Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the Safety profile
In clinical studies, the overall incidence of adverse drug reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.

Tabulated list of adverse reactions
Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreased seriousness. The following terminologies have been used in order to classify the occurrence of undesirable 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).

The following adverse drug reactions were reported during clinical trials with Relestat:

System Organ Class          Frequency              Adverse Reaction 
Nervous system              Uncommon               Headache disorders
Eye disorders               Common                 Burning sensation, eye irritation Uncommon               Conjunctival/ocular hyperaemia,
eye discharge, eye dryness, eye pruritus, visual disturbance
Respiratory, thoracic and Uncommon                 Asthma, nasal irritation, rhinitis mediastinal disorders
Gastrointestinal disorders Uncommon                Dysgeusia 
The following adverse drug reactions were reported during post marketing use of epinastine in clinical practice:

System Organ           Frequency Adverse Reaction
Class
Immune system          Not known    Hypersensitivity reaction including symptoms or disorders                           signs of eye allergy and extra-ocular allergic reactions, including angioedema, skin rash and redness
Eye disorders          Not known    Increased lacrimation, eye pain, eye swelling, eyelid oedema

Paediatric population

Frequency, type and severity of adverse reaction in adolescents ≥ 12 years of age are expected to be the same as in adults.
There is limited experience in children aged 3-12 years regarding frequency, type and severity of adverse reactions.

Adverse reactions reported in phosphate containing eye drops Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas (see section 4.4).

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