Zymelin – Xylometazoline hydrochloride uses, dose and side effects

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Contents hide
1 WHAT ZYMELIN IS AND WHAT IT IS USED FOR
2 BEFORE YOU USE ZYMELIN
3 Do not use Zymelin
4 Be especially careful with Zymelin
5 Use of other medicines
6 Use of Zymelin with food and drink
7 Pregnancy and breastfeeding
8 Driving ability and use of machinery
9 HOW TO USE ZYMELIN
10 If you have taken too much Zymelin
11 POSSIBLE SIDE EFFECTS
12 STORAGE OF ZYMELIN
13 OTHER INFORMATION
14 Contents declaration
15 Appearance and package sizes of the medicine
16 Marketing Authorisation Holder
17 Manufacturer

0.5 mg/ml and 1 mg/ml nasal spray, solution
xylometazoline hydrochloride

WHAT ZYMELIN IS AND WHAT IT IS USED FOR

Zymelin is used for the short-term treatment of nasal congestion during colds.

Zymelin contains xylometazoline hydrochloride, which has a constricting effect on the blood vessels of the nose and thus makes it easier to breathe through the nose.

BEFORE YOU USE ZYMELIN

Do not use Zymelin

– if you are allergic to xylometazoline hydrochloride or any other ingredient in this medicine (listed in section 6)

– if you have had a pituitary gland removed via the nose

– after operations through the nose or mouth, where the meninges may have been exposed and/or damaged

– if you have glaucoma (increased pressure in the eye).

Be especially careful with Zymelin

Talk to your doctor, pharmacist or nurse before using Zymelin:

– if you are sensitive to adrenergic substances (e.g. adrenaline, ephedrine ) which can cause symptoms such as insomnia, dizziness, tremors, heart rhythm disturbances, or high blood pressure

– if you have cardiovascular disease (eg long QT syndrome)  or high blood pressure

– if you have diabetes

– if you have increased release of thyroid hormone ( hyperthyroidism )

– if you have difficulty urinating due to an enlarged prostate

– if you take medication against depression (tricyclic or tetracyclic antidepressants or so-called MAO inhibitors )

– if you have pheochromocytoma, a condition that causes increased production of adrenaline and/or norepinephrine.

Zymelin 0.5 mg/ml and 1 mg/ml nasal spray should not be used in children under 2 years of age due to the risk of overdose with a depressant effect on the central nervous system as a result.

The duration of treatment (0.5 mg/ml: maximum 5 days, 1 mg/ml: maximum 10 days) should not be exceeded. Prolonged or frequent use can lead to dependence and recurrent nasal congestion with chronic inflammation, hypersensitivity, and changes in the nasal mucosa.

Use of other medicines

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

If Zymelin is used at the same time as tri- or 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) may increase.

Use of Zymelin with food and drink

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

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

Zymelin can be used with caution during breastfeeding.

Driving ability and use of machinery

Zymelin does not affect the ability to drive or use machines.

HOW TO USE ZYMELIN

Always use Zymelin as described in this leaflet, unless otherwise instructed by your doctor. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Nasal spray 1 mg/ml, adults and children over 10 years:

1 spray dose in each nostril no more than 3 times daily.

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

Zymelin 1 mg/ml should not be given to children under 10 without a doctor’s prescription.

Nasal spray 0.5 mg/ml, children 2-10 years:

1 spray dose in each nostril no more than 3 times daily.

The treatment should continue until the symptoms have disappeared, but for a maximum of 5 days.

Zymelin 0.5 mg/ml should not be given to children under 2 years of age without a doctor’s prescription.

Use Zymelin like this:

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 simultaneously 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

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

Like all medicines, Zymelin can cause side effects, 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 (affects more than 1 in 100 users): Burning in the nose and throat, dry and irritated nasal mucosa, sneezing, temporary burning sensation in the nose, runny nose.

Uncommon (may affect up to 1 in 100 people): Nasal congestion, especially if the nasal spray is used often or for a long time. Nosebleed.

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

Very rare (affects less than 1 in 10,000 users): Severe allergic reactions, fast or irregular pulse, restlessness, insomnia, fatigue, headache, temporary visual disturbances.

STORAGE OF ZYMELIN

Store out of sight and reach of children.

Use before the expiry date on the packaging. 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 medications that are no longer used. These measures will help to protect the environment.

OTHER INFORMATION

Contents declaration

– The active substance is xylometazoline hydrochloride.

0.5 mg/ml: 1 ml contains 0.5 mg of xylometazoline hydrochloride and 1 spray dose contains 35 micrograms of xylometazoline hydrochloride.

1 mg/ml: 1 ml contains 1 mg of xylometazoline hydrochloride and 1 spray dose contains 140 micrograms of xylometazoline hydrochloride.

– Other ingredients are disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, and purified water.

Zymelin does not contain preservatives.

Appearance and package sizes of the medicine

Zymelin is a clear, colorless solution.

Zymelin is available in the following pack sizes:

– 0.5 mg/ml: 10 ml nasal spray with pump.

– 1 mg/ml: 10 ml nasal spray with pump.

Possibly not all pack sizes will be marketed. T

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

Manufacturer

Takeda GmbH

Singen, Germany

or

Curia AS

Elverum, Norway

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