Bisoratio Asa

Package Leaflet: Information for the Patient

Bisoratio ASA, 5 mg + 75 mg, hard capsules

Bisoratio ASA, 10 mg + 75 mg, hard capsules

Bisoprolol fumarate + Acetylsalicylic acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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. Contents of the pack and other information

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

Bisoratio ASA hard capsules contain two active substances, bisoprolol fumarate and acetylsalicylic acid.
Bisoprolol belongs to a group of medicines called beta-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 hard capsules are used to treat high blood pressure or 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 you are allergic to bisoprolol fumarate or acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have severe heart failure or cardiogenic shock causing shortness of breath and circulatory collapse
• if you have certain severe heart rhythm disorders, such as sinoatrial block, sick sinus syndrome, or second- or third-degree atrioventricular block (without a pacemaker)
• if you have a slow heart rate which causes problems. If you are not sure if this applies to you, ask your doctor
• if you have very low blood pressure (which may cause dizziness when standing up)
• if you have ever had an asthma attack or swelling of certain parts of the body, such as the face, lips, tongue, or throat (angioedema) after taking non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have severe asthma or wheezing
• if you have severe circulatory problems in your fingers and toes, such as Raynaud's syndrome
• if you have an untreated phaeochromocytoma (a rare tumour of the adrenal gland)
• if you have metabolic acidosis (a condition where the blood is too acidic)
• if you have had stomach or duodenal ulcers (peptic ulcers) or bleeding from the stomach or duodenum, or other types of bleeding, such as cerebral haemorrhage
• if you have had indigestion or stomach problems after taking acetylsalicylic acid
• if you have severe liver or kidney disease
• if you have had a haemorrhagic stroke
• if you have haemophilia or hypoprothrombinaemia (rare blood disorders)
• if you are taking anticoagulant medicines (such as warfarin, heparin, or acenocoumarol)
• if you have a deficiency of glucose-6-phosphate dehydrogenase (a hereditary condition that affects the red blood cells)
• if you are 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 you have gout
• if you are breastfeeding
• if you are in the third trimester of pregnancy, acetylsalicylic acid should not be taken in doses greater than 100 mg per day (see "Pregnancy and breastfeeding")

Tell your doctor if any of the above applies to you.

Bisoratio ASA hard capsules contain soya lecithin.

Do not take this medicine if you are allergic to soya or peanuts.

Warnings and precautions

Before starting treatment with Bisoratio ASA, discuss with your doctor or pharmacist if:

• you have breathing difficulties or asthma in your medical history. The dose may need to be monitored, and any new symptoms (such as cough, shortness of breath, or wheezing) should be reported to your doctor.
• you have diabetes (bisoprolol may mask the symptoms of low blood sugar)
• you do not eat solid food or follow a strict diet (food and fluids)
• you have heart problems, such as chest pain and concurrent heart failure
• you are being treated for allergic reactions, as bisoprolol may increase the risk of an allergic reaction or worsen its severity
• you have any conduction disorders (problems with the electrical impulses in the heart)
• you have variant angina (a type of chest pain caused by spasm of the coronary arteries, which supply blood to the heart muscle)
• you have any circulatory problems in your hands or feet
• you are scheduled for surgery - inform your anaesthetist that you are taking bisoprolol and acetylsalicylic acid
• you have a history of stomach ulcers (peptic ulcers) or bleeding disorders
• you have recurring skin disorders, including psoriasis (a condition where the skin becomes red, scaly, and flaky)
• you have a tumour of the adrenal gland (phaeochromocytoma); this medicine should only be used in combination with certain other medicines (such as alpha-blockers)
• you have thyroid function disorders, as this medicine may mask the symptoms of hyperthyroidism
• you have mild or moderate liver or kidney disease
• you have hives or a stuffy nose and sinusitis, which is caused by an allergy (rhinitis)
• you have stomach ulcers
• you have heavy menstrual bleeding
• you are undergoing surgery or having a tooth extracted
• if you are dehydrated

Make sure your doctor is aware of any of the above conditions that apply to you.
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, do not give hard capsules containing bisoprolol and acetylsalicylic acid to children under 16 years of age, unless explicitly recommended by a doctor.
Non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, should be used with caution in the elderly, who are more prone to side effects such as stomach bleeding. Treatment should be reviewed at regular intervals.
Athletes should be aware that this medicine contains an active substance that may cause positive results in anti-doping tests.

Bisoratio ASA and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, as the effect of these medicines and/or Bisoratio ASA hard capsules may be altered. This includes medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines used to control high blood pressure or heart disease (such as amiodarone, amlodipine, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, propafenone, quinidine, rilmenidine, verapamil, and beta-blockers)
• medicines used in anaesthesia during surgery (see also "Warnings and precautions")
• medicines used to treat epilepsy, such as phenobarbital, valproate, or phenytoin
• non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, or naproxen
• medicines used to treat asthma or nasal congestion
• medicines used to treat certain eye diseases, such as glaucoma (increased pressure in the eye) or to dilate the pupils (such as acetazolamide)
• certain medicines used to treat shock, such as adrenaline, dobutamine, or noradrenaline
• mefloquine, a medicine used to treat malaria
• medicines used to treat diabetes, including insulin and sulfonylurea derivatives (such as 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 (such as 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 its derivatives: hirudin, fondaparinux), medicines that prevent blood clots (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 fluid retention (such as diuretics)
• ACE inhibitors used to treat high blood pressure (such as captopril, enalapril, ramipril)
• corticosteroids
• methotrexate used to treat psoriasis (a skin disease) or cancer
• metoclopramide (used to treat nausea and vomiting or digestive disorders)
• alkalizing medicines, antacids
• iron salts (used to treat iron deficiency anaemia)
• antacids (used to treat stomach ulcers and reflux)
• medicines used to prevent transplant rejection (such as cyclosporin, tacrolimus)
• metamizole (a painkiller and antipyretic) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells), 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 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 soya or peanuts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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. Do not take Bisoratio ASA if you are in the last three months of pregnancy.
If you continue or start treatment with Bisoratio ASA hard capsules during pregnancy, after consulting your doctor, follow the doctor's advice and do not take more than the recommended dose.
Pregnancy - third trimester
Do not take acetylsalicylic acid in doses greater than 100 mg per day if you are in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney or heart problems in the unborn baby. It may affect the mother's and baby's bleeding and cause a longer or more difficult delivery.
If you take acetylsalicylic acid in low doses (up to 100 mg per day), very close monitoring of the pregnancy is required, as advised by your doctor.
Pregnancy - first and second trimester
Do not take Bisoratio ASA hard capsules during the first six months of pregnancy, unless it is absolutely necessary and advised by your doctor. If you need treatment during this period or when trying to conceive, use the lowest dose 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 levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your 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 during treatment with this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bisoratio ASA hard capsules usually do not affect the ability to drive or use machines. If you feel tired or dizzy, wait until the symptoms have resolved before driving or using machines.

3. How to take Bisoratio ASA

Bisoratio ASA hard capsules should be swallowed whole with water.
Recommended dose
The usual dose for adults is one capsule per day, taken at the same time every day. Your doctor will decide on the appropriate dose for you.
Bisoratio ASA hard capsules are 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 disease

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

Overdose of Bisoratio ASA

If you have taken more than the recommended dose of this medicine, contact your doctor or pharmacist immediately. Take the remaining capsules or this package leaflet with you, so that the medical staff knows exactly what medicine you have 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), 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 loss of consciousness or coma. Patients with heart failure may be more sensitive to these effects.

Missed dose of Bisoratio ASA

If you forget to take a capsule, take it as soon as you remember, within 12 hours. If more than 12 hours have passed, wait until the next dose. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Stopping treatment with Bisoratio ASA

Do not stop taking Bisoratio ASA hard capsules abruptly, as your condition may worsen and your blood pressure may increase again. Instead, the dose should be gradually reduced 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, this medicine can cause side effects, although not everybody gets them.

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

If you notice any of the following serious side effects, stop taking Bisoratio ASA and contact your doctor immediately:

• 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 are seen:

• common (affects 1 to 10 users in 100): feeling of coldness or numbness in hands or feet
• nausea (feeling sick) or vomiting
• diarrhoea or constipation
• increased risk of bleeding
• gastritis (inflammation of the stomach lining)
• feeling tired
• 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 users in 1,000):

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

rare (affects 1 to 10 users in 10,000):

• 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, seizures, or stroke), changes in blood cell counts
• increased liver enzyme activity
• hepatitis (inflammation of the liver), which can cause stomach 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 (such as increased triglycerides, increased liver enzyme activity)
• nightmares, hallucinations
• hearing disorders
• reduced tear secretion (important if you wear contact lenses)
• reduced sex drive
• fainting
• nosebleeds, bleeding gums, vomiting blood, blood in the stool, heavy menstrual bleeding
• constriction of the airways causing difficulty breathing or asthma attacks
• vasculitis (inflammation of the blood vessels)
• bruises and bleeding under the skin
• painful red lumps or nodules on the lower legs (erythema nodosum).

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

• 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 levels of uric acid 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
• fluid and salt retention in the body
• kidney disease.

Tell your doctor as soon as possible if you experience any of the above symptoms.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoratio ASA

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.

Do not use 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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

For more information about this medicine and its names in other European Economic Area countries, contact the representative of the marketing authorization holder:

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