Nebivolol 5 mg. 60 tablets

WHAT nebivolol SANDOZ AND WHAT IT IS USED
Nebivolol Sandoz contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (ie with a selective action on the cardiovascular system). It prevents increased heart rate and controls the pumping strength of the heart. Also, dilate blood vessels, which contributes to lowering blood pressure.
It is used to treat high blood pressure (hypertension),
Nebivolol Sandoz is also used to treat mild and moderate chronic heart failure in patients 70 years or more, in addition to other therapy.

2. BEFORE YOU TAKE SANDOZ nebivolol
Do not take nebivolol Sandoz:
if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebivolol Sandoz;
if you have one or more of the following offenses:
hypotension;
serious circulation problems in the arms or legs;
very slow heartbeat (less than 60 beats per minute);
some other heart rhythm problems (eg. second and third degree atrioventricular block, cardiac conduction abnormalities);
heart failure, which occurred recently or has deteriorated recently, or are receiving treatment for circulatory shock due to acute heart failure by intravenous systems to support the work of your heart;
asthma or wheezing (now or in the past);
untreated pheochromocytoma localized in the top of the kidneys (in the adrenal glands);
hepatic dysfunction;
metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.
Take special care with nebivolol Sandoz
Tell your doctor if you have or if any one of the following problems:
unusually slow heartbeat;
type of chest pain due to spontaneously occurring spasm of the blood vessel of the heart, called angina of Prinzmetal;
untreated chronic heart failure;
1st degree heart block (a kind of minor infringement of the conductivity of the heart that affects heart rhythm);
poor circulation in the arms or legs, for example. disease or syndrome of Raynaud, similar to understanding pain when walking;
prolonged breathing problems;
diabetes: This medicine has no effect on blood sugar, but may mask the warning signs of low blood sugar (eg. palpitations, fast heartbeat);
overactive thyroid gland: this medicine may mask the symptoms of abnormally rapid heart rate due to this condition;
allergy: This medicine may intensify your reaction to pollen or other substances you are allergic;
psoriasis (a skin disease - scaly pink patches) or if you have ever had psoriasis;
if you need surgery, always previously tell your anesthetist that you are being treated with nebivolol.
If you have serious kidney problems do not take Nebivolol for heart failure and tell your doctor.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by a physician experienced (see. Point 3).
This treatment should not be stopped abruptly unless it is done in a clear need and judgment of your doctor (see. Point 3).

Children and adolescents
Due to lack of data on the use of the product in children and adolescents is not recommended the use of nebivolol Sandoz them.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some drugs can be administered simultaneously with other drugs and the need to make specific changes (in the dose, for example).

Always tell your doctor if you are using or receiving any of the following medicines together with nebivolol Sandoz:
Drugs to control blood pressure or medicines for heart problems (such as amiodarone, amlodipine, tsibenzolin, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil);
Sedatives and medicines for the treatment of psychosis (mental illness) eg. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine;
Medicines for depression eg. amitriptyline, paroxetine, fluoxetine;
Medicines used for anesthesia during surgery;
Medicines to treat asthma, blocked nose or certain eye diseases such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
All these drugs as well as nebivolol, may affect blood pressure and / or heart function.
Medicines to treat high gastric acid secretion or ulcers (antacid), eg. tsimetdin; You should take nebivolol Sandoz during meals, and antacids between meals.
Taking nebivolol Sandoz with food and drink
Nebivolol Sandoz may be taken with or without food, it is best, however, the tablet should be taken with a little water.

Pregnancy and lactation
Sandoz nebivolol should not be used during pregnancy, unless clearly necessary.
Not recommended for use during breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine may cause dizziness or fatigue. If this applies to you, do not drive or operate machinery.

Important information about some of the ingredients of Nebivolol Sandoz
This product contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE SANDOZ nebivolol
Always take nebivolol Sandoz exactly as your doctor tells you. If you are not sure, ask your doctor.
Sandoz nebivolol can be administered before, during or after meals. Yet you can take it without food. It is best to take the tablets with some water.

Treat high blood pressure (hypertension):
The usual dose is one tablet daily. Preferably, the dose of medication to be taken every day at the same time.
Elderly patients and patients with kidney problems usually start with 1/2 (half) tablet daily.
The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is observed after 4 weeks.
Treatment of chronic heart failure:
Your treatment should be initiated and supervised by an experienced physician.
Your doctor will start you on a 1/4 (quarter) tablet daily. The dose may be increased after 1-2 weeks to 1/2 (half) tablet daily, then to 1 tablet per day and then to 2 tablets per day until the optimal dose for you.
The maximum recommended dose is two tablets (10 mg) per day.
You must be under the supervision of an experienced doctor for two hours at baseline and at each increasing dose.
The doctor may reduce your dose if necessary.
You should not stop treatment abruptly as this can lead to worsening of heart failure.
Patients with serious kidney disease should not take this medicine.
Take your medicine once daily, preferably at the same time of day.
Instructions for dividing the tablet
If your doctor has told you to take 1/4 or 1/2 (two quarters) tablet, place the tablet on a flat hard surface such as a table, with the score up. Apply uniform pressure on the whole tablet, until you hear the sound of cracking. Now the tablet is divided into 4 parts, which can be carefully separated.
Your doctor may decide to combine Nebivolol Sandoz tablets with other medicines to treat your condition.
Not be used in children or adolescents.

If you take more dose nebivolol Sandoz
If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately. The most frequent symptoms and signs of an overdose of nebivolol Sandoz are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure. You can take activated charcoal (which is available in the pharmacy) while waiting for the arrival of the doctor.

If you forget to take nebivolol Sandoz
If you miss a dose of nebivolol Sandoz, but a little later you remember that you have to take it, take the dose for that day as usual. If, however, the period of delay is large (eg. Several hours), so it is almost time for your next dose, skip the missed dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose. However, frequent omission must be avoided.

If you stop taking nebivolol Sandoz
You should always consult your doctor before stopping treatment with nebivolol Sandoz you take for high blood pressure or chronic heart failure. Should not suddenly discontinue treatment with nebivolol Sandoz, as this may temporarily worsen heart failure. If it is necessary to stop the treatment with nebivolol Sandoz chronic heart failure, the dose should be gradually reduced by lowering half of the week.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nebivolol Sandoz can cause side effects, although not everybody gets them.
When nebivolol Sandoz is used to treat hypertension, the possible side effects are:

Common side effects (more than 1 in 100 people treated, but less than 1 in every 10 treated):
headache;
dizziness;
fatigue;
unusual itching or tingling;
diarrhea;
constipation;
nausea;
shortness of breath;
swelling of hands or feet.
Uncommon side effects (more than 1 in every 1000 people treated, but less than 1 in 100 treated):
slow heartbeat or other heart problems;
low blood pressure;
like spasm leg pain when walking;
violation in vision;
impotence;
feelings of depression;
disorders of digestion (dyspepsia), gas in stomach or intestines, vomiting;
skin rash, itching;
breathlessness such as in asthma, due to sudden spasm of the muscles around the airways (bronchospasm);
nightmares.
Very rare side effects (less than 1 in every 10,000 treated):
seizures;
swelling of the lips, eyes or tongue, with the danger of sudden difficulty in breathing;
worsening of psoriasis (a skin disease - scaly pink patches).
In a clinical study for chronic heart failure has been observed following side effects:
Very common side effects (more than 1 in 10 persons treated):
slow heartbeat;
dizziness.
Common side effects (more than 1 in 100 but less than 1 in 10 persons treated):
worsening heart failure;
low blood pressure (and the feeling of fainting when standing up quickly);
inability to tolerate this medicine;
type lightly degree heart disorder that affects heart rhythm (AV block first degree);
swelling of the lower limbs (eg swollen ankles).
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SANDOZ nebivolol
Keep out of reach of children.
Do not use Nebivolol Sandoz after the expiry date stated on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Nebivolol Sandoz should not be disposed of via 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
What nebivolol Sandoz
The active substance is nebivolol. Each tablet contains 5,45 mg nebivololov hydrochloride equivalent to 5 mg of nebivolol.
Other ingredients are: croscarmellose sodium, lactose monohydrate, maize starch, microcrystalline cellulose, hypromellose 5 cp, silica colloidal anhydrous, magnesium stearate.