Ivineb

Package leaflet: Information for the user

Ivineb 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 so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any symptoms, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Ivineb is and what it is used for

Ivineb contains nebivolol, which is a selective beta-blocker with vasodilating properties.
This medicine is used to treat high blood pressure (hypertension).
Ivineb is also used in the treatment of chronic heart failure in patients aged 70 years or older.

2. Important information before using Ivineb

When not to use Ivineb

• If the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6),
• in case of low blood pressure (systolic pressure less than 90 mmHg),
• if the patient has severe circulatory disorders in the limbs,
• in case of very slow heart rate (less than 60 beats per minute before starting treatment with this medicine),
• if the patient has been diagnosed with conduction disorders of the heart (such as sick sinus syndrome or atrioventricular block) and does not have a pacemaker implanted,
• in case of acute heart failure or intravenous treatment (by intravenous infusion) intended to support heart function,
• in case of breathing difficulties or wheezing (currently or in the past),
• if the patient has a tumour of the adrenal gland called phaeochromocytoma,
• if the patient has severe liver disease or impaired liver function,
• in case of metabolic acidosis (such as in patients with diabetes when blood sugar levels become too high and blood pH becomes too acidic),
• if the patient is taking medicines containing floctafene or sultopride.

Warnings and precautions
Before starting treatment with Ivineb, discuss this with your doctor or pharmacist.

• If the patient has or develops any of the following conditions:
  • heart failure (inability of the heart to pump sufficient blood to meet the body's needs)
  • mild atrioventricular heart block (first degree) (a mild conduction disorder affecting heart rhythm)
  • chest pain caused by spasm of the coronary arteries (so-called Prinzmetal's angina or nocturnal angina)
  • poor circulation in the limbs, e.g. Raynaud's disease or syndrome, muscle cramp-like pains during walking
  • chronic respiratory disorders
  • diabetes: because Ivineb may mask symptoms of low blood sugar (hypoglycaemia) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulphonylureas (such as glyquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
  • hyperthyroidism, because Ivineb may mask abnormally rapid heart rate associated with this condition
  • allergy, because allergic reactions may be more severe
  • skin changes known as psoriasis, because Ivineb may worsen symptoms
  • wearing contact lenses, because Ivineb may reduce tear secretion and cause dry eyes.

In such cases, the doctor may modify treatment or monitor the patient’s condition more frequently.
Children and adolescents
There is no data available on the use of this product in children and adolescents. Therefore, its use is not recommended in these age groups.
If surgery is planned and anaesthesia is required, it is important that the patient informs the surgeon or dentist about taking Ivineb.
Ivineb should not be used in heart failure if the patient has severe kidney disorders; inform the doctor about this.
Ivineb and other medicines
Tell your doctor about all medicines you are currently taking, including those obtained without a prescription.
Always inform your doctor or pharmacist if you are taking any of the following medicines together with Ivineb:

• diltiazem or verapamil (used to treat high blood pressure or other heart conditions); verapamil should not be administered intravenously during treatment with Ivineb
• other medicines known as calcium antagonists, used to treat high blood pressure or other heart conditions, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
• other antihypertensive medicines or organic nitrates used to treat chest pain
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure
• medicines used to treat heart rhythm disorders (irregular heartbeat), such as quinidine, hydroquinidine, amiodarone, cybenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
• tricyclic antidepressants (used to treat depression), phenothiazines (used to treat psychosis) or barbiturates (used to treat epilepsy)
• medicines for diabetes, such as insulin or oral antidiabetic medicines
• digoxin or other so-called cardiac glycosides (used to treat heart failure)
• non-steroidal anti-inflammatory drugs (NSAIDs) used for pain and inflammation – note that low daily doses of acetylsalicylic acid (e.g. 50 or 100 mg) used for antithrombotic purposes can be safely taken with Ivineb
• medicines used to treat asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation
• anaesthetics: always inform the anaesthesiologist that you are taking Ivineb before undergoing anaesthesia
• cimetidine (used in case of excessive gastric acid secretion) – Ivineb should be taken with meals, and antacids should be taken between meals
• medicines affecting nebivolol metabolism, i.e. terbinafine (used for fungal or yeast infections), bupropion (used to aid smoking cessation), chloroquine (used to treat malaria or rheumatoid arthritis), levomepromazine (used to treat psychosis), paroxetine, fluoxetine, thioridazine (used to treat depression)
• amifostine (a protective agent used during chemotherapy or radiotherapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial medicine).

