Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
riociguat, Quantity: 2.5 mg
Bayer Australia Ltd
riociguat
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium lauryl sulfate; hypromellose; titanium dioxide; crospovidone; propylene glycol; lactose monohydrate; iron oxide red; microcrystalline cellulose; iron oxide yellow; hyprolose
Oral
84, 42, 21
(S4) Prescription Only Medicine
Pulmonary arterial hypertension:,Adempas, as monotherapy or in combination with approved PAH treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with WHO functional Class II, lll or IV symptoms,Chronic thromboembolic pulmonary hypertension:,Adempas is indicated for the treatment of:,Persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or,inoperable CTEPH in adult patients with WHO functional Class II, lll or IV symptoms
Visual Identification: Red orange, round, biconvex tablets marked with the Bayer cross on one side and 2.5 and an 'R' on the other side.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-04-14
Adempas ® CMI VX2.0 1 ADEMPAS ® (AH-DEM-PAS) _RIOCIGUAT _ _ _ CONSUMER MEDICINE INFORMATION ADEMPAS MAY CAUSE BIRTH DEFECTS AND MUST NOT BE TAKEN DURING PREGNANCY. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Adempas. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Adempas against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ADEMPAS IS USED FOR Adempas is used to treat adults with high blood pressure in the lung vessels caused by: • blood clots in the lungs (known as chronic thromboembolic pulmonary hypertension or CTEPH) • narrowing of the vessels that carry blood from the heart to the lungs (known as pulmonary arterial hypertension or PAH) If the high blood pressure in the lung vessels is caused by CTEPH it can sometimes be treated with surgery. Adempas may be used if surgery is not possible or if there is still high blood pressure in the lung vessels after surgery. High blood pressure in the lung vessels means that the heart needs to work harder to pump blood through the lungs. This may cause you to feel tired, dizzy and short of breath. Adempas contains the active substance riociguat. Riociguat is a soluble guanylate cyclase (sGC)-stimulator. Adempas relaxes the lung vessels making it easier for the heart to pump blood through them. This lowers the pressure in these vessels, relieves the symptoms, and can lead to an improvement in the ability to exercise and perform physical tasks. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE ADEMPAS _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE ADEMPA Read the complete document
ADEMPAS PI XV2.0; CCDS 7 1 AUSTRALIAN PRODUCT INFORMATION ADEMPAS (RIOCIGUAT) ADEMPAS MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY. (SEE SECTION 4.3 CONTRAINDICATIONS AND SECTION 4.6 FERTILITY, PREGNANCY AND LACTATION. 1 NAME OF THE MEDICINE Riociguat. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Adempas 0.5 mg: Each film-coated tablet for oral administration contains 0.5 mg of riociguat. Adempas 1 mg: Each film-coated tablet for oral administration contains 1 mg of riociguat. Adempas 1.5 mg: Each film-coated tablet for oral administration contains 1.5 mg of riociguat. Adempas 2 mg: Each film-coated tablet for oral administration contains 2 mg of riociguat. Adempas 2.5 mg: Each film-coated tablet for oral administration contains 2.5 mg of riociguat. Excipients with known effect: sugars as lactose Each 0.5 mg film-coated tablet contains 39.8 mg lactose monohydrate. Each 1 mg film-coated tablet contains 39.2 mg lactose monohydrate. Each 1.5 mg film-coated tablet contains 38.7 mg lactose monohydrate. Each 2 mg film-coated tablet contains 38.2 mg lactose monohydrate. Each 2.5 mg film-coated tablet contains 37.7 mg lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Adempas is a film-coated tablet. • 0.5 mg film-coated tablet: White, round, biconvex tablets marked with the Bayer cross on one side and 0.5 and an “R” on the other side. • 1 mg film-coated tablet: Pale yellow, round, biconvex tablets marked with the Bayer cross on one side and 1 and an “R” on the other side. • 1.5 mg film-coated tablet: Yellow orange, round, biconvex tablets marked with the Bayer cross on one side and 1.5 and an “R” on the other side. • 2 mg film-coated tablet: Pale orange, round, biconvex tablets marked with the Bayer cross on one side and 2 and an “R” on the other side. • 2.5 mg film-coated tablet: Red orange, round, biconvex tablets marked with the Bayer cross on one side and 2.5 and an “R” on the other side. ADEMPAS PI XV2.0; CCDS 7 Read the complete document