Bisoratio Asa

Leaflet accompanying the packaging: patient information

Bisoratio ASA, 5 mg + 75 mg, hard capsules

Bisoratio ASA, 10 mg + 75 mg, hard capsules

Bisoprolol fumarate + Acetylsalicylic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bisoratio ASA and what is it used for
• 2. Important information before taking Bisoratio ASA
• 3. How to take Bisoratio ASA
• 4. Possible side effects
• 5. How to store Bisoratio ASA
• 6. Package contents and other information

1. What is Bisoratio ASA and what is it used for

Bisoratio ASA in the form of hard capsules contains two active substances, bisoprolol fumarate and acetylsalicylic acid.
Bisoprolol belongs to a group of medicines called beta-adrenergic blockers. This medicine works by affecting the body's response to certain nerve impulses, especially in the heart, and lowering blood pressure. Acetylsalicylic acid is an antiplatelet agent that prevents blood clots from forming.
Acetylsalicylic acid is also known as aspirin.
Bisoratio ASA in the form of hard capsules is used to treat high blood pressure or in patients at risk of heart disease, heart attack, or stroke, who have previously been treated with single active substances of this medicine.
Bisoratio ASA hard capsules can also be used to prevent complications after certain types of heart surgery.

2. Important information before taking Bisoratio ASA

When not to take Bisoratio ASA

• if the patient is allergic to bisoprolol fumarate or acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe heart failure or cardiogenic shock causing shortness of breath and circulatory collapse
• if the patient has certain severe heart rhythm disorders, such as sinoatrial block, sick sinus syndrome, or second- or third-degree atrioventricular block (without a pacemaker)
• if the patient has a slow heart rate which causes problems. If the patient is not sure if this applies to them, they should ask their doctor
• if the patient has very low blood pressure (which may cause dizziness when standing up)
• if the patient has ever had an asthma attack or swelling of certain parts of the body, such as the face, lips, throat, or tongue (angioedema) after taking non-steroidal anti-inflammatory drugs (NSAIDs)
• if the patient has severe asthma or wheezing
• if the patient has severe circulatory problems in the fingers and toes, arms and legs, such as Raynaud's syndrome
• if the patient has an untreated phaeochromocytoma (a rare tumour of the adrenal gland)
• if the patient has acid-base balance disorders in the body (metabolic acidosis)
• if the patient has or has had stomach or duodenal ulcers (peptic ulcers) or bleeding from the stomach or duodenum, or other types of bleeding, such as cerebral haemorrhage
• if the patient has previously experienced indigestion or stomach problems after taking acetylsalicylic acid
• if the patient has severe liver or kidney disease
• if the patient has ever had a haemorrhagic stroke
• if the patient has haemophilia or hypoprothrombinaemia (rare blood disorders)
• if the patient is taking anticoagulant medicines (e.g. warfarin, heparin, or acenocoumarol)
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a congenital disorder characterized by low activity of the enzyme glucose-6-phosphate dehydrogenase (G6PD))
• if the patient is being treated with methotrexate (a medicine used to treat psoriasis, rheumatoid arthritis, Crohn's disease, and certain types of cancer) in doses greater than 15 mg per week
• if the patient has or has had gout
• if the patient is breastfeeding
• if the patient is in the third trimester of pregnancy, acetylsalicylic acid should not be taken in doses greater than 100 mg per day (see "Pregnancy and breastfeeding")

The patient should inform their doctor if any of the above conditions apply to them.

Bisoratio ASA, hard capsules, contain soy lecithin.

This medicine should not be taken if the patient is allergic to soy or peanuts.

Warnings and precautions

Before starting treatment with Bisoratio ASA, the patient should discuss it with their doctor or pharmacist if:

• the patient has difficulty breathing or asthma in their medical history. The dose may need to be monitored, and any new symptoms (e.g. cough, exercise intolerance, or shortness of breath) should be reported to the doctor.
• the patient has diabetes (bisoprolol may mask the symptoms of low blood sugar)
• the patient does not eat solid foods or follows a strict diet (food and fluids)
• the patient has heart problems, such as chest pain and concurrent heart failure
• the patient is being treated for allergic reactions, as bisoprolol may increase the risk of an allergic reaction or worsen its severity
• the patient has any conduction disorders in the heart
• the patient has Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries supplying the heart muscle
• the patient has any circulatory problems in their hands or feet
• the patient is scheduled for surgery - they should inform the anaesthetist about taking bisoprolol and acetylsalicylic acid
• the patient has a history of stomach ulcers (peptic ulcers) or blood clotting disorders
• the patient has or has had recurring skin disorders, including psoriasis and dry skin rash
• the patient has an adrenal gland tumour (phaeochromocytoma); this medicine should only be taken with certain other medicines (so-called alpha-adrenergic blockers)
• the patient has thyroid function disorders, as this medicine may mask the symptoms of hyperthyroidism
• the patient has mild or moderate liver or kidney disease
• the patient has hives or a stuffy nose and sinusitis, which is caused by an allergy (rhinitis)
• the patient has stomach ulcers
• the patient has heavy menstrual bleeding
• the patient is undergoing surgery or having a tooth extracted
• if the patient is dehydrated.

The patient should ensure that their doctor is informed about any of the above conditions that apply to them.
There is a potential link between the use of acetylsalicylic acid in children and the development of Reye's syndrome. Reye's syndrome is a very rare disease that can be fatal.
Therefore, hard capsules containing bisoprolol and acetylsalicylic acid should not be taken by children under the age of 16, unless explicitly recommended by a doctor.
In general, non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, should be used with caution in the elderly with a tendency to adverse effects such as stomach bleeding. Treatment should be verified at regular intervals.
Athletes should be aware that the medicine contains an active substance that may cause positive doping test results.

Bisoratio ASA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as the effects of these medicines and/or Bisoratio ASA may change. This also applies to medicines that are available without a prescription.
In particular, the patient should tell their doctor if they are taking any of the following medicines:

• medicines used to control blood pressure or heart disease (such as: amiodarone, amlodipine, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, propafenone, quinidine, rilmenidine, verapamil, and beta-adrenergic blockers)
• medicines used in anaesthesia during surgery (see also "Warnings and precautions")
• medicines used to treat epilepsy, such as phenobarbital, valproate, or phenytoin
• anti-inflammatory medicines known as NSAIDs (e.g. diclofenac, ibuprofen, naproxen)
• medicines used to treat asthma or nasal congestion
• medicines used to treat certain eye diseases, such as glaucoma (increased eye pressure) or used to dilate the pupils (e.g. acetazolamide)
• certain medicines used to treat shock (e.g. adrenaline, dobutamine, noradrenaline)
• mefloquine, a medicine used to treat malaria
• medicines used to treat diabetes, including insulin and sulfonylurea derivatives (e.g. glibenclamide)
• medicines used to treat tuberculosis, such as rifampicin
• medicines used to treat migraines, such as ergotamine
• anticoagulant medicines used to thin the blood, such as warfarin
• medicines used to treat gout, such as probenecid or sulfinpyrazone
• medicines used to treat severe depression (e.g. moclobemide) and mental disorders, such as: tricyclic antidepressants, selective serotonin reuptake inhibitors, phenothiazines, lithium, and monoamine oxidase inhibitors (except for MAO-B inhibitors)
• other medicines used to thin the blood (heparin and derivatives: hirudin, fondaparinux), medicines that reduce blood clotting (clopidogrel, ticlopidine, tirofiban, and eptifibatide) or medicines used to dissolve blood clots during a heart attack or stroke
• spironolactone or other medicines used to treat water retention in the body (e.g. diuretics)
• ACE inhibitors used to treat high blood pressure (e.g. captopril, enalapril, ramipril)
• corticosteroid-containing medicines
• methotrexate used to treat psoriasis (skin disease) or cancer
• metoclopramide (used to treat nausea and digestive disorders)
• alkalizing medicines, antacids
• iron salts (used for iron deficiency anaemia)
• carbonates (used for stomach ulcers and reflux)
• medicines used to prevent transplant rejection (e.g. cyclosporine, tacrolimus)
• metamizole (a medicine with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and clot formation), if these medicines are taken together. Therefore, caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.

Bisoratio ASA with food, drink, and alcohol

Bisoratio ASA, hard capsules, can be taken with or without food; the capsules should be swallowed whole, with a glass of water.
Bisoratio ASA, hard capsules, should not be taken by patients who regularly consume large amounts of alcohol.
Bisoratio ASA, hard capsules, should not be taken by patients who are allergic to soy or peanuts.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Bisoratio ASA, hard capsules, should not be taken during pregnancy, unless it is absolutely necessary, as the potential risk to the baby is not known. Bisoratio ASA should not be taken if the patient is in the last three months of pregnancy.
If the patient continues or starts treatment with Bisoratio ASA capsules during pregnancy on the advice of their doctor, they should take Bisoratio ASA capsules as directed by their doctor and not take a higher dose than recommended.
Pregnancy - third trimester
Acetylsalicylic acid should not be taken in doses greater than 100 mg per day if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. There may be problems with the baby's kidneys and heart. It may affect the patient's and baby's bleeding tendency and cause the delivery to be delayed or longer than expected.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day), very close obstetric monitoring is required, as directed by the doctor.
Pregnancy - first and second trimester
Acetylsalicylic acid should not be taken during the first six months of pregnancy, unless it is absolutely necessary and recommended by the doctor. If the patient needs treatment during this period or when trying to conceive, the lowest dose should be used for the shortest possible time.
If acetylsalicylic acid is taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If the patient needs treatment for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, but acetylsalicylic acid may be present in breast milk. Therefore, breastfeeding is not recommended while taking this medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Bisoratio ASA, in capsules, usually does not affect the ability to drive or use machines. If the patient feels tired or dizzy, they should wait until the symptoms have passed before driving or using machines.

3. How to take Bisoratio ASA

Bisoratio ASA, hard capsules, should be swallowed whole, with a glass of water.
Recommended dose
The usual dose for an adult is one capsule per day, taken at the same time every day. The doctor will decide on the appropriate dose for the patient.
Bisoratio ASA, hard capsules, is not suitable for use in children.

Elderly patients

Usually, dose adjustment is not necessary. It is recommended to start treatment with the lowest possible dose.

Patients with severe kidney or liver impairment

Patients should not take this medicine if they have severe kidney or liver disease.
In patients with mild or moderate kidney or liver impairment, caution should be exercised.
Treatment with bisoprolol is usually long-term. If treatment needs to be completely stopped, the doctor will usually recommend gradual dose reduction, as the patient's condition may worsen otherwise.

Taking a higher dose of Bisoratio ASA than recommended

If the patient has taken a higher dose of the medicine than recommended, they should immediately consult their doctor or pharmacist. They should take the remaining tablets or this leaflet with them, so the medical staff knows exactly what medicine the patient has taken. The likely symptoms of overdose are sudden slowing of the heart rate and/or lowering of blood pressure, which may cause dizziness, fainting, disorientation, shortness of breath, nausea, or vomiting. Other symptoms may include vertigo (dizziness of labyrinthine origin), headache, ringing in the ears, and abdominal pain. Severe overdose may cause: rapid breathing (hyperventilation), breathing difficulties, heat stroke, sweating, restlessness, seizures, hallucinations, low blood sugar, and eventually loss of consciousness or coma. Patients with heart failure may be more susceptible to these effects.

Missing a dose of Bisoratio ASA

If the patient forgets to take a capsule, they should take it as soon as they remember, within 12 hours. If more than 12 hours have passed, they should wait until the next dose. They should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

Stopping treatment with Bisoratio ASA

The patient should not suddenly stop taking Bisoratio ASA capsules, as they may feel worse and their blood pressure may rise again. Instead, the dose should be gradually reduced over one or two weeks, as directed by the doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although severe allergic reactions are rare.

If the patient notices any of the following serious side effects, they should stop taking Bisoratio ASA and immediately consult their doctor:

• worsening of heart failure leading to increased shortness of breath and/or fluid retention
• unusual bleeding, such as: coughing up blood, vomiting blood, or blood in the urine, or black stools
• sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, or swelling of the limbs
• rash or itching (especially affecting the whole body).

The following terms have been used to describe how often side effects have been observed:
Common (affects 1 to 10 in 100 patients):

• feeling of coldness or numbness in the hands or feet
• nausea (vomiting) or vomiting
• diarrhoea or constipation
• increased risk of bleeding
• gastritis
• feeling of tiredness
• dizziness
• headache
• indigestion
• mild to moderate gastrointestinal bleeding; with prolonged or frequent use of the medicine, this bleeding may lead to anaemia.

Uncommon (affects 1 to 10 in 1,000 patients):

• low blood pressure
• slow heart rate
• feeling of weakness
• irregular heartbeat
• breathing difficulties in patients with asthma or chronic lung disease
• sleep disorders
• depression
• muscle weakness, muscle cramps
• hives
• allergic rhinitis.

Rare (affects 1 to 10 in 10,000 patients):

• severe skin reactions, including a rash known as erythema multiforme and its life-threatening forms: Stevens-Johnson syndrome and Lyell's syndrome
• severe bleeding in the stomach or intestines, cerebral haemorrhage (bleeding in the brain, which can cause sudden, severe headache, seizure, or stroke), changes in blood cell count
• increased liver enzyme activity
• hepatitis, which can cause abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the skin or whites of the eyes and dark urine
• changes in blood test results (e.g. increased triglyceride levels, increased liver enzyme activity)
• nightmares, hallucinations
• hearing disorders
• reduced tear secretion (important if the patient wears contact lenses)
• reduced libido
• fainting
• nosebleeds, bleeding gums, vomiting blood, blood in the stool, increased menstrual bleeding
• constriction of the airways causing breathing difficulties or asthma attacks
• vasculitis
• bruises and haematomas (subcutaneous bleeding)
• painful red lumps or nodules on the lower legs (erythema nodosum).

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

• development or worsening of psoriasis or psoriasis-like rash
• irritation or redness of the eyes (conjunctivitis)
• hair loss
• low blood sugar
• liver disease
• worsening of food allergy symptoms.

Side effects with unknown frequency:

• ringing in the ears (tinnitus)
• high uric acid levels in the blood
• stomach or small intestine ulcers and perforation
• prolonged bleeding time, symptoms may persist for 4-8 days after stopping acetylsalicylic acid; there is an increased risk of bleeding during surgical procedures
• retention of salt and water in the body
• kidney disease.

The patient should inform their doctor as soon as possible if they experience any of the above symptoms.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bisoratio ASA

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.

Do not take this medicine after the expiry date stated on the carton and blister after:

EXP.The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What Bisoratio ASA, hard capsules, contain:

Each capsule contains 5 mg of bisoprolol fumarate and 75 mg of acetylsalicylic acid.
Bisoratio ASA, 10 mg + 75 mg, hard capsules:
Each capsule contains 10 mg of bisoprolol fumarate and 75 mg of acetylsalicylic acid.
The other ingredients are: maize starch, stearic acid, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin, xanthan gum.
Coating: gelatin, titanium dioxide (E 171).
Ink: shellac, iron oxide black (E 172), propylene glycol, ammonium hydroxide.

What Bisoratio ASA looks like and contents of the pack

Bisoratio ASA, 5 mg + 75 mg, hard capsules: White capsule with imprint 5/75.
Bisoratio ASA, 10 mg + 75 mg, hard capsules: White capsule with imprint 10/75.
Bisoratio ASA, 5 mg + 75 mg, hard capsules, and Bisoratio ASA, 10 mg + 75 mg, hard capsules, are available in packs containing 14, 28, 30, or 90 capsules.
The capsules are packaged in PVC/PE/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Zakłady Farmaceutyczne Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A,
14 km National road 1, Kato Kifisia Attiki. 145 64
Greece
Hennig Arzneimittel GmbH & Co. KG
Liebigstraße 1-2
65439 Flörsheim am Main
Germany
Inpharmasci
Zone Industrielle No. 2, 1 rue Nungesser
59121 Prouvy
France

To obtain more detailed information on the medicine and its names in other European Economic Area countries, the patient should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.
Date of last revision of the leaflet:March 2025.