Negara: Inggris
Bahasa: Inggris
Sumber: 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: 5051562033505
Recto Pharma code XXXX ® Congestion Relief 0.1% Nasal Spray Xylometazoline Hydrochloride Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This medicine is available without a prescription. However, you still need to use Otrivine Congestion 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 Congestion Relief 0.1% Nasal Spray is and what it is used for 2. Before you use Otrivine Congestion Relief 0.1% Nasal Spray 3. How to use Otrivine Congestion Relief 0.1% Nasal Spray 4. Possible side effects 5. How to store Otrivine Congestion Relief 0.1% Nasal Spray 6. Further information 1. What Otrivine Congestion Relief 0.1% Nasal Spray is and what it is used for Otrivine Congestion 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 inflammation of the nasal mucous membranes, including hay fever) • sinusitis. Otrivine Congestion 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 Congestion 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 • have narrow angle glaucoma. Do not use this spray for children under 12 years old. Take special care Before using the spray tell your doctor Baca dokumen lengkapnya
OBJECT 1 OTRIVINE CONGESTION RELIEF 0.1% NASAL SPRAY Summary of Product Characteristics Updated 02-Nov-2016 | 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 Congestion Relief 0.1% Nasal Spray 2. Qualitative and quantitative composition Otrivine Congestion Relief 0.1% Nasal Spray, nasal solution contains 1 mg/ml of xylometazoline hydrochloride. Each metered-dose spray delivers 0.14 mg of xylometazoline hydrochloride. Excipients with known effect: polyoxyl hydrogenated castor oil (2.750 mg/ml) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Nasal spray, (solution) Metered-dose spray: opalescent, white solution, with menthol and eucalyptol (cineole) odour. 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 Posology _Paediatric population_ Otrivine Co Baca dokumen lengkapnya