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Xylodex 1 mg/ml. 10ml.

Product Code: Xylodex 1 mg/ml. 10ml.
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What Xilodex is and what it is used for
Xilodex is a nasal spray. Xilodex contains the active substance xylometazoline hydrochloride, which constricts blood vessels and thus reduces swelling of the nasal mucosa.
Xilodex also contains the active substance dexpanthenol, which is a derivative of the vitamin pantothenic acid. It helps heal wounds and protects the mucous membrane.

Xilodex is used:

To reduce swelling of the nasal mucosa in runny nose and as an adjunctive treatment for wound healing on the skin and mucous membranes, to relieve the symptoms of a runny nose (vasomotor rhinitis) and to treat nasal congestion after nasal surgery.
To reduce swelling of the nasal mucosa in runny nose associated with acute inflammation of the sinuses (rhinosinusitis).
Xilodex is used in adults and children over 6 years of age.

If after 7 days you do not feel better or your condition worsens, You should
seek medical attention.

2. What you need to know before you use Xilodex
Do not use Xilodex
if you are allergic to xylometazoline hydrochloride or dexpanthenol, or to any of the other ingredients of this medicine (listed in section 6),
if you have dry inflammation of the nasal mucosa, including crusting (dry rhinitis),
after surgical removal of the pituitary gland through the nose (traasphenoidal hypophysectomy) or other surgical procedures giving access to the meninges,
in infants and children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Xilodex if

you have been treated with monoamine oxidase inhibitors (MAO inhibitors) or have taken them in the last two weeks, or you have taken other medicines that can cause an increase in blood pressure,
you have increased intraocular pressure, especially in the case of narrow-angle glaucoma,
you have severe cardiovascular disease (e.g. coronary heart disease) or high blood pressure (hypertension),
suffer from heart disease (e.g. long QT syndrome),
you have a tumor of the adrenal gland (phaeochromocytoma),
you have a metabolic disease such as an overactive thyroid gland (hyperthyroidism) or diabetes mellitus,
you have a metabolic disease (porphyria),
you have an enlarged prostate (prostatic hyperplasia).
For chronic colds, it should be used only under medical supervision, as there is a risk of thinning of the nasal mucosa.

If symptoms such as dizziness, insomnia, tremors, non-rhythmic heart activity, increased blood pressure appear, the drug should be discontinued. This applies especially to patients who have experienced such symptoms earlier when taking other similar drugs.

Do not use Xilodex for longer than 7 days, as taking it for a longer period of time can lead to changes in the nasal mucosa that are difficult to treat.

To reduce the risk of spreading infection, the medicine should not be used by more than one person and the tip should be rinsed after use.

Children and adolescents
Long-term use and the use of doses higher than recommended should be avoided, especially in children. Higher doses can only be administered under medical supervision.

The concentration of active substances in Xilodex is intended for adults and children over 6 years of age, and is therefore not suitable for infants and children under 6 years of age. For children between 2 and 6 years of age, there are suitable nasal sprays with a lower dose of the active, decongestant xylometazoline hydrochloride.

Other medicines and Xilodex
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The simultaneous use of Xilodex with mood-enhancing drugs (monoamine oxidase inhibitors or tricyclic antidepressants) and blood pressure-increasing drugs can cause an increase in blood pressure, which is due to the effects on the cardiovascular system of these substances.

Avoid the simultaneous use of Xilodex with drugs such as ephedrine, pseudoephedrine (which are used as components of cold medicines).

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Due to insufficient information on the use of xylometazoline hydrochloride in pregnant women.
Xilodex should not be used during pregnancy.

Breastfeeding
It is not known whether the medicinal substance xylometazoline hydrochloride passes into breast milk; therefore, Xilodex should not be used during breast-feeding.

Fertility
There are no data indicative of the effects of xylometazoline hydrochloride and dexpanthenol on fertility in humans and there are no animal studies.

Driving and using machines
With proper use, this drug does not negatively affect the ability to drive and operate machinery, but if you feel
Be careful not to get spray in the eyes.
3. Clean your nose.
4. Hold the bottle upright, with the thumb under the base and the tip between two fingers.
5. Tilt your head slightly forward and insert the tip into one nostril.
6. Spray while inhaling slightly through the nose. Repeat the same procedure for the other nostril.
7. Immediately after use, dry the tip and put the cap on it.
8. To prevent the possible spread of infection, the spray should only be used by one person.

If you have used more than the required dose of Xilodex
In case of overdose or accidental ingestion, the following effects may occur:

constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, paleness, blue lips (cyanosis), nausea, cramps,
cardiovascular disorders such as heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension),
pulmonary disorders (pulmonary edema, breathing problems), mental disorders.
drowsiness, drop in body temperature, slow heart rate, drop in blood pressure to a shock-like state, respiratory failure and loss of consciousness (coma).
If you suspect an overdose, contact your doctor immediately. Appropriate measures may need to be taken.

If you forget to take Xilodex
Do not take a double dose to make up for a missed dose. Proceed as described in the dosing instructions.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)
allergic reactions (rash, itching, swelling of the skin and mucous membrane).
Rare side effects (may affect up to 1 in 1,000 people)
palpitations, fast heart rate (tachycardia), increase in blood pressure (hypertension).
Very rare side effects (may affect up to 1 in 10,000 people)
anxiety, insomnia, increased fatigue (drowsy, sleepy), headache, hallucinations (mainly in children),
heart rhythm disorders (arrhythmias),
increase in edema of the mucous membrane, due to weakening of the effect of the drug, bleeding from the nose,
convulsions (mostly in children).
Not known (frequency cannot be estimated from the available data)
burning or dryness of the nasal mucosa, sneezing.
5. How to store Xilodex
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton
packaging after "Expired by:". The expiration date corresponds to the last day of the indicated month.
Do not store at a temperature above 25°C.

Shelf life after first opening the bottle: 24 weeks.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Xilodex contains
The active substances are xylometazoline hydrochloride and dexpanthenol.
Each dose of 0.1 ml of the spray solution contains 0.1 mg xylometazoline hydrochloride and 5 mg dexpanthenol. 1 ml of the solution contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol.

Excipients are disodium phosphate dodecahydrate; potassium dihydrogen phosphate; benzalkonium chloride solution; Purified water.
What Xilodex looks like and contents of the pack
Xilodex is a clear, colorless solution.

High-density polyethylene (HDPE) bottle with a capacity of 15 ml and a mechanical dosing pump with a dose volume of 0.1 ml with a polypropylene (PP) nose tip with a low-density polyethylene (LDPE) protective cap in a cardboard box.

The bottle contains 10 ml of solution.

 

 

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