Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Xylometazoline hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Otrivine Congestion Relief 0.1% Nasal Spray is for application in the nose to give relief from:
e Otrivine Congestion Relief 0.1% Nasal Spray DO NOT use the spray if you:
Otrivine Congestion Relief 0.1% Nasal Spray Dosage: For adults and children over 12 years of age: One spray in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril. Administration:
Remove cap. Be careful not to spray in the eyes. 1. Clear the nose. 2. Hold the bottle with thumb on the actuation button. 3. For a no dripping effect, stay upright and insert the short nozzle into a nostril. 4. Press on the button to spray and breathe in gently through the nose at the same time. Repeat this procedure (steps 2 to 4) in the other nostril. 5. After each use, clean and dry the nozzle. 6. Put the protective cap back on until an audible "click" is heard.
1. Clear nose
2. Thumb on button
3. Insert in nose
k Clic
4. Press button
5. Clean and dry
6. Replace cap
To avoid possible spread of infection, this pack should only be used by one person. For reasons of hygiene, do not use this bottle for more than 28 days after opening it. Do not exceed the recommended dosage, especially in children and the elderly.
If you use more Otrivine Congestion Relief 0.1% Nasal Spray than you should, consult your doctor or pharmacist immediately.
Uncommon (may affect up to 1 in 100 people):
Like all medicines, Otrivine Congestion Relief 0.1% Nasal Spray can cause side effects, although not everybody gets them.
What Otrivine Congestion Relief 0.1% Nasal Spray looks like and the contents of the pack Otrivine Congestion Relief 0.1% Nasal Spray is a white solution in a 10 ml bottle.
Stop using Otrivine Congestion Relief 0.1% Nasal Spray and seek medical help immediately if you experience:
Marketing Authorisation Holder: Haleon UK Trading Limited, Weybridge, KT13 0NY, U.K.
Common (may affect up to 1 in 10 people):
This leaflet was last revised in April 2024.
Manufacturer: Haleon UK Trading Services Limited, Weybridge, KT13 0NY, U.K. Trade Marks are owned by or licensed to the Haleon group of companies.
62000000210483
Otrivine Congestion Relief 0.1% Nasal Spray Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month. Do not store above 25 °C. Store in the original package. Do not use this bottle for more than 28 days after opening it. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Otrivine Congestion Relief 0.1% Nasal Spray contains The active ingredient is xylometazoline hydrochloride (0.1% w/v).
If you forget to use Otrivine Congestion Relief 0.1% Nasal Spray Do not take a double dose to make up for a forgotten one.
The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, levomenthol, cineole, sorbitol, polyoxylhydrogenated castor oil (macrogol glycerol hydroxystearate) and purified water.
Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray comes as nasal spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray is xylometazoline hydrochloride.
Medicines with the same active substance, strength and form include: Otrivine Adult Nasal Drops, Otrivine Allergy Relief 0.1% Nasal Spray with Khone Spray, Otrivine Blocked Nose Relief, 0.1% w/v Nasal Spray, Solution. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.
Otrivine Congestion Relief 0.1% Nasal Spray should not be used in children aged less than 12 years old.
Adults and children over 12 years: One application in each nostril up to 3 times daily as needed.
Do not exceed 3 applications daily into each nostril.
Route of administration: Nasal use
Laterally actuated pump (Khone): The laterally actuated metered-dose spray ensures that the solution is well distributed over the surface of the nasal mucosa by spraying a fine mist.
Before using for the first time, prime the pump by actuating 5 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 actuations.
Vertically actuated pump (Freepod): Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.
If the full spray is not administered, the dose should not be repeated.
The recommended dose should not be exceeded, especially in children and the elderly.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Like other vasoconstrictors, Otrivine Congestion Relief 0.1% Nasal Spray should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater, Narrow-angle glaucoma, rhinitis sicca or atrophic rhinitis.
Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have used them in the last two weeks.
Otrivine 0.1% is contraindicated in children aged less than 12 years.
Otrivine Congestion Relief 0.1% Nasal Spray should not be used for more than seven consecutive days, prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Otrivine Congestion Relief 0.1% Nasal Spray, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus or tri and tetra-cyclic antidepressants (see Interactions).
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Keep medicines out of the sight and reach of children.
Information concerning excipients
This medicine contains polyoxyl hydrogenated castor oil (2.750 mg/ml) which may cause skin reactions.
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 substances (see Contraindications).
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.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.
Otrivine Congestion Relief 0.1% Nasal Spray has no or negligible influence on the ability to drive and use machines.
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), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
MeDRA SOC
Adverse reaction
Frequency
Immune System Disorders
Hypersensitivity reaction (angioedema, rash, pruritus)
Very rare
Nervous System Disorders
Headache
Common
Eye Disorders
Transient visual impairment
Very rare
Cardiac Disorders
Heart rate irregular
Heart rate increased
Very rare
Very rare
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
Nasal Discomfort
Epistaxis
Common
Common
Uncommon
Gastrointestinal disorders
Nausea
Common
General disorders and administration site
Application site burning
Common
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
Symptoms and Signs
Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
Treatment
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours.
Ask anything about Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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