NEBIPHAR 5MG TBL N28

ATC code: C07AB12 

Active substances: Nebivololum

Vendor, principal: Teva Pharmaceutical. 
NEBIPHAR 5MG TBL N28 is compensated medicine in Latvia. 

 Prescription drug (℞) 

NEBIPHAR 5MG N28

Package leaflet: Information for the user

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

1.   What Nebiphar is and what it is used for

Nebiphar contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes as well to lower blood pressure
Nebiphar is used for the treatment of patients with:
•   high blood pressure (hypertension)
•   mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies.

2.   What you need to know before you take Nebiphar Do not take Nebiphar

•   if you are allergic to nebivolol hydrochloride or any of the other ingredients of this medicine (listed in section 6)
•   if you have problems with your liver
•   if you suffer from heart failure, which has just occurred or which has recently become worse, or if you are receiving treatment for circulatory shock due to acute heart failure by intravenous drip feed to help your heart work
•   if you suffer from heart rhythm disorders (such as sick sinus syndrome including sino-atrial block)
•   if you suffer from heart conduction disorders (such as second and third degree heart block and do not have a pacemaker)
•   if you have asthma or have ever suffered from difficulty in breathing or wheezing
•   if you have severe chronic obstructive pulmonary disease
•   if you have high blood pressure, flushing or diarrhoea caused by an untreated tumor of the adrenal medulla (phaeochromocytoma)
•   if you have a metabolic disorder where there is a change in the acid/base balance of the body (metabolic acidosis)
•   if you have a slow heart rate (less than 60 beats per minute before you start taking this medicine)
•   if you have low blood pressure (systolic blood pressure less than 90 mmHg)
•   if you have poor circulation in the arms or legs
•   If you are treated with floctafenine (used for relieving pain and swelling) or sultopride (use for treating nervous system disorders) (see section ‘Other medicines and Nebiphar’).

Warnings and precautions

Talk to your doctor before taking Nebiphar:
•   if you are to have an operation requiring an anaesthetic, your doctor may ask you to stop taking this medicine 24 hours before your operation
•   if you suffer from congestive heart failure which is not being treated or has not been stabilised
•   if you find your heart rate slows down while taking Nebiphar
•   if you suffer from circulation problems in the arms or legs (such as Raynaud's disease or syndrome, intermittent claudication), these may become worse when you take Nebiphar
•   if you    suffer from first degree heart block
•   if you    suffer from heart chest pain at rest that occurs in cycles    (Prinzmetal’s angina). Nebivolol
may increase the duration of the chest pain and the number of times it occurs
•   if you are diabetic, as nebivolol may hide the symptoms of low blood sugar (hypoglycaemia)
•   if you suffer thyroid problems, as nebivolol may hide the symptoms of high heart rate (tachycardia); these symptoms may become worse if you suddenly stop taking Nebiphar
•   If you    have patches of thickened and sore skin (psoriasis)
•   If you    suffer from allergic reactions, as nebivolol may increase the severity    of these reactions
•   In patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction may be aggravated.
•   if you suffer from prolonged breathing problems.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by an
experienced physician (see section 3). This treatment should not be stopped abruptly unless clearly
indicated and evaluated by your doctor (see section 3).

Other medicines and Nebiphar

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Nebiphar with the following medicinal products:
•   Floctafenine (used for relieving pain and swelling)
•   Sultopride (used to treat nervous system disorders).
Talk to your doctor if you are taking any of the following:
•   medicines used to treat heart rate rhythm disorders such as quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone and amiodarone
•   medicines known as calcium channel antagonists which slow the heart rate and lower blood pressure such as verapamil and diltiazem
•   medicines known as centrally-acting antihypertensives such as clonidine, guanfacin, moxonidine, methyldopa and rilmenidine
•   anaesthetics
•   insulin and oral antidiabetic drugs
•   medicines used to treat congestive    heart failure such as digitalis glycosides
•   medicines known as dihydropyridine calcium antagonists such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine and nitrendipine
•   other antihypertensive medicinations or organic nitrates that treat chest pain
•   antipsychotics (such as phenothiazines) and antidepressants (such as fluoxetine or imipramine), these may increase the blood pressure lowering effect of nebivolol
•   medicines to relieve pain and inflammation such as non steroidal anti-inflammatory drugs
•   medicines know as sympathicomimetic agents that mimic or block the action of norepinephrine and epinephrine in the body
•   medicines known to inhibit the cytochrome P450 isoenzyme CYP2D6, such as paroxetine, fluoxetine, thioridazine, quinidine, terbinafine, bupropion, chloroquine and levopromazine
•   cimetidine, a medicine used to treat peptic ulcers
•   medicines used to treat high blood pressure and angina such as nicardipine.
•   amifostine, a protecting substance used during chemo or radiation therapy.
•   baclofen, a muscle relaxant.
•   mefloquine, an antimalarian drug.

Nebiphar with food and drink

Nebiphar can be taken with meals.

Pregnancy and breast-feeding

Nebiphar should not be taken during pregnancy or while breast-feeding.
Breast-feeding is not recommended during administration of Nebiphar.
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 this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects of nebivolol on the ability to drive and use machines have been performed. Nebiphar may cause dizziness and fatigue. If this happens to you, do not drive or take on activities where impaired alertness may put you or others at risk of serious injury or death (e.g. operating machines) until the dizziness and fatigue has disappeared.

Nebiphar contains lactose

Patients who are intolerant to lactose should note that Nebiphar tablets contain 142.21 mg of 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 Nebiphar

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration:
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food. The tablet can be divided into equal doses.
If you have been told by your doctor to take V (quarter) or V (half) tablet daily, please refer to the instructions below on how to break Nebiphar cross-scored tablets.
•   Place the tablets onto a flat, hard surface (e.g. a table or worktop), with the cross score facing
^up.
•   Break the tablet by pushing it with the index fingers of both hands placed along one breakmark (Diagrams 1 and 2).
•   Tablet quarters are obtained by breaking the halves in the same way (Diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet in half.

Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored tablet into quarters. Hypertension

Adults
The recommended dose is 5 mg (one tablet) daily, preferably at the same time of the day.
The blood pressure lowering effect becomes evident after 1 -2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.
Combination with other antihypertensive agents
Beta-blockers can be used alone or concomitantly with other antihypertensive agents. To date, an additional antihypertensive effect has been observed only when nebivolol is combined with hydrochlorothiazide 12.5/25 mg.
Patients with kidney problems
If you have kidney problems, the recommended starting dose is 2.5 mg daily (half a tablet). If needed your doctor will increase your daily dose to 5 mg.
Patients with liver problems
Patients with serious liver problems should not take this medicine.
Older people
If you are over 65 years old, the recommended starting dose is 2.5 mg daily (half a tablet). If needed, your doctor will increase your daily dose to 5 mg. If you are over 75 years old, your doctor will monitor you carefully whilst you are on this medication.
Use in children and adolescents
Nebiphar is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Chronic heart failure
Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment.
Adults
The initial dose is 1.25 mg (quarter of a tablet) per day. The dose may be increased until the correct dose is reached for you. The dose may be increased after 1-2 weeks to 2.5 mg (half a tablet) per day, then to 5 mg (one tablet) per day and then to 10 mg (2 tablets) per day. The maximum recommended dose is 10 mg (two tablets) nebivolol once daily. You will need to be under the close supervision for 2 hours by an experienced physician when you start treatment and every time your dose is increased.
Patients with kidney problems
In patients with mild to moderate kidney problems no dose adjustment is required as your dose will be tailored to what you need. Nebiphar is not recommended for patients with severe kidney problems.
Patients with liver problems
Patients with serious liver problems should not take this medicine..
Older people
No adjustment of your dose is required as you will be carefully monitored to determine what dose you need by your physician.
Use in children and adolescents
Nebiphar is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
If you stop taking Nebiphar
The treatment with nebivolol is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased, divided into halves weekly.

