Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLYCOPYRRONIUM BROMIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
GLYCOPYRRONIUM BROMIDE
30 capsules & 1 inhalerunits Capsules; 30 capsules & 1 inhaler units Capsules
Siegfried Barbera, S.L.
_Consumer Medication Information Leaflet (RiMUP)_ SEEBRI ® BREEZHALER ® INHALATION POWDER HARD CAPSULES Glycopyrronium bromide (50 microgram) 1 WHAT IS IN THIS LEAFLET 1. WHAT SEEBRI BREEZHALER IS USED FOR 2. HOW SEEBRI BREEZHALER WORKS 3. BEFORE YOU USE SEEBRI BREEZHALER 4. HOW TO USE SEEBRI BREEZHALER 5. WHILE USING SEEBRI BREEZHALER 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF SEEBRI BREEZHALER 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER 12. INSTRUCTIONS FOR USE OF SEEBRI BREEZHALER INHALER WHAT SEEBRI BREEZHALER IS USED FOR This medicine contains an active substance called glycopyrronium bromide. This belongs to a group of medicines called bronchodilators. This medicine is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). HOW SEEBRI BREEZHALER WORKS In COPD the muscles around the airways tighten. This makes breathing difficult. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. If you use Seebri Breezhaler _ _ once a day, it will help to reduce the effects of COPD on your everyday life. BEFORE YOU USE SEEBRI BREEZHALER _When you must not use it _ _DO NOT USE SEEBRI BREEZHALER _ If you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed under Product Description) _PREGNANCY, BREAST-FEEDING AND _ _FERTILITY _ If you are pregnant or breast- feeding, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk. _CHILDREN AND ADOLESCENTS _ Do not give this medicine to children or adolescents below the age of 18 years. _ _ _Before you start to use it _ _WARNINGS AND PRECAUTIONS _ Talk to your doctor before us Baca dokumen lengkap
Novartis Page 2 Malaysia Package Leaflet 11 Feb 2020 Seebri Breezhaler 2 1. NAME OF THE MEDICINAL PRODUCT Seebri Breezhaler 50 mcg Inhalation Powder Hard Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above a black bar and the company logo ( ) printed in black below a black bar. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Seebri Breezhaler is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is the inhalation of the content of one capsule once daily using the Seebri Breezhaler inhaler. Seebri Breezhaler is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. Special populations _Elderly population _ Seebri Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8). _ _ _Renal impairment _ Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased Baca dokumen lengkap