Țară: Africa de Sud
Limbă: engleză
Sursă: South African Health Products Regulatory Authority (SAHPRA)
Pfizer Laboratories (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS MISOPROSTOL 200 ug
Registered
1989-04-10
Pfizer Laboratories (Pty) Ltd. Page 1 of 5 Misoprostol Pfizer Final approved PIL – 16 February 2023 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: MISOPROSTOL PFIZER ® (tablets) READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE MISOPROSTOL PFIZER. ▪ Keep this leaflet. You may need to read it again. ▪ If you have further questions, please ask your doctor or pharmacist. ▪ MISOPROSTOL PFIZER has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT MISOPROSTOL PFIZER CONTAINS The active ingredient of MISOPROSTOL PFIZER is misoprostol. The inactive ingredients include; microcrystalline cellulose, sodium starch glycolate and hydrogenated castor oil. 2. WHAT IS MISOPROSTOL PFIZER USED FOR: MISOPROSTOL PFIZER is used for co-administration with non-steroidal anti-inflammatory drugs (NSAIDs) for the prevention of gastric and duodenal ulcers, haemorrhagic lesions and erosions induced by NSAIDs. Pfizer Laboratories (Pty) Ltd. Page 2 of 5 Misoprostol Pfizer Final approved PIL – 16 February 2023 3. BEFORE YOU TAKE MISOPROSTOL PFIZER: If you are taking medicines on a regular basis, concomitant use of the medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice. DO NOT TAKE MISOPROSTOL PFIZER: If you are pregnant or breast feeding. If you are allergic to misoprostol or other prostaglandins or any of the other ingredients of MISOPROSTOL PFIZER. TAKE SPECIAL CARE WITH MISOPROSTOL PFIZER: Some people will need special care from their doctors when they are taking MISOPROSTOL PFIZER. If the answer to any of the following questions is “yes”, you should talk to your doctor or pharmacist before taking MISOPROSTOL PFIZER as it may not be suitable for you: ▪ Have you ever had a reaction to misoprostol or any of its ingredients? ▪ Are you pregnant, trying to become pregnant, or breas Citiți documentul complet
Pfizer Laboratories (Pty) Ltd. Page 1 of 8 Misoprostol Pfizer Final approved PI – 16 February 2023 SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: MISOPROSTOL PFIZER ® Tablets COMPOSITION: Each tablet contains 200 mcg misoprostol. The inactive ingredients include; microcrystalline cellulose, sodium starch glycolate and hydrogenated castor oil. PHARMACOLOGICAL CLASSIFICATION: A 11.10 Medicines acting on the gastro-intestinal tract - Special combinations and/or substances. PHARMACOLOGICAL ACTION: Misoprostol is a synthetic prostaglandin E 1 analogue which has gastric antisecretory and mucosal protective properties. The antisecretory activity is mediated by direct action on specific prostaglandin receptors on the surface of gastric parietal cells. The mucosal protective effect against various damaging agents has been demonstrated in humans with doses that inhibit, and doses which minimally affect acid secretion. ANTISECRETORY ACTIVITY: _Effect on acid secretion_: In healthy human subjects, misoprostol inhibits daytime and nocturnal basal gastric acid secretion and acid secretion stimulated by histamine, pentagastrin, food, tetragastrin, betazole and coffee. _Effect on pepsin secretion and gastric fluid volume_: Misoprostol decreases pepsin and gastric volume under basal conditions. Pfizer Laboratories (Pty) Ltd. Page 2 of 8 Misoprostol Pfizer Final approved PI – 16 February 2023 _Effect on serum gastrin_: Misoprostol has no persistent effects on fasting levels of, or on postprandial increase in, serum gastrin. MUCOSAL PROTECTIVE ACTIVITY: Misoprostol has properties in animals and humans that strengthen the integrity of the gastroduodenal mucosal barrier against damaging agents. These include stimulation of duodenal bicarbonate secretion and gastric mucus production. In addition, misoprostol maintains mucosal haemodynamics. OTHER PHARMACOLOGICAL EFFECTS: Misoprostol has been shown to produce uterine contractions which may endanger pregnancy (see Contraindications). Misoprostol does not produce clinically Citiți documentul complet