NESYRGY 5 MG/5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nesyrgy 5 mg / 5 mg Film-Coated Tablets

nebivolol/amlodipine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Nesyrgy and what is it used for
2. What you need to know before you take Nesyrgy
3. How to take Nesyrgy
4. Possible side effects
5. Storage of Nesyrgy
6. Contents of the pack and further information

1. What is Nesyrgy and what is it used for

Nesyrgy contains two active substances called nebivolol and amlodipine. These two substances help control high blood pressure:

• nebivolol is a medicine with cardiovascular action, belonging to the group of "selective beta-blockers" (i.e., with selective activity in the cardiovascular system). It prevents an increase in heart rate and controls the heart's pumping force. It also has a vasodilating effect on blood vessels, which in turn helps to lower blood pressure.

• amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing and, in turn, reduces blood pressure.

Nesyrgy is used to treat high blood pressure in adult patients who are already taking nebivolol and amlodipine in separate tablets at the same doses.

2. What you need to know before you take Nesyrgy

Do not take Nesyrgy if:

• you are allergic to nebivolol, amlodipine, or any special group of calcium channel blockers, dihydropyridines, or any of the other components of this medicine (listed in section 6)
• you have liver problems
• you have heart failure that has recently occurred or worsened, or you are receiving treatment for circulatory shock due to acute heart failure with intravenous infusion to help your heart work
• you have severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block, cardiac conduction disorders)
• you have asthma or wheezing (now or in the past)
• you have an untreated pheochromocytoma, a tumor located in the adrenal glands, which are located at the top of the kidneys
• you have a metabolic disorder (metabolic acidosis)
• your heart rate is very slow (less than 60 beats per minute)
• you have low or severely low blood pressure
• you have severe circulation problems in your arms and legs
• you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body)
• you have heart failure after a heart attack.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Tell your doctor if:

• your heart rate is abnormally slow
• you have a type of chest pain due to a spontaneous spasm of the heart called "Prinzmetal's angina"
• you have untreated chronic heart failure
• you have first-degree heart block (a type of mild cardiac conduction disorder that affects heart rate)
• you have poor circulation in your arms or legs, e.g., Raynaud's disease or syndrome, cramp-like pain when walking
• you have prolonged respiratory problems
• you have diabetes: this medicine does not affect blood sugar, but it could hide the warning signs of low blood sugar (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with a certain type of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide)
• you have hyperthyroidism: this medicine may mask the signs of an abnormally rapid heart rate due to this condition.
• you have an allergy: this medicine may intensify your reaction to pollen or other substances you are allergic to
• you have psoriasis (a skin disease - scaly pink patches) or if you have ever had psoriasis
• you need to have surgery, always inform your anesthesiologist that you are taking this medicine before being anesthetized
• you have had a recent heart attack
• you have recently had heart failure or problems with your heart valves or heart muscle
• you have a severe increase in blood pressure (hypertensive crisis)

As with any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with disorders of blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

See also the information under the heading 'Do not take Nesyrgy'.

Children and adolescents

Due to the lack of data on the use of this medicine in children and adolescents under 18 years of age, the use of Nesyrgyis not recommended in them.

Other medicines and Nesyrgy

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking:

• Other medicines to lower blood pressure, as they may increase the effect of this medicine.
• Amiodarone, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil, medicines to control blood pressure or medicines for heart problems.
• Barbiturates(a group of medicines used as sedatives and therapy for psychosis, but also for epilepsy, anxiety, insomnia, and convulsive disorders), as they may increase the effect of this medicine.
• Phenothiazines(a group of medicines used as sedatives and for psychosis, but also for vomiting and nausea), as they may increase the effect of this medicine.
• Thioridazine(a group of medicines used as sedatives and therapy for psychosis), as it may increase the effect of this medicine.
• Amitriptyline, paroxetine, fluoxetine, medicines for depression, as they may increase the effect of this medicine.
• Medicines used for anesthesia during an operation.
• Medicines for asthma, nasal congestion, and some eye disorders such as glaucoma (increased pressure in the eye) or dilation (enlargement) of the pupil.
• Baclofen(an antispastic medicine); Amifostine(a protective medicine used during cancer treatment).
• Medicines for diabetes, such as insulinor oral antidiabetics; this medicine does not affect blood sugar, but it could hide the signs that warn of low blood sugar (e.g., palpitations, rapid heartbeat). However, the concomitant use of Nesyrgy with a group of medicines called sulfonylureas may increase the risk of severe hypoglycemia (see also the information under the heading "Warnings and precautions").
• Medicines to treat excess acidity in the stomach or ulcers (antacid medicines): you should take this medicine during meals and the antacid medicine between meals.
• Ketoconazole, itraconazole(antifungal medicines).
• Ritonavir, indinavir, nelfinavir(protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin(antibiotics).
• Hypericum perforatum(St. John's Wort).
• Dantrolene(infusion for severe body temperature disorders).
• Tacrolimus, sirolimus, temsirolimus, and everolimus(medicines used to modify the functioning of your immune system).
• Simvastatin(a medicine to lower cholesterol).
• Ciclosporin(an immunosuppressive medicine).

Taking Nesyrgy with food and drinks

Nesyrgy can be taken with or without food.

People taking this medicine should not consume grapefruit juice or grapefruit. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of this medicine.

