Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Loperamide hydrochloride
JNTL Consumer Health I (Ireland) Limited
A07DA; A07DA03
Loperamide hydrochloride
Capsule, soft
Antipropulsives; loperamide
Marketed
2011-04-01
■ If you have SEVERE DIARRHOEA as your body loses more fluid, sugars and salts than normal. ■ Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in IMODIUM ® LiquiRelief Capsules. OTHER MEDICINES AND IMODIUM ® LIQUIRELIEF CAPSULES ■ If you are taking any OTHER MEDICINES, including: ■ _ritonavir_ (used to treat HIV) or quinidine (used to treat ABNORMAL HEART RHYTHMS or MALARIA). ■ _itraconazole_ or _ketaconazole_ (ANTIFUNGAL medicines) ■ _gemfibrozil_ (used to treat HIGH CHOLESTEROL) ■ _oral desmopressin_ (used to CONTROL THIRST and URINE PRODUCTION in patients with diabetic insipidus) If any of these bullet points apply to you now or in the past, TALK TO A DOCTOR OR PHARMACIST. If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. PREGNANCY AND BREAST-FEEDING ■ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. ■ Do not take this medicine if you are breast-feeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment. DRIVING AND USING MACHINES ■ This medicine may make you feel dizzy, tired or sleepy. If affected do not drive or operate machinery. OTHER INFORMATION ABOUT THIS MEDICINE ■ IMODIUM ® LiquiRelief Capsules only treat the symptoms of diarrhoea. When you have diarrhoea, your body can lose large amounts of fluids and salts. You will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about special powders (known as ORAL REHYDRATION THERAPY) which replace fluids and salts lost during diarrhoea. The prevention of fluid depletion (dehydration) is of particular importance in infants, children and fr Læs hele dokumentet
Health Products Regulatory Authority 01 March 2024 CRN00F4T9 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium LiquiRelief 2mg Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2 mg Loperamide hydrochloride. Excipient with known effect – Each capsule contains 115.31 mg Propylene Glycol which is equivalent to 0.65 mg/mg, also contains trace amounts of soya lecithin. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, soft (Capsules) A clear blue size 2, oval soft gelatin capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ACUTE DIARRHOEA Adults and children aged 12 years and over: 2 capsules initially followed by 1 capsule after every loose stool. The capsules should be taken with water. The maximum daily dose should not exceed 5 capsules. USE IN ELDERLY No dose adjustment is required for the elderly. RENAL IMPAIRMENT No dose adjustment is required for patients with renal impairment. HEPATIC IMPAIRMENT Although no pharmacokinetic data are available in patients with hepatic impairment, Imodium LiquiRelief should be used with caution in such patients because of reduced first pass metabolism. (see 4.4 Special warnings and special precautions for use). Method of administration Oral use. 4.3 CONTRAINDICATIONS Imodium LiquiRelief must not be used in: Children less than 12 years of age Patients with a known hypersensitivity (allergy) to any component of the product Acute dysentery, which is characterised by blood in stool and high fever Acute ulcerative colitis Pseudomembranous colitis associated with broad spectrum antibiotics Health Products Regulatory Authority 01 March 2024 CRN00F4T9 Page 2 of 6 Patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter This product contains traces of soya lecithi Læs hele dokumentet