Operil P nasal drops for children 10ml

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Read this manual carefully because it contains information that is important to you.

You can buy this medicine without a doctor's prescription, for the treatment of mild diseases without the help of your doctor. In addition, you need to use this medicine carefully to get the best results from it. If you need any additional information or advice, contact your doctor or pharmacist. If your symptoms worsen or you do not feel better, be sure to see your doctor.

What is the drug Operil P and what is it intended for:
Operil P is intended only for children aged between 2 and 7 years.
For adults and children older than 7 years, Operil, spray or drops for the nose, solution, 500mcg/ml is suitable.
Operil P contains oxymetazoline. Oxymetazoline is used as a nasal decongestant. It works by narrowing the blood vessels of the nasal mucosa, which reduces the swelling of the nasal mucosa. The consequence of this effect is a reduced feeling of nasal congestion and a better elimination of secretions from the nose. Operil® P begins to work within a few minutes and its effect lasts up to 12 hours. Also, oxymetazoline has anti-inflammatory and antioxidant effects.
Operil P has an antiviral effect on certain viruses that mainly cause respiratory diseases.

Operil P is used:

• for reducing the sensation of nasal congestion in acute inflammations of the nasal mucosa during colds, allergic or vasomotor sneezing (rhinitis)
• in inflammation of the middle ear
• to facilitate nasal breathing after nose surgery

What you need to know before taking Operil P medicine:
Operil P must not be used:

• if you are allergic (hypersensitive) to oxymetazoline or any other ingredient of Operil P
• if you have dry inflammation of the nasal mucosa with sores and scabs
• in children younger than 2 years

When taking Operil P, be especially careful:
In the following text, it will be described when you may use Operil P for a sneeze only under certain conditions and with special precautions. Please ask your doctor about them. This also applies if these allegations were related to you in the past.

• if you are taking (or have taken in the last two weeks) monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of Parkinson's disease and depression) or other medicines that can lead to an increase in blood pressure
• if you have elevated intraocular pressure, especially angle-closure glaucoma
• if you have severe cardiovascular disease (eg coronary heart disease, hypertension), acute heart disease or asthma caused by heart disease (Cardiac asthma)
• if you have an adrenal medulla tumor (phaeochromocytoma)
• if you have porphyria (hereditary blood disease with symptoms of increased sensitivity of the skin to light, the appearance of scabs, bleeding on the skin, dark discoloration of the skin, increased lethargy, dark-red discoloration of the urine, sometimes with nerve damage and partial or complete loss)
• if you have had surgery to remove your pituitary gland (pituitary gland)
• if you have metabolic disorders (eg hyperthyroidism, diabetes)
• if you have an enlarged prostate (prostatic hypertrophy)

Operil P nasal drops should be applied for a maximum of 7 days continuously.
Prolonged or excessive use of Operil P should be avoided since the therapeutic effect may be reduced; rebound congestion of the nasal mucosa may occur (rebound phenomenon), which makes the patient use the drug more often, leading to chronic use. This use is the cause of chronic swelling (rhinitis medicamentosa), which leads to atrophy of the nasal mucosa.
In milder cases, it is useful to stop injecting the drug first into one nostril, and after the symptoms subside, into the other, in order to preserve nasal breathing at least partially.

Application of other drugs:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that can be obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of Parkinson's disease and depression). Do not use Operil P if you have taken an MAOI during the previous two weeks, because hypertensive crises may occur (blood pressure greater than 180/110mmHg, headache, chest pain, shortness of breath, swelling).
• medicines used to treat depression (maprotiline tricyclic antidepressants such as amitriptyline and imipramine)
• medicines for the treatment of high blood pressure. Tell your doctor before using this medicine if you are taking betanidin, debrisoquine and guanethidine, because the effects of these medicines may be reduced.
• drugs for the treatment of Parkinson's disease (bromocriptine). These drugs can affect the effectiveness of Operil P therapy, if they are administered simultaneously.

Taking Operil P with food or drinks:
Operil P can be used independently of meals.

Use of Operil P during pregnancy and breastfeeding:
Before you start taking any medicine, consult your doctor or pharmacist.
The use of Operil P during pregnancy and breastfeeding is not recommended, except on the advice of a doctor.

The effect of the drug Operil P on driving motor vehicles and operating machines:
Provided that it is used in the recommended doses, Operil P does not affect the ability to drive a vehicle and operate machines.
Important information about some of the ingredients of Operil P
Due to the content of benzalkonium chloride as a preservative that can cause skin reactions and narrowing of the airways (bronchospasm), Operil P nasal drops for sneezing must not be used in case of established hypersensitivity to this substance.

How to use Operil p:
Always take Operil P exactly as your doctor has explained it to you. If you are not absolutely sure, check with your doctor or pharmacist.
 Children aged between 2 and 7 years: instill 1 to 2 drops of Operil P in each nostril two to three times a day; while the drops are being applied, children should tilt their head back and breathe normally.
The drug Operil P should not be used for more than five to seven days continuously. If symptoms do not improve, consult a doctor who can prescribe longer therapy. The maximum length of therapy that a doctor can prescribe is two to three weeks without interruption.
Nasal drops are intended for one person only. If multiple patients use the same vial, it is likely that the infection will spread. After use, wipe the dropper with a clean tissue.

If you have taken more Operil P than you should:
If you have taken a larger dose of Operil P, talk to your doctor or pharmacist immediately
After giving excessive doses, a transient burning sensation in the nose, dry nasal mucosa and sneezing may occur. Insomnia, headache, narrowing of the pupils, blood pressure disorder, tachycardia or bradycardia (rapid or slow heart rate), nithermia (drop in body temperature) and disturbance of consciousness may also occur. These symptoms disappear within 12 to 36 hours after reducing the dose.
In case you or your child accidentally swallows this medicine, seek medical advice immediately.

If you forget to take Operil P:
Never take a double dose to make up for a missed dose!

If you forget to give Operil P:
it is recommended that you take it as soon as possible
if it is almost time for your second dose, skip the one you missed and go back to your regular dosing schedule

If you suddenly stop taking Operil P:
In rare cases, transient nasal congestion may occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Possible side effects:
The drug Opera P, like other drugs, can have side effects, although they do not necessarily occur in everyone.
The assessment of side effects is based on the following frequency information:

• Very common (more than 1 in 10 patients treated)
• Common (less than 1 in 10 but more than 1 in 100 treated patients)
• Uncommon (less than 1 in 100 but more than 1 in 1000 treated patients)
• Rare (less than 1 in 1000 but more than 1 in 10000 treated patients)
• Very rare (less than 1 in 10,000 patients), frequency not known

Disorders of the heart and blood vessels occasionally: slower heart rate
Rarely: increased heart rate, increased blood pressure, feeling of abnormal heart rate (palpitations)
Disorders of the nervous system
Rarely: dizziness, drowsiness, agitation, irritability, sleep disorder in children, insomnia
Disorders of the respiratory system
Periodically: sneezing, dryness and irritation of the nasal mucosa, mouth and throat
Prolonged use may produce reactive niperemia of the nasal mucosa (medicinal rhinitis).
The frequency is not known.

General disorders:
Rarely:transient redness at the site of drug application (reactive hyperemia), headache, nausea, rash and visual disturbances
Administration of the drug for a longer period of time than recommended may lead to a reduced effect of the drug and/or repeated congestion (nasal congestion).
If any side effect becomes serious or you notice any side effect that is not listed in this guide, please inform your doctor or pharmacist.

How to store Operil p:
Keep out of the reach and sight of children.

Expiration date:
3 years. Do not use Operil P after the expiration date indicated on the outer packaging.
The term of use expires on the last day of the specified month.

Storage:
Store the medicine at a temperature of up to 25°C.
Medicines should not be thrown into the sewer or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures help to preserve the environment.
Unused medicine is destroyed in accordance with current regulations.

What Operil P contains:
The active substance is: oxymephazoline.
One milliliter of Operil p contains 0.25 mg of oxymetazoline hydrochloride (0.025% solution).
Other ingredients are:

• Benzalkonium chloride
• Sodium hydroxide
• Sodium dihydrogen phosphate, dihydrate Disodium phosphate, dihydrate
• Water, purified

What Operil P looks like and contents of the package:
A clear, colorless solution.
The drug Operil P contains 10 ml of solution.

Packaging: Plastic bottle with dropper.

Mode of administration of the drug:
The drug can also be dispensed without a prescription.

Manufacturer:
Lek farmacevtska družba dd
Verovškova 57, Ljubljana, Slovenia

Before use, study the instructions in detail. Consult your doctor or pharmacist about indications, precautions and adverse drug reactions.