Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
sildenafil citrate
Accord Healthcare S.L.U.
G04BE03
sildenafil
Urologicals
Hypertension, Pulmonary
AdultsTreatment 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.Paediatric populationTreatment 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.
Revision: 8
Authorised
2016-11-14
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GRANPIDAM 20 MG FILM-COATED TABLETS sildenafil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Granpidam is and what it is used for 2. What you need to know before you take Granpidam 3. How to take Granpidam 4. Possible side effects 5. How to store Granpidam 6. Contents of the pack and other information 1. WHAT GRANPIDAM IS AND WHAT IT IS USED FOR Granpidam contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Granpidam brings down blood pressure in the lungs by widening the blood vessels in the lungs. Granpidam is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRANPIDAM DO NOT TAKE GRANPIDAM - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”). Granpidam can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist. - if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Granpidam 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate). Excipient(s) with known effect Each tablet also contains 0.2 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off white, round shaped, approximately 6.6 mm in diameter, biconvex, film-coated tablets, debossed with ‘20’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults 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. Paediatric population 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. Posology _Adults _ 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. _Paediatric population (1 year to 17 years) _ 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 Lestu allt skjalið