Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lansoprazole
Sigma Pharmaceuticals Plc
A02BC03
Lansoprazole
15mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
350 mm 235 mm 5670 Lansoprazole 15mg Orodispersible Tablets/ Lansoprazole 30mg Orodispersible Tablets 258216 PACKAGE LEAFLET: INFORMATION FOR THE USER LANSOPRAZOLE 15MG ORODISPERSIBLE TABLETS LANSOPRAZOLE 30MG ORODISPERSIBLE TABLETS Lansoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. · Keep this leaflet. You may need to read it again. · If you have any further questions, ask your doctor or pharmacist. · This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. · If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lansoprazole orodispersible tablets are and what they are used for 2. What you need to know before you take Lansoprazole orodispersible tablets 3. How to take Lansoprazole orodispersible tablets 4. Possible side effects 5. How to store Lansoprazole orodispersible tablets 6. Contents of the pack and other information 1. WHAT LANSOPRAZOLE ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Lansoprazole 15mg and 30mg orodispersible tablets is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Lansoprazole orodispersible tablets are used to treat adults Your doctor may prescribe Lansoprazole orodispersible tablets for the following indications: · Treatment of duodenal and stomach ulcer · Treatment of inflammation in your oesophagus (reflux oesophagitis) · Prevention of reflux oesophagitis · Treatment of heartburn and acid regurgitation · Treatment of infections caused by the bacteria _ Helicobacter pylori _ when given in combination with antibiotic therapy · Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflamma Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lansoprazole 15mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg of lansoprazole Excipient(s) with known effect: Each orodispersible tablet contains 5.25 mg of aspartame For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. White to yellowish white uncoated tablets, speckled with orange to dark brown pellets, debossed with “I5” on one side of the tablet and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of _Helicobacter pylori_ (_H. pylori_) concurrently given with appropriate antibiotic therapy for treatment of _H.pylori_-associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome. Lansoprazole orodispersible tablets are indicated in adults 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment of duodenal ulcer: The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks. Treatment of gastric ulcer: The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks. Reflux oesophagitis: The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. Prophylaxis of reflux oesophagitis: 15 mg once daily. The dose may be increased up to 30 Izlasiet visu dokumentu