Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATIONCLA943_958 SmPCv1.0/ZA-v1/122020 Page 1 of 9 SCHEDULING STATUS1. NAME OF THE MEDICINAL PRODUCT CLARITYNE™ Syrup, 1 mg/ml CLARITYNE™ Tablets, 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CLARITYNE™ Syrup per 5 ml
: Active ingredients: 5 mg of loratadine (micronized). Contains sugar: Sucrose. 3.0 g for a full list of excipients, see section 6.1CLARITYNE™ Tablets per tablet: Active ingredient: 10 mg loratadine (micronized). Excipients with known effect: Contains sugar: Lactose monohydrate 0.071 g/tablet. For a full list of excipients, see section 6.13. PHARMACEUTICAL FORM Syrup: Clear, colourless to light-yellow syrup, with a characteristic peach odour and flavour, and free from foreign matter. Tablets: Oval, convex, white tablet, scored on one side with the trademark above the score, and the number 10 below the score [S1] Applicant/ PHCR: Bayer (Pty) Ltd
MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATIONCLA943_958 SmPCv1.0/ZA-v1/122020 Page 2 of 94. CLINICAL PARTICULARS
4.1. Therapeutic indications CLARITYNE™ is indicated for the relief of symptoms associated with perennial and /or seasonal allergic rhinitis, chronic urticaria, and other allergic skin disorders
4.2. Posology and method of administration Posology
CLARITYNE™ Syrup: Children 2 to 12 years of age: Body Weight equal to or less than 30 kg: 5 ml (1 medicine measure) once daily. Body Weight more than 30 kg: 10 ml (2 medicine measures) once daily. Adults and Children 12 years of age and over: 10 ml (2 medicine measures) once daily. CLARITYNE™ Tablets: Adults: One tablet once daily. Special Populations: Elderly population Safety of CLARITYNE™ in the elderly has not been established. Patients with hepatic impairment Patients with severe liver impairment should be administered a lower initial dose of CLARITYNE™ because they may have a reduced clearance of loratadine; an initial dose of 5 ml (or 5 mg tablet) once daily, or 10 ml (or 10 mg tablet) every other day is recommended
Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATION CLA943_958 SmPCv1.0/ZA-v1/122020 Page 3 of 9 Paediatric population safety and efficacy of CLARITYNE™ in children under 2 years of age have not been established. No data are available Method of administration for oral use only. CLARITYNE™ can be taken with or without a meal.
4.3. Contraindications CLARITYNE™ is contraindicated in patients who have shown sensitivity or idiosyncrasy to its components. Safety of CLARITYNE™ in the elderly has not been established. CLARITYNE™ is contraindicated in children under two years of age as safety has not been established.
4.4. Special warnings and precautions for use. Patients with severe liver impairment should be administered a lower initial dose of CLARITYNE™ because they may have a reduced clearance of loratadine; an initial dose of 5 ml (or 5 mg tablet) once daily, or 10 ml (or 10 mg tablet) every other day is recommended. Efficacy of CLARITYNE™ Syrup has not yet been established in children younger than 2 years of age. However, the pharmacokinetic profile of loratadine in infants 1 to 2 years after the administration of a single 2.5 mg dose of CLARITYNE™ Syrup is similar to that in older children and adults. When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies. Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1
Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATION CLA943_958 SmPCv1.0/ZA-v1/122020 Page 4 of 9
CLARITYNE™ contains sugar. Patients with rare hereditary problems of fructose or galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take CLARITYNE™. Weight gain has been reported with the use of loratadine, but the frequency is unknown.
4.5. Interaction with other medicinal products and other forms of interaction Medicine/laboratory test interactions. The use of CLARITYNE™ should be discontinued approximately 48 hours prior to skin testing procedures since it may prevent or diminish otherwise positive reactions to dermal reactivity indicators. An increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin, or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other medicines known to inhibit hepatic metabolism should be co-administered with caution together with CLARITYNE™ until definitive interaction studies can be completed or in the absence of formal interaction studies.
4.6. Fertility, pregnancy, and lactation. The safe use of CLARITYNE™ during pregnancy or lactation has not been established.
