देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
dexlansoprazole
Takeda Malaysia Sdn Bhd
dexlansoprazole
14 Capsules; 7 Capsules
Takeda GmbH
_Consumer Medication Information Leaflet (RiMUP)_ DEXILANT _ _ DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES (30MG AND 60MG) __________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Dexilant is used for 2. How Dexilant works 3. Before you use Dexilant 4. How to use Dexilant 5. While you are using it 6. Side Effects 7. Storage and Disposal of Dexilant 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DEXILANT IS USED FOR Dexilant is a prescription medicine called a proton pump inhibitor (PPI). • Dexilant is used in children 12 years and above for up to 8 weeks to heal acid- related damage to the lining of the esophagus (called erosive esophagitis or EE). • Dexilant is used for up to 4 months in adolescents 12- 17 years of age and 6 months in adults to continue healing of erosive esophagitis and relief of heartburn. • Dexilant is used in children 12 years and above for 4 weeks to treat heartburn related to symptomatic non- erosive gastroesophageal reflux disease (GERD). GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping. In some cases, acid can damage the lining of your esophagus. This damage is called erosive esophagitis or EE. HOW DEXILANT WORKS Dexilant reduces the amount of acid in your stomach. D exilant may help your acid- related symptoms, but you could still have serious stomach problems. Talk with your doctor. BEFORE YOU USE DEXILANT - _When you must not use it _ You should not take Dexilant if you are allergic to dexlansoprazole or any of the other ingredients of this medicine. - _Before you start to use it _ Before you take Dexilant, tells your doctor if you : • Have low magnesium levels in your blood • have liver problems • have any other medical conditions • Are pregnant or plan to become pregnant. It is not known if Dexilant can harm your unb पूरा दस्तावेज़ पढ़ें
1 _ _ 1. NAME OF THE MEDICINAL PRODUCT Dexilant delayed-release Capsules 30mg Dexilant delayed-release Capsules 60mg 2. NAME AND STRENGTH OF ACTIVE SUBSTANCES Dexilant is available in two dosage strengths: 30 mg and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following excipients: _Excipients: Sugar spheres, magnesium carbonate, sucrose, low-substituted_ _hydroxypropyl cellulose, _ _titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, _ _polyethylene glycol 8000, triethyl citrate, polysorbate 80, colloidal silicon dioxide, hypromellose, _ _carrageenan, potassium chloride, _ _FD&C Blue No. 2 aluminum lake (Blue capsule) and black ferric oxide (Gray capsule). _ _ _ 3. PRODUCT DESCRIPTION 30 mg delayed-release capsules are opaque, blue and gray with TAP and “30” imprinted on the capsule. 60 mg delayed-release capsules are opaque, blue with TAP and “60” imprinted on the capsule. 4. CLINICAL PHARMACOLOGY ATC code: A02BC06 4.1 MECHANISM OF ACTION Dexlansoprazole is a PPI that suppresses gastric acid secretion by specific inhibition of the (H + ,K + )- ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production. 4.2 PHARMACODYNAMICS Antisecretory Activity The effects of Dexilant 60 mg (n=20) or lansoprazole 30 mg (n=23) once daily for five days on 24-hour intragastric pH were assessed in healthy subjects in a multiple-dose crossover study. The results are summarized in Table 1. TABLE 1: EFFECT ON 24-HOUR INTRAGASTRIC PH ON DAY 5 AFTER ADMINISTRATION OF DEXILANT OR LANSOPRAZOLE IN ADULTS DEXILANT 60 MG LANSOPRAZOLE 30 MG MEAN INTRAGASTRIC PH 4.55 4.13 % TIME INTRAGASTRIC PH > 4 (HOURS) 71 (17 hours) 60 (14 hours) Serum Gastrin Effects The effect of Dexilant on serum gastrin concentrations was evaluated in approximately 3460 patients in clinical trials up to 8 weeks and in 1023 patients for up to 6 to 12 months. The पूरा दस्तावेज़ पढ़ें