Adverse reactions : תופעות לוואי

4.8 Undesirable effects

a.   Summary of the safety profile
The majority of adverse reactions relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.4). Other ocular adverse reactions are generally transient and occur on dose administration.
b. Tabulated list of adverse reactions
Adverse reactions are categorized by frequency as follows: 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) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).




System Organ Class      Very Common             Common              Uncommon        Rare                 Very Rare ≥1/10                   ≥1/100 to           ≥1/1,000 to     ≥1/10,000 to         <1/10,000 < 1/10              <1/100          <1/1,000

Infections and                                                                      Herpetic infestations                                                                        keratitis*§ Nervous system                                                      Headache*; disorders                                                           dizziness* Eye disorders           Iris                    Punctate            Eyelid          Iritis*; corneal     Periorbital and hyperpigmentation;      keratitis, mostly   oedema; dry     oedema*; corneal     lid changes mild to moderate        without             eye;            erosion;             resulting in conjunctival            symptoms;           keratitis*;     periorbital          deepening of the hyperaemia; eye         blepharitis; eye    vision          oedema;              eyelid sulcus irritation (burning     pain;               blurred;        trichiasis*;
grittiness, itching,    photophobia;        macular         distichiasis; iris stinging and            conjunctivitis*     oedema          cyst*§; localised foreign body                                including       skin reaction on sensation); eyelash                         cystoid         the eyelids;
and vellus hair                             macular         darkening of the changes of the                              oedema*;        palpebral skin of eyelid (increased                           uveitis*        the eyelids;
length, thickness,                                          pseudopemphigoi pigmentation and                                            d of ocular
number of                                                   conjunctiva*§
eyelashes)

Cardiac disorders                                                   Angina;                              Angina unstable palpitations*
Respiratory, thoracic                                               Asthma*;        Asthma and mediastinal                                                     dyspnoea*       exacerbation disorders
System Organ Class     Very Common            Common              Uncommon        Rare                 Very Rare ≥1/10                  ≥1/100 to           ≥1/1,000 to     ≥1/10,000 to         <1/10,000 < 1/10              <1/100          <1/1,000

Gastrointestinal                                                  Nausea*;
disorders                                                         Vomiting* Skin and                                                          Rash            Pruritus subcutaneous tissue
disorders
Musculoskeletal and                                               Myalgia*; connective tissue                                                 arthralgia* disorders
General disorders                                                 Chest pain* and administration
site conditions
*ADR identified post-marketing
§ADR frequency estimated using “The Rule of 3”

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.


c. Description of selected adverse reactions
No information is provided.

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/