Ivineb with food and drink
Ivineb may be taken with or without food. The tablet or its parts should be swallowed with water or another liquid.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Ivineb should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Breastfeeding is not recommended while taking Ivineb.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been conducted.
When driving motor vehicles or operating mechanical equipment, patients should consider the possibility of occasional dizziness and fatigue.
These are more likely to occur at the beginning of treatment or after dose increase (see also section 4).
Ivineb contains lactose
This medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, he or she should contact the doctor before taking the medicine.

3. How to take Ivineb

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) once daily. It is recommended to take the dose at the same time each day.
• For elderly patients and patients with impaired kidney function, the initial dose is usually 2.5 mg (1/2 tablet) once daily.
• The blood pressure-lowering effect becomes apparent after 1–2 weeks of treatment. Sometimes optimal effect is only achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and monitored by an experienced physician.
• The doctor will start treatment with a dose of 1.25 mg (1/4 tablet) once daily. This dose may be increased after 1–2 weeks to 2.5 mg (1/2 tablet) once daily, then to 5 mg (1 tablet) once daily, and finally to 10 mg (2 tablets) once daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets once daily).
• An experienced physician will monitor the patient’s condition for 2 hours after starting treatment and after each dose increase.
• If necessary, the doctor may reduce the dose; treatment should not be stopped suddenly, as this may worsen heart failure.
• Patients with severe kidney impairment must not take this medicine.

The medicine should be taken once daily, preferably at the same time each day.
Your doctor may recommend concomitant use of another medicine, depending on the patient's condition.
The use of Ivineb is not recommended in children and adolescents.

Accidental overdose of Ivineb
If too many tablets are taken accidentally (overdose), the following may occur:
slow heart rate, low blood pressure, or other heart-related disturbances, breathing difficulties, or wheezing.
Seek immediate medical attention at the nearest hospital emergency department or contact your doctor.
Bring the pack containing the remaining tablets with you.

Missed dose of Ivineb
If the patient forgets to take the medicine but remembers shortly afterwards, the next tablet should be taken at a time close to the usual dosing time. However, if a significant delay has occurred (e.g. a full day), the missed dose should be skipped and the next dose taken at the usual time the following day.
Do not take a double or higher dose to make up for a missed dose. Avoid repeatedly missing doses.

Stopping Ivineb treatment
Do not stop taking Ivineb without first consulting your doctor. Sudden discontinuation of the medicine may cause dangerous worsening of symptoms. This is particularly important for patients with angina pectoris.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions which may occur when taking Ivineb for the treatment of high blood pressure:

Common adverse reactions (occur in more than 1 in 100 treated people, but less frequently than
in 1 in 10 treated people):

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

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

• Slow heart rate or other heart-related disorders
• Low blood pressure
• Cramping leg pain during walking
• Vision disturbances
• Impotence (difficulty achieving erection)
• Depressive feelings
• Indigestion, gas in stomach or intestines, vomiting
• Skin rash, itching
• Asthma-like shortness of breath caused by sudden contraction of airway muscles (bronchospasm)
• Nightmares

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

• Fainting
• Worsening of psoriasis (a skin disease characterized by scaly, pink patches)

The following adverse reactions have been observed only in isolated cases during treatment with Ivineb:

• Systemic allergic reactions with generalized skin eruptions (hypersensitivity reactions)
• Sudden swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulty (angioedema)
• Urticaria (a type of rash characterized by pale red, raised, itchy wheals)

In a clinical trial concerning chronic heart failure, the following adverse reactions were observed:
Very common adverse reactions (occur in more than 1 in 10 treated people):

• Slow heart rate
• Dizziness

Common adverse reactions (occur in more than 1 in 100 treated people, but less frequently than in
1 in 10 treated people):

• Worsening of heart failure
• Low blood pressure (e.g. feeling faint when standing up quickly)
• Drug intolerance
• Mild disturbances in heart conduction affecting heart rhythm (first-degree atrioventricular block)
• Swelling of lower limbs (e.g. swollen ankles)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; Tel.: +48 22 4921301; Fax: +48 22 4921309
e-mail: [email protected]

5. How to store Ivineb

Keep this medicine out of sight and reach of children.
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 specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Other information

What Ivineb contains

• The active substance is nebivolol.
• Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.

Other components are:
Monohydrate lactose
Crospovidone (type A)
Poloxamer 188
Povidone K-30
Microcrystalline cellulose
Magnesium stearate

What Ivineb looks like and contents of the pack
Ivineb tablets are white, round, biconvex, with crossed score lines on one side, approximately 9 mm in diameter.
Ivineb tablets can be divided into equal doses.
The tablets are packed in PVC/PE/PVDC/Aluminium blisters containing 7, 10 or 14 tablets.
Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets.

Marketing Authorization Holder
BIOTON S.A.
ul. Starościńska 5
02-516 Warszawa
Poland

Manufacturer
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 12351
Greece