OTRIVINE ADULT Nasal spray, solution (2021)
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Περιεχόμενα
1. Name of the medicinal product
Otrivine Adult Nasal Spray.
2. Qualitative and quantitative composition
Xylometazoline Hydrochloride 0.1% w/v. For excipients, see section 6.1.
3. Pharmaceutical form
Nasal spray, solution. The spray is a clear, colourless solution.
4.1. Therapeutic indications
For the treatment of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.
4.2. Posology and method of administration
Otrivine Adult Nasal Spray should not be used in children aged less than 12 years old. Adults, children over 12 years One application in each nostril up to 3 times daily. Do not exceed 3 applications daily ...
4.3. Contraindications
Known hypersensitivity to xylometazoline or any of the excipients listed in section 6.1 Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater. Narrow-angle glaucoma Rhinitis ...
4.4. Special warnings and precautions for use
Patients are advised not to take decongestants for more than seven consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa. Otrivine, like other preparations ...
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these ...
4.6. Pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy. ...
4.7. Effects on ability to drive and use machines
Otrivine has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), ...
4.9. Overdose
Symptoms and Signs Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, ...
5.1. Pharmacodynamic properties
Otrivine Adult Nasal Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa ...
5.2. Pharmacokinetic properties
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.
5.3. Preclinical safety data
There are no findings in the preclinical testing which are of relevance to the prescriber.
6.1. List of excipients
Benzalkonium chloride Disodium phosphate dodecahydrate (Sodium phosphate) Disodium edetate Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate) Sodium chloride Purified water
6.2. Incompatibilities
None.
6.3. Shelf life
<u>Unopened:</u> 24 months. <u>After the container is opened for the first time:</u> 28 days.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
<u>Bottle:</u> Low density polyethylene <u>Cap:</u> High density polyethylene <u>Spray valve and capillary:</u> Low density polyethylene <u>Carton:</u> Cardboard <u>Pack size:</u> 10 ml.
6.6. Special precautions for disposal and other handling
Keep all medicines out of the reach of children
7. Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
8. Marketing authorization number(s)
PL 44673/0149
9. Date of first authorization / renewal of the authorization
1<sup>st</sup> October 1997/19<sup>th</sup> August 2010
10. Date of revision of the text
6<sup>th</sup> August 2021
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