Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
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 of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
The recommended dose is 40 mg (two x 20 mg film-coated tablets) taken once daily.
The recommended once daily doses based on age and weight categories in paediatric patients are shown below.
| Paediatric patient's age and/or weight | Recommended daily dose and dosing regimen |
| Age ≥2 years old Body weight ≥40 kg Body weight <40 kg | 40 mg (two 20 mg tablets) once daily 20 mg (one 20 mg tablet or 10 mL of oral suspension (OS), 2 mg/mL tadalafil*) once daily |
* Oral suspension is available for administration to paediatric patients who require 20 mg and are not able to swallow tablets.
For patients <2 years old no PK or efficacy data are available from clinical trials. The most appropriate dose of ADCIRCA in children aged between 6 months to <2 years has not been established. Therefore, ADCIRCA is not recommended in this age subset.
If there is a delay in the administration of ADCIRCA, but yet within the same day, the dose should be taken with no changes to the subsequent dose schedules. Patients should not take an extra dose if a dose is missed.
Patients should not take an extra dose if vomiting occurs.
Dose adjustments are not required in elderly patients.
Adults and paediatric population (2 to 17 years, weighing at least 40 kg):
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).
Paediatric population (2 to 17 years, weighing less than 40 kg):
In patients <40 kg and with mild to moderate renal impairment a starting dose of 10 mg once per day is recommended. The dose may be increased to 20 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).
Adults and paediatric population (2 to 17 years, weighing at least 40 kg):
Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), a starting dose of 20 mg once per day may be considered.
Paediatric population (2 to 17 years, weighing less than 40 kg):
In patients <40 kg and with mild to moderate hepatic impairment, a starting dose of 10 mg once per day may be considered. For patients of all ages, if tadalafil is prescribed, a careful individual benefit/risk assessment 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).
Dosing and efficacy of ADCIRCA has not been established for children aged <2 years. Currently available data are described in sections 4.8 and 5.1.
ADCIRCA is for oral use.
The film-coated tablets should be swallowed whole with water, with or without food.
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.
Store in the original package in order to protect from moisture. Do not store above 30°C.
Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.
Not all packs sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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