Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
The recommended dose is 40 mg (2 × 20 mg) taken once daily with or without food.
Dose adjustments are not required in elderly patients.
In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 4.4 and 5.2).
The safety and efficacy of tadalafil in the paediatric population has not yet been established. Currently available data are described in section 5.1.
Talmanco is for oral use.
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients with erectile dysfunction. Adverse reactions were similar to those seen at lower doses.
In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes negligibly to tadalafil elimination.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 × 1 and 56 × 1 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.
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