BLOKBIS 5 mg. / 100 mg. 30 capsules

What is Blokbis ASA capsules and what it is used
Blokbis ACA contains two active substances - bisoprolol fumarate and atsetilsalitsinova acid. Bisoprolol belongs to a group of medicines called beta-blockers. This drug works by blocking the body's response to some nerve impulses, especially in the heart and lowers blood pressure. Aspirin prevents blood clots. Atsetilsalisilovata acid is also known as Aspirin.
Blokbis ASA capsules are used to treat high blood pressure in patients at risk of cardiovascular disease who have previously been treated with various components.

2. Before you take Blokbis ASA capsules
Do not take Blokbis ASA capsules if:
know that you are allergic to bisoprolol or acetylsalicylic acid or any of the other ingredients of this medicine (See "Further Information" for a list of ingredients);
know that you are allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs);
you have severe heart failure or cardiogenic shock, causing shortness of breath and circulatory collapse;
have serious heart rhythm problems, eg. sinoatrial block or AV-block second or third degree (without pacemaker);
have a slow heart rate (heart rate below 60 beats per minute). Consult your doctor if you are not sure;
have very low blood pressure (which can cause you dizzy when standing up);
suffer from asthma or wheezing;
you know you suffer from hemophilia or hypoprothrombinaemia (rare conditions affecting the blood);
have untreated pheochromocytoma - a rare tumor of the adrenal gland;
suffer from a condition in which there is a change in the equilibrium acids / bases in the body (metabolic acidosis);
have severe circulatory problems in the fingers and toes, as Raynaud's phenomenon;
have a stomach ulcer or intestines (peptic ulcer) or stomach / intestinal bleeding or any other kind of bleeding, such as bleeding in the brain;
you have indigestion or have suffered from stomach problems when taking acetylsalicylic acid;
you spent hemorrhagic stroke;
have severe liver or kidney disease;
suffer from glucose-6-phosphate dehydrogenase deficiency (an inherited disease characterized by low levels of glucose-6-phosphate dehydrogenase (G6Pd));
are treated with methotrexate (a drug used to treat psoriasis, rheumatoid arthritis, Crohn's disease and some cancers) at doses greater than 15 mg per week.
If you suffer from any of these conditions, make sure your doctor is aware of it.
Blokbis ASA capsules contain soy lecithin. Do not take this medicine if you are allergic to soy or peanuts.

Take special care when taking Blokbis ASA capsules if:
have difficulty breathing or a history of asthma in your family;
diabetes (as bisoprolol may mask the symptoms of low blood sugar);
Lent avoiding solid food or fasting strictly;
you have heart problems, eg. chest pain and concomitant heart failure;
are treated for hypersensitivity (allergy) as bisoprolol may increase the likelihood of allergic reaction or may be more severe;
have any disturbances in the electrical system of the heart;
suffer from Prinzmetal angina, which is a type of chest pain caused by spasms in the coronary arteries supplying the heart muscle;
you have any problems with blood flow to your hands and feet;
yet your anesthesia - the anesthetist that you are taking bisoprolol and acetylsalicylic acid;
you had peptic ulcers or bleeding problems;
suffer (or have suffered) from chronic skin disorder involving scaling and dry skin rash (psoriasis);
have a tumor of the adrenal medulla (pheochromocytoma); This medicine may be used only with certain medications (ie. called. alpha-blockers);
suffer from thyroid problems, as this medicine mask the symptoms of hyperactivity;
suffer from mild or moderate liver or kidney disease;
suffer from hives (urticaria) or stuffy, runny nose caused by allergy (rhinitis);
have gout (a condition that causes pain, inflammation and swelling in one or more joints);
suffer from stomach or intestinal ulcers;
suffer from heavy menstrual periods;
you are going to surgery or tooth extraction.
Make sure your doctor knows about it.
Athletes should be aware that this product contains an active substance, which may give a positive reaction in doping tests.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, as their effects and / or the effect of ASA Blokbis may change. This includes medicines obtained without a prescription.
It is particularly important to tell your doctor if you are taking any of the following medications:
drugs controlling high blood pressure and drugs for heart problems (such as amiodarone, amlodipine, clonidine, digitalis, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil and beta-blockers) ;
drugs used in anesthesia during surgery (see. also "Take special care when taking Blokbis ASA capsules");
drugs used for the treatment of epilepsy, e. barbiturates such as phenobarbital;
anti-inflammatory drugs known as non-steroidal anti-inflammatory agents (eg. diclofenac, ibuprofen, naproxen);
drugs used to treat asthma or nasal congestion;
medicines used to treat certain eye disorders such as glaucoma (increased eye pressure) or drugs used to expand the pupil of the eye;
certain drugs used for treatment of clinical shock (eg. adrenaline, dobutamine, noradrenaline);
mefloquine - a medicament for the treatment of malaria;
drugs used for treating diabetes including insulin and tablets;
drugs used for treatment of tuberculosis, for example. rifampicin;
drugs for migraine, eg. ergotamine;
anticoagulants used to thin the blood, for example. warfarin;
drugs used to treat gout, e. probenecid;
antimalarials, e. mefloquine;
drugs used for the treatment of major depression (eg. moclobemide) and mental disorders, such as tricyclic antidepressants, phenothiazines and monoamine oxidase inhibitors (except MAO-B) inhibitors;
other medicines used to thin the blood (heparin derivatives, hirudin, fondaparinux); drugs that reduce the likelihood of blood clots (clopidogrel, ticlopidine, tirofiban and eptifibatide) or medication used to dissolve blood clots in heart attack or stroke;
drugs for the treatment of water retention (e. diuretics);
drugs containing corticosteroids;
methotrexate used to treat psoriasis (skin disorders) or cancer;
antacids used to treat indigestion.
Taking Blokbis ASA capsules with food and drink
Blokbis ASA capsules can be taken with or without food and should be swallowed whole with water.
Blokbis ASA capsules should not be administered to patients who regularly consume large amounts of alcohol.
Blokbis ASA capsules should not be administered to patients who are allergic to soy or peanuts.

Pregnancy and lactation
Please tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant, or breastfeeding. Blokbis ASA capsules should not be used during pregnancy unless clearly necessary as the risks to the baby are not known. Your doctor will advise you.
It is not known whether bisoprolol is excreted in human milk, however, acetylsalicylic acid may be excreted in human milk. Therefore, breast-feeding is not recommended while using this medicine.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Blokbis ASA usually does not affect the ability to drive and use machines. If you feel tired or dizzy, wait until symptoms subside before driving or operating machinery.

3. How to take Blokbis ASA capsules
Blokbis ASA capsules should be swallowed whole with water.
The normal adult dose is taken once a day at the same time. Your doctor will decide the most appropriate dose for you.
Blokbis ASA capsules are suitable for children.

Elderly
Usually not necessary to adjust the dose. It is recommended to start with the lowest possible dose.

Patients with significantly impaired renal or hepatic function
Patients suffering from severe kidney or liver disease should not take this medicine. Special care is required in patients with mild or moderate renal or hepatic function.
Treatment with bisoprolol is usually long-term. If you need to stop treatment altogether. Your doctor will usually advise you to reduce the dose gradually, as your condition may get worse.

If you take more dose Blokbis ASA capsules:
If you take more than the recommended dose, immediately tell your doctor / pharmacist. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken. Usually the symptoms of overdose are a sudden drop in heart rate and / or blood pressure, which may make you feel dizzy, stunned, confused, feel nausea and keep you sick, cause tinnitus and shortness of breath. Other symptoms may include dizziness, headache, tinnitus, confusion, nausea, vomiting and abdominal pain. In massive overdose may experience rapid breathing (hyperventilation), breathing difficulties, heart attack, sweating, restlessness, seizures, hallucinations, low blood sugar and possible loss of consciousness or coma.

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

If you stop taking Blokbis ASA capsules:
Treatment with Blokbis ASA capsules should not be stopped abruptly as your condition may get worse or your blood pressure may start to rise again. Instead, the capsules should 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, Blokbis ASA capsules can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor about any sudden shortness of breath, difficulty breathing, swelling of eyelids, face or lips; swelling of limbs (edema); rash or itching (especially if it affected the whole body).

The following definitions used below refer to the incidence of adverse reactions:
Very common: affects more than 1 in 10 patients;
Common: affects 1 to 10 patients in 100;
Uncommon: affects 1 to 10 patients in 1000;
Rare: affects 1 to 10 patients in 10,000;
Very rare: affects less than 1 to 10 patients in 10,000;
Not known: from the available data can not be estimated;
Very common (affects more than 1 in 10 patients):
slow heartbeat;
nausea;
pain or discomfort in the stomach or lower chest (under the spoon) after meals.
Common (affects less than 1 in 10 patients):
fatigue, weakness, dizziness, headache (these side effects occur predominantly at the start of therapy and usually mild and often disappear within 1-2 weeks);
cold feeling or numbness in hands or feet;
hypotension;
nausea, vomiting, diarrhea or constipation;
stomach pain;
or black tarry stools, which may be caused by blood in stool;
vomiting blood;
increased risk of bleeding.
Uncommon (affects less than 1 in 100 patients):
sleep disorders;
depression;
dizziness;
breathing problems in patients with asthma or chronic lung disease;
muscle weakness, muscle cramps (cramps);
irregular heartbeat;
blood in the urine;
allergic reactions such as itching, skin rash and swelling (face, hands, feet);
increase in liver enzymes;
gastrointestinal bleeding, stomach ulcers.
Rare (affects less than 1 in 1000 patients):
hearing problems;
runny nose due to allergies;
reduced lacrimation (important with the use of contact lenses);
inflammation of the liver, which can cause yellowing of the skin or the whites of the eyes;
changes in blood test results (eg. raising the type of blood fat (triglycerides));
allergic reactions such as itching, redness, rash;
reduction of sexual activity;
nightmares, hallucinations;
seizures;
nosebleeds, bleeding gums, increased menstrual bleeding;
tinnitus, headache, dizziness, these signs usually associated with overdose of aspirin.
Very rare (affects less than 1 in 10,000 patients):
irritation and redness of the eyes (conjunctivitis);
hair loss;
causing or worsening of psoriasis or skin rash similar to psoriasis;
low blood sugar;
liver and kidneys;
high levels of uric acid in your blood;
anaphylactic shock or worsening symptoms of food allergies;
severe skin reactions (eg. erythema multiforme exudativum).
Please tell your doctor if you notice any of these side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Blokbis ASA capsules
Keep out of the reach and sight of children.
Do not store above 25 ° C.
Do not use after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.