Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1).
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered.
The recommended dose is 20 mg three times a day (TID). Physicians should advise patients who forget to take Granpidam to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10 mg three times a day and for patients >20 kg is 20 mg three times a day. Higher than recommended doses should not be used in paediatric patients with PAH (see also sections 4.4 and 5.1). The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. Other pharmaceutical forms are available for administration to patients ≤20 kg and other younger patients who are not able to swallow tablets.
In general, any dose adjustment should be administered only after a careful benefit-risk assessment. A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone. For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Dose adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min). A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B). A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Granpidam is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Outside its authorised indications, sildenafil should not be used in neonates with persistent pulmonary hypertension of the newborn as risks outweigh the benefits (see section 5.1). The safety and efficacy of sildenafil in other conditions in children below 1 year of age has not been established. No data are available.
Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension. However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered. Intensified monitoring is recommended during the discontinuation period.
Granpidam is for oral use only. Tablets should be taken approximately 6 to 8 hours apart with or without food.
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
5 years.
This medicinal product does not require any special storage conditions.
PVC/Alu blisters packs containing 90 tablets and 300 tablets.
PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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