Rosuvastatin Teva film-coated tablets 10 mg 30 pcs.

• active ingredient: rosuvastatin (as rosuvastatin calcium);
• 1 film-coated tablet contains 10 mg of rosuvastatin as 10.43 mg of rosuvastatin calcium.
• excipients: core: microcrystalline cellulose, lactose monohydrate, crospovidone (Type B), hydroxypropylcellulose, sodium bicarbonate, magnesium stearate;
• film coating: lactose monohydrate, hypromellose 2910/6cP, titanium dioxide (E 171), triacetin, red iron oxide (E 172).

The drug Rosuvastatin-Teva is contraindicated:

• patients with hypersensitivity to rosuvastatin or any of the excipients of the drug;
• patients with active liver disease, including those of unknown etiology, persistent elevations of serum transaminases, and any elevation of serum transaminases greater than three times the upper limit of normal (ULN);
• patients with severe renal impairment (creatinine clearance < 30 ml/min);
• patients with myopathy;
• patients who are concurrently receiving the combination of sofosbuvir/velpatasvir/voxilaprevir;
• patients who are simultaneously receiving cyclosporine;
• during pregnancy or breastfeeding, as well as women of reproductive age who do not use adequate contraception.

Blood and lymphatic system disorders: Rare: thrombocytopenia.

Immune system disorders: Rare: hypersensitivity reactions, including angioedema.

Endocrine disorders: Common: diabetes mellitus1.

Psychiatric disorders: Frequency not known: depression.

Nervous system disorders: Common: headache, dizziness. Very rare: polyneuropathy, memory loss. Frequency unknown: peripheral neuropathy, sleep disorders (including insomnia and nightmares).

Respiratory, thoracic and mediastinal disorders: Frequency not known: cough, shortness of breath.

Gastrointestinal disorders: Common: constipation, nausea, abdominal pain. Rare: pancreatitis. Frequency unknown: diarrhea.

Hepatobiliary system: Rare: increased hepatic transaminases. Very rare: jaundice, hepatitis.

Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash, urticaria. Frequency not known: Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS).

Before starting treatment, the patient should be placed on a standard cholesterol-lowering diet and should continue to follow it throughout treatment. The dose should be individualised according to the patient’s goals and response to treatment, in accordance with current guidelines.

The drug Rosuvastatin-Teva can be taken at any time of the day, regardless of meals.

Use during pregnancy or breastfeeding

The drug Rosuvastatin-Teva is contraindicated during pregnancy or breastfeeding.

Women of reproductive age should use adequate contraception.

Children

The safety and efficacy of the drug in children under 6 years of age have not been studied. Therefore, rosuvastatin is not recommended for use in children under 6 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

Studies on the effect of rosuvastatin on the ability to drive and use machines have not been conducted. Given its pharmacodynamic properties, it is unlikely that rosuvastatin will affect this ability. When driving or operating machinery, the possibility of dizziness should be taken into account during treatment.

There is no specific treatment for overdose. In the event of overdose, the patient should be treated symptomatically and, if necessary, supportive measures should be taken. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be effective.

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.