Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 transmitting 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 (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 your 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;

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if the patient has symptoms of Parkinson's disease (tremors, rigidity, mask-like facial expression, slow movements, and shuffling gait);
if the patient suffers from severe respiratory disorders (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
You must 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 medicines (quinidine, digoxin, β-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 (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 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 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:
Nivalin is available in strengths of 2.5 mg/ml and 5 mg/ml.
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 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 often, 40 to 60 days.
Treatment cycles may be repeated 2–3 times with intervals of 1–2 months.
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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 your doctor.

4. Possible adverse reactions

Like all medicines, Nivalin may cause adverse reactions, although not everyone experiences them.
The Nivalin medicine may slow down the 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: miosis (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 respiratory disturbances.
Loss of appetite and weight loss have been reported. In some patients, allergic reactions may occur, 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 symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist 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 allows for the collection of further information on the safety of medicine use.

5. How to store the medicine Nivalin

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Keep in the original packaging to protect from light.
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.
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 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.
Packaging:
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Colourless glass ampoules, packed in quantities of 5 pieces into cardboard inserts or 10 pieces into PVC blisters.
1 blister placed in a cardboard box together with the patient leaflet.
Pack size:
Nivalin 5 mg/ml, 1 blister containing 5 or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Latvia, country of export: 06-0145
Parallel Import Authorisation Number: 360/17
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