Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Otrivine Child Nasal Drops
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for 2. Before you use Otrivine Child Nasal Drops 3. How to use Otrivine Child Nasal Drops 4. Possible side effects 5. How to store Otrivine Child Nasal Drops 6. Further information
- 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 1. WHAT OTRIVINE CHILD NASAL DROPS ARE child is taking or has recently taken any medicines (especially antidepressants, moclobemide, medicines for AND WHAT THEY ARE USED FOR high blood pressure or heart problems, appetite Otrivine Child Nasal Drops are for application in the nose suppressants, oxytocin or ergot alkaloids) including those to give relief from: obtained without a prescription.
- nasal congestion (blocked nose, including colds) Pregnancy or breast-feeding
- perennial and allergic rhinitis (recurring inflammation of If you are pregnant or breast-feeding, consult your doctor the nasal mucous membranes, including hay fever) before using Otrivine. Ask your doctor or pharmacist for
- sinusitis. advice before taking any medicine. Otrivine Child Nasal Drops contain the active ingredient Driving and using machines xylometazoline hydrochloride which helps to open up and Otrivine has no effect on the ability to drive and use clear the nasal passages by reducing the excessive nasal machines. secretions and returning the swollen blood vessels to their Important information about some of the other normal size. ingredients Otrivine contains benzalkonium chloride which may cause 2. BEFORE YOU USE OTRIVINE CHILD NASAL nasal irritation.
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
V2
08 – Mar – 2023
D2A
Non Production
Production
AWP No:
X TR2767744/B
Site Component No:
Nyon
62000000203012
Approving Market:
1.
Black
20%
Total Special Finishes: 0
OTRIVINE BABY DROPS
Leaflet
Technical Drawing No:
Material Spec No:
N-PN-P08 v2.1
P08
Print Process:
Pharma Code No:
Offset – Lithography
476
Barcode No:
Bar Width Reduction:
N/A
N/A
Formulation Code
Body Text Size: 8.0pt Leading: 9.0pt Horizontal Scale: 100% Smallest Text Size: 8.0pt
Micro Text: No
Studio Location: Europe
Site Change Control No: 201227616
Product Market Trade Name: Component Type:
N/A
AIP_CHAMPS_2022_HALEON_Version 1
CHAMPS No: 0000014934
Manufacturing Site:
Great Britain 50%
62000000203012
Artwork Information Panel
Total Number of Colours including Varnish & Foils: 1
70%
How to take it
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.
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 476 100 0 Micrometre
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 476 100 0 Micrometre
Verso Recto 62000000123456
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
Possible 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
V2
08 – Mar – 2023
D2A
Non Production
Production
AWP No:
X TR2767744/B
Site Component No:
Nyon
62000000203012
Approving Market:
1.
Black
20%
Total Special Finishes: 0
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.
62000000203012
Site Change Control No: 201227616
OTRIVINE BABY DROPS
Leaflet
Technical Drawing No:
Material Spec No:
N-PN-P08 v2.1
P08
Print Process:
Pharma Code No:
Offset – Lithography
476
Barcode No:
Bar Width Reduction:
N/A
N/A
Formulation Code
Body Text Size: 8.0pt Leading: 9.0pt Horizontal Scale: 100% Smallest Text Size: 8.0pt
Micro Text: No
Studio Location: Europe
6. FURTHER INFORMATION
Product Market Trade Name: Component Type:
N/A
AIP_CHAMPS_2022_HALEON_Version 1
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.
CHAMPS No: 0000014934
Manufacturing Site:
Great Britain 50%
How to store it
OTRIVINE CHILD NASAL DROPS
Artwork Information Panel
Total Number of Colours including Varnish & Foils: 1
70%
- 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.
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 476 100 0 Micrometre
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 476 100 0 Micrometre
Frequently asked questions about Otrivine Child Nasal Drops
How do I take Otrivine Child Nasal Drops?
Otrivine Child Nasal Drops comes as nasal spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Otrivine Child Nasal Drops?
The active substance in Otrivine Child Nasal Drops is xylometazoline hydrochloride.
Are there equivalent medicines to Otrivine Child Nasal Drops?
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.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Otrivine Child Nasal Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Otrivine Child Nasal Drops without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: xylometazoline hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever), sinusitis.
4.2. Posology and method of administration
Adults and elderly: Not applicable.
Otrivine Child Nasal Drops are contra-indicated in children under 6 years of age.
Children between 6 and 12 years under adult supervision (all indications): 1 or 2 drops, in each nostril up to 2 times a day.
Not to be used for more than 5 days without the advice of a doctor. (see warnings and precautions)
Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Not more than 2 doses should be given in any 24 hours.
Route of administration: Nasal use Do not exceed the stated dose
Keep out of the reach and sight of children.
4.3. Contraindications
Known hypersensitivity to Otrivine or any of the excipients
Concomitant use of other sympathomimetic decongestants
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Prostatic hypertrophy
Hyperthyroidism
Closed angle glaucoma
Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)
Beta-blockers – (see section 4.5)
Inflammation of the skin and/or mucosa of the nasal vestibule
Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater
Not to be used in children under the age of 6 years
Rhinitis sicca or atrophic rhinitis
4.4. Special warnings and precautions for use
Patients are advised not to take decongestants for more than five 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.
Use with caution in occlusive vascular disease and in patients taking tri or tetra-cyclic antidepressant treatment (see Interactions).
If any of the following occur, Otrivine should be stopped
• Hallucinations
• Restlessness
• Sleep disturbances
Keep away from eyes.
Keep medicines out of the sight and reach of children.
Otrivine 0.05% is contraindicated in children aged less than 6 years old
Information concerning excipients
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors, reversible inhibitors of monoamine oxidase (RIMAs) or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (see Contraindications).
Moclobemide: risk of hypertensive crisis.
Antihypertensives (including adrenergic neurone blockers & beta-blockers): Otrivine may block the hypotensive effects.
Cardiac glycosides: increased risk of dysrhythmias
Ergot alkaloids (ergotamine & methylsergide): increased risk of ergotism
Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension
Oxytocin – risk of hypertension
4.6. Fertility, 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.
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.
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), 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
Irritability, Anxiety, Restlessness, Excitability, Insomnia, Hallucinations and Paranoid Delusions - particularly with prolonged and/or excessive use
Unknown
Eye Disorders
Transient visual impairment
Very rare
Cardiac Disorders
Heart rate irregular, Heart rate increased - particularly with prolonged and/or excessive use
Very rare
Other cardiac dysrhythmias and hypertension- particularly with prolonged and/or excessive use
Unknown
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
Tolerance with diminished effect – especially with prolonged and/or heavy use
Unknown
Rebound congestion (rhinitis medicamentosa) – especially with prolonged and/or heavy use
Unknown
Irritation & dryness
Unknown
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.
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, 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 about this leaflet
Ask anything about Otrivine Child Nasal Drops. 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.
Medicines containing Xylometazoline hydrochloride
- 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
- Otrivine Congestion Relief 0.1% Nasal Spray with Khone Spray
- Otrivine Sinusitis Relief, 0.1% w/v Nasal Spray, Solution with Khone Spray
- Sudafed Blocked Nose Spray
- Sudafed Sinus-Ease 0.1% Nasal Spray