Sudafed spray classic kids

Package leaflet: Information for the user

Sudafed Spray Classic Kids, 0,5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• 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 symptoms worsen, consult your doctor.

Contents of the leaflet

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

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

Sudafed Spray Classic Kids contains xylometazoline, which helps to constrict blood vessels inside the nasal cavity, thereby reducing swelling of the nasal mucosa (nasal lining) and making breathing easier.
The nasal spray is used for short-term treatment of nasal congestion or sinus congestion with watery nasal discharge occurring during colds or sinusitis.

2. Important information before using Sudafed Spray Classic Kids

When NOT to use Sudafed Spray Classic Kids:

• if the patient is allergic to xylometazoline or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has increased intraocular pressure, especially in cases of narrow-angle glaucoma;
• if the patient has chronic inflammation of the nasal mucosa (long-term nasal irritation), with little or no discharge (rhinitis sicca);
• if the patient is taking or has taken monoamine oxidase inhibitors (MAO inhibitors) within the last two weeks;
• if the patient is taking other medicines that may increase blood pressure;
• if the patient has inflammation caused by nasal blood vessel hypersensitivity;
• if the patient has inflammation associated with thinning of the nasal mucosa, with or without discharge;
• if the patient has undergone brain surgery performed via the nose or mouth.

DO NOT use the aerosol in children under 2 years of age.
Warnings and precautions
Before starting to use this medicine, consult a doctor or pharmacist if:

• the patient has a strong reaction to sympathomimetics (substances similar to adrenaline), as use of Sudafed Spray Classic Kids in such patients may cause insomnia, dizziness, uncontrolled muscle tremors, irregular heartbeat, or increased blood pressure;
• the patient has heart disease (e.g. long QT syndrome), hypertension, or circulatory disorders;
• the patient has hyperthyroidism, diabetes, or another metabolic disorder;
• the patient has adrenal gland disorders;
• the patient has enlarged prostate gland (prostatic hyperplasia).

Prolonged use of this medicine over a long period may worsen sinusitis or inflammation of the nasal mucosa.
Sudafed Spray Classic Kids and other medicines
Before starting to use Sudafed Spray Classic Kids, consult a doctor or pharmacist.
DO NOT take this medicine while using:

• certain antidepressants, such as tricyclic and tetracyclic antidepressants, monoamine oxidase inhibitors, or within two weeks after discontinuing monoamine oxidase inhibitors (see section "When NOT to use Sudafed Spray Classic Kids");
• other medicines that increase blood pressure.

Inform the pharmacist about all medicines currently or recently taken by the patient, including those available without a prescription.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do NOT use Sudafed Spray Classic Kids during pregnancy due to lack of data on its effects on the fetus.
Breastfeeding patients should consult their doctor before using this medicine.
It is not known whether the active substance of this medicine passes into breast milk.
Driving and operating machinery
No effects of Sudafed Spray Classic Kids on the ability to drive vehicles or operate machinery have been observed.
Sudafed Spray Classic Kids contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml, equivalent to 0.014 mg/0.070 ml (per dose). Benzalkonium chloride may cause nasal irritation or swelling, especially if used for prolonged periods.

3. How to use Sudafed Spray Classic 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.
Children aged 2 to 12 years
Unless otherwise advised by a doctor or pharmacist, administer one dose of Sudafed Spray Classic Kids into each nostril, up to 3 times daily, for no longer than 7 days. Do not exceed the recommended dose.

1. Remove the protective cap. Before first use, press the pump several times until a fine, uniform spray appears (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an upright, nearly vertical position. Insert the applicator into the nostril – do not spray the medicine if the applicator tip is positioned below the nostril opening (see Fig. 2).
3. Press the pump once while inhaling through the nose. Repeat the same procedure when administering the medicine into the other nostril.
4. After use, replace the protective cap on the bottle.

To minimize the risk of spreading infections, this medicine container should not be used by more than one person, and the applicator should be rinsed after each use.
DO NOT use this medicine in children under 2 years of age.
Use of more than the recommended dose of Sudafed Spray Classic Kids
Contact a doctor, pharmacist, or the nearest emergency department immediately, taking the medicine package or this leaflet with you.
Overdose may cause central nervous system disturbances, such as loss of muscle function, fatigue, dry mouth, sweating, rapid and irregular heartbeat, and increased blood pressure.
Missed dose of Sudafed Spray Classic Kids
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
STOP using the medicine and contact a doctor IMMEDIATELY if any of the following adverse effects occur, which may be symptoms of an allergic reaction:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat;
• itching with red rash or blisters.

Other adverse effects:
Common (occur less frequently than in 1 in 10 people):

• stinging or burning sensation in the nose and throat, and dryness of the nasal mucosa

Uncommon (occur less frequently than in 1 in 100 people):

• nosebleeds

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

• headache, increased blood pressure, nervousness, nausea, dizziness, insomnia, and palpitations
• transient visual disturbances and systemic allergic reactions

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

• worsening of symptoms of sinusitis or nasal mucosa inflammation after discontinuation of the medicine

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sudafed Spray Classic Kids

Keep the medicine out of the sight and reach of children.
Store below 25°C.
After first opening the container, do not use Sudafed Spray Classic Kids for longer than 20 weeks.
Do not use Sudafed Spray Classic Kids after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Sudafed Spray Classic Kids contains
The active substance is xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of
xylometazoline hydrochloride. Each dose (0.070 ml) of Sudafed Spray Classic Kids contains
35 micrograms (or 0.035 mg) of xylometazoline hydrochloride.
The other ingredients are: disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate,
disodium phosphate dihydrate, liquid sorbitol, non-crystallising, benzalkonium chloride solution, water for injections.
What Sudafed Spray Classic Kids looks like and contents of the pack
The spray is a clear, colourless solution contained in a 10 ml bottle made of amber glass with a metering pump,
packaged in a cardboard box.
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:
Delpharm Orléans
5, avenue de Concyr
45071 Orléans Cedex 2
France
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Sudafed Spray Classic Kids
Romania: Olynth 0.5 mg/ml nasal spray, solution