Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
TWICOR is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with TWICOR.
TWICOR can be administered within the dose range of 10/10 mg to 20/10 mg. The recommended dose is one film-coated tablet of the given strength per day, with or without food.
TWICOR is not suitable for initial therapy. Treatment initiation 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.
Treatment should be individualised according to the target lipid levels, the recommended goal of therapy, and the patient’s response. A dose adjustment can be made after 4 weeks where necessary.
TWICOR 10 mg/10 mg is not suitable for the treatment of patients requiring 20 mg dose of rosuvastatin.
TWICOR should be taken either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
The safety and efficacy of TWICOR in children below the age of 18 years has 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.
A start dose of 5 mg rosuvastatin is recommended in patients >70 years (see section 4.4). The fixed dose combination is not suitable for initial therapy. Treatment initiation 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.
No dose adjustment is necessary in patients with mild renal impairment.
The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min). The fixed dose combination is not suitable for initial therapy. Treatment initiation 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. The use of rosuvastatin in patients with severe renal impairment is contraindicated for all doses (see sections 4.3 and 5.2).
No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with TWICOR 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.). TWICOR is contraindicated in patients with active liver disease (see section 4.3).
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. Treatment initiation 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.
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 is recommended.
The recommended start dose is rosuvastatin 5 mg in patients with predisposing factors to myopathy (see section 4.4). The fixed dose combination is not suitable for initial therapy. Treatment initiation 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.
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when ROSUVASTATINE/EZETIMIBE MYLAN HEALTHCARE is 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 TWICOR therapy. In situations where co-administration of these medicinal products with TWICOR is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see Section 4.5).
For oral use.
TWICOR should be taken each day once at the same time of the day with or without food.
The film-coated 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.
3 years for TWICOR 10 mg/10 mg.
3 years for TWICOR 20 mg/10 mg.
Store in the original package in order to protect from light and moisture.
TWICOR 10 mg/10 mg and 20 mg/10 mg film-coated tablets.
OPA/Al/PVC-Al blister packs.
Packs of 10, 30, 60, 90 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
