For the treatment of high blood pressure.
What is the medicinal product Nebilet and what is it used for?
Active substance:one tablet contains 5 mg nebivolol (as nebivolol hydrochloride): 2.5 mg d-nebivolol and 2.5 mg l-nebivolol.
Other ingredients: lactose monohydrate, polysorbate 80 (E433), hypromellose (E464), maize starch, croscarmellose sodium (E468), microcrystalline cellulose (E460), colloidal anhydrous silicon dioxide (E551), magnesium stearate (E572).
The medicinal product Nebilet contains nebivolol – a cardiovascular medicine belonging to the group of selective beta-adrenoblockers (i.e. it acts selectively on the cardiovascular system). It prevents an increase in heart rate and controls the heart’s pumping function. The effect of the product also causes dilation of blood vessels, which helps to lower blood pressure.
It is used:
- For the treatment of high blood pressure (arterial hypertension).
- As an add-on treatment to other therapies for mild and moderate chronic heart failure in patients aged 70 years and older.
- For the treatment of stable coronary heart disease accompanied by clinical symptoms – a condition characterized by episodes of chest pain or discomfort, often triggered by physical exertion, emotions, or other stressful situations; these symptoms occur when the blood supply to the heart is reduced or completely interrupted.
Do not take Nebilet:
• If you are allergic to nebivolol or any of the other ingredients of this product
• If you have one or more of the following disorders:
- Low blood pressure
- Severe circulatory disorders in the limbs
-Very slow pulse (less than 60 beats per minute)
- Certain other serious heart rhythm disorders (e.g., second- and third-degree atrioventricular block, cardiac conduction disorders)
- Newly developed or worsened heart failure, treatment of circulatory failure in acute heart failure with intravenous medicines that improve heart function
- Asthma or wheezing (currently or in the past)
- Untreated pheochromocytoma – a tumor of the adrenal gland (located above the kidneys)
- Impaired liver function
- Metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis.
Warnings and precautions:
Before taking Nebilet, consult your doctor or pharmacist.
Tell your doctor if you have or develop any of the following disorders:
- Marked reduction in heart rate
- Chest pain caused by sudden spasm of the coronary arteries (Prinzmetal’s angina)
- Untreated chronic heart failure
- First-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
- Poor circulation in the limbs, for example Raynaud’s disease or syndrome, cramp-like pain when walking
- Prolonged breathing difficulties
- Diabetes: this medicine does not affect blood sugar levels, but it may mask signs of low blood sugar (e.g., palpitations, rapid heartbeat)
- Overactive thyroid gland: this medicine may mask signs of an abnormally fast heartbeat caused by this condition
- Allergy: this medicine may intensify your reaction to pollen or other substances to which you are allergic
- Psoriasis (a skin disease characterized by scaly pink patches), or if you have had psoriasis in the past
- Before undergoing surgery and anesthesia, always inform the anesthesiologist that you are taking Nebilet.
- If you have severe kidney impairment, do not take Nebilet for the treatment of heart failure and consult your doctor.
At the beginning of treatment for chronic heart failure, regular monitoring by an experienced physician is necessary.
Treatment with this medicine must not be stopped abruptly without clear instructions and evaluation by your doctor.
Children and adolescents:
Due to the lack of data on use in children and adolescents, Nebilet is not recommended in this age group.
Other medicines and Nebilet:
Always inform your doctor if you are taking or receiving any of the following medicines together with Nebilet:
- Medicines for blood pressure control or heart conditions (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil).
- Sedatives and medicines for psychosis (mental disorders), such as barbiturates (also used for epilepsy), phenothiazine (also used for nausea and vomiting), and thioridazine.
- Medicines for depression, such as amitriptyline, paroxetine, fluoxetine.
- Anesthetic agents used during surgery.
- Medicines for asthma, nasal congestion, certain eye disorders such as glaucoma (increased intraocular pressure), or medicines used to dilate the pupil.
- Baclofen (an antispastic muscle relaxant), amifostine (a protective agent used during cancer treatment).
All these medicines, as well as nebivolol, may affect blood pressure and/or heart function.
- Medicines for increased stomach acidity or ulcers (antacids): Nebilet should be taken with food, while the antacid should be taken between meals.
Pregnancy and breastfeeding:
Nebilet must not be taken during pregnancy unless clearly necessary.
It must not be taken while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines: This medicine may cause dizziness or weakness. If affected, do not drive or operate machinery.
Nebilet contains lactose. If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e., it is essentially “sodium-free.”
Method of administration:
- Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
- Nebilet may be taken before, during, or after meals, or independently of meals. Tablets are best taken with water.
Treatment of high blood pressure (arterial hypertension):
- The usual dose is 1 tablet per day. The tablet should preferably be taken at the same time each day.
- In elderly patients and patients with kidney disease, the starting dose is usually ½ (half) tablet per day.
