OXYRIN APTEO MED

Package leaflet: Information for the user

Oxyrin Apteo Med
0.5 mg/ml
nasal spray, solution
Oxymetazolini hydrochloridum
Read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
• Contact a physician if there is no improvement or if the patient feels worse after 7 days.

Table of contents:

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

1. What Oxyrin Apteo Med is and what it is used for

Oxyrin Apteo Med belongs to a group of medicines called sympathomimetics, which act locally as vasoconstrictors and help clear nasal congestion.
This medicine is indicated for the local and temporary relief of nasal mucosal swelling caused by inflammation of the nasal mucosa.
Contact a physician if there is no improvement or if the patient feels worse after 7 days.

2. Important information before using Oxyrin Apteo Med

When not to use Oxyrin Apteo Med

• if the patient is allergic to oxymetazoline or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently using or has used antidepressant medicines (used to treat depression) within the last 14 days;
• if the patient is using other sympathomimetic nasal decongestants;
• if the patient has high intraocular pressure (narrow-angle glaucoma);
• if the patient has recently undergone neurosurgery (transsphenoidal removal of the pituitary gland or any other surgical procedure involving exposure of the dura mater);
• if the patient has heart disease or circulatory problems;
• if the patient has atrophic rhinitis with crust formation (dry rhinitis).

Oxyrin Apteo Med should not be used in children under 12 years of age.
Warnings and precautions
Before using Oxyrin Apteo Med, consult a doctor or pharmacist:

• if the patient has high blood sugar levels (diabetes);
• if the patient has high blood pressure (hypertension);
• if the patient has an enlarged prostate (prostatic hyperplasia);
• if the patient has thyroid disease (hyperthyroidism);
• if the patient has a tumour of the adrenal glands (pheochromocytoma);
• if the patient is taking adrenergic bronchodilators (for asthma treatment), phenothiazines (sedatives), or methyldopa (to lower blood pressure);
• if the patient suffers from insomnia (rare cases), the medicine should be avoided late in the evening or at night.

Using the same bottle of spray by more than one person may lead to the spread of infection.
Children and adolescents
This medicine should not be used in children under 12 years of age. Children may be particularly susceptible to adverse effects.
Oxyrin Apteo Med and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, including those obtained without a prescription, homeopathic medicines, herbal preparations, and other health-related products, as it may be necessary to discontinue or adjust the dosage of some of them.
Some medicines may interact with Oxyrin Apteo Med, requiring a dosage adjustment or discontinuation of treatment. It is important to inform your doctor or pharmacist if the patient is taking any of the following medicines: antidepressants (monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants), phenothiazine derivatives (sedatives), antiasthmatic drugs, antihypertensives, or methyldopa (to lower blood pressure), bromocriptine (for Parkinson's disease), cardiac glycosides (digoxin, for controlling heart function), and ergot alkaloids (for migraine headaches).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Oxymetazoline should not be used during pregnancy.
Breastfeeding
This medicine should not be used during breastfeeding without medical advice, as it may pass into breast milk.
Driving and operating machinery
Although no effect on the ability to drive or operate machinery is expected, if the patient experiences drowsiness or dizziness, he or she should not drive or operate machinery.
Oxyrin Apteo Med contains benzalkonium chloride
Oxyrin Apteo Med contains 0.2 mg of benzalkonium chloride per ml of nasal spray.
Benzalkonium chloride may cause nasal irritation or swelling, especially if used for prolonged periods.

3. How to use Oxyrin Apteo Med

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and children over 12 years of age
The recommended dose is one spray into each nostril, up to two times per day.
Do not use the medicine for longer than 7 days without consulting a doctor.
One dose of the nasal spray before bedtime should ensure nasal patency throughout the night.
Use of the medicine in children
Do not use this medicine in children under 12 years of age. Children may be particularly susceptible to adverse effects.
Instructions for correct use of the medicine
Before first use, prime the spray. To do this, hold the bottle away from you and press the pump several times downwards until a spray is released.

1. Remove protective cap 2. Holding the bottle, place 3. Insert the nozzle of the bottle middle and index fingers on applicator into the upper area and press down with thumb at the bottom

Before using the medicine, clear the nose.
After each use and before closing the bottle, wipe the applicator with a clean, damp cloth.
Inform your doctor or pharmacist if you feel the effect of the medicine is too strong or too weak.
Use of a higher than recommended dose of Oxyrin Apteo Med
If excessively large doses are used, if the medicine is used continuously, or if Oxyrin Apteo Med is accidentally swallowed, symptoms such as headache, tremor, sleep disturbances, excessive sweating, palpitations, and nervousness may occur. If such symptoms occur, reduce the dose and consult a doctor or pharmacist if the patient is unsure of the correct dosage.
In case of overdose or accidental ingestion, contact a doctor, pharmacist, or go immediately to the nearest hospital emergency department.
Missed dose of Oxyrin Apteo Med
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common (may affect fewer than 1 in 10 people): burning, dryness and/or irritation of the nasal mucosa or sneezing. Excessive or prolonged use of the medicine may lead to rebound congestion of the nasal mucosa due to the rebound effect.

Rare (may affect fewer than 1 in 1000 people): restlessness, fatigue, irritability, sleep disturbances in children, rapid heartbeat, palpitations, increased blood pressure, sensation of nasal obstruction, swelling of the nasal mucosa, headache, nausea, redness, rash and visual disturbances.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. Side effects 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, tel.: (22) 49 21 301, fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl .

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

Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Oxyrin Apteo Med

Do not store at temperatures above 30°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the EXP marking. The expiry date refers to the last day of the stated month. The medicine should be used within 30 days of first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Oxyrin Apteo Med contains

• The active substance is oxymetazoline hydrochloride 0.5 mg/ml.
• The other ingredients are: benzalkonium chloride, disodium phosphate anhydrous, sodium dihydrogen phosphate dihydrate, glycine, liquid non-crystallizing sorbitol, purified water.

What Oxyrin Apteo Med looks like and contents of the pack
Oxyrin Apteo Med is a nasal solution in a polyethylene bottle with a spray pump and a cap.
Each bottle contains 15 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer:
ITALFARMACO, S.A.
San Rafael, 3
28108 Alcobendas (Madrid)
Spain