País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loratadine
Numark Ltd
R06AX13
Loratadine
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5010441013113 5010441011416 5010441011409 5010441012994
ARTWORK LEGEND PRODUCT NAME PRODUCT LICENCE NO. COMPONENT DIMENSION STRENGTH PACK SIZE FONT & SIZE REMARKS REASON FOR CHANGE COUNTRY MANUFACTURER SOFTWARE ARTIST NUMARK ALLERGY AND HAYFEVER TABLETS 20395-0088 Pil 140 x 260 mm 10 mg - Accord Alternate, (min 9 pt), Arial Narrow (min 9 pt) - Comments received from Shivraj on 30.09.2022 UK (English) Marksans Adobe illustrator CC Santosh NO. OF COLORS 01 ██ Black ██ Dieline 1.6 VERSION XXXXX DATE 03.10.2022 ALLERGY AND HAYFEVER 10MG TABLETS LORATADINE PATIENT INFORMATION LEAFLET that you give the correct amount of medicine. For example a 9 year old child weighs about 30kg (4st 7lb). If in doubt weigh your child and then follow the instructions in the table. Do not give to children under 2 years or who weigh 30kg (4st 7lb) or less. HOW MUCH TO TAKE: If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions. • Swallow the tablet with a drink of water • Do not take more than the amount recommended above • If symptoms do not go away talk to your pharmacist or doctor. IF YOU FORGET TO TAKE NUMARK ALLERGY AND HAYFEVER 10MG TABLETS • If you forget to take your dose, take it as soon as you remember, then continue to take it as usual. • Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse. IF YOU TAKE MORE NUMARK ALLERGY AND HAYFEVER 10MG TABLETS THAN YOU SHOULD If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you. Symptoms of an overdose may include sleepiness, rapid heart beat and headache. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of these serious side effects, stop taking the tablets. See a doctor at once: • Difficulty in breathing, swelling of the fa Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RelonChem Hayfever & Allergy 10mg Tablets Bells Healthcare Hayfever & Allergy relief 10mg Tablets Peach Hayfever & Allergy 10mg Tablets Haylief Hayfever & Allergy 10mg Tablets Tesco Health one-a-day Hayfever & Allergy Relief 10mg Tablets Essential waitrose Hayfever & Allergy 10mg Tablets Health essentials Hayfever & Allergy 10mg Tablets Numark Allergy & Hayfever 10mg Tablets Wilko one a day Hayfever & Allergy relief 10mg Tablets OptiPharma Hayfever & Allergy Relief 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg loratadine. Excipients with known effect. The quantity of lactose monohydrate in the Loratadine 10 mg tablet composition is 75 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Appearance: white, round, flat tablets with a break line 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RelonChem Hayfever and Allergy 10mg tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Adults, including the elderly, and children 12 years of age and over_: One 10mg tablet once daily Children 2 to 12 years of age with: Body weight more than 30kg: 10mg once daily (one tablet) Body weight 30kg or less: 5ml (5mg) of the syrup once daily. The 10mg strength tablet is not appropriate in children with a body weight less than 30kg. Efficacy and safety of RelonChem Hayfever and Allergy 10mg tablets in children under 2 years of age has not been established in this age group. _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 10mg every other day is recommended for adults and children weighing more than 30kg _Patients with renal impairment: _ No dosage adjustments are required in the elderly or in patients with renal insufficiency. Method of administratio Leia o documento completo