Do not use this nasal spray if you:
- Are allergic to oxymetazoline or any of the other ingredients of this medicine (listed in section 6).
- Have phaeochromocytoma (a rare benign tumour of the adrenal glands that produces high amounts of adrenaline and noradrenaline).
- 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.
- Have chronic nasal inflammation with very dry nasal passageways (atrophic rhinitis or rhinitis sicca).
- Have damage to the nerve in the eye caused by pressure inside the eye rising rapidly because fluid cannot drain out (angle closure glaucoma).
- Have coronary heart disease, or any other heart condition (e.g. angina).
- Have high blood pressure.
- Have an over-active thyroid gland (hyperthyroidism) or other problems with your thyroid function.
- Have diabetes.
- Are taking monoamine oxidase inhibitors for depression or used such treatments during the last two weeks.
- Are under 12 years of age.
Warnings and precautions
Talk to your doctor before using this medicine, if you:
- Have an enlarged prostate or other prostate problems (as there is a risk for development of difficulty passing urine).
- Have occlusive vascular disease (narrowed blood vessels).
- Are elderly.
- Have kidney or liver problems.
- Are taking tricyclic antidepressants for depression (e.g. amitriptyline, imipramine).
If symptoms persist or do not improve after 5 days, a doctor should be consulted.
Do not use this medicinal product for more than 5 consecutive days to avoid drug induced stuffy and runny nose (rebound effect and drug induced rhinitis (rhinitis medicamentosa)).
If any of the following occur, this medicine should be stopped:
- hallucinations
- restlessness
- sleep disturbances.
Keep away from eyes.
Children
Do not give this medicine to children under 12 years of age.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking or using, or have recently taken or used any other medicines, especially:
- Monoamine Oxidase Inhibitors and/or Reversible Inhibitors of Monoamine Oxidase A (used for treatment of depression, e.g. moclobemide, rasagiline). If you are taking or have taken these medicines in the last two weeks, your blood pressure may increase significantly.
- Beta-blockers or adrenergic neurone blockers (for treatment of high blood pressure). Do not use if you are taking beta blockers as their effect may be reduced.
- Other decongestant products. Do not use if you are taking other decongestant products, e.g. ephedrine and pseudoephedrine.
- 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 heartbeat (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) as these can give rise to additive effects.
- 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 taking this medicine.
Pregnancy, breastfeeding and fertility
Do not use if you are pregnant. Talk to your doctor or pharmacist before using the nasal spray if you are breastfeeding, think you may be pregnant or are planning to have a baby before taking this medicine.
Driving and using machines
No effect on ability to drive or use of machinery has been observed.
Important information about some of the ingredients of this medicine:
- This medicine contains 0.4mg benzalkonium chloride in each 1ml which is equivalent to 6mg/15ml and 8mg/20ml. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
- Benzalkonium chloride can also cause shortness of breath.
- 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.
4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reaction
Stop using the nasal spray and contact your doctor or go to the 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
Rare: Eye irritation, dryness, discomfort or redness
Very Rare: Nervousness
Not Known:
- Irritation, dryness, swelling or soreness in the nose, mouth or throat
- Swelling of the lips, tongue
- Headache, Dizziness
- Weakness, fatigue
- Anxiety, Fear, Irritability, Restlessness or sleep disturbance, Confusion or seeing things (psychotic disorder)
- Sleep disorder in children
- Tremor
- Sleepiness
- Sneezing
- Pain
- 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. abnormal, rapid or irregular heartbeat, an increase in awareness of your 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 a drug induced stuffy and runny nose with 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.
- Drug tolerance with drug effect decreased.
- This product contains thiomersal as a preservative and it is possible that this may cause local skin reactions (e.g., contact dermatitis) and skin 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 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 THIS MEDICINE
Do not use this medicine after the expiry date shown on the bottle and carton. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.