Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
SIMETHICONE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
A16AX
DROPS
SIMETHICONE 66.67 MG/ML
PER OS
Not required
CTS CHEMICAL INDUSTRIES LTD
VARIOUS ALIMENTARY TRACT AND METABOLISM PRODUCTS
Antiflatulent for relief of gripping pain, infant colic or wind due to swallowed air.
2021-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription SIMICOL ORAL DROPS The active ingredient and its concentration: Simethicone 20 mg/0.3 ml (66.67 mg/1 ml) Inactive ingredients and allergens in the preparation – see the subsection “Important information about some of the ingredients of the medicine” and section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Use the preparation according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you need further information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the relief of abdominal pain in infants and young children caused by the accumulation of gas. THERAPEUTIC CLASS: medicines for the relief of gastrointestinal gas. 2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF: • There is a known sensitivity (allergy) to the active ingredient or to any of the other ingredients this medicine contains (see section 6). DRUG INTERACTIONS: IF THE CHILD IS TAKING OR HAS RECENTLY TAKEN OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. Especially if the child is taking: • Levothyroxine for treatment of thyroid disorders. Tiptipot Simicol may reduce the amount of absorbed levothyroxine and diminish its effect. PREGNANCY, BREASTFEEDING AND FERTILITY: Tiptipot Simicol is intended especially for children. If you are an adult woman using the medicine, consult a doctor or pharmacist before starting treatment if you are pregnant, may be pregnant, are planning to become pregnant or are breastfeeding. Do not use the preparation during pregnancy unless the doctor tells you to. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS O Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TIPTIPOT SIMICOL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SIMETHICONE 20 MG / 0.3 ML (66.67 MG / 1 ML) For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Drops 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Antiflatulent for relief of gripping pain, infant colic or wind due to swallowed air. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral Recommended Dosage: 0.3 ml (20 mg) before each meal. Dosage may be increased to 0.6 ml (40 mg) if required. Do not exceed 12 doses of 0.3 ml or 6 doses of 0.6 ml (totaling 240 mg) a day. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or any of its excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE None stated. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Tiptipot Simicol are given concurrently to infants treated for thyroid disorders. 4.6. PREGNANCY AND LACTATION As simeticone is not absorbed, it is not anticipated that Tiptipot Simicol will have any adverse effects on pregnancy and lactation. However, as with all drugs, caution should be exercised in these conditions. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8. UNDESIRABLE EFFECTS Minor adverse effects: nausea and constipation. Rarely, hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema and respiratory difficulty have been reported. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ 4.9. OVERDOSE No cases of overdose have been reported. Theoretically, constipation may occur. Treat with fl Olvassa el a teljes dokumentumot