Be careful when drinking alcohol while taking this medicine, as you may feel dizzy or faint. If this happens, do not drink alcohol, including wine, beer, or soft drinks that contain alcohol.

Pregnancy and breast-feeding

Pregnancy

As there are no sufficient clinical data available related to pregnant women, this medicine is not recommended during pregnancy. This medicine may only be considered if there is no safer alternative and after your doctor has performed a careful individual benefit/risk assessment, so if you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not forget to consult your doctor before taking this medicine.

In case of use during pregnancy, careful monitoring of the fetus and newborn may be necessary.

Breast-feeding

If you are breast-feeding or plan to start breast-feeding, consult your doctor before using this medicine. This medicine is not recommended in breast-feeding mothers, and your doctor may choose another medicine for you if you wish to breast-feed.

Driving and using machines

This medicine may affect your ability to drive or use machines. If the medicine makes you feel unwell, dizzy, or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Nesyrgy

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day, preferably at the same time each day.

Nesyrgy can be taken before, during, or after meals, but, alternatively, it can be taken independently of meals. The tablet is best taken with water, without chewing. Do not take Nesyrgy with grapefruit juice.

The score line is only for breaking the tablet if you have difficulty swallowing the whole tablet.

If you take more Nesyrgy than you should

If you accidentally take an overdose of this medicine, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

The most frequent symptoms and signs of overdose are low blood pressure with fainting (hypotension) with possible increased heart rate (reflex tachycardia), very slow heart rate (bradycardia), asthma-like shortness of breath (bronchospasm), and acute heart failure.

Excess fluid may accumulate in your lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you forget to take Nesyrgy

If you forget to take this medicine, but remember soon after when you should have taken it, take the daily dose as you usually do. However, if a long time has passed (e.g., several hours), so that it is close to the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for missed doses. However, repeated forgetting should be avoided.

If you stop taking Nesyrgy

Always consult your doctor before stopping treatment with this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions including intense skin rash, hives, skin redness, severe itching, blisters, peeling and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort.

Other adverse effects that have been reported are presented below. If any of them cause you problems, consult your doctor.

Other possible adverse effects withNesyrgy:

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

• swelling of feet and hands (edema)

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

• fatigue
• abdominal pain, nausea
• dizziness
• headache
• drowsiness
• burning sensation, tingling, itching, numbness, prickling, "pins and needles" or tingling
• palpitations
• flushing
• alteration of intestinal habits (including diarrhea and constipation)
• indigestion
• swelling of ankles
• muscle cramps
• weakness
• visual disturbances, double vision

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

• slow heartbeats or other cardiac disorders
• low blood pressure
• leg pain similar to cramps when walking
• feeling of depression
• vomiting
• shortness of breath as in asthma, due to sudden cramps in the muscles around the airways (bronchospasm)
• nightmares
• insomnia
• mood changes (including anxiety)
• taste disturbances
• feeling of numbness or tingling in the extremities; loss of pain sensation
• fainting
• tremors
• ringing in the ears
• arrhythmia (including ventricular tachycardia and atrial fibrillation)
• heart failure
• cough
• sneezing/nasal secretion caused by inflammation of the nasal mucosa
• dry mouth
• flatulence
• hair loss
• increased sweating
• itching of the skin, red rashes, skin discoloration
• joint or muscle pain
• back pain
• inability to obtain or maintain an erection
• breast tenderness or enlargement in men
• urination problems, increased need to urinate at night, increased number of times urinating
• pain, feeling of discomfort
• weight loss or gain

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

• confusion

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

• decrease in the number of white blood cells, decrease in blood platelets that may result in unusual bruising or easy bleeding
• worsening of psoriasis (a skin disease - pink scaly patches)
• excess sugar in the blood (hyperglycemia)
• increased muscle tension
• a nerve disorder that can cause muscle weakness, tingling or numbness
• inflammation of blood vessels, often with skin rash
• abdominal swelling (gastritis)
• inflammation of the gums
• abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may have an effect on some medical tests
• sensitivity to light

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

• tremors, rigid posture, mask-like face, slow movements and unsteady gait

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nesyrgy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the drains or into the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Nesyrgy

• The active ingredients are nebivolol (as nebivolol hydrochloride) and amlodipine (as amlodipine besylate).

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).

• The other components are:

Core of the tablet:microcrystalline cellulose, sodium croscarmellose, corn starch, hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate.

Film coating:OPADRY^®02B220019 yellow (composed of: hypromellose, titanium dioxide, macrogol 400, yellow iron oxide (E172)).

Appearance of the Product and Package Contents

Nesyrgy 5 mg/5 mg film-coated tablets are yellow, oval.

Nesyrgy is available in PVC/PVDC-Al or OPA/Al/PVC-Al blisters, abbreviated as Al-Al blisters, in packages containing 14, 28, 30, 56, 84, 90 film-coated tablets.

Only some package 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

Local Representative

Laboratorios Menarini, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona), Spain

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

Belgium, Bulgaria, Cyprus, Croatia, Estonia, Slovenia, Spain, France, Greece, Hungary, Italy, Latvia, Luxembourg, Poland, Czech Republic, Slovakia, Romania: Nesyrgy

Austria, Ireland, Portugal: Nebkliq

Lithuania: Kliqqo

Date of the last revision of this prospectus: April 2025

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS http://www.aemps.gob.es/)