NEBIVOLOL SANDOZ 5mg x 30 tabl
Leaflet: patient information
Nebivolol Sandoz 5 mg tablets
Nebivolol Sandoz 5 mg tablets
nebivolol ( nebivolol )
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Don't leave it to other people. It can harm them even though the signs of their illness are the same as yours.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
What this leaflet contains:
- What Nebivolol Sandoz is and what it is used for
- What you need to know before you take Nebivolol Sandoz
- How to take Nebivolol Sandoz
- Possible side effects
- How to store Nebivolol Sandoz
- Package contents and additional information
1. What Nebivolol Sandoz is and what it is used for
Nebivolol Sandoz contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blockers (i.e. with a selective effect on the cardiovascular system). It prevents the heart rate from increasing and controls the pumping power of the heart. It also dilates blood vessels, which helps lower blood pressure.
It is used to treat high blood pressure (hypertension).
Nebivolol Sandoz is also used to treat mild to moderate chronic heart failure in patients 70 years of age or older, as an adjunct to other therapy.
2. What you need to know before you take Nebivolol Sandoz
Do not take Nebivolol Sandoz
- if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of this medicine (listed in section 6).
- if you have one or more of the following disorders:
- low blood pressure
- serious problems with blood circulation in the arms or legs
- very slow heart rate (less than 60 beats per minute)
- certain other heart rhythm problems (eg, 2nd and 3rd degree atrioventricular block, conduction disorders of the heart)
- heart failure that has recently occurred or worsened recently, or you are being treated for circulatory shock as a result of acute heart failure using intravenous systems to help your heart work
- asthma or wheezing (now or in the past)
- untreated pheochromocytoma located in the upper pole of the kidney (in the adrenal glands)
- liver function disorder
- metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.
Warnings and precautions
Tell your doctor or pharmacist before taking Nebivolol Sandoz if you have or if any of the following problems occur:
- abnormally slow heart rate
- a type of chest pain that is caused by a spontaneously occurring spasm of a blood vessel in the heart, called Prinzmetal's angina
- untreated chronic heart failure
- 1st degree heart block (a type of mild heart conduction disorder that affects the heart rhythm)
- poor circulation in the arms or legs, e.g. Raynaud's disease or syndrome, cramp-like pain when walking
- persistent breathing problems
- diabetes: this drug does not affect blood sugar, but may mask the warning signs of low blood sugar (eg palpitations, fast heart rate).
- overactive thyroid: this medicine may mask the symptoms of an abnormally fast heart rate due to this condition
- allergy: this medicine may increase your reaction to pollen or other substances to which you are allergic
- psoriasis (skin disease - pink scaly plaques) or if you have ever had psoriasis
- if you need surgery, always inform your anesthetist beforehand that you are being treated with Nebivolol Sandoz.
If you have serious kidney problems, do not take Nebivolol Sandoz for heart failure and inform your doctor.
You will be regularly monitored at the start of your chronic heart failure treatment by an experienced doctor (see point 3).
This treatment should not be stopped suddenly unless clearly necessary and at the discretion of your doctor (see section 3).
Children and adolescents
Due to the lack of data on the use of the product in children and adolescents, the use of Nebivolol Sandoz in them is not recommended.
Other medicines and Nebivolol Sandoz
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Some medications cannot be taken at the same time, and other medications require specific changes (to the dose, for example).
Always inform your doctor if you are using or receiving any of the following medicines at the same time as Nebivolol Sandoz:
- Medicines to control blood pressure or medicines to treat heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lasidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
- Sympathomimetics (drugs whose effects mimic the effects of sympathetic innervation on the heart and circulation)
- Tranquilizers and medicines to treat psychosis (mental illness) e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
- Medicines to treat depression e.g. amitriptyline, paroxetine, fluoxetine.
- Medicines used for anesthesia during surgery.
- Medicines to treat asthma, nasal congestion or certain eye conditions such as glaucoma (increased pressure inside the eye) or dilatation (enlargement) of the pupils.
- Amifostine, used in the treatment of cancer
- Baclofen, used to treat epilepsy
All of these drugs, as well as nebivolol, can affect blood pressure and/or heart function.
- Medicines to treat increased stomach acid or ulcers (antacids), e.g. cimetidine; You should take Nebivolol Sandoz with meals and antacids between meals.
Nebivolol Sandoz with food and drink
Nebivolol Sandoz can be taken with food or on an empty stomach, but it is best to take the tablet with a little water.
Pregnancy and breastfeeding
Nebivolol Sandoz should not be used during pregnancy unless clearly necessary .
Not recommended for use during breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine may make you feel dizzy or tired. If this applies to you, do not drive or use machines.
Nebivolol Sandoz contains lactose and sodium
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.
3. How to take Nebivolol Sandoz
Always take Nebivolol Sandoz exactly as your doctor has told you. If you are not sure about something, ask your doctor.
Nebivolol Sandoz can be taken before, during or after meals, but you can take it regardless of meals. It is best to take the tablet with some water.
Treatment of high blood pressure (hypertension)
- The usual dose is 1 tablet daily. It is preferable to take the dose of the medicine every day at the same time.
- Elderly patients and patients with kidney problems usually start therapy with ½ (half) tablet daily.
- The therapeutic effect on blood pressure is noticeable after 1-2 weeks of treatment. In some cases, the optimal effect is observed only after 4 weeks.
Treatment of chronic heart failure
- Your treatment should be initiated and monitored by an experienced physician.
- Your doctor will start your treatment with ¼ (one quarter) tablet daily. The dose can be increased after 1-2 weeks to ½ (half) tablet daily, then to 1 tablet daily and then to 2 tablets daily until the optimal dose for you is reached.
