Nebivololo PensA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nebivololo Pensa 5 mg tablets

Generic medicine
Nebivololo
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including any 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 taking 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 NEBIVOLOLO PENSA IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING NEBIVOLOL PENSA

Do not take Nebivolol Pensa if:

• You are allergic to nebivolol or to any of the excipients of Nebivolol Pensa (listed in section 6)
• You have low blood pressure (if your systolic or "high" blood pressure is below 90 mmHg)
• You have severe circulation problems in arms or legs
• You have a very slow heart rate (less than 60 beats per minute before starting this medicine)
• You have been diagnosed with heart conduction disorders (such as sick sinus syndrome or atrioventricular block) and do not have a functioning pacemaker
• You have acute heart failure, or are receiving intravenous (i.v.) treatment to support heart function
• You have severe breathing difficulties or shortness of breath (currently or in the past)
• You have a tumor of the adrenal gland called phaeochromocytoma
• You have severe liver disease or impaired liver function
• You have metabolic acidosis (such as in diabetic patients when blood sugar is too high and blood becomes too acidic)
• You are taking medicines containing floctafénine or sultopride

Warnings and precautions
Talk to your doctor before taking Nebivolol Pensa if:

• You have or develop any of the following conditions:
  • Heart failure (inability of the heart to pump enough blood to meet the body's needs)
  • Mild (first-degree) atrioventricular heart block (a mild type of heart conduction disorder affecting heart rhythm)
  • Chest pain caused by narrowing of the coronary arteries (called Prinzmetal’s or variant angina)
  • Poor circulation in arms and legs, e.g. Raynaud’s disease or syndrome, cramp-like pain when walking
  • Long-standing breathing problems
  • Diabetes: Nebivolol Pensa has no effect on blood sugar, but may mask signs of low blood sugar (e.g. tremor, rapid heartbeat)
  • Overactive thyroid gland, as Nebivolol Pensa may mask symptoms of abnormally fast heart rate due to this condition
  • Allergies, as allergic reactions may become more severe
  • A skin condition called psoriasis, as Nebivolol Pensa may worsen symptoms
  • Use of contact lenses, as Nebivolol Pensa may reduce tear production and cause dry eyes

In these cases, your doctor may need to adjust your treatment or perform more frequent monitoring.

Children and Adolescents
The use of Nebivolol Pensa is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

If you need surgery and require an anaesthetic, 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 Nebivolol Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.

Always inform your doctor or pharmacist if you are using or taking any of the following medicines in addition to Nebivolol Pensa:

• Diltiazem or verapamil (used for high blood pressure or other heart problems). During treatment with Nebivolol Pensa, verapamil must not be administered intravenously.
• Other medicines known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipina, nimodipine, nitrendipine
• Other antihypertensive medicines or organic nitrates for chest pain
• Clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure
• Medicines 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)
• Medicines for diabetes mellitus (insulin and oral preparations)
• Digoxin and other so-called digitalis glycosides (to treat heart failure)
• Non-steroidal anti-inflammatory analgesics (NSAIDs) for pain and inflammation – note that low-dose daily antiplatelet aspirin (e.g. 50 or 100 mg) can be safely used with Nebivolol Pensa
• Medicines for asthma, nasal congestion, or certain eye diseases such as glaucoma (increased pressure in the eye) or pupil dilation
• Anaesthetics: always inform your anaesthetist that you are taking Nebivolol Pensa before receiving anaesthesia
• Cimetidine (used to treat excessive stomach acidity) – Nebivolol Pensa should be taken with meals, and the antacid taken between meals
• Medicines that affect the metabolism of nebivolol, namely terbinafine (for fungal and yeast infections), bupropion (to help stop smoking), chloroquine (for malaria and rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression)
• Amifostine (a protective agent during chemo- or radiotherapy)
• Baclofen (a muscle relaxant)
• Mefloquine (an antimalarial)

Nebivolol Pensa with food and drink
Nebivolol Pensa 5 mg tablets can be taken with or without food. The tablet or parts of the tablet should be swallowed with water or another liquid.

Pregnancy and breastfeeding
Pregnancy
Nebivolol Pensa must not be taken during pregnancy unless absolutely necessary.

Breastfeeding
Breastfeeding is not recommended during treatment with Nebivolol Pensa.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
This medicine may cause fatigue, dizziness or fainting as a result of lowered blood pressure. If this occurs, do NOT drive or operate machinery. These effects are more likely to occur at the start of treatment or after dose increases (see also section 4).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Nebivolol Pensa contains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE NEBIVOLOLO PENSA

Always take Nebivololo Pensa exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Treatment of high blood pressure (hypertension)

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

Treatment of chronic heart failure

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

Take your medicine once daily, preferably at the same time each day.
Your doctor may decide to combine your tablets with another medicine for your condition.
Use in children and adolescents
Nebivololo Pensa is not recommended for use 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 breathing difficulties or shortness of breath. Contact the
nearest hospital emergency department or inform your doctor or pharmacist immediately. Bring the
pack with any remaining tablets with you.
If you forget to take Nebivololo Pensa
If you forget to take your medicine but remember shortly afterwards, take the next tablet at the usual
time. However, if a long delay has occurred (e.g. the entire day), skip the missed dose and take the next
dose the following day at the usual time, skipping the forgotten dose. Do not take a double or higher dose to make up for missed doses. Repeated missed doses should be avoided.
If you stop taking Nebivololo Pensa
Do not stop taking Nebivololo Pensa without first consulting your doctor. If treatment is stopped
abruptly, the patient may experience dangerous worsening of symptoms. This is especially relevant for
patients with angina pectoris.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Nebivololo Pensa can cause adverse reactions, although not everyone experiences them.
When Nebivololo Pensa is used for the treatment of high blood pressure, possible adverse reactions are:

Common adverse reactions (more than 1 in 100 treated patients but less than 1 in 10 treated patients):

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet

Uncommon adverse reactions (more than 1 in 1,000 treated patients but less than 1 in 100 treated patients):

• Slow heartbeat or other heart disturbances
• Low blood pressure
• Leg cramps-like pain while walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depressive feelings
• Digestive difficulties (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, itching
• Breathlessness resembling asthma due to sudden cramping of the airway muscles (bronchospasm)
• Nightmares

Very rare adverse reactions (less than 1 in 10,000 treated patients):

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

The following adverse reactions have been reported with unknown frequency, only in isolated cases during treatment with Nebivololo Pensa:

• Allergic reactions affecting the whole body, with generalized skin rash (hypersensitivity reactions)
• Rapid-onset swelling, especially around the lips, eyes, or swelling of the tongue, possibly causing sudden breathing difficulty (angioedema)
• Pustular erythema (urticaria)

In a clinical study for chronic heart failure, the following adverse reactions were observed:

Very common adverse reactions (more than 1 in 10 treated patients):

• Low heart rate
• Dizziness

Common adverse reactions (more than 1 in 100 treated patients but less than 1 in 10 treated patients):

• Worsening of heart failure
• Low blood pressure (such as faintness when standing up quickly)
• Intolerance to this medicine
• A mild type of heart conduction disturbance affecting heart rate (first-degree AV block)
• Swelling of the lower limbs (such as swollen ankles)

Reporting of suspected adverse reactions
If you experience any adverse reaction, talk to your doctor or pharmacist. This includes any adverse reaction not listed in this leaflet. You can report adverse reactions directly via the national reporting system listed in Appendix V*. By reporting adverse reactions, 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 carton or aluminium sheet after
Exp.
The expiry date refers to the last day of the month indicated.
Do not store 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. PACKAGING CONTENTS AND OTHER INFORMATION

What Nebivololo Pensa contains
The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
The excipients are:
Monohydrate lactose,
Crospovidone Type A,
Poloxamer 188,
Povidone K 30,
Microcrystalline cellulose,
Magnesium stearate.

Description of the appearance of Nebivololo Pensa and packaging contents
The tablets of Nebivololo Pensa are white, round, biconvex tablets, scored on one side with a cross,
approximately 9 mm in diameter.
Nebivololo Pensa can be divided into four equal parts.
The tablets are available in PVC/PE/PVDC/AL blisters of 7, 10 and 14.
Pack sizes: 28, 30 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorization 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 authorized in the European Economic Area Member States under the following
names:
Denmark: Nebivolol Pensa,
Italy: Nebivololo Pensa

This Patient Information Leaflet has been last reviewed on: