Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language!
Nivalin
5 mg/ml, solution for injection
Galantamini hydrobromidum
Please read this leaflet carefully 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 doubts, 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

What Nivalin is and what it is used for
Important information before using Nivalin
How to use Nivalin
Possible side effects
How to store Nivalin
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 cord 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 (difficulty breathing)
if the patient has a slow heart rate (bradycardia) or conduction disorders (atrioventricular block)
if the patient has ischaemic 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 your doctor:

if the patient has sick sinus syndrome (impaired generation of electrical impulses in the heart), prolonged QTc interval, or other cardiac conduction disorders;
if the patient is taking other medicines that may slow the 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 (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 gland or urinary bladder, or during surgical procedures under general anaesthesia.
If excessive weight loss occurs during treatment with Nivalin, it should be monitored.

Nivalin with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 (for treatment of fungal infections); ritonavir (for 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 her 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, solution for injection, 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 prescribed by the physician, depending on the child's age.
The drug is given subcutaneously in the following daily doses:
1 to 2 years 0.25 - 1.0 mg
3 to 5 years 0.50 - 5.0 mg
6 to 8 years 0.75 - 7.5 mg
9 to 11 years 1.0 - 10.0 mg
12 to 15 years 1.25 - 12.5 mg
above 15 years 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 intervals of 1-2 months.
Use of a higher than recommended dose of Nivalin
The drug 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 drug, consult your physician.

4. Possible adverse reactions

Like all medicines, 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, abdominal pain. Sometimes, high or low blood pressure may occur. Other symptoms include pupil 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 breathing disorders. Loss of appetite and weight loss have been reported. Allergic reactions may occur in some patients, including itching, skin rash, urticaria, 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 at 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Nivalin

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light. Store at a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nivalin contains

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

What Nivalin looks like and contents of the pack
1 ampoule with a capacity of 1 ml contains 5 mg of galantamine hydrobromide.
Nivalin, solution for injection, is a clear, colourless or slightly yellow liquid.
Pack:
Ampoules made of colourless glass in a PVC foil blister, packed in a cardboard box.
Pack size:
1 blister containing 10 ampoules in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Sopharma AD
16 Iliensko shose str.
1220 Sofia
Bulgaria
Manufacturer:
Sopharma AD
16 Iliensko shose str.
1220 Sofia
Bulgaria
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Bulgaria, the country of export: 9700574
Parallel import licence number: 233/19