País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
xylometazoline (xylometazoline hydrochloride)
Biodeal Pharmaceuticals Pvt. Ltd.
R01AA07
xylometazoline (xylometazoline hydrochloride)
0,5mg/ml
drops nasal
20ml plastic bottle-dropper
OTC
Registered
2023-11-25
XYLOFACT NASAL DROP s XYLOMETAZOLINEHYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without a prescription. However, you still need to use Xylofact carefully to get the best results from it. – Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – You must contact a doctor if the symptoms worsen or do not improve after 5 days. – If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1.What Xylofact is and what it is used for 2. Before you use Xylofact 3. How to use Xylofact 4. Possible side effects 5. How to store Xylofact 6. Further information 1. WHAT XYLOFACT IS AND WHAT IT IS USED FOR Xylofact is for application in the nose to give relief from: • Nasal congestion (blocked nose, including colds) • Perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever) • Sinusitis. Xylofact contains the active ingredient xylometazoline hydrochloride which helps to open up and clear the nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size. 2. BEFORE YOU USE XYLOFACT DO NOT use the drops if your child: • Is under 6 years old. • Is allergic to xylometazoline hydrochloride or any of the other ingredients in the drops. • Has an inflamed nasal p assage. • Is allergic to other decongestants. • Has had recent neurosurgery or nasal surgery. • Has heart or circulatory disease or hypertension • Has diabetes • Has hyperthyroidism (overactive thyroid gland) • Has closed angle glaucoma • Has an enlarged prostate gland • Has phaeochromocytoma (a tumour of the nerves associated with the hormone glands) • Is taking monoamine oxidase inhibitors (MAOIs) or has stopped taking them in the last 14 days • Is taking betablockers • Has chronic nasal inflamma Leia o documento completo
MODULE I : ADMINISTRATIVE INFORMATION 1.3 LABELLING AND PACKAGING 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1. NAME OF THE MEDICINAL PRODUCT XYLOFACT 2. QUALITATIVE AND QUANTITATIVECOMPOSITION Composition: Each ml contains: Xylometazoline Hydrochloride ……..0.5 mg Excipients………………………………..q.s. For full list of excipients, see section 6.1. 3. PHARMACEUTICALS FORM Nasal Drops Colorless to almost colorless clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever), sinusitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and elderly:_ Not applicable. Xylofact are contra-indicated in children under 6 years of age. Children between 6 and 12 years under adult supervision (all indications): 1 or 2 drops, in each nostril up to 2 times a day. Not to be used for more than 5 days without the advice of a doctor. (see warnings and precautions) Parents or carers should seek medical attention if the child's condition deteriorates during treatment. Not more than 2 doses should be given in any 24 hours. _Route of administration:_ Nasal use, Do not exceed the stated dose Keep out of the reach and sight of children 4.3 CONTRAINDICATION Known hypersensitivity to Xylofact or any of the excipients Concomitant use of other sympathomimetic decongestants Cardiovascular disease including hypertension Diabetes mellitus Phaeochromocytoma MODULE I : ADMINISTRATIVE INFORMATION 1.3 LABELLING AND PACKAGING Prostatic hypertrophy Hyperthyroidism Closed angle glaucoma Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5) Beta-blockers – (see section 4.5) Inflammation of the skin and/or mucosa of the nasal vestibule Trans-sphenoidalhypophysectomy or nasal surgery exposing the dura mater Not to be used in children under the age of 6 years Rhinitis sicca or atrophic rhinitis 4.4 SPECIAL WAR Leia o documento completo