Nivalin

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nivalin, 5 mg/ml, Solution for Injection

Galantamine Hydrobromide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 compound called acetylcholine, which participates in the transmission of nerve impulses in the central and peripheral nervous system. Nivalin is used in the symptomatic treatment of neurological diseases, neuromuscular and spinal cord diseases.

2. Important information before using Nivalin

When not to use Nivalin

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

Warnings and precautions

Before starting to use Nivalin, the patient should discuss it with their doctor:

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

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

Nivalin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

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

Nivalin contains sodium

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

3. How to use Nivalin

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: Nivalin is available in a dose of 2.5 mg/ml and 5 mg/ml.

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. Usually, 40 to 60 days. Treatment cycles can be repeated 2-3 times at intervals of 1-2 months. Page 2 of 4

Use of a higher dose of Nivalin than recommended

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

4. Possible side effects

Like all medicines, Nivalin can cause side effects, although not everybody gets them. Nivalin may slow the 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: narrowed 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. Weight loss and loss of appetite have been reported. Some patients may experience allergic reactions, including itching, skin rash, hives, and rhinitis. In rare cases, severe hypersensitivity reactions with loss of consciousness have been observed.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Nivalin

The medicine should be stored out of 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 medicine 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. The patient should ask their 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 Nivalin contains

• The active substance of the medicine 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 5 mg of galantamine hydrobromide.

Packaging:

Page 3 of 4. Ampoules made of colorless glass, packaged in cardboard inserts, 5 pieces, or in PVC blisters, 10 pieces. 1 blister placed in a cardboard box with a patient leaflet.

Package size:

Nivalin 5 mg/ml, 1 blister of 5 or 10 ampoules in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the 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, the country of export: 06-0145

Parallel import authorization number: 360/17 Date of approval of the leaflet: 17.10.2022

[Information about the trademark]
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