Sudafed Xilosprai Dex dla dzieci

Package Leaflet: Information for the Patient

Sudafed Xylospray DEX for Children, (0.5 mg + 50 mg)/ml, Nasal Spray, Solution
Xylometazoline Hydrochloride + Dexpanthenol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in the leaflet, tell the doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet

• 1. What is Sudafed Xylospray DEX for Children and what is it used for
• 2. Important information before using Sudafed Xylospray DEX for Children
• 3. How to use Sudafed Xylospray DEX for Children
• 4. Possible side effects
• 5. How to store Sudafed Xylospray DEX for Children
• 6. Contents of the pack and other information

1. What is Sudafed Xylospray DEX for Children and what is it used for

Sudafed Xylospray DEX for Children nasal spray contains xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride quickly constricts the blood vessels of the nasal mucosa and reduces its swelling. Dexpanthenol is a derivative of vitamin, pantothenic acid, which accelerates wound healing and protects the nasal mucosa.
Sudafed Xylospray DEX for Children is indicated:

• to reduce swelling of the nasal mucosa in rhinitis and to support the treatment of nasal mucosa injuries,
• to alleviate symptoms of non-allergic rhinitis (vasomotor rhinitis),
• to treat nasal congestion after nasal surgery, the use of Sudafed Xylospray DEX for Children for this indication is possible only on the advice of a doctor.

Sudafed Xylospray DEX for Children is intended for use in children from 2 to 6 years old.

2. Important information before using Sudafed Xylospray DEX for Children

When not to use Sudafed Xylospray DEX for Children:

• in children after surgical removal of the pituitary gland or other operations involving exposure of the meninges (membranes surrounding the brain). Sudafed Xylospray DEX for Children should not be used in children under 2 years of age.

Warnings and precautions

Before starting to use Sudafed Xylospray DEX for Children, discuss it with a doctor or pharmacist:

If any of the above situations apply to the child, before using the medicine, consult a doctor or pharmacist.

Long-term and improper use

Due to the risk of atrophy of the nasal mucosa, the medicine can be used in the period of chronic rhinitis only under the supervision of a doctor.
Improper use or administration of an excessive amount of the medicine may cause systemic side effects, especially in children (see section Possible side effects).
Long-term use or use of higher doses than recommended may lead to chronic swelling and potential atrophy (damage) of the nasal mucosa.
Direct contact of the medicine with the eyes should be avoided.

Children

Long-term use or use of higher doses than recommended should be avoided, especially in children.
Sudafed Xylospray DEX for Children is recommended for use only in children from 2 to 6 years old. For children over 6 years old, a nasal spray containing higher doses of active substances is available.
The use of this medicine in children should be supervised.

Sudafed Xylospray DEX for Children and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as about medicines the patient plans to take.
Concomitant use of Sudafed Xylospray DEX for Children with certain medicines for the treatment of depression (monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants) and medicines that increase blood pressure may cause an increase in blood pressure due to the effect of the active substances on the cardiovascular system.
Concomitant use of Sudafed Xylospray DEX for Children with other medicines containing sympathomimetics (cough and cold medicines used to treat nasal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may lead to side effects from the cardiovascular and central nervous systems.
Medicines that lower blood pressure (e.g. methyldopa) should not be used with xylometazoline, which may cause an increase in blood pressure.
Consult a doctor before using Sudafed Xylospray DEX for Children if the child is taking any of the above medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Due to the lack of data on the safety of using the medicine in pregnant women, this medicine should not be used during pregnancy.
It is not known whether xylometazoline hydrochloride passes into breast milk, therefore this medicine should not be used during breastfeeding.

Driving and using machines

If the medicine is used as described in this leaflet, its use should not affect the ability to drive and use machines.

3. How to use Sudafed Xylospray DEX for Children

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose of Sudafed Xylospray DEX for Children is one spray into each nostril up to three times a day, as needed, unless the doctor recommends otherwise. Do not use for more than 7 days. Re-use is possible only after a few days' break.
If after 3 days there is no improvement or the child feels worse, consult a doctor.

Method of administration

Sudafed Xylospray DEX for Children is intended for intranasal use.
Remove the protective cap from the tip of the dispenser.
Before first use, press the pump 5 times until a uniform mist appears. If the spray has not been used for a longer period, press the pump 2 times before use.

Place the tip of the dispenser in the nostril in a position close to vertical, and then press the pump once. During dosing, gently inhale through the nose. If necessary, repeat the procedure in the other nostril. After each use, wipe the tip of the dispenser with a paper tissue and replace the protective cap.

For hygiene reasons, to avoid infections, the medicine should be used by only one person.

Use in children

The recommended dose of Sudafed Xylospray DEX for Children is one spray into each nostril up to three times a day, as needed. To determine the duration of use in children, consult a doctor.

Using a higher dose of Sudafed Xylospray DEX for Children than recommended

In case of using a higher dose of the medicine than recommended or accidental ingestion of large amounts of the medicine, the following side effects may occur:

• pupil constriction,
• pupil dilation,
• fever,
• sweating,
• pallor,
• cyanosis (blue discoloration of the lips),
• nausea,
• seizures,
• cardiovascular disorders (increased heart rate, decreased heart rate, arrhythmias, heart failure, cardiac arrest, hypertension),
• respiratory disorders (pulmonary edema, respiratory disorders),
• psychiatric disorders,
• drowsiness, decreased body temperature, slowed heart rate, and decreased blood pressure, respiratory arrest, and coma.

If any of these symptoms occur, consult a doctor immediately.

Missing a dose of Sudafed Xylospray DEX for Children

Do not use a double dose to make up for a missed dose. Continue using as described in the leaflet.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people):

• hypersensitivity reactions, such as skin and mucous membrane edema, rash, itching.

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

• palpitations (feeling of heartbeat), tachycardia (accelerated heart rate), hypertension (high blood pressure).

Very rare (may affect up to 1 in 10,000 people):

• restlessness, difficulty falling asleep, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children),
• arrhythmias,
• nasal mucosa swelling (after stopping treatment), nosebleeds,
• seizures (mainly in children).

Frequency not known (frequency cannot be estimated from the available data):

• burning and dryness of the nasal mucosa, sneezing.

Reporting side effects

If side effects occur, including those not listed in the leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sudafed Xylospray DEX for Children

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Shelf life after first opening the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sudafed Xylospray DEX for Children contains

• The active substances of the medicine are xylometazoline hydrochloride and dexpanthenol. Each ml of solution contains 0.5 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol. One spray of the nasal spray (0.1 ml of solution) contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• The other ingredients are: potassium dihydrogen phosphate, disodium phosphate dodecahydrate, water for injections.

What Sudafed Xylospray DEX for Children looks like and contents of the pack

Clear, colorless to slightly yellowish solution, free from particles.
The packaging of Sudafed Xylospray DEX for Children is a 10 ml HDPE bottle with a dosing pump in a cardboard box. 10 ml of solution is sufficient for 80 doses.

Marketing authorization holder and manufacturer

Marketing authorization holder:

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer:

Famar Health Care Services Madrid S.A.U.
Avda Leganés, 62, Alcorcón
28923 Madrid
Spain
Ursapharm Arzneimittel GmbH
Industriestraße 35 66129
Saarbrücken
Germany
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Latvia
Olydex
Poland
Sudafed Xylospray DEX for Children
Slovakia
Olynth Plus
Lithuania
Olydex
Germany
Olynth Plus 0.05% / 5%
Estonia
Sudafed Xylospray DEX
Czech Republic
Olynth Plus
To obtain more detailed information, please contact:
email: [email protected]

Date of last revision of the leaflet: