ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
MACITENTAN
J-C HEALTH CARE LTD
C02KX04
FILM COATED TABLETS
MACITENTAN 10 MG
PER OS
Required
ACTELION PHARMACEUTICALS LTD., SWITZERLAND
MACITENTAN
Opsumit ® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.
2019-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only OPSUMIT ® 10 MG FILM-COATED TABLETS ACTIVE INGREDIENT AND ITS QUANTITY EACH FILM-COATED TABLET CONTAINS: Macitentan 10 mg For the list of inactive and allergenic ingredients in the preparation, please see section 6 "Further information" and subsection "Important information about some of the ingredients of this medicine" in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar. Patient Safety Information Card In addition to the leaflet, Opsumit also has a patient safety information card. This card contains important safety information that you should know, before beginning and during treatment with Opsumit and act accordingly. Refer to the patient safety information card and patient leaflet before using the preparation. Keep the card and the leaflet for further reference if required. Do not use Opsumit if you are pregnant, since use of this medicine may cause harm to the fetus (see section 2 "Before you take the medicine" subsections "Do not use the medicine if" and "Pregnancy, breastfeeding and fertility"). If you are a woman of child-bearing age who could become pregnant, you should take a pregnancy test before you start taking Opsumit and regularly every month while you are taking the medicine and a month after termination of treatment. A negative result in each pregnancy test must be assured. You must use a reliable contraceptive method while taking Opsumit and one additional month after termination of treatment (see section 2 subsection "Pregnancy, breastfeeding and fertility"). 1. WHAT IS THE MEDICINE INTENDED FOR? • The medicine is intended for อ่านเอกสารฉบับเต็ม
1 Opsumit_PI_Clean_January-2023 OPSUMIT PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan. _U_ Excipients with known effect _U_ : Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides. • WARNING: EMBRYO-FETAL TOXICITY Do not administer Opsumit to a pregnant female because it may cause fetal harm [see Contraindications (4.3) and Fertility, pregnancy and lactation (4.6)]. Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception [see Fertility, pregnancy and lactation (4.6)]. Each patient should receive a Patient alert card, emphasizing the risks of embryo fetal toxicity. PATIENT SAFETY INFORMATION CARD The marketing of Opsumit is subject to risk management plan (RMP) including a 'Patient Safety Information Card'. The patient safety information card, emphasizes important safety information that the patient should be aware of before and during the treatment. The patient safety information card is included in the pack. Please explain to the patient the need to review the card before starting treatment. 2 Opsumit_PI_EUPI update_January-2023 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OPSUMIT _P_ ® _P_ is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-mi อ่านเอกสารฉบับเต็ม