Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Vonoprazan Fumarate
Takeda Malaysia Sdn Bhd
Vonoprazan Fumarate
3 x 10 Tablets; 1 x 10 Tablets
Takeda Pharmaceutical Company Limited.,
_Consumer Medication Information Leaflet (RiMUP) _ VOCINTI FILM-COATED TABLET _ _ VONOPRAZAN 10MG AND 20MG __________________________________________________________________________________________ pg. 1 WHAT IS IN THIS LEAFLET 1. What Vocinti is used for 2. How Vocinti works 3. Before you use Vocinti 4. How to use Vocinti 5. While you are using it 6. Side Effects 7. Storage and Disposal of Vocinti 8. Manufacturer and Product Registration Holder 9. Date of Revision WHAT VOCINTI IS USED FOR Your doctor may prescribe Vocinti for the following indication in adults: • Treatment of stomach and duodenal ulcer. • Treatment and maintenance of inflammation of your esophagus (reflux esophagitis) up to52 weeks. • Prevention of recurrence of stomach or duodenal ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) • Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy HOW VOCINTI WORKS Vocinti is a Vonoprazan is a potassium competitive acid blocker (PCAB) and inhibits H+, K+-ATPase in a reversible and potassium-competitive manner. It does not require activation by acid. BEFORE YOU USE VOCINTI • When you must not use it Do not take Vocinti if you are allergic to vonoprazan or any of the other ingredients of this medicine. (see Product Description). If you are currently taking a medicine containing the active substance atazanavir or rilpivirine. • Before you start to use it Warning and precautions Before you take Vocinti, tell your doctor if you : • Have liver problems • Have kidney problems • Are pregnant or plan to become pregnant. • Are breastfeeding or plan to breastfeed. It is not known if Vocinti passes into breast milk. Do not breastfeed during treatment with Vocinti. • Taking other medicines • Tell your doctor about all the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements. Contact your doctor before you start or stop ot Baca dokumen lengkap
1 NAME OF THE MEDICINAL PRODUCT Vocinti Film-Coated Tablet 10mg Vocinti Film-Coated Tablet 20mg NAME AND STRENGTH OF ACTIVE SUBSTANCES Each tablet contains 10mg and 20mg of Vonoprazan. Excipients: D-Mannitol, Crystalline Cellulose, Croscarmellose Sodium, Hydroxypropyl Cellulose, Fumaric Acid, Magnesium Stearate, Hypromellose, Macrogol 6000, Titanium Oxide (contained in all products), Yellow Ferric Oxide (contained Vocinti 10 mg Film-Coated Tablet only), Iron Sesquioxide (contained Vocinti 20 mg Film-Coated Tablet only)._ _ PRODUCT DESCRIPTION Vocinti is supplied as a film-coated tablet containing 10mg or 20mg of vonoprazan: • 10mg tablet is pale yellow, oval in shape and are printed with “B217” on the upperside • 20mg tablet is pale red, oval in shape with scored and is printed with “B218” on the upperside PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Proton Pump Inhibitor ATC code: A02BC08 CLINICAL PHARMACOLOGY MECHANISM OF ACTION Vonoprazan is a potassium competitive acid blocker (PCAB) and inhibits H+, K+-ATPase in a reversible and potassium-competitive manner. It does not require activation by acid. Vonoprazan is a strong base with a high affinity for the acid pump of gastric cells inhibiting gastric acid production. SERUM GASTRIN AND SERUM PEPSINOGEN EFFECTS Increased serum gastrin and serum pepsinogen concentrations are physiological responses to treatment with acid suppression therapy, including vonoprazan. Increased serum gastrin and serum pepsinogen concentrations were reported with a higher incidence in the vonoprazan treatment groups compared with lansoprazole treatment groups. Serum gastrin and serum pepsinogen concentrations returned to baseline over time upon discontinuation of vonoprazan. The increase in serum gastrin concentration occurred early in treatment with vonoprazan and remained stable for the remainder of treatment. PHARMACOKINETIC PROPERTIES PHARMACOKINETICS AT SINGLE ADMINISTRATION Following 7 day repeat once daily doses of vonoprazan at doses of 10-40 mg, in healthy Baca dokumen lengkap