PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
NIVALIN
5 mg/ml, injection solution
Galantamini hydrobromidum
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet:

What is Nivalin and what is it used for
Important information before using Nivalin
How to use Nivalin
Possible side effects
How to store Nivalin
Contents of the package and other information

1. WHAT IS NIVALIN AND WHAT IS IT USED FOR

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

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINAL PRODUCT NIVALIN

When not to use Nivalin

if the patient is allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6);
if the patient has bronchial asthma (difficulty breathing);
if the patient has slow heart rate (bradycardia) or conduction disorders (atrioventricular block);
if the patient has ischemic heart disease (inadequate 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 treatment with Nivalin, discuss with the doctor:

if the patient has sick sinus syndrome (impaired generation 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 heart rate (digoxin, β-adrenergic receptor blockers);
if the patient has been diagnosed with high or low blood potassium levels;
if the patient has symptoms of Parkinson's disease (tremor, rigidity, mask-like facial expression, slow movements, and shuffling gait);
if the patient suffers from severe respiratory disease (chronic 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 gland or urinary bladder; as well as during surgical procedures under general anesthesia. If excessive weight loss occurs during treatment with Nivalin, it should be monitored.

Nivalin and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient intends to take.
Some medicines may increase the likelihood of adverse effects in patients taking Nivalin. These include: antiarrhythmic or antihypertensive drugs (quinidine, digoxin, β-adrenergic receptor blockers, e.g. atenolol, propranolol); drugs 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicinal product.

Driving and operating machinery
Nivalin may cause visual disturbances, dizziness, and drowsiness, which may affect the ability to drive and operate machinery.

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

3. HOW TO USE THE MEDICINAL PRODUCT NIVALIN

The medicinal product Nivalin is administered by qualified medical personnel under medical supervision.
The dosage and duration of treatment are determined by the physician according to the type and severity of the disease.
Nivalin injection solution is administered subcutaneously, intramuscularly, or intravenously. Unless otherwise directed by the physician, the following dosage is recommended:
Treatment of neurological disorders
Use in adults
The recommended initial dose is 2.5 mg. Every 3–4 days the dose should be 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 physician, depending on the child's age. The drug is given subcutaneously in the following daily doses:
from 1 to 2 years of age 0.25 – 1.0 mg
from 3 to 5 years of age 0.50 – 5.0 mg
from 6 to 8 years of age 0.75 – 7.5 mg
from 9 to 11 years of age 1.0 – 10.0 mg
from 12 to 15 years of age 1.25 – 12.5 mg
above 15 years of age 1.25 – 15.0 mg
The duration of treatment depends on the nature and severity of the disease being treated. Most frequently, treatment lasts 40 to 60 days.
Treatment cycles may be repeated 2–3 times with an interval of 1–2 months.
Use of a higher than recommended dose of Nivalin
The medicinal product is administered by qualified medical personnel; therefore, overdose is unlikely. Nevertheless, any suspicion of overdose should be reported to the physician.
In case of any doubts regarding the use of the medicinal product, consult a physician.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, Nivalin may cause adverse reactions, although not everyone experiences them. Nivalin may slow heart rate or cause cardiac arrhythmia, chest pain, palpitations, nausea, vomiting, diarrhoea, increased peristalsis, and abdominal pain. Sometimes, hypertension or hypotension may occur. Other symptoms include miosis (pupillary constriction), increased sweating and salivation, as well as excessive secretion from the nose, lacrimal glands, and bronchi, insomnia, muscle cramps, dizziness, headache, rapid breathing, and respiratory disturbances. Loss of appetite and weight loss have been reported. In some patients, allergic reactions may occur, including pruritus, skin rash, urticaria, and rhinitis. In isolated cases, severe hypersensitivity reactions with loss of consciousness have been observed.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions, additional information on the safety of this medicinal product can be collected.

5. HOW TO STORE NIVALIN

Keep this medicine 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 stated month.
Store below 25 °C. Keep in the original packaging to protect from light. Do not freeze.

6. PACK CONTENTS AND OTHER INFORMATION

What the medicine Nivalin contains

The active substance is galantamine hydrobromide.
The other components are: sodium chloride and water for injections.

What Nivalin looks like and contents of the pack
1 ampoule with a volume of 1 ml contains 5 mg of galantamine hydrobromide.
Nivalin, solution for injection, is a clear, colourless or slightly yellow liquid.
Packaging:
Ampoules made of colourless type I glass in a PVC blister. 1 blister placed in a cardboard box together with the patient leaflet.
Pack size:
1 blister containing 10 ampoules of 1 ml, in a cardboard box.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, 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 Czesky Tesin, Czech Republic
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa, Działkowa 56, 02-234 Warsaw
Production site: Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY,
Wł. Żeleńskiego 45, 31-353 Kraków
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Marketing authorisation number in Bulgaria, country of export: 9700574
Parallel import authorisation number: 269/19