Sudafed spray classic

Package leaflet: Information for the user

Sudafed Spray Classic, 1 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 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

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

Xylometazoline is a vasoconstrictor agent that reduces swelling of the nasal mucosa. The onset of action occurs within 2 minutes after administration. Reduction of mucosal swelling facilitates nasal breathing and promotes drainage of secretions.
Sudafed Spray Classic is intended for use in adults and children over 6 years of age.
Indications
Reduction of nasal mucosal swelling in acute rhinitis, vasomotor rhinitis, and allergic rhinitis.
Facilitation of secretion drainage in acute sinusitis and in otitis media with Eustachian tube involvement associated with the common cold.

2. Important information before using Sudafed Spray Classic

When not to use Sudafed Spray Classic:

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

Warnings and precautions
This medicine should be used only after careful consideration by a physician of the benefit-risk ratio associated with its use in patients:

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

This medicine is intended for short-term use only. Using xylometazoline in doses higher than recommended or for longer than recommended periods may lead to reactive hyperaemia of the nasal mucosa. This causes nasal congestion, leading to frequent and prolonged use of the medicine by the patient. As a result, this may lead to drug-induced rhinitis and atrophy of the nasal mucosa.
Consult a doctor if symptoms do not improve or worsen, or if new symptoms occur.
Other medicines and Sudafed Spray Classic
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When administered intranasally, the likelihood of interactions with other medicines appears to be low; however, interactions cannot be ruled out.
Pregnancy and breastfeeding
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.
Driving and operating machinery
No effect of Sudafed Spray Classic, when used at recommended doses, on the ability to drive or operate machinery has been demonstrated.
The medicine contains 0.2 mg of benzalkonium chloride in each millilitre of solution.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Sudafed Spray Classic

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Sudafed Spray Classic is intended for nasal administration only (including in cases of eustachian tube
inflammation).
Adults and children over 6 years of age
1 spray dose into each nostril up to 3 times daily.
Do not administer more than 3 doses into each nostril per day.
Not recommended for infants and children under 6 years of age.
Do not exceed the recommended doses.
Sudafed Spray Classic should not be used for longer than 7 days unless otherwise advised by a
doctor.
Repeated use may be resumed after an interval of several days.
For information on duration of treatment in children, medical advice should be sought.
For hygienic reasons, one package of the medicine should be used by only one patient.
Instructions for use
Remove the plastic cap.
Before first use, press the pump several times until a uniform spray mist appears (Fig. 1). This ensures
the spray is ready for use.
To administer a dose, insert the applicator tip into the nostril and press the pump once while
inhaling through the nose (Fig. 2). During administration, hold the bottle in an upright or nearly
upright position. Replace the plastic cap after use.

Overdose of Sudafed Spray Classic
In case of overdose or accidental ingestion, the following symptoms may occur:
pupil dilation, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes),
fever, seizures, tachycardia (increased heart rate), cardiac arrhythmias, circulatory collapse, cardiac
arrest, hypertension, pulmonary edema (fluid accumulation in the lungs, manifesting, among
others, as shortness of breath), respiratory disturbances, and psychiatric disturbances.
Additional symptoms may include central nervous system depression with drowsiness, decreased
body temperature, bradycardia (slowed heart rate), drop in arterial blood pressure resembling shock,
apnea, and coma.
Keep the medicine out of reach of children.
In case of overdose, seek immediate medical help. The physician may initiate appropriate measures
such as administration of activated charcoal. In justified cases, gastric lavage and oxygen therapy may
be necessary. To reduce arterial blood pressure, the physician may administer phentolamine at a dose
of 5 mg in 0.9% sodium chloride solution by slow intravenous infusion or 100 mg orally.
Vasoconstrictive agents are contraindicated.
If necessary, antipyretic and anticonvulsant medications may be used.
Missed dose of Sudafed Spray Classic
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is presented according to the following classification:

• Common: affects less than 1 in 10 patients
• Uncommon: affects less than 1 in 100 patients
• Rare: affects less than 1 in 1,000 patients

Commonly occurring symptoms may include local irritation (nasal mucosal burning or dryness), sneezing, especially in sensitive individuals. After discontinuation of the medicine, rebound congestion of the nasal mucosa (reactive hyperemia) may occur.

Uncommonly, local nasal administration may cause:

• systemic effects of the medicine such as palpitations, increased heart rate, elevated blood pressure,
• nosebleeds.

Rarely, nausea, visual disturbances, allergic reactions, headache, insomnia, or fatigue may occur.

Prolonged or frequent use, as well as administration in doses higher than recommended, may lead to rebound hyperemia with drug-induced rhinitis, manifested by nasal congestion, nasal discharge, nasal itching, and sneezing. This effect may occur as early as after 5 days of treatment, and if continued, may progress to dry atrophic rhinitis.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
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 Classic

Keep the medicine out of the reach and sight of children.
Store below 25°C.
The shelf life after first 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sudafed Spray Classic contains

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

What Sudafed Spray Classic looks like and contents of the pack
The pack consists of an amber glass bottle with a metering pump containing 10 ml of solution,
placed 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 Concyr
45071 Orléans Cedex 2
France
For further information, please contact:
email: [email protected]