BISOPLUS AL 5 mg. 12.5 mg. 30 tablets

BISOPLUS AL 5 mg.  12.5 mg. 30 tablets
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Bisoplus AL is a drug that is used for the treatment of essential hypertension. The fixed combination is suitable for patients in whom control of blood pressure is not adequately using bisoprolol and hydrochlorothiazide alone.
Farmakoterapsvtichna group: selective beta blocker and thiazide (a diuretic medicine).

BISOPLUS AL 5 mg. / 12.5 mg. 30 tablets

What is Bisoplus AL and what it is used?

Bisoplus AL is a drug that is used for the treatment of essential hypertension. The fixed combination is suitable for patients in whom control of blood pressure is not adequately using bisoprolol and hydrochlorothiazide alone.
Farmakoterapsvtichna group: selective beta blocker and thiazide (a diuretic medicine).

2 Before you take Bisoplus AL
Do not use Bisoplus AL
- If you are allergic to hydrochlorothiazide or other thiazides, sulfonamides, bisoprolol or to any component of this medication.
- In acute heart failure or decompensated heart failure requiring intravenous treatment with amplification cardiac (inotropic) medicinal products
- With Cardiogenic shock
- In conduction disorders and cardiac ventricle heart chamber (second or third degree AV block without pacemaker)
- In syndrome sick sinus
- If interference excited conduction between the sinus node and the cardiac atria (sinoatrial block)
- In a strong slowing heartbeat (less than 60 beats / min) before treatment
- In the late stage peripheral arterial occlusive disease, and Raynaud's syndrome.
- In severe asthma or severe chronic obstructive pulmonary disease
- With increased acidity of the blood (metabolic acidosis)
- If untreated potassium deficiency
- In severe sodium deficiency
- With increased concentration of calcium in the blood
- In severe renal failure with severely decreased urine output or no such (creatinine clearance <30 ml / min and / or serum creatinine> 1,8 mg / 100 ml)
- In acute inflammation of the kidneys (glomerulonephritis)
- In severe hepatic dysfunction, including hepatic coma and coma
- If untreated adrenal gland tumor (pheochromocytoma)
- In gout
- In pregnancy
- If you are breastfeeding.

Take special care is Bisoplus AL
Described conditions indicate when to use Bisoplus AL with caution. Please consult your doctor if you have had any of the following conditions.

Careful monitoring by your doctor is required for:
- Heart failure (in patients with both stable chronic heart failure need to start treatment as monotherapy bizoprololov fumarate, using special phase titration)
- Bronchospasm (bronchial asthma, obstructive airway disease)
- Concomitant treatment with drugs for anesthesia (inhalational anesthetics)
- Diabetes (diabetes mellitus) with large fluctuations in blood glucose, the symptoms of a drop in blood sugar (hypoglycemia) can be masked
- Strict fasting
- In desensitization
- Conduction disorders in cardiac atrium and ventricle (AV block -1 degree)
- Disruption in the blood supply to the heart due to spasm of the coronary vessels (Prinzmetal Angina)
- Peripheral arterial occlusive disease (possibly strengthening the complaints, especially at the beginning of treatment)
- Reduced blood volume (hypovolemia)
- Abnormal liver function.
In bronchial asthma and other chronic obstructive pulmonary disease, must both be used and bronchodilating (dilate bronchi) treatment. Sometimes in asthmatic patients is possible resistance of the airways, so that dosage bronchodilatory drugs 02-stimulants) can be increased.
Prolonged treatment with Bisoplus AL can lead to a violation of fluid and electrolyte balance, and in particular to reduce the values of the towers, sodium, magnesium, chloride, or an increase in blood calcium.
The reduced concentration of potassium facilitates the development of severe arrhythmia (especially torsade dc points, which can be fatal).
Metabolic alkalosis (increased alkalinity of the blood) may deteriorate due to reduced content of fluids and electrolytes in the body.
Bisoplus AL as other beta blockers may increase sensitivity to substances that cause allergies and the severity of allergic (anaphylactic) reactions. Adrenaline does not always show the expected therapeutic effect.
Patients with psoriasis or with a history of psoriasis should use beta blockers (eg. Bisoprolol) after careful consideration of the benefit / risk ratio.
Patients with pheochromocytoma can use beta-blockers (eg. Bisoprolol) after prior treatment with alpha receptor blockers.
When treated with Bey blockers (eg. Bisoprolol) symptoms of increased thyroid function (tirsotoksikoza) can be masked.
Treatment with Bisoplus AL must not be stopped suddenly, unless there is a clear reason.
In patients with gallstones (cholelithiasis) is reported acute inflammation (cholecystitis).


During long term treatment with Bisoplus AL is necessary to regularly monitor serum electrolytes (especially potassium, sodium, calcium) urea, creatinine, blood levels (cholesterol and triglycerides), uric acid, and glucose.
During treatment with Bisoplus AL, patients should take plenty of fluids and potassium rich food (eg. Bananas, vegetables, nuts) to compensate for the possible loss of potassium. Potassium loss can be offset by concomitant potassium-sparing diuretics.

