Patient Information Leaflet GB726-0250LF-AM01

Slow-Trasicor® Tablets

Oxprenolol hydrochloride

o

AMDIPHARM

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

In this leaflet:

1.    What Slow-Trasicor Tablets are and what they are used for

2.    Before you take Slow-Trasicor Tablets

3.    How to take Slow-Trasicor Tablets

4. Possible side effects

5. How to store Slow-Trasicor Tablets

6.    Further information

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

The name of your medicine is Slow-Trasicor Tablets.

Slow-Trasicor Tablets contain oxprenolol hydrochloride.

Oxprenolol hydrochloride belongs to a group of medicines

called beta-blockers.

Slow-Trasicor is used to treat high blood pressure and to

reduce or prevent chest pain (angina).

2.    BEFORE YOU TAKE SLOW-TRASICOR TABLETS

Do not take Slow-Trasicor if you:

•    are allergic to oxprenolol, any other beta-blockers, or any of the other ingredients of Slow-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.

Slow-Trasicor is not recommended for use in children.

Take special care with Slow-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 (hyperthyroidism);

•    have any serious liver or kidney problems;

•    have Raynaud's disease (poor circulation in the hands and feet).

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

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

Taking other medicines

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

This is especially important if you are taking:

•    any calcium channel blockers (used to treat 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, disopyramide);

•    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 Slow-Trasicor with food and drink

It is advisable not to drink alcohol whilst taking Slow-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 Slow-Trasicor. Slow-Trasicor passes into breast milk, therefore breast-feeding is not recommended whilst taking Slow-Trasicor.

Driving and using machines

You can drive while being treated with Slow-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 Slow-Trasicor Tablets contain lactose, a type of sugar.

3.    HOW TO TAKE SLOW-TRASICOR TABLETS

Always take Slow-Trasicor exactly as your doctor has told you. You should check with your doctor if you are not sure.

Swallow your tablets whole with a drink of water. Do not crush or chew the tablets as this may affect their special slow-release system.

The usual dosages of Slow-Trasicor Tablets are as follows: Chest pain (angina)

160 mg to be tafren once daily. The maximum daily dose is 320 mg.

High blood pressure (hypertension)

160 mg to be taken once daily. The maximum daily dose is 320 mg.

If you take more Slow-Trasicor than you should

If you take more Slow-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 Slow-Trasicor Tablets

If you forget to take a dose, take the next dose at the usual time. DO NOT take a double dose.

If you stop taking Slow-Trasicor Tablets

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

4.    POSSIBLE SIDE EFFECTS

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

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;

•    Reduced sex drive or impotence.

o

AMDIPHARM

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).

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

•    Hallucinations;

•    Tiredness on exertion;

•    Worsening of psoriasis;

•    Dry or sore eyes.

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.

5.    HOW TO STORE SLOW-TRASICOR TABLETS

Do not use Slow-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 Slow-Trasicor Tablets contain

Slow-Trasicor Tablets contain 160 mg of the active ingredient oxprenolol hydrochloride.

They also contain the following inactive ingredients: lactose, silicon dioxide, calcium stearate, methacrylic acid copolymer, glyceryl palmitostearate, magnesium stearate, hydroxypropylmethylcellulose, polysorbate, talc, titanium dioxide.

What Slow-Trasicor looks like and contents of the pack

Slow-Trasicor Tablets are white, round, slightly biconvex with bevelled edges approximately 10.1 mm in diameter. They are either impressed CIBA on one face and SLOW-TRASICOR on the other or impressed SLOW-TRASICOR on one side and blank on the other side.

Slow-Trasicor comes in calendar packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Amdipharm UK Limited,

Regency House,

Miles Gray Road,

Basildon,

Essex SS14 3AF.

This leaflet was last revised in August 2013

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.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

PAGE 1 OF 1