Zymelin Menthol – Xylometazoline hydrochloride uses, dose and side effects

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1 mg/ml nasal spray, solution
xylometazoline hydrochloride

What is Zymelin menthol and what is it used for

Zymelin Menthol nasal spray is used for the short-term treatment of nasal congestion during colds. Zymelin Menthol can also be prescribed by doctors as an aid in examinations of the nasal cavity.

Zymelin Menthol contains xylometazoline which has a decongestant effect on the nose and thus facilitates breathing through the nose.

Xylometazoline contained in Zymelin Menthol may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

What you need to know before using Zymelin Menthol

Do not use Zymelin Menthol

  • if you are allergic (hypersensitive) to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • if you had a pituitary gland removed through the nose
  • after operations through the nose or mouth, where the meninges may have been damaged
  • if you have glaucoma (increased pressure in the eye)

Warnings and precautions

Talk to your doctor or pharmacist before using Zymelin Menthol:

  • if you are sensitive to adrenergic substances (e.g. adrenaline, ephedrine ) which can cause symptoms such as insomnia, dizziness, tremors, irregular heart rhythm, or high blood pressure
  • if you have any cardiovascular disease (eg long QT syndrome) or high blood pressure
  • if you have diabetes
  • if you have increased release of thyroid hormone ( hyperthyroidism )

The treatment period should not exceed 10 days. Prolonged or frequent use can lead to dependence and recurrent nasal congestion with chronic inflammation and hypersensitivity as well as changes in the nasal mucosa.

Other medicines and Zymelin Menthol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.

If Zymelin Mental is used at the same time as tri- and tetracyclic antidepressants (e.g. amitriptyline, nortriptyline, imipramine, clomipramine, trimipramine) or MAO inhibitors (e.g. isocarboxazid, moclobemide), the risk of systemic side effects (nausea, vomiting, headache, palpitations) may increase.

Use of Zymelin Menthol with food and drink

Zymelin Menthol can be used regardless of the intake of food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Zymelin Menthol if you are pregnant. Pregnant women are advised to consult a doctor before use.

Zymelin Menthol can be used with caution during breastfeeding.

Driving ability and use of machinery

Zymelin Menthol does not affect the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Zymelin Menthol contains

Zymelin Menthol contains castor oil which can cause skin reactions.

How to use Zymelin Menthol

Always use this medicine exactly as described in this leaflet or as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults and children over 12 years of age:

1 spray dose in each nostril 2-3 times daily.

The treatment should continue until the symptoms have disappeared, but for a maximum of 10 days.

Zymelin Menthol should not be given to children under 12 years of age.

Use Zymelin Menthol as follows:

Always blow your nose before using the nasal spray.

Remove the protective cap.

Before first use: Pump the spray several times until an even shower is obtained.

Hold the bottle upright.

Bend your head slightly forward.

Hold one nostril and insert the tip of the spray into the other. Make a quick push on the pump and at the same time breathe in through your nose.

Repeat the same procedure in the other nostril.

The effect comes within 5-10 minutes and lasts up to 6-8 hours.

If you have taken too much Zymelin Menthol

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

The symptoms of overdose (especially in children) are increased or irregular pulse increased blood pressure, and in some cases unconsciousness.

If you have further questions about this medicine, contact your doctor or pharmacist.

Possible side effects

This medicine can cause side effects like all medicines, although not everybody gets them.

If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.

Common (may affect up to 1 in 10 users): Temporary burning sensation in the nose, dry and irritated nasal mucosa, sneezing.

Long-term or frequent use of xylometazoline can cause dependence and recurrent nasal congestion with chronic inflammation of the nasal mucosa.

Uncommon (may affect up to 1 in 100 people): Nosebleeds.  

Rare (may affect up to 1 in 1,000 users): Nausea, vomiting.

Very rare (may affect up to 1 in 10,000 users): Severe allergic reaction, headache, temporary visual disturbances, fast or irregular heartbeat, difficulty sleeping, restlessness, and tiredness/exhaustion.

Zymelin Menthol can cause skin reactions depending on the reaction to the excipient castor oil.

How to store Zymelin Menthol

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the label. The expiration date is the last day of the specified month.

Store at a maximum of 30 o C.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is xylometazoline hydrochloride1 ml contains 1 mg xylometazoline hydrochloride1 spray dose contains 140 micrograms of xylometazoline hydrochloride
  • Other ingredients are disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, sorbitol, castor oil (polyoxyl hydrogenated), levomenthol, eucalyptol, water (purified)

Zymelin Menthol does not contain preservatives.

Appearance and package sizes of the medicine

Zymelin Menthol is a clear solution.

Zymelin Menthol is available in packs of 10 ml nasal spray with a pump.

Marketing Authorisation Holder

Orifarm Healthcare A/S

Energizer 15

5260 Odense S Denmark

info@orifarm.com

Local Representative

Orifarm Healthcare

Box 56048

102 17 Stockholm

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