Sudafed spray ha comfort kids

Package leaflet: Information for the user

Sudafed Spray HA Comfort Kids, 0,5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using the medicine, because 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, so that you can read it again if necessary.
• If you need advice or further information, 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.

Contents of the leaflet:

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

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

Sudafed Spray HA Comfort Kids contains xylometazoline, which helps constrict blood vessels
inside the nasal cavity, thereby reducing swelling of the nasal mucosa and facilitating
breathing. Sudafed Spray HA Comfort Kids also contains hyaluronic acid (in the form of sodium salt), which protects and moisturizes the nasal mucosa.
The spray is used for short-term treatment of nasal mucosal congestion with watery nasal discharge occurring during colds or sinusitis.

2. Important information before using Sudafed Spray HA Comfort Kids

When NOT to use Sudafed Spray HA Comfort Kids:

• if the patient is allergic to xylometazoline or 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 undergone brain surgery performed through the nose or mouth.

This medicine is not intended for 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 HA Comfort Kids in such patients may cause insomnia, dizziness, uncontrollable muscle tremors, irregular heartbeat, or increased blood pressure;
• the patient has heart disease (e.g. long QT syndrome), vascular disease, or high blood pressure;
• the patient has hyperthyroidism, diabetes, or another metabolic disorder;
• the patient has an adrenal gland disorder;
• the patient has benign prostatic hyperplasia (enlarged prostate).

Prolonged use of this medicine over a long period may worsen nasal congestion symptoms.
Sudafed Spray HA Comfort Kids and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
DO NOT take this medicine while using:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Sudafed Spray HA Comfort Kids during pregnancy due to lack of data on its effects on the fetus.
Breastfeeding women should consult their doctor before using this medicine.
It is unknown whether the active substance of this medicine passes into human milk.
Driving and operating machinery
No effects of Sudafed Spray HA Comfort Kids on the ability to drive or operate machinery have been observed.

3. How to use Sudafed Spray HA Comfort 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 HA Comfort Kids into each nostril, up to 3 times daily, for no longer than 5-7 days. Do not exceed the recommended dose.

1. Remove the protective cap. Before first use, press the pump several times until a uniform spray mist appears (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an approximately upright position. Insert the applicator into the nostril – do not spray the medicine if the applicator tip is 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, the 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 HA Comfort Kids
Contact a doctor, pharmacist, or nearest emergency department immediately, taking the medicine packaging or this leaflet with you.
Exceeding the recommended dose 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 HA Comfort 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should STOP using the medicine and seek immediate medical advice if any of the following adverse reactions occur, which may be symptoms of an allergic reaction:

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

Other adverse reactions:
Common (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

• nosebleeds

Rare (affects less than 1 in 1000 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 the available data):

• worsening of nasal congestion symptoms after stopping the use of the medicine

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 provide more information on the safety of the medicine.

5. How to store Sudafed Spray HA Comfort Kids

Keep the medicine out of sight and reach of children.
Store below 25°C.
The shelf life of Sudafed Spray HA Comfort Kids after first opening the bottle: 1 year.
Do not use Sudafed Spray HA Comfort 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. This will help protect the environment.

6. Contents of the package and other information

What Sudafed Spray HA Comfort Kids contains
The active substance is xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of
xylometazoline hydrochloride. Each dose (70 μl (micrograms), equivalent to 0.070 ml)
of Sudafed Spray HA Comfort Kids contains 35 μg (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredients are: sodium hyaluronate, sorbitol (E420), glycerol (E422), sodium dihydrogen phosphate dihydrate,
disodium phosphate dihydrate, sodium chloride, water for injections.
What Sudafed Spray HA Comfort Kids looks like and contents of the pack
The spray is a clear to slightly opalescent, colourless to slightly yellowish solution contained in a 10 ml white HDPE bottle with a metering pump and a protective HDPE cap, packed in a cardboard box. The solution is sufficient for 110 doses.
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
Ursapharm Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Latvia Olynth HA 0.5 mg/ml nasal spray, solution without preservatives
Poland Sudafed Spray HA Comfort Kids
For more detailed information, please contact:
email: [email protected]