Nivalin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Nivalin, 5 mg/ml, solution for injection
Galantamini hydrobromidum
Please read carefully the information in this leaflet before using the 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 questions, please 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 someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet

1. What Nivalin is and what it is 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 Nivalin is and what it is 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 substance called acetylcholine, which is involved in the transmission of nerve impulses in the central and peripheral nervous systems.
Nivalin is used in symptomatic supportive treatment of neurological neuromuscular and spinal disorders.

2. Important information before using Nivalin

When not to use Nivalin

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has bronchial asthma (breathing difficulties)
• 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, consult a doctor:

• if the patient has sick sinus syndrome (impaired generation of electrical impulses in the heart), prolonged QTc interval, or other conduction disorders;
• 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 shows symptoms of Parkinson's disease (tremor, rigidity, mask-like face, slow movements, and shuffling gait);
• if the patient suffers from severe respiratory disease (obstructive lung disease);
• if the patient has moderate renal impairment or urinary tract obstruction, if the patient has recently undergone surgical treatment of the prostate or urinary bladder, or 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 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 (used to treat fungal infections); ritonavir (used in the treatment of AIDS).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

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 medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, meaning 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 physician depending on 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 daily doses administered subcutaneously are as follows:
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 commonly, 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
Since Nivalin is administered by qualified medical personnel, overdose is unlikely. Nevertheless, any suspicion of overdose should be reported to the physician.
In case of any doubts regarding the use of the medicine, consult a physician.

4. Possible adverse effects

Like any medicine, Nivalin can cause adverse effects, although not everyone experiences them.
The Nivalin medicine may slow heart rate or cause cardiac arrhythmia, chest pain, palpitations,
nausea, vomiting, diarrhoea, increased peristalsis, abdominal pain. Sometimes hypertension or low
blood pressure may occur. Other symptoms include pupil constriction, increased sweating and
salivation, as well as excessive nasal, lacrimal and bronchial secretion, insomnia, muscle cramps,
dizziness, headache, rapid breathing and respiratory disturbances. Loss of appetite and weight loss
have been reported. Allergic reactions may occur in some patients, including itching, skin rash,
urticaria, and rhinitis. In isolated cases, severe hypersensitivity reactions with loss of consciousness
have been observed.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform
your doctor or nurse.
Adverse effects 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 effects, additional information on the safety of the medicine 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 in the original packaging to protect from light. Store at a temperature below 25°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nivalin contains

• The active substance is galantamine hydrobromide (Galantamini hydrobromidum).
• The other components are: sodium chloride and water for injections.

What Nivalin looks like and contents of the pack
Each 1 ml ampoule contains 5 mg of galantamine hydrobromide (Galantamini hydrobromidum).
Nivalin, solution for injection, is a clear, colourless or slightly yellow liquid.
Pack:
Ampoules made of colourless glass (Type I hydrolytic class) in PVC blisters, packed in a cardboard box.
Pack size:
Nivalin 5 mg/ml, 10 ampoules of 1 ml
For further information, please contact the responsible party or the parallel importer.
Responsible party in Latvia, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation number in Latvia, country of export: 06-0145
Parallel import licence number: 48/22