Due to lack of clinical experience in children and adolescents Bisoplus AL should not be used in this age group.

Taking other medicines
Before taking Bisoplus AL, tell your doctor, "if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
General information:
It should be borne in mind that due to abnormalities in serum potassium content, some medicines may be affected.

Bisoplus AL must be taken to:

Calcium channel blockers such as veratmil less diltiazem: negative influence on contractility and excitability (atrio-ventricular conduction) of the heart. Intravenous administration of verapamil in patients receiving treatment with beta-blockers may result in hypotension and atrioventricular block.

Clonidine: Increased risk of "rebound hypertension '' (very high blood pressure) and a significant reduction of heart rate and conduction. Taking clonidine can be stopped if a few days before it was discontinued from Bisoplus AL. Only then can begin the gradual withdrawal of clonidine.

Monoamine oxidase inhibitors (except MAO-B oxidase inhibitors): Influences to blood pressure lowering (lowering) effect of P-bloksrite, but increases the risk of a sharp rise in blood pressure.

Lithium Bisoplus AL, may increase the toxicity of the heart and nerves due to reduced emission of lithium.

Neaitiaritmichni drugs that can cause heart rhythm problems (torsade de pointes): astemizole, iv erythromycin, halofantrine, pentamidine, sparfloxacin, terfenadine, vincamine. In the case of potassium deficiency should be administered medicinal products that do not cause torsade de pointes.

Combinations Bisoplus AL, which need attention:

Calcium channel blockers such as dihydropyridine derivatives (eg. Iifedipin): Increased risk of low blood pressure, especially at the beginning of the combination. In patients with latent cardiac insufficiency, concurrent therapy with beta-blockers may result in heart failure.
ACE inhibitors (eg. Captopril. Enalapril): risk of severe low blood pressure, especially at the beginning of treatment.
Class-I antiarrhythmic drugs (eg. Disopyramide, quinidine): You gain the effect on atrial conduction time and increase the negative inotropic effect.
Class-III antiarrhythmic drugs (eg. Amiodarone); possible enhancing effect on atrial conduction time.
Some antiarrhythmic drugs can cause torsade de pointes: Class IA drugs (disopyramide, quinidine), amiodarone, sotalol. Must be prevented hipokalismiya and if necessary corrected. QT - interval should be monitored. If pa torsade de pointes should be given antiarrhythmics.
Parasympathomimetic (including tacrine): may extend the time of atrio-ventricular conduction.
Drugs that decrease blood pressure as reserpine, alpha-methyldopa, clonidine guaifatsii or can lead to a strong decrease in blood pressure, heart rate or cardiac conduction slowing.
Other beta blockers, incl. eye drops, increase the effect of Bisoplus AL
Antidiabetics (insulin or other oral medicines that reduce blood sugar): increase the effect of lowering blood sugar. Blocking beta adrenoreceptors may mask symptoms of hypoglycemia.
Medicines for anesthesia (anesthetic): attenuation of the reflex tachycardia and increase the risk of low blood pressure (hypotension). Continuation of beta blockade reduces the risk of arrhythmia during the introduction of anesthesia and intubation.
Please inform the anesthetist if you are taking Bisoplus AL.
Digitalis glycosides: extension of time atrio-ventricular conduction of the heart. During the treatment with AL in Bisoplus developing hypokalemia and / or hypomagnesemia, the heart muscle may show increased sensitivity to cardiac glycosides, yielding potentsirans of their effects and side effects.
Drugs that inhibit synthesis prostaglaidinoviya: reduce the blood pressure lowering effect. Applying sapitsilati in high doses may be potentiated by their toxic effects on the central nervous system.
In patients with low blood volume, concomitant administration of NSAIDs can provoke acute renal failure.
Ergot derivatives: may intensify existing disturbances in blood flow to the hands and feet.
Sympathomimetics: Combination with bisoprolol may reduce the effect of both drugs. High doses of spinefrin may be necessary to treat allergic reactions.
Tricyclic antidepressants, barbiturates, phenothiazines, and antihypertensive agents: increase the effect of lowering blood pressure.
Rifampicin: reduced effect of bisoprolol. Is not usually necessary to adjust dosing.
The effect of drugs lowering uric acid may be extended with concomitant Bisoplus AL.
Coadministration of Bisoplus AL and glucocorticoids adrenok,
hormone carbenoxolone amfoteratsii B. furosemide or laxatives may potentiate the loss of potassium.
The effect of muscle relaxants curare-type can be enhanced or extended by Bisoplus AL.
Cytostatics (tsikyaofosfamid, fluorouracil, methotrexate): should expect increased bone marrow toxicity.
Cholestyramine, kolestkpol: decreased absorption of hydrochlorothiazide combination product Bisoplus AL.
Methyldopa: haemolysis (breakdown of red blood cells) in combination with hydrochlorothiazide is described in isolated cases.

