Sudafed spray ha comfort kids

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Sudafed Spray HA Comfort Kids
0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
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
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents:

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 nasal mucosal swelling and facilitating easier breathing. Sudafed Spray HA Comfort Kids also contains hyaluronic acid (in the form of sodium salt), which protects and moisturizes the nasal mucosa.
The nasal spray is used for short-term treatment of nasal mucosal congestion with watery nasal discharge occurring during the common cold 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 treatment, 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 adrenal gland disease;
• the patient has benign prostatic hyperplasia (enlarged prostate).

Prolonged and continuous use of this medicine over a long period may worsen nasal congestion symptoms.

Sudafed Spray HA Comfort Kids and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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.
Sudafed Spray HA Comfort Kids should not be used 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 breast milk.

Driving and operating machinery
No influence of Sudafed Spray HA Comfort Kids on the ability to drive or operate machinery has 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 fine, uniform spray is produced (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an upright or near-upright 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 steps 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 shared between individuals, 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 the nearest emergency department immediately, taking the medicine package or this leaflet with you.
Taking more than 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP using the medicine and immediately consult a doctor 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;
• severe itching with red rash or blisters.

Other adverse effects:
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, palpitations
• transient visual disturbances and systemic allergic reactions

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

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse effects 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, 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 or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sudafed Spray HA Comfort Kids

Keep this medicine out of the sight and reach of children.
Do not store above 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. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Sudafed Spray HA Comfort Kids contains
Active substance: xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of
xylometazoline hydrochloride. Each dose (70 μl (microlitres), equivalent to 0.070 ml)
of Sudafed Spray HA Comfort Kids contains 35 μg (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredients: sodium hyaluronate, sorbitol (E 420), glycerol, 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 aerosol 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 cap,
packaged in a cardboard box. The solution is sufficient for 110 doses.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Germany, country of export:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany
Manufacturer:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warszawa
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warszawa
Authorisation number in Germany, country of export: 26497.00.00
Parallel import authorisation number: 19/26
This medicinal product is authorised for marketing 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