国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Peppermint oil
Sanofi-Aventis Ireland Limited T/A SANOFI
A03AX
Peppermint oil
0.2 millilitre(s)
Gastro-resistant capsule, soft
Other drugs for functional gastrointestinal disorders
2021-04-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PEPPERMINT OIL SANOFI 0.2 ML GASTRO-RESISTANT SOFT CAPSULES peppermint oil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. WHAT IS IN THIS LEAFLET 1. What Peppermint Oil Sanofi, capsules is and what it is used for 2. What you need to know before you take Peppermint Oil Sanofi, capsules 3. How to take Peppermint Oil Sanofi, capsules 4. Possible side effects 5. How to store Peppermint Oil Sanofi, capsules 6. Contents of the pack and other information 1. WHAT PEPPERMINT OIL SANOFI, CAPSULES IS AND WHAT IT IS USED FOR Peppermint Oil Sanofi, capsules is a herbal medicinal product which is used to relieve the symptoms of abdominal pain, minor spasms of the gastrointestinal tract (cramps), and flatulance (bloating), especially in patients with irritable bowel syndrome. Peppermint Oil Sanofi is indicated for use in adults and adolescents 12 years of age and above (who weigh at least 40 kg). You must talk to a doctor if you do not feel better or if you feel worse after two weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPPERMINT OIL SANOFI, CAPSULES DO NOT TAKE PEPPERMINT OIL SANOFI, CAPSULES: If you are allergic to peppermint oil or menthol or any of the other ingredients of this medicine (listed in section 6). If you suffer from liver disease, infection of the bile duct, reduced gastric acid production, gallstones or any other biliary disorders. If you weigh less than 40 kg (6 stone) bodyweight, because of safety concerns. Peppermint Oil S 完全なドキュメントを読む
Health Products Regulatory Authority 17 May 2021 CRN009WZ8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Peppermint Oil Sanofi 0.2 ml gastro-resistant soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.2 ml (= 181.6 mg) of _Mentha_ x _piperita_ L., aetheroleum (peppermint oil). Excipients with known effect: less than 1mmol (23 mg) sodium per dosage unit. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, soft. Dull, green-coloured, oval-shaped soft capsule containing a colourless, pale yellow or pale greenish-yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbal medicinal product for the symptomatic relief of abdominal pain, minor spasms of the gastrointestinal tract, and flatulence, especially in patients with irritable bowel syndrome. Peppermint Oil Sanofi is indicated for use in adults and adolescents 12 years of age and above (who weigh at least 40 kg). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One gastro-resistant capsule 3 times a day for patients who weigh at least 40 kg. _ _ _Paediatric population_ Peppermint Oil Sanofi is contraindicated in children under 12 years of age and adolescents who weigh less than 40 kg because of safety concerns (see 4.3 and 5.3). _Renal impairment_ No data are available for a dosing instruction in case of impaired renal function. Duration of use The gastro-resistant capsules should be taken until symptoms resolve, usually within one or two weeks. After two weeks, the patient is instructed to seek medical advice in case of persistent or deteriorating symptoms. At times when the symptoms are more persistent, the intake of gastro-resistant capsules can be continued for periods up to 3 months per treatment course. Method of administration For oral use. They must not be chewed, crushed or broken before swallowing (see 4.4). To be taken 30 minutes before meal with plenty of liquid. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to 完全なドキュメントを読む