Nedal

Package Leaflet: Information for the Patient

Nedal, 10 mg, Tablets

Nebivolol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nedal and what is it used for

Nedal contains nebivolol, which is a selective beta-adrenergic blocker with vasodilating properties. This medicine is used to treat high blood pressure (hypertension).
Nedal is also used to treat chronic heart failure in patients aged 70 or older.
Nedal may also be used to treat symptomatic stable angina pectoris.

2. Important information before taking Nedal

When not to take Nedal

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6);
• in case of low blood pressure (systolic blood pressure or "upper" blood pressure is less than 90 mm Hg);
• in case of poor blood circulation in the limbs;
• in case of very slow heart rate (less than 60 beats per minute before starting treatment with this medicine);
• if you have been diagnosed with conduction disorders in the heart (such as sick sinus syndrome or atrioventricular block) and you do not have a pacemaker;
• in case of acute heart failure or intravenous treatment (through a drip) to support heart function;
• in case of breathing difficulties or wheezing;
• if you have an untreated pheochromocytoma (a rare tumor of the adrenal gland);
• if you have severe liver disease or liver function disorders;
• in case of metabolic acidosis (as in diabetic patients when blood sugar levels become too high and the blood becomes too acidic),
• if you are taking medicines containing floctafenine or sultopride.

Warnings and precautions

Before starting treatment with Nedal, consult your doctor or pharmacist.
If you have or develop any of the following conditions:

• untreated heart failure (the heart is unable to pump enough blood to meet the body's needs);
• abnormal, very slow heart rate;
• mild (first-degree) atrioventricular block in the heart;
• chest pain caused by coronary artery spasm (so-called Prinzmetal's angina or nocturnal angina);
• poor circulation in the limbs, such as Raynaud's disease or syndrome, or muscle cramps while walking;
• long-term breathing difficulties;
• diabetes, as nebivolol may mask the symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic medicines called sulfonylureas (such as gliclazide, glibenclamide, glipizide, gliburide, or tolbutamide);
• hyperthyroidism, as Nedal may mask the symptoms of abnormal heart rate in this disease;
• allergy, as allergic reactions may be more severe and may require more medication to treat;
• skin changes called psoriasis, as Nedal may worsen symptoms,
• wearing contact lenses, as Nedal may reduce tear production and cause dry eyes.

In such cases, your doctor may adjust the treatment or monitor you more closely.
In case of planned surgery and the need for anesthesia, it is essential to inform the surgeon or dentist about taking this medicine.
In case of severe kidney function disorders, do not take this medicine for the treatment of heart failure. Inform your doctor about this.
At the beginning of treatment for chronic heart failure, the patient should be under constant medical supervision (see section 3.).
Do not stop taking this medicine abruptly without consulting your doctor (see section 3.).

Children and adolescents

Do notrecommend the use of Nedal in children and adolescents due to the lack of data on its use in this age group.

Nedal and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription, herbal medicines, vitamins, and minerals in high doses.
Always inform your doctor or pharmacist if you are taking any of the following medicines with Nedal:

• diltiazem or verapamil (used to treat high blood pressure or other heart disorders); during treatment with Nedal, verapamil should not be administered intravenously;
• other calcium channel blockers used to treat high blood pressure or other heart disorders, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine;
• other antihypertensive medicines or organic nitrates used to treat chest pain;

piersiowej;

• 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 medicines called cardiac glycosides (used to treat heart failure);
• non-steroidal anti-inflammatory medicines (NSAIDs) used for pain and inflammation;
• medicines used to treat asthma, nasal congestion, or certain eye disorders, such as glaucoma (increased eye pressure) or pupil dilation;
• anesthetics: always inform the anesthesiologist about taking Nedal before undergoing anesthesia;
• cimetidine (used to treat stomach acid); Nedal should be taken during meals, and antacids between meals;
• medicines that affect the metabolism of nebivolol, such as paroxetine, fluoxetine, thioridazine (used to treat depression);
• amifostine (a protective medicine used during chemotherapy or radiotherapy);
• baclofen (a muscle relaxant),
• medicines that affect the metabolism of nebivolol, such as terbinafine (used to treat fungal or yeast infections), bupropion (used to help quit smoking), chloroquine (used to treat malaria or rheumatoid arthritis), levomepromazine (used to treat psychosis),
• mefloquine (an antimalarial medicine).

Nedal with food and drink

Nedal can be taken before, during, or after a meal, and can also be taken without food.
The tablet or its parts should be swallowed with a sufficient amount of liquid (e.g., one glass of water).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Nedal during pregnancy, unless your doctor decides otherwise.
Breastfeeding
Women taking Nedal should not breastfeed.

Driving and using machines

This medicine may cause dizziness and fatigue. In this case, do notdrive or operate machinery.

Nedal contains lactose and sodium

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Nedal

Always take this medicine exactly as your doctor has told you.
If you are not sure, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• Usually, the recommended dose is 5 mg (half a tablet) per day.
• In elderly patients and patients with kidney function disorders, the initial dose is usually 2.5 mg (one quarter of a tablet) per day.
• It may take up to 4 weeks for the medicine to start working fully.

Treatment of chronic heart failure

• Treatment will be started and monitored by an experienced doctor.
• Treatment starts with an initial dose of 1.25 mg per day (which cannot be achieved with a 10 mg tablet of Nedal - other medicines or a 5 mg tablet of Nedal, which can be divided into four doses of 1.25 mg, should be used). This dose may be increased after 1-2 weeks to 2.5 mg (one quarter of a tablet) per day, then to 5 mg (half a tablet) per day, and then to 10 mg (one tablet) per day, until the optimal dose for the patient is reached.
• The maximum recommended dose is 10 mg (one tablet) per day.
• The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose of the medicine is increased.
• If necessary, the doctor may reduce the dose of the medicine. Do not stop taking this medicine abruptly, as it may worsen heart failure.
• Patients with severe kidney function disorders should not take this medicine.

Treatment of symptomatic stable angina pectoris

• Treatment will be started and monitored by an experienced doctor.
• Treatment starts with an initial dose of 1.25 mg per day (which cannot be achieved with a 10 mg tablet of Nedal - other medicines or a 5 mg tablet of Nedal, which can be divided into four doses of 1.25 mg, should be used). This dose may be increased after 1-2 weeks, depending on the patient's tolerance, to 2.5 mg (one quarter of a tablet) per day, then to 5 mg (half a tablet) per day, and then to 10 mg (one tablet) per day, until the optimal dose for the patient is reached.
• The maximum recommended dose is 10 mg (one tablet) per day.
• Patients with severe kidney function disorders should not take this medicine.

The medicine should be taken once a day, preferably at the same time every day.
The tablet can be divided into four equal parts.
If your doctor has prescribed one quarter or half a tablet per day, follow the instructions for breaking the tablet below.

• Place the tablet on a flat, hard surface (e.g., a table or countertop), with the scored lines facing up.
• Break the tablet along the vertical line, pressing it against the surface with your index fingers, as shown in figures 1 and 2.
• Quarter-tablets can be obtained by breaking the halves in the same way, as shown in figures 3 and 4.

Fig.1
Fig. 2

Fig. 3
Fig. 4
Your doctor may decide to use tablets with another medicine indicated for the patient.

Use in children and adolescents

Do not recommend the use of Nedal in children and adolescents.

Overdose of Nedal

In case of accidental ingestion of too many tablets (overdose), the patient may experience: slow heart rate, low blood pressure, and other heart disorders, difficulty breathing or wheezing. Contact the nearest hospital or consult a doctor or pharmacist immediately.

Missed dose of Nedal

If you forget to take your medicine, but remember soon after, take the missed dose as soon as possible. However, if it has been a long time (e.g., several hours or a whole day), skip the missed dose and take the next dose at the usual time the next day. Do not take a double dose or increase the dose to make up for the missed dose. Avoid repeatedly missing doses.

Stopping treatment with Nedal

Do not stop taking Nedal without consulting your doctor first. Do not stop taking Nedal abruptly. Stopping the medicine abruptly may cause a dangerous worsening of symptoms in the patient. This is especially true for patients with angina pectoris.
If you have any further questions about taking 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.
During treatment with nebivolol for high blood pressure, the following side effects have been reported:

• headache,
• dizziness,
• fatigue,
• unusual itching or tingling sensation,
• diarrhea,
• constipation,
• nausea,
• shortness of breath,
• swelling, e.g., of hands or feet.

Uncommon (occurring in less than 1 in 100 people):

• slow heart rate or other heart disorders,
• low blood pressure,
• painful leg cramps while walking (or worsening of existing cramps),
• abnormal vision,
• impotence (difficulty achieving an erection),
• depression,
• indigestion, gas in the stomach or intestines, vomiting,
• skin rash, itching,
• chest tightness, difficulty breathing or wheezing,
• nightmares.

Rare (occurring in less than 1 in 10,000 people):

• fainting,
• worsening of psoriasis (a skin disease with scaly, pink patches).

Frequency not known (cannot be estimated from the available data):

• angioedema: swelling of the skin of the face or limbs, lips, tongue, mucous membranes of the throat and airways, causing difficulty breathing or swallowing - contact your doctor immediately!
• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions),
• hives.

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

• very common (occurring in more than 1 in 10 people):
• slow heart rate,
• dizziness.

Common (occurring in less than 1 in 10 people):

• worsening of heart failure,
• low blood pressure (e.g., feeling faint when standing up),
• intolerance to the medicine,
• mild heart conduction disorder affecting the heart rhythm (first-degree atrioventricular block),
• swelling (e.g., swelling of the ankles).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nedal

Keep this medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nedal contains

• The active substance is nebivolol. Each tablet contains 10 mg of nebivolol, equivalent to 10.90 mg of nebivolol hydrochloride.
• Other ingredients: lactose monohydrate, cornstarch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

What Nedal looks like and contents of the pack

Nedal tablets are white or almost white, round, biconvex with four beveled edges and cross-scored on both sides of the tablet. On each quarter of one side of the tablet, "N" is embossed. The tablet is approximately 11 mm in diameter.
The Nedal tablet can be divided into four equal parts.
Nedal is available in aluminum/PVC/PVDC blisters containing 28 or 56 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: