What is Xylo-Mepha and when is it used?

Xylo-Mepha is used against Colds of various kinds used. Xylo-Mepha is intended for use in the nose, where it constricts the blood vessels and thereby reduces swelling of the mucous membrane in the nose and in the adjacent area of ​​the pharynx.

This allows you to breathe more freely through your nose when you have a cold. The effect sets in within minutes and lasts for several hours.

When should Xylo-Mepha not be used?

After transnasal surgery (surgical interventions in the nose area where the meninges were exposed), Xylo-Mepha, like others, may decongestants, are not used.

Xylo-Mepha must not be used on:

• very dry or chronically inflamed nasal mucosa (rhinitis sicca or rhinitis atrophicans),
• narrow-angle glaucoma (glaucoma, increased intraocular pressure),
• known hypersensitivity to xylometazoline or an excipient .

When is caution required when using Xylo-Mepha?

When using Xylo-Mepha, sleep and vision disorders can occur or dizziness as signs of increased sensitivity.

Please contact your doctor

• if you find these symptoms very annoying,
• if your cold persists or gets worse, or
• if you have additional symptoms.

In the following cases, Xylo-Mepha should be used with caution and only after consultation with the doctor, pharmacist or druggist:

• High blood pressure, cardiovascular diseases,
• Hyperthyroidism,
• Sugar disease (diabetes mellitus),
• Enlarged prostate,
• Pheochromocytoma (a tumor of the adrenal gland)

If you are taking MAO inhibitors (medicines for depression), or have taken them within the last 14 days, you should not use Xylo-Mepha.

If you are taking certain mood-enhancing medicines (tri- or tetracyclic antidepressants) or anti-Parkinson medicines (levodopa), you should also not use this medicine.

Xylo-Mepha must not be used for longer than 1 week, since prolonged use can trigger medication-related swelling of the nasal mucosa (rhinitis medicamentosa or rhinitis atrophicans), the symptoms of which are very similar to a cold.

Xylo-Mepha 0.05% should not be used in children under the age of 1 year. For children between 1 and 2 years of age, use only as prescribed by a doctor. Use in children from 2 to 11 years under adult supervision.

Xylo-Mepha nasal spray 0.1% must not be used in children under 6 years of age.

Xylo-Mepha should not get in the mouth or eyes.

Tell your doctor, pharmacist or druggist if you suffer from heart disease (e.g. long QT syndrome). In patients suffering from long QT syndrome, severe cardiac arrhythmia can occur when using Xylo-Mepha.

Tell your doctor, pharmacist or druggist if you

• suffer from other illnesses,
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally!

Can Xylo-Mepha be used during pregnancy or breastfeeding?

Xylo-Mepha should not be used during pregnancy. Xylo-Mepha should only be used during breast-feeding on medical advice.

Ask your doctor, pharmacist or druggist before using any medicines.

How do you use Xylo-Mepha?

Unless otherwise prescribed by the doctor, the following dosage recommendations apply: For children from 2 to 11 years of age under adult supervision use.

Infants from 2 to 6 years

Nasal spray 0.05%: 1 spray with the nasal spray 0.05% in each nostril, whereby 3 applications per day may not be exceeded.

Adults and children from 6 years

Nasal spray 0.1%: 1 spray with the nasal spray 0.1% in each nostril, whereby 4 applications per day are usually sufficient.

Only the 0.05% nasal spray should be used for children under the age of 6.

Using the nasal spray

Nasal spray (without propellant): Remove the protective cap. Before using for the first time, pump several times until an even spray is produced. Inhale gently through your nose while spraying. Insert the nozzle into your nostril and press the nasal spray nozzle firmly once. For further applications, the nasal spray is ready to use without prior pumping. Put the protective cap back on after use.

Xylo-Mepha should not be used for longer than 1 week.

If you use more Xylo-Mepha than you should, you should inform your doctor immediately. Poisoning can occur from significant overdose or from accidental ingestion of the drug.

Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Xylo-Mepha have?

Stop using Xylo-Mepha and seek medical help straight away if you or your child have any of the following symptoms is detected; it could be an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue and/or throat
• Intense itching with a red rash and/or bumps on the skin
• Irregular heartbeat

Common side effects (affects 1 to 10 users in 100):

Dryness and irritation of the Nasal mucosa, nausea, headache and local burning sensation.

Uncommon side effects (affects 1 to 10 users in 1,000):

nosebleeds.

Very rare side effects (affects 1 in 10,000 users):

Allergic reactions (rash, itching), temporary blurred vision, irregular or accelerated heartbeat, swelling caused by medication the nasal mucosa (rhinitis medicamentosa).

If a small child accidentally ingests a large amount of the spray, medical supervision is indicated after consultation with a doctor or a toxicological information centre.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

Shelf life

The medicinal product may only be used up to the date marked on the pack with « EXP» designated date can be used.

Use by after opening

Once opened, do not use for more than one year.

Storage Instructions

Store in the original packaging and at room temperature (15-25°C). Keep out of reach of CHILDREN.

Further information

Your doctor, pharmacist or pharmacist can provide you with further information (in particular for Xylo-Mepha 0.05% nasal spray for children under the age of 6) or your Druggist or your druggist. These people have the detailed information for specialists.

What does Xylo-Mepha contain?

Active ingredients

Xylo-Mepha 0.1%, nasal spray contains 1mg/ ml xylometazoline hydrochloride.

1 spray corresponds to 0.09 mg xylometazoline hydrochloride.

Xylo-Mepha 0.05%, nasal spray contains 0.5 mg/ml xylometazoline hydrochloride.

1 spray corresponds to 0.045 mg xylometazoline hydrochloride.

Excipients

Citric acid monohydrate, sodium citrate dihydrate, glycerol 85%, water for injections.

Approval number

57259 (Swissmedic).

Where can you get Xylo-Mepha? What packs are available?

In pharmacies and drugstores, without a doctor's prescription:

Xylo-Mepha Nasal Spray 0.05%: packs of 10 ml.

Xylo-Mepha Nasal Spray 0.1%: packs of 10 ml.

Authorization holder

Mepha Pharma AG, Basel.

This package leaflet was last checked by the medicines authority (Swissmedic) in March 2021.

Internal version number: 8.1