Skip to Content

BISOPROLOL AND ASPIRIN 5MG/100MG CAPSULES

Active substance(s): ACETYLSALICYLIC ACID / BISOPROLOL FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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

Revision 14; Jan 15















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 alphablockers)

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
Page 2 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15


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.

Page 3 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15

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.

Page 4 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15

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

Page 5 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15

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.

Page 6 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15

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

Page 7 of 7 131-pl
Bisoprolol and Acetylsalicylic acid Capsules

Revision 14; Jan 15

Expand view ⇕

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.

Hide