Humex Allergy Loratadine 10mg, Box of 7

1. NAME OF DRUG HUMEX ALLERGY LORATADINE 10mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Loratadine ...................................................................................................................................... 10 mg Per tablet. Dilutants: Each tablet contains 75mg of monohydrous lactose. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round tablet with a score line. The score line is only to help take the tablet, dividing it does not make it an equal half-dose. 4. CLINICAL DATA 4.1. Therapeutic Indications HUMEX ALLERGY LORATADINE 10mg tablet is a symptomatic treatment for rhinitis. 4.2. Dosage and how to use Adults and children over 12 years of age: 10 mg once per day (1 tablet per day). The tablet can be taken at any time of the day. Children heavier than 30kg: 10 mg once per day (1 tablet per day). The 10mg tablet is not suitable for children lighter than 30kg. The effective of HUMEX ALLERGY LORATADINE has not been studied enough for children under 2. Severe hepatic failure For patients suffering from hepatic failure the dose should be reduced due to the loratadine content. An initial dose of 10mg every two days is recommended for adults and children over 30kg. Elderly and kidney failure No change in dose is needed for elderly and kidney failure patients. Length of treatment The length of treatment should not be more than 3 days without medical advice. 4.3. Contraindications HUMEX ALLERGY LORATADINE is not recommended for those who are sensitive to loratadine or one of the ingredients. 4.4. Special warnings and side effects HUMEX ALLERGY LORATADINE should be taken carefully for those with severe hepatic failure (see section 4.2). This drug contains lactose. This drug is not recommended for patients with a galactose intolerance, a Lapp lactose intolerance or glucose-galactose malabsorption (rare hereditary illnesses). Taking HUMEX ALLERGY LORATADINE should be discontinued for at least 48 hours prior to skin testing for the diagnosis of allergy as antihistamines may inhibit or reduce the skin’s response. 4.5. Interactions with other drugs Psychomotor performance studies did not demonstrate potentiation of the effects of HUMEX ALLERGY LORATADINE during the simultaneous administration of alcohol. The risk of interactions with cytochrome CYP3A4 or CYP2D6 inhibitors resulting in increased plasma concentrations of loratadine may increase the risk of side effects (see section 5.2). 4.6. Pregnancy and breast feeding Pregnancy Studies on animals have not shown any teratogen effect of loratadine. The safety of loratadine during pregnancy has not been studied. Therefore this medication is not recommended during pregnancy. Breast feeding Loratadine passes into human milk. Therefore this medication is not recommended when breast-feeding. 4.7. Effects on the ability to drive and operate machinery In clinical studies evaluating the ability to drive, no deleterious effects were observed in patients taking loratadine. However, patients should be informed that very rarely in some people have experienced drowsiness that could affect their ability to drive vehicles or use machines. 4.8. Side effects In clinical studies in children aged 2 to 12, the frequent side effects reported with a higher frequency than placebo were: headache (2.7%), nervousness (2.3%) And fatigue (1%). In clinical studies for adults and adolescents with rhinitis and chronic urticaria at the recommended dose of 10mg, the side effects of loratadine were experienced by 2% more of the patients than those with the placebo. The most common side effects reported: drowsiness (1.2%), headache (0.6%), increase in appetite (0.5%) and insomnia (0.1%). Other side effects have been reported: Immune system problems Anaphylaxia Nervous system problems Vertigo Cardiac problems Tachycardia, palpitations Gastro-intestine infections Nausea, dry mouth, gastritis Live biliary problems Hepatic function problems Skin & under the skin infections Rash, alopecia General/anomalies Tiredness 4.9. Overdose An overdose of loratadine increases the anti-cholinergic symptoms. Drowsiness, tachycardia and headaches have been reported after an overdose. In case of overdose, symptomatic treatment and maintenance of vital functions are recommended. Active charcoal with water should be taken. A gastric clean-out should also be done. Loratadine is not eliminated by hemodialysis and it is not known whether peritoneal dialysis can eliminate it. The patient must be medically checked after this emergency treatment. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTIHISTAMINES A SYSTEMATIC USAGE, Code ATC: R06AX13. Loratadine, the active ingredient in HUMEX ALLERGY LORATADINE, is a tricyclic antihistamine that selectively acts on peripheral H1 receptors. Loratadine does not have a significant sedative or anticholinergic effect among most people when used at the recommended dose. During long-term treatment, there were no clinically significant changes in vital functions, biological parameters, clinical examination or electrocardiographic tracings. Loratadine has no significant effect on H2 receptors. It does not inhibit the uptake of noradrenaline and has virtually no influence on cardiovascular function or intrinsic pacemaker activity. 5.2. Pharmacokinetics properties Following oral administration, loratadine is rapidly and well absorbed and undergoes a significant first-pass hepatic effect by essential metabolism with CYP3A4 and CYP2D6. The main metabolite - desloratadine - is pharmacologically active and largely responsible for the clinical effect. Maximum plasma concentrations of loratadine and desloratadine are reached (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively. In controlled clinical studies, elevated plasma concentrations of loratadine have been reported with simultaneous administration of ketoconazole, erythromycin or cimetidine, but without significant clinical consequences (or ECG path changes). The binding of loratadine to circulating proteins is intense (97% to 99%), while that of the metabolite is more moderate (73% to 76%). In healthy volunteers, the distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The main elimination half-life for healthy volunteers was 8.4 hours (ranging from 3 to 20 hours) for loratadine and 28 hours (ranging from 8.8 to 92 hours) for the main active metabolite. Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a period of 10 days and mainly as conjugated metabolites. Approximately 27% of the dose is excreted in the urine during the first 24 hours. Less than 1% of the active substance is excreted in the active form unchanged loratadine or desloratadine. The bioavailability of loratadine and its active metabolite is dose dependent. The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult and elderly volunteers. Simultaneous ingestion of food may cause a slight delay in the absorption of loratadine without any effect on the clinical effect. In patients with chronic renal insufficiency, AUC and peak plasma concentrations (Cmax) of loratadine and its metabolite were higher than AUC and peak plasma concentrations (Cmax) observed in patients with chronic renal function Renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from those observed in normal subjects. Hemodialysis has no effect on the pharmacokinetics of loratadine and its active metabolite in patients with chronic renal insufficiency. In patients with chronic hepatic disease of ethyl origin, the AUC and plasma loratadine peaks (Cmax) observed were doubled while the pharmacokinetic profile of the active metabolite was not significantly modified compared to Of patients with normal liver function. The elimination half-lives of loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with the severity of liver disease. Loratadine and its active metabolite passes through breast milk in lactating women. 5.3. Preclinical safety data Preclinical data does not indicate a specific risk to humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity or carcinogenicity. The study of reproductive functions revealed no teratogenic effects in animals. However, prolonged childbirth and decreased viability of offspring were observed in rats exposed to plasma levels (AUC) 10 times higher than those achieved with clinical doses. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Monohydrous lactose, microcrystalline cellulose, corn starch, magnesium stearate. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions No specific storage precautions. 6.5. Nature and contents of outside packaging 5, 6 or 7 tablets in blister packs (PVC/Alu). 5 or 7 tablets in a vial (polypropylene). Not all pack sizes will be available. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER LABORATOIRES URGO 42 RUE DE LONGVIC 21300 CHENOVE 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 498 942-7 or 34009 498 942 7 7: 5 tablets in blister packs (PVC/Alu). · 274 576-7 or 34009 274 576 7 8: 6 tablets in blister packs (PVC/Alu). · 498 943-3 or 34009 498 943 3 8: 7 tablets in blister packs (PVC/Alu). · 498 945-6 or 34009 498 945 6 7: 5 tablets in a vial (polypropylene). · 498 946-2 or 34009 498 946 2 8: 7 tablets in a vial (polypropylene). 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.