Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Loratadine
McDermott Laboratories Ltd., T/A Gerard Laboratories
R06AX; R06AX13
Loratadine
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antihistamines for systemic use; loratadine
Not marketed
2003-01-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HISTACLAR 10 MG FILM-COATED TABLETS loratadine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Histaclar is and what it is used for 2. What you need to know before you take Histaclar 3. How to take Histaclar 4. Possible side effects 5. How to store Histaclar 6. Contents of the pack and other information 1. WHAT HISTACLAR IS AND WHAT IT IS USED FOR Histaclar belongs to a group of medicines called antihistamines which are used to treat the symptoms of allergies such as hayfever and year-round allergies, for example from house dust mites. Histaclar helps to reduce your allergy symptoms by stopping the effects of a substance called “histamine”, which is produced in the body when you are allergic to something. Histaclar acts to reduce the allergic reactions and their unpleasant symptoms such as sneezing, runny or itchy nose, and burning or itchy eyes in adults and children over the age of 6 years and with a body weight more than 30 kg. Histaclar can also be used to help relieve symptoms of urticaria, an allergic skin reaction like itching, rashes, hives or nettle rash. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HISTACLAR DO NOT TAKE HISTACLAR: - if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Histaclar: - if you have liver disease. - if you are due to have any skin tests for allergies. You should stop taking Hi Read the complete document
Health Products Regulatory Authority 23 February 2022 CRN00CSDJ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Histaclar 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg loratadine. Excipient with known effect: each tablet contains 84.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex film-coated tablets scored on one side and marked “LR 10” on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Histaclar Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years with a body weight more than 30 kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology_:_ _Adults:_ One tablet once daily. _Paediatric population_ _Children _6 years of age and older with a body weight greater than 30 kg: One tablet once daily For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, other more suitable formulations may be available. _Children under 2 years of age_ The safety and efficacy of Histaclar Tablets have not been established. No data are available. _Patients with hepatic impairment_ Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg. _Patients with renal impairment_ No dosage adjustments are required in patients with renal insufficiency. _Elderly _ No dosage adjustments are required in the elderly. Method of administration For oral use. The tablet may be taken without regard to mealtime. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 23 February 2022 CRN00CSDJ Page 2 of 6 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Read the complete document