- The blood pressure-lowering effect appears after 1–2 weeks of treatment. Sometimes the optimal effect is achieved only after 4 weeks.
Treatment of chronic heart failure:
- Treatment should be initiated under the supervision of an experienced physician.
- Your doctor will start treatment with ¼ (quarter) tablet per day. After 1–2 weeks, the dose may be increased to ½ (half) tablet per day, then to 1 tablet per day, and then to 2 tablets per day until the appropriate dose is reached. Your doctor will prescribe the dose best suited to you at each stage of treatment. You must strictly follow your doctor’s instructions.
- The maximum recommended dose is 2 tablets (10 mg) per day.
- At the start of treatment and after each dose increase, you should be monitored by an experienced physician for 2 hours.
- If necessary, your doctor may reduce the dose.
- Treatment must not be stopped abruptly as this may worsen heart failure.
- Patients with severe kidney impairment must not take this medicine.
- Take the medicine once daily, preferably at the same time each day.
Treatment of stable coronary heart disease with symptoms:
- Treatment should be initiated and monitored by an experienced physician.
- Your doctor will start treatment with 1.25 mg (¼ tablet) per day. After 1–2 weeks, the dose may be increased to 2.5 mg (½ tablet) per day, then to 5 mg (1 tablet) per day, and then to 10 mg (2 tablets) per day until the dose suitable for you is reached.
- The maximum recommended dose is 10 mg (2 tablets per day).
- Do not stop taking Nebilet tablets abruptly, as this may increase the risk of heart attack. Dose adjustment or discontinuation should only be done after consulting your doctor.
Patients with severe kidney impairment must not take this medicine.
Patients with severe liver impairment must not take this medicine.
Your doctor may decide to combine Nebilet with other medicines to treat your condition.
Do not use in children and adolescents.
If you take more Nebilet than you should:
Contact your doctor or pharmacist immediately. The most common symptoms and signs of overdose are marked slowing of the heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), shortness of breath as in bronchial asthma (bronchospasm), and acute heart failure.
You may take activated charcoal (available in pharmacies) until the doctor arrives.
If you forget to take Nebilet:
Take the usual dose. However, if you remember much later (for example, several hours after the scheduled time), and it is almost time for the next dose, skip the missed dose and take the normal scheduled dose at the usual time. Do not take a double dose. Avoid repeatedly missing doses.
If you stop taking Nebilet:
Always consult your doctor before stopping treatment with Nebilet, whether you are taking it for high blood pressure or chronic heart failure.
Treatment with Nebilet must not be stopped abruptly, as this may temporarily worsen heart failure. If it is necessary to stop treatment for chronic heart failure, the daily dose should be gradually reduced, halving the dose at weekly intervals.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects:
When Nebilet is used for the treatment of high blood pressure, the following side effects may occur:
Common:
- Headache
- Dizziness
- Fatigue
- Unusual itching or tingling sensation
- Diarrhea
- Constipation
- Nausea
- Shortness of breath
- Swelling of hands or feet.
Uncommon:
- Slow heartbeat or other heart disorders
- Low blood pressure
- Cramp-like leg pain when walking
- Visual disturbances
- Impotence
- Depressed mood
- Digestive disorders (dyspepsia), gas in the stomach or intestines, vomiting
- Skin rash, itching
- Shortness of breath due to sudden spasm of airway muscles (bronchospasm)
- Nightmares.
Very rare:
- Fainting
- Worsening of psoriasis (a skin disease characterized by scaly pink patches).
- In isolated cases, the following side effects have been reported in patients taking Nebilet:
- Systemic allergic reactions with generalized skin rash (hypersensitivity reactions)
- Rapidly developing swelling, particularly around the lips, eyes, or tongue, possibly with acute breathing difficulty (angioedema)
- Skin rash characterized by pale red itchy wheals (urticaria).
- In a clinical study of Nebilet for chronic heart failure, the following side effects were observed:
Common:
- Slow heartbeat
- Dizziness
- Worsening heart failure
- Low blood pressure (e.g., weakness when standing up quickly)
- Intolerance to this medicine
- Mild cardiac conduction disorder affecting heart rhythm (first-degree atrioventricular block)
- Swelling of the lower limbs (e.g., swollen ankles).
Data on side effects in patients with stable ischemic heart disease are based on clinical studies in chronic heart failure. It can be assumed that the above-mentioned side effects may also occur in patients with ischemic heart disease.
Storage conditions:
- Keep out of the reach of children.
- No special storage conditions are required.
- Do not use after the expiry date. The expiry date refers to the last day of the stated month. Shelf life: 3 years.
- Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
Dispensing conditions: Pharmaceutical product Group II, dispensed with prescription form №3.
Marketing authorization holder
Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturer Berlin-Chemie AG Glienicker Weg 125
12489 Berlin
Germany
