Nedal

Package Leaflet: Information for the User

Nedal, 5 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package 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 over.
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 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 severe breathing difficulties or wheezing;
• if you have an untreated adrenal gland tumor called phaeochromocytoma;
• 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 blood pH becomes too acidic).

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 (inability of the heart to pump blood in sufficient quantities for 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, e.g. Raynaud's disease or muscle cramps during walking;
• long-term breathing problems;
• 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 anti-diabetic medicines called sulfonylureas (such as gliclazide, glipizide, glibenclamide, glimepiride, or tolbutamide);
• hyperthyroidism, as Nedal may mask the symptoms of irregular heart rate in this condition;
• allergy, as allergic reactions may be more severe and may require more medication to treat;
• skin changes called psoriasis, as Nedal may worsen symptoms.

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 suddenly stop treatment without prior consultation and recommendation by your doctor (see section 3.).

Children and adolescents

Nedal is not recommended for use in children and adolescents under 18 years of age.

Nedal and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, including those available without a prescription, herbal preparations, vitamins, and minerals in high doses.
Always inform your doctor or pharmacist if you are taking any of the following medicines at the same time as 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;
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure;
• medicines used to treat heart rhythm disorders (irregular heart rate), 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);
• diabetes medicines, such as insulin or oral anti-diabetic medicines;
• digoxin or other digitalis 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 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 nebivolol metabolism, i.e. paroxetine, fluoxetine, thioridazine (used to treat depression);
• amifostine (a protective medicine used during chemotherapy or radiotherapy);
• baclofen (a muscle relaxant).

Nedal with food and drink

Nedal can be taken before, during, or after meals, and can also be taken without food.
The tablet or its parts should be swallowed with water or another liquid.

Pregnancy and breastfeeding

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

Driving and using machines

No studies have been conducted on the effects on driving ability or using machines.
The medicine may occasionally cause dizziness or fatigue due to lowering blood pressure.
If such symptoms occur, DO NOT drive or operate machines.

Nedal contains lactose

This medicine contains lactose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Nedal

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet per day.
• For elderly patients and patients with kidney function disorders, the initial dose is usually ½ (half) 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 ¼ (one quarter) tablet per day. This dose may be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and then to 2 tablets per day, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets) per day.
• The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose is increased.
• Depending on the need, the doctor may reduce the dose; do not suddenly stop treatment, as this 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 ¼ tablet per day (1.25 mg). This dose may be increased, depending on tolerance, after 1-2 weeks to ½ tablet (2.5 mg) per day, then to 1 tablet (5 mg) per day, and then to 2 tablets (10 mg) per day, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets per day).

The medicine should be taken once a day, preferably at the same time every day.
The tablet can be divided into equal doses.
Your doctor may decide to take the tablets with another medicine prescribed for you.

Use in children and adolescents

Nedal is not recommended for use 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, breathing difficulties or wheezing. Contact the nearest hospital or inform your doctor or pharmacist immediately.

Missed dose of Nedal

If you forget to take the medicine, but remember soon after, take the missed dose as soon as possible. However, if a long time has passed (e.g. 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 prior consultation with your doctor. Do not suddenly stop taking Nedal. Stopping the medicine suddenly may cause a worsening of symptoms in the patient. This is especially true for patients with angina pectoris.
If you have any further questions about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nedal can cause side effects, although not everybody gets them.
Common side effects (occurring in less than 1 in 10 people, but more than 1 in 100):

• in the treatment of high blood pressure:
• Headache;
• Dizziness;
• Fatigue;
• Unusual itching or tingling sensation;
• Diarrhea;
• Constipation;
• Nausea;
• Shortness of breath;
• Swelling of hands or feet.

Uncommon side effects (occurring in less than 1 in 100 people, but more than 1 in 1000):

• Slow heart rate or other heart disorders;
• Low blood pressure;
• Painful leg cramps during walking (or worsening of them);
• Abnormal vision;
• Impotence (difficulty achieving erection);
• Depressive feelings;
• Indigestion, gas in the stomach or intestine;
• Vomiting;
• Skin rash;
• Chest tightness, breathing difficulties, or wheezing;
• Nightmares;
• In a clinical study on chronic heart failure, the following side effects were observed: slow heart rate, dizziness, worsening of heart failure, low blood pressure (e.g. feeling of fainting when standing up suddenly), intolerance to the medicine, irregular heart rate, swelling (e.g. swelling around the ankles).

Rare side effects (occurring in less than 1 in 10000 people):

• Fainting;
• Worsening of psoriasis.

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!
• Hypersensitivity reactions;
• Hives.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 the medicine out of sight and reach of children.
Do not store above 25°C.
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 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 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
• Other ingredients: lactose monohydrate, crospovidone Type A, poloxamer 188, povidone K-30, microcrystalline cellulose, magnesium stearate.

What Nedal looks like and contents of the pack

Nedal tablets are white, round, biconvex, with a cross-shaped groove on one side, approximately 9 mm in diameter.
The Nedal tablet can be divided into four equal parts.
The tablets are packaged in PVC/PE/PVDC/Aluminum blisters of 7, 10, or 14 tablets.
Pack sizes: 10, 14, 20, 28, 30, or 56 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:April 2025