Orinox ha

Package leaflet: Information for the user

Orinox HA, 1 mg/mL, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
You must always use this medicine 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, or if your condition worsens, you should contact your doctor.

Contents of the leaflet:

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

1. What Orinox HA is and what it is used for

Orinox HA belongs to a group of medicines called sympathomimetics, which are used in the treatment of nasal disorders. The active substance in Orinox HA is xylometazoline hydrochloride, which reduces nasal mucosal congestion, thereby decreasing swelling of the nasal mucosa.
Orinox HA is used for symptomatic relief of nasal mucosal congestion with nasal discharge caused by colds or sinusitis.
The effect of the medicine begins within a few minutes and lasts for several hours.
Orinox HA is indicated for use in adults and adolescents aged 12 years and older.

2. Important information before using Orinox HA

When not to use Orinox HA:

• if the patient is allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has dry rhinitis (rhinitis sicca);
• if the patient has recently undergone neurosurgery (transsphenoidal pituitary surgery or any other surgery exposing the meninges);
• if the patient has elevated intraocular pressure, particularly narrow-angle glaucoma.

Warnings and precautions
Before using Orinox HA, consult a doctor or pharmacist:

• if the patient is currently taking monoamine oxidase inhibitors (MAOIs) (e.g. tranylcypromine and moclobemide – medicines used in the treatment of depression), or if the patient has taken MAO inhibitors within the last two weeks, or is taking tricyclic or tetracyclic antidepressants, or other medicines that may increase blood pressure;
• if the patient has cardiovascular diseases (e.g. hypertension);
• if the patient has heart disease (e.g. long QT syndrome);
• if the patient has a tumour of the adrenal gland (pheochromocytoma);
• if the patient has an enlarged prostate;
• if the patient suffers from porphyria (a metabolic disorder affecting the skin and/or central nervous system);
• if the patient has metabolic disorders (e.g. hyperthyroidism, diabetes).

Prolonged use of Orinox HA, as with other similar medicines, may lead to chronic swelling of the nasal mucosa, which may eventually result in mucosal atrophy (thinning).
To prevent this, treatment duration should be kept to a minimum (see section 3).
Avoid prolonged and excessive use of the medicine, especially in children. The duration of treatment in children should always be discussed with a doctor.
If the patient suspects a bacterial infection of the nose or sinuses, medical advice should be sought, as such infections require appropriate treatment.
Avoid contact of the medicine with eyes and mouth.
Like other similar medicines, Orinox HA may cause sleep disturbances, dizziness and tremor in sensitive individuals. Consult a doctor if symptoms worsen.

Children
Orinox HA 1 mg/mL nasal spray, solution should not be used in children under 12 years of age. Other dosage forms may be more suitable for this patient group.

Orinox HA and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Concomitant use of Orinox HA with monoamine oxidase inhibitors (MAOIs, e.g. tranylcypromine, moclobemide) or use within the last two weeks of MAO inhibitors, tricyclic or tetracyclic antidepressants, or other medicines that may increase blood pressure (e.g. doxapram, ergotamine, oxytocin), may lead to increased blood pressure due to the effects of these medicines on the heart and blood vessels. Therefore, concomitant use of these medicines is not recommended.
Interactions may occur when xylometazoline is used with certain antidepressants, antihypertensives, or medicines for local or systemic treatment of influenza. There is a risk of altered effects of beta-adrenergic receptor blocking agents (used in the treatment of high blood pressure, certain heart conditions, and elevated intraocular pressure).
This should be taken into account when using such medicines, and advice from a doctor or pharmacist should be sought.

Pregnancy, breastfeeding and fertility

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

Pregnancy
Consult a doctor or pharmacist before using this medicine if the patient is pregnant. The doctor will decide whether the medicine can be used safely. As a precaution, use of xylometazoline during pregnancy is not recommended.

Breastfeeding
This medicine should not be used during breastfeeding, as it is unknown whether xylometazoline passes into breast milk and a risk to the breastfed infant cannot be excluded. The doctor will decide whether to discontinue breastfeeding or to discontinue xylometazoline treatment, taking into account the benefits of breastfeeding for the infant and the benefits of treatment for the mother. Since overdose may lead to reduced milk production, it is particularly important not to exceed the recommended dose of xylometazoline during breastfeeding.

Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery
No effect on the ability to drive or operate machinery is expected when the medicine is used according to the instructions in the leaflet.

3. How to use Orinox HA

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age:
1 spray into each nostril, no more than 3 times daily.
Orinox HA must not be used for longer than 5 days unless otherwise advised by a doctor. Treatment
may be repeated after a break of several days.
Do not exceed the recommended dose.
If there is no improvement after 5 days of continuous treatment, or if symptoms worsen,
consult your doctor.
Use in children
Orinox HA must not be used in children under 12 years of age.
Other pharmaceutical forms may be more suitable for this patient group.
Method of administration

Before using the medicine, the patient should blow their nose. Remove the protective cap as shown in Figure 1.	Figure 1
Hold the bottle so that its base rests on the thumb, and the pump is positioned between the index and middle fingers, as shown in Figure 2. To release a dose, press the pump downwards toward the base of the bottle. If this medicine is being used for the first time, spray it several times (5 times) into the air to ensure a uniform dose. If the medicine has not been used for several days, perform at least one test spray into the air before use to ensure a consistent dose.	Figure 2
Insert the nozzle of the pump into the nostril as shown in Figure 3 (do not use the aerosol below the nostril). Press the pump down toward the base of the bottle while inhaling through the nose, gently closing the other nostril with the index finger of the other hand. Release the pump and remove the nozzle from the nostril. To administer the medicine into the other nostril, repeat the above steps. After using the medicine, carefully wipe the top part of the pump with a clean, dry paper tissue and replace the protective cap.	Figure 3

For hygienic reasons and to avoid spreading infection, each aerosol bottle should be used by only one person.
Use of a higher than recommended dose of Orinox HA
If too high a dose of this medicine is used, contact your doctor or pharmacist immediately.
Overdose may occur both after intranasal 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) and coma. Other symptoms of overdose may include: constriction of pupils, or even dilation of pupils, sweating, pallor, bluish discoloration (cyanosis) of the skin and mucous membranes, palpitations, and apnea (temporary cessation of breathing).
Missed dose of Orinox HA
Do not use a double dose to make up for a missed dose; continue using the medicine as recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The use of Orinox HA must be discontinued and immediate medical advice must be sought if
the patient experiences any of the symptoms described below (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 (urticaria).

The following adverse reactions have been reported:
Common (may occur in fewer than 1 in 10 people):

• headache,
• transient and mild irritation symptoms such as stinging or dryness of the nasal and/or throat mucosa,
• sneezing,
• nausea.

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

• sensation of nasal congestion (after the medicine wears off),
• nosebleeds.

Rare (may occur in fewer than 1 in 1,000 people):

• dizziness,
• irregular and rapid heartbeat,
• increased blood pressure,
• transient visual disturbances,
• allergic reactions such as skin rash, itching, swelling.

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

• nervousness,
• insomnia,
• arrhythmia (heart rhythm disturbances),
• tachycardia (rapid heartbeat).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 provide more information on the safety of this medicine.

5. How to store Orinox HA

Keep this medicine out of sight and reach of children.
Store below 25°C.
The shelf life after the first opening of the bottle is 6 months.
Do not use this medicine after the expiry date stated on the label and carton following the abbreviation: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Orinox HA contains

• The active substance is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride. One dose (140 microlitres) contains 0.140 milligrams of xylometazoline hydrochloride.
• The other ingredients are: purified sea water, monopotassium phosphate, sodium hyaluronate, purified water.

What Orinox HA looks like and contents of the pack
Orinox HA is a clear, colourless, sterile solution.
10 ml of solution is contained in a white plastic bottle closed with a spray pump, nozzle, and protective cap, packed in a cardboard box.
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:
Jadran – Galenski laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia
This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Xylomax Neo
Poland: Orinox HA
Slovakia: Orinox Neo
Romania: Orinox HA 1 mg/ml nasal spray, solution