Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Xylometazoline hydrochloride
Haleon UK Ltd
R01AA07
Xylometazoline hydrochloride
1mg/1ml
Spray
Nasal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12020200; GTIN: 5051562028204
Recto Pharma code XXXX Allergy Relief 0.1% Nasal Spray Xylometazoline Hydrochloride 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 Otrivine Allergy Relief 0.1% Nasal Spray 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 7 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 Otrivine Allergy Relief 0.1% Nasal Spray is and what it is used for 2. Before you use Otrivine Allergy Relief 0.1% Nasal Spray 3. How to use Otrivine Allergy Relief 0.1% Nasal Spray 4. Possible side effects 5. How to store Otrivine Allergy Relief 0.1% Nasal Spray 6. Further information 1. What Otrivine Allergy Relief 0.1% Nasal Spray is and what it is used for Otrivine Allergy Relief 0.1% Nasal Spray is for application in the nose to give relief from: • nasal congestion (blocked nose, including colds) • perennial and allergic rhinitis (recurring inflam- mation of the nasal mucous membranes, includ- ing hay fever) • sinusitis. Otrivine Allergy Relief 0.1% Nasal Spray 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 Otrivine Allergy Relief 0.1% Nasal Spray DO NOT use the spray if you: • are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see Section 6) • have had recent neurosurgery. Do not use this spray for children under 12 years old. Take special care Before using the spray tell your doctor if you: • have an overactive thyroid gland (hyperthyroidism) • have glaucoma • have diabet Leggi il documento completo
OBJECT 1 OTRIVINE ALLERGY RELIEF 0.1% NASAL SPRAY Summary of Product Characteristics Updated 01-Feb-2017 | GlaxoSmithKline Consumer Healthcare • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Otrivine Adult Measured Dose Sinusitis Spray Otrivine Adult Metered Dose, 0.1% Nasal Spray Otrivine Allergy Relief, 0.1% Nasal Spray 2. Qualitative and quantitative composition Active ingredient: 0.1% _wlv _Xylometazoline Hydrochloride For excipients see 6.1 3. Pharmaceutical form Nasal spray, solution A clear, colourless solution 4. Clinical particulars 4.1 Therapeutic indications For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis. 4.2 Posology and method of administration Adults and elderly: One application in each nostril 1 to 3 times daily. Not suitable for children under 12 years. Route of administration: Application to the nasal passages. 4.3 Contraindications Known hypersensitivity to xylometazoline. Patients with t Leggi il documento completo