GB797-9768LF-AM01

Trasicor® Tablets

Oxprenolol hydrochloride

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AMDIPHARM

Irregular heart beats

20-80 mg taken 2 or 3 times a day. The maximum daily dose is 240 mg.

Anxiety

The starting dose is 40 mg taken twice a day. A single dose of Trasicor (40-80 mg) may be taken for anxiety during a specific stressful situation.

Very rare side effects (occurring in less than 1 in 10,000 patients)

• A reduction in blood platelets which increases the risk of bruising or bleeding (thrombocytopenia);

If any of the side effects becomes severe, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist immediately.

Read all of this leaflet carefully before you start taking this medicine.

-    Please 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 any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you are going to have a general anaesthetic, you should tell the doctor or dentist in charge that you are taking Trasicor, as your treatment might need to be stopped a few days before the surgery.

If any of these apply to you, or if you are not sure, tell your doctor before being treated with Trasicor.

Taking other medicines

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

Swallow your tablets whole with a drink of water.

If you take more Trasicor than you should

If you take more Trasicor than you should contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Trasicor Tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose, DO NOT take a double dose.

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s leaflet:

What Trasicor Tablets are and what they are used for

Before you take Trasicor Tablets

How to take Trasicor Tablets

Possible side effects

How to store Trasicor Tablets

urther information

1. WHAT TRASICOR TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Trasicor Tablets.

Trasicor Tablets contain the active ingredient oxprenolol hydrochloride.

Oxprenolol hydrochloride belongs to a group of medicines called beta-blockers.

Trasicor is used to treat high blood pressure and to reduce or prevent chest pain (angina). It is also used to treat some heart disorders such as irregular heart beat and to relieve the symptoms of anxiety.

2. BEFORE YOU TAKE TRASICOR TABLETS Do not take Trasicor if you:

•    are allergic to oxprenolol, any other beta-blockers, or any of the other ingredients of Trasicor Tablets (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

•    have a history of asthma or wheezing attacks;

•    have any heart problems (e.g. heart failure, cardiogenic shock);

•    have an untreated tumour of the adrenal gland phaeochromocytoma);

•    have any heart rhythm disorders (sick-sinus syndrome);

•    have a very low pulse rate (less than 50 beats per minute);

•    have Prinzmetal's angina (a specific type of chest pain);

•    have high levels of acid in your blood (metabolic acidosis);

•    are planning any procedures which involve an anaesthetic

•    are suffering from severe peripheral circulatory problems.

Trasicor is not recommended for use in children.

This is especially important if you are taking:

•    any calcium channel blockers (used totreat high blood pressure and angina) (e.g. verapamil, nifedipine);

•    any barbiturates (e.g. phenobarbitone);

•    any other medicines for high blood pressure (hypertension);

•    a medicine which belongs to a group of medicines called sympathomimetics (e.g. phenylephrine).

or if you are taking any medicines for:

•    problems such as depression or mental illness (lithium, monoamine oxidase inhibitors (MAOIs), tri-cyclic antidepressants, phenothiazides);

•    heart failure (e.g. digoxin);

•    an irregular heart beat (e.g. Iidocaine, amiodarone,

•    diabetes (e.g. insulin or other sugar lowering anti-diabetic medicines);

•    stomach ulcers (e.g. cimetidine);

•    relief of pain (e.g. aspirin, ibuprofen, naproxen or other medicines known as non steroidal anti-inflammatory drugs).

Taking Trasicor with food and drink

It is advisable not to drink alcohol whilst taking Trasicor as it may increase the effect of your medicine.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor before taking Trasicor.

Trasicor passes into breast milk, therefore breast-feeding is not recommended whilst taking Trasicor.

Driving and using machines

You can drive while being treated with Trasicor but do not drive until you know how it affects you. It may make you feel dizzy, if it affects you in this way, do not drive or operate any machinery.

Important information about some of the ingredients

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Trasicor Tablets (20 mg and 40 mg) contain sucrose, a type of sugar.

The 20 mg and 40 mg Trasicor tablets also contain gluten and may be unsuitable for patients with Coeliac disease (an intolerance to gluten).

If you stop taking Trasicor Tablets

Ask your doctor before stopping treatment with Trasicor. If you stop taking your tablets suddenly it may cause your condition to get worse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Trasicor can cause side effects, although not everyone gets them.

5.    HOW TO STORE TRASICOR TABLETS

Do not use Trasicor after the expiry date which is stated on the carton.

Keep your tablets in a dry place.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

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.

6.    FURTHER INFORMATION What Trasicor Tablets contain

Trasicor Tablets contain the active ingredient oxprenolol hydrochloride.

The tablets are available in three strengths containing 20 mg, 40 mg and 80 mg of oxprenolol hydrochloride.

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

If you notice:

•    Itching or skin rashes;

•    Difficulty in breathing or wheeziness.

Stop taking the medicine and seek medical advice immediately. These may be signs of an allergic reaction.

Other side effects may include:

Very common side effects (occurring in more than 1 in 10 patients)

•    Dry mouth;

•    Constipation.

Common side effects (occurring in between 1 in 10 and 1 in 100 patients)

•    Tiredness;

•    Dizziness;

•    Headache;

•    Depression;

•    Heart failure;

•    Low blood pressure;

•    Coldness, numbness or tingling in your hands and feet;

•    Feeling sick;

•    Wheezing or difficulty breathing;

•    Reducedsex drive or impotence.

Uncommon side effects (occurring in between 1 in 100 and 1 in 1000 patients)

•    Sleeping problems and nightmares;

•    A very slow heart beat;

•    Diarrhoea;

•    Being sick;

•    Blurred vision;

•    Irregular heart beat;

•    Wind;

•    Skin problems (an allergic skin reaction which may include reddening, itching or a rash).

Trasicor Tablets also contain the following inactive ingredients: 20 mg and 40 mg tablets: calcium phosphate tribasic, magnesium stearate, polyvinylpyrrolidone K25, sucrose powdered, talc, wheat starch, hydroxypropyl methylcellulose, kollidon VA64, purified talc special, titanium dioxide (E171) and purified water.

80 mg tablets: calcium phosphate, maize starch, povidone K25, colloidal anhydrous silica, sodium starch glycollate, purified talc special, magnesium stearate, hydroxypropylmethyl cellulose 3 CPS, polysorbate 80, purified talc special, titanium dioxide (E171), yellow iron oxide (E172) and purified water.

What Trasicor looks like and contents of the pack Trasicor Tablets 20 mg are white, round, biconvex tablets approximately 7 mm in diameter. They are either impressed CIBA on one face and TRASICOR 20 on the other or impressed TRASICOR 20 on one side and blank on the other side.

Trasicor Tablets 40 mg are white, circular, flat, film-coated tablets with bevelled edges approximately 8 mm in diameter. They are either impressed CIBA on one face and TRASICOR 40 on the other or impressed TRASICOR 40 on one side and blank on the other side.

Trasicor Tablets 80 mg are light yellow, round, biconvex tablets approximately 9 mm in diameter. They are either impressed CIBA on one face and TRASICOR 80 on the other or impressed TRASICOR 80 on one side and blank on the other side.

The 20 mg, 40 mg and 80 mg tablets come in blister packs of 56 tablets.

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Take special care with Trasicor if you:

•    have a first degree atrioventricular block (a heart problem where electrical signals to your heart are slowed down);

•    are diabetic and are taking insulin or any other anti-diabetic drugs;

•    have ever had a serious allergic reaction

(e.g. abnormal sensitivity to insect bites or stings, severe eczema or hayfever);

•    have an overactive thyroid gland (

have any serious liver or kidney problems; lave Raynaud's disease (poor circulation in the hands and feet);

3. HOW TO TAKE TRASICOR TABLETS

Always take Trasicor exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dosages are:

Chest pain (angina)

80-160 mg a day taken in 2 to 3 doses. The maximum daily dose is 320 mg.

High blood pressure (hypertension)

80-160 mg a day given in 2 to 3 doses. The maximum daily dose is 320 mg.

Rare side effects (occurring in between 1 in 1000 and 1 in 10,000 patients)

•    Hallucinations;

•    Tiredness or exertion;

•    Worsening of psoriasis;

•    Dry or sore eyes.

AMDIPHARM

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and the manufacturer responsible for release is Amdipharm UK Limited,

Regency House,Miles Gray Road, Basildon, Essex SS14 3AF.

This leaflet was last revised in August 2013