Nebivolol Medreg

Leaflet attached to the packaging: patient information

Nebivolol Medreg, 5 mg, tablets

Nebivolol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nebivolol Medreg and what is it used for
• 2. Important information before taking Nebivolol Medreg
• 3. How to take Nebivolol Medreg
• 4. Possible side effects
• 5. How to store Nebivolol Medreg
• 6. Contents of the pack and other information

1. What is Nebivolol Medreg and what is it used for

Nebivolol Medreg contains nebulol, which acts on the cardiovascular system. Nebivolol belongs to a group of selective beta-adrenergic blockers (i.e., they selectively affect the cardiovascular system). It prevents the acceleration of heart activity and controls the strength of heart contractions. It also dilates blood vessels, which helps to lower blood pressure. Nebivolol Medreg is used to treat high blood pressure (hypertension). Nebivolol Medreg is also used to treat mild and moderate, chronic heart failure, as an addition to standard therapy in patients over 70 years old.

2. Important information before taking Nebivolol Medreg

When not to take Nebivolol Medreg

• if the patient is allergic to nebulol or any of the other ingredients of this medicine (listed in section 6)
• if the patient has one or more of the following disorders:
• low blood pressure
• severe circulatory disorders in the hands or feet
• very slow heart rate (less than 60 beats per minute)
• certain other severe heart rhythm disorders (e.g., second- and third-degree atrioventricular block, conduction disorders in the heart)
• heart failure that has recently occurred or worsened, or if the patient is receiving intravenous medications to support heart function due to cardiogenic shock in acute heart failure
• asthma or wheezing (currently or in the past)
• untreated pheochromocytoma - a tumor located in the upper part of the kidney (in the adrenal gland)
• liver function disorders
• metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions

Before starting treatment with Nebivolol Medreg, discuss it with your doctor or pharmacist. Inform your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate
• chest pain caused by spontaneous contraction of the coronary arteries (Prinzmetal's angina)
• untreated chronic heart failure
• first-degree heart block (mild conduction disorder in the heart that affects heart rhythm)
• circulatory disorders in the hands or feet, such as Raynaud's disease or intermittent claudication
• persistent breathing difficulties
• diabetes - because nebulol may mask the symptoms of low blood sugar (hypoglycemia) (e.g., palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain types of anti-diabetic medications called sulfonylureas (such as gliclazide, glipizide, or tolbutamide)
• hyperthyroidism - this medicine may mask the symptoms of abnormally rapid heart rate in this disease
• allergy - this medicine may exacerbate the reaction to pollen or other substances to which the patient is allergic
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past
• planned surgical procedure - before anesthesia, inform the anesthesiologist about taking Nebivolol Medreg.

In case of severe kidney function disorders, do not take Nebivolol Medreg for the treatment of heart failure and discuss it with your doctor. At the beginning of heart failure treatment, an experienced doctor will regularly monitor the patient's clinical condition (see section 3). Do not suddenly stop treatment unless it is clearly advised by your doctor (see section 3).

Children and adolescents

Nebivolol Medreg is not recommended for children and adolescents due to the lack of data on its use in this age group.

Nebivolol Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Inform your doctor about taking any of the following medicines at the same time as Nebivolol Medreg:

• medicines used to treat high blood pressure or heart disease (such as amiodarone, amlodipine, cybenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, meksiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, or verapamil)
• sedatives and antipsychotic medicines (used in mental disorders), such as barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), and thioridazine
• antidepressant medicines, such as amitriptyline, paroxetine, or fluoxetine
• medicines used for anesthesia during surgery
• medicines used for asthma, stuffy nose, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils
• baclofen (a medicine that reduces muscle tension), amifostine (a medicine with a protective effect, used during cancer treatment)
• diabetes medicines, such as insulin or oral anti-diabetic medicines. All of the above medicines, as well as nebulol, may affect blood pressure and/or heart rate.
• Medicines used for hyperacidity or stomach ulcers (medicines that reduce stomach acid production): Nebivolol Medreg should be taken during meals, and antacids between meals.

Nebivolol Medreg with food and drink

Nebivolol Medreg can be taken with or without food, preferably with a glass of water. See section 3.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Nebivolol Medreg should not be used during pregnancy unless it is absolutely necessary. Breastfeeding is not recommended while taking Nebivolol Medreg.

Driving and using machines

This medicine may cause dizziness and fatigue. In such cases, do not drive or operate machines.

Nebivolol Medreg contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Nebivolol Medreg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Nebivolol Medreg

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist. Nebivolol Medreg can be taken before, during, or after meals, as well as independently of meals. Take the tablet with a sufficient amount of water.

Treatment of high blood pressure (hypertension)

The usual dose is 1 tablet per day. Take the dose every day at the same time. In elderly patients and patients with kidney function disorders, treatment usually starts with ½ tablet per day. The effect on blood pressure is visible after 1-2 weeks of treatment. In rare cases, optimal efficacy is achieved after 4 weeks.

Treatment of chronic heart failure

Treatment will be started and monitored by an experienced doctor. The doctor will start treatment with ¼ tablet per day. After 1-2 weeks of treatment, the dose may be increased to ½ tablet per day, then to 1 tablet per day, and subsequently to 2 tablets per day, until the optimal dose for the patient is achieved. The doctor will determine the appropriate dose at each stage of treatment, and the patient should strictly follow the doctor's instructions. The maximum recommended dose is 2 tablets (10 mg) per day. The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose is increased. The doctor may recommend reducing the dose of the medicine if necessary. Do not suddenly stop treatment, as it may worsen heart failure. Patients with severe kidney failure should not take this medicine. Take the medicine once a day, preferably at the same time every day. The doctor may recommend taking Nebivolol Medreg in combination with other medicines used to treat the disease.

Use in children and adolescents

Nebivolol Medreg is not recommended for children and adolescents.

Use of a higher than recommended dose of Nebivolol Medreg

In case of accidental overdose, consult a doctor or pharmacist immediately. The most common subjective and objective symptoms of Nebivolol Medreg overdose are: very slow heart rate (bradycardia), low blood pressure that can cause fainting (hypotension), shortness of breath similar to that in asthma (bronchospasm), and acute heart failure. The patient may take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

Missing a dose of Nebivolol Medreg

In case of missing a dose of Nebivolol Medreg but remembering it soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and the time for the next dose is approaching, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose of the medicine to make up for the missed dose. Avoid missing doses of the medicine frequently.

Stopping treatment with Nebivolol Medreg

Always consult a doctor before stopping treatment with Nebivolol Medreg, whether it is taken for high blood pressure or chronic heart failure. Do not suddenly stop treatment, as it may worsen heart failure. If it is necessary to stop treatment for chronic heart failure with Nebivolol Medreg, the doctor will recommend gradually reducing the dose by half at weekly intervals. In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivolol Medreg can cause side effects, although not everybody gets them. During treatment with Nebivolol Medreg for high blood pressure, the following side effects have been reported:

Frequent(may occur in up to 1 in 10 patients):

• headache, dizziness, unusual tingling or prickling sensation
• shortness of breath
• constipation, nausea, diarrhea
• fatigue, swelling of hands or feet

Uncommon(may occur in up to 1 in 100 patients):

• nightmares, feeling of depression
• vision disorders
• slow heart rate or other heart disorders
• low blood pressure, cramping leg pain while walking
• shortness of breath similar to that in asthma, caused by sudden contraction of the airway muscles (bronchospasm)
• digestive disorders (indigestion), gas in the stomach or intestines, vomiting
• itching, skin rash
• impotence

Rare(may occur in up to 1 in 10,000 patients):

• fainting
• worsening of psoriasis (a skin disease characterized by scaly, pink patches)

The following side effects have been reported in single cases during treatment with Nebivolol Medreg:

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions)
• rapidly developing swelling, especially around the lips, eyelids, or tongue, with possible sudden breathing difficulties (angioedema)
• a type of skin rash characterized by pale red, raised, itchy bumps, resulting from an allergy or without an allergic background (urticaria)

In a clinical study on chronic heart failure, the following side effects were observed:

Very common(may occur in more than 1 in 10 patients):

• slow heart rate
• dizziness

Common(may occur in up to 1 in 10 patients):

• worsening of heart failure
• low blood pressure (such as a feeling of fainting when standing up quickly)
• intolerance to this medicine
• a type of mild conduction disorder in the heart that affects heart rhythm (first-degree atrioventricular block)
• swelling of the lower limbs (such as swelling around the ankles).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivolol Medreg

Keep the medicine out of sight and reach of children. There are no special precautions for storing the medicine. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nebivolol Medreg contains

• -The active substance of the medicine is nebulol. Each tablet contains 5 mg of nebulol (in the form of nebulol hydrochloride).
• -The other ingredients are: colloidal anhydrous silica, magnesium stearate, sodium croscarmellose, macrogol 6000, and lactose monohydrate.

What Nebivolol Medreg looks like and contents of the pack

Round, white, convex tablets with a diameter of 9 mm, with crossed dividing lines on one side and the marking "N 5" on the other side. The tablet can be divided into equal doses. The tablets are provided in aluminum/PVC/PE/PVdC blisters in a cardboard box. Pack sizes: 28, 30, 56, 60, 90, 98, and 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Balkanpharma Dupnitsa AD
3 Samokovsko Shosse str.
2600 Dupnitsa
Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Nebivolol Medreg
Poland:
Nebivolol Medreg
Slovakia:
Nebivolol Medreg
Romania:
Nebivolol Gemax Pharma 5 mg tablets

Date of last revision of the leaflet: 04/2025