4.7. Effects on ability to drive and use machines CLARITYNE™ lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual responses before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATION CLA 943_958 SmPCv1.0/ZA-v1/122020 Page 5 of 94.8. Undesirable effects) Summary of the safety profile. In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 10 mg daily, side effects with CLARITYNE™ Tablets were reported in 2% of patients in excess of those treated with placebo. The most frequent side effects reported in excess of placebo were somnolence (1.2 %), headache (0.6 %), increased appetite (0.5 %) and insomnia (0.1 %) b) Tabulated summary of adverse reactions & other side effects reported during post-marketing period are listed in the following table. Immune system disorders Anaphylaxis including angioedema Metabolism and nutrition disorders, Increased appetite, Nervous system disorders, Headache, somnolence, sedation, nervousness, Dizziness, convulsion Cardiac disorders Tachycardia, palpitation Gastrointestinal disorders, Nausea, dry mouth, gastritis hepatobiliary disorders, abnormal hepatic function. skin and subcutaneous tissue disorders, rash, alopecia, general disorders, and administrative site conditions Fatigue, reporting of suspected adverse reactions Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found under SAHPRA’s publications: Https://www.sahpra.org.za/Publications/Index/8. Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength:Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine P
ROFESSIONAL INFORMATION CLA943_958 SmPCv1.0/ZA-v1/122020 Page 6 of 94.9.OverdoseRefer to “4.8 Undesirable effects”
Overdosage Information: Somnolence, tachycardia, and headache have been reported with overdoses. In the event of overdosage, treatment should be started immediately. Treatment: Treatment is symptomatic and supportive. Consider standard measures to remove any unabsorbed medicine in the stomach, such as adsorption by activated charcoal administered as a slurry with water. The administration of gastric lavage should be considered.0,9 % Sodium chloride solution is the lavage solution of choice, particularly in children. In adults tap water can be used; however, as much as possible of the amount administered should be removed before the next instillation. Sodium chloride or saline cathartics draw water into the bowel by osmosis and therefore, may be valuable for their action in rapid dilution of bowel content. Loratadine is not cleared by haemodialysis to any appreciable extent. After emergency treatment, the patient should continue to be medically monitored.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Category and class: A. 5.7.1 Antihistaminics Mechanism of action Loratadine is a long-acting, tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. Loratadine does not readily cross the blood-brain barrier.
5.2. Pharmacokinetic properties Absorption and Distribution Maximal serum levels were achieved within 1,5 hours. Clinical effect was achieved within two hours. Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATION CLA943_958 SmPCv1.0/ZA-v1/122020 Page 7 of 9BiotransformationLoratadine undergoes rapid hepatic metabolism to an active metabolite, desloratadine. Elimination Excretion occurred equally via renal and faecal routes.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients CLARITYNE ™ Syrup Citric acid monohydrate, Glycerol, Peach flavour, Propylene glycol, Purified water Sucrose. CLARITYNE™ Tablets Lactose monohydrate, Magnesium stearate, Maize starch Purified water.
6.2. Incompatibilities Not applicable.
6.3. Shelf life CLARITYNE ™ Syrup: 36 months CLARITYNE™ Tablets: 48 months
Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine
PROFESSIONAL INFORMATION CLA943_958 SmPCv1.0/ZA-v1/122020 Page 8 of 96.4. Special Precautions for storage: Store at or below 25 °C. CLARITYNE™ Tablets: Protect from moisture6.5. Nature and contents of container CLARITYNE™ Syrup: Bottles of 100 ml CLARITYNE™ Tablets: Blister packs of 10 and 30 tablets6.6. Special precautions for disposal, No special requirements7. HOLDER OF CERTIFICATE OF REGISTRATION Bayer (Pty) Ltd 27 Wrench Road Isando, 1600SOUTH AFRICA1968/011192/07+27 11 921 50008. REGISTRATION NUMBER(S) CLARITYNE™ Syrup: Z/5.7.1/56 CLARITYNE™ Tablets: U/5.7.1/279. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATIONCLARITYNE™ Syrup: Date on the registration certificate: 15 January 1992 CLARITYNE™ Tablets: Date on the registration certificate: 03 October 1990
Applicant/ PHCR: Bayer (Pty) Ltd MODULE 11.3.1 Product Name: Clarityne Dosage Form and Strength: Syrup, 5 mg loratadine per 5 ml& Tablets, 10 mg Loratadine PROFESSIONAL INFORMATIONCLA943_958 SmPCv1.0/ZA-v1/122020 Page 9 of 910. DATE OF REVISION OF THE TEXTCLARITYNE™ Syrup: Date of most recently revised professional information: 31 October 2018CLARITYNE™ Tablets: Date of most recently revised professional information: 31 October 2018Clarityne Tablets Clarityne Syrup Registration Number/ Scheduling Status Registration Number/Scheduling Status
