Nebivololo Accord

PACKAGE LEAFLET

Package leaflet: Information for the user

Nebivololo Accord 5 mg tablets

Generic medicine
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nebivololo Accord is and what it is used for

Nebivololo Accord contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system). Nebivololo Accord 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). Nebivololo Accord is also used to treat mild to moderate chronic heart failure, in addition to other therapies, in elderly patients aged 70 years and over.

2. What you should know before taking Nebivololo Accord

Do not take Nebivololo Accord
if you are allergic to nebivolol hydrochloride or to any of the other ingredients of
this medicine (listed in section 6),
if you have one or more of the following conditions:
liver function disorder
heart failure, recently developed or recently worsened, or if you are being treated for circulatory shock due to acute heart failure with intravenous therapy to support heart function
certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders)
asthma or wheezing (current or previous)
untreated phaeochromocytoma, a tumour located above the kidneys (in the adrenal glands)
metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis
very slow heart rate (less than 60 beats per minute)
low blood pressure
severe circulation problems in arms or legs

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Accord.
Inform your doctor if you notice 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, for example Raynaud’s disease or syndrome, cramp-like pain while walking
prolonged breathing difficulties

• Diabetes: this medicine does not affect blood glucose levels, but it may mask warning signs of low blood sugar (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g. chlorpropamide, gliclazide, glyburide, glipizide, glimepiride or tolbutamide).

Overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition
Allergy: this medicine may worsen reactions to pollen or other substances you are allergic to
Psoriasis (a skin disease – 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 Nebivololo Accord before receiving anaesthesia.
Do not take Nebivololo Accord for the treatment of heart failure if you have severe kidney problems, and inform your doctor.
During the initial phase of treatment for chronic heart failure, you should be monitored by an experienced physician (see section 3).
Do not stop this treatment abruptly unless clearly indicated and evaluated by your doctor (see section 3).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Due to lack of data on the use of this medicine in children and adolescents, the use of Nebivololo Accord is not recommended in these age groups.

Other medicines and Nebivololo Accord
Tell 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 given any of the following medicines in addition to Nebivololo Accord:
Medicines for controlling blood pressure or heart conditions (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, nasal congestion, or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation (enlargement).
Baclofen (an antispastic medicine); Amifostine (a protective agent used during anticancer treatment).
Medicines for diabetes, such as insulin or oral antidiabetics.
All these medicines, like nebivolol, may affect blood pressure and/or heart function.
Medicines for treating excess stomach acid or ulcers (antacids): take Nebivololo Accord with meals and the antacid between meals.

Nebivololo Accord with food and drink
Refer to section 3.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Nebivololo Accord should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Use during breastfeeding is not recommended.

Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive and do not operate machinery.

Nebivololo Accord contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Nebivololo Accord

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Nebivololo Accord 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 recommended dose is 5 mg of nebivolol once 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 2.5 mg of nebivolol 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 1.25 mg daily. After 1–2 weeks, the dose may be increased to 2.5 mg daily, then to 5 mg daily, and subsequently to 10 mg 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 carefully follow their instructions.
The maximum recommended dose is 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.
Do not stop treatment abruptly, as this may worsen heart failure.
Patients with severe kidney problems must not take this medicine.
Take the medicine once daily, preferably always at the same time.
If your doctor has prescribed ¼ (one quarter) or ½ (half) of a tablet, place the tablet on a flat, hard surface, such as a table, with the break lines facing upwards. Press evenly over the entire surface of the tablet until you hear a click.
The tablet is now divided into 4 parts, which can be accurately separated.
Your doctor may decide to combine Nebivololo Accord with other medicines to treat your condition.

Do not use in children and adolescents.

If you take more Nebivololo Accord 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 overdose with Nebivololo Accord 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 the doctor to arrive.

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

If you stop taking Nebivololo Accord
You must always consult your doctor before stopping treatment with Nebivololo Accord, whether you are taking it for high blood pressure or for chronic heart failure.
Do not stop treatment with Nebivololo Accord abruptly, as this may temporarily worsen heart failure. If treatment for heart failure with Nebivololo Accord needs to be discontinued, 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
everyone will experience them.
When Nebivololo Accord is used to treat high blood pressure,
possible side effects are:
Common side effects (may affect up to 1 in 10 people)

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

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

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

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

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

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

• generalized allergic reactions with widespread rash (hypersensitivity reactions);
• sudden swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulties (angioedema);
• a type of skin rash characterized by pale, raised, itchy bumps of either allergic or non-allergic origin (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 when standing up quickly)
• inability to tolerate this medicine
• a mild cardiac 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 or pharmacist. You can also report side effects via
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 Nebivolol Accord

Keep this medicine out of the 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 that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Nebivololo Accord contains

• The active substance is nebivolol.

Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of
nebivolol.
The other ingredients are: hydrated colloidal silica (E551), magnesium stearate (E572),
sodium croscarmellose (E468), macrogol (E1521) and lactose.

Description of the appearance of Nebivololo Accord and pack contents
Tablet
5 mg:
White, round, convex tablets approximately 9 mm in diameter with a double break line (with notch), marked with “NE3” on the other side.
5 mg: Transparent PVC/PE/PVdC aluminium blisters and PVC/PVDC aluminium blisters are available in packs of 14, 28, 30, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.,
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.,
Ul. Lutomierska 50,
Pabianice, 95-200, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
Utrecht, 3526 KV, The Netherlands
Pharmadox Healthcare Limited,
Kw20a, Kordin Industrial Estate,
Paola, PLA 3000, Malta
Laboratori Fundació Dau,
C/c 12-14 Poligon Industrial Zona Franca,
Barcelona, 08040, Spain
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
The Netherlands Nebivolol Accord 2.5/5 mg tabletten
Austria Nebivolol Accord 5 mg Tabletten
Denmark Nebivolol Accord
Finland Nebivolol Accord 5 mg tabletti
Ireland Nebivolol Accord 5 mg Tablets
Cyprus Nebivolol Accord 2.5/5 mg Tablets
Italy Nebivololo Accord