Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Loperamide hydrochloride
Johnson & Johnson (Ireland) Limited
A07DA; A07DA03
Loperamide hydrochloride
2 milligram(s)
Capsule, hard
Product not subject to medical prescription
Antipropulsives; loperamide
Marketed
1989-05-03
– 1 – Loperamide Hydrochloride 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. ■ This medicine is used to treat sudden short- lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. ■ DO NOT TAKE THIS MEDICINE: ■ There are some people who should not use this medicine. To find out if you are one of them. See Section 2 ▶ ■ If you are allergic to loperamide or any of the other ingredients of this medicine. ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in Section 2 ▶ ■ If you are taking any other medicines. See Section 2 ▶ ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the dosage table. See Section 3 ▶ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. ■ 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 pharmacist. 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 24 hours. WHAT IS IN THIS LEAFLET 1. What ARRET™ Capsules are, and what they are used for. 2. What you need to know before you take ARRET™ Capsules. 3. How to take ARRET™ Capsules. 4. Possible side effects. 5. How to store ARRET™ Capsules. 6. Contents of the pack and other information. 1 WHAT ARRET™ CAPSULES ARE AND WHAT THEY ARE USED FOR ARRET™ Capsules is a medicine which is used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. The capsules contain loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from the bowel. ARRET™ Capsules should be used in conjunction with oral rehydrati Pročitajte cijeli dokument
Health Products Regulatory Authority 12 April 2023 CRN00CPN7 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arret 2mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains loperamide hydrochloride 2 mg. Excipient with known effect - Each capsule contains Lactose Monohydrate 127.0mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (short term: capsule) Brown and light green hard gelatine capsules containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the management of acute diarrhoea together with fluid and electrolyte replacement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The capsules should be taken with water. Adults and children over 12 years only: The usual dose is 2 capsules initially, followed by 1 capsule after each further episode of diarrhoea up to a maximum of 5 in 24 hours. 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, Arret should be used with caution in such patients because of reduced first pass metabolism _(see 4.4 Special warning and precautions for use)._ Method of Administration: Oral. 4.3 CONTRAINDICATIONS Arret is contra-indicated in children under 12 years of age Health Products Regulatory Authority 12 April 2023 CRN00CPN7 Page 2 of 6 Arret is contrainidicated in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients Arret should not be used as the primary therapy: In patients with acute dysentery, which is characterised by blood in the stools and high fever. In patients with acute ulcerative colitis In patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter. In patients with Pseudomenbraneous colitis associa Pročitajte cijeli dokument