Afrin Nd

Package Leaflet: Information for the Patient

Afrin ND, 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

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

What is Afrin ND

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

How Afrin ND works

Afrin ND is a decongestant for the upper respiratory tract, which 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

Afrin ND is used to treat symptoms of a blocked nose caused by hay fever, common cold, and sinusitis. The medicine is used every 12 hours. If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using Afrin ND

When not to use Afrin ND:

• if you are allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you are being treated with monoamine oxidase inhibitors (MAOIs, medicines used for Parkinson's disease and depression). MAOIs may enhance the increase in blood pressure caused by oxymetazoline;
• if you have glaucoma (increased pressure in the eye) with a narrow angle of the anterior chamber,
• if you have had transsphenoidal surgery (surgical removal of the pituitary gland),
• if you have atrophic rhinitis (dry, atrophic inflammation of the nasal mucosa),
• if you have acute coronary syndrome and left ventricular heart failure ("cardiac asthma").

Warnings and precautions

Tell your doctor if you have:

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

Afrin ND used for a longer period may cause a feeling of a blocked nose. Do not use the medicine for more than 7 days. If after 7 days the symptoms worsen or do not improve, contact your doctor.

Children

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

Afrin ND and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan 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 can 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 should not be used during breastfeeding.

Driving and using machines

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

Afrin ND contains benzalkonium chloride and benzyl alcohol

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

3. How to use Afrin ND

This medicine should always be used exactly as described in the leaflet. If you are unsure, ask your doctor or pharmacist.
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 not more than 4 sprays) in 24 hours.
Do not exceed the recommended dose.
Afrin ND should not be used for more than 7 days, unless advised by a doctor. Before reusing the medicine, a few days' break should be taken.
Method of administration
Shake well before use. Before first use, prepare the spray pump by pressing the pump several times until the first full spray appears. Holding the container upright, insert the tip into each nostril, press the container firmly once or twice, while breathing in through the nose.
After use, clean the spray pump. Using the spray pump by more than one person may contribute to the spread of infection.

Using a higher dose of Afrin ND than recommended

In case of taking a higher dose of the medicine than recommended, contact a doctor or go to the hospital immediately, taking the medicine package with you.

Missing a dose of Afrin ND

Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects:
Uncommon(occurring in 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(occurring in less than 1 in 1,000 people): restlessness, 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 you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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: 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

Store the medicine at a temperature below 25°C. Do not store in the refrigerator or freeze.
Keep the medicine out of the 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 from first opening.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist 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 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, purified water, benzyl alcohol (2.5 mg/ml), microcrystalline cellulose, and sodium carmellose, lemon flavor containing natural and artificial flavors, alcohol, and DL-alpha-tocopherol.

What Afrin ND looks like and contents of the pack

Afrin ND is a white to off-white viscous solution in a 15 ml white, light-protective plastic bottle with a white plastic spray pump.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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, Poland
NASAROX:Portugal
Rhinacept:Greece

Date of last revision of the leaflet: 07.2018