DANEB 5 mg Tablets

Contents of the leaflet

1. What is Daneb and what is it used for
2. Important information before taking Daneb
   1. When not to take Daneb
   2. Warnings and precautions
   3. Daneb and other medicines
   4. Daneb with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Daneb contains lactose
3. How to take Daneb
   1. Treatment of high blood pressure (hypertension)
   2. Treatment of chronic heart failure
   3. Taking a higher dose of Daneb than recommended
   4. Missing a dose of Daneb
   5. Stopping treatment with Daneb
4. Possible side effects
   1. Reporting side effects
5. How to store Daneb
   1. Store in a place inaccessible and invisible to children.
6. Contents of the pack and other information
   1. What Daneb contains
   2. What Daneb looks like and what the pack contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer:

1. What is Daneb and what is it used for

Daneb contains nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of selective beta-adrenergic blocking agents (i.e., they selectively affect the cardiovascular system). It prevents the acceleration of heart rate and controls the strength of heart contractions. It also dilates blood vessels, which helps to lower blood pressure.

Daneb is used to treat high blood pressure (hypertension). It is also used to treat mild and moderate, chronic heart failure, as an addition to standard therapy in patients over 70 years of age.

2. Important information before taking Daneb

When not to take Daneb

• if you have been diagnosed with an allergy (hypersensitivity) to nebivolol or any of the other ingredients of Daneb (listed in section 6)
• if you have been diagnosed with one or more of the following disorders:
• low blood pressure,
• severe circulatory disorders in the upper or lower limbs,
• 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 you are 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), e.g., diabetic ketoacidosis

in diabetes.

Warnings and precautions

Before starting to take Daneb, you should discuss it with your doctor or pharmacist. You should 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, e.g., Raynaud's disease or syndrome, intermittent claudication,
• persistent breathing difficulties,
• diabetes - Daneb does not affect blood sugar levels, but may mask the warning signs of low blood sugar (e.g., palpitations, rapid heart rate),
• hyperthyroidism - Daneb may mask the symptoms of abnormally rapid heart rate in this disease,
• allergy - Daneb may exacerbate the reaction to pollen or other allergens,
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past,
• planned surgical procedure - before anesthesia, you should inform the anesthesiologist about taking Daneb.

In the case of severe kidney function disorders, you should not take Daneb for the treatment of heart failure, and you should discuss it with your doctor. The patient's condition with chronic heart failure at the beginning of treatment will be monitored by an experienced doctor (see section 3). You should not suddenly stop treatment unless it is clearly recommended by your doctor (see section 3). Children and adolescents It is not recommended to use Daneb in children and adolescents due to the lack of data on its use in this age group.

Daneb and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You should always inform your doctor or pharmacist if you are taking any of the following medicines at the same time as Daneb:

• 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, mexiletine, moksonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and antipsychotic medicines (used in mental disorders), e.g., barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), thioridazine.
• Antidepressant medicines, e.g., amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines used for asthma, nasal congestion, 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).

All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.

• Medicines used for stomach acid or stomach ulcers (medicines that reduce stomach acid secretion), e.g., cimetidine - Daneb should be taken during meals, and the antacid between meals.

Daneb with food and drink

Daneb can be taken with or without food. The tablet or its parts should be swallowed with water or another liquid.

Pregnancy and breastfeeding

Pregnancy
You should not take Daneb during pregnancy unless it is absolutely necessary.
Breastfeeding
You should not breastfeed while taking Daneb.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines. The medicine may cause dizziness or fainting due to low blood pressure. If such symptoms occur, YOU SHOULD NOT DRIVE VEHICLES OR OPERATE MACHINES. Their occurrence is more likely at the beginning of treatment or after increasing the dose (see also section 4).

Daneb contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Daneb

You should always take Daneb as recommended by your doctor. If you have any doubts, you should consult your doctor or pharmacist again.

Treatment of high blood pressure (hypertension)

The usual dose is 5 mg (1 tablet) per day. It is recommended to take the dose every day at the same time. For elderly patients and patients with kidney function disorders, the initial dose is usually 2.5 mg (1/2 tablet) per day. The blood pressure-lowering effect becomes apparent after 1-2 weeks of treatment. Sometimes the optimal effect occurs only after 4 weeks.

Treatment of chronic heart failure

Treatment will be started and monitored by an experienced doctor. The doctor will start treatment with a dose of 1.25 mg (1/4 tablet) per day. This dose may be increased after 1-2 weeks to a dose of 2.5 mg (1/2 tablet) per day, then to a dose of 5 mg (1 tablet) per day, and finally to a dose of 10 mg (2 tablets) per day, until the appropriate dose for the patient is reached. The maximum recommended dose is 10 mg (2 tablets per day). An experienced doctor will monitor the patient's condition for 2 hours after starting treatment and after each dose increase. If necessary, the doctor may reduce the dose; you should not suddenly stop treatment, as it may worsen heart failure. Patients with severe kidney function disorders cannot take Daneb. The medicine should be taken once a day, preferably every day at the same time. The doctor may recommend taking another medicine at the same time, depending on the patient's condition. It is not recommended to use Daneb in children and adolescents.

Taking a higher dose of Daneb than recommended

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

Missing a dose of Daneb

If you forget to take the medicine, but remember soon after, you should take the next tablet at a time close to the usual time of administration. If, however, a long time has passed (e.g., a whole day), you should skip the missed dose and take the next dose at the usual time the next day. You should not take a double dose or a larger dose to make up for the missed dose. You should avoid repeatedly missing doses.

Stopping treatment with Daneb

You should always consult your doctor before stopping treatment with Daneb, whether it is taken to treat high blood pressure or chronic heart failure. You should not suddenly stop treatment, as it may lead to a transient worsening of heart failure symptoms. If treatment needs to be stopped, the dose should be gradually reduced by half at weekly intervals. If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Daneb can cause side effects, although they may not occur in everyone. Side effects that may occur when taking Daneb to treat high blood pressure: Common side effects (may affect up to 1 in 10 people):headache, dizziness, fatigue, unusual sensation of itching or tingling, diarrhea, constipation, nausea, shortness of breath, swelling of hands or feet. Uncommon side effects (may affect up to 1 in 100 people):slow heart rate or other heart disorders, low blood pressure, cramping leg pain when walking, vision disorders, impotence (difficulty achieving an erection), depressive mood, digestive disorders (indigestion), bloating, vomiting, skin rash, itching, shortness of breath similar to that in asthma, caused by sudden contraction of the airway muscles (bronchospasm), nightmares. Rare side effects (may affect up to 1 in 10,000 people):fainting, worsening of psoriasis (a skin disease - scaly, pink patches). The following side effects have been observed only in individual cases during treatment with Daneb: allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions), rapidly developing swelling, especially around the lips, eyes, 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 side effects (may affect more than 1 in 10 people):slow heart rate, dizziness. Common side effects (may affect up to 1 in 10 people):worsening of heart failure, low blood pressure (e.g., feeling of fainting when standing up quickly), intolerance to the medicine, mild conduction disorders in the heart that affect heart rhythm (first-degree atrioventricular block), swelling of the lower limbs (e.g., swelling of the ankle area).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products (current address, phone number, and fax of the aforementioned Department), e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Daneb

Store in a place inaccessible and invisible to children.

Do not take Daneb after the expiry date stated on the outer and inner packaging . The expiry date refers to the last day of the given month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. You should 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 Daneb contains

The active substance is nebivolol. Each tablet contains 5 mg of nebivolol, which corresponds to 5.45 mg of nebivolol hydrochloride. The other ingredients of the medicine are: lactose monohydrate, crospovidone (type A), poloxamer 188, povidone K-30, microcrystalline cellulose, magnesium stearate

What Daneb looks like and what the pack contains

Daneb tablets are white, round, biconvex, with crossed score lines on one side, approximately 9 mm in diameter. The Daneb tablet can be divided into four equal parts. The tablets are packaged in PVC/PE/PVDC/Aluminum blisters (containing 7, 10, or 14 tablets). Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Manufacturer:

Specifar S.A.
1,28 Octovriou str.
Ag. Varvara
123 51 Athens
Greece
Date of last revision of the leaflet:April 2016