If you take more Nebiphar than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
The most frequent symptoms and signs of a nebivolol overdose are very slow heart beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Nebiphar

If you forget a dose of Nebivolol, but remember a little later on that you should have taken it, take that day’s dose as usual. However, if a long delay has occurred (e.g. for several hours), so that the next due dose is near, skip the forgotten dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose. Repeated skipping, however, should be avoided.

If you stop taking Nebiphar

Do not stop taking Nebiphar without talking to your doctor. Suddenly stopping this medicine may make your condition worse; therefore your doctor will gradually reduce your dose. Contact your doctor if your symptoms get worse when you stop taking Nebiphar or if you have any further questions on the use of this product.
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 following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
•   headache or dizziness
•   tingling or numbness in the hands and feet
•   shortness of breath
•   constipation, nausea or diarrhoea
•   tiredness or water retention (oedema or swelling).
Uncommon (may affect up to 1 in 100 people):
•   slow heart beat or other heart complaints
•   heart conduction disorder that affects heart rhythm (1st degree AV-block)
•   heart problems which may cause shortness of breath or ankle swelling
•   problems with vision
•   difficulty in breathing or wheezing
•   indigestion, flatulence or vomiting
•   itching, rash or redness of the skin
•   low blood pressure
•   cramp like pain in the calves brought on by exercise.
•   impotence (erectile dysfuntion)
•   nightmares
•   depression
•   In a clinical study for chronic heart failure, the side effects seen were slow heart beat, dizziness, worsening of heart failure, low blood pressure (such as feeling faint when getting up quickly), inability to tolerate medicine, irregular heart beat, swelling (such as swollen ankles).
Very rare (may affect up to 1 in 10,000 people):
•   fainting
•   worsening of psoriasis (skin rash).
Not known (cannot be estimated from the available data)
Other side effects that have been reported include hives, swelling of the face, tongue, lips and throat with possible difficulty to breathe or swallow and allergic reactions (hypersensitivity). If this happens
stop taking Nebiphar and contact your doctor immediately
The following adverse reactions have also been reported with some similar medicines (beta adrenergic antagonists): seeing and hearing thing that are not real (hallucinations), psychoses, confusion, your fingers or toes turn white or blue with a feeling of numbness; poor circulation in the arms or legs, e.g. Raynaud’s phenomenon, dry eyes, scarring, fibrosis and shrinkage of the lining inside of eyelids, scaling rash and ear inflammation (oculomucocutaneous syndrome).

Reporting of side effects

If you get any of the 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 Nebiphar
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 blister foil and carton. 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 of 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 Nebiphar contains
The active substance is nebivolol (as hydrochloride). Each tablet contains 5 mg nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
The other ingredients are lactose monohydrate, maize starch, croscarmellose sodium, cellulose microcrystalline, hypromellose (E464), silica colloidal anhydrous and magnesium stearate.
What Nebiphar looks like and contents of the pack
Nebivolol 5 mg is a white to off-white, round, biconvex tablet, with quartering lines on one side and plain on the other.
Tablets are provided in PVC-PVDC/Aluminium clear/transparent blisters. Pack sizes: 7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500 and 50 x 1 unit dose blisters (hospital pack).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Teva Pharma B.V.
Swensweg 5 2031 GA Haarlem The Netherlands
Manufacturers
TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary TEVA UK Ltd., Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, UK. Pharmachemie BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.
Teva Operations Poland Sp.z.o.o., Mogilska 80 Street, 31-546 Krakow Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonian branch UAB Sicor Biotech Estonian branch Hallivanamehe 4
11317 Tallinn Phone: +372 661 0801
This leaflet was last revised in August 2017.