Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
DIMETICONE, ACTIVATED
Forest Laboratories UK Ltd
A03AX13
DIMETICONE, ACTIVATED
40 Milligram
Oral Drops Suspension
Product not subject to medical prescription
silicones
Marketed
1991-02-27
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use 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 your baby gets any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if your baby’s symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET: 1. What Infacol is and what it is used for 2. What you need to know before you use Infacol 3. How to use Infacol 4. Possible side effects 5. How to store Infacol 6. Contents of the pack and other information 1. WHAT INFACOL IS AND WHAT IT IS USED FOR Your baby’s medicine is called Infacol. Infacol contains the active substance simeticone. It is an antiflatulent which means that it helps to bring up wind or air trapped in the tummy. Infacol is given to babies to relieve griping pain, infant colic or wind due to trapped air. The pain associated with colic may be caused by the build-up of small gas bubbles trapped in your baby’s tummy. Simeticone, the active ingredient in Infacol, helps all the little trapped gas bubbles join into bigger bubbles which your baby can easily bring up as wind. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INFACOL DO NOT USE INFACOL AND GET ADVICE FROM A DOCTOR IF - your baby is being treated for a thyroid disorder. - you think your baby might be allergic to any of the ingredients of Infacol (listed in section 6). OTHER MEDICINES AND INFACOL Tell your doctor or pharmacist if your baby is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. If your baby is being treated with levothyroxine for a thyroid disorder using Infacol might reduce the amount of this type of medicine that is absorbed and w Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Infacol 40mg/ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml dose of suspension contains 20 mg of Simeticone. Excipients with known effect: Methyl hydroxybenzoate (E218) 0.18%w/v Propyl hydroxybenzoate (E216) 0.02% w/v For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension Orange – flavoured, colourless, translucent suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An antiflatulent for the relief of griping pain, colic or wind due to swallowed air. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _For adults and elderly:_ Not applicable _For infants:_ 20mg (0.5ml). If necessary this may be increased to 40mg (1ml). Method of administration Infacol should be administered orally before each feed. 4.3 CONTRAINDICATIONS None stated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Methyl and propyl hydroxybenzoates (E218 and E216) which are also ingredients in Infacol 40mg/ml Oral Suspension, may cause allergic reactions (possible delayed). If symptoms persist, seek medical advice. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _1_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _4_ _4_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Infacol is given concurre Baca dokumen lengkapnya