ction studies have only been performed in adults. The extent of interactions in the paediatric population is not known.
4.6 Fertility, pregnancy and lactation
Crestor is contraindicated in pregnancy and lactation.
Women of child bearing potential should use appropriate contraceptive measures.
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity (see section 5.3). If a patient becomes pregnant during use of this product, treatment should be discontinued immediately.
Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans (see section 4.3).
4.7 Effects on ability to drive and use machines
Studies to determine the effect of Crestor on the ability to drive and use machines have not been conducted. However, based on its pharmacodynamic properties, Crestor is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account that dizziness may occur during treatment.
4.8 Undesirable effects
The adverse reactions seen with Crestor are generally mild and transient. In controlled clinical trials, less than 4% of Crestor-treated patients were withdrawn due to adverse reactions.
Tabulated list of adverse reactions
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for rosuvastatin. Adverse reactions listed below are classified according to frequency and system organ class (SOC).
The frequencies of adverse reactions are ranked according to the following convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Table 2. Adverse reactions based on data from clinical studies and post-marketing experience
System organ class
Common
Uncommon
Rare
Very rare
Not known
Blood and lymphatic system disorders
Thrombocytopenia
Immune system disorders
Hypersensitivity reactions including angioedema
Endocrine disorders
Diabetes mellitus1
Psychiatric disorders
Depression
Nervous system disorders
Headache
Dizziness
Polyneuropathy
Memory loss
Peripheral neuropathy
Sleep disturbances (including insomnia and nightmares)
Respiratory, thoracic and mediastinal disorders
Cough
Dyspnoea
Gastro-intestinal disorders
Constipation
Nausea
Abdominal pain
Pancreatitis
Diarrhoea
Hepatobiliary disorders
Increased hepatic transaminases
Jaundice
Hepatitis
Skin and subcutaneous tissue disorders
Pruritus
Rash
Urticaria
Stevens-Johnson syndrome
Musculo-skeletal and connective tissue disorders
Myalgia
Myopathy (including myositis)
Rhabdomyolysis
Arthralgia
Tendon disorders, sometimes complicated by rupture
Immune-mediated necrotising myopathy
Renal and urinary disorders
Haematuria
Reproductive system and breast disorders
Gynaecomastia
General disorders and administration site conditions
Asthenia
Oedema
1 Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI >30 kg/m2, raised triglycerides, his |
