Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1.25 mg
ORAL SOLUTION
PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1.25 mg
OTC
NASAL PREPARATIONS
Authorised
2016-02-09
1 PILmedofsyrcom2.2-MT PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEDOFED 30 MG/1.25 MG PER 5 ML, ORAL SOLUTION Pseudoephedrine hydrochloride Triprolidine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Medofed is and what it is used for 2. What you need to know before you take Medofed 3. How to take Medofed 4. Possible side effects 5. How to store Medofed 6. Contents of the pack and other information 1. WHAT MEDOFED IS AND WHAT IT IS USED FOR Medofed is a medicine which is used to relieve the symptoms of colds and allergies including sneezing, runny nose, watery eyes, nasal congestion and blocked sinuses. The liquid contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes. This medicine is for use in adults and children aged 6 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDOFED This medicine is suitable for most adults and children aged 6 years and over but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. 2 PILmedofsyrcom2.2-MT DO NOT TAKE MEDOFED: • If you are allergic to pseudoephedrine hydrochloride, triprolidine hydrochloride or any of the other ingredients of this medicine (listed in section 6). • If you have high blood pressure or heart disease. • If you are taking beta blockers (used to treat high blood pressure) • If you are Baca dokumen lengkap
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Medofed 30 mg/1.25 mg per 5 ml, oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of solution contains 30 mg pseudoephedrine hydrochloride and 1.25 mg triprolidine hydrochloride. Excipients with known effect: sucrose, methyl para-hydroxybenzoate, tartrazine yellow lake. Each 5 ml of oral solution contain 3500 mg sucrose, 5 mg methyl para-hydroxybenzoate and 0.08 mg tartrazine yellow lake. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, yellow, flavoured solution for oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Medofed contains a decongestant and antihistamine and is indicated for the management of upper respiratory tract conditions such as the common cold, hay fever, allergic and vasomotor rhinitis and aerotitis (otitis barotrauma). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Use only when simple measures have failed to provide adequate relief. Use for more than 5 consecutive days is not recommended. _Adults and children over 12 years _ Page 2 of 11 10 ml every 4 - 6 hours up to 4 times a day. Maximum daily dose: 40 ml _Children 6 - 12 years _ Medofed can only be used on the advice of a physician in children 6-12 years. Oral: 5 ml every 4 - 6 hours, up to 3 times a day. Maximum daily dose: 15 ml. A pharmacist or other healthcare professional should be consulted before use in children aged 6 to 12 years. _Children under 6 years: _ This medicine is contraindicated in children under 6 years. (See section 4.3) _Elderly _ There have been no specific studies of pseudoephedrine or triprolidine in the elderly. Experience has indicated that normal adult dosage is appropriate. _Patient with hepatic impairment _ Caution should be exercised when administering Medofed to patients with severe hepatic impairment. _Patients with renal impairment _ Caution should be exercised when administering Medofed to patients with mild to moderate renal impairment Baca dokumen lengkap