EZEHRON DUO Tablet Ref.[51124] Active ingredients: Ezetimibe Rosuvastatin

Posology

Ezehron Duo is indicated in adult patients whose hypercholesterolemia is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended combination. The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezehron Duo tablets.

The recommended daily dose is one tablet of the given strength with or without food. Ezehron Duo are not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Ezehron Duo 5 mg/10 mg, 10 mg/10 mg and 20 mg/10 mg tablet are not suitable for the treatment of patients requiring 40 mg dose of rosuvastatin.

Ezehron Duo should be taken either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

Paediatric population

The safety and efficacy of Ezehron Duo in children below the age of 18 years have not yet been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

Use in the elderly

A start dose of 5 mg rosuvastatin is recommended in patients 70 years (see section 4.4). The combination is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.

Dosage in patients with renal insufficiency

No dose adjustment is necessary in patients with mild to moderate renal impairment. The recommended start dose of rosuvastatin is 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min). The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. The use of rosuvastatin in patients with severe renal impairment is contraindicated for all doses (see sections 4.3 and 5.2).

Dosage in patients with hepatic impairment

No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with Ezehron Duo is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction (See sections 4.4 and 5.2.). Ezehron Duo is contraindicated in patients with active liver disease (see section 4.3).

Race

Increased systemic exposure of rosuvastatin has been seen in Asian subjects (see sections 4.4 and 5.2). The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.

Genetic polymorphisms

Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure (see Section 5.2). For patients who are known to have such specific types of polymorphisms, a lower daily dose of Ezehron Duo is recommended.

Dosage in patients with pre-disposing factors to myopathy

The recommended start dose is 5 mg of rosuvastatin in patients with predisposing factors to myopathy (see section 4.4). The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.

Concomitant therapy

Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Ezehron Duo tablets are administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; (see Sections 4.4 and 4.5).

Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Ezehron Duo tablets therapy. In situations where co-administration of these medicinal products with Ezehron Duo tablets is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see Section 4.5).

Method of administration For oral use.

Ezehron Duo tablets should be taken each day once at the same time of the day with or without food. The tablet should be swallowed whole with a drink of water.

There is no published literature data on rosuvastatin overdose.

There is no specific treatment in the event of overdose with rosuvastatin. In clinical studies, administration of ezetimibe, 50 mg/day, to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days, was generally well tolerated. In animals, no toxicity was observed after single oral doses of 5,000 mg/kg of ezetimibe in rats and mice and 3,000 mg/kg in dogs.

A few cases of overdosage with ezetimibe have been reported: most have not been associated with adverse experiences. Reported adverse experiences have not been serious.

In the event of an overdose, symptomatic and supportive measures should be employed. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.

30 months.

Store in the original package in order to protect from light. This medicinal product does not require any special temperature storage conditions.

Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 tablets in blister (PA/AL/PVC // Al). Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.