AFRIN ND

Patient Information Leaflet

Afrin ND, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible side effects 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 is and what it is 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 Afrin ND is and what it is used for

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

How does Afrin ND work?
Afrin ND is a decongestant that relieves nasal congestion by constricting blood vessels in the nasal passages. It starts working within minutes, and the effect lasts for several hours.

When should Afrin ND be used?
Afrin ND 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

When not to use Afrin ND:

• 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 enhance the blood pressure increasing effect of oxymetazoline;
• if the patient has glaucoma (increased pressure in the eye) with narrow drainage angle,
• in patients after transsphenoidal hypophysectomy (surgical removal of the pituitary gland),
• if the patient suffers from nasal vestibulitis with crust formation (dry atrophic rhinitis),
• if the patient has 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 (overactive thyroid gland),
• diabetes,
• difficulty in urination due to benign prostatic hyperplasia (enlarged prostate).

Prolonged use of Afrin ND may cause a feeling of nasal congestion. The medicine should not be used for longer than 7 days. If symptoms worsen or no improvement is seen after 7 days, consult a 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 the patient is currently 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 (MAO inhibitors).

Pregnancy and breastfeeding
Pregnancy
No adverse effects of oxymetazoline on pregnancy have been observed. Afrin ND may be used in pregnant women 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 human milk. Due to lack of data on the use of oxymetazoline during lactation, Afrin ND should not be used during breastfeeding.
Driving and operating machinery
No effects of the medicine on the ability to drive or operate machinery have been observed.
Afrin ND contains benzalkonium chloride and benzyl alcohol
Benzalkonium chloride (a preservative) may cause irritation or swelling inside the nose, especially when used for prolonged periods.
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 in doubt, consult a 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 should not be used for longer than 7 days unless otherwise advised by a doctor. Before reusing the medicine, a break of several days should be taken.
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 firmly once or twice on the container, 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 more than the recommended dose of Afrin ND
If more medicine has been used than recommended, seek immediate medical advice from a doctor or go to a hospital, taking the medicine packaging with you.
Missed dose of Afrin ND
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Possible adverse effects:
Uncommon (occur in less than 1 in 100 people): sneezing, dryness or irritation of the mucous membranes of the nose, mouth or throat, and sensation of blocked nose.
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 this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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]. By reporting adverse effects, more information on the safety of the medicine can be collected.

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 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 must not be disposed of down the drain or in household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package 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, monosodium 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 flavour containing natural and artificial flavours, alcohol and DL-alpha-tocopherol.

What Afrin ND looks like and contents of the pack
Afrin ND 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 following names in the Member States of the European Economic Area:
AFRIN: Czech Republic, Estonia, Latvia, Lithuania, Netherlands, Slovakia, Slovenia, Spain, Romania
AFRIN Comfort: Hungary
AFRIN ND: Bulgaria, Poland
NASAROX: Portugal
Rhinacept: Greece