Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
AMBROXOL HYDROCHLORIDE
PIAM Farmaceutici S.p.A. Via Fieschi, 8/7 1-16124, Genoa, Italy
R05CB06
AMBROXOL HYDROCHLORIDE 75 mg
MODIFIED-RELEASE CAPSULE
AMBROXOL HYDROCHLORIDE 75 mg
OTC
COUGH AND COLD PREPARATIONS
Authorised
2006-09-14
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MUCICLAR 15MG/5ML SYRUP MUCICLAR 75 MG PROLONGED RELEASE CAPSULES Ambroxol hydrochloride Generic medicine PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE, AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. - Keep this leaflet. You may need to read it again. - If you would like any further information or advice, please consult your pharmacist. - If any of the side effects occur, including any effects not listed in this leaflet, please consult your doctor or pharmacist. See section 4. - Please consult your doctor if you see no improvement or if you notice a worsening of symptoms after a few days. CONTENTS OF THIS LEAFLET: 1. What is MUCICLAR and what is it used for 2. What you need to know before taking MUCICLAR 3. How to take MUCICLAR 4. Possible side effects 5. How to store MUCICLAR 6. Contents of the pack and other information 1. WHAT IS MUCICLAR AND WHAT IS IT USED FOR This medicine contains the active ingredient ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus in the airways. MUCICLAR is used for the treatment of acute and chronic secretions in diseases of the bronchi and the lungs (in case of cough and catarrh). Please consult your doctor if you do not see an improvement, or if you begin to feel worse. 2. WHAT YOU NEED TO KNOW BEFORE TAKING MUCICLAR DO NOT TAKE MUCICLAR - if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6); - if you suffer from serious liver or kidney problems. MUCICLAR must not be used in children under 2 years of age. WARNINGS AND PRECAUTIONS Please consult your doctor or pharmacist before taking MUCICLAR. Take this medicine with caution and inform your doctor: - if you suffer from a problem with the stomach or the intestines called peptic ulcers; - if you suffer from kidney problems (ren Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MUCICLAR 15 mg/5 ml syrup MUCICLAR 75 mg slow-release capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MUCICLAR 15 mg/5 ml syrup 100 ml of syrup contains: Active ingredient: Ambroxol hydrochloride 300 mg MUCICLAR 75 mg slow-release capsules One capsule contains: Active ingredient: Ambroxol hydrochloride 75 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup; Slow-release capsule. 4. CLINICAL INFORMATION 4.1. THERAPEUTIC INDICATIONS Secretion problems in acute and chronic bronchopulmonary disorders. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION MUCICLAR 15 MG/5 ML SYRUP: adults: 5-10 ml syrup 3 times a day, children over two years old: 5 ml of syrup 2 or 3 times a day. MUCICLAR 75 MG SLOW-RELEASE CAPSULE: adults: we recommend 2 capsules in a single administration after breakfast in the morning for 8 days (treatment of attack). Thereafter, the dose can be reduced to a single capsule until the end of the treatment. 4.3. CONTRAINDICATIONS Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Serious changes to liver and/or kidney function. Taking the medicinal product is contraindicated in the case of rare hereditary disorders that may be incompatible with one of the excipients (see para. 4.4.). The drug is contraindicated in children under the age of 2 years (for oral forms). 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ambroxol must be administered with caution in patients with peptic ulcer disease. In very few cases, while taking mucolytic substances such as ambroxol, serious skin lesions were observed such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN). Most of these could be explained by the severity of underlying diseases or other concomitant medications. Also, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially feel non-specific symptoms similar to those of flu, such as, for example fever, chills, rhinitis, cough and sore Citiți documentul complet