Sudafed spray extra kids

Patient Information Leaflet

Sudafed Spray Extra Kids, (0.5 mg + 50 mg)/ml, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of Contents

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

1. What Sudafed Spray Extra Kids is and what it is used for

Sudafed Spray Extra Kids nasal spray contains xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride rapidly constricts blood vessels in the nasal mucosa and reduces swelling. Dexpanthenol is a derivative of vitamin B5 (pantothenic acid) that accelerates wound healing and protects the nasal mucosa.

Sudafed Spray Extra Kids is indicated:

• To reduce swelling of the nasal mucosa in nasal inflammation and to support treatment of nasal mucosa damage;
• To relieve symptoms of non-allergic rhinitis (vasomotor rhinitis);
• For treatment of nasal passage obstruction following nasal surgery; use for this indication is permitted only on a doctor's recommendation.

Sudafed Spray Extra Kids is indicated for use in children aged 2 to 6 years.

2. Information before using Sudafed Spray Extra Kids

When not to use Sudafed Spray Extra Kids:

• if the child is allergic to xylometazoline hydrochloride or dexpanthenol, or to any of the other ingredients of this medicine (listed in section 6),
• if the child has dry rhinitis with crust formation ( rhinitis sicca ),
• in children after surgical removal of the pituitary gland or other surgeries involving exposure of the meninges (the membrane surrounding the brain). Sudafed Spray Extra Kids should not be used in children under 2 years of age.

Warnings and precautions
Before starting to use Sudafed Spray Extra Kids, discuss this with a doctor or pharmacist:

• if the child is taking monoamine oxidase inhibitors (MAOIs) or other medicines that may increase blood pressure,
• if the child has increased intraocular pressure (glaucoma), especially narrow-angle glaucoma,
• if the child has a severe cardiovascular disorder (e.g. long QT syndrome, ischemic heart disease, hypertension),
• if the child has a metabolic disorder (e.g. diabetes, hyperthyroidism presenting as increased sweating, elevated body temperature, or rapid heart rate),
• if the child has a pheochromocytoma,
• if the child has a metabolic disorder called porphyria,
• if the child has prostate enlargement.

If any of the above conditions apply to the child, consult a doctor or pharmacist before using this medicine.
Prolonged and improper use
Due to the risk of nasal mucosa atrophy, this medicine should only be used during chronic rhinitis under medical supervision.
Improper use or administration of excessive doses may cause systemic adverse effects, especially in children (see section Possible side effects).
Prolonged use or use of doses higher than recommended may lead to chronic swelling and potential atrophy (damage) of the nasal mucosa.
Avoid direct contact of the medicine with the eyes.
Children
Avoid prolonged use or use of doses higher than recommended, especially in children.
Sudafed Spray Extra Kids is recommended for use only in children aged 2 to 6 years. For children over 6 years of age, a nasal spray containing higher doses of active substances is available.
The use of this medicine in children should be supervised.
Sudafed Spray Extra Kids and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Concurrent use of Sudafed Spray Extra Kids with certain antidepressants (monoamine oxidase inhibitors such as tranylcypromine or tricyclic antidepressants) and medicines that increase blood pressure may lead to elevated blood pressure due to the effects of active substances on the circulatory system.
Concurrent use of Sudafed Spray Extra Kids 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 adverse effects on the cardiovascular and central nervous systems.
Do not use blood pressure-lowering medicines (e.g. methyldopa) together with xylometazoline, which may increase blood pressure.
Consult a doctor before using Sudafed Spray Extra Kids if the child is taking any of the above-mentioned medicines.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Due to lack of safety data regarding use in pregnant women, this medicine should not be used during pregnancy.
It is unknown whether xylometazoline hydrochloride passes into breast milk; therefore, this medicine should not be used during breastfeeding.
Driving and operating machinery
When used according to the instructions in this leaflet, this medicine should not affect the ability to drive or operate machinery.

3. How to use Sudafed Spray Extra Kids

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose of Sudafed Spray Extra Kids is one spray dose into each nostril up to three times daily, as needed, unless otherwise advised by a doctor. Do not use for longer than 7 days. Repeated use is possible only after a break of several days.
If there is no improvement after 3 days, or if the child feels worse, consult a doctor.

Method of administration
Sudafed Spray Extra Kids is intended for intranasal use.
Remove the protective cap from the nozzle of the dispenser.
Before first use, press the pump 5 times until a uniform spray appears. If the spray has not been used for an extended period, press the pump twice before use.

Insert the dispenser nozzle into one nostril in an upright position, then press the pump once. During administration, gently inhale through the nose. If necessary, repeat the procedure in the other nostril. After each use, wipe the dispenser nozzle with a paper tissue and replace the protective cap.

For hygienic reasons, to avoid infections, this medicine should be used by only one person.

Use in children
The recommended dose of Sudafed Spray Extra Kids is one spray dose into each nostril up to three times daily, as needed. For guidance on duration of treatment in children, consult a doctor.

Use of a higher than recommended dose of Sudafed Spray Extra Kids
If more medicine is used than recommended, or if large amounts are accidentally swallowed, the following adverse effects may occur:

• constriction of pupils,
• dilation of pupils,
• fever,
• sweating,
• pallor,
• bluish discoloration of lips (cyanosis),
• nausea,
• seizures,
• circulatory disturbances (increased heart rate, decreased heart rate, cardiac arrhythmias, circulatory failure, cardiac arrest, high blood pressure (hypertension)),
• respiratory disturbances (pulmonary edema, breathing difficulties),
• psychiatric disturbances,
• drowsiness, decreased body temperature, slowed heart rate and low blood pressure, respiratory arrest, and coma.

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

Missed dose of Sudafed Spray Extra Kids
Do not use a double dose to make up for a missed dose. Continue treatment as described in the leaflet.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Not common (may occur in less than 1 in 100 people):

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

Rare (may occur in less than 1 in 1,000 people):

• palpitations (awareness of heartbeat), tachycardia (increased heart rate), arterial hypertension (high blood pressure).

Very rare (may occur in less than 1 in 10,000 people):

• restlessness, difficulty sleeping, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children),
• cardiac arrhythmias,
• nasal mucosa swelling (after discontinuation of treatment), nosebleeds,
• convulsions (mainly in children).

Frequency unknown (frequency cannot be estimated from available data):

• burning and dryness of nasal mucosa, sneezing.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sudafed Spray Extra Kids

Keep this 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 stated month.
Do not store above 25°C.
Period of use after first opening the bottle: 6 months.
Medicines must 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 Spray Extra Kids contains

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

What Sudafed Spray Extra Kids looks like and contents of the pack
A clear, colourless to slightly yellowish solution, free from particles.
The pack of Sudafed Spray Extra Kids consists of a 10 ml bottle made of HDPE with a metering pump in a cardboard box. 10 ml of solution is sufficient for 80 doses.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Kenvue Germany GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany
This medicinal product is authorised in the European Economic Area member states under the following names:
Latvia Olydex
Poland Sudafed Spray Extra Kids
Slovakia Olynth Plus
Lithuania Olydex
Germany Olynth Plus 0.05% / 5%
Estonia Sudafed Xylospray DEX
Czech Republic Olynth Plus
For more detailed information, please contact:
email: [email protected]