AFRIN ND MENTHOL

Package leaflet: Information for the user

Afrin ND Menthol, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.
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 contact 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 7 days or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Afrin ND Menthol is and what it is used for

What Afrin ND Menthol is
Afrin ND Menthol, nasal spray, solution contains the active substance oxymetazoline hydrochloride.
How Afrin ND Menthol works
Afrin ND Menthol is a decongestant medicine that provides relief from nasal congestion by constricting blood vessels in the nose. It starts to work within minutes and the effect lasts for hours.
When to use Afrin ND Menthol
Afrin ND Menthol is used to treat symptoms of nasal congestion caused by hay fever, colds, and sinusitis. The medicine should be used every 12 hours.
If there is no improvement after 7 days or if you feel worse, consult your doctor.

2. Important information before using Afrin ND Menthol

When not to use Afrin ND Menthol:

• if the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient is being treated with monoamine oxidase inhibitors (MAO inhibitors, medicines used in Parkinson's disease and depression). MAO inhibitors may intensify the blood pressure increase caused by oxymetazoline;
• if the patient suffers from glaucoma (increased eye pressure) with narrow filtration angle,
• in patients after transsphenoidal removal of the pituitary gland (surgical removal of the pituitary gland),
• if the patient suffers from nasal vestibular dermatitis and mucositis with crust formation (dry atrophic rhinitis),
• if the patient suffers from acute coronary disease and left ventricular heart failure ("cardiac asthma").

Warnings and precautions
Inform the doctor if the patient has:

• coronary artery disease,
• hypertension (high blood pressure),
• hyperthyroidism (overactivity of the thyroid gland),
• diabetes,
• difficulty in urination due to benign prostatic hyperplasia (enlarged prostate gland).

Prolonged use of Afrin ND Menthol may cause a sensation of nasal congestion. The medicine should not be used for longer than 7 days. If symptoms worsen or no improvement is observed after 7 days, consult a doctor.
Children
Afrin ND Menthol should not be used in children under 6 years of age (see section 3. How to use Afrin ND Menthol).
Afrin ND Menthol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
The blood pressure-increasing effect of oxymetazoline may be intensified by concomitant use of:

• certain antidepressants: tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors (MAO inhibitors).

Pregnancy and breastfeeding
Pregnancy
No negative effects of oxymetazoline on pregnancy have been observed. Afrin ND Menthol may be used during pregnancy according to recommendations. Caution should be exercised in patients with hypertension or symptoms of reduced placental perfusion. Frequent or prolonged use of high doses of the medicine may reduce placental perfusion.
Breastfeeding
It is not known whether oxymetazoline passes into breast milk. Due to lack of data on the use of oxymetazoline during lactation, Afrin ND Menthol should not be used during breastfeeding.
Driving and operating machinery
No influence of the medicine on the ability to drive or operate machinery has been observed.
Afrin ND Menthol contains benzalkonium chloride, benzyl alcohol, and propylene glycol
Benzalkonium chloride (a preservative) may cause irritation or swelling inside the nose, especially if used for a prolonged period.
Benzyl alcohol may cause allergic reactions.
Propylene glycol may cause skin irritation.

3. How to use Afrin ND Menthol

This medicine should always be used exactly as described in the leaflet. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Adults and children over 10 years of age: 1-2 sprays into each nostril every 12 hours.
Children aged 6-10 years: 1 spray into each nostril every 12 hours.
In adults, do not use more than 8 sprays (in children, no more than 4 sprays) within 24 hours.
Do not exceed the recommended dosage.
Afrin ND Menthol should not be used for longer than 7 days unless advised by a doctor. A break of
several days should elapse before reusing the medicine.
Method of administration
Shake well before use. Before first use, prime the spray pump by pressing it several times until the first full
spray appears.
Holding the dispenser upright, insert the tip into each nostril in turn, and press the container firmly once or twice,
while inhaling through the nose.
After use, clean the dispenser. Using the dispenser by more than one person may contribute to the spread of infection.
Use of a higher than recommended dose of Afrin ND Menthol
If more medicine has been used than recommended, consult a doctor immediately or go to hospital,
taking the medicine package with you.
Missed dose of Afrin ND Menthol
Do not use a double dose to make up for a forgotten dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody experiences them.
Possible adverse effects:
Uncommon (occur in less than 1 in 100 people): sneezing, dryness or irritation of the nasal, oral or pharyngeal mucosa, and sensation of nasal congestion.
Rare (occur in less than 1 in 1000 people): anxiety, fatigue, irritability, sleep disturbances in children,
increased heart rate, palpitations, increased blood pressure, nasal mucosal swelling, headache,
nausea, redness, rash, and visual disturbances.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform a doctor or pharmacist. Adverse effects 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, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: [email protected]
Reporting adverse effects enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Afrin ND Menthol

Store the medicine at a temperature below 25°C. Do not store in the refrigerator or freeze.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month.
Do not use the medicine more than 30 days after first opening.
Medicines should 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 package and other information

What Afrin ND Mentol contains

• The active substance is oxymetazoline hydrochloride 0.5 mg/ml.
• The other ingredients (excipients) are: disodium edetate, disodium phosphate, monosodium dihydrogen phosphate monohydrate, povidone K29-32, benzalkonium chloride (0.25 mg/ml), macrogol 1450, propylene glycol, purified water, benzyl alcohol (3 mg/ml), microcrystalline cellulose and sodium carmellose, cineole, racemic camphor, levomenthol.

What Afrin ND Mentol looks like and contents of the pack
Afrin ND Mentol is a viscous solution, white to off-white in colour, contained in a white, light-protective, plastic bottle with a capacity of 15 ml, equipped with a white plastic spray pump.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00

Manufacturer:
Berlimed S.A.
C/Francisco Alonso no.7
Poligono Industrial Santa Rosa Alcalá de Henares
28806 Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
AFRIN: Czech Republic, Estonia, Latvia, Lithuania, Netherlands, Slovakia, Slovenia, Spain, Romania
AFRIN Comfort: Hungary
AFRIN ND: Bulgaria
AFRIN ND Mentol: Poland
NASAROX: Portugal
Rhinacept: Greece