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OXPRENOLOL 80 MG TABLETS

Active substance(s): OXPRENOLOL HYDROCHLORIDE / OXPRENOLOL HYDROCHLORIDE

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GB 727-0382-APIL

Oxprenolol 20 mg, 40 mg and 80 mg Tablets

SOVEREIGN
M E D I C A L

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
(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.
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 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 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.

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).

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.

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.

Swallow your tablets whole with a drink of water.

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.

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
Ask your doctor before stopping treatment with Oxprenolol Tablets.
If you stop taking your tablets suddenly it may cause your
condition to get worse.
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:
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.
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 1in 10,000
patients)
• Hallucinations;
• Tiredness on exertion;
• Worsening of psoriasis;
• Dry or sore eyes.

SOVEREIGN
M E D I C A L

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 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 plc, Regency House, Miles Gray Road,
Basildon. Essex. SS14 3AF.
Distributed by:
Waymade Plc trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon. Essex. SS14 3FR.
Date of leaflet: September 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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