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WHAT BIVOLET AND WHAT IT IS USED
Bivolet contains the active ingredient nebivolol, a cardiovascular drug belonging to the group of selective beta-blockers (i.e. with a selective action on the cardiovascular system).
Bivolet prevents increased heart rate and controls the volume of the pumping function of the heart. It also dilates blood vessels and thus helps to reduce blood pressure.
Bivolet be used in the treatment of high blood pressure (hypertension).
Bivolet be used in the treatment of mild to moderate chronic heart failure in patients 70 years of age or more, in addition to other standard therapy.
2. BEFORE YOU TAKE BIVOLET
Do not take Bivolet:
If you are allergic (hypersensitive) to the active substance nebivolol or any of the other ingredients;
If you have one or more of the following offenses:
low blood pressure;
serious circulation problems in the arms and legs;
very low heart rate (less than 60 beats / minute);
certain other serious heart rhythm problems (eg. second or third degree atrioventricular block, cardiac conduction disorders);
heart failure that occurred now or worsening of an existing one, or if you apply intravenous therapy to support the work of the heart for treatment of circulatory shock in acute heart failure;
asthma or wheezing (now or before);
untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands);
abnormal liver function;
metabolic disorder (metabolic acidosis), for example. diabetic ketoacidosis.
Take special care with Bivolet
Please tell your doctor if you currently have or have ever had the following problems:
severely slow heartbeat;
defined chest pain due to spontaneously occurring heart cramp called Prinzmetal angina;
untreated chronic heart failure;
first degree heart block (light conduction abnormalities of the heart, leading to heart rhythm disturbances);
impaired blood supply to the arms or legs, for example. disease or Raynaud's syndrome, cramps and pains when walking;
prolonged breathing problems;
diabetes: this medicine does not affect blood sugar levels, but may mask the symptoms of low blood sugar (eg. heart palpitations, increased heart rate);
overactive thyroid gland: This medicine may mask the symptoms of increased heart rate due to this condition;
allergy: This medicine may intensify the reaction to pollen or other substances you are allergic to;
psoriasis (a skin disease with scaly pink patches) or have had psoriasis;
if you are having surgery, always tell your anesthesiologist before the application of anesthesia acceptance Bivolet.
If you have severe kidney problems, do not take Bivolet to treat heart failure and inform your doctor.
At the beginning of the treatment of chronic heart failure need regular monitoring of your condition by an experienced physician (see section 3).
Treatment should not be stopped abruptly unless otherwise expressly indicated or as determined by your doctor (see section 3).
Use in children and adolescents
Since no data on the use of Bivolet in children and adolescents is not recommended use of this medicine in them.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Certain medicines can not be taken simultaneously with Bivolet while others require changes in dosage.
Always tell your doctor if you are using or taking any of these medicines together with Bivolet:
drugs to control blood pressure or medicines for heart problems (such as amiodarone, amlodipine, tsibenzolin, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hidroksihinidin, lacidipine, lidocaine, methyldopa, mexiletine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil);
sedatives and such for the treatment of psychoses eg. barbiturates (used for epilepsy), phenothiazines (used to treat nausea and vomiting) and thioridazine;
medicines for depression, for example. amitriptyline, paroxetine, fluoxetine; drugs used for anesthesia during surgery;
medicines to treat asthma, blocked nose or certain eye diseases such as glaucoma (increased eye pressure) or dilation (widening of the pupil). All these drugs as well Bivolet can affect blood pressure and / or heart function.
Tell your doctor if you are taking medicines to treat profuse secretion of stomach acid or ulcers (antacid) for example. cimetidine. You should take Bivolet during the meal, and the antacid between meals.
Use of Bivolet with food and drink
Bivolet taken before or after meals, preferably with a glass of water.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Use of the product should not be used during pregnancy, unless it is imperative
If treatment with the product is essential, breast-feeding should be discontinued.
Driving and using machines
This medicine may cause dizziness or fatigue. In this case, do not drive or operate machinery.
Important information about some of the ingredients of Bivolet
This medicinal product contains excipient lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
3. HOW TO TAKE BIVOLET
Always take Bivolet just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Bivolet can be taken before, during or after a meal, and regardless of food intake. It is recommended that the tablets should be taken with water.
