this could cause severe heart problems, including heart attack and death.

Your doctor will decide when and how you should stop taking Sotalol. You must follow your doctor's instructions.

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

^ POSSIBLE SIDE EFFECTS

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

The following side effects have been reported:

•    blood disorders (such as changes in the numbers of white or red blood cells) which may be characterised by unusual bleeding or unexplained bruising, fever or chills, sore throat, ulcers in the mouth or throat. If you develop these symptoms, you should contact your doctor.

•    low blood sugar

•    cold hands and/or feet

•    problems with sight

•    slow heartbeat, breathlessness, wheezing, chest pain, palpitations, ankle swelling, ECG (cardiogram) abnormalities, low blood pressure, worsened irregular heartbeat, fainting, heart failure

•    skin rashes, itching, sweating, sensitivity to light

•    nausea, vomiting, diarrhoea, indigestion, abdominal pain and flatulence

•    cramp, muscle or joint pain

•    sexual problems including impotence

•    fatigue, dizziness, light-headedness, vertigo, lethargy, headaches, depression, sleeping difficulties, pins-and-needles, numbness, anxiety.

In exceptional cases, there have been reports of inflammation of the joints and connective tissue (e.g. tendons) with skin rashes. These symptoms usually disappear once treatment is stopped.

If you have psoriasis, or intermittent claudication (cramp-like leg pain brought on by walking), your symptoms may become worse.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE SOTALOL

Keep out of the reach and sight of children. Do

not use Sotalol after the expiry date that is stated on the outer packaging. Store in the original package and protect from light.

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

^ FURTHER INFORMATION

What Sotalol contains:

•    The active ingredient is sotalol hydrochloride.

•    Each tablet contains either 80 mg or 160 mg of sotalol hydrochloride.

•    The other ingredients are lactose monohydrate, maize starch, magnesium stearate, povidone and indigo carmine (E132).

What Sotalol looks like and contents of the pack:

•    Sotalol 80 mgTablets are light blue, oval shaped tablets, scored on one side and debossed with the number "93" and "61" on each side of the score, plain on the other side.

•    Sotalol 160 mgTablets are light blue, oval shaped tablets, scored on one side and debossed with the number "93" and "62" on each side of the score, plain on the other side.

•    The tablets can be divided into equal halves.

•    The 80 mg product is available in pack sizes of 20, 28, 30, 40, 50, 60, 90 and 100 tablets.

•    The 160 mg product is available in pack sizes of 20, 28, 30, 50, 60, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in: May 2015 PL 00289/0389-0390

85697-V

TEVA UK LIMITED    160 X 323