Trasicor Tablets 20mg
GB 727-0382-APIL
Oxprenolol 20 mg, 40 mg and 80 mg Tablets ^medical
Oxprenolol hydrochloride
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.
In this leaflet:
1. What Oxprenolol Tablets are and what they are used for
2. Before you take Oxprenolol Tablets
3. How to take Oxprenolol Tablets
4. Possible side effects
5. How to store Oxprenolol Tablets
6. Further information
1. WHAT OXPRENOLOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Oxprenolol 20 mg, 40 mg or 80 mg Tablets.
Oxprenolol Tablets contain the active ingredient oxprenolol hydrochloride.
Oxprenolol hydrochloride belongs to a group of medicines called beta-blockers.
Oxprenolol 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 OXPRENOLOL TABLETS Do not take Oxprenolol Tablets if you:
• are allergic to oxprenolol, any other beta-blockers, or any of the other ingredients of Oxprenolol 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
• 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.
Oxprenolol Tablets are not recommended for use in children.
Take special care with Oxprenolol Tablets 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 Oxprenolol Tablets, 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 Oxprenolol Tablets.
Taking other medicines
Tell your doctor or 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 belongsto 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 heartbeat (e.g. Iidocaine, amiodarone, disopyramide);
• diabetes (e.g. insulin or other sugar lowering anti-diabetic medicines);
• stomach ufcers (e.g. cimetidine),
• relief of pain (e.g. aspirin, ibuprofen, naproxen or other medicines known as non steroidal anti-inflammatory drugs).
Taking Oxprenolol Tablets with food and drink
It is advisable not to drink alcohol whilst taking Oxprenolol Tablets 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 Oxprenolol Tablets. Oxprenolol passes into breast milk, therefore breast-feeding is not recommended whilst taking Oxprenolol Tablets.
Driving and using machines
You can drive while being treated with Oxprenolol Tablets 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 Oxprenolol Tablets (20 mg and 40 mg) contain sucrose, a type of sugar.
The 20 mg and 40 mg Oxprenolol Tablets also contain gluten and may be unsuitable for patients with Coeliac disease (an intolerance to gluten).
3. HOW TO TAKE OXPRENOLOL TABLETS
Always take Oxprenolol Tablets 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.
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 Oxprenolol Tablets (40-80 mg) may be taken for anxiety during a specific stressful situation.
Swallow your tablets whole with a drink of water.
If you take more Oxprenolol Tablets than you should
If you take more Oxprenolol Tablets 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 Oxprenolol 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.
If you stop taking Oxprenolol Tablets
condition to get worse.
Ask your doctor before stopping treatment with Oxprenolol Tablets. If you stop taking your tablets suddenly it may cause your
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxprenolol Tablets 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:
Veiy 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.
Uncommon side effects (occurring in between 1 in 100 and 1 in 1000 patients)
• Sleeping problems and nightmares;
• A veiy 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.
©SOVEREIGN
MEDICAL
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 OXPRENOLOL TABLETS
Do not use Oxprenolol Tablets 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 reguired. These measures will help to protect the environment.
6. FURTHER INFORMATION What Oxprenolol Tablets contain
Oxprenolol 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.
Oxprenolol 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 Oxprenolol Tablets look like and contents of the pack Oxprenolol 20 mg Tablets are white, round, biconvex tablets approximately 7 mm in diameter. They are impressed OXP 20 on one side and blank on the other side.
Oxprenolol 40 mg Tablets are white, round, biconvex tablets approximately 8 mm in diameter. They are impressed OXP 40 on one side and blank on the other side.
Oxprenolol 80 mg Tablets are light yellow, round, biconvex tablets approximately 9 mm in diameter. They are impressed OXP 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and the manufacturer responsible for release is Amdipharm pic, Regency House, Miles Gray Road, Basildon. Essex. SS14 3AF.
Distributed by:
Waymade Pic trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon. Essex. SS14 3FR.
Date of leaflet: September 2012