Nesirgi

Leaflet attached to the packaging: information for the user

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

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

Nebivolol + Amlodipine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their 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 lower high blood pressure.

• Nebivolol is a medicine that acts on the cardiovascular system, belonging to the group of selective beta-adrenergic blockers (i.e., selectively affecting the cardiovascular system). It prevents the acceleration of heart activity and controls the strength of heart contractions. It also dilates blood vessels, which helps lower blood pressure.
• Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine inhibits the penetration of calcium into the walls of blood vessels, preventing their 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 the patient is 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).
• 6).
• if the patient has liver disorders
• if the patient has heart failure that has recently occurred or worsened, or if the patient is receiving intravenous treatment to support heart function due to cardiogenic shock in acute heart failure
• if the patient has certain severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block, heart conduction disorders)
• if the patient has asthma or wheezing (currently or in the past)
• if the patient has an untreated pheochromocytoma: a tumor located in the adrenal glands on top of the kidneys
• if the patient has metabolic disorders (metabolic acidosis)
• if the patient has a very slow heart rate (less than 60 beats per minute)
• if the patient has low or very low blood pressure
• if the patient has severe circulation disorders in the upper or lower limbs
• if the patient has aortic stenosis or cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood)
• if the patient has heart failure after a heart attack.

You should not take Nesyrgy if you have any of the above conditions. In case of any doubts, you should discuss this with your doctor before taking Nesyrgy.

Warnings and precautions

You should discuss taking Nesyrgy with your doctor or pharmacist before starting treatment.
You should tell your doctor if you have:

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

Like other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with heart or brain circulation disorders may lead to heart attack or stroke. The doctor will recommend careful blood pressure monitoring in such patients.
See also the information under the heading "When not to take Nesyrgy".

Children and adolescents

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

Nesyrgy and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, you should 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,

moxonidine, 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 convulsive 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, stuffy nose, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupil.
• 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 warning signs of low blood sugar levels (e.g., palpitations, rapid heart rate). However, concomitant use of Nesyrgy with a group of medicines called sulfonylureas (such as gliclazide, glipizide, glibenclamide, glimepiride, or tolbutamide) may increase the risk of severe hypoglycemia (see also the information in the subsection "Warnings and precautions").
• Medicines used in hyperacidity and peptic ulcer disease (medicines that reduce stomach acid secretion): Nesyrgy should be taken during meals, 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's activity)
• Simvastatin(a medicine used to reduce cholesterol levels)
• Cyclosporine(an immunosuppressive medicine, a medicine that inhibits the immune system's activity)

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 cause an increase in the level of the active substance amlodipine in the blood, which may result in unpredictable enhancement of Nesyrgy's blood pressure-lowering effect.
Caution should be exercised when drinking alcohol while taking Nesyrgy, as fainting or dizziness may occur. In such cases, you should not drink alcohol, including wine, beer, and alcoholic fizzy drinks.

Pregnancy and breastfeeding

Pregnancy

As there is not enough clinical data available on pregnant women, Nesyrgy should not be used during pregnancy. The use of Nesyrgy can be considered only when no other safer options are available and after careful, individual assessment of the risk-to-benefit ratio by the doctor. Therefore, if you are pregnant, think you may be pregnant, or plan to have a baby, you should 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 start breastfeeding, you should consult your doctor before taking this medicine. Nesyrgy should not be used in breastfeeding mothers, and the 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, you should not drive or operate machinery. You should consult your doctor immediately.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Nesyrgy

This medicine should always be taken exactly as prescribed by your doctor. In case of doubts, you should 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 meals, during meals, 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. You should not take Nesyrgy with grapefruit juice.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Taking a higher dose of Nesyrgy than recommended

In case of accidental overdose, you should immediately inform your doctor or pharmacist.
The most common subjective and objective symptoms of overdose are: low blood pressure that can lead to fainting (hypotension) with possible rapid heart rate (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 caused by 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, you should take the missed dose for that day. However, if there is a significant delay (e.g., several hours) and the next dose is approaching, you should skip the missed dose and take the next scheduled dose at the usual time. You should not take a double dose to make up for the missed dose. You should avoid missing doses of Nesyrgy frequently.

Stopping treatment with Nesyrgy

Before stopping treatment with Nesyrgy, you should always consult your doctor.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should immediately consult your doctor 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 condition.

The following other side effects have been reported. You should contact your doctor if any of the following side effects cause a problem.

Other possible side effects of Nesyrgy:

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

• swelling of the hands or feet (edema)

Common(may occur less frequently than in 1 in 10 people):

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

Uncommon(may occur less frequently than in 1 in 100 people):

• slow heart rate or other heart disorders
• low blood pressure
• cramping leg pain while walking
• depressive disorders
• vomiting
• shortness of breath similar to that in asthma, caused by sudden contraction of the airway muscles (bronchospasm)
• nightmares
• insomnia
• mood changes (including anxiety disorders)
• taste disturbances
• tingling or numbness sensation in the limbs; loss of pain sensation
• fainting
• tremors
• ringing in the ears
• arrhythmia (including ventricular tachycardia and atrial fibrillation)
• heart failure
• cough
• runny nose or nasal congestion due to inflammation of the nasal mucosa
• dryness of the mucous membranes 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 condition
• weight gain or loss

Rare(may occur less frequently than in 1 in 1000 people):

• disorientation

Very rare(may occur less frequently than in 1 in 10,000 people):

• decrease in white blood cell count, decrease in platelet count, which may result in unusual bruising or prolonged bleeding
• exacerbation of psoriasis (a skin disease characterized by scaly, pink patches)
• increase in blood sugar levels (hyperglycemia)
• increase in muscle tone
• nerve disorder, which can cause muscle weakness, tingling, or numbness
• inflammation of blood vessels (often with skin rash)
• abdominal 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 any side effects not mentioned in this leaflet, you should 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

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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, corn 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 dividing line on one side.
Nesyrgy is available in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, 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, you should 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