Nivalin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

NIVALIN

5 mg/ml, solution for injection
Galantamine hydrobromide

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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 snowdrop bulbs.
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 supportive treatment of neurological diseases
of the nervous and muscular system and spinal cord.

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, 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 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 during treatment with Nivalin, excessive weight loss occurs, it should be monitored.

Nivalin and other medicines

You should tell your doctor about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
Some medicines may increase the likelihood 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 (AIDS treatment).

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:

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 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 they may not occur in everyone. Nivalin may slow down the heart rate or cause irregular heart rhythm, 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. Weight loss and loss of appetite have been reported. In some patients, allergic reactions may occur, including itching, skin rash, urticaria, 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, you should tell 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, more information can be collected on the safety of the use 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 a temperature below 25 ° C. Store in the original packaging to protect from light. Do not freeze.

6. CONTENTS OF THE PACKAGING 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 what the packaging contains

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

Packaging:

Ampoules made of type I colorless glass in a PVC blister. 1 blister placed in a cardboard box with a patient leaflet.

Package size:

1 blister of 10 ampoules of 1 ml, in a cardboard box.

In order to obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export, and manufacturer:

SOPHARMA AD, 16 Iliensko Shose Str., 1220 Sofia, Bulgaria

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czeski Cieszyn, Czech Republic

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Euceryna Laboratory Pharmaceutical COEL S.J. E.Z.M. KONSTANTY,
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw

Marketing authorization number in Bulgaria, the country of export: 9700574

Parallel import authorization number: 269/19

Date of approval of the leaflet: 01.07.2024

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