国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Xylometazoline hydrochloride
McNeil Products Ltd
R01AA07
Xylometazoline hydrochloride
1mg/1ml
Spray
Nasal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12020200; GTIN: 3574661433400
FONTS USED CTE SFO01 2861 Sudafed Sinus Ease 0.1% 15ml CCDS Leaflet GB CC/SS/LG 03/03/2018 614719_V1 Leaflet N/A N/A N/A 18-0126 148 x 210mm N/A N/A N/A BLACK PMS 186 C Bliss Pro-ExtraBold Bliss Pro-ExtraLight Italic Bliss Pro-Italic Bliss Pro-Regular Qlassik Bold-Regular Wingdings 3-Regular Zapf Dingbats-Regular BODY COPY SIZE 7.5pt n This medicine is used to help clear the blocked up feeling in your nose and sinuses, and helps relieve congestion caused by sinusitis, colds and hayfever. n This medicine is for use by adults and children aged 12 years and over. n DO NOT TAKE THIS MEDICINE: n There are some people who should not take this medicine. _To find out if you are one of them see _ _section 2_ n If you have ever had a BAD REACTION to any of the ingredients. _For the list of ingredients see section 6_ n SPEAK TO YOUR DOCTOR: n If you suffer from any of the conditions mentioned in section 2. _See section 2_ n FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the table. _See section 3_ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Sudafed Sinus-Ease 0.1% Nasal Spray is a medicine which is used to help clear the blocked up feeling in your nose and sinuses, and helps relieve congestion caused by sinusitis, colds and hayfever. The metered spray gives an exact dose that lasts for up to 10 hours. The spray contains xylometazoline hydrochloride, which is a topical decongestant that relieves nasal and sinus congestion. This medicine is for use in adults and children aged 12 years and over. 2 BEFORE TAKING THIS MEDICINE 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 THIS MEDICINE… n If you have ever had a BAD REACTION (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients. n If you are taking, or have taken in the last two weeks, DRUGS FOR DEPRESSION known as Mo 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Non-Drowsy Sudafed Decongestant Nasal Spray Sudafed Blocked Nose Spray Sudafed Mucus Relief 0.1% Nasal Spray Sudafed Sinus-Ease 0.1% Nasal Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Aqueous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN 12 YEARS AND OVER: One spray to be expressed into each nostril 2-3 times daily, as necessary. Maximum daily dose: 3 sprays in 24 hours. Use for more than seven consecutive days is not recommended, [See section 4.4]. CHILDREN UNDER 12 YEARS: Do not give to children under 12 years of age. THE ELDERLY Experience has indicated that normal adult dosage is appropriate, [See section 5.2]. HEPATIC/RENAL DYSFUNCTION Normal adult dosage is appropriate, [See section 5.2]. Method of administration Nasal 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under 12 years of age. This product is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus. Patients with long QT syndrome treated w 阅读完整的文件