Orinox

Package Leaflet: Information for the Patient

Orinox, 0.5 mg/ml, nasal spray, solution
Xylometazoline hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What is Orinox and what is it used for
• 2. Important information before using Orinox
• 3. How to use Orinox
• 4. Possible side effects
• 5. How to store Orinox
• 6. Package contents and other information

1. What is Orinox and what is it used for

Orinox contains xylometazoline hydrochloride as the active substance, which belongs to a group of medicines called sympathomimetics. Xylometazoline reduces nasal congestion, decreasing the amount of nasal discharge and restoring the swollen blood vessels to their normal state. Xylometazoline helps maintain nasal patency and facilitates breathing in patients with nasal congestion.

Orinox is used to relieve nasal congestion caused by acute rhinitis, hay fever, or other allergic rhinitis or sinusitis.

A doctor may also prescribe it for use before a professional nasal examination.

The effect of the medicine starts within 2 minutes and lasts up to 12 hours.

This medicine is suitable for children aged 1 to 11 years.

It is well-tolerated, even in patients with sensitive nasal mucosa.

If there is no improvement after 5 days or if the patient feels worse, they should consult their doctor.

2. Important information before using Orinox

When not to use Orinox:

• if the child is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the child has recently undergone nasal surgery. The doctor or pharmacist should be consulted to determine if xylometazoline hydrochloride can be started in the child;
• if the child has dry rhinitis with crust formation (atrophic rhinitis);
• if the child has narrow-angle glaucoma.

The doctor or pharmacist should be informed if any of the above points apply to the child, as this means the medicine is not suitable for them.

Warnings and precautions

Before starting to use Orinox, the doctor or pharmacist should be consulted if any of the following conditions apply:

• high blood pressure,
• heart disease (e.g., long QT syndrome),
• vascular disease,
• hyperthyroidism,
• diabetes,
• prostatic hyperplasia,
• phaeochromocytoma (a tumor of the adrenal gland),
• if the child is being treated or has been treated with medicines for depression known as monoamine oxidase inhibitors (MAOIs) in the last two weeks.

Like other similar medicines, Orinox may cause sleep disturbances, dizziness, tremors, irregular heartbeat, or increased blood pressure in sensitive individuals. The doctor should be contacted if any of these symptoms occur.

As with other nasal decongestants, Orinox should not be used continuously for more than 5 days. Prolonged or excessive use may lead to thickening of the nasal mucosa, causing the symptoms for which the medicine is used to persist or recur.

If there is no improvement after 5 days, the doctor should be contacted.

The recommended dose should not be exceeded.

Contact with the eyes and mouth should be avoided.

Children

Orinox should not be used in children under 1 year of age.

Administration to children aged 1 to 11 years should be under adult supervision.

Orinox and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Xylometazoline should not be used in a child who is taking (or has taken in the last 2 weeks) any medicines for depression.

These include:

• monoamine oxidase inhibitors (MAOIs): this medicine should not be used in a child who is taking or has taken MAOIs in the last 2 weeks,
• tricyclic or tetracyclic antidepressants.

Interactions may occur when xylometazoline is used concomitantly with medicines for high blood pressure. There is a risk of impaired efficacy of beta-adrenergic receptor blockers (used to treat high blood pressure, certain heart diseases, and increased eye pressure).

If the patient is taking such medicines, this should be taken into account and discussed with the doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Orinox should not be used during pregnancy.

Breastfeeding

There is no data on the excretion of xylometazoline into breast milk. The doctor should be consulted about the suitability of using this medicine before administration.

Driving and using machines

Orinox has no or negligible influence on the ability to drive and use machines.

Orinox contains benzalkonium chloride

This medicine contains 0.1 mg of benzalkonium chloride per milliliter of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Orinox

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

Orinox should not be used in children under 1 year of age. In children aged 1 to 11 years, it should be used under adult supervision.

Recommended dose:

Children aged 1 to 5 years

Use under adult supervision.

1 spray into each nostril, 1 to 3 times a day, as needed.

There should be an 8-10 hour interval between doses.

Children aged 6 to 11 years

Use by an adult or under adult supervision.

1 to 2 sprays into each nostril, 1 to 3 times a day, as needed.

There should be an 8-10 hour interval between doses.

Method of administration

Remove the protective cap.

The pump should be pressed 5 times before the first application. If the pump has not been used for more than 14 days (after the first use), press the pump once to prepare the spray for reuse. The spray is ready for use during regular use.

Ensure that the medicine is not sprayed towards the eyes or into the mouth.

Clear the nose.

Hold the bottle upright and tilt the head slightly forward. Place the tip in the nostril and press the pump. Keep the pump pressed until it is removed from the nostril. Apply one spray into each nostril. During application, the child should breathe slowly through the nose.

After use, clean and dry the tip and replace the protective cap.

To avoid the spread of infection, the bottle should only be used by one person.

Duration of treatment

Xylometazoline hydrochloride should not be used in a child for more than 5 days. If symptoms do not improve or recur after 5 days of using the medicine, the doctor should be consulted.

The child's doctor may provide advice on further treatment of the condition in the child.

Using a higher dose of Orinox than recommended

If too much of this medicine is used, the doctor or pharmacist should be contacted immediately.

Overdose can occur with both nasal and oral administration.

Overdose, especially in small children, may cause the following symptoms: anxiety, agitation, hallucinations, or convulsions alternating with decreased body temperature, extreme drowsiness leading to loss of consciousness (lethargy) or coma.

Other symptoms of overdose may include: pinpoint pupils, or even dilated pupils, sweating, pallor, cyanosis (bluish discoloration) of the skin and mucous membranes, palpitations, and apnea (temporary cessation of breathing).

Missing a dose of Orinox

A double dose should not be used to make up for a missed dose.

Stopping use of Orinox

No disturbances should occur when stopping the use of this medicine.

If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Orinox can cause side effects, although not everybody gets them.

USE OF THE MEDICINE SHOULD BE STOPPED AND THE DOCTOR OR PHARMACIST SHOULD BE CONTACTED IMMEDIATELY IF THE PATIENT EXPERIENCES ANY OF THE FOLLOWING SYMPTOMS, WHICH MAY BE SIGNS OF AN ALLERGIC REACTION:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• severe itching with redness and blisters (hives).

Common(may affect up to 1 in 10 people):

• headache,
• dryness in the nose or discomfort in the nose, burning,
• nausea.

Uncommon(may affect up to 1 in 100 people):

• nasal bleeding.

Rare(may affect up to 1 in 10,000 people):

• dizziness,
• tremors,
• insomnia,
• transient visual disturbances,
• irregular or rapid heartbeat,
• increased blood pressure,
• allergic reactions (skin rash, itching, swelling).

Reporting side effects

If any side effects occur, including any possible side effects not listed in this package leaflet, the doctor or pharmacist should be informed.

Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Orinox

Store in a temperature below 25°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after: EXP.

The expiry date refers to the last day of the month.

The shelf life after first opening the bottle is 1 month. To help remember, the date of opening should be written in the space on the carton.

Medicines should not be disposed of via wastewater or household waste.

The pharmacist should be asked how to dispose of medicines no longer required.

This will help protect the environment.

6. Package contents and other information

What Orinox contains

• The active substance is xylometazoline hydrochloride. One milliliter of Orinox contains 0.5 mg of xylometazoline hydrochloride. One dose (138 microliters) contains 70 micrograms of xylometazoline hydrochloride.
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, purified water.

What Orinox looks like and contents of the pack

Orinox is a clear, colorless or almost colorless solution.

Orinox is available in glass bottles (type III) with a capacity of 10 ml, with a dosing pump and a protective cap made of PP or HDPE, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.

Na Florenci 2116/15, Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer:

Basic Pharma Manufacturing B.V.

Burgemeester Lemmensstraat 352

6163 JT Geleen

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic

Xylomax

Poland

Orinox

Romania

Orinox 0.5 mg/ml spray nazal, soluţie

Slovakia

Orinox 0.5 mg/ml

Date of last revision of the package leaflet: