NIVOLON 5 mg Tabletki Powlekane

Treść ulotki

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

Nivolon 5 mg tablets

nebivolol
Generic Equivalent

Read this leaflet carefully before you start 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Nivolon and what is it used for

Nebivolol belongs to a group of medicines called “beta-blockers” used to lower blood
pressure. Nebivolol is used to treat:

• high blood pressure (hypertension),
• elderly patients suffering from mild to moderate heart failure, in addition to standard therapy (e.g. diuretics, digoxin, ACE-inhibitors, angiotensin II receptor antagonists).

2. What you need to know before you take Nivolon

Do not take Nivolon:

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rashes, itching, swelling or difficulty breathing
• if you have liver problems,
• if you have had a heart attack, if you have heart failure that may worsen or if you have received medical treatment via intravenous route for heart failure,
• if you have irregular heartbeat (conditions such as sinus node disease, sino-atrial block or 2nd or 3rd degree cardiac block), but you have not had a “pacemaker” inserted,
• if you suffer from or have suffered from asthma or other serious breathing problems,
• if you have a tumor of the adrenal gland called pheochromocytoma, which is not being treated,
• if you suffer from a condition called metabolic acidosis,
• if you suffer from a slow heart rate (less than 60 beats per minute, known as bradycardia),
• if you suffer from low blood pressure or have poor circulation,
• if you are using medicines containing floctafenine or sultopride.

Warnings and precautions
Talk to your doctor before taking Nivolon if:

• you have untreated heart problems, because Nivolon may worsen them,
• you suffer from Raynaud's disease, poor circulation in the arms and legs or if there are periods when you find it difficult to walk or have fainting attacks or limping, as Nivolon may worsen these conditions,
• you have been told by a doctor that you have a first-degree heart block (alteration of the heartbeat), as Nivolon may worsen it or slow down your heartbeat. Your doctor may want to check your heartbeat and if necessary change the dosage of the medicine,
• you suffer from Prinzmetal's angina, as Nivolon may worsen your angina attacks,
• you are diabetic, as Nivolon may mask some of the signs that indicate that blood sugar levels are low (hypoglycemia) and may increase the risk of severe hypoglycemia if used in conjunction with certain types of antidiabetic medicines called sulfonylureas (for example glimepiride, gliclazide, glibenclamide, glipizide, tolbutamide),
• you have an overactive thyroid (hyperthyroidism), as Nivolon may mask some of the symptoms of this condition, such as increased heart rate (tachycardia),
• you have lung problems, as Nivolon may cause further breathing difficulties, your doctor will give you advice, if you are at risk,
• you suffer from a skin condition called psoriasis or “hay fever” or other allergies, as Nivolon may worsen these conditions. If you are not sure whether to take this medicine or not, talk to your doctor,
• you wear contact lenses, as Nivolon may cause dry eyes.

For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Nivolon
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription, or the following medicines:
Do not take Nivolon if you are taking other medicines containing floctafenine or sultopride (see the
previous paragraph “Do not take Nivolon”).
Taking one of these medicines together with Nivolon may lower blood pressure excessively or cause heart problems:

• medicines used to lower blood pressure such as verapamil, diltiazem, clonidine, guanfacine, moxonidine, methyldopa, rilmenidine, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine)
• medicines for diabetes such as insulin or oral antidiabetic medicines
• medicines used for the treatment of abnormal heartbeat such as amiodarone, quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone,
• medicines used for the treatment of depression or other mental problems such as paroxetine, fluoxetine, thioridazine,
• barbiturates (used for epilepsy, anxiety or insomnia)
• baclofen (a muscle relaxant),
• amifostine (used in cancer therapy),
• mefloquine (an anti-malarial),
• organic nitrates (used to treat angina),
• quinidine (used to reduce the heartbeat)
• terbinafine (for fungal and yeast infections),
• bupropion (to help quit smoking),
• chloroquine (to treat malaria or rheumatoid arthritis),
• levomepromazine (for mental health problems).

In addition

• stimulants containing dopamine or nasal decongestants containing ephedrine, as they may increase blood pressure excessively or cause heart problems,
• insulin or oral antidiabetics, as Nivolon may mask the symptoms of hypoglycemia (low blood sugar levels), such as tachycardia or palpitations.

Surgery
Nivolon may react with some anesthetics used in surgical operations. Therefore, if you need
any surgery, you must inform your doctor, your dentist and the hospital medical staff that you are taking Nivolon.

Pregnancy and breastfeeding
Nivolon should not be taken during pregnancy or breastfeeding, unless the benefits to the mother
outweigh the risk to the fetus or newborn.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine may cause dizziness or fainting due to reduced blood
pressure. If you experience these symptoms, do not drive or use machines. These effects are more likely
at the beginning of treatment or after an increase in doses (see also section 4).

Nivolon contains lactose and sodium
Nivolon contains lactose. If your doctor has diagnosed you with intolerance to some sugars, such as
lactose, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Nivolon

Take this medicine following exactly the instructions of your doctor. If you have doubts, you should
consult your doctor or pharmacist.
Always check that you have enough tablets to avoid running out.
Try to take the tablets at the same time each day.
Swallow the tablet with a glass of water. You can take the tablets with or without food.
The tablets can be divided into 4 equal parts.

Treatment of high blood pressure (hypertension):
Use in adults: The usual dose is 1 tablet (5 mg) of Nivolon once a day. Usually
it takes 1-2 weeks for the drug to take effect, but sometimes it can take up to 4
weeks.
Elderly: if you are over 65 years old and are taking Nivolon to lower your blood pressure, the usual starting dose is
half a tablet (2.5 mg) per day. However, your doctor may increase the dose to 1 tablet (5 mg) per
day, if they consider it necessary.
Patients with kidney problems: the usual dose is half a tablet (2.5 mg) once a day. However
your doctor may increase the dose to 1 tablet (5 mg) per day, if they consider it necessary.

Patients taking Nivolon and another medicine to lower blood pressure.
When using hydrochlorothiazide, the usual daily dose is 5 mg of Nebivolol and 12.5 – 25 mg of
hydrochlorothiazide per day.

Treatment of heart failure:
Use in adults and the elderly: The doctor will start with a low dose and gradually increase it
at intervals of 1-2 weeks until your condition has stabilized. The usual starting dose
is one quarter of a tablet (1.25 mg) once a day for 1-2 weeks, which may be increased to
half a tablet (2.5 mg) once a day and then to 1 tablet (5 mg) per day and subsequently to 2
tablets (10 mg) once a day. The maximum recommended dose is 2 tablets (10 mg) once a
day. Your doctor will tell you how much medicine to take.

Patients with kidney problems:
Nivolon is not recommended for use in patients with severe kidney problems. Your doctor will tell you if Nivolon is
suitable for your condition.

Patients with liver disease:
If you suffer from liver disease you must nottake Nivolon.

Use in children and adolescents:
Nivolon is not recommended for use in children and adolescents under the age of 18 years.

If you take more Nivolonthan you should
Contact your doctor or the Emergency Room immediately. Take the packaging and any remaining tablets
with you. The signs and symptoms of overdose include: slow heartbeat, low blood
pressure, wheezing and difficulty breathing, and sudden heart problems.

If you forget to take Nivolon
If you forget to take your dose of Nivolon do nottake a double dose to make up for the
missed dose. Take the next tablet at the scheduled time. If you have missed several
doses, contact your doctor.

If you stop taking Nivolon
If you suddenly stop taking Nivolon, you are likely to experience undesirable effects or your condition may worsen. If you need to stop taking this medicine, your doctor will gradually reduce
the dose over a period of 2 weeks.
If you have any further questions about 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.

If any of the following side effects occur, stop taking Nivolon and immediately inform your doctor or go to the emergency room of the nearest hospital:

• feeling of tightness in the chest and difficulty breathing.
• severe allergic reactions that can cause skin rash, itching, hives or swelling of the face, lips, mouth or throat, which can cause difficulty swallowing or breathing
• heart failure which can cause shortness of breath, feeling tired after light activity or swelling of the feet or legs due to fluid accumulation
• changes in the electrical activity of the heart causing heartbeats to skip
• eye problems such as inflammation, dryness, redness or irritation of the eyelid which can cause eye damage
• mental health problems (psychosis) that can cause hearing, seeing or feeling things that are not there (hallucinations), having false beliefs (delusions), being confused, having disturbed or abnormal thoughts or behaviors

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

• headache
• tingling or prickling sensation
• fainting when standing up
• constipation, nausea or diarrhea
• feeling tired
• fluid retention (swelling)
• shortness of breath

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

• nightmares
• feeling depressed
• vision problems
• slow heartbeat or other heart problems
• other changes in heart function, detectable during heart tests
• low blood pressure
• difficulty walking including muscle pain, weakness and limping
• shortness of breath, such as in asthma, due to sudden spasms of the airway muscles (bronchospasm)
• indigestion, flatulence (gas in the intestines), feeling unwell (vomiting)
• inability to get or maintain an erection
• skin rash, itchy skin

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

• fainting
• worsening of psoriasis or psoriasis-like skin rashes (thickened patches of red skin, often with silvery scales).

Not known(frequency cannot be estimated from the available data)

• widespread allergic reactions throughout the body, including generalized skin rashes (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes, or tongue with possible sudden breathing difficulties (angioedema);
• a type of allergic or non-allergic skin rash characterized by the appearance of raised, light red bumps that are itchy (urticaria).

The following side effects have been reported following the use of medicines of the same type as
nebivolol, therefore they may occur with this medicine. Frequency cannot be
estimated from the available data

• cold fingers and toes, with bluish discoloration of the skin (Raynaud's phenomenon)
• dry eyes

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):

• dizziness
• slowed heart rate

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

• worsening of heart failure
• low blood pressure (with feeling of fainting when getting up quickly)
• intolerance to nebivolol
• a mild disturbance of heart conduction that affects the heart rhythm (1st degree AV block)
• swelling of the lower limbs (swollen ankles).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly via the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Nivolon

Keep out of sight and reach of children .
Do not use this medicine after the expiry date that is stated on the blister or the packaging, after the
wording “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use Nivolon if you notice any sign of deterioration of the tablets.
Do not dispose of any medicine in 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 Nivolon contains
The active ingredient is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to
5 mg of nebivolol.
The other ingredients are lactose monohydrate (see section 2 ‘Nivolon contains lactose and
sodium’) , sodium croscarmellose, corn starch, polysorbate 80, hypromellose, microcrystalline cellulose,
anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Nivolon and contents of the pack
Nivolon tablets are white, oval, 9.5 mm x 8.5 mm, quarter-scored, flat with bevelled
edges. Each tablet is marked with “N” in the upper left quadrant and “L” in the upper
right quadrant on one side only.
The medicinal product is available in PVC/PVdC – Alu blisters, in packs of 7, 10, 14, 28, 30, 50, 56, 60, 84,
90, 98 and 100 tablets, in an opaque plastic bottle containing 100 or 500 tablets or in perforated
unit-dose PVC/PVdC – Alu blisters of 28 x 1, 56 x 1, 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer.
McDermott Laboratories Limited t/a Gerard laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13 Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Viatris Santé, 1 Rue de Turin, 69007 Lyon, France

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
France Nebivolol Viatris Santé 5 mg quadrisécable tablet
Italy Nivolon 5 mg tablets
Portugal Nebivolol Mylan 5 mg tablets
Spain Nebivolol Viatris 5 mg EFG tablets
United Kingdom Nebivolol 5 mg Tablets