Country: Malta
Language: English
Source: Medicines Authority
LORATADINE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
R06AX13
LORATADINE 10 mg
TABLET
LORATADINE 10 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2006-12-15
PACKAGE LEAFLET BCH22023 2 September 2022 Package leaflet: Information for the User Clarityn 10 mg tablets Loratadine 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, pharmacist, or nurse has told you. - 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 doctor, pharmacist or nurse. 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. See section 4. What is in this leaflet: 1. What Clarityn is and what it is used for 2. What you need to know before you take Clarityn 3. How to take Clarityn 4. Possible side effects 5. How to store Clarityn 6. Contents of the pack and other information 1. What Clarityn is and what it is used for The full name of your medicine is Clarityn tablets. What Clarityn is Clarityn tablets contain the active substance loratadine which belongs to a class of medicines called “antihistamines”. How Clarityn works Clarityn 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. When Clarityn should be taken Clarityn relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes. Clarityn may also be used to help relieve symptoms of urticaria (itching, redness and number and size of hives). The effect of Clarityn will last a whole day and should help you to continue your normal daily activities and sleep. You must talk to a doctor if you do not feel better or if you feel worse. 2. What you need to know before you take Clarityn Do not take Clarityn if you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medi Read the complete document
BCH22023 1 September 2022 SUMMARY OF PRODUCT CHARACTERISTICS BCH22023 2 September 2022 1. NAME OF THE MEDICINAL PRODUCT Clarityn 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg loratadine. Excipients with known effect: The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, to off-white, oval tablet with a, score and “10” on one side and plain on the other side. The score line of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Clarityn tablet is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 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, there are other formulations more suitable. Children under 2 years of age: The safety and efficacy of Clarityn 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 Oral use. The tablet may be taken without regard to mealtime. BCH22023 3 September 2022 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Clarityn should be administered with caution in patients with severe Read the complete document