Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Side-effects may occur particularly at the beginning of treatment and if the dosage is increased too quickly (see Section 4.2). Due to the unknown number of users, the percentage frequency of spontaneously recorded side-effects cannot be determined exactly.

The following frequencies are used as the basis in the evaluation of side-effects: Very common (>1/10)
Common (>1/100 to <1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)


Infections and infestations
Not known: Parotitis.

Immune system disorders
Very rare: Hypersensitivity.

Psychiatric disorders
Rare: In higher doses excitement, agitation, fear, confusion, delirious syndromes, hallucinations, sleeplessness.
Central excitation effects are frequently seen in patients with symptoms of a cerebral deficiency and can necessitate a decrease in the dosage.
There have been reports of temporarily reduced REM sleep (sleeping phase with rapid eye movements), characterised by an increase in the time needed to reach this stage and a percentage decrease in the length of this phase in the total sleep.
Very rare: Nervousness, euphoria.

Nervous system disorders
Rare: Fatigue, dizziness and disturbance of memory.
Very rare: Headache, dyskinesia, ataxia and speaking disorder, increased disposition to cerebral seizures and convulsions.


Eye disorders
Very rare: Disturbance of accommodation, mydriasis, and photosensitivity. Closed- angle glaucoma might occur (controlling of intraocular pressure).

Cardiac disorders
Rare: Tachycardia
Very rare: Bradycardia. A fall in blood pressure may occur following parenteral administration.

Gastrointestinal disorders
Rare: Dryness of mouth, nausea, gastric disorder.
Very rare: Constipation

Skin and subcutaneous tissue disorders
Very rare: Reduced perspiration, allergic rash.
Musculoskeletal and connective tissue disorders
Rare: Muscle twitching.

Renal and urinary disorders
Very rare: Voiding disorders, especially in patients with prostate adenoma (dose reduction), more seldom: urinary retention.

General disorders and administration site conditions
Rare: Drowsiness.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il