BISOHEXAL 10 mg. 30 tablets
- Pain as a result of impaired blood supply to the heart (coronary artery disease: angina pectoris) .
BISOHEXAL 10 mg. 30 tablets
What is the active ingredient?
1 tablet contains 10 mg bisoprolol fumarate (2: 1).
What else BisoHEXAL tablets contain?
Calcium hydrogen, phosphate, microcrystalline cellulose, croscarmellose sodium, hypromellose, lactose monohydrate, macrogol 4000, magnesium stearate, corn starch, highly dispersed silicon dioxide, iron oxide colorant, titanium dioxide.
Advice to diabetics:
1 tablet contains less than 0.01 carbohydrate units.
Formulation and packaging:
Original package containing 30, 50 and 100 tablets.
What is BisoHEXAL tablets?
Cardioselective beta-adrenergic blocker.
What is it used BisoHEXAL tablets?
- High blood pressure (essential hypertension)
- Pain as a result of impaired blood supply to the heart (coronary artery disease: angina pectoris)
When you must not take BisoHEXAL tablets?
BisoHEXAL should not be used in the following cases:
- Hypersensitivity to beta-adrenergic blockers, or to any of the excipients
- Overt heart failure
- Shock - AV-block and IInd degree IIIta (severely impaired conduction from the atria to the cameras)
- Syndrome sick sinus (sick sinus syndrome)
- Sino-atrial block (impaired conduction from the sinus node to the atria)
- Decreased heart rate (bradycardia: resting pulse below 50 beats per minute) before treatment
- Low blood pressure (hypotension: systolic pressure below 90 mmHg)
- Increased acidity of the blood (acidosis)
- Bronchial hyperreactivity (e. Obstructive respiratory diseases, bronchial asthma)
- Later stages of disturbances of peripheral blood flow
- Simultaneous administration of monoamine oxidase (MAO) inhibitors (except MAO B inhibitor)
- Children (no clinical experience)
Intravenous administration of calcium channel blockers of the verapamil or diltiazem type or other antiarrhythmic drugs (eg. Disopyramide, quinidine, amiodarone) is contraindicated in patients treated with BisoHEXAL® (exception: intensive care).
When you take BisoHEXAL tablets only after consultation with your doctor?
BisoHEXAL may be applied under certain conditions with caution. Please consult your doctor.
Especially careful monitoring by a physician is necessary in the following cases:
- AV block first-degree (mild disease conductivity of the upper to the lower chambers)
- Manifest or latent diabetes mellitus (possible severe conditions with low blood sugar symptoms can be masked, regular monitoring of blood sugar levels)
- Continuous strict diet and intense physical stress (as a prerequisite for severe hypoglycemia / low blood sugar /)
- Patients with meduloadrenalen tumor (pheochromocytoma; BisoHEXAL® can be applied only after pre-treatment with alpha-adrenergic blockers)
In patients with psoriasis in their personal or family history of beta-adrenergic blockers (such BisoHEXAL®) should be prescribed only after careful consideration of the benefit / risk ratio.
What special precautions must be observed?
In case of hepatic or renal impairment have recommendations dozirane.Beta-adrenergic blockers may increase sensitivity to allergens and the severity of anaphylactic reactions (acute generalized allergic reactions). For this reason, it is recommended that crushed the discretion of the indications in patients with severe hypersensitivity reactions in their history and in patients desenzibilizirashta therapy (note: strong anaphylactic reactions) .Lechenie BisoHEXAL with hypertension requires regular medical supervision.
Other products that interfere with the effect of BisoHEXAL tablets or can be influenced by the product?
BisoHEXAL effect of lowering blood pressure may be potentiated by other drugs that lower blood pressure (eg. ACE) inhibitors, diuretics, vasodilators, barbiturates, phenothiazines and tricyclic antidepressants.
Concomitant use of calcium antagonists and BisoHEXAL of nifedipinov type can lead to a sharp drop in blood pressure, in some cases to the development of heart failure. Concomitant use of BisoHEXAL and calcium antagonists of the verapamil or diltiazem type or other antiarrhythmics (eg. Disopyramide, quinidine, amiodarone) is necessary to carefully monitor patients because of the risk of low blood pressure (hypotension), slow heart rate (bradycardia) or other arrhythmias and / or heart failure. Intravenous administration of calcium antagonists of the verapamil or diltiazem type or other antiarrhythmic drugs (eg. Disopyramide, quinidine, amiodarone) is contraindicated in patients treated with BisoHEXAL® (except for acute treatment).
Cardiodepressant effect BisoHEXAL and antiarrhythmics may be additive.
Coadministration of BisoHEXAL and reserpine, a-methyldopa, guanfacine, clonidine or cardiac glycosides may lead to a sharp drop in heart rate and cardiac conduction delays. After abrupt discontinuation of clonidine when administered with BisoHEXAL possible excessive increase in blood pressure. Therefore, administration of clonidine may be interrupted if BisoHEXAL was stopped a few days before. Then take clonidine may break gradually.
Possible increases in blood pressure concomitant BisoHEXAL and noradrenaline, adrenaline or other sympathomimetics (eg. Medicines cough, nasal drops and eyes). Concomitant administration of ergot derivatives (eg. Ergotamine-containing medicines to treat migraine) and BisoHEXAL can lead to increased peripheral perfusion. MAOIs should not be taken together with BisoHEXAL because of the risk of a large increase in blood pressure.
Co-administration of BisoHEXAL and insulin or oral antidiabetics may respectively increase or prolong, and attenuate their effects. The warning symptoms of hypoglycaemia -lower particular tachycardia and tremor are masked or suppressed. Therefore require regular blood sugar control.
Rifampicin may reduce the effect of lowering blood sugar BisoHEXAL®.Efektat of BisoHEXAL can be increased by cimetidine, hydralazine and alcohol.
Coadministration of BisoHEXAL and drug products may cause a drop in blood pressure. The negative inotropic effect of both products can be additive. Therefore, prior to general anesthesia the anesthetist should be informed about the treatment BisoHEXAL®.
Please note that these figures apply to newly accepted products.
What foods and drinks you should avoid?
BisoHEXAL effect of lowering blood pressure can be increased by alcohol.
What should I take into account children and adults in the application of BisoHEXAL tablets?
Children should not be treated BisoHEXAL®, because until now there is not enough data on use in this age group.
What special precautions should be taken during pregnancy and lactation?
No data on the use of bisoprolol in pregnant women. BisoHEXAL can be used during pregnancy only if the physician has determined that the benefit to the mother outweighs the risk to the child. Due to the risk of disorders of the cardiovascular function of the newborn, bisoprolol treatment should be discontinued 48-72 hours before delivery. If this is not possible, the infant should be closely monitored by a physician for a period of 48-72 hours after birth.
Not studied the passage of bisoprolol in human breast milk. Since the active ingredient can be found in milk in animal experiments, newborns should be monitored carefully for the effects of beta-blockade. You may need weaning.
What to be aware when driving, operating machinery, or insecure (eg. Climbing stairs)?
Due to different individual reactions, the reactivity can be reduced to such an extent that the ability to drive, operate machinery or work in insecure (eg. Climbing stairs) to be impaired. This applies largely to the start of treatment, during dose escalation and change of medicines and when taken together with alcohol.
Dosage, method and duration of administration
Unless otherwise prescribed by your doctor product, please follow the instructions for use leaflet.
How much and how often you can take / BisoHEXAL® tablets?
Treatment should be initiated with low doses with gradual and slow increase. The dose should be individualized, particularly depending on the pulse rate and the therapeutic success.
Essential hypertension (high blood pressure)
The recommended dose is 1/2 tablet once a day BisoHEXAL (corresponding to 5 mg bisoproloi fumarate).
If necessary, the dose may be increased to 1 tablet BisoHEXAL once daily (equivalent to 10 mg bisoproloi fumarate). Further dose escalation is allowed only in exceptional cases.
Coronary artery disease (angina pectoris)
The recommended daily dose is 1/2 tablet BisoHEXAL once daily (corresponding to 5 mg bisoproloi fumarate) If it is necessary, the dose may be increased to 1 tablet BisoHEXAL once daily (equivalent to 10 mg bisoproloi fumarate). Further dose escalation is allowed only in exceptional cases.
Dosage in hepatic and / or renal dysfunction
In patients with mild or moderate hepatic and / or renal failure is generally not necessary to adjust the dose. In patients with advanced renal insufficiency (creatinine clearance <20 ml / min) and in patients with severe hepatic impairment should not exceed a daily dose of 10 mg bisoproloi fumarate.
When and how you can take BisoHEXAL tablets?
The film-coated tablets should be swallowed whole with sufficient liquid (eg. Glass of water) in the morning on an empty stomach or with breakfast.
To split the tablet, place it on a hard surface with the score line up and press gently with your thumb.
How long you can apply BisoHEXAL tablets?
The duration of application is determined by the type and severity of zabolyavaneto.Dozirovkata of BisoHEXAL should not be changed without consulting a doctor. You should not stop or terminate treatment prematurely BisoHEXAL without consulting a doctor.
