PACKAGE LEAFLET: INFORMATION FOR THE USER Totamol 25mg Tablets Totamol 50mg Film-Coated Tablets Totamol 100mg Film-Coated Tablets

Totamol (Referred to as Totamol Tablets in this leaflet)

If you suffer from asthma or other breathing problems, or have a history of obstructive airways disease (bronchospasm), speak to you doctor first before taking this medicine.

Read all of this leaflet carefully before

you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Totamol Tablets are and what they are used for

2.    Before you take Totamol Tablets

3.    How to take Totamol Tablets

4.    Possible side effects

5.    How to store Totamol Tablets

6.    Further information

1. What Totamol Tablets are and what they are used for

The name of your medicine is Totamol Tablets. The active ingredient is Totamol. These tablets belong to a group of medicines known as beta-blockers, which are used to treat a variety of heart and blood vessel conditions. Totamol Tablets may be used to:

•    prevent chest pains associated with angina

•    reduce the risk of a heart attack if you have already had one

•    treat irregular or abnormal heart rate

•    treat high blood pressure.

2. Before you take Totamol Tablets

You should not take Totamol Tablets if

you:

•    are allergic (hypersensitive) to Totamol or to any of the other ingredients in Totamol Tablets (see section 6, Further information)

•    have a very slow heart rate

•    have a heart condition where you may be treated with a pacemaker

•    suffer from uncontrolled heart failure

•    suffer from low blood pressure

•    suffer from poor circulation causing pains in lower legs

•    suffer from sick sinus syndrome, causing problems with your heart rhythm

•    suffer from a heart condition known as prinzmetal angina (chest pain)

•    your heart cannot maintain good blood circulation

•    have a tumour called phaeochromocytoma

•    have been told by your doctor that you have higher than normal levels of acid in your blood

•    have asthma or any other breathing problem unless your doctor has specifically recommended it.

Talk to your doctor, before taking

Totamol Tablets if you:

•    suffer from a heart condition known as first degree AV block

•    have high blood pressure (portal hypertension)

•    have or have had any allergies, as your allergies may become more severe

•    suffer from a condition known as myasthenia gravis (a type of muscle weakness)

•    are diabetic

•    suffer from itching and flaking of the skin (psoriasis)

•    have any liver or kidney problems.

If you suffer from heart disease or have been taking Totamol for a long time, your treatment should be withdrawn slowly over two to three weeks time. Always speak to your doctor first before you stop taking this medicine.

If you are going for surgery; you should tell your doctor you are taking this medication, you may be asked to stop this medicine 24 hours before surgery.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Totamol Tablets:

•    aldesleukin (used to treat kidney cancer)

•    alprostadil (used to treat erectile dysfunction)

•    amphetamines (used to treat a variety of conditions)

•    ampicillin (used to treat bacterial infections)

•    anaesthetics (used during surgery e.g. ether, halothane enflurane)

•    analgesics (pain killers e.g. indomethacin)

•    antacids (used to neutralise stomach acids e.g. calcium or aluminium hydroxide)

•    antiarrhythmics (used to treat heart rhythm disorders e.g. disopyramide, amiodarone and quinidine)

•    anticholinesterase agents (used to treat heart conditions)

•    antidepressant and antipsychotics (used to treat mental health conditions e.g. phenothiazine, tricyclic antidepressants, tropisetron and MAOIs)

•    antidiabetics (used to treat diabetes)

•    antihypertensives (used to treat high blood pressure e.g. ACE inhibitors, angiotensin-II antagonists, alpha blockers, diltiazem, nifedipine and verapamil)

•    antimalarials (used to reduce the risk of infection with malaria e.g. mefloquine)

•    anxiolytics and hypnotics (used to reduce anxiety and induce sleep e.g. benzodiazepines)

•    carbenoxolone (used to treat ulcers)

•    cardiac glycosides (used to treat abnormal heart conditions)

•    clonidine (used to treat ADHD)

•    ergot alkaloids (used to treat headaches and migraines)

•    moxisylyte (used to treat Raynaud's disease)

•    oral contraceptives

•    parasympathomimetics (used to simulate nervous system)

•    sympathomimetics (used to lower blood pressure)

•    theophylline (used to treat asthma).