The tablets are taken orally, after meals, with sufficient liquid.
Treatment of high blood pressure
The usual dose is 1 tablet daily. It is recommended that the dose be adopted at the same time of day;
Elderly patients and patients with renal impairment usually start treatment with half tablet daily;
The therapeutic effect on blood pressure occurs after 1-2 weeks of treatment. In some cases, the optimal effect is reached after 4 weeks of treatment.
Treatment of chronic heart failure
Your treatment will be initiated and monitored by an experienced physician;
Your doctor will start with 1/4 tablet daily. The dose may be increased after 1 -2 weeks to 1/2 tablets per day, then to 1 tablet per day, followed by 2 tablets per day until the correct dose for you. Your doctor will prescribe the right dose for each step of the treatment and you must strictly follow his instructions;
The maximum recommended dose is two tablets (10 mg) per day;
At the start of therapy and any elevation of dose the doctor will monitor your condition for 2 hours;
If necessary, your doctor may reduce your dose;
You should not stop treatment abruptly as this can worsen heart failure;
Patients with severe kidney problems should not take this medicine;
Take your medicine once daily, preferably at the same time of day;
Your doctor may decide to combine Bivolet tablets with other medicines to treat your condition;
Do not use in children and adolescents.
Children and adolescents under the age of 18
The product is not recommended for use in children, as there is no proven efficacy and safety in this age group.
If you take more than the amount Bivolet
If you take more tablets than prescribed, immediately consult a doctor. The most common symptoms and signs of overdose are very slow heart rate (bradycardia), low blood pressure with possible fainting, difficulty breathing, such as asthma and acute heart failure.
You can take activated charcoal while waiting for the doctor to come.
If you forget to take Bivolet
If you miss a dose, take it as soon as possible. If it is almost done time for your next dose, take it as normal. Do not take a double dose to make up for the forgotten. Continue to take the medicine as prescribed. Re missed dose should be avoided.
If you stop taking Bivolet
Always consult your doctor before stopping treatment with Bivolet, whether you are taking it for high blood pressure or chronic heart failure.
Do not stop yourself taking Bivolet tablets. Your doctor will tell you how to stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bivolet can cause side effects, although not everybody gets them
In applying Bivolet to treat high blood pressure are possible following side effects:
Common side effects (more than one in every 100 treated but fewer than 1 person in every 10 patients treated):
indigenous, itching or numbness;
shortness of breath;
swelling of the hands and feet.
Uncommon side effects (more than 1 in 1,000, but less than 1 in every 100 patients treated):
slow heartbeat or other heart complaints;
low blood pressure;
cramps and pain when walking;
feelings of depression;
digestive problems, accumulation of gas in the stomach and intestines, vomiting;
skin rash, itching;
difficulty breathing due to spasm of the musculature of the respiratory system;
Very rare side effects (in less than 1 in every 10,000 patients treated):
worsening of psoriasis (a skin disease with scaly pink patches).
The following adverse reactions were observed only in isolated cases:
allergic reaction covering the entire body with generalized rash (hypersensitivity reaction);
rapid onset of swelling, especially in the lips, eyes or tongue with possible sudden difficulty in breathing.
In a clinical study for chronic heart failure the following adverse reactions:
Very common side effects (more than 1 in every 10 patients treated):
Common side effects (more than 1 in every 100 treated but fewer than 1 in every 10 patients treated):
worsening of heart failure;
low blood pressure;
intolerance to the drug;
light conduction abnormalities of the heart that can cause arrhythmias;
swelling of the lower limbs
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BIVOLET
Store in original container, protected from light.
Keep out of reach of children.
Do not use Bivolet after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is nebivolol 5 mg, as nebivololov hydrochloride in one tablet.
The other ingredients are lactose monohydrate; cornstarch; croscarmellose sodium; hypromellose; microcrystalline cellulose; silica colloidal anhydrous; magnesium stearate.
Bivolet looks like and contents of the pack
White to off-white, round, convex tablets with cross-scored on one side and plain on the other.
10 tablets in blister PVC / Aluminium foil; 3 blisters in a cardboard box along with a leaflet.
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