NEBIVOLOLO 5 mg Таблетка

Содержание инструкции

1. Nebivololo Pensa 5 mg tablets
2. Nebivololo
   1. WHAT IS NEBIVOLOL PENSA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL PENSA
   3. HOW TO TAKE NEBIVOLOL PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NEBIVOLOLO PENSA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Nebivololo Pensa 5 mg tablets

Generic medicine

Nebivololo

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Never give it to other people even if their symptoms are the same as yours, because it could be dangerous. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS NEBIVOLOL PENSA AND WHAT IS IT USED FOR

Nebivololo Pensacontains nebivolol which is a selective beta blocker and it dilates blood vessels
(vasodilator). It is used for the treatment of high blood pressure (hypertension).
Nebivololo Pensa is also used to treat chronic heart failure in patients aged 70 years and over.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL PENSA

Do not take Nebivololo Pensa if:

• You are allergic to nebivolol or to any of the excipients of Nebivololo Pensa (listed in section 6)
• You have low blood pressure (if your systolic or “high” blood pressure is less than 90 mmHg)
• You have severe circulation problems in your arms or legs
• You have a very slow heartbeat (less than 60 heartbeats per minute before starting to take this medicine)
• You have been diagnosed with heart conduction diseases (such as sick sinus syndrome or atrioventricular block) and do not have a working pacemaker
• You have acute heart failure, or if you are undergoing treatment by vein (for “via” intravenous) to help the heart's work
• You have severe breathing difficulties or shortness of breath (now or in the past)
• You have a tumor of the adrenal gland called pheochromocytoma
• You have a severe liver disease or impaired liver function
• You have metabolic acidosis (such as in diabetic patients when blood sugar rises too much and the blood becomes too acidic)
• You are using medicines containing floctafenine or sultopride. Warnings and precautionsTalk to your doctor before taking Nebivololo Pensa
• If you have or develop any of the following conditions:
• Heart failure (inability of the heart to pump enough blood for the body's needs)
• A mild (first degree) atrioventricular block of the heart (a type of mild heart conduction disorder that affects the heart rate)
• Chest pain caused by narrowing of the coronary arteries (called Prinzmetal's angina or variant angina)
• Poor circulation in the arms and legs, e.g. Raynaud's disease or syndrome, cramp-like pain while walking
• Prolonged breathing problems
• Diabetes: Nebivololo Pensa has no effect on blood sugar, but may mask the signs of low blood sugar (e.g. tremor, fast heartbeat)
• Hyperactive thyroid gland, as Nebivololo Pensa may mask the signs of an abnormally fast heart rate due to this condition
• Allergy, as allergic reactions may become stronger
• A skin condition called psoriasis, as Nebivololo Pensa may worsen the symptoms
• Use of contact lenses, as Nebivololo Pensa may reduce tear production and make your eyes dry

In these cases, your doctor may need to adjust the treatment or perform checks more frequently.

Children and Adolescents
The use of Nebivololo Pensa is not recommended in children and adolescents under 18 years of age due
to the lack of safety and efficacy data
If you need an operation and require an anesthetic, it is important that you inform your doctor or dentist
that you are taking this medicine
If you have severe kidney problems, do not take this medicine for heart failure and inform your doctor.

Other medicines and Nebivololo Pensa
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Always tell your doctor or pharmacist if you are using or taking any of the following medicines in addition
to Nebivololo Pensa :

• diltiazem or verapamil (used for high blood pressure or other heart problems). During treatment with Nebivololo Pensa ,verapamil should not be injected intravenously
• other medicinal products known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
• other antihypertensive medicines or organic nitrates to treat chest pain
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure
• medicinal products for cardiac arrhythmia (irregular heartbeat) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
• tricyclic antidepressants (for depression), phenothiazines (for psychosis), or barbiturates (for epilepsy)
• medicinal products for diabetes mellitus (insulin and oral preparations)
• digoxin and other so-called digitalis glycosides (to treat heart failure)
• non-steroidal anti-inflammatory pain relievers (NSAIDs) for pain and inflammation - note that low doses of acetylsalicylic acid (e.g. 50 or 100 mg) can be used safely with Nebivololo Pensa
• medicinal products for asthma, nasal congestion or certain eye diseases such as glaucoma (increased pressure in the eye) or pupil dilation
• anesthetics: always inform your anesthesiologist that you are taking Nebivololo Pensa before being anesthetized
• cimetidine (to treat excessive stomach acid) - you should take Nebivololo Pensa during meals, and the antacid medicine in the interval between meals
• medicinal products that affect the metabolism of nebivolol namely terbinafine (for fungal and yeast infections), bupropion (to help quit smoking), chloroquine (for malaria and rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression)
• amifostine (a protective substance during chemo- or radio-therapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial)

Nebivololo Pensa with food and drink
Nebivololo Pensa5 mg tablets can be taken with or without food. The tablet or its parts must
be swallowed with water or other liquid.

Pregnancy and breastfeeding

Pregnancy
Nebivololo Pensa should not be taken during pregnancy unless absolutely necessary

Breastfeeding
Breastfeeding is not recommended during the administration of Nebivololo Pensa
Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines
Studies on the effects on the ability to drive and use machines have not been conducted.
This medicine may cause fatigue or dizziness or fainting as a result of lowering
blood pressure. If this happens DO NOT drive or use machines. These effects are more likely
to occur after the start of treatment or after dose increases (see also section 4).
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Nebivololo Pensacontains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact
him/her before taking this medicine

3. HOW TO TAKE NEBIVOLOL PENSA

Always take Nebivololo Pensaexactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist

Treatment of high blood pressure (hypertension)

• The usual dose is 5mg (one tablet) per day. The dose should be taken preferably at the same time of day
• Elderly patients and patients with kidney disease usually start with 2.5mg (½ tablet) per day
• The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is achieved only after 4 weeks

Treatment of chronic heart failure

• Your treatment will be started and monitored by an experienced doctor.
• Your doctor will start treatment with 1.25mg (¼ tablet) per day. This may be increased after 1-2 weeks to 2.5mg (½ tablet) per day, then to 5mg (1 tablet) per day and then to 10mg (2 tablets) per day until the correct dose for you is reached.
• The maximum recommended dose is 10 mg (2 tablets per day).
• You will need to be monitored for 2 hours by an experienced doctor when you start treatment and each time the dose is increased.
• Your doctor may reduce the dose if necessary, and you should not abruptly stop treatment as this may worsen heart failure.
• Patients with serious kidney problems should not take this medicine.

Take your medicine once a day, preferably at the same time of day.
The doctor may decide to combine your tablets with another medicine for your condition.

Use in children and adolescents
Nebivololo Pensais not recommended in children and adolescents.

If you take more Nebivololo Pensa than you should
If you accidentally take too many tablets (overdose), you may experience a slow heartbeat, low
blood pressure or other heart problems, or difficulty breathing or shortness of breath. Contact the emergency
room of the nearest hospital or inform your doctor or pharmacist immediately. Bring with you the
package with the remaining tablets.

If you forget to take Nebivololo Pensa
If you forget to take your medicine, but remember shortly afterwards, take the next tablet normally, at the time you are supposed to take it. However, if a long delay has occurred (e.g.
the whole day) skip that dose and take the next dose the next day at the usual time and skip the forgotten dose. Do not take a double or higher dose to compensate for the missed dose/s. Repeated omissions should
be avoided.

If you stop taking Nebivololo Pensa
Do not stop taking Nebivololo Pensawithout consulting your doctor first. If the therapy is stopped
abruptly, the patient may experience dangerous worsening of symptoms. This is especially true for
patients with angina pectoris.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nebivololo Pensacan cause side effects, although not everybody gets them.
When Nebivololo Pensais used for the treatment of increased blood pressure, the
possible side effects are:

Common side effects(more than 1 in 100 people treated but less than 1 in 10

treated):

• Headache
• Dizziness
• Fatigue
• An unusual itching or tingling sensation
• Diarrhoea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet

Uncommon side effects (more than 1 in 1,000 people treated but less than 1 in 100

treated):

• Slow heartbeat or other heart problems
• Low blood pressure
• Leg pains similar to cramps while walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depressive feelings
• Difficulty with digestion (dyspepsia), gas in the stomach or intestines, vomiting
• Skin rash, itching
• Wheezing like in asthma, due to sudden cramps of the muscles of the airways (bronchospasm)
• Nightmares

Very rare side effects (less than 1 in 10,000 people treated):

• Fainting
• Worsening of psoriasis (a skin disease - pink scaly patches)

The following side effects have been reported with unknown frequency, only in isolated cases during the
treatment with Nebivololo Pensa:

• allergic reactions involving the whole body, with widespread rash (hypersensitivity reactions)
• Rapidly developing swelling, particularly around the lips, eyes, or swelling of the tongue with possible sudden difficulty breathing (angioedema)
• Pustular eruption (urticaria)

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

Very common side effects(more than 1 in 10 people treated):

• low heart rate
• dizziness Common side effects(more than 1 in 100 people treated but less than 1 in 10treated):
• worsening of heart failure
• low blood pressure (such as feeling faint when getting up quickly)
• intolerance to this medicine
• a type of mild disturbance of heart conduction that affects the heart rate (first-degree AV block)
• swelling of the lower limbs (such as swollen ankles)

Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through your national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE NEBIVOLOLO PENSA

Keep this medicine out of the sight and reach of children.
Do not use Nebivololo Pensa after the expiry date stated on the pack or on the blister foil after
Exp.
The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nebivololo Pensa contains
The active ingredient is nebivolol.
Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
The excipients are:
Lactose monohydrate,
Croscarmellose sodium,
Poloxamer 188,
Povidone K 30,
Microcrystalline Cellulose,
Magnesium Stearate

Description of the appearance of Nebivololo Pensaand contents of the pack
Nebivololo Pensatablets are white, round, biconvex tablets, with a cross engraved on one side,
with a diameter of approximately 9 mm.
Nebivololo Pensa can be divided into equal quarters.
The tablets are available in PVC/PE/PVDC/AL blisters of 7, 10 and 14.
Packs: 28, 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan
Italy

Manufacturer
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara
12351 Athens,
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Denmark: Nebivolol Pensa,
Italy: Nebivololo Pensa