Taking Totamol Tablets with food and drink

Alcohol should be avoided when taking this medicine as it could cause a lowering of your blood pressure.

Pregnancy and breast-feeding

If you are pregnant, this medicine should not be taken during the first six months of pregnancy. Totamol Tablets can be taken during the last three months of pregnancy but must be done under close supervision of your doctor.

Totamol Tablets can be taken if you are breast-feeding, but must be done under close supervision of your doctor. Always check with your doctor before taking this medicine.

Driving and using machinery

This medicine may cause tiredness and dizziness, if affected do not drive or operate machinery.

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3. How to use Totamol Tablets

Always take Totamol Tablets as your doctor has told you. Your doctor will decide the right dose for you; this will be on the pharmacist's label. Check this carefully, it will tell you how many tablets to take and how often to take them; the usual dose in adults is as follows:

Treatment of high blood pressure

•    one 50mg tablet each day.

Treatment of angina

•    one 100mg tablet each day or one 50mg tablet twice a day.

Treatment of irregular or abnormal heart rate

•    after an initial injection of Totamol, a single maintenance dose of 50mg to 100mg tablet each day.

Treatment of heart attack

•    after an initial injection of Totamol, one 50mg tablet after 15 minutes followed by

•    one 50mg tablet after 12 hours from the initial injection followed by 12 hour interval then

•    one 100mg tablet each day.

Treatment of patients with liver or kidney problems or patients who are elderly

•    your dose may be reduced.

Totamol Tablets are not recommended for children under 12 years.

If you have taken more Totamol Tablets than you should

If you (anybody else or a child), takes more Totamol Tablets than you should contact your nearest hospital casualty department or doctor immediately. Always take the container and leaflet with you if possible, even if the container is empty.

If you forget to take Totamol Tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

Do not stop taking Totamol Tablets suddenly, always speak to your doctor first.

•    tiredness

•    headache

•    dry mouth

•    problems with blood cells

•    increased levels of liver enzymes identified through bloods tests

•    weakening of the muscles

•    pains in the muscles and joints

•    pins and needles feeling in the arms and legs

•    reduced control of the muscles

•    increases or decreases in the blood sugar levels

•    feeling confused, anxious or nervous.

If you experience any side effects or feel

that the medicine is affecting you badly tell

your doctor or pharmacist immediately.

5. How to store Totamol Tablets

Keep out the reach and sight of children.

•    Totamol Tablets should not be stored above 25°C. Store in the original container to protect from moisture; do not transfer your tablets to another container

•    Totamol Tablets should not be taken after the expiry date on the carton, the expiry date refers to the last day of the month.

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 protect the environment.

6. Further information

4. Possible side effects

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

If you experience any of the following, stop taking Totamol Tablets and seek medical help immediately:

•    red itchy skin rashes

•    problems breathing

•    heart failure (symptoms include shortness of breath, feeling tired and weak, and swelling in the legs, ankle and feet).

Other side effects that have been reported with Totamol Tablets:

•    irregular heart beats

•    low blood pressure

•    dizziness

•    pains in legs

•    sore or dry eyes

•    visual problems

•    blurred vision

•    conjunctivitis

•    constipation

•    diarrhoea

•    stomach pains

•    problems sleeping

•    feeling depressed

•    hallucinations

•    hair loss

•    erection problems

•    cough

•    raised temperature

•    reduced blood flow to the skin

•    coldness in arms and legs

•    feeling and/or being sick (nausea/vomiting)

•    obstruction in the small bowel

•    obstruction in tubes between the kidney and bladder

What Totamol Tablets contain

The active ingredient is: Totamol 25mg, 50mg or 100mg.

The other ingredients in Totamol Tablets are: maize starch, heavy magnesium carbonate, povidone K30, sodium starch glycollate and magnesium stearate. Totamol 50mg and 100mg Tablets also contain: purified water, opadry orange OY-3455.

What Totamol Tablets look like and the contents of the pack

Totamol Tablets are supplied in blister packs of 28 tablets or in polypropylene or polyethylene containers of 500 tablets.

Marketing Authorisation Holder:

Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: July 2011

WOCKHARDT

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