Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The overall safety profile of Norlip is based on a combination of clinical study data and post-marketing experience.

The frequency of adverse drug reactions (ADRs) is displayed in the table below. Frequency of reporting: Common (≥ 1/100 and <1/10), Uncommon ( ≥ 1/1,000 and <1/100), Rare ( ≥ 1/10,000 and <1/1000), Very rare (<1/10,000).

Blood and lymphatic system disorders:
Very rare: Pancytopenia, thrombocytopenic purpura.

Immune system disorders:
Uncommon: Hypersensitivity reactions including anaphylactic reactions.
Metabolism and nutrition disorders:
Common: Decreased appetite.

Nervous system disorders:
Uncommon: Dizziness, headache.
Rare: Peripheral neuropathy, paraesthesia.

Psychiatric disorders:
Rare: Depression, insomnia.
Gastrointestinal disorders:
Common: Gastrointestinal disorders.
Uncommon: Abdominal pain, constipation, dyspepsia, abdominal distension, diarrhoea, nausea.
Rare: Pancreatitis
Hepatobiliary disorders:
Uncommon: Cholestasis.
Very rare: Cholelithiasis.

Skin and subcutaneous tissue disorders:
Uncommon: Pruritus, urticaria, photosensitivity reaction, alopecia, rash.
Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders:
Uncommon: Muscular weakness, myalgia, muscle cramp.
Very rare: Rhabdomyolysis.

Renal and urinary disorders:
Uncommon: Acute renal failure.
Reproductive system and breast disorders:
Uncommon: Erectile dysfunction NOS.

Respiratory, thoracic and mediastinal disorders:
Very rare: Interstitial lung disease.

Investigations:
Uncommon: Increased blood creatinine phosphokinase, blood creatinine increased, decreased gamma-glutamyl transferase and in parallel alkaline phosphatase
Very rare: Haemoglobin decreased, platelet increased, white blood cell count decreased, gamma-glutamyl transferase increased, transaminase increased.

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: http://forms.gov.il/globaldata/getsequence.aspx?formType=AdversEffectMedic@mo h.gov.il