Patient leaflet - Otrivine Child nasal drops
1. WHAT OTRIVINE CHILD NASAL DROPS ARE AND WHAT THEY ARE USED FOR
Otrivine Child Nasal Drops are 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 Child Nasal Drops contain 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 CHILD NASAL DROPS
DO NOT use the drops if your child:
- is under 6 years old
- is allergic to xylometazoline hydrochloride or any of the other ingredients in the drops (see Section 6) • has an inflamed nasal passage
is allergic to other decongestants
- has had recent neurosurgery or nasal surgery • has heart or circulatory disease or hypertension • has diabetes
- has hyperthyroidism (overactive thyroid gland) • has closed angle glaucoma
- has an enlarged prostate gland
- has phaeochromocytoma (a tumour of the nerves associated with the hormone glands)
- is taking monoamine oxidase inhibitors (MAOIs) or has stopped taking them in the last 14 days • is taking betablockers
- has chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis)
Do not use these drops in children under 6 years old. Take special care
Before using the drops tell your doctor if your child is taking:
- tri and tetra-cyclic antidepressant treatment • any other medicine or is under doctor's care
Like other products for the relief of blocked nose, Otrivine may give rise to sleep disturbances, dizziness, tremor in very sensitive patients. Consult your doctor if such signs prove to be troublesome.
If your child experiences hallucinations, restlessness or sleep disturbances stop using Otrivine Child Nasal Drops. Do not take Otrivine Child Nasal Drops for more than 5 days in a row. Prolonged or excessive use may cause stuffiness in the nose to return or worsen. Keep away from the eyes.
Using other medicines
Do not use these drops if your child is using other decongestants. Please tell your doctor or pharmacist if your child is taking or has recently taken any medicines (especially antidepressants, moclobemide, medicines for high blood pressure or heart problems, appetite suppressants, oxytocin or ergot alkaloids) including those obtained without a prescription.
Pregnancy or breast-feeding
If you are pregnant or breast-feeding, consult your doctor before using Otrivine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Otrivine has no effect on the ability to drive and use machines.
Important information about some of the other ingredients
Otrivine contains benzalkonium chloride which may cause nasal irritation.
3. HOW TO USE OTRIVINE CHILD NASAL DROPS Dosage:
For children aged 6–12 years, under adult supervision: 1 to 2 drops in each nostril once or twice daily. Not more than 2 doses should be given in any 24 hours. Child Nasal Drops
Xylometazoline Hydrochloride
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62000000203012 Do not use in children under 6 years of age. Administration:
- 1. Practise using the dropper to develop good dosage control
- 2. Clear and wipe your child’s nose
- 3. Tilt your child’s head right back (see diagram) 4. Apply drops to each nostril as per dosage instructions. Parents or carers should seek medical attention if the child’s condition worsens.
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. Do not take with any other cough and cold medicines.
If you use more Otrivine Child Nasal Drops than you should, consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Otrivine Child Nasal Drops can cause side effects, although not everybody gets them. Stop using Otrivine Child Nasal Drops and seek medical help immediately if you experience:
- Allergic reactions which may include difficulty breathing or swallowing
- Swelling of the face, lips, tongue or throat Common (may affect up to 1 in 10 people): • Headache
- Dryness or irritation of the nasal mucosa • Nausea
- Local burning sensation
Uncommon (may affect up to 1 in 100 people): • Nosebleeds
Very rare (may affect up to 1 in 10,000 people): • Blurred vision
- Irregular or fast heartbeat
Other side effects include:
- Hallucinations and paranoid delusions
- Restlessness and sleep disturbances
- A burning sensation in the nose and throat • Excitability, irritability and anxiety
- Urinary retention
High blood pressure
- Tolerance with diminished effect & rebound congestion with prolonged use
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effect 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 side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OTRIVINE CHILD NASAL DROPS
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 “Expiry”. The expiry date refers to the last day of that month.
Protect from heat.
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.
6. FURTHER INFORMATION
What Otrivine Child Nasal Drops contain
The active ingredient is xylometazoline hydrochloride (0.05% w/v).
The other ingredients are sodium chloride, sodium phosphate, sodium acid phosphate, disodium edetate, benzalkonium chloride, sorbitol, hypromellose and water. What Otrivine Child Nasal Drops look like and the contents of the pack
Clear aqueous solution in a 10ml 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 February 2024. Trade Marks are owned by or licensed to the Haleon group of companies.
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