Nesirgi

Leaflet accompanying the packaging: information for the user

Nesyrgy, 5 mg + 5 mg, film-coated tablets

Nesyrgy, 5 mg + 10 mg, film-coated tablets

Nebivolol + Amlodipine

Read the 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 tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Nesyrgy and what is it used for

Nesyrgy contains two active substances called nebivolol and amlodipine. Both of these substances help to lower high blood pressure.

• Nebivolol is a medicine that acts on the heart and blood vessels, belonging to a group of selective beta-blockers (i.e., they selectively affect the heart and blood vessels). It prevents the heart from beating too quickly and controls the strength of the heart's contractions. It also widens the blood vessels, which helps to lower blood pressure.
• Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine prevents calcium from entering the walls of blood vessels, preventing them from narrowing, and thus lowering blood pressure.

Nesyrgy is used to treat high blood pressure in adult patients who have already taken nebivolol and amlodipine in the form of separate tablets, in the same dose.

2. Important information before taking Nesyrgy

When not to take Nesyrgy

• if you are allergic to nebivolol, amlodipine, or a calcium antagonist of the dihydropyridine group, or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems
• if you have heart failure that has recently occurred or worsened, or if you are receiving intravenous treatment to support the heart due to cardiogenic shock in acute heart failure
• if you have certain severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block, heart conduction disorders)
• if you have asthma or wheezing (currently or in the past)
• if you have an untreated phaeochromocytoma (a tumor in the adrenal glands on top of the kidneys)
• if you have metabolic disorders (metabolic acidosis)
• if you have a very slow heart rate (less than 60 beats per minute)
• if you have low or very low blood pressure
• if you have severe circulatory disorders in the upper or lower limbs
• if you have a narrowing of the aortic valve or cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood)
• if you have heart failure after a heart attack.

Do not take Nesyrgy if you have any of the above conditions. If you are unsure, consult your doctor before taking Nesyrgy.

Warnings and precautions

Before taking Nesyrgy, consult your doctor or pharmacist. Tell your doctor if you have:

• a slow heart rate
• chest pain caused by spasm of the coronary arteries (Prinzmetal's angina)
• untreated chronic heart failure
• first-degree atrioventricular block (a mild heart conduction disorder that affects the heart rhythm)
• circulatory disorders in the hands or feet, such as Raynaud's disease or syndrome, or cramping pain when walking
• persistent breathing difficulties
• diabetes: this medicine does not affect blood sugar levels, but it may mask the warning signs of low blood sugar levels (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic medicines called sulfonylureas (e.g., gliclazide, glimepiride, glibenclamide, glipizide, or tolbutamide)
• hyperthyroidism: this medicine may mask the symptoms of an abnormally fast heart rate that occurs in this disease
• allergies: this medicine may increase the reaction to allergens
• psoriasis (a skin disease characterized by scaly, pink patches) or a history of psoriasis
• planned surgery - before anesthesia, always inform the anesthesiologist about taking Nesyrgy
• recent myocardial infarction
• recent heart failure or heart valve disorders or heart muscle disorders
• a significant increase in blood pressure (hypertensive crisis)

As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with heart or brain circulation disorders may lead to a heart attack or stroke. Your doctor will monitor your blood pressure closely in such cases. See also the information under "When not to take Nesyrgy".

Children and adolescents

Nesyrgy should not be used in children and adolescents under 18 years of age due to a lack of data on the use of the medicine in this age group.

Nesyrgy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, inform your doctor if you are taking:

• Other blood pressure-lowering medicines- may enhance the effect of Nesyrgy.
• Amiodarone, cybenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, molsidomine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil, blood pressure-lowering medicines or medicines used in heart disorders.

Barbiturates(a group of medicines used as sedatives and antipsychotics, but also in epilepsy, anxiety disorders, insomnia, and seizure disorders), as the effect of Nesyrgy may be enhanced.

• Phenothiazine(a group of medicines used as sedatives and antipsychotics, but also in the case of vomiting and nausea), as the effect of Nesyrgy may be enhanced.
• Thioridazine(a group of medicines used as sedatives and antipsychotics), as the effect of Nesyrgy may be enhanced.
• Amitriptyline, fluoxetine, paroxetine, antidepressant medicines, as the effect of Nesyrgy may be enhanced.
• Medicines used for anesthesia during surgery.
• Medicines used for asthma, nasal congestion, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils.
• Baclofen(a muscle relaxant); amifostine(a medicine with a protective effect, used during cancer treatment).
• Medicines used in diabetes, such as insulinor oral antidiabetic medicines; Nesyrgy does not affect blood sugar levels, but it may mask the warning signs of low blood sugar levels (e.g., palpitations, rapid heartbeat). However, concomitant use of Nesyrgy with sulfonylureas may increase the risk of severe hypoglycemia (see also the information under "Warnings and precautions").
• Medicines used in acid reflux and ulcers (medicines that reduce stomach acid production): take Nesyrgy with food, and the antacid between meals.
• Ketoconazole, itraconazole(antifungal medicines)
• Ritonavir, indinavir, nelfinavir(so-called protease inhibitors, used in the treatment of HIV infections)
• Rifampicin, erythromycin, clarithromycin(antibiotics)
• St. John's Wort (Hypericum perforatum)
• Dantrolene(given by infusion in the case of severe body temperature disorders)
• Tacrolimus, sirolimus, temsirolimus, everolimus(medicines used to modify the immune system)
• Simvastatin(a medicine used to lower cholesterol levels)
• Cyclosporin(an immunosuppressive medicine, a medicine that suppresses the immune system)

Taking Nesyrgy with food, drink, and alcohol

Nesyrgy can be taken with or without food.
Patients taking Nesyrgy should not consume grapefruit juice or grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may result in unpredictable enhancement of the blood pressure-lowering effect of Nesyrgy.
Caution is advised when drinking alcohol while taking Nesyrgy, as it may cause dizziness or fainting. In such cases, do not drink alcohol, including wine, beer, and carbonated alcoholic beverages.

Pregnancy and breastfeeding

Pregnancy

As there is no sufficient clinical data available on pregnant women, Nesyrgy should not be used during pregnancy. The use of Nesyrgy may be considered only when no other safer alternatives are available and after careful individual assessment of the risk-benefit ratio by the doctor. Therefore, if you are pregnant, think you may be pregnant, or plan to have a baby, tell your doctor. Consult your doctor before taking this medicine.
In the case of using Nesyrgy during pregnancy, careful monitoring of the fetus and newborn may be necessary.

Breastfeeding

If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine. Nesyrgy should not be used in breastfeeding mothers, and your doctor may recommend using a different medicine if you want to breastfeed.

Driving and using machines

Nesyrgy may affect your ability to drive and use machines. If you experience nausea, dizziness, fatigue, or headache while taking Nesyrgy, do not drive or operate machinery. Consult your doctor immediately.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., it is essentially "sodium-free".

3. How to take Nesyrgy

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day, preferably at the same time every day.
Nesyrgy can be taken before, during, or after meals, as well as independently of meals.
It is best to take the tablet with a sufficient amount of water, without chewing the tablet. Do not take Nesyrgy with grapefruit juice.
The score line on the tablet is only to facilitate breaking and swallowing.

Taking a higher dose of Nesyrgy than recommended

In case of accidental overdose, tell your doctor or pharmacist immediately.
The most common subjective and objective symptoms of overdose are: low blood pressure that can lead to fainting (hypotension) with possible rapid heartbeat (reflex tachycardia), very slow heart rate (bradycardia), shortness of breath similar to that in asthma (bronchospasm), acute heart failure.
Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Nesyrgy

If you miss a dose of Nesyrgy but remember soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and the time for the next dose is approaching, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose. Avoid missing doses of Nesyrgy repeatedly.

Stopping treatment with Nesyrgy

Before stopping treatment with Nesyrgy, always consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nesyrgy can cause side effects, although not everybody gets them.

Consult your doctor immediately if you experience any of the following side effects after taking this medicine:

side effects:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue or throat, which can cause severe breathing difficulties
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching of the skin, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by very poor general health.

