Active ingredients: Xylometazoline Hydrochloride
ACTIFED DECONGESTANT 1 mg / ml NASAL SPRAY, SOLUTION
Indications
What is ACTIFED DECONGESTANT and what is it for
ACTIFED DECONGESTANT contains xylometazoline, a substance that helps constrict the blood vessels of the nose, reducing edema 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 moisturizes the nasal mucosa.
The spray is used for the short-term treatment of nasal congestion with runny nose due to the common cold or sinusitis.
Contraindications
When Actifed Decongestant Must Not Be Used
Do not use ACