Nobistar

Package leaflet: Information for the user

NOBISTAR 5 mg Tablets

Nebivolol
Please read all of this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Nobistar is and what it is used for

Nobistar contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system).
Nobistar prevents the increase in heart rate and controls the force of the heart's pumping action. In addition, it exerts a dilating effect on blood vessels, which helps lower blood pressure. It is used to treat high blood pressure (hypertension). Nobistar is also used to treat mild to moderate chronic heart failure, in addition to other therapies, in elderly patients aged 70 years and older.

2. What you should know before taking Nobistar

Do not take Nobistar

• If you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6)
• If you have one or more of the following conditions:
  • Low blood pressure
  • Severe circulation problems in arms or legs
  • Very slow heart rate (less than 60 beats per minute)
  • Other serious heart rhythm disorders (e.g., second- or third-degree atrioventricular block and cardiac conduction disorders)
  • Recently developed or recently worsened heart failure, or if you are receiving intravenous therapy to treat circulatory shock due to acute heart failure to support heart function
  • Asthma or wheezing (current or past)
  • Untreated phaeochromocytoma, a tumour located above the kidneys (in the adrenal glands)
  • Impaired liver function
  • Metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nobistar.
Inform your doctor if you experience or develop any of the following symptoms:

• Abnormally slow heartbeat
• A type of chest pain caused by spontaneous spasm of the heart muscle known as Prinzmetal's angina
• Untreated chronic heart failure
• First-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• Poor circulation in arms and legs, e.g., Raynaud’s disease or syndrome, cramp-like pain while walking
• Prolonged breathing difficulties
• Diabetes: this medicine does not affect blood glucose levels, but may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat)
• Overactive thyroid gland: this medicine may mask signs of abnormally fast heart rate caused by this condition
• Allergy: this medicine may worsen allergic reactions to pollen or other allergens
• Psoriasis (a skin disease causing scaly pink patches), or if you have previously suffered from psoriasis
• If you are undergoing surgery, always inform the anaesthetist that you are being treated with Nobistar before receiving anaesthesia.

Do not take Nobistar for the treatment of heart failure if you have severe kidney problems; inform your doctor.
During the initial phase, treatment for chronic heart failure must be regularly monitored by an experienced physician (see section 3).
Do not abruptly stop this treatment unless directed and evaluated by your doctor (see section 3).
For athletes: using this medicine without a therapeutic indication constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
Due to lack of data on the use of this product in children and adolescents, the use of Nobistar is not recommended for these age groups.

Other medicines and Nobistar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor if you are taking or have recently been administered any of the following medicines in addition to Nobistar:

• Medicines for controlling blood pressure or heart problems (e.g., 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 treatments for psychosis (a mental illness), e.g., barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine
• Medicines for depression, e.g., amitriptyline, paroxetine, fluoxetine
• Medicines used for anaesthesia during surgery
• Medicines for asthma, sinusitis, or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation (enlargement)
• Baclofen (an antispastic drug); Amifostine (a protective agent used during anti-tumour therapy)

All these medicines, as well as nebivolol, may affect blood pressure and/or heart function.

• Medicines for treating excess stomach acid or ulcers (antacids): take Nobistar with meals and antacids between meals.

Nobistar with food and drink
Refer to section 3.
Pregnancy and breastfeeding
Nobistar should not be used during pregnancy unless absolutely necessary.
Use during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive or operate machinery.
Nobistar contains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Nobistar

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Nobistar may be taken before, during, or after meals, or alternatively, independently
of meals. It is preferable to swallow the tablet with water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. The dose should preferably be taken at the same time each day.
• In elderly patients and in patients with renal impairment, treatment usually starts with ½ (half) a tablet daily.
• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Sometimes the optimal effect is only achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment must be initiated and closely supervised by an experienced physician.
• Your doctor will start treatment with ¼ (one-quarter) of a tablet daily. After 1–2 weeks, the dose may be increased to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the appropriate dose required for your condition is reached. Your doctor will prescribe the appropriate dose for you at each stage of treatment, and you must follow their instructions carefully.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• You must be monitored by an experienced physician for 2 hours following the initiation of treatment and after each dose increase.
• Your doctor may reduce the dose if necessary.
• You must not stop treatment abruptly, as this could worsen heart failure.
• This medicine must not be taken by patients with severe kidney problems.
• Take the medicine once daily, preferably at the same time each day.

