NEBIVOLOL RPH 5MG N28

ATC code: C07AB12 

Active substances: Nebivololum

Vendor, principal: Ratiopharm. 
NEBIVOLOL RPH 5MG N28 is compensated medicine in Latvia. 

 Prescription drug (℞) 

NEBIVOLOL ACTAVIS 5MG N28

Package leaflet: Information for the user

Nebivolol Actavis 5 mg tablets

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    only.    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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.   What Nebivolol Actavis is and what it is used for
2.   What you need to know before you take Nebivolol Actavis
3.   How to takeNebivolol Actavis
4.   Possible side effects
5.   How to store Nebivolol Actavis
6.   Contents of the pack and other information

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

Nebivolol Actavis is a medicinal product that mainly acts on the function of your heart (beta-blocker).
It decreases the blood pressure and improves the heart power.
Nebivolol Actavis is used
•   for the treatment of high blood pressure (essential hypertension)
•   in addition to standard therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists) for the treatment of stable mild or moderate chronic heart failure in patients aged 70 years or over.

2.   What you need to know before you take Nebivolol Actavis

Do not take Nebivolol Actavis

-   if you are allergic to the active substance nebivolol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
-   if you have liver function disorders or impaired liver function (hepatic insufficiency),
-   if you are pregnant or breast-feeding,
-   if you suffer from acute heart failure, cardiogenic shock or episodes of worsening heart failure (decompensation), which requires intravenous treatment with inotropic active substances,
-   if you suffer from sinus syndrome (a certain type of disturbance in heart rhythm) including sino-arterial block (SA block),
-   if you suffer from certain heart conduction disorders (2^nd and 3^rd degree heart block - AV block [without pacemaker]),
-   if you have a history of bronchial spasm and bronchial asthma,
-   if you suffer from untreated adrenal gland tumours (phaeochromocytoma),
-   if you suffer from hyperacidity of the blood (metabolic acidosis),
-   if you have a heart rate (pulse rate) at rest before treatment of less than 60 beats per minute lying down (bradycardia),
-   if you have a pathologically low blood pressure (systolic blood pressure < 90 mmHg),
-   if you have seriously poor circulation in the limbs.
If you are unsure, contact your doctor.

Warnings and precautions

Talk to you doctor or pharmacist before taking Nebivolol Actavis
-   if the pulse is unusually low (less than 50 - 55 beats per minute at rest and/or symptoms such as dizziness, weakness and unsteady gait) during treatment with nebivolol,
-   if you are suffering from heart disease (e.g. angina pectoris, ischaemic heart disease, heart rhythm disorders); in patients with ischaemic heart disease, treatment should be stopped gradually, i.e. over the course of 1 - 2 weeks, and if necessary alternative treatment should be started at the same time,
-   if you have circulatory problems in your arms or legs,
-   if you suffer from constant respiratory problems, especially chronic obstructive airway disease,
-   if you have diabetes. Nebivolol Actavis does not affect the blood sugar level but it may mask signs of low blood sugar (nervousness, shaking, fast pulse). Sweating as symptom is however not masked by Nebivolol Actavis.
-   if you have an overactive thyroid gland: possible masking of an increased pulse (tachycardia) as a sign of disease; abruptly stopping medication with Nebivolol Actavis can lead to an increased heart rate,
-   if you have an allergy. Nebivolol Actavis may intensify the reaction against pollen or other items that you are allergic to.
-   if you suffer from psoriasis: patients with existing psoriasis or a known history of the disorder should only take Nebivolol Actavis after the benefits and risks have been carefully weighed,
-   Nebivolol Actavis can reduce the flow of tears (for information if you are wearer of contact lenses).
Children and adolescents
No studies have been conducted in children and adolescents. Therefore, the use in children and adolescents below 18 years is not recommended.
Elderly people
In patients over 65 years of age a lower starting dose is recommended (see section “How to take Nebivolol Actavis”).
In patients over 75 years of age, special care should be taken and treatment should be closely monitored by the doctor.

Other medicines and Nebivolol Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This applies particularly for:
-   some medicines for the treatment of heart rhythm disorders (class I anti-arrhythmics such as quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, mexiletine, propafenone and lidocain as well as amiodarone) can increase the depressant effects of nebivolol on cardiac activity when taken at the same time as nebivolol.
-   certain medicines against high blood pressure and cramps of the blood vessels of the heart (so-called calcium antagonists) which may increase the effect of Nebivolol Actavis (e.g. verapamil and diltiazem, or amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine and nitrendipine).
-   other centrally acting medicines against high blood pressure (clonidine, guanfacin, moxonidine, methyldopa, rilmenidine) may increase the risk of a strong rise in blood pressure (“rebound hypertension”) - especially after abrupt withdrawal of these medicines when taken for a long time. They may only be withdrawn if the beta-blocker (e.g. nebivolol) has been stopped a few days before.
-   if beta-receptor blockers and digitalis glycosides are used at the same time, a certain disturbance of cardiac activity may occur (prolonged conduction time).
However, clinical studies with nebivolol have not shown any evidence of this interaction. Nebivolol did not influence the blood concentration of digoxin.
-   certain medicines against asthma, stuffed nose or certain eye diseases (so-called sympathomimetics) which may reduce the effect of Nebivolol Actavis (e.g. dopamine, ephedrine).
-   medicines against diabetes (insulin and medicines for oral use). See also “Take special care with Nebivolol Actavis”.
-   baclofen (used to treat muscle spasm) and amifostine (used during cancer chemotherapy): may increase the fall in blood pressure. Your doctor might adjust your dose of Nebivolol Actavis.
-   anaesthetics: always inform the anaesthetist that you take Nebivolol Actavis before narcosis.
-   certain antipsychotics may increase the effect of Nebivolol Actavis.
Simultaneous treatment with agents for treating depression (tricyclic antidepressants, paroxetine), barbiturates (e.g. for the treatment of epilepsy), sedatives (phenothiazines, e.g. thioridazin), organic nitrates (treatment of angina and heart failure) and other medicinal products against high blood pressure may lead to a sharp drop in blood pressure.
-   if serotonin-reuptake inhibitors (certain agents for depression, e.g. paroxetine and fluoxetine) are administered at the same time as Nebivolol Actavis the doctor may need to adjust the dose.
-   certain medicines, that are metabolised in a similar way as nebivolol, may lead to increased blood levels of nebivolol, associated with increased adverse events. Some of these are e.g. bupropion (antidepressant), chloroquin (used for the prevention of malaria and for the treatment of autoimmune diseases like rheumatoid arthritis), levomepromazin (neuroleptic agent) and terbinafine (antifungal).
If you in addition to Nebivolol Actavis also take an antacid against excess of acid in the stomach, you should take Nebivolol Actavis with food and the antacid between the meals.

Nebivolol Actavis with food and drink

You can take Nebivolol Actavis with food and drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There is a risk that the foetus is affected. Therefore, do not use Nebivolol Actavis during pregnancy. Breast-feeding
It is not known whether Nebivolol Actavis is excreted in breast milk. Therefore, do not use Nebivolol Actavis during breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.
Dizziness or fatigue may occasionally occur as an adverse reaction of Nebivolol Actavis. Take this into consideration when you drive a car or use machines (see section 4 “Possible side effects”).

Nebivolol Actavis contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Nebivolol Actavis

Always take this medicineexactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Hypertension

Adults:
The usual dose is 1 tablet per day (5 mg nebivolol). It usually takes 1 to 2 weeks before the maximum effect of Nebivolol Actavis is achieved.
Combination with other antihypertensive medicines:
Beta-receptor blockers can be used alone or in combination with other antihypertensive medicines.
To date, an added antihypertensive effect has only been observed in the combination of 5 mg nebivolol with 12.5 - 25 mg of the active substance hydrochlorothiazide.
Patients with impaired kidney function (renal insufficiency):
In patients with renal insufficiency, the recommended starting dose is 54 a tablet (2.5 mg nebivolol) daily. If necessary, the daily dose can be increased to 1 tablet (5 mg nebivolol).
Patients with impaired liver function (hepatic insufficiency):
Not enough experience has been gained in the use of Nebivolol Actavis in patients with impaired liver function or disorders of liver function. For this reason, Nebivolol Actavis must not be used in these patients (see “Do not take Nebivolol Actavis”).
Elderly patients:
In patients aged 65 or more, the recommended starting dose is 54 a tablet (2.5 mg nebivolol) daily. If necessary, the daily dose can be increased to 1 tablet (5 mg nebivolol). In all cases, special care should be taken and treatment should be closely monitored in view of the limited experience in patients over 75 years of age.
Use in children and adolescents:
No studies have been conducted in children and adolescents. Therefore, the use in children and adolescents below 18 years is not recommended.

Chronic heart failure

The treatment of stable chronic heart failure must be started with a slow increase in dose, until the optimum individual maintenance dose has been reached.
In patients taking other cardiovascular medicines such as diuretics, digoxin, ACE inhibitors or angiotensin II antagonists, the dosage of these medicines must be stabilized before treatment with Nebivolol Actavis is started.
The initial dose titration should be as follows with adjustments every one or two weeks, depending on how the dose is tolerated by the patient:
-   5% tablet (1.25 mg nebivolol) once daily,
-   increased to 54 tablet (2.5 mg nebivolol) once daily,
-   then to 1 tablet (5 mg nebivolol) once daily and
-   then to 2 tablets (10 mg nebivolol) once daily.
The recommended maximum dose is 2 tablets (10 mg nebivolol) once a day.
The patient should be monitored during the first 2 hours after taking the first dose and during the first 2 hours after each dose increase to make sure the clinical condition has remained stable.
Patients with impaired kidney function (renal insufficiency):
Since the dose is increased individually up to the maximum tolerated dose, no adjustment is necessary in patients with mild to moderate renal insufficiency. There is no experience in patients with severe renal insufficiency, therefore the use of nebivolol in these patients is not recommended.
Patients with impaired liver function (hepatic insufficiency):
Not enough experience has been gained in patients with impaired liver function. Nebivolol Actavis must therefore not be used in these patients (see “Do not take Nebivolol Actavis”).
Elderly patients:
Since the dose is increased individually up to the maximum tolerated dose, no adjustment is necessary.
Use in children and adolescents:
No studies have been conducted in children and adolescents. Therefore, the use in children and adolescents below 18 years is not recommended.
Mode of administration:
The prescribed daily dose should preferably always be taken at the same time of day.
The tablets should be swallowed with a sufficient amount of liquid (e.g. one glass of water) with or without meals.
If you feel that the effect of Nebivolol Actavis is too strong or too weak, contact your doctor or pharmacist.

If you take more Nebivolol Actavis than you should

The symptoms of an overdose are: slow heartbeat, low blood pressure, breathing difficulties and sudden (acute) heart problems.
Contact you doctor if you have taken more Nebivolol Actavis than you should.
You should lie down with your legs higher than the heart.

If you forget to take Nebivolol Actavis

If you have forgotten to take your medicine one day, then continue the medication next day at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Nebivolol Actavis

Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
When treatment is interrupted or ended early the blood pressure can rise or the heart problems will increase.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed are listed below, arranged according to frequencies.
The following side effects may occur:

In patients with high blood pressure

Common (affects 1 to 10 users in 100)
Headache, dizziness, tingling skin, difficulty breathing, constipation, nausea, diarrhoea, tiredness, swelling with water retention (oedema)
Uncommon (affects 1 to 10 users in 1,000)
Nightmares, depression, visual disturbances, unusually low heart rate (slow pulse), weak cardiac performance, conduction defects in the heart, low blood pressure (hypotension), occurrence of or increase in pain occurring in the feet when walking due to narrowed arteries and insufficient blood circulation (intermittent claudication), wheezing or shortness of breath (bronchospasm), indigestion, flatulence, vomiting, itching, skin rash, impotence
Very rare (affects less than 1 user in 10,000)
Fainting (syncope), worsening of psoriasis
Not known (frequency cannot be estimated from the available data)
Swelling of face, lips, throat or tongue (angioneurotic oedema), allergy (hypersensitivity), itchy skin rash (hives).
The following side effects have also been reported with similar medicines: hallucinations, psychotic reactions (psychoses), confusion, cold/bluish-red discoloration of the arms and legs, pain in fingers and toes which first turn bluish, then whitish, and finally reddish (Raynaud’s syndrome), dry eyes and also formation of new connective tissue in the eyes and the diaphragm (practolol-type oculo-mucocutaneous toxicity).

In patients with chronic heart failure

Very common (affects more than 1 user in 10)
Dizziness, unusually low heart rate (slow pulse)
Common (affects 1 to 10 users in 100)
Headache, worsening of heart failure, heart rhythm disorder (called first degree AV-block), fall in blood pressure on standing up (postural hypotension), tiredness/weakness, drug intolerance, water retention (oedema) in the legs, reduction of pulse, fall in blood pressure

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nebivolol Actavis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, HDPE tablet container or blister 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 throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nebivolol Actavis contains

-   The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
-   The other ingredients are silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, macrogol 6000 and lactose monohydrate

What Nebivolol Actavis looks like and contents of the pack

Round, white, convex, 9 mm cross-scored tablets, marked with ‘N 5’ on the other side.
The tablets can be divided into equal halves and quarters.
Pack sizes:
Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 and hospital pack with 500 (10x50) tablets HDPE tablet container: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 and hospital pack with 500 (10x50) tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Actavis Group PTC ehf.,
Reykjavikurvegi 76-78,
220 Hafnarf)0röur,
Iceland
Manufacturers:
Actavis ehf.,
Reykjavikurvegi 78,
IS-220 Hafnarfj0röur,
Iceland
Actavis Ltd.,
BLB016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
Balkanpharma Dupnitsa AD,
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB Sicor Baltics Estonian Branch,
UAB Sicor Biotech Eesti filiaal Hallivanamehe 4 11317 Tallinn Tel: +372 661 0801

This leaflet was last revised in August 2018.