- The maximum recommended dose is 2 tablets (10 mg) daily.
- It is necessary to be under the supervision of an experienced doctor for two hours when starting the treatment and with each increase in the dose.
- Your doctor may lower your dose if necessary.
- You should not stop your treatment suddenly ¸ as this may lead to worsening of heart failure.
- Patients with severe kidney disease should not take this medicine.
- Take your medicine once a day, preferably at the same time of day.
Instructions for splitting the tablet
If your doctor has told you to take ¼ or ½ (two quarters) of a tablet, follow the directions:
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3. Apply equal pressure to the entire tablet until a cracking sound is heard.
Your doctor may decide to combine Nebivolol Sandoz Tablets with other medicines to treat your condition.
Do not use in children or adolescents.
If you have taken more Nebivolol Sandoz than you should
If you accidentally take an overdose of this medicine, inform your doctor or pharmacist immediately . The most common symptoms and signs of an overdose of Nebivolol Sandoz are a very slow heart rate (bradycardia), low blood pressure with the risk of fainting (hypotension), asthma-like breathlessness (bronchospasm) and acute heart failure.
You can take activated charcoal (which is available at the pharmacy) while you wait for the doctor to arrive.
If you forget to take Nebivolol Sandoz
If you miss a dose of Nebivolol Sandoz, but remember a little later that you should take it, take that day's dose as usual. If, however, the delay period is long (eg several hours) so that it is almost time for the 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 skipping should be avoided.
If you have stopped taking Nebivolol Sandoz
You should always consult your doctor before stopping treatment with Nebivolol Sandoz that you are taking for high blood pressure or chronic heart failure.
You should not stop treatment with Nebivolol Sandoz suddenly, as this may temporarily worsen heart failure. If it is necessary to stop treatment with Nebivolol Sandoz of chronic heart failure, the daily dose should be gradually reduced by halving every week.
If you have any further questions related to 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 high blood pressure , possible side effects are:
Common side effects (may affect up to 1 in 10 people):
- headache
- dizziness
- fatigue
- unusual itching or tickling
- diarrhea
- constipation
- nausea
- out of breath
- swelling of the hands or feet.
Uncommon side effects (may affect up to 1 in 100 people):
- slow heartbeat or other heart problems
- low blood pressure
- spasm-like pains in legs when walking
- visual impairment
- impotence
- feeling depressed
- indigestion (dyspepsia), gas in the stomach or intestines, vomiting
- skin rash, itching
- shortness of breath as in asthma, due to sudden spasm of the muscles around the airways (bronchospasm)
- nightmares.
Very rare side effects (may affect up to 1 in 10,000 people):
- seizures
- worsening of psoriasis (skin disease - pink scaly plaques).
Not known (frequency cannot be determined from the available data):
- hypersensitivity
- angioedema (swelling of the face, lips, mouth, tongue or throat)
- urticaria (itchy rash)
The following side effects have also been reported with similar medicinal products:
- hallucinations
- psychoses
- confusion
- cold extremities, bluing of the extremities (blue or purple skin color)
- Raynaud's phenomenon (discoloration of fingers, toes and sometimes other areas)
- dry eyes
- formation of new connective tissue in the eyes and diaphragm (practolol-type oculo-mucosal-cutaneous toxicity).
In a clinical trial for chronic heart failure, the following side effects were observed :
Very common side effects (may affect more than 1 in 10 people):
- slow pulse
- dizziness
Common side effects (may affect up to 1 in 10 people):
- worsening heart failure
- low blood pressure (as well as feeling faint when standing up quickly)
- inability to tolerate this drug
- type of mild heart disorder that affects heart rhythm (AV block 1st degree)
- swelling of the lower limbs (for example, swollen ankles).
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Nebivolol Sandoz
Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.
This medicinal product does not require special storage conditions.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Nebivolol Sandoz contains
- The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as hydrochloride).
- The other ingredients are: croscarmellose sodium, lactose monohydrate, corn starch, microcrystalline cellulose, hypromellose 5 cps, silica colloidal anhydrous, magnesium stearate.
What Nebivolol Sandoz looks like and contents of the pack
White or off-white tablets, four-leaf clover-shaped on one side, convex on the other side, with a score of four and score lines on both sides (diameter: 9 mm).
The tablets are packed in PVC/Aluminium blisters or polyethylene bottles with tamper-evident polyethylene caps placed in cardboard boxes.
Packaging:
Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500 tablets
Bottle: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500 tablets
Not all packages can be put on sale.
License holder
Sandoz dd
Verovškova 57, 1000 Ljubljana
Slovenia
Manufacturers
Lek Pharmaceuticals dd
Verovškova 57
1526 Ljubljana, Slovenia
LEK SA
street Domaniewska 50 C,
02-672 Warszawa, Poland
LEK SA
street Podlipie 16,
95-010 Strykow, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
This medicinal product is authorized for use in the EEC member states under the following names:
Austria: Nebivolol Sandoz 5 mg – Tabletten
Belgium: Nebivolol Sandoz 5 mg tabletten
Bulgaria: Nebivolol Sandoz
Czech Republic: Nebivolol Sandoz 5 mg
Germany: Nebivolol Sandoz 5 mg Tabletten
Spain: Nebivolol Sandoz 5 mg comprimidos EFG
France: NEBIVOLOL Sandoz 5 mg, comprimé quadrisécable
Italy: NEBIVOLOLO SANDOZ 5 mg compresse
The Netherlands: Nebivolol Sandoz 5 mg
Poland: NebivoLEK
Portugal: Nebivolol Sandoz
Romania: Nebivolol Sandoz 5 mg comprimate
Slovenia: Nebivolol Lek 5 mg tablete
United Kingdom: Nebivolol 5 mg Tablets
