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 Sinusitis Relief 0.1% w/v Nasal Spray is for application in the nose to give relief from:
e Otrivine Sinusitis Relief 0.1% w/v Nasal Spray DO NOT use the spray if you:
Otrivine Sinusitis Relief 0.1% w/v Nasal Spray Dosage: For adults and children over 12 years of age: 1 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. Do not exceed the recommended dosage, especially in children and the elderly If you use more Otrivine Sinusitis Relief 0.1% w/v Nasal Spray than you should, consult your doctor or pharmacist. If you forget to use Otrivine Sinusitis Relief 0.1% w/v Nasal Spray Do not take a double dose to make up for a forgotten one. 4. Possible side effects Like all medicines, Otrivine Sinusitis Relief 0.1% w/v Nasal Spray can cause side effects, although not everybody gets them. Stop using Otrivine Sinusitis Relief 0.1% w/v Nasal Spray and seek medical help immediately if you experience:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting
you can help provide more information on the safety of this medicine.
Otrivine Sinusitis Relief 0.1% w/v 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 after "EXP". The expiry date refers to the last day of that month. Do not store above 30 °C. 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 Sinusitis Relief 0.1% w/v Nasal Spray contains The active ingredient is xylometazoline hydrochloride (0.1% w/v). The other ingredients are benzalkonium chloride, sodium phosphate, disodium edetate, sodium acid phosphate, sodium chloride, sorbitol, hypromellose and purified water. What Otrivine Sinusitis Relief 0.1% w/v Nasal Spray looks like and the contents of the pack Clear aqueous solution in a 10 ml bottle. Marketing Authorisation Holder: Haleon UK Trading Limited, Weybridge, KT13 0NY, U.K. Manufacturer: Haleon UK Trading Services Limited, Weybridge, KT13 0NY, U.K. This leaflet was last revised in April 2024. Trade Marks are owned by or licensed to the Haleon group of companies.
62000000210287
Otrivine Sinusitis Relief, 0.1% w/v Nasal Spray, Solution 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 Sinusitis Relief, 0.1% w/v Nasal Spray, Solution 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 Sinusitis Relief, 0.1% w/v Nasal Spray, Solution 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.
Adults and elderly: One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.
Not suitable for children under 12 years.
Route of administration: Application to the nasal passages.
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.
The recommended dose should not be exceeded, especially in children and the elderly.
Known hypersensitivity to xylometazoline.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Narrow-angle glaucoma.
Rhinitis sicca or atrophic rhinitis.
Otrivine 0.1% is contraindicated in children aged less than 12 years.
Use in people with phaeochromocytoma, prostatic hypertrophy or those receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.
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 belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus or tri and tetra-cyclic antidepressant treatment (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
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
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 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
Other side effects include:
• A burning sensation in the nose and throat
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 Sinusitis Relief, 0.1% w/v Nasal Spray, Solution 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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