Afrin Nd Glicerol

Leaflet attached to the packaging: patient information

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

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

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

What is Afrin ND Glycerol

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

How Afrin ND Glycerol works

Afrin ND Glycerol 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 Glycerol

Afrin ND Glycerol 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 there is no improvement after 7 days or the patient feels worse, they should consult a doctor.

2. Important information before using Afrin ND Glycerol

When not to use Afrin ND Glycerol:

• 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 for Parkinson's disease and depression). MAOIs may enhance the blood pressure-increasing effect of oxymetazoline;
• if the patient has glaucoma (increased eye pressure) with a narrow angle of filtration,
• in patients who have undergone transsphenoidal removal of the pituitary gland (surgical removal of the pituitary gland),
• if the patient has atrophic rhinitis (dry atrophy of the nasal mucosa),
• if the patient has acute coronary artery disease and left ventricular heart failure ("cardiac asthma").

Warnings and precautions

The patient should inform their doctor if they have:

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

Afrin ND Glycerol 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, the patient should consult a doctor.

Children

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

Afrin ND Glycerol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 Glycerol 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 Glycerol 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 Glycerol 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 Glycerol

This medicine should always be used exactly as described in the leaflet. If you have any doubts, consult a doctor or pharmacist.
Recommended dose
Adults and children over 10 years: 1-2 sprays into each nostril, every 12 hours.
Children between 6 and 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 Glycerol 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 Glycerol than recommended

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

Missing a dose of Afrin ND Glycerol

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a 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 1000 people): restlessness, fatigue, irritability, sleep disturbances in children, rapid heartbeat, palpitations, increased blood pressure, swelling of the nasal mucosa, headache, nausea, redness, rash, and vision disturbances.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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 Glycerol

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 of first opening.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Afrin ND Glycerol 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, glycerol, lemon flavor containing natural and artificial flavors, alcohol, and DL-alpha-tocopherol.

What Afrin ND Glycerol looks like and what the pack contains

Afrin ND Glycerol is a viscous solution, white to off-white, 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
Afrin ND Glycerol: Poland
Nasarox: Portugal
Rhinacept: Greece

Date of last revision of the leaflet: 07.2018