NEBIVOLOL SANDOZ 5mg x 30 tabl
Patient information leaflet
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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 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 medicine belonging to the group of selective beta-blockers (i.e. with a selective effect on the cardiovascular system). It prevents an increase in heart rate and controls the pumping force of the heart. It also dilates blood vessels, which helps to 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 aged 70 years or older, as an add-on 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 circulation problems in the arms or legs
- very slow heart rate (less than 60 beats per minute)
- certain other heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders)
- heart failure that has recently occurred or has recently worsened, or you are being treated for circulatory shock as a result of acute heart failure using intravenous systems to support the work of your heart
- asthma or wheezing (now or in the past)
- untreated pheochromocytoma located in the upper pole of the kidneys (in the adrenal glands)
- liver dysfunction
- 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:
- unusually slow heart rate
- a type of chest pain 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 blood circulation in the hands or feet, e.g. Raynaud's disease or syndrome, cramp-like pain when walking
- prolonged breathing problems
- diabetes: this medicine does not affect blood sugar, but may mask the warning signs of low blood sugar (e.g. palpitations, fast heartbeat).
- overactive thyroid gland: this medicine may mask the symptoms of an abnormally fast heart rate due to this condition
- allergy: this medicine may increase your reaction to pollens or other substances to which you are allergic
- psoriasis (a skin disease - pink scaly plaques) or if you have ever had psoriasis
- If you need surgery, always inform your anaesthetist beforehand that you are being treated with Nebivolol Sandoz.
If you have serious kidney problems, do not take Nebivolol Sandoz for heart failure and tell your doctor.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by an experienced doctor (see section 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 a 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 medicines obtained without a prescription. Some medicines cannot be taken at the same time, and other medicines may require specific changes (for example, dosage).
Always tell 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, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
- Sympathomimetics (drugs whose effects resemble the effects of sympathetic innervation on the heart and circulation)
- Sedatives and medicines to treat psychosis (mental illness) such as barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea) and thioridazine.
- Medicines to treat depression, e.g. amitriptyline, paroxetine, fluoxetine.
- Drugs used for anesthesia during surgery.
- Medicines to treat asthma, nasal congestion or certain eye diseases, such as glaucoma (increased intraocular pressure) or to dilate (widen) the pupils.
- Amifostine, used in cancer treatment
- 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, however, 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 cause dizziness or tiredness. If this applies to you, do not drive or operate machinery.
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 medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially '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 anything, ask your doctor.
Nebivolol Sandoz can be taken before, during or after meals, however, 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 at the same time every day.
- 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 started and supervised by an experienced doctor.
- Your doctor will start your treatment with ¼ (one quarter) tablet daily. The dose may 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.
- You need to be under the supervision of an experienced doctor for two hours when starting treatment and with each dose increase.
- Your doctor may lower your dose if necessary.
- You should not stop your treatment suddenly as this may cause your heart failure to worsen.
- Patients with serious kidney disease should not take this medicine.
- Take your medicine once a day, preferably at the same time of day.
Instructions for dividing the tablet
If your doctor has told you to take ¼ or ½ (two quarters) of a tablet, follow the instructions:
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3. Apply even 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 take more Nebivolol Sandoz than you should
If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately . The most common symptoms and signs of an overdose of Nebivolol Sandoz are very slow heart rate (bradycardia), low blood pressure with a risk of fainting (hypotension), shortness of breath like in asthma (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 have missed a dose of Nebivolol Sandoz, but remember a little later that you need to take it, take the dose for that day as usual. However, if the delay is long (e.g. 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 omissions should be avoided.
If you stop taking Nebivolol Sandoz
You should always consult your doctor before stopping treatment with Nebivolol Sandoz, which 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 for chronic heart failure, the daily dose should be gradually reduced by halving it per 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 high blood pressure , the 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
- shortness 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 pain in the legs when walking
- vision 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 estimated from the available data):
- hypersensitivity
- angioedema (swelling of the face, lips, mouth, tongue or throat)
- urticaria (itchy rash)
The following adverse reactions have also been reported with similar medicinal products:
- hallucinations
- psychoses
- confusion
- cold extremities, cyanosis of the extremities (blue or purple skin color)
- Raynaud's phenomenon (discoloration of the 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 study for chronic heart failure, the following adverse reactions were observed :
Very common side effects (may affect more than 1 in 10 people):
- slow heartbeat
- dizziness
Common side effects (may affect up to 1 in 10 people):
- worsening of heart failure
- low blood pressure (as well as a feeling of fainting when standing up quickly)
- inability to tolerate this medication
- a type of mild heart disorder that affects the heart rhythm (1st degree AV block)
- swelling of the lower extremities (for example, swollen ankles).
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system to the Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, tel.: +35928903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on 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 expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Nebivolol Sandoz contains
- The active substance is nebivolol. Each tablet contains 5 mg nebivolol (as hydrochloride).
- The other ingredients are: croscarmellose sodium, lactose monohydrate, corn starch, microcrystalline cellulose, hypromellose 5 cps, colloidal anhydrous silica, magnesium stearate.
What Nebivolol Sandoz looks like and contents of the pack
White or almost white tablets, shaped like a four-leaf clover on one side, convex on the other side, with a shape for dividing into four and score lines on both sides (diameter: 9 mm).
The tablets are packaged 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 may be marketed.
Marketing Authorisation Holder
Sandoz dd
Verovškova 57, 1000 Ljubljana
Slovenia
Manufacturers
Lek Pharmaceuticals dd
Verovškova 57
1526 Ljubljana, Slovenia
LEK SA
ul. Domaniewska 50 C,
02-672 Warsaw, Poland
LEK SA
Podlipie Street 16,
95-010 Strykow, Poland
Salutas Pharma GmbH
Otto von Guericke Allee 1
39179 Barleben, Germany
This medicinal product is authorised for use in the Member States of the EEA 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
Netherlands: Nebivolol Sandoz 5 mg
Poland: NebivoLEK
Portugal: Nebivolol Sandoz
Romania: Nebivolol Sandoz 5 mg tablets
Slovenia: Nebivolol Lek 5 mg tablete
United Kingdom: Nebivolol 5 mg Tablets
