0.5 mg/ml and 1 mg/ml nasal spray, solution
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
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.
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.
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.
– 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
5260 Odense S
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