Nivalin

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Nivalin, 2.5 mg/ml, solution for injection
Galantamine hydrobromide
Please read the entire 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, 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 the 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 package and other information

1. What Nivalin is and what it is used for

Nivalin is a medicine 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 disorders
of the neuromuscular 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 to any of the other components 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 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 in the heart;
• 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 shows symptoms of Parkinson's disease (tremors, 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 or urinary bladder, or during surgical procedures under general anaesthesia. 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 by the patient, 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 medicines (quinidine, digoxin, β-adrenergic receptor blockers, e.g. atenolol, propranolol); medicines 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 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 or 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 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 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
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 an interval of 1-2 months.
Use of a higher than recommended dose of Nivalin
Since the drug is administered by qualified medical personnel, overdose is unlikely. Nevertheless, any suspicion of overdose should be reported to the physician.
In case of doubts regarding the use of the medicine, consult your doctor.

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, and abdominal pain. Sometimes hypertension or low blood pressure may occur. Other symptoms include pupillary constriction, increased sweating and salivation, excessive discharge 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 itching, 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 symptoms occur, including any adverse effects 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, phone: +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 the sight and reach of children.
Do not use Nivalin after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Do not freeze. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Nivalin contains

• The active substance is galantamine hydrobromide. Each 1 ml ampoule contains 2.5 mg of galantamine hydrobromide.
• Other components: sodium chloride and water for injections.

What Nivalin looks like and contents of the pack
Nivalin, solution for injection is a clear, colourless or slightly yellow liquid.
Packaging:
Colourless glass ampoules in a blister.
1 blister pack contained in a cardboard box with a patient leaflet.
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 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:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warszawa
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warszawa
Marketing authorisation number in Latvia, country of export: 06-0144
Parallel import authorisation number: 90/18