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Bisoprolol And Aspirin 10mg/100mg Capsules

Document: leaflet MAH GENERIC_PL 32226-0004 change

1.3.1 Patient Information Leaflet

Text Version of Package Leaflet

PATIENT INFORMATION LEAFLET

Bisoprolol and Aspirin 5mg/75 mg capsules, hard Bisoprolol and Aspirin 10mg/75 mg capsules, hard Bisoprolol and Aspirin 5mg/100 mg capsules, hard Bisoprolol and Aspirin 10mg/100 mg capsules, hard

Bisoprolol Fumarate / Acetylsalicylic acid_

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

In this leaflet:

1.    What Bisoprolol and Aspirin capsules are and what they are used for

2.    What you need to know before you take Bisoprolol and Aspirin capsules

3.    How to take Bisoprolol and Aspirin capsules

4.    Possible side effects

5.    How to store Bisoprolol and Aspirin capsules

6.    Contents of the pack and other information

1. What Bisoprolol and Aspirin capsules are and what they are used for

Bisoprolol and Aspirin capsules contain two active ingredients, bisoprolol fumarate and acetylsalicylic acid. Bisoprolol belongs to a group of drugs called beta blockers. This medicine works by affecting the body's response to some nerve impulses, especially in the heart and has the effect of reducing blood pressure. Acetylsalicylic acid has the effect of preventing the development of blood clots. Acetylsalicylic acid is also known as Aspirin.

Bisoprolol and Aspirin capsules are used in the treatment of high blood pressure or in patients at risk of heart disease who were previously treated with the individual ingredients.

2. What you need to know before you take Bisoprolol and Aspirin capsules Do not take Bisoprolol and Aspirin capsules if you:

•    are allergic to bisoprolol fumarate or acetylsalicylic acid or any of the other ingredients of this medicine (listed in Section 6).

•    know you are allergic to any other non-steroidal anti-inflammatory drugs (NSAIDs)

•    have severe heart failure or cardiac shock causing breathlessness and circulation collapse

•    have certain serious heart rhythm problems e.g. sinoatrial block, sick sinus syndrome Page 1 of 7 131 -pl

Bisoprolol and Acetylsalicylic acid Capsules

and or second or third degree AV block (without pacemaker))

•    have a slow heart rate, causing problems. Ask your doctor if you are unsure

•    have very low blood pressure (which may make you dizzy when you stand up)

•    suffer from severe asthma or wheezing

•    know you are suffering from haemophilia or hypoprothrombinaemia (rare conditions affecting the blood)

•    you have untreated phaeochromocytoma, a rare tumour of the adrenal gland

•    suffer from a condition where there is a change in the acid/base balance of the body (metabolic acidosis)

•    suffer from severe blood circulation problems in the fingers, toes, arms and legs, like Raynaud's phenomenon.

•    have a stomach or bowel ulcer (peptic ulcer) or stomach/intestinal bleeding or any other kind of bleeding such as bleeding in the brain

•    have had stomach upset problems or have suffered stomach problems when you have taken acetylsalicylic acid before

•    have ever had a haemorrhagic stroke

•    have severe liver disease or kidney disease

•    suffer from glucose-6-phosphate dehydrogenase deficiency (a hereditary disease marked by low levels of glucose-6-phosphate dehydrogenase (G6Pd),

•    are being treated with methotrexate (a medicine used to treat psoriasis, rheumatoid arthritis, Crohn’s disease and some types of cancer) at doses above 15 mg per week.

Make sure your doctor knows if you suffer from any of the above.

Bisoprolol and Aspirin capsules contains soya lecithin. Do not use this product if you are

allergic to soya or peanuts. Warnings and precautions

Talk to your doctor or pharmacist before taking Bisoprolol and Aspirin capsules, if:

•    you have difficulty with breathing or a history of asthma in your family

•    you suffer from diabetes (as bisoprolol can hide the symptoms of low blood sugar)

•    you are fasting from solid food or strict fasting

•    you have problems with your heart e.g. chest pain and accompanying heart failure

•    you are being treated for hypersensitivity (allergic) reactions because Bisoprolol may make it more likely that you experience an allergic reaction, or the reaction may be more severe

•    you have any irregularity of the electrical system of the heart

•    you suffer from Prinzmetal’s angina which is a type of chest pain caused by spasm of the coronary arteries that supply the heart muscle

•    you have any problems with the circulation to your hands and feet

•    you are due to have an anaesthetic - let the anaesthetist know you are taking bisoprolol and acetylsalicylic acid

•    you have a past history of peptic ulcer or blood clotting problems

•    you suffer (or have suffered) from a recurrent skin disorder involving a scaling, dry skin rash (psoriasis).

•    you have a tumour of the adrenal medulla (phaeochromocytoma); this medicine may only be used in combination with certain medicinal products (the so-called alpha-blockers)

•    you suffer from a thyroid problem, as this medicine may hide the symptoms of an overactive thyroid

•    you suffer from mild or moderate liver or kidney disease

•    you suffer from hives (urticaria), or stuffy, runny nose caused by allergy (rhinitis),

•    you have gout (a condition that causes pain, inflammation and swelling in one or more of the joints

•    you suffer from stomach or intestinal ulcers

•    you suffer from heavy periods

•    you are having surgery or tooth extraction Make sure your doctor is aware of these situations

Athletes should note that this product contains an active substance which may cause a positive reaction in doping tests.

Other medicines and Bisoprolol and Aspirin capsules,

Please tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines as the effects of these and/or Bisoprolol and Aspirin capsules may change. This includes medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    Medicines for controlling blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil and beta blocking agents)

•    Medicines used for anaesthesia during an operation (see also “Warnings and precautions”)

•    Medicines used to treat epilepsy e.g. barbiturates such as phenobarbital

•    Anti-inflammatory medicines known as NSAIDs (for example diclofenac, ibuprofen, naproxen)

•    Medicines for asthma or medicines used for a blocked nose

•    Medicines used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to widen the pupil of the eye

•    Certain medicines to treat clinical shock (e. g. adrenaline, dobutamine, noradrenaline)

•    Mefloquine, a medicine for malaria

•    Medication for diabetes including insulin and tablets

•    Medicines for tuberculosis e.g. rifampicin

•    Medicines used for migraine e.g. ergotamine

•    anticoagulant medicines used for thinning the blood, e.g. warfarin

•    medicines used to treat gout e.g. probenecid

•    medicines used to treat severe depression (e.g. moclobemide) and mental disorders such as tricyclic antidepressants, phenothiazines, lithium and monoamine oxidase inhibitors (except MAO-B inhibitors)

•    other medicines used to thin the blood (heparin and derivatives: hirudin, fondaparinux), medicines that reduce the chances of blood clots forming (clopidrogel, ticlopidine, tirofiban and, eptifibatide) or medicines used to dissolve blood clots during a heart attack or a stroke.

•    medicines to treat water retention (e.g.diuretics)

•    medicines containing corticosteroids

•    Methotrexate used to treat psoriasis (a skin disorder) or cancer.

•    antacids for indigestion

Bisoprolol and Aspirin capsules, with food and drink

Bisoprolol and Aspirin capsules may be taken with or without food and should be swallowed whole with water.

Bisoprolol and Aspirin capsules should not be taken by patients who regularly consume large amounts of alcohol.

Bisorpolol and Aspirin capsules should not be taken by patients who are allergic to soya or peanuts.

Pregnancy and breast feeding

Please let the doctor know if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding. Bisoprolol and Aspirin capsules are not recommended during pregnancy unless absolutely necessary, as the possible risks to the baby are not known. Your doctor will be able to advise you.

It is unknown if bisoprolol is excreted in the breast milk, however, acetylsalicylic acid may be present in breast milk. Breast-feeding during the use of this medicinal product is therefore not recommended.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bisoprolol and Aspirin capsule should not usually affect your ability to drive or use machines. If they make you feel tired or dizzy wait until the symptoms have worn off before driving or using machines.

3. How to take Bisoprolol and Aspirin capsules

Bisoprolol and Aspirin capsules should be swallowed whole with water.

The normal dose for adults is one daily taken at about the same time each day. Your doctor will decide on the most suitable dose for you.

Bisoprolol and Aspirin capsules are not suitable for children

Older patients In general an adjustment of the dose is not needed. It is recommended to start with the lowest possible dose.

Patients with a severely reduced kidney & liver function Patients should not take this product if they suffer from severe kidney or liver disease. For patients with mild or moderate kidney or liver function, special care should be taken.

Treatment with bisoprolol is usually long-term. If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.

If you take more Bisoprolol and Aspirin capsules than you should

If you have accidentally taken more than the prescribed dose, tell your doctor/pharmacist immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken. The likely signs of an overdose are a sudden drop in pulse rate and/or blood pressure which may make you feel dizzy, light-headed, confused, sick or even be sick, cause buzzing in the ears and breathlessness. Other symptoms could include a feeling of spinning (vertigo), headache, ringing in the ears, confusion, nausea, vomiting and abdominal pain. A large overdose could cause breathing more quickly than normal (hyperventilation), difficulty breathing, heat stroke, sweating, restlessness, fits, seeing things, low blood sugar and eventually loss of consciousness or coma. Patients with heart failure may be more sensitive to these effects.

If you miss a dose of Bisoprolol and Aspirin capsules

If you forget a capsule, take it if you remember within 12 hours. If more than 12 hours have passed wait until your next dose. Do not take a double dose to catch up.

If you have any further questions on the use of this product ask your doctor or pharmacist.

If you stop taking Bisoprolol and Aspirin capsules

Treatment with Bisoprolol acetylsalicylic acid capsules must not be stopped abruptly as your condition may get worse, or your blood pressure may start to rise again. Instead, the capsules must be reduced gradually over one or two weeks as advised by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Bisoprolol and Aspirin capsules can sometimes cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, swelling of limbs (oedema), rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

The following terms are used to describe how often side effects have been reported:

very common: affects more than 1 user in 10_

common: affects 1 to 10 users in 100_

uncommon: affects 1 to 10 users in 1,000_

rare: affects 1 to 10 users in 10,000_

very rare: affects less than 1 user in 10,000_

not known: frequency cannot be estimated from the available data


Very Common (affects more than 1 person in 10):

•    nausea

•    pain or discomfort in your stomach or lower chest after eating Common (affects less than 1 person in 10):

•    tiredness, dizziness, headache (these side effects occur especially at the beginning of the treatment and are generally mild in nature and often disappear within 1 -2 weeks)

•    feeling of coldness or numbness in hands    or feet

•    vomiting, diarrhoea, or constipation.

•    stomach pain

•    black or tarry bowels which may be caused by blood in your faeces

•    vomiting blood

•    increased risk of bleeding

Uncommon (affects less than 1 person in 100):

•    low blood pressure

•    slow heart beat

•    feeling weak

•    sleep disturbances

•    depression

•    breathing problems in patients with asthma or chronic lung disease

•    muscle weakness, muscle cramps.

•    irregular heart beat; worsening of existing heart failure

•    blood in your urine

•    allergic reactions such    as itching, redness, skin    rash and    swelling    (face, hands, feet)

•    stomach bleeding, stomach ulcers and perforation, brain    haemorrhage

Rare (affects less than 1 person in 1,000):

•    hearing problems

•    allergic runny nose

•    reduced tear flow (important if you use contact lenses)

•    inflammation of the liver which can cause yellowing of the skin or whites of the eyes

•    changes in blood test results (e.g increase in a type of fat found in the blood (triglycerides) increased chemicals from the liver)

•    allergy-like reactions such as itching, flush, rash

•    reduced sexual potency

•    nightmares, hallucinations

•    fainting

•    nose bleeds, bleeding from the gums, increased menstrual bleeding

•    Ringing in the ears, headaches, dizziness: these signs usually reflect an overdose of acetylsalicylic acid

•    increase in liver enzymes

Very rare (affects less than 1 person in 10,000):

•    irritation and redness of the eye (conjunctivitis)

•    hair loss

•    cause or worsen psoriasis or a skin rash    similar to psoriasis

•    low blood sugar

•    liver and kidney disorders

•    high levels of uric acid in your blood

•    Anaphylactic shock or worsening symptoms of food allergy.

•    severe skin reactions (e.g. erythema exsudativum multiforme)

Please tell your doctor as soon as possible if any of these have occurred.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol and Aspirin capsules

Keep out of the sight and reach of children.

Do not store above 25°C. Do not use Bisoprolol and Aspirin capsules after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Further information

The active substances are bisoprolol fumarate and acetylsalicylic acid.

The other ingredients are maize starch, cellulose microcrystalline, magnesium stearate, stearic acid, polyvinyl alcohol hydrolysed, titanium dioxide (E171), talc, lecithin (soya) (E322), xanthan gum.

Capsule: gelatin, titanium dioxide (E171)

Printing ink: Shellac, iron oxide black (E172), propylene glycol, ammonium hydroxide. What Bisoprolol and Aspirin capsules look like and contents of pack

The capsules are white with the strength printed on them.

Bisoprolol and Aspirin 5 mg/75 mg and 10 mg/75 mg capsules are supplied in packs of 14, 28, 30 and 90 capsules.

Bisoprolol and Aspirin 5 mg/100 mg and 10 mg/100 mg capsules are supplied in packs of 10, 14, 28, 30, 56, 60, 90, 98 and 100 capsules.

Not all pack sizes may be marketed

Marketing authorization holder:

ASA Pharma PLC 6 Northbrook Road Dublin 6 Ireland

Manufacturer :

Pharmaceutical Works Polpharma S.A 19, Pelplinska Str., 83-200 Starogard,

Gdanski, Poland

ExtractumPharma Co. Ltd 6413 Kunfeherto IV.,

Korzet 6 Hungary

Additionally, for 5mg/100mg & 10mg/100mg only:

Sanico NV

Veedijk 59, 2300 Turnhout Belgium

Lamp San Prospero S.p.A

Via Della Pace 25/A, 41030 San Prospero s/S Modena Italy

This leaflet was last revised in:

January 2015

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Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15