Operil 0.5 mg/mL nasal spray – for blocked nose in adults and children over 12
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- Stock: Zabrana online prodaje
- Brand: SANDOZ
- Model: BR-4512
Operil 0.5 mg/mL nasal spray, solution contains oxymetazoline, a medicine from the group of adrenergic agents (decongestants). Oxymetazoline narrows the blood vessels in the nasal mucosa and thus reduces its swelling – the nose quickly becomes unblocked.
According to the approved leaflet, the medicine is used for the rapid relief of nasal congestion in colds, allergic rhinitis and rhinosinusitis. The effect starts within a few minutes and lasts 6 to 8 hours. This form is intended for adults and children over 12 years.
Important warning
- Supply status in Serbia: medicine available without a prescription (according to the leaflet approved by ALIMS).
- Operil 0.5 mg/mL spray is not intended for children under 12; Operil P 0.25 mg/mL is intended for children aged 6 to 12.
- Do not use for more than 5 consecutive days – longer use may cause rebound congestion (medicine-induced rhinitis).
- It must not be combined with other decongestants (drops, sprays or tablets with phenylephrine, pseudoephedrine, ephedrine) or used with MAO inhibitors; caution in heart disease, high blood pressure, diabetes and thyroid disease.
- This page is for information only and is not an offer to buy the medicine online.
What is Operil nasal spray used for and how is it correctly dosed?
Key facts about the medicine
| Name of the medicine | Operil®, 0.5 mg/mL, nasal spray, solution |
|---|---|
| Active substance | oxymetazoline (as oxymetazoline hydrochloride) |
| Strength | 0.5 mg (500 micrograms) oxymetazoline hydrochloride per 1 mL |
| Pharmaceutical form | nasal spray, solution |
| Therapeutic group | sympathomimetics, plain – nasal decongestants (ATC R01AA05) |
| Pack | plastic bottle with spray pump, 10 mL |
| Marketing authorisation holder | Pontus Pharma d.o.o., Belgrade (according to the current ALIMS list of non-prescription medicines) |
| Supply status (Serbia) | medicine available without a prescription |
What is Operil spray used for?
According to the patient leaflet, Operil spray is used for the rapid relief of nasal congestion in:
- inflammation of the nasal mucosa due to a cold
- allergic rhinitis (inflammation of the nasal mucosa due to an allergic reaction)
- rhinosinusitis (inflammation of the nasal mucosa and sinuses)
The spray is intended for adults and children over 12 years.
How is it used and dosed?
Usual dosage according to the leaflet for adults and children over 12 years:
- no more than 1 to 2 sprays into each nostril, 2 to 3 times a day
- do not use for more than 5 consecutive days
- do not exceed the prescribed dose
- Method of administration: the medicine is for nasal use only.
- If symptoms persist after 3–5 days of use, get worse or new symptoms appear, stop use and see a doctor.
Special patient groups
- Children under 12 years: the spray is not intended for this age group; Operil P 0.25 mg/mL is intended for children aged 6 to 12.
- Elderly: the leaflet gives no specific dosage; as heart disease and high blood pressure are common in this group, consult a doctor or pharmacist before use.
- People with impaired liver or kidney function: consult a doctor before use.
- People with heart disease, high blood pressure, diabetes or thyroid disease: use only on a doctor's advice.
Contraindications – when the medicine must not be used
Do not use the medicine:
- if you are allergic (hypersensitive) to oxymetazoline or any of the excipients
- if you have inflammation or damage of the nasal mucosa or the skin around the nostrils, including dry nasal mucosa with or without crusts
- if you have cardiovascular disease
- if you have an overactive thyroid (hyperthyroidism)
- if you have raised eye pressure (angle-closure glaucoma)
- if you have an enlarged prostate
- during treatment with monoamine oxidase inhibitors (MAOIs) and for 14 days after stopping them
- if you have convulsions
- after surgical removal of the pituitary gland (transsphenoidal hypophysectomy)
- with other indirect-acting sympathomimetics – nasal decongestants used orally or nasally (phenylephrine, pseudoephedrine, ephedrine) and methylphenidate; combining two decongestants is contraindicated regardless of the route
Precautions and warnings
- Do not exceed the prescribed dose or use the medicine for more than 5 consecutive days.
- If you have high blood pressure, heart disease (including angina pectoris), diabetes, thyroid disease, an adrenal tumour (phaeochromocytoma) or impaired liver or kidney function, consult a doctor before use.
- Use should be stopped if hallucinations, restlessness or sleep disturbance occur.
- Caution with concomitant phenothiazines or tricyclic antidepressants, digitalis, beta blockers, methyldopa or other medicines for high blood pressure.
- Avoid using several preparations containing sympathomimetics at the same time (e.g. cold tablets plus nasal or eye drops).
- The medicine contains 55 micrograms of benzalkonium chloride per 1 mL, which may cause irritation and swelling of the nasal mucosa, especially with long-term use; if this happens, a preservative-free product is needed.
Interactions with other medicines, alcohol and food
Tell your doctor or pharmacist about all medicines you take, including those without a prescription. According to the leaflet:
- tricyclic antidepressants (e.g. amitriptyline, imipramine) or phenothiazines – possible rise in blood pressure and heart rhythm disturbance
- beta blockers, methyldopa and other medicines for high blood pressure – oxymetazoline may reduce their efficacy
- bromocriptine (for Parkinson's disease) – possible increased toxicity to the heart and blood vessels
- MAO inhibitors, other decongestants (phenylephrine, pseudoephedrine, ephedrine) and methylphenidate – concomitant use is contraindicated
The leaflet mentions no specific interactions with food or alcohol.
Pregnancy and breastfeeding
Use is not recommended during pregnancy and breastfeeding. If the doctor judges that the benefit outweighs the risk to the foetus, the medicine may only be used under medical supervision. There are no data on the effect on fertility.
Driving and using machines
According to the Summary of Product Characteristics, it is not known whether the medicine affects the ability to drive or use machines.
Possible side effects
- Common (up to 1 in 10 patients): burning and dryness of the nasal mucosa, sneezing.
- Uncommon (up to 1 in 100): hypersensitivity reactions (swelling of the face, lips, tongue or throat with possible difficulty breathing and swallowing, rash, itching); recurrence of congestion caused by the medicine (rebound congestion); nosebleed.
- Rare (up to 1 in 1,000): excitation, restlessness, insomnia; palpitations, fast heartbeat; increased blood pressure.
- Very rare (up to 1 in 10,000): agitation, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children), convulsions (especially in children); heart rhythm disturbance; cessation of breathing in infants and newborns.
Suspected side effects can be reported to a doctor, pharmacist or the Medicines and Medical Devices Agency of Serbia (ALIMS).
Overdose, missed dose and stopping treatment
- Overdose: if more medicine has been used than needed, seek a doctor's advice or go to the nearest hospital and take the pack with you. Symptoms of moderate to severe overdose may include dilated pupils, nausea, fever, bluish lips, spasms, fast or irregular heartbeat, high blood pressure, difficulty breathing and mental disturbances, as well as drowsiness, low body temperature, slow heartbeat, low blood pressure, shock and loss of consciousness.
- Missed dose: skip it and use the next dose at the usual time. Do not use a double dose.
- Stopping treatment: in rare cases a temporary feeling of nasal congestion may occur.
When to seek medical help immediately?
- swelling of the face, lips, tongue or throat, difficulty breathing or swallowing
- strong palpitations or irregular heartbeat, chest pain, severe headache
- hallucinations, convulsions or unusual drowsiness (especially in a child)
- suspected overdose or accidental swallowing of the medicine – take the pack with you
Pharmacist's advice
Blow your nose before use, keep your head upright and press the pump once or twice into each nostril. The spray should be used by one person only, and the bottle discarded 14 days after opening.
Do not use the spray for more than 5 days in a row – longer use can cause exactly what you are treating: a chronically blocked nose. If you also take cold sachets or tablets, check with your pharmacist whether they contain phenylephrine or pseudoephedrine, as two decongestants must not be combined.
Availability and price
The medicine is available without a prescription, but under the regulations of the Republic of Serbia it cannot be ordered online. This page is for information only.
Please contact a pharmacy to check availability and for advice on use.
Further information
For additional care and support with blocked nose, see also the Clogged nose category – products in this category do not replace the medicine you have been prescribed.
Composition, packaging and manufacturer
- 1 mL of solution contains 500 micrograms (0.5 mg) oxymetazoline hydrochloride.
- Excipients: benzalkonium chloride, sodium hydroxide (for pH adjustment), sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injections.
- Appearance: clear, colourless to pale yellow solution.
- Pack: white plastic bottle with spray pump and cap, 10 mL solution, in a carton with the leaflet.
- Marketing authorisation holder: Pontus Pharma d.o.o., Belgrade (according to the ALIMS list of non-prescription medicines, 2026; the 2023 leaflet names the Representative Office of Sandoz Pharmaceuticals d.d. Belgrade). Manufacturer: Lek farmacevtska družba d.d., Ljubljana, Slovenia.
Storage
- Store below 25 °C.
- Shelf life after first opening of the bottle: 14 days.
- Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.
Frequently asked questions
How many times a day is Operil spray used?
Adults and children over 12 use no more than 1 to 2 sprays into each nostril, 2 to 3 times a day.
Why must Operil spray not be used for more than 5 days?
Longer use may cause a rebound effect, i.e. medicine-induced rhinitis – the nose stays blocked because of the spray itself. If symptoms persist after 3–5 days, stop use and see a doctor.
Can children use Operil spray?
Operil 0.5 mg/mL spray is not intended for children under 12. Operil P 0.25 mg/mL is intended for children aged 6 to 12.
May Operil spray be used with cold tablets?
Not with products containing another decongestant (phenylephrine, pseudoephedrine, ephedrine) – combining two decongestants is contraindicated regardless of the route.
Sources
- ALIMS – Patient leaflet Operil, 0.5 mg/mL, nasal spray (March 2023, corrected August 2023)
- ALIMS – Summary of Product Characteristics Operil, 0.5 mg/mL (authorisation 515-01-01513-22-001, 09.03.2023)
- ALIMS – List of medicines available without a prescription (2026) – current authorisation holder
Date sources were checked: 23 October 2026.
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