Nivalin

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Nivalin, 2.5 mg/ml, Solution for Injection

Galantamine Hydrobromide

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicinal product has been prescribed to you personally. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Nivalin and What is it Used For
• 2. Important Information Before Using Nivalin
• 3. How to Use Nivalin
• 4. Possible Side Effects
• 5. How to Store Nivalin
• 6. Contents of the Pack and Other Information

1. What is Nivalin and What is it Used For

Nivalin is a medicinal product containing galantamine - an alkaloid isolated from snowdrops. Galantamine belongs to a group of medicines called acetylcholinesterase inhibitors. It increases the concentration of a chemical substance called acetylcholine, which participates in the transmission of nerve impulses in the central and peripheral nervous system. Nivalin is used for the symptomatic treatment of neurological diseases of the neuromuscular junction and spinal cord.

2. Important Information Before Using Nivalin

When Not to Use Nivalin

• if you are allergic to the active substance or any of the other ingredients of this medicinal product (listed in section 6)
• if you have asthma (breathing difficulties)
• if you have a slow heart rate (bradycardia) or conduction disorders (atrioventricular block)
• if you have coronary heart disease (insufficient blood supply to the heart muscle) or severe heart failure (impaired heart function)
• if you have epilepsy
• if you have excessive motor activity (movement)
• if you have severe kidney or liver failure.

Warnings and Precautions

Before starting to use Nivalin, discuss it with your doctor:

• if you have sick sinus syndrome (disrupted formation of electrical impulses in the heart), prolonged QTc interval, or other conduction disorders in the heart;
• if you are taking other medicines that may slow down your heart rate (digoxin, beta-adrenergic receptor blockers);
• if you have high or low potassium levels in your blood;

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• if you have symptoms of Parkinson's disease (tremors, stiffness, mask-like face, slow movements, and shuffling gait);
• if you have severe respiratory disease (obstructive pulmonary disease);
• if you have moderate kidney failure or urinary tract obstruction, if you have recently undergone surgical treatment of the prostate or bladder, as well as during surgical operations under general anesthesia. If you lose too much weight during treatment with Nivalin, it should be monitored.

Nivalin and Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Some medicines may increase the risk of side effects in people taking Nivalin. These include: anti-arrhythmic or antihypertensive medicines (quinidine, digoxin, beta-adrenergic receptor blockers, e.g., atenolol, propranolol); medicines affecting the QTc interval; antibiotics (gentamicin, amikacin, erythromycin); antidepressants (paroxetine, fluoxetine); ketoconazole (treatment of fungal infections); ritonavir (treatment of AIDS).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicinal product.

Driving and Using Machines

Nivalin may cause vision disturbances, dizziness, and drowsiness, which may affect your ability to drive and use machines.

Nivalin Contains Sodium

This medicinal product contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means that it is considered "sodium-free".

3. How to Use Nivalin

Nivalin is available in a dose of 2.5 mg/ml and 5 mg/ml. Nivalin is administered by qualified medical personnel under medical supervision. The dosage and duration of treatment are determined by the doctor, depending on the type and severity of the disease. Nivalin solution for injection is administered subcutaneously, intramuscularly, or intravenously. If the doctor does not recommend otherwise, the following dosage is recommended:

Treatment of Neurological Diseases

Use in Adults

The recommended initial dose is 2.5 mg. Every 3-4 days, the dose is gradually increased by 2.5 mg in 2 or 3 divided doses. The maximum single dose in adults is 10 mg subcutaneously, and the maximum daily dose is 20 mg.

Use in Children and Adolescents

Nivalin is administered subcutaneously in doses determined by the doctor, depending on the child's age. The medicine is administered subcutaneously in the following daily doses: from 1 to 2 years: 0.25-1.0 mg; from 3 to 5 years: 0.50-5.0 mg; from 6 to 8 years: 0.75-7.5 mg; from 9 to 11 years: 1.0-10.0 mg; from 12 to 15 years: 1.25-12.5 mg; over 15 years: 1.25-15.0 mg. The duration of treatment depends on the nature and severity of the treated disease. Most often, it is 40 to 60 days. Treatment cycles can be repeated 2-3 times at intervals of 1-2 months. Page 2 of 4

Overdose of Nivalin

The medicine is administered by qualified medical personnel, so overdose is unlikely. Nevertheless, suspected overdose should be reported to the doctor. In case of doubts about the use of the medicinal product, consult your doctor.

4. Possible Side Effects

Like all medicines, Nivalin can cause side effects, although not everybody gets them. Nivalin may slow down your heart rate or cause irregular heartbeat, chest pain, palpitations, nausea, vomiting, diarrhea, increased peristalsis, abdominal pain. Sometimes, high or low blood pressure is observed. Other symptoms include: narrowing of the pupils, increased sweating and salivation, as well as excessive discharge from the nose, tear glands, and bronchi, insomnia, muscle cramps, dizziness, headaches, rapid breathing, and respiratory disorders. Loss of appetite and weight loss have been reported. Some patients may experience allergic reactions, including itching, skin rash, urticaria, and rhinitis. In rare cases, severe hypersensitivity reactions with loss of consciousness have been observed.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Nivalin

Keep the medicinal product out of the sight and reach of children. Store in a temperature below 25°C. Do not freeze. Store in the original packaging to protect from light. Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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 Nivalin Contains

• The active substance is galantamine hydrobromide.
• The other ingredients are sodium chloride and water for injections.

What Nivalin Looks Like and Contents of the Pack

1 ampoule of 1 ml contains 2.5 mg of galantamine hydrobromide. Nivalin, solution for injection, is a clear, colorless or pale yellow liquid.

Packaging:

Ampoules made of colorless glass in a PVC blister. 1 blister placed in a cardboard box with a patient leaflet. Page 3 of 4

Package Size:

1 blister of 10 ampoules in a cardboard box. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Latvia, Country of Export:

Sopharma AD, 16, Iliensko Shosse Str., 1220 Sofia, Bulgaria

Manufacturer:

Sopharma AD, 16, Iliensko Shosse Str., 1220 Sofia, Bulgaria

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Marketing Authorization Number in Latvia, Country of Export: 06-0144

Parallel Import Authorization Number: 132/18 Date of Approval of the Leaflet: 18.04.2023

[Information about the trademark] Page 4 of 4