Particularly in patients with angina pectoris therapy BisoHEXAL should not be stopped abruptly but gradually (eg. About 7-10 days), as the abrupt termination may result in a sharp deterioration in the clinical course of the patient.
What should I do if BisoHEXAL tablets was adopted in very large quantities (intentional or unintentional overdose)?
In case of suspected overdose of the product, please tell your doctor, he / she will take the necessary measures. Overdose can cause severe lowering of blood pressure (severe hypotension), decreased heart rate (bradycardia) to cardiac arrest, heart failure and shock. It is possible to monitor respiratory complaints, bronchospasm, vomiting, disturbed consciousness also generalized convulsive seizures. In case of overdose BisoHEXAL treatment should be stopped.
What should you do if you take more than the prescribed dose BisoHEXAL tablets or you forget to take a product?
Do not take a double dose the next dose and resume treatment with the usual prescribed doza.Kakvo need to know if you have discontinued or have it terminated prematurely? Please do not interrupt or stop treatment prematurely BisoHEXAL®, without consulting your doctor .
Treatment with BisoHEXAL should not be stopped abruptly, especially in patients with coronary heart disease, and progressive (e. About 7-10 days), as the abrupt termination may result in severe deterioration of patient's condition.
What side effects can cause the application of BisoHEXAL tablets?
Due to the possible improvement of respiratory resistance, patients who have a tendency to bronchospastic effects (particularly in patients with obstructive pulmonary disease, bronchial asthma), it can be seen dyspnoea (breathlessness).
In rare cases, visual disturbances, conjunctivitis and decreased lacrimation (it should be borne in mind when wearing contact lenses).
In some cases observed impaired libido and potency. Uncommonly, skin may be allergic skin reactions, eg. redness, itching, photoallergic exanthema, hives (urticaria), and sweating.
Uncommon therapy BisoHEXAL can result in very low blood pressure, as well as a change in position from supine to upright (ortostichna dysregulation), decreased heart rate (bradycardia), conduction from the atria to the camera (AV-conduction abnormalities) or strengthening of heart failure with edema of the legs (peripheral edema) and / or dispneya.Nablyudavani are increased complaints in patients with impaired peripheral perfusion - including patients suffering from the syndrome of Raynaud (spasms of the blood vessels of the fingers and toes) .
Musculoskeletal system (locomotor system)
Uncommon may occur muscle weakness, muscle cramps (e.g.,. N and calf) or in some cases, joint disease (arthropathy) infection with one or several joints (polyarthritis or mono).
Infrequently can be observed CNS disorders such as fatigue, dizziness, headache, depressive moods, confusion, nightmares or increased activity of dreaming, sleep disorders and halyutsinatsii.Nechesto may occur stabbing and feeling cold in the extremities (paresthesia).
It is possible to Latent diabetes mellitus and diabetes manifistiran to vloshi.Sled long strict diet or heavy physical stress concomitant BisoHEXAL can lead to hypoglycemia (low blood sugar). The warning signs of a hypo coming - tachycardia (rapid heartbeat), and tremor (shaking hands) can be maskirani.Po during therapy with BisoHEXAL rarely increases in serum lipids (cholesterol, triglycerides).
In patients with overactive thyroid gland clinical symptoms (such as tachycardia, tremor) may be masked during the treatment BisoHEXAL®.
In some cases the observed increased serum transaminases (GOT, GPT), or the onset of hepatitis (liver inflammation) during treatment with BisoHEXAL®.
Uncommonly observed loss of appetite and gastrointestinal symptoms (eg. Nausea, vomiting, constipation, diarrhea, pain and cramps in the stomach).
Beta-adrenergic blockers (such BisoHEXAL®) may trigger psoriasis in some cases, worsening of the symptoms of the disease or lead to psoriazifirmena ekzantema.Beta-adrenergic blockers may increase sensitivity to allergens and the severity of anaphylactic reactions (severe generalized allergic reactions) . In patients with severe hypersensitivity reactions in their history and patients desenzibilizirashta therapy may experience severe anaphylactic reactions.
During therapy with beta-adrenergic blockers in isolated cases have been reported hair loss, hearing problems or tinnitus, weight gain, emotional instability, short-term memory loss, allergic rhinitis or induratio penis plastica (disease Peyronie) .If watch some of the described side effects, please tell your doctor or pharmacist.
What measures should be taken in relation to the side effects?
Please tell your doctor who will decide tezhesttta of side effects and what steps to take.
The shelf life of the drug printed on the packaging.
Do not use after the expiry date stated on the packaging!
Keep out of reach of children!