Combinations requiring discussion:
Meflokim: increased risk of slow heart rate (bradycardia). Pregnancy and lactation
Application of Bisoplus AL during pregnancy. Bega-blockers (eg bisoprolol) can cause a decrease in heart rate (bradycardia), low blood sugar (hypoglycemia) and blood pressure (hypotension) in the fetus or newborn. Hydrochlorothiazide may cause a reduction in platelet count (thrombocytopenia) in the newborn.
Bisoplus AL should not be used during lactation, bp hydrochlorothiazide and probably bisoprolol is excreted in breast milk. Hydrochlorothiazide can suppress the production of breast milk.

Driving and using machines
AL Bisoplus no or negligible effect on the ability to drive and use machines. In rare cases, due to individual variations in reactions to the product, the ability to drive and use machines may be impaired. This should be considered especially in the beginning of treatment, changes in treatment and in combination with alcohol.

3 How to take Bisoplus AL?
Always take Bisoplus AL as instructed by your doctor. If you have any doubts or further questions, ask your doctor or pharmacist.

Dosage, route of administration and duration of treatment
These instructions apply only if your doctor prescribes otherwise for drug Bisoplus AL. Please follow the instructions for use given by your doctor, as otherwise Bisoplus AL will not have the desired effect and safety!
Bisoplus AL can be used in patients in which control of blood pressure is not adequately using bisoprolol and hydrochlorothiazide alone.
It is recommended that first of all the individual determination of the individual components. If clinically more appropriate, you can switch from monotherapy to the fixed combination.
In what quantities and how often you should take the tablets for Bisoplus AL
The individual dose is determined by your doctor. Elderly
Usually there is no need for dose adjustment. It is recommended to start treatment with the lowest possible dose.

Compromised kidney or liver function
In patients with mild to moderate renal insufficiency (creatinine clearance> 30 ml / min) and mild to moderate hepatic insufficiency do not require dosage adjustment. However, in patients with mild to moderate impairment of liver function is recommended periodic medical supervision.
In concurrent disorders in renal and hepatic function of the component hydrochlorothiazide elimination is delayed.

How to take the tablet Bisoplus AL
The film-coated tablets should be swallowed whole with some liquid breakfast. The film-coated tablets have scored and, if necessary, to separate.

How long can you take the tablets for Bisoplus AL
The duration of treatment solves physician.

If you take more than you should Bisoplus AL
If you suspect overdose with Bisoplus AL inform your doctor immediately. He / she will decide what measures to take, depending on the severity of overdose / poisoning.
Overdose Bisoplus AL slows down the heart rate, lowering blood pressure, bronchospasm, acute cardiac insufficiency and disturbances in conduction impulses ECG.
Overdose needed treatment Bisoplus AL to stop immediately. If you forget to take Bisoplus AL
Do not take a double dose next dose and continue treatment as prescribed by your doctor.
He must not stop or interrupt treatment with AL Bisoplus before checking with your doctor.
Treatment Bisoplus AL, should not stop suddenly but it gradually - half the dose for 7-10 days, because Abrupt discontinuation can lead to acute deterioration.

4 Possible side effects
Like all medicines, AL Bisoplus can cause side effects, although not everybody gets them.
Common: Increased levels of blood parameters (triglycerides and cholesterol), increased sugar in the blood and urine (hyperglycemia and glycosuria), increased levels of uric acid in the blood, abnormal contents of fluids and electrolytes (especially potassium and low sodium, magnesium and increased calcium), increased alkalinity of the blood (metabolic alkalosis).

cardiac disorders
Uncommon: Slow heart rate (bradycardia), impaired transmission of excitatory impulses to the heart (AV-conduction), worsening heart failure, low blood pressure when changing body position, eg. from sitting / lying to standing (orthostatic hypotension). Very rare: Chest pain.

Blood and lymphatic system
Rare: decreased number of white blood cells and platelets (leukopenia, thrombocytopenia)
Very rare: reducing the number of certain white blood cells with severe disease symptoms (agranulocytosis).

Nervous System Disorders
Common: Tiredness, fatigue, dizziness, headache. These symptoms are particularly common at the beginning of treatment and are mild and resolve within 1-2 weeks.
Uncommon: Sleep disturbances, depression Rare: Nightmares, hallucinations

Eye disorders
Rare: Increased lacrimation (keep in mind when wearing contact lenses), visual impairment. Very rare: Stables winding

Ear and labyrinth (inner ear)
Rare: Decreased hearing

Respiratory, thoracic and mediastinal disorders
Uncommon: bronchospasm in patients with bronchial asthma or airway disease with bronchoconstriction as a prequel.
Rare: Allergic rhinitis
Gastrointestinal disorders
Common: Nausea, vomiting, diarrhea or constipation.
Uncommon: loss of appetite, abdominal pain, increased amylase, inflammation of the pancreas (pancreatitis).
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