Skip to Content

BISOPROLOL AND ASPIRIN 5MG/75MG CAPSULES

Active substance(s): ACETYLSALICYLIC ACID / BISOPROLOL FUMARATE / ACETYLSALICYLIC ACID / BISOPROLOL FUMARATE / ACETYLSALICYLIC ACID / BISOPROLOL FUMARATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PATIENT INFORMATION LEAFLET

Bisoprolol and Aspirin 5 mg/75 mg capsules
Bisoprolol and Aspirin 10 mg/75 mg capsules
Bisoprolol and Aspirin 5 mg/100 mg capsules
Bisoprolol and Aspirin 10 mg/100 mg capsules
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 signs of illness
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
Possible side effects
4.
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.
have ever had an asthma attack or swelling of some
parts of the body e.g. face, lips, throat or tongue
(angioedema) after taking 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 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
suffer from gout or have a history of gout
know you are suffering from haemophilia or
hypoprothrombinaemia (rare conditions affecting the
blood)
are taking medicines to prevent blood clotting
(e.g.warfarin, heparin or acenocoumarol)
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 or have ever had 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
are in the third trimester of pregnancy at a dose
>100mg of aspirin per day

Make sure your doctor knows if you suffer from any of the
above.
Bisoprolol and Aspirin capsules contain 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 (food
and fluids)
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 suffer from stomach or intestinal ulcers
you suffer from heavy periods
you are having surgery or tooth extraction
you are suffering from dehydration

Make sure your doctor is aware of these situations
There is a possible association between acetylsalicylic
acid and Reye’s Syndrome when given to children. Reye’s
Syndrome is a very rare disease which can be fatal. For
this reason Bisoprolol and Aspirin capsules should not
be given to children aged under 16 years, unless on the
advice of a doctor.
In general NSAIDs such as acetylsalicylic acid should be
used with caution in elderly patients who are more prone
to side effects such as bleeding in the stomach. Treatment
should be reviewed at regular intervals.
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, 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 such as

phenobarbital, valproate or phenytoin

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 (e.g. acetazolamide)

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

mefloquine, a medicine for malaria

medication for diabetes including insulin and
sulfonylureas (e.g. glibenclamide)
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 or
sulfinpyrazone
medicines used to treat severe depression (e.g.

moclobemide) and mental disorders such as
tricyclic antidepressants, selective serotonin re-uptake
inhibitors, 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
spironolactone or other medicines to treat water

retention (e.g.diuretics)

ACE inhibitors used for treating high blood pressure
(captopril, enalapril, ramipril)

medicines containing corticosteroids
methotrexate used to treat psoriasis (a skin disorder)

or cancer

metoclopramide (for sickness or digestive disorders)
alkali hydroxides, antacids (for indigestion)


iron salts (for treatment of iron deficiency anaemia)

carbonates (for treatment of peptic ulcer and reflux)

medicines used to prevent organ rejection after
transplantation (ciclosporin, tacrolimus)

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.
Bisoprolol 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. You should
not take Bisoprolol and Aspirin capsules if you are in
the last 3 months of pregnancy, unless you are advised
to do so by your doctor as taking regular or high doses
of acetylsalicylic acid at this stage can cause serious
complications in the mother or baby.
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 capsules 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 capsule 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, lightheaded, confused, breathless, sick or even be sick. Other
symptoms could include a feeling of spinning (vertigo),
headache, ringing in the ears 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.





muscle weakness, muscle cramps
hives
allergic runny nose

Rare (affects less than 1 person in 1,000):
severe skin reactions such as rash known as

‘erythema multiforme’ and its life-threatening forms
Stevens-Johnson syndrome and Lyell’s syndrome

severe bleeding in the stomach or intestines, brain
haemorrhage (a bleed in the brain which can cause
sudden severe headache, fit or stroke); altered
number of blood cells

increase in liver enzymes

inflammation of the liver (hepatitis), causing
abdominal pain, loss of appetite and sometimes
jaundice with yellowing of the whites of the eyes and
skin and dark urine

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

nightmares, hallucinations

hearing problems

reduced tear flow (important if you use contact lenses)

reduced sexual potency

fainting

nose bleeds, bleeding from the gums, vomiting blood,
blood in faeces, increased menstrual bleeding

restriction of airways causing breathing difficulties, or
asthma attack

inflammation in the blood vessels

bruising with purple spots (cutaneous bleeding)

tender red nodules or lumps on the shins (erythema
nodosum)
Very rare (affects less than 1 person in 10,000):

cause or worsen psoriasis or a skin rash similar to
psoriasis
irritation and redness of the eye (conjunctivitis)


hair loss

low blood sugar

liver disorders

worsening of symptoms of food allergy
Side effects with unknown frequency:

ringing in the ears (tinnitus)

high levels of uric acid in your blood

ulcers in stomach or small intestine and perforation
prolonged bleeding time, symptoms may persist for

a period of 4-8 days after acetylsalicylic acid
discontinuation. Increased risk of bleeding during
surgical procedures

salt and water retention
kidney disorders

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
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Bisoprolol and Aspirin
capsules

If you miss a dose of Bisoprolol and Aspirin
capsules

Keep this medicine out of the sight and reach of children.

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.

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.

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 and Aspirin 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 medicine, 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 rare. If you notice any
of the following serious side effects, stop taking
Bisoprolol and Aspirin capsules and contact a doctor
immediately:





worsening of heart failure causing increased
breathlessness and / or retention of fluid
unusual bleeding, such as coughing up blood,
blood in your vomit or urine, or black stools
any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, swelling of the
limbs (oedema)
rash or itching (especially affecting your whole
body)

The following side effects have also been reported:
Common (affects less than 1 person in 10):

feeling of coldness or numbness in hands or feet

nausea (feeling sick) or vomiting (being sick)

diarrhoea or constipation

increased risk of bleeding

gastritis

tiredness

dizziness

headaches

indigestion

mild to moderate blood loss in the gastrointestinal
tract. With long-term or repeated use this blood
loss can lead to aneamia
Uncommon (affects less than 1 person in 100):

slow heart beat

low blood pressure

feeling weak

irregular heart beat

breathing problems in patients with asthma or chronic
lung disease

sleep disturbances

depression

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

6. Contents of the pack and other
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
This leaflet was last revised in: May 2017

Expand Transcript

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