Nivalin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Nivalin, 5 mg/ml, solution for injection

Galantamini hydrobromidum

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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. Contents of the packaging 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
• if the patient has severe renal or hepatic impairment.

Warnings and precautions

Before starting to use Nivalin, you should discuss it with your 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 down the heart rate (digoxin, beta-adrenergic receptor blockers);
• if the patient has high or low potassium levels in the blood;
• if the patient has symptoms of Parkinson's disease (tremors, stiffness, mask-like face, slow movements and shuffling gait);
• if the patient suffers from severe respiratory disease (obstructive pulmonary disease);
• if the patient has moderate renal impairment 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

You should tell your doctor about all medicines that you are currently taking or have recently taken, as well as about medicines that you plan to take. Some medicines may increase the risk of side effects in people taking Nivalin. These include: anti-arrhythmic or anti-hypertensive medicines (quinidine, digoxin, beta-adrenergic receptor blockers, e.g. atenolol, propranolol); medicines that affect 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 are planning to have a baby, you should consult your doctor before using this medicine.

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 medicine 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 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.

Use of a higher than recommended dose of Nivalin

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 related to the use of the medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, 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 respiratory disorders. Loss of appetite and weight loss have been reported. Some patients may experience allergic reactions, including itching, skin rash, urticaria, rhinitis. In individual cases, severe hypersensitivity reactions with loss of consciousness have been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Nivalin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Store in the original packaging to protect from light. Store at a temperature below 25°C. Do not freeze. 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 packaging and other information

What Nivalin contains

• The active substance of the medicine is galantamine hydrobromide (Galantamini hydrobromidum)
• The other ingredients are: sodium chloride and water for injections

What Nivalin looks like and what the packaging contains

One ampoule of 1 ml contains 5 mg of galantamine hydrobromide (Galantamini hydrobromidum). Nivalin, solution for injection, is a clear, colorless or pale yellow liquid.

Packaging:

Ampoules made of colorless glass (I hydrolytic class) in a PVC blister pack in a cardboard box.

Package size:

Nivalin, 5 mg/ml, 10 ampoules of 1 ml. For more detailed information, please contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Latvia, the country of export: 06-0145
Parallel import authorization number: 48/22
Date of approval of the leaflet: 19.01.2022
[Information about the trademark]