Daneb
Poland
Table of Contents
Package leaflet: Information for the patient
Daneb, 5 mg, tablets
Nebivololum
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:
- What Daneb is and what it is used for
- Important information before taking Daneb
- How to take Daneb
- Possible side effects
- How to store Daneb
- Contents of the pack and other information
1. What Daneb is and what it is used for
Daneb contains nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of medicines called selective beta-adrenolytics (i.e. selectively affecting the cardiovascular system). It prevents the heart from beating too fast and controls the force of heart contractions. It also dilates blood vessels, which helps lower blood pressure.
Daneb is used to treat high blood pressure (hypertension).
It is also used in the treatment of mild to moderate chronic heart failure, as an addition to standard therapy in patients aged 70 years and older.
2. Important information before using Daneb
When not to use Daneb
- if the patient has a known hypersensitivity (allergy) to nebivolol or any of the other ingredients of Daneb (listed in section 6)
- if the patient has one or more of the following conditions:
- low blood pressure,
- severe circulatory disorders in the upper or lower limbs,
- very slow heart rate (less than 60 beats per minute),
- certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders),
- heart failure which has recently developed or worsened, or if the patient is receiving intravenous drugs to support heart function due to cardiogenic shock in acute heart failure,
- asthma or wheezing (currently or in the past),
- untreated phaeochromocytoma – a tumour located in the upper part of the kidney (adrenal gland),
- liver function disorders,
- metabolic disorders (metabolic acidosis), e.g. ketoacidosis in diabetes.
Warnings and precautions
Before starting treatment with Daneb, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or develops any of the following conditions:
- abnormally slow heart rate,
- chest pain caused by spontaneous spasm of the coronary arteries (Prinzmetal's angina),
- untreated chronic heart failure,
- first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm),
- circulatory disorders in the hands or feet, e.g. Raynaud’s disease or syndrome, cramping pain while walking,
- persistent breathing difficulties,
- diabetes – Daneb does not affect blood glucose levels, but it may mask warning symptoms of low blood sugar (e.g. palpitations, rapid heartbeat), and may increase the risk of severe hypoglycaemia when used with certain types of antidiabetic drugs called sulfonylureas (such as gliclazide, glimepiride, glipizide, glyburide, tolbutamide, or glibenclamide),
- hyperthyroidism – Daneb may mask symptoms of abnormally rapid heartbeat associated with this condition,
- allergies – Daneb may intensify reactions to pollen or other allergens,
- psoriasis (a skin disease characterized by scaly, red patches) or history of psoriasis,
- planned surgical procedure – inform the anaesthetist about taking Daneb before anaesthesia.
Daneb should not be used in patients with severe renal impairment for the treatment of heart failure; discuss this with your doctor.
The patient's condition with chronic heart failure will be monitored by an experienced physician at the beginning of treatment (see section 3).
Do not stop treatment suddenly unless explicitly advised by your doctor (see section 3).
Children and adolescents
Daneb is not recommended for use in children and adolescents due to lack of data on safety and efficacy in this age group.
Daneb and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Always inform your doctor or pharmacist if the patient is taking any of the following medicines together with Daneb:
- Medicines used to treat high blood pressure or heart conditions (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).
- Sedatives and antipsychotic medicines (used in psychiatric disorders), e.g. barbiturates (also used in epilepsy), phenothiazines (also used for nausea and vomiting), thioridazine.
- Antidepressant medicines, e.g. amitriptyline, paroxetine, fluoxetine.
- Medicines used for anaesthesia during surgery.
- Medicines used for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure) or to dilate the pupil.
- Baclofen (a muscle relaxant), amifostine (a protective agent used during cancer treatment).
- Medicines for diabetes, such as insulin or oral antidiabetic drugs.
All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.
- Medicines used for acid reflux or peptic ulcer disease (medicines that reduce stomach acid secretion), e.g. cimetidine – Daneb should be taken with food, and antacids should be taken between meals.
Daneb with food and drink
Daneb may be taken with or without food.
The tablet or its divided parts should be swallowed with water or another liquid.
Pregnancy and breastfeeding
Pregnancy
Daneb should not be used during pregnancy unless clearly necessary.
Breastfeeding
Breastfeeding is not recommended while taking Daneb.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
No studies have been conducted on the effect of Daneb on the ability to drive or operate machinery.
The medicine may cause dizziness or fainting due to lowering of blood pressure. If such symptoms occur, DO NOT drive or operate machinery. These symptoms are more likely at the beginning of treatment or after a dose increase (see also section 4).
Daneb contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, he/she should consult a doctor before taking this medicine.
3. How to use Daneb
Daneb should always be taken exactly as directed by the physician. In case of doubt, consult your doctor or pharmacist again.
