Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
ALUM, LIDOCAINE HYDROCHLORIDE, PROPYL HYDROXYBENZOATE
Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany
R02AD02
ALUM 1 mg LIDOCAINE HYDROCHLORIDE 1 mg PROPYL HYDROXYBENZOATE 1.8 mg
LOZENGE
ALUM 1 mg LIDOCAINE HYDROCHLORIDE 1 mg PROPYL HYDROXYBENZOATE 1.8 mg
OTC
THROAT PREPARATIONS
Authorised
2006-08-28
PATIENT INFORMATION HOW DO INFLAMMATORY DISEASES IN THE ORAL AND PHARYNGEAL CAVITIES COME ABOUT? Inflammation in the mouth and throat is caused by germs such as bacteria, viruses or fungi, particularly when the body’s natural defensive powers are weakened (e.g. in the case of a cold). Symptoms are reddening and hyper- sensivity of the mucosae, which can be accompanied by a burning sensation in the mouth, difficulty in swallowing, sore throat and hoarseness. TRACHITOL ® ACTS RAPIDLY AND EFFECTIVELY The active ingredients combined in Trachitol ® have anti-bacterial, painrelieving and antiseptic properties. The antiseptic component in Trachitol ® Lozenges tar- gets the germs causing inflammation by effectively fighting the infection. Pain in the mouth and throat is rapidly and effectively relieved by the local anaesthetic lidocaine. GOOD TOLERANCE – AN IMPORTANT FACTOR The active ingredients contained in Trachitol ® Lozenges are generally very well tolerated, if the preparation is taken according to the directions of use. HELPS IN THE EVENT OF TROUBLESOME BAD BREATH Bad breath is an upleasant symptom, which often accompanies inflammatory diseases in the oral and pharyngeal cavities. The product Trachitol ® Lozenges eradicates bad breath through its peppermint aroma. Trachitol ® Lozenges are SUGAR-FREE , thus kind to the teeth and help to prevent caries. We wish you a speedy recovery. PACK SIZE: Boxes of 20 lozenges. Engelhard Arzneimittel GmbH & Co. KG Herzbergstraße 3 D-61138 Niederdorfelden, Germany MA048/00202 PAIN-RELIEVING, ANTI-INFLAMMATORY, ANTISEPTIC SUGAR-FREE – KIND TO THE TEETH Information for use. Please read carefully! COMPOSITION: Each lozenge contains 1.0 mg of lidocaine HCI 1 H 2 O 1.8 mg of propyl hydroxybenzoate, 1.0 mg of alum, 2.5 mg of peppermint oil as taste corrigent and 0.69 g of the sugar substitute sorbitol, corresponding to 0.057 BU. INDICATIONS: Inflammatory diseases of the oral and pharyngeal cavities: inflammation of the oral mucosa and the gums Đọc toàn bộ tài liệu
1. NAME OF THE MEDICINAL PRODUCT Trachitol ® lozenges 1 mg + 1.8 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Trachitol ® lozenge contains 1.0 mg of Lidocaine hydrochloride (as monohydrate) and 1.8 mg of Propyl-4-hydroxybenzoate. Excipient: Each lozenge contains 0.69 g Sorbitol For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lozenge White, round, flat lozenge with bevelled edge. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inflammatory diseases of the oral and pharyngeal cavities: Inflammation of the oral mucosa and the gums, tonsillitis, laryngitis, sore throat and infections of the upper respiratory tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oropharyngeal Let dissolve one lozenge every 2 hours slowly in the mouth. The maximum daily dose of 8 lozenges (adults) respectively 6 lozenges (children) should not be exceeded. Not suitable for very small children, who are not able to suck a lozenge. If there is no significant improvement after 7 (3-10) days, a physician should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to lidocaine hydrochloride and propyl-4-hydroxybenzoate or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Trachitol ® contains 0.69 mg sorbitol, corresponding to 0.057 BU. Patients with rare hereditary problems of fructose intolerance should not take this medicine after consultation with the doctor. Trachitol Lozenges contain Lidocaine. Cross-allergy to lidocaine hydrochloride is expected in patients with a history of known allergy to other local amide type anaesthetics 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 1 Adverse effects associated with the concomitant use of other drugs in conjunction with Trachitol® Lozenges have not become known so far. 4.6 PREGNANCY AND LACTATION _ _ Trachitol should only be used during pregnancy or lactation after consulting a doctor. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES If Trachitol is used according to the instructions no co Đọc toàn bộ tài liệu