Afrin Nd Mentol

Package Leaflet: Information for the Patient

Afrin ND Mentol, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride

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

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

Table of Contents of the Leaflet

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

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

What is Afrin ND Mentol

Afrin ND Mentol, nasal spray, solution contains the active substance oxymetazoline hydrochloride.

How Afrin ND Mentol works

Afrin ND Mentol is a decongestant that provides relief from a blocked nose by narrowing the blood vessels in the nose. It starts working within a few minutes and the effect lasts for hours.

When to use Afrin ND Mentol

Afrin ND Mentol is used to treat the symptoms of a blocked nose caused by hay fever, colds, and sinusitis. The medicine is used every 12 hours.
If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

2. Important information before using Afrin ND Mentol

When not to use Afrin ND Mentol:

• if the patient is hypersensitive 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 (MAOIs, medicines used in Parkinson's disease and depression). MAOIs may enhance the blood pressure-increasing effect of oxymetazoline;
• if the patient has glaucoma (increased pressure in the eye) with a narrow angle of the anterior chamber,
• in patients who have had transsphenoidal removal of a pituitary tumor (surgical removal of the pituitary gland),
• if the patient has atrophic rhinitis (dry, crusty inflammation of the nasal mucosa),
• if the patient has acute coronary syndrome and left ventricular heart failure ("cardiac asthma").

Warnings and precautions

The doctor should be informed if the patient has:

• coronary artery disease,
• hypertension (high blood pressure),
• hyperthyroidism (overactive thyroid gland),
• diabetes,
• difficulty urinating due to an enlarged prostate gland.

Afrin ND Mentol used for a longer period may cause a feeling of a blocked nose. The medicine should not be used for more than 7 days. If the symptoms worsen or do not improve after 7 days, a doctor should be consulted.

Children

Afrin ND Mentol should not be used in children under 6 years of age (see section 3. How to use Afrin ND Mentol).

Afrin ND Mentol and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
The blood pressure-increasing effect of oxymetazoline may be enhanced by concomitant use of:

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

Pregnancy and breastfeeding Pregnancy

No negative effect of oxymetazoline on pregnancy has been found. Afrin ND Mentol may be used in pregnant women as directed. Caution should be exercised in patients with hypertension or signs 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 the lack of data on the use of oxymetazoline during lactation, Afrin ND Mentol should not be used during breastfeeding.

Driving and using machines

No effect of the medicine on the ability to drive or use machines has been found.

Afrin ND Mentol contains benzalkonium chloride, benzyl alcohol, and propylene glycol

Benzalkonium chloride (preservative) may cause irritation or swelling inside the nose, especially if used for a long time.
Benzyl alcohol may cause allergic reactions.
Propylene glycol may cause skin irritation.

3. How to use Afrin ND Mentol

This medicine should always be used exactly as described in the package leaflet. If in doubt, a doctor or pharmacist should be consulted.
Recommended dose
Adults and children over 10 years: 1-2 sprays into each nostril, every 12 hours.
Children 6-10 years: 1 spray into each nostril, every 12 hours.
Adults should not use more than 8 sprays (children no more than 4 sprays) in 24 hours.
Do not exceed the recommended dose.
Afrin ND Mentol should not be used for more than 7 days, unless advised by a doctor. A few days' break should be taken before reusing the medicine.
Method of administration
Shake well before use. Before first use, the spray pump should be prepared for use by pressing the pump several times until the first full spray appears.
Holding the container upright, the tip of the container should be inserted into each nostril in turn, and the container pressed firmly once or twice, while breathing in through the nose.
After use, the spray pump should be cleaned. Using the spray pump by more than one person may contribute to the spread of infection.

Using more than the recommended dose of Afrin ND Mentol

In case of overdose, a doctor or hospital should be consulted immediately, taking the package leaflet and any remaining medicine with you.

Missing a dose of Afrin ND Mentol

A double dose should not be used to make up for a missed dose.
If there are any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Afrin ND Mentol can cause side effects, although not everybody gets them.
Possible side effects:
Uncommon(affecting less than 1 in 100 people): sneezing, dryness or irritation of the nasal mucosa, mouth, or throat, and a feeling of a blocked nose.
Rare(affecting less than 1 in 1,000 people): anxiety, fatigue, irritability, sleep disturbances in children, rapid heartbeat, palpitations, increased blood pressure, swelling of the nasal mucosa, headache, nausea, flushing, rash, and vision disturbances.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Pharmacovigilance, 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: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Afrin ND Mentol

The medicine should be stored at a temperature below 25°C. Do not store in the refrigerator or freeze.
The medicine should be kept 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 month.
Do not use after 30 days of first opening.
Medicines should not be disposed of via wastewater or household waste.
A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, sodium 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, camphor, and levomenthol.

What Afrin ND Mentol looks like and contents of the pack

Afrin ND Mentol is a white to off-white viscous solution in a 15 ml white, light-protective plastic bottle 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 Member States of the European Economic Area 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

Date of last revision of the leaflet: 07.2018