Treatment of high blood pressure (hypertension)
The usual dose is 5 mg (1 tablet) once daily. It is recommended to take the dose at the same time each day.
For elderly patients and patients with impaired kidney function, the initial dose is usually 2.5 mg (1/2 tablet) once daily.
The blood pressure-lowering effect becomes apparent after 1–2 weeks of treatment. Sometimes optimal effect is achieved only after 4 weeks.
Treatment of chronic heart failure
Treatment must be initiated and monitored by an experienced physician.
The physician will start treatment with a dose of 1.25 mg (1/4 tablet) once daily. This dose may be increased after 1–2 weeks to 2.5 mg (1/2 tablet) once daily, then to 5 mg (1 tablet) once daily, and finally to 10 mg (2 tablets) once daily, until the appropriate dose for the patient is reached.
The maximum recommended dose is 10 mg (2 tablets per day).
An experienced physician will monitor the patient’s condition for 2 hours after initiation of treatment and after each dose increase.
If necessary, the physician may reduce the dose; do not stop treatment suddenly, as this may worsen heart failure.
Daneb must not be used in patients with severe kidney impairment.
The medicine should be taken once daily, preferably at the same time each day.
The physician may recommend concomitant use of another medicine, depending on the patient's condition.
Use of Daneb is not recommended in children and adolescents.
Overdose of Daneb
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist. The most common subjective and objective symptoms of Daneb overdose are: very slow heart rate (bradycardia), low blood pressure which may cause fainting (hypotension), shortness of breath resembling that seen in bronchial asthma, and acute heart failure.
The patient may take activated charcoal (available in pharmacies) while waiting for medical assistance.
Missed dose of Daneb
If the patient forgets to take the medicine but remembers shortly afterwards, the next tablet should be taken at the usual time. However, if a significant delay has occurred (e.g., a full day), the missed dose should be skipped and the next dose taken at the usual time the following day. Do not take a double or higher dose to make up for a missed dose. Repeated missed doses should be avoided.
Stopping Daneb treatment
Always consult your doctor before stopping Daneb, regardless of whether it is being used to treat high blood pressure or chronic heart failure.
Do not stop taking the medicine suddenly, as this may lead to a temporary worsening of heart failure symptoms.
If treatment with Daneb needs to be discontinued, the dose should be gradually reduced by half, at weekly intervals.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, Daneb may cause adverse reactions, although not everyone experiences them.
Adverse reactions that may occur when using Daneb for the treatment of high blood pressure:
Common adverse reactions (may affect up to 1 in 10 patients):
headache
dizziness
fatigue
unusual sensation of itching or tingling
diarrhea
constipation
nausea
shortness of breath
swelling of hands or feet.
Uncommon adverse reactions (may affect up to 1 in 100 patients):
slow heart rate or other heart-related disorders
low blood pressure
cramping leg pain during walking
vision disturbances
impotence (difficulty achieving erection)
depressive mood
digestive disorders (dyspepsia), bloating, vomiting
skin rash, itching
asthma-like shortness of breath caused by sudden contraction of airway muscles (bronchospasm)
nightmares.
Very rare adverse reactions (may affect up to 1 in 10,000 patients):
fainting
worsening of psoriasis (skin disease – scaly, pink patches)
The following adverse reactions have been observed only in individual cases during treatment with Daneb:
generalized allergic reactions involving the whole body, with widespread skin changes (hypersensitivity reactions)
rapid-onset swelling, particularly around the lips, eyes, or tongue, possibly leading to sudden breathing difficulties (angioedema)
a type of skin rash characterized by pale red, raised, itchy wheals, resulting from allergy or non-allergic causes (urticaria).
In a clinical trial concerning chronic heart failure, the following adverse reactions were observed:
Very common adverse reactions (may affect more than 1 in 10 patients):
slowing of heart function
dizziness.
Common adverse reactions (may affect up to 1 in 10 patients):
worsening of heart failure
low blood pressure (e.g., feeling faint when standing up quickly)
drug intolerance
mild disturbances in cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
swelling of lower limbs (e.g., ankle swelling)
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone and fax number of the above Department}, e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Daneb medicine
Keep out of the reach and sight of children.
Do not use Daneb after the expiry date stated on the outer and immediate packaging.
The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. 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, equivalent to 5.45 mg of nebivolol hydrochloride.
Other ingredients of the medicine are:
Monohydrate lactose
Crospovidone (type A)
Poloxamer 188
Povidone K-30
Microcrystalline cellulose
Magnesium stearate
What Daneb looks like and contents of the pack
Daneb tablets are white, round, biconvex, with crossed grooves dividing the tablet on one side, approximately 9 mm in diameter.
Daneb tablets can be divided into four equal parts.
The tablets are packed in blisters made of PVC/PE/PVDC/Aluminium (containing 7, 10 or 14 tablets).
Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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