New Drynol® (bilastine) 10 mg orodispersible tablets formulation now available
A.Menarini Pharmaceuticals Ireland Ltd. is delighted to announce the launch of a new paediatric formulation of Drynol® (bilastine): Drynol® 10 mg orodispersible tablets.
Drynol® 10mg orodispersible tablets are indicated for the symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight of at least 20 kg.
Drynol® 10mg orodispersible tablets are included on the Primary Care Reimbursement Service (PCRS) list since June 2019.
Celebrating 20 years in Ireland in October 2019, A. Menarini has grown rapidly. Dedicated to launching products that respond to the genuine medical needs of patients and physicians, the company now markets a portfolio of 18 products in the following therapeutic areas: cardiology, respiratory medicine, rheumatology, neurology, analgesia and anti-allergy and employs approximately 50 staff in sales, medical, marketing, administration & finance.
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For full prescribing information, please refer to the Summary of Product Characteristics on www.medicines.ie.
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Drynol 10 mg orodispersible tablets (bilastine)
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: Orodispersible tablets (ODT): round, slightly biconvex white tablets containing 10 mg bilastine.
Uses: Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight of at least 20 kg.
Dosage: Oral administration. Children aged 6 to 11 years with a body weight of at least 20 kg. Take 1 tablet once daily. Take one hour before or two hours after food or fruit juice. Elderly, renal impairment or hepatic impairment: no dose adjustment required. Children under 6 years: no information. In adults and adolescents (over 12 years of age) the administration of Drynol 20 mg tablets is appropriate.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Avoid co-administration with P-glycoprotein inhibitors in patients with moderate or severe renal impairment. Do not use in children under 6 years of age.
Interactions: No interaction data available for children. Consider interactions as for adults: food, grapefruit juice, ketoconazole, erythromycin, diltiazem; medicinal products that are substrates or inhibitors of P-gp, such as cyclosporine.
Pregnancy and Lactation: Avoid use during pregnancy.
Side Effects: Common: rhinitis, headache, allergic conjunctivitis, abdominal pain/upper abdominal pain.
Uncommon: dizziness, loss of consciousness, eye irritation, diarrhoea, nausea, lip swelling, eczema, urticaria, fatigue. Frequency not known: palpitations, tachycardia, hypersensitivity reactions.
Pack Size: 30 orodispersible tablets.
Legal Category: POM.
Product Authorisation Numbers: PA 865/18/02
Product Authorisation Holder: Menarini International Operations Luxembourg S.A, 1 Avenue de la Gare, L-1611 Luxembourg.
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd.
Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation: May 2019