Actifed decongestant
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIFED DECONGESTANT
"1 mg/ml NASAL SPRAY, SOLUTION"
( xylometazoline hydrochloride )
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What ACTIFED DECONGESTANT is and what it is used for
- What you need to know before using ACTIFED DECONGESTANT
- How to use ACTIFED DECONGESTANT
- Possible side effects
- How to store ACTIFED DECONGESTANT
- Contents of the pack and other information
1. WHAT IS ACTIFED DECONGESTANT AND WHAT IS IT USED FOR?
ACTIFED DECONGESTANT contains xylometazoline, a substance that helps constrict the blood vessels in the nose, reducing swelling of the nasal mucosa (the inner lining of the nose), and facilitating breathing. ACTIFED DECONGESTANT also contains hyaluronic acid (in the form of sodium hyaluronate), which protects and hydrates the nasal mucosa.
The spray is used for the short-term treatment of nasal congestion with rhinorrhea due to the common cold or sinusitis.
2. WHAT YOU NEED TO KNOW BEFORE USING ACTIFED DECONGESTANT
Do not use ACTIFED DECONGESTANT in the following cases:
- allergy to xylometazoline or to any of the other ingredients of this medicine (listed in section 6)
- high intraocular pressure, especially in presence of narrow-angle glaucoma
- chronic rhinitis (long-term nasal irritation) with little or no nasal discharge (dry rhinitis)
- currently undergoing treatment with monoamine oxidase inhibitors (MAOIs), or have taken MAO inhibitors within the previous 2 weeks
- currently being treated with other medicines that may increase blood pressure
- inflammation caused by hypersensitivity of the nasal blood vessels
- inflammation associated with thinning of the nasal membranes with or without discharge
- recent surgery involving the brain via the nasal or oral route. This spray must not be used in children under 12 years of age.
Warnings and precautions
Consult your doctor or pharmacist before using this spray in the following cases:
- marked sensitivity to sympathomimetic agents (substances similar to adrenaline), as use of ACTIFED DECONGESTANT may cause insomnia, dizziness, tremor, uncontrolled spasms, irregular heartbeat or abnormal heart rhythm, or increased blood pressure.
- heart problems, heart disease (such as Long QT Syndrome), vascular disorders, hypertension
- overactive thyroid, diabetes or other metabolic disorders
- disorders of the adrenal glands
- enlarged prostate (prostatic hypertrophy).
Prolonged and continuous use of this product may lead to worsening of congestion symptoms.
Other medicines and ACTIFED DECONGESTANT
Consult your doctor or pharmacist before using ACTIFED DECONGESTANT.
Do not use the spray if you are taking:
- certain antidepressant medications, such as tricyclic or tetracyclic antidepressants, or MAOIs, or if you have taken MAOIs within the last 2 weeks (see section “Do not use”);
- other medicines that may increase blood pressure.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine,
including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or
pharmacist before using this medicine.
ACTIFED DECONGESTANT must not be used during pregnancy, as its effects on the fetus are not fully known.
During breastfeeding, consult your doctor before using this medicine.
It is not known whether the active ingredient is transferred into breast milk.
Driving and operating machinery
ACTIFED DECONGESTANT has no known effects on the ability to drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
3. HOW TO USE ACTIFED DECONGESTANT
Adults and children over 12 years of age.
Unless otherwise directed by a doctor or pharmacist, it is recommended to administer one spray of
ACTIFED DECONGESTANT into each nostril up to three times a day for a maximum of 7 days.
- Remove the protective cap. Prime the bottle before first use by pressing several times until a fine, uniform spray is produced (see Figure 1). The spray is now ready for use.
- Hold the spray upright. Insert the nozzle into one nostril – do not spray outside the nose (see Figure 2).
- Press once. Breathe in through the nose while spraying. Repeat the procedure in the other nostril.
- After use, replace the cap on the bottle.
To reduce the risk of infection, the bottle must not be used by more than one person, and the nozzle
should be cleaned after each use.
DO NOT use this spray in children under 12 years of age.
If you use more ACTIFED DECONGESTANT than you should
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest emergency room, taking the
medicinal product or its package leaflet with you.
If you forget to use ACTIFED DECONGESTANT
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, ACTIFED DECONGESTANT may cause adverse effects, although not everyone experiences them.
Stop using the nasal spray and contact your doctor immediately if you experience any of the following symptoms, which could indicate an allergic reaction:
- difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
- severe itching of the skin, with red rash or swellings
Other adverse effects include:
Common (may affect up to 1 in 10 people):
sensation of nasal or throat irritation (pricking or burning) and dryness of the nasal mucosa.
Rare (may affect up to 1 in 1,000 people):
- headache, increased blood pressure, nervousness, feeling unwell, dizziness, insomnia, palpitations
- systemic allergic reactions and temporary visual disturbances.
Frequency not known (frequency cannot be estimated from the available data):
- worsening of nasal congestion symptoms after discontinuation of the product;
- nosebleeds.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ACTIFED DECONGESTANT
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
After opening the package, DO NOT use ACTIFED DECONGESTANT for more than 12 months.
Do not use ACTIFED DECONGESTANT after the expiry date stated on the packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. PACK CONTENTS AND OTHER INFORMATION
What ACTIFED DECONGESTANT contains
The active substance is xylometazoline hydrochloride, at a concentration of 1 mg per millilitre of solution. Each
spray-dose of ACTIFED DECONGESTANT (= 140 microlitres) contains 140 micrograms of
xylometazoline hydrochloride.
The other components are: sodium hyaluronate, sorbitol (E420), glycerol (E422), sodium dihydrogen phosphate
dihydrate, disodium phosphate dihydrate, sodium chloride and water for injections.
Description of the appearance of ACTIFED DECONGESTANT and pack contents
The spray is a solution ranging from clear to slightly opalescent, colourless or slightly yellowish, contained in a white plastic bottle of 10 ml equipped with a metering pump.
Marketing Authorisation Holder
Johnson & Johnson S.p.A.
Via Ardeatina Km 23,500 – 00071 Santa Palomba, Pomezia (Roma)
Responsible manufacturer for batch release
Famar Health Care Services Madrid, S.A.U.
Avda. Leganés, 62
Alcorcón
28923 Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Latvia: Olynth HA 1 mg/ml deguna aerosols bez konservantiem, šķīdums
Cyprus: Hexarhinal
Greece: Hexarhinal
Ireland: Sudafed Blocked Nose 1mg/ml Nasal Spray Solution
Portugal: Nasexilo 1 mg/ml solução para pulverização nasal, sem conservantes
Romania: Olynth HA 1 mg/ml spray nazal, solutie
Sweden: Olynth
This leaflet was last approved on:
Detailed and up-to-date information on this medicinal product is available by scanning the QR Code
on the outer packaging with a smartphone. Information is also available on the database