Patient Information Leaflet

Afrin ND Glycerol, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, 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 of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

What Afrin ND Glycerol is and what it is used for
Important information before using Afrin ND Glycerol
How to use Afrin ND Glycerol
Possible side effects
How to store Afrin ND Glycerol
Contents of the pack and other information

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

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

How Afrin ND Glycerol works
Afrin ND Glycerol 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 hours.

When to use Afrin ND Glycerol
Afrin ND Glycerol 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 of treatment, or if you feel worse, consult your doctor.

2. Important information before using Afrin ND Glycerol

When not to use Afrin ND Glycerol:

if the patient is allergic to oxymetazoline hydrochloride or to 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 pressure in the eye) with narrow drainage angle,
in patients after transsphenoidal removal of the pituitary gland (surgical removal of the pituitary gland),
if the patient suffers from inflammation of the skin and nasal vestibular mucosa with formation of crusts (atrophic rhinitis),
if the patient suffers from acute coronary disease and left ventricular heart failure ("cardiac asthma").

Warnings and precautions
Inform your doctor if the patient has:

coronary artery disease,
arterial hypertension (high blood pressure),
hyperthyroidism (overactive thyroid gland),
diabetes,
difficulty in urination caused by benign prostatic hyperplasia (enlarged prostate).

Prolonged use of Afrin ND Glycerol may cause a feeling of nasal congestion. Do not use the medicine for longer than 7 days. If symptoms worsen or no improvement occurs after 7 days, consult your 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future 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 Glycerol 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 Glycerol 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 Glycerol contains benzalkonium chloride and benzyl alcohol
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.

3. How to use Afrin ND Glicerol

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 Glicerol 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 in an upright position, 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.
If you use more Afrin ND Glicerol than you should
If you take more than the recommended dose, seek medical advice immediately or go to a hospital, taking the medicine package with you.
If you forget to use Afrin ND Glicerol
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side游戏副本

5. How to store Afrin ND Glicerol

Store the medicine at a temperature not exceeding 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 more than 30 days after first opening.
Medicines must 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 pack and other information

What Afrin ND Glicerol 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, glycerol, lemon flavour containing natural and artificial flavours, alcohol and DL-alpha-tocopherol.

What Afrin ND Glicerol looks like and contents of the pack
Afrin ND Glicerol 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 Glicerol: Poland
NASAROX: Portugal
Rhinacept: Greece