If your doctor has prescribed you to take ¼ (one-quarter) or ½ (half) a tablet daily,
please refer to the instructions below describing how to split the Nobistar 5 mg tablet with double break lines.

• Place the tablet on a flat, hard surface (e.g. a table or countertop) with the break lines facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed along one of the break lines (Figures 1 and 2).
• Break the half tablet in the same way to obtain quarters (Figures 3 and 4).

Figures 1 and 2: How to easily split in half the Nebivolol 5 mg tablet with
double break lines.

Figures 3 and 4: How to easily split into quarters the Nebivolol 5 mg tablet with
double break lines.

• Your doctor may decide to combine Nobistar with other medicines to treat your condition.
• Not for use in children and adolescents.

If you take more Nobistar than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or
pharmacist immediately. The most common symptoms and signs of an overdose of
Nobistar are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing as in asthma (bronchospasm), and acute heart failure.
You may take activated charcoal (available from pharmacies) while waiting for medical help.

If you forget to take Nobistar
If you forget to take a dose of Nobistar but remember shortly afterwards, take your daily dose as usual. If you remember much later (i.e. several hours later), and it is close to the time for your next scheduled dose, do not take the missed dose; instead, take your next regular dose at the usual time. Do not take a double dose. However, avoid repeatedly skipping doses of this medicine.

If you stop taking Nobistar
You must always consult your doctor before stopping treatment with Nobistar, whether you are taking it for high blood pressure or for chronic heart failure.
You must not stop treatment with Nobistar abruptly, as this could temporarily worsen heart failure. If it becomes necessary to discontinue treatment for heart failure with Nobistar, the daily dose should be gradually reduced by halving the dose at weekly intervals.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Nobistar is used for the treatment of high blood pressure, possible side effects are:

Common side effects (may affect up to 1 in 10 people):

• headache
• dizziness
• tiredness
• unusual sensation of itching or tingling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of the hands and feet

Uncommon side effects (may affect up to 1 in 100 people):

• slowed heart rate or other heart problems
• low blood pressure
• cramp-like pain in the legs when walking
• abnormal vision
• impotence
• feeling of depression
• difficulty in digestion (dyspepsia), gas in the stomach or intestines, vomiting
• skin rashes, itching
• shortness of breath as in asthma, due to sudden cramping of the airway muscles (bronchospasm)
• nightmares

Very rare side effects (may affect up to 1 in 10,000 people):

• fainting
• worsening of psoriasis (a skin disease causing scaly pink patches)

During treatment with Nobistar, the following side effects have been reported only in isolated cases:

• widespread allergic reactions, including generalized skin rashes (hypersensitivity reactions)
• sudden swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulties (angioedema)
• a type of skin rash characterized by itchy, raised, pale red wheals, either allergic or non-allergic in nature (urticaria)

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

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

• slow heartbeat
• dizziness

Common side effects (may affect up to 1 in 10 people):

• worsening of heart failure
• low blood pressure (with feeling of faintness upon standing up quickly)
• inability to tolerate this medicine
• a mild heart conduction disorder affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (swollen ankles)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nobistar

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nobistar contains

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
• The other components are: monohydrate lactose, polysorbate 80 (E433), hypromellose (E464), maize starch, sodium croscarmellose (E468), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), magnesium stearate (E572).

Description of the appearance of Nobistar and contents of the pack
Nobistar is available as white, round tablets with two score lines, available in packs containing 7, 14, 28, 30, 50, 56, 90, 100, or 500 tablets. The tablets are packaged in blisters (PVC/aluminum).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A.
Avenue de la Gare 1
L-1611 Luxembourg
Selling Agent:
Istituto Luso Farmaco d’Italia S.p.A.
Milanofiori - Strada 6 - Edificio L - Rozzano (MI), Italy

Manufacturer
Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13, 01097 Dresden, Germany
or
Qualiphar N.V.
Rijksweg 9, 2880 Bornem, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Nobistar
Netherlands: Lobivon
Spain: Nebilet