Afrin 0,5 mg/ml neusspray oplossing met kamille

ATC-Code
R01AA05
Afrin 0,5 mg/ml neusspray oplossing met kamille

Merck Sharp & Dohme Gesellschaft m.b.H.

Stof(fen)
Oxymetazoline
Verdovend
Nee
Farmacologische groep Decongestiva en andere nasale preparaten voor lokaal gebruik

Advertentie

Alles om te weten

Vergunninghouder

Merck Sharp & Dohme Gesellschaft m.b.H.

Waarvoor wordt dit middel gebruikt?

Afrin is used for the symptomatic relief of nasal congestion due to hay fever, common cold and sinusitis. It can be taken every 12 hours. The active substance is oxymetazoline hydrochloride.

Advertentie

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Do not use Afrin

  • if you are allergic (hypersensitive) to active substance(s) oxymetazoline hydrochloride or any of the other ingredients of Afrin
  • if you are taking monoamine oxidase inhibitors (MAO inhibitors, used in the treatment of Parkinson’s disease and depression). MAO inhibitors may increase the hypertensive effects of oxymetazoline
  • if you have narrow angle glaucoma
  • if you have had trans-sphenoidal hypophysectomy
  • if you have inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca)
  • if you have acute coronary disease or cardiac asthma

Do not use Afrin in children under 6 years of age (See Section 3 How to use Afrin)

Take special care with Afrin

Before treatment with Afrin, consult your doctor if you have:

  • coronary artery disease
  • hypertension
  • hyperthyroidism
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland
NL/H/1971/001-004/IB/008 1 August 2013

If used over a longer period Afrin may cause a blocked nose. It is not recommended to use for longer than one week. Contact your doctor if symptoms worsen or do not improve after 7 days.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The hypertensive effects of oxymetazoline may increase when used together with:

  • some types of antidepressants: tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors (MAO inhibitors)

Consult a doctor or pharmacist before using Afrin if you use any of the medicines listed above. (see also 'Do not use Afrin' in Section 2).

Pregnancy and breast-feeding

If you are pregnant ask your doctor or pharmacist for advice before taking any medicines.

Pregnancy

Oxymetazoline has not been associated with adverse pregnancy outcome. Afrin can be used in pregnant women if used as recommended. Caution should be exercised in patients with hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental perfusion.

Breast Feeding

It is not known if oxymetazoline is excreted into breast milk. In view of the lack of data on the use of oxymetazoline during lactation, Afrin should not be used during breast feeding.

Driving and using machines

No effect on ability to drive or use of machines has been observed.

Important information about some of the ingredients of Afrin

Benzalkonium chloride (a preservative) is an irritant and may cause skin reactions.

Propylene glycol may cause skin irritation

Hoe gebruikt u dit middel?

Always use Afrin exactly as directed on this leaflet. You should check with your doctor or pharmacist if you are not sure.

Dosage

Adults and children > 10 years; 1-2 sprays in each nostril, every 12 hours. Children 6-10 years 1 spray in each nostril, every 12 hours.

Not more than a total of 8 sprays for adults ( 4 for children )should be given in any 24 hours. Do not exceed the stated dose

Afrin should not be used for longer than 7 days unless prescribed by your doctor. An interval of several days should elapse before re-administration of the product.

Administration

Shake well before use. Before first use, prime the unit by depressing the pump several times until the first full spray is achieved.

Whilst holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly one or two times whilst breathing in.

After use wipe nozzle clean. Use of this product by more than one person may spread infection.

If you use more Afrin than you should

If you use more Afrin than you should, you should contact your doctor or go to a hospital immediately and take the bottle with you.

NL/H/1971/001-004/IB/008 2 August 2013

If you forget to use Afrin

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Mogelijke bijwerkingen?

Like all medicines, Afrin can cause side effects, although not everybody gets them.

Possible side effects are:

Uncommon (occurring in less than 1 in 100 people), sneezing, dryness or irritation in the nose, mouth or throat.

Rare (occurring in less than 1 in 1000 people), anxiety, fatigue, irritability, disturbed sleep in children, rapid heart beat, palpitations, raised blood pressure, blocked nose, swelling of the nasal lining, headache, nausea, flushing, rash and visual disturbances.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Hoe bewaart u dit middel?

Store below 25 ºC. Do not refrigerate or freeze. Keep out of the reach and sight of children.

Do not use Afrin after the expiry date which is stated on the bottle after Exp: The expiry date refers to the last day of that month. Use within 30 days of first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Anvullende Informatie

What Afrin contains

Afrin

  • The active substance is oxymetazoline HCl 0.5 mg/ml
  • The other ingredients are disodium edetate, disodium phosphate anhydrous, sodium phosphate monobasic monohydrate, povidone K29-32, benzalkonium chloride, PEG 1450, purified water, benzyl alcohol, microcrystalline cellulose and carmellose sodium, lemon flavour.

Afrin Menthol

  • The active substance is oxymetazoline HCl 0.5 mg/ml
- The other ingredients disodium edetate, disodium phosphate anhydrous, sodium phosphate
  monobasic monohydrate, povidone K29-32, benzalkonium chloride, PEG 1450, propylene glycol,
  purified water, benzyl alcohol, microcrystalline cellulose and carmellose sodium, cineole, camphor,
  levomenthol.  

Afrin Glycerol

  • The active substance is oxymetazoline HCl 0.5 mg/ml
  • The other ingredients are disodium edetate, disodium phosphate anhydrous, sodium phosphate monobasic monohydrate, povidone K29-32, benzalkonium chloride, PEG 1450, purified water, benzyl alcohol, microcrystalline cellulose and carmellose sodium , lemon flavour, glycerol.

Afrin Chamomile

  • The active substance is oxymetazoline HCl 0.5 mg/ml
NL/H/1971/001-004/IB/008 3 August 2013
  • The other ingredients are disodium edetate, disodium phosphate anhydrous, sodium phosphate monobasic monohydrate, povidone K29-32, benzalkonium chloride, PEG 1450, purified water, benzyl alcohol, microcrystalline cellulose and carmellose sodium ,glycerol, chamomile.

What Afrin looks like and contents of the pack

Afrin is a white to off white gel like solution in a white light-resistant 15 ml high density plastic bottle with a white plastic pump.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder: [To be completed nationally]

Manufacturer:

Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg, Antwerpen Belgium B-2220

This medicinal product is authorised in the Member States of the EEA 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

This leaflet was last approved in 11 november 2013

NL/H/1971/001-004/IB/008 4 August 2013

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