Nivalin

Package Leaflet: Information for the Patient

Nivalin, 2.5 mg/ml, Solution for Injection

Nivalin, 5 mg/ml, Solution for Injection

Galantamine Hydrobromide

Read the Leaflet Carefully Before Using the Medication, 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 medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, 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 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. Package Contents 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 medications 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 for the symptomatic treatment of neurological diseases of the nervous and muscular system and the spinal cord.

2. Important Information Before Using Nivalin

When Not to Use Nivalin

Warnings and Precautions

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

Nivalin and Other Medications

Tell your doctor about all medications the patient is currently taking or has recently taken, as well as medications the patient plans to take. Some medications may increase the likelihood of side effects in people taking Nivalin. These include: anti-arrhythmic or antihypertensive medications (quinidine, digoxin, beta-blockers, e.g., atenolol, propranolol); medications 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 medication.

Driving and Operating Machines

Nivalin may cause vision disturbances, dizziness, and drowsiness, which may affect the ability to drive vehicles and operate machines. Nivalin contains sodium. This medication contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means the medication 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:

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 medication 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.

Use of a Higher Than Recommended Dose of Nivalin

The medication is administered by qualified medical personnel, so its overdose is unlikely. Nevertheless, any suspicions of overdose should be reported to the doctor. In case of doubts about the use of the medication, consult a doctor.

4. Possible Side Effects

Like all medications, Nivalin can cause side effects, although not everybody gets them. Nivalin may slow down 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 breathing difficulties. Weight loss and loss of appetite have been reported. Some patients may experience allergic reactions, including itching, skin rash, hives, and rhinitis. In individual 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, inform your doctor 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to Store Nivalin

Store the medication out of sight and reach of children. Do not use this medication after the expiry date stated on the label after "Expiry Date (EXP)". The expiry date refers to the last day of the specified month. Store at a temperature below 25°C. Do not freeze. Protect from light.

6. Package Contents and Other Information

What Nivalin Contains

• The active substance of the medication is galantamine hydrobromide
• Other ingredients are: sodium chloride and water for injections

What Nivalin Looks Like and What the Package Contains

1 ampoule of 1 ml contains 2.5 mg or 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 blister pack. 1 blister pack placed in a cardboard box with a patient leaflet.

Package Size:

Nivalin, 2.5 mg/ml: 1 blister pack of 10 ampoules in a cardboard box. Nivalin, 5 mg/ml: 1 blister pack of 5 or 10 ampoules in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sopharma Warszawa Sp. z o.o. Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

SOPHARMA AD 16 Iliensko Shosse str. 1220 Sofia Bulgaria

Date of Last Update of the Leaflet: