Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
R01BA02
PSEUDOEPHEDRINE HYDROCHLORIDE
30 MG/5ml
Syrup
Product not subject to medical prescription
Sympathomimetics
Authorised
1994-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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 after 5 days. WHAT IS IN THIS LEAFLET 1. What Non-Drowsy Sudafed Decongestant Syrup is and what it is used for 2. What you need to know before you use Non-Drowsy Sudafed Decongestant Syrup 3. How to use Non-Drowsy Sudafed Decongestant Syrup 4. Possible side-effects 5. How to store Non-Drowsy Sudafed Decongestant Syrup 6. Contents of the pack and other information 1 What Non-Drowsy Sudafed Decongestant Syrup is and what it is used for Non-Drowsy Sudafed Decongestant Syrup is used to provide relief from the symptoms of colds and flus including nasal congestion and blocked sinuses. It can also provide relief from nasal congestion when this is due to hay fever and similar allergic conditions. The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion. This medicine is for use in adults and children aged 6 years and over. 2 What you need to know before you use Non-Drowsy Sudafed Decongestant Syrup This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE NON-DROWSY SUDAFED DECONGESTANT SYRUP... n If you have ever had a BAD REACTION (ALLERGIC REACTION) to any of the ingredients _(listed in section 6_). n If you have SEVERE KIDNEY PROBLEMS. n If you have DIABETES. n If you have PHAEOCHROMOCYTOMA (rare tumour which affects your heart rate and blood pressure). n If you have an Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Non – Drowsy Sudafed Decongestant 30mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of Non-Drowsy Sudafed Decongestant Syrup contains 30.0 mg pseudoephedrine hydrochloride. Excipients: Each 5 ml also includes sucrose 3.5g, methyl parahydroxybenzoate (E218) 5mg, ponceau 4R (E124) 1.50mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup. A clear, red liquid with a characteristic raspberry odour and taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses and is indicated for the symptomatic relief of nasal congestion in conditions such as allergic rhinitis, vasomotor rhinitis, the common cold and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: ADULTS AND CHILDREN AGED 12 YEARS AND OVER 10 ml syrup every 4-6 hours, up to four times a day. Maximum daily dose: 40 ml (240 mg pseudoephedrine). CHILDREN 6-12 YEARS 5 ml syrup every 4-6 hours, up to four times a day. Maximum daily dose: 20ml. (120 mg pseudoephedrine). A pharmacist or other healthcare professional should be consulted before use in children aged 6 to 12 years. Use only when simple measures have failed to provide adequate relief. CHILDREN UNDER 6 YEARS This medicine is contraindicated in children under the age of 6 years [See Section 4.3]. USE IN THE ELDERLY There have been no specific studies of this medicine in the elderly. Experience has indicated that normal adult dosage is appropriate. HEPATIC DYSFUNCTION Caution should be exercised when administering this medicine to patients with severe hepatic impairment. RENAL DYSFUNCTION Caution should be exercised when administering this medicine to patients with mild to moderate renal impairment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document