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What Bisostad is and what it is used for
Bisostad belongs to a group of medicines called beta-blockers. It contains the active substance bisoprolol fumarate.
Bistoda is used:
to treat high blood pressure;
for the treatment of chronic angina pectoris (coronary heart disease, cardiac pain due to circulatory problems in blood vessels supplying blood to the heart).
2. What you need to know before taking Bifida
Do not take Bisostad
if you are allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of Bisostad
or in the case of:
Acute heart failure or episodes of heart failure (impaired heart activity, expressed in its inability to force enough blood in the body) requiring intravenous drug treatment;
Impaired blood circulation caused by disturbances in heart function (so called cardiogenic shock accompanied by very low blood pressure);
heart failure impulses (so-called sick sinus syndrome or second and third degree AV block without a pacemaker);
Low heart rate - less than 50 beats per minute before taking Bison;
decreased blood pressure (hypotension, systolic blood pressure lower than 100 mmHg);
severe bronchial asthma or severe chronic obstructive airways disease - COPD;
if you have a severe form of blood circulation in the legs and arms (cold legs and arms, walking pain);
Raynaud's syndrome - a peripheral disease with fingers and toes pain and change in color from white to blue and subsequent redness;
metabolic acid accumulation in the blood (metabolic acidosis in diabetic patients with high blood sugar);
untreated phaeochromocytoma (a rare tumor, usually originating from the adrenal medulla);
concomitant use of fluptafenin (an anti-inflammatory drug) or sulpotri (a medicine for the treatment of psychiatric disorders).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisostad
Bistoda should not be used in chronic heart failure.
Tell your doctor before taking Bisostad if any of the following applies to you:
difficulty breathing caused by sudden respiratory muscle spasm (bronchospasm), bronchial asthma or other chronic obstructive airway diseases. A pulmonary functional test is recommended immediately prior to initiation of treatment;
Diabetes (diabetes mellitus) with large fluctuations in blood sugar. Bison may mask the symptoms of hypoglycaemia. Blood glucose levels should be monitored during bisoprolol therapy;
Thyroid overactivity: Bisostad may mask the symptoms of hyperthyroidism;
Patients with liver diseases;
Allergy susceptibility (including anaphylactic reactions);
mild disturbances in ventricular impulses to the ventricles (first degree AV pruritus of Princezilla (chest pain due to coronary artery spasm);
Peripheral circulatory disorders such as Raynaud's syndrome (pain and change in the color of the toes and hands), intermittent claudication (pain in the toes that may cause lameness);
Bistosta should be used with caution in patients who have a low heart rate of 50 to 60 beats / minute (bradycardia) just prior to initiation of therapy;
In the case of a personal or familial history of psoriasis.
Starting treatment with Bistostad requires regular monitoring, especially in the treatment of elderly patients.
If you are using contact lenses, you should take into consideration that Bifidogrel reduces secretion of the eye and may cause eye irritation.
You should tell your doctor if you are undergoing:
This medicinal product contains a drug that gives a positive reaction during anti-doping control.
There is no information on the efficacy and safety of Bistostad in adolescents and children below 18 years of age and therefore its use in these is not recommended.
Other Drugs and Bistoda
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Fluctafenin (analgesic and anti-inflammatory drugs):
fluptafenin may lower blood pressure and cause shock. Beta-blockers can block compensatory reactions of the heart and blood vessels.
Sultopride (a neuroleptic for the treatment of mental illness):
Bistosta should not be taken concomitantly with sulptopy as this increases the risk of specific heart rhythm disturbances (ventricular arrhythmias).
Combinations that are not recommended:
Calcium antagonists (medicines such as verapamil, diltiazem, bepridil, lowering blood pressure;
Clonidine (an antihypertensive medicinal product with a central de
Combinations to be used with caution:
antiarrhythmic drugs (medicinal products counteracting heart rhythm disturbances, eg disopyramide, quinidine);
Calcium antagonists, dihydropyridine derivatives such as nifedipine (blood pressure lowering medicines);
Parasympathicomimetic drugs (substances simulating the parasympathetic nervous system), incl. tacrine and ganthamine;
Anesthetics: An anesthesiologist should be informed if you are taking Bifidazide before being subjected to surgical intervention;
Digitalis glycosides (so-called cardiac glycosides, for example, in the treatment of heart failure);
Ergotamine derivatives (medicinal products for the treatment of migraine);
Sympathomimetic drugs (eg adrenaline, ephedrine);
Tricyclic antidepressants (medicines to treat depression), barbiturates (specific anesthetics), phenothiazines (neuroleptics or antihistamines), and other antihypertensive agents: increased hypotensive effect;
Baclofen (a central muscle relaxant, eg in muscle spasms);
Iodine-containing contrast agents: B-blockers may hinder the body's compensatory effects in the event of hypotension or iodine-induced shock containing contrast media;
Mefloquinone hydrochloride (antimalarial medicine);
Corticosteroids (cortisone products);
Rifampicin (a medicine to treat tuberculosis); non-steroidal anti-inflammatory medicinal products.
Please note that this information also applies to medicinal products you have recently taken.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Bistoda may be taken during pregnancy only if the doctor decides that the benefit to the pregnant woman outweighs the possible risk to the child.
It is not known whether Bisexad passes into breast milk. Therefore, you should not breast-feed while taking Bison.
If necessary, the infant may be weaned.
Bison with food, beverages and alcohol
Bistoda may be taken with or without food.
Driving and using machines
Bridging may affect the ability to drive and use machines.
This should be taken into account especially in:
initiation of therapy;
at dose change;
when using alcohol at the same time.
In such a case, you should not drive or carry out an activity requiring caution.
3. How to take Bisostad
Always take Bifida exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
In general, treatment with Bifidaz is a long-term therapy.
The dosage is determined by your doctor individually. It is recommended that therapy be started at the lowest possible dose. In most patients, 5 mg per day (equivalent to ½ film-coated tablet Bison) is sufficient. The usual dose is 10 mg daily (equivalent to 1 film-coated tablet Bistoda). The recommended maximum dose is 20 mg daily (equivalent to 4 film-coated tablets).
Film-coated tablets should be taken whole with liquid in the morning.
Patients with renal insufficiency:
In patients with severe renal impairment (creatinine clearance
Data available so far suggests that Bistostaz is not dialyzed. Because of this, patients undergoing renal dialysis do not need to take an additional dose after dialysis.
Patients with severe hepatic insufficiency:
Patients with severe hepatic insufficiency should not take a dose higher than 10 mg.
Dosage change is usually not required. It is recommended that therapy be started with the lowest possible dose.
There is no experience with Bistostad in children and adolescents, so its use can not be recommended.
Duration of treatment:
Bison treatment is usually long. Your doctor will determine the duration of treatment.
If you take more Bison than you should
The most common symptoms of Biodostat overdose are decreased heart rate, hypotension, acute heart failure, impulse disturbances, bronchospasm and hypoglycaemia.
If in doubt about overdose, tell your doctor immediately to decide what to do or seek urgent medical attention immediately.
If you have forgotten to accept Bisostad
If you forget to take Bifidor Do not take a double dose to make up for a forgotten tablet.
Better continue with the regimen prescribed by your doctor.
If you stop taking Bisostad
Do not stop the treatment sharply and do not change the dose except on prescription.
Treatment should not be stopped suddenly, except in some special cases. If treatment is stopped abruptly, there is a risk of myocardial infarction and sudden death in patients with ischemic heart disease.
The dose should be reduced slowly by gradual reduction and halving every week.
The undesirable effects described are grouped according to the frequency of their occurrence:
Very common: (≥ 1/10)
Common: (≥ 1/100 to <1/10)
Uncommon: (≥ 1/1000 to <1/100)
Rare: (≥ 1 / 10,000 to <1 / 1,000)
Very rare: (≥ 1/10 000 to <1/1000), not known (can not be estimated from the available data)
Common (may affect 1 in 10 patients):
feeling cold or tingling of limbs;
worsening of existing intermittent claudication (intermittent claudication due to pain resulting from circulatory problems, usually in calves);
fatigue, exhaustion, dizziness, headache (especially at the beginning of therapy, as symptoms usually mitigate and often disappear for 1-2 weeks) and dizziness;
nausea, vomiting, diarrhea, stomach pain (abdominal pain) and constipation;
low blood pressure (hypotension).
Uncommon (may affect 1 in 100 patients):
muscle weakness and cramps;
feeling weak (asthenia);
joint diseases (arthropathy);
decreased heart rate (bradycardia), cardiac conduction disturbances (delayed AV conduction or worsening of an existing AV block), worsening of heart failure;
hypotension when changing the position e.g. from lying in sitting or standing (orthostatic hypotension);
Sleep disorders, depression;
bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.
Rare (may affect 1 to 1,000 patients)
hypersensitivity (itching, redness, rash);
increased liver enzymes (ALAT, ASAT), hepatitis (jaundice);
increased triglyceride levels, hypoglycaemia (decreased blood glucose levels);
reduced tear (important if you wear contact lenses);
the occurrence of specific (antinuclear) antibodies and rare clinical symptoms such as lupus syndrome that disappear upon discontinuation of treatment.
Very rare (affects 1 out of 10,000 patients)
beta-blockers can provoke or aggravate psoriasis or induce psoriasis such a rash;
alopecia (hair loss);
How to Store a Bisostad
Store below 25 ° C.
Store in the original package.
Keep out of the reach and sight of children.
Do not use Bifida after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. Package Contents and Additional Information
What contains Bisostad
The active substance is bisoprolol fumarate. One film-coated tablet contains 10 mg of bisoprolol fumarate.
The other ingredients are: Microcrystalline cellulose, Calcium hydrogen phosphate, Pregelatinised maize starch, Crospovidone, Silica, Colloidal anhydrous, Magnesium stearate, Hypromellose, Macrogol 400, Titanium dioxide (E171), Iron oxide yellow (E172) (E172).
What Bzestad looks like and what the package contains
The tablets are pale pink, round, biconvex, scored on both sides and embossed "BSL10" on one side.
Bisostad is available in packs of:
30 and 60 film-coated tablets in a PVC / PE / PVDC / Al blister placed in Alsace or without Alsace.
Not all types of packaging can be placed on the market.
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