Other side effects have been reported. If any of the following side effects cause you a problem, contact your doctor.

Other possible side effects of Nesyrgy:

Very common(may affect more than 1 in 10 people):

• swelling of the hands or feet (edema)

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

• fatigue
• abdominal pain, nausea
• dizziness
• headache
• drowsiness
• tingling, burning, numbness, or prickling sensation
• palpitations
• hot flushes
• change in bowel movements (including diarrhea and constipation)
• indigestion
• swelling of the ankles
• muscle cramps
• weakness
• vision disturbances, double vision

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

• slow heart rate or other heart disorders
• low blood pressure
• cramping leg pain when walking
• depressive disorders
• vomiting
• shortness of breath similar to that in asthma, caused by sudden constriction of the airways (bronchospasm)
• nightmares
• insomnia
• mood changes (including anxiety disorders)
• taste disturbances
• tingling or numbness in the limbs; loss of pain sensation
• fainting
• tremors
• ringing in the ears
• arrhythmia (including ventricular tachycardia and atrial fibrillation)
• heart failure
• cough
• runny or stuffy nose due to inflammation of the nasal mucous membrane
• dryness of the mucous membrane of the mouth
• bloating
• hair loss
• excessive sweating
• itching skin, red spots on the skin, skin discoloration
• joint or muscle pain
• back pain
• inability to achieve or maintain an erection
• discomfort or enlargement of the breasts in men
• discomfort while urinating; increased need to urinate at night; increased frequency of urination
• pain, poor general health
• weight gain or loss

Rare(may affect up to 1 in 1,000 people):

• disorientation

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

• reduced white blood cell count, reduced platelet count, which may result in unusual bruising or prolonged bleeding
• exacerbation of psoriasis (a skin disease characterized by scaly, pink patches)
• increased blood sugar levels (hyperglycemia)
• increased muscle tension
• nerve disorders, which can cause muscle weakness, tingling, or numbness
• inflammation of blood vessels (often with skin rash)
• stomach bloating (gastritis)
• gum swelling
• abnormal liver function, hepatitis, jaundice, increased liver enzyme activity, which may affect some medical tests
• increased sensitivity to light

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

• tremors, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Nesyrgy

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 the month.
There are no special storage precautions for this medicine.
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 Nesyrgy contains

• The active substances of Nesyrgy are nebivolol (as nebivolol hydrochloride) and amlodipine (as amlodipine besylate). Nesyrgy, 5 mg + 5 mg: each film-coated tablet contains 5 mg of nebivolol (as nebivolol hydrochloride: 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 5 mg of amlodipine (as amlodipine besylate). Nesyrgy, 5 mg + 10 mg: each film-coated tablet contains 5 mg of nebivolol (as nebivolol hydrochloride: 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 10 mg of amlodipine (as amlodipine besylate).
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, maize starch, hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate. tablet coating: Nesyrgy, 5 mg + 5 mg: OPADRY 02B220019 Yellow (consisting of: hypromellose, titanium dioxide, macrogol 400, yellow iron oxide (E 172)); Nesyrgy, 5 mg + 10 mg: OPADRY Y-1-7000 White (consisting of: hypromellose, titanium dioxide, macrogol 400).

What Nesyrgy looks like and contents of the pack

Nesyrgy 5 mg + 5 mg film-coated tablets are yellow, oval.
Nesyrgy 5 mg + 10 mg film-coated tablets are white, oval, with a score line on one side.
Nesyrgy is available in blisters of PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum, in packs containing 14, 28, 30, 56, 84, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Menarini International Operations Luxembourg S.A.
1 Avenue de la Gare
L-1611 Luxembourg
Luxembourg
Manufacturer:
Saneca Pharmaceuticals, a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, France, Greece, Hungary, Italy, Latvia, Luxembourg, Poland, Romania, Slovenia, Slovakia, Spain: Nesyrgy
Austria, Ireland, Portugal: Nebkliq
Lithuania: Kliqqo
Date of last revision of the leaflet:06/2025