Orinox

Package leaflet: Information for the user

Orinox, 0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read the entire leaflet carefully before use, as it contains
important information for the user.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment, or if you feel worse, consult your doctor.

Table of contents

1. What Orinox is and what it is used for
2. Important information before using Orinox
3. How to use Orinox
4. Possible side effects
5. How to store Orinox
6. Contents of the pack and other information

1. What Orinox is and what it is used for

Orinox contains xylometazoline hydrochloride as the active substance, which belongs to a group of medicines called sympathomimetics. Xylometazoline reduces nasal mucosal congestion, thereby decreasing nasal discharge and helping swollen blood vessels return 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, as well as sinusitis.
Your doctor may also prescribe it for use prior to a professional nasal examination.
The effect of the medicine begins 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 of treatment, or if you feel worse, consult your 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. Consult a doctor or pharmacist whether it is safe to start using xylometazoline hydrochloride in the child;
• if the child has dry rhinitis with formation of crusts (atrophic rhinitis);
• if the child has narrow-angle glaucoma.

Inform the doctor or pharmacist if any of the above conditions apply to the child, as this means the medicine is not suitable for them.

Warnings and precautions

Before starting to use Orinox, consult a doctor or pharmacist if any of the following apply:

• high blood pressure,
• heart diseases (e.g. long QT syndrome),
• circulatory system disorders,
• hyperthyroidism,
• diabetes,
• benign prostatic hyperplasia,
• adrenal gland tumor (pheochromocytoma),
• if the child is currently being treated or has been treated with antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) within the last two weeks.

Like other similar medicines, Orinox may cause sleep disturbances, dizziness, tremor, irregular heartbeat, or increased blood pressure in sensitive individuals. Contact a doctor if any of these symptoms occur.

As with other medicines reducing nasal mucosal congestion, Orinox should not be used continuously for longer than 5 days. Prolonged or excessive use may lead to thickening of the nasal mucosa, causing the symptoms the medicine is intended to treat to persist or even return.

If there is no improvement within 5 days, contact a doctor.

Do not exceed the recommended dose.

Avoid contact with eyes and mouth.

Children

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

Administration to children aged 1 to 11 years should be supervised by an adult.

Orinox with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

Do not use xylometazoline in a child who is taking (or has taken within the last 2 weeks) any medicines for depression.

These include:

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

Interactions may occur when xylometazoline is used concomitantly with antihypertensive medicines. There is a risk of interference with the action of beta-adrenergic receptor blocking agents (used in the treatment of high blood pressure, certain heart conditions, and elevated intraocular pressure).

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Orinox should not be used during pregnancy.

Breastfeeding

There is no data available on the passage of xylometazoline into breast milk. Consult a doctor regarding the suitability of using this medicine before administration.

Driving and operating machinery

Orinox has no effect or has negligible effect on the ability to drive and operate machinery.

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 prolonged period.

3. How to use Orinox

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Orinox should not be used in children under 1 year of age. In children aged 1 to 11 years, use should be
under adult supervision.
Recommended dose:
Children aged 1 to 5 years
Use under adult supervision.
1 spray into each nostril, 1 to 3 times daily, as needed.
An interval of 8 to 10 hours should be maintained 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 daily, as needed.
An interval of 8 to 10 hours should be maintained between doses.
Method of administration
Remove the protective cap.
Press the pump 5 times before the first use. If the pump has not been used for more than 14 days
(after initial use), press the pump once to prepare the spray for reuse. The spray is ready for use
during regular use.
Ensure 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. Insert the tip into the nostril and press
the pump. Keep the pump pressed until it is removed from the nostril. Administer one dose into
each nostril. During administration, the child should breathe slowly through the nose.
After use, clean and dry the tip and replace the protective cap.
To avoid spreading infection, the bottle should be used by only one person.
Duration of treatment
Do not use xylometazoline hydrochloride in a child for longer than 5 days. If symptoms persist or
return after 5 days of treatment, consult a doctor.
The child's doctor can advise on further treatment for the child's condition.
Use of a higher than recommended dose of Orinox
If too much of this medicine has been used, contact a doctor or pharmacist immediately.
Overdose may occur with both nasal and oral administration.
Overdose, especially in young children, may cause the following symptoms: anxiety, agitation,
hallucinations, or seizures alternating with decreased body temperature, extreme drowsiness up to
loss of consciousness (lethargy) or coma. Other overdose symptoms may include: constricted pupils,
or even dilated pupils, sweating, pallor, bluish discoloration (cyanosis) of the skin and mucous
membranes, palpitations, and apnea (temporary cessation of breathing).
Missed dose of Orinox
Do not use a double dose to make up for a missed dose.
Stopping Orinox treatment
If treatment is stopped, no disturbances should occur.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should STOP using the medicine and contact a doctor immediately or go to
the emergency department of the nearest hospital if any of the following symptoms occur in an adult or child,
as they may be signs of an allergic reaction:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue or throat,
• severe itching with red rash or blisters (urticaria).

Common (may occur in fewer than 1 in 10 people):

• headache,
• nasal dryness or nasal discomfort, burning sensation,
• nausea.

Uncommon (may occur in fewer than 1 in 100 people):

• nosebleeds.

Very rare (may occur in fewer than 1 in 10,000 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Orinox

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following: EXP.
The expiry date refers to the last day of the stated month.
The shelf-life after first opening the bottle is 1 month. To help remember easily,
write the date of opening in the space provided on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the package and other information

What Orinox contains

• The active substance is xylometazoline hydrochloride. One ml of Orinox contains 0.5 mg of xylometazoline hydrochloride. One dose (138 microlitres) 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, colourless or almost colourless solution.
Orinox is supplied in 10 ml amber glass type III bottles with a metered pump dispenser and a PP or HDPE cap, packed in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
The Netherlands
This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic Xylomax
Poland Orinox
Romania Orinox 0.5 mg/ml nasal spray, solution
Slovakia Orinox 0.5 mg/ml