What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16028/0049 .


Boots Decongestant 0.05% w/v Nasal spray

Information for the user

Boots Decongestant 0.05% w/v Nasal Spray (Oxymetazoline Hydrochloride)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet:

1. What Decongestant Nasal Spray is and what it is used for
2. What you need to know before you use Decongestant Nasal Spray
3. How to use Decongestant Nasal Spray
4. Possible side effects
5. How to store Decongestant Nasal Spray
6. Contents of the pack and further information

1. What Decongestant Nasal Spray is and what it is used for

This nasal spray contains Oxymetazoline Hydrochloride which is a decongestant. It relieves a stuffy, blocked nose by shrinking the blood vessels helping to open the nasal passages. It acts within a few minutes and lasts for up to 12 hours.

The medicine is a solution which is sprayed into the nostrils to relieve the congestion in the nose and sinuses which you get in conditions such as colds, catarrh and hayfever.

2. What you need to know before you use Decongestant Nasal Spray

Do not use this nasal spray if you:

  • are allergic to oxymetazoline or any of the other ingredients in this medicine (listed in section 6)
  • have phaeochromocytoma (a rare tumour of the adrenal glands)
  • have had an operation to remove your pituitary gland or you have recently had an operation on your nose or sinuses.
  • are already taking medicines to unblock your nose
  • have inflamed skin or mucous membranes of your nostrils or have scabs in your nose

Do not give this nasal spray to children under 12 years of age

Warnings and precautions

Talk to your doctor or pharmacist before using this nasal spray, if you:

  • have prostate problems
  • are elderly
  • have glaucoma (increased pressure in the eye)
  • have coronary heart disease, cardiac asthma, or any other heart condition
  • have high blood pressure
  • have an over-active thyroid gland or other problems with your thyroid function
  • have diabetes
  • have kidney or liver problems

If any of the following occur, this nasal spray should be stopped:

  • hallucinations
  • restlessness
  • sleep disturbances

Keep away from the eyes.

Other medicines and Decongestant Nasal Spray

Tell your doctor or pharmacist if you are taking or using, or have recently taken or used any other medicines:

  • Do not use if you are taking or have recently taken Monoamine Oxidase Inhibitors (see above)
  • Do not use if you are taking beta blockers as their effect may be reduced
  • Tricyclic antidepressants (drugs used in the treatment of depression such as amitriptyline and imipramine)
  • High blood pressure medicines (such as bethanidine, debrisoquine and guanethidine) as their effect may be reduced
  • Parkinson's disease medicine (bromocriptine and rasagiline) treatment may be affected if it is used at the same time
  • Digoxin or digitoxin for heart failure, as it can cause irregular heart beat (dysrhythmias) if it is taken at the same time
  • Ergotamine or methysergide for migraine relief
  • Medicines or supplements to reduce appetite or make you more alert (amphetamine-like psychostimulants)
  • Thyroid hormones e.g. levothyroxine
  • Oxytocin used to assist birth or breastfeeding

If you are taking any other medicines, you should see your doctor or pharmacist for advice before using this medicine.

Pregnancy and breastfeeding:

Do not use if you are pregnant. Talk to your doctor or pharmacist before using the nasal spray if you are breastfeeding .

Driving and using machines

No effect on ability to drive or use of machinery has been observed.

Important information about some of the ingredients in this medicine

  • Contains benzalkonium chloride which may cause irritation or swelling inside the nose, especially if used for a long time.
  • Contains thiomersal as a preservative which may cause local skin reactions (e.g. contact dermatitis) and discolouration. It may also cause allergic reactions.

Tell your doctor if you have any known allergies

3. How to use Decongestant Nasal Spray

For nasal use only

Adults, the elderly and children aged 12 years and above

Remove the cap. Hold the container upright, place the tip of the spray nozzle just into each nostril. Hold the other nostril closed. Lightly squeeze the container twice as you breathe in through the nose at the same time. Repeat for the other nostril. Wipe the nasal applicator with a clean, wet tissue and replace the cap immediately after the application.

The nasal spray dose may be applied up to twice daily, or used at bedtime to give relief through the night

Do not use in children under 12 years

Do not exceed the stated dose.

Do not use continuously for more than 7 days.

This product is not suitable for long-term use (see also section 4 'Possible Side Effects’).

If symptoms persist, consult your doctor.

If you do not understand these instructions or if you require any further information about your medicine, ask your doctor or pharmacist

If you use too much:

If you have used more spray than the stated dose, talk to a doctor or pharmacist immediately.

4. Possible side effects

Most people use this nasal spray without any problems but, like all medicines, it can have side effects

Allergic reaction

Stop using the nasal spray and contact your doctor or go to your nearest hospital casualty department immediately if you notice:

  • skin rashes or itching
  • sneezing or stinging or burning of the nose
  • swelling of the nose, lips, tongue or throat
  • shortness of breath or difficulty in breathing

Other side effects

  • Irritation, dryness or soreness in the nose, mouth or throat
  • Eye irritation, dryness, discomfort or redness
  • Headache, dizziness
  • Weakness, fatigue and trembling
  • Anxiety, fear, irritability, nervousness, restless or not sleeping, confused or seeing things
  • Nausea (feeling sick), vomiting (being sick), less saliva than usual in your mouth, decreased appetite
  • Flushing and visual disturbances
  • Effects on the heart e.g rapid or irregular heartbeat, palpitations
  • Effects on the circulation e.g. cold feet or hands, high blood pressure
  • If the spray is used regularly over a long period it may cause a condition called rebound congestion. This is an unusual swelling of the lining of the nose, leading to itching, sneezing and a blocked nose following the last dose of the spray. Therefore do not use the spray continuously for more than 7 days
  • This medicine contains thiomersal as a preservative and it is possible that this may cause local skin reactions (e.g. contact dermatitis) and discolouration around the nose. It may also cause an allergic reaction (see above)
  • Prolonged and/or heavy use beyond the recommended use of 7 days, may lead to cardiovascular and/or CNS effects.

Reporting of side effects

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 the 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 Decongestant Nasal Spray

Do not use this medicine after the expiry date shown on the bottle and carton.

Keep out of the sight and reach of children.

6. Contents of the pack and other information

What is in this nasal spray?

The active ingredient is: Oxymetazoline hydrochloride 0.05% w/v

Other ingredient are: Benzalkonium chloride, thiomersal, sodium chloride, menthol, eucalyptol, camphor, methyl salicylate, poloxamer, sodium citrate, anhydrous citric acid and purified water.

What this medicine looks like and contents of the pack

The product is a clear liquid which is sprayed in fine droplets out of the nozzle of the container. A pack contains a white 15 ml bottle

Marketing Authorisation Holder:

Galpharm Healthcare Ltd.
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by the

Manufacturer:

Galpharm International Ltd.
Elmhirst Park
Middle Field Road
Barnsley
South Yorkshire
S75 4LS
United Kingdom

Text revised: September 2020

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Decongestant 0.05% Nasal Spray

Reference number: PL 16028/0049

This is a service provided by the Royal National Institute of Blind People.