XYLODEX nasal spray 0.5mg + 50mg/ml 10ml
Leaflet: information for the user
Xilodex 0.5 mg/ml + 50 mg/ml, nasal spray, solution
Xylometazoline Hydrochloride + Dexpanthenol
Xylodex 0.5 mg/ml + 50 mg/ml nasal spray, solution
Xylometazoline hydrochloride + Dexpanthenol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 7 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Xilodex is and what it is used for
2. What you need to know before you use Xilodex
3. How to use Xilodex
4. Possible side effects
5. How to store Xilodex
6. Contents of the pack and other information
1. 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 case of a runny nose and as an adjunct treatment for the healing of wounds on the skin and mucous membranes, to relieve the symptoms of a runny nose (vasomotor rhinitis) and to treat a blocked nose after nasal surgery.
- To reduce swelling of the nasal mucosa in cases of runny nose associated with acute inflammation of the sinuses (rhinosinusitis).
Xilodex is indicated in children aged 2 to 6 years.
If you do not feel better after 7 days 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 (transsphenoidal hypophysectomy) or other surgical procedures providing access to the meninges,
- in babies and children under 2 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 case of narrow-angle glaucoma,
- you have severe cardiovascular disease (e.g. coronary heart disease) or high blood pressure (hypertension),
- you suffer from heart disease (e.g. long QT syndrome),
- you have a tumor of the adrenal gland (pheochromocytoma),
- 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 only be used under medical supervision, as there is a risk of thinning of the nasal mucosa.
If symptoms such as dizziness, insomnia, tremor, irregular heartbeat, increased blood pressure occur, the drug should be discontinued. This is especially true for patients who have experienced such symptoms previously while taking other similar drugs.
Do not use Xilodex for longer than 7 days, as taking it for a longer period of time may cause 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 use of doses higher than recommended should be avoided, especially in children. Higher doses should only be administered under medical supervision.
The concentration of active substances in Xilodex is intended for children aged 2 to 6 years, and is therefore not suitable for babies and children under 2 years.
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-elevating drugs (monoamine oxidase inhibitors or tricyclic antidepressants) and blood pressure-increasing drugs may 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, breastfeeding 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 drug substance xylometazoline hydrochloride is excreted in breast milk; therefore Xilodex should not be used during breastfeeding.
Fertility
There are no conclusive data on the effects of xylometazoline hydrochloride and dexpanthenol on fertility in humans, and there are no animal studies.
Driving and using machines
When used correctly, this medicine does not negatively affect the ability to drive or use machines, but if you feel dizzy or drowsy, you should not drive or use machines.
Xilodex contains benzalkonium chloride
This medicine contains 0.2 mg benzalkonium chloride in each millilitre. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
If you experience any discomfort while using Xilodex, talk to your doctor or pharmacist.
3. How to use Xilodex
Always use this medicine exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist.
The recommended dose is
For children 2 to 6 years of age, one spray of Xilodex in each nostril up to 3 times daily as needed, unless otherwise prescribed by a doctor.
The dose depends on the individual sensitivity of the patient and the clinical response. Do not administer more than 3 times in each nostril daily.
Duration of treatment
The medicine should not be used for more than 7 days unless the doctor has specifically prescribed otherwise.
Before using the medicine again, you should have a break of several days.
You should always consult a doctor regarding the duration of treatment with this medicine in children.
Continuous use of this medication may cause chronic swelling and eventual loss of the nasal mucosa.
Method of administration
Xilodex is a nasal spray solution and is used in the nose.
1. Remove the protective cap from the nozzle.
2. Before initial use, press the dispenser 3-5 times until a fine spray appears.
This step does not need to be repeated for subsequent use.
Once activated, the pump will normally remain primed for the duration of the usual treatment period. If the pump was not initially fully primed or the spray has not been used for several days, the pump must be re-primed by pressing twice.
Be careful not to get spray in your eyes.
3. Clean your nose.
4. Hold the bottle upright with your thumb under the base and the nozzle between two fingers.
5. Tilt your head slightly forward and place the nozzle in one nostril.
6. Spray while inhaling gently through your nose. Repeat the same procedure for the other nostril.
7. Immediately after use, dry the nozzle and place the cap on it.
8. To prevent possible spread of infection, the spray should only be used by one person.
If you use more Xilodex than you should
In case of overdose or accidental ingestion, the following effects may occur:
- constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, blue lips (cyanosis), nausea, cramps,
- cardiovascular disorders such as heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension),
- lung disorders (pulmonary edema, breathing problems), mental disorders,
- drowsiness, decreased body temperature, slowed heart rate, decreased 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 forgotten dose. Continue as described in the dosing instructions.
If you have any further questions on 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 membranes).
Rare side effects (may affect up to 1 in 1,000 people)
- palpitations, rapid heart rate (tachycardia), increased blood pressure (hypertension).
Very rare side effects (may affect up to 1 in 10,000 people)
- anxiety, insomnia, increased fatigue (drowsiness, drowsiness), headache, hallucinations (mainly in children),
- heart rhythm disorders (arrhythmias),
- increased swelling of the mucous membrane due to weakening of the effect of the drug, nosebleeds,
- seizures (mainly in children).
Not known (frequency cannot be estimated from the available data)
- burning or dryness of the nasal mucosa, sneezing.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
Tel.: +35 928903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
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 after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25ºC.
Shelf life after first opening the bottle: 12 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Xilodex contains
- The active substances are xylometazoline hydrochloride and dexpanthenol.
Each dose of 0.1 ml of spray solution contains 0.05 mg xylometazoline hydrochloride and 5 mg dexpanthenol.
1 ml of the solution contains 0.5 mg xylometazoline hydrochloride and 50 mg dexpanthenol.
- The 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) nasal tip with a low-density polyethylene (LDPE) protective cap in a cardboard box.
The bottle contains 10 ml of solution.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
street Pelplińska 19, 83-200 Starogard Gdański, Poland
Manufacturer
MEDANA PHARMA SA
street W. Łokietka 10, 98-200 Sieradz, Poland
This medicinal product is authorised in the Member States of the EEA under the following names:
Latvia: Galathenol 0.5 mg/50 mg/ml, deguna aerosols, solutions
Lithuania: Galanas 0.5mg/50mg/ml nosies purškalas (tirpalas)
Hungary: Novorin Plus 0.5 mg/ml+50 mg/ml oldatos orrspray
Date the leaflet was last revised