Orinox

Leaflet accompanying the packaging: patient information

Orinox, 1 mg/ml, nasal spray, solution

Xylometazoline hydrochloride

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 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. Contents of the packaging 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, which decreases the amount of nasal discharge and helps to restore swollen blood vessels to their normal state. Xylometazoline helps to 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.

The 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 adults and adolescents over 12 years of age.

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

If there is no improvement after 7 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 patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has recently undergone nasal surgery, they should consult their doctor or pharmacist before starting treatment with xylometazoline hydrochloride;
• if the patient has dry rhinitis with crust formation (atrophic rhinitis);
• if the patient has narrow-angle glaucoma.

The patient should inform their doctor or pharmacist if any of the above points apply to them, as this means that the medicine is not suitable for them.

Warnings and precautions

Before starting treatment with Orinox, the patient should discuss it with their doctor or pharmacist if they have:

• 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 patient 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 patient should contact their doctor if they experience any of these symptoms.

As with other nasal decongestants, Orinox should not be used continuously for more than 7 days.

Prolonged or excessive use may lead to thickening of the nasal mucosa, which can cause the symptoms for which the medicine is used to persist or even return.

If there is no improvement after 7 days, the patient should contact their doctor.

The patient should not exceed the recommended dose.

The patient should avoid contact with the eyes and mouth.

Children

Orinox 1 mg/ml should not be used in children under 12 years of age.

A different strength of the medicine (0.5 ml/mg) is available for children between 1 and 11 years of age.

Orinox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Xylometazoline should not be used in patients who are taking (or have taken in the last 2 weeks) any medicines for depression.

These include:

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

Interactions may occur when xylometazoline is used concomitantly with medicines for hypertension. 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, they should consult their 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 penetration of xylometazoline into breast milk. The patient should consult their doctor about the suitability of using this medicine before taking it.

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 the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Orinox should not be used in children under 12 years of age.

Recommended dose:

Adults and adolescents over 12 years of age:

1 spray into each nostril, once or several times a day as needed, but not more than 3 times a day.

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

Method of administration

Remove the protective cap.

Press the pump 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.

Make sure not to spray the medicine 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 dose to each nostril. Breathe slowly through the nose during application.

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

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

Duration of treatment

Xylometazoline hydrochloride should not be used for more than 7 days. If symptoms do not improve or return after 7 days of using the medicine, the patient should consult their doctor. The doctor may provide advice on further treatment of the condition.

Using a higher dose of Orinox than recommended

If the patient has used too much of this medicine, they should contact their doctor or pharmacist immediately.

Overdose can occur with both nasal and oral administration.

Overdose, especially in small children, can cause the following symptoms: anxiety, agitation, hallucinations, or convulsions alternating with a decrease in body temperature, extreme drowsiness up to loss of consciousness (lethargy) or coma. Other symptoms of overdose may include: pupil constriction, or even pupil dilation, sweating, pallor, cyanosis (bluish discoloration) of the skin and mucous membranes, palpitations, and apnea (temporary cessation of breathing).

Missing a dose of Orinox

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Orinox

If treatment is stopped, no disturbances should occur.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should STOPusing the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately if they experience 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 red rash or 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 and rapid heartbeat,
• increased blood pressure,
• allergic reactions (skin rash, itching, swelling).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Orinox

Store in a temperature 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 after: EXP.

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

The shelf life after first opening the bottle is 1 month. To help remember, the patient should write the opening date on the carton.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Orinox contains

• The active substance of Orinox is xylometazoline hydrochloride. One milliliter of Orinox contains 1 mg of xylometazoline hydrochloride. One dose (138 microliters) contains 140 micrograms of xylometazoline hydrochloride.
• The other ingredients of the medicine 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 (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

Italy

Rimet

Poland

Orinox

Romania

Orinox 1 mg/ml spray nazal, soluţie

Slovakia

Orinox 1 mg/ml

Date of last revision of the leaflet: