SUDAFED SPRAY EXTRA

Package leaflet: Information for the user

Sudafed Spray Extra, (1 mg + 50 mg)/ml, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
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, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days (3 days in children) or if symptoms worsen, consult your doctor.

Contents of the leaflet

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

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

Sudafed Spray Extra nasal spray contains xylometazoline hydrochloride and dexpanthenol. Xylometazoline hydrochloride rapidly constricts blood vessels in the nasal mucosa and reduces swelling. Dexpanthenol is a derivative of vitamin B5 (pantothenic acid) that accelerates wound healing and protects the nasal mucosa.

Sudafed Spray Extra is indicated:

• to reduce swelling of the nasal mucosa in rhinitis and for supportive treatment of nasal mucosal damage;
• to relieve symptoms of non-allergic rhinitis (vasomotor rhinitis);
• for the treatment of nasal passage obstruction following nasal surgery; use of Sudafed Spray Extra for this indication is permitted only on a doctor's advice.

Sudafed Spray Extra is intended for use in adults and children aged 6 years and older.

2. Information before using Sudafed Spray Extra

When not to use Sudafed Spray Extra:

• if the patient is allergic to xylometazoline hydrochloride or dexpanthenol, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has dry nasal mucosa inflammation with crust formation ( rhinitis sicca ),
• in patients after surgical removal of the pituitary gland or other operations involving exposure of the meninges (the membrane surrounding the brain).

Sudafed Spray Extra must not be used in children under 6 years of age.

Warnings and precautions
Before starting to use Sudafed Spray Extra, discuss this with your doctor or
pharmacist:

• if the patient is taking monoamine oxidase inhibitors (MAOIs) or other medicines that may increase blood pressure,
• if the patient has increased intraocular pressure (glaucoma), particularly narrow-angle glaucoma,
• if the patient has severe cardiovascular disease (e.g. long QT syndrome, ischemic heart disease, hypertension),
• if the patient has a metabolic disorder (e.g. diabetes, hyperthyroidism presenting as increased sweating, elevated body temperature, or rapid heartbeat),
• if the patient has a chromaffin cell tumor of the adrenal gland (pheochromocytoma),
• if the patient has a metabolic disorder called porphyria,
• if the patient has benign prostatic hyperplasia.

If any of the above conditions apply to the patient, consult a doctor or pharmacist before using this medicine.
Prolonged and improper use
This medicine should not be used continuously for longer than 7 days (see section 3 below). Prolonged use or use of doses higher than recommended may lead to chronic swelling and possible atrophy (damage) of the nasal mucosa.
Due to the risk of nasal mucosa atrophy, this medicine should be used during chronic rhinitis only under medical supervision.
Improper use or overdose may cause systemic adverse effects, particularly in children (see section Possible side effects).
Avoid direct contact of the medicine with the eyes.
Children
Avoid prolonged use or use of doses higher than recommended, especially in children.
Sudafed Spray Extra is intended for use only in children aged 6 years and above. For children under 6 years of age, a nasal spray containing lower doses of active substances is available.
Use of this medicine in children under 12 years of age should be supervised.
Sudafed Spray Extra and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Concomitant use of Sudafed Spray Extra with certain antidepressants (monoamine oxidase inhibitors such as tranylcypromine or tricyclic antidepressants) and medicines that increase blood pressure may lead to elevated blood pressure due to the effects of the active substances on the cardiovascular system.
Concomitant use of Sudafed Spray Extra with other medicines containing sympathomimetics (cough and cold medicines used to treat nasal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may lead to adverse effects on the cardiovascular system and central nervous system.
Do not use blood pressure-lowering medicines (e.g. methyldopa) together with xylometazoline, which may cause increased blood pressure.
Consult your doctor before using Sudafed Spray Extra if you or your child is taking any of the medicines listed above.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Due to lack of safety data in pregnant women, this medicine should not be used during pregnancy.
It is not known whether xylometazoline hydrochloride passes into breast milk; therefore, this medicine should not be used during breastfeeding.
Driving and operating machinery
When used according to instructions, this medicine is not expected to affect the ability to drive or operate machinery.

3. How to use Sudafed Spray Extra

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose of Sudafed Spray Extra for adults is one spray dose into each nostril up to three times daily, as needed, unless otherwise advised by a physician. Do not use the medicine for longer than 7 days. If there is no improvement after 7 days, or if symptoms worsen, consult a doctor. Repeated use is possible only after an interval of several days.
If there is no improvement in a child after 3 days, or if the child feels worse, consult a doctor.

Method of administration
Sudafed Spray Extra is intended for nasal use.
Remove the protective cap from the dispenser nozzle.
Before first use, press the pump 5 times until a uniform spray is produced. If the spray has not been used for 7 days or longer, press the pump 2 times before using again.

Insert the dispenser nozzle into the nostril in an upright position, then press the pump once. While spraying, gently inhale through the nose. If necessary, repeat the procedure in the other nostril. After each use, wipe the dispenser nozzle with a clean tissue and replace the protective cap.

For hygienic reasons and to avoid infections, the medicine should be used by only one person.

Use in children
The recommended dose of Sudafed Spray Extra for children over 6 years of age is one spray dose into each nostril up to three times daily, as needed. The duration of treatment in children should be determined in consultation with a doctor.

Overdose of Sudafed Spray Extra
If more medicine is used than recommended, or if large amounts are accidentally swallowed, the following adverse effects may occur:

• constriction of the pupils,
• dilation of the pupils,
• fever,
• sweating,
• pallor,
• bluish discoloration of the lips (cyanosis),
• nausea,
• seizures,
• cardiovascular disturbances (increased heart rate, decreased heart rate, cardiac arrhythmias, circulatory failure, cardiac arrest, high blood pressure (hypertension)),
• respiratory disturbances (pulmonary edema, breathing difficulties),
• psychiatric disturbances,
• drowsiness, decreased body temperature, bradycardia, hypotension, respiratory arrest, and coma.

If any of these symptoms occur, contact a doctor immediately.

Missed dose of Sudafed Spray Extra
Do not use a double dose to make up for a missed dose. Continue using the medicine as instructed in the leaflet.
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 everybody will experience them.

Not common (may occur in fewer than 1 in 100 people):

• hypersensitivity reactions such as skin and mucosal swelling, skin rash, itching.

Rare (may occur in fewer than 1 in 1,000 people):

• palpitations (awareness of heartbeat), tachycardia (increased heart rate), arterial hypertension (high blood pressure).

Very rare (may occur in fewer than 1 in 10,000 people):

• anxiety, difficulty sleeping, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children),
• cardiac arrhythmias,
• nasal mucosal swelling (after discontinuation of treatment), nosebleeds,
• convulsions (mainly in children).

Frequency unknown (frequency cannot be estimated from available data):

• burning and dryness of the nasal mucosa, sneezing.

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 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 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 Extra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Period of use after first opening the bottle: 6 months. On the carton, after the words
"Date of opening:", there is a space for the patient to enter this information.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures help
protect the environment.

6. Contents of the pack and other information

What Sudafed Spray Extra contains

• The active substances in this medicine are xylometazoline hydrochloride and dexpanthenol. Each ml of solution contains 1 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol. One nasal spray dose (0.1 ml of solution) contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other ingredients are: potassium dihydrogen phosphate, disodium phosphate dodecahydrate, water for injections.

What Sudafed Spray Extra looks like and contents of the pack
A clear, colourless to slightly yellowish solution, free from particles.
The pack of Sudafed Spray Extra consists of a bottle with a metering pump containing 10 ml of solution.
Each bottle contains at least 80 doses.
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:
Famar Health Care Services Madrid S.A.U.
Avda Leganés, 62, Alcorcón
28923 Madrid
Spain

This medicinal product is authorized for sale in the European Economic Area member states under the following names:

For more detailed information, please contact:
email: [email protected]