Sudafed Xilosprai

Leaflet attached to the packaging: patient information

Sudafed XyloSpray, 1 mg/ml, nasal spray, solution

Xylometazoline hydrochloride

Read the 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 patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Sudafed XyloSpray and what is it used for
• 2. Important information before using Sudafed XyloSpray
• 3. How to use Sudafed XyloSpray
• 4. Possible side effects
• 5. How to store Sudafed XyloSpray
• 6. Package contents and other information

1. What is Sudafed XyloSpray and what is it used for

Xylometazoline is a vasoconstrictor that reduces swelling of the nasal mucosa, making it easier to breathe and facilitating the flow of secretions. The onset of action occurs within 2 minutes of administration. Sudafed XyloSpray is intended for use in adults and children over 6 years of age.

Indications for use

Reduction of nasal mucosa swelling in acute rhinitis, vasomotor rhinitis, and allergic rhinitis. Facilitating the flow of secretions in sinusitis and otitis media associated with a cold.

2. Important information before using Sudafed XyloSpray

When not to use Sudafed XyloSpray:

• if the patient is allergic to xylometazoline hydrochloride or any other component of the medicine (listed in section 6);
• do not use in children under 6 years of age;
• do not use in patients after pituitary surgery and other surgical procedures involving exposure of the dura mater.

Warnings and precautions

The medicine should only be used after careful consideration by a doctor of the benefit-to-risk ratio in patients:

• treated with monoamine oxidase inhibitors (MAOIs) or other medicines that may cause increased blood pressure;
• with increased intraocular pressure, especially in patients with narrow-angle glaucoma;
• with severe cardiovascular diseases (e.g., coronary heart disease, hypertension, long QT syndrome);
• with pheochromocytoma;
• with metabolic disorders (e.g., hyperthyroidism, diabetes);
• with prostatic hyperplasia;
• with hypersensitivity to substances with similar effects to xylometazoline, manifested by insomnia, tremors, dizziness, cardiac arrhythmias, and increased blood pressure.

The medicine is intended for short-term use. Using xylometazoline in higher doses or for a longer period than recommended may lead to reactive hyperemia of the nasal mucosa. This causes narrowing of the airways, leading to frequent and prolonged use of the medicine by the patient. As a result, it leads to drug-induced rhinitis and atrophy of the nasal mucosa.
Consult a doctor if symptoms do not improve or worsen, or if new symptoms appear.

Other medicines and Sudafed XyloSpray

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
When administered intranasally, the likelihood of interactions with other medicines seems to be low, but they cannot be ruled out.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects of Sudafed XyloSpray on the ability to drive and use machines have been observed when used as recommended.

The medicine contains 0.2 mg of benzalkonium chloride per milliliter of solution.

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Sudafed XyloSpray

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Sudafed XyloSpray is intended for intranasal use only (also in otitis media).
Adults and children over 6 years of age
1 spray into each nostril up to 3 times a day.
Do not administer more than 3 sprays into each nostril per day.
Do not use in infants and children under 6 years of age.
Do not use higher doses than recommended.
Sudafed XyloSpray should not be used for more than 7 days, unless advised by a doctor.
Repeated use of the medicine can be started after a few days' break.
For the duration of use in children, consult a doctor.
For hygiene reasons, one package of the medicine should be used by one patient only.
Instructions for use
Remove the plastic cap.
Before first use, press the pump until a uniform mist of the sprayed medicine appears (fig. 1). This makes the spray ready for use.
To administer a dose of the spray into the nose, place the tip of the applicator into the nostril, then press the pump once, while inhaling through the nose (fig. 2). During administration, hold the bottle in a position close to vertical. After use, replace the plastic cap.

Using a higher dose of Sudafed XyloSpray than recommended

In case of overdose or accidental ingestion, the following symptoms may occur:
pupil dilation, nausea, vomiting, cyanosis (blue discoloration of the skin and mucous membranes), fever, seizures, tachycardia (rapid heart rate), arrhythmias, circulatory collapse, cardiac arrest, hypertension, pulmonary edema (fluid accumulation in the lungs, manifested by shortness of breath), respiratory disorders, mental disorders.
The following symptoms may also occur: central nervous system depression with drowsiness, decreased body temperature, bradycardia (slow heart rate), hypotension as in shock, apnea, and coma.
Keep the medicine out of the reach of children.
In case of overdose, seek medical help immediately. The doctor will take appropriate actions, such as administering activated charcoal. In justified cases, gastric lavage and oxygen therapy may be necessary. To lower blood pressure, the doctor may recommend administering phentolamine in a dose of 5 mg in a 0.9% sodium chloride solution by slow intravenous infusion or 100 mg orally.
It is contraindicated to use medicines with vasoconstrictor effects.
If necessary, use antipyretic and anticonvulsant medicines.

Missing a dose of Sudafed XyloSpray

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is presented according to the following scheme:
Very common
occurs in less than 1 in 10 patients
Common
occurs in less than 1 in 100 patients
Rare
occurs in less than 1 in 1,000 patients
Very common side effects may include irritation (burning or dryness of the nasal mucosa), sneezing, especially in sensitive patients. After discontinuation of the medicine, there may be an exacerbation of nasal mucosa swelling (reactive hyperemia).
Common side effects may include:

• systemic effects, such as palpitations, rapid heart rate, increased blood pressure,
• nasal bleeding.

Rare side effects may include nausea, vision disorders, allergic reactions, headache, insomnia, or fatigue.
Prolonged or frequent use, as well as administration in higher doses than recommended, may lead to reactive hyperemia with drug-induced rhinitis, manifested by a feeling of nasal congestion, nasal discharge, nasal itching, and sneezing. This effect may occur after 5 days of treatment, and if the use of the medicine continues, it may lead to atrophic rhinitis.
Reporting side effects
If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sudafed XyloSpray

Keep the medicine out of the reach and sight of children.
Store in a temperature below 25°C.
The shelf life after opening the bottle is 24 weeks. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sudafed XyloSpray contains

• The active substance is xylometazoline hydrochloride. 1 ml of Sudafed XyloSpray solution contains 1 mg of xylometazoline hydrochloride.
• The other ingredients are: benzalkonium chloride solution, disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sorbitol liquid 70% (non-crystallizing), purified water.

What Sudafed XyloSpray looks like and what the package contains

The medicine is a bottle made of orange glass with a dosing pump, containing 10 ml of solution, placed in a cardboard box.

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:

Delpharm Orléans
5, avenue Concyr
45071 Orléans Cedex 2
France
To obtain more detailed information, please contact:
email: [email protected]

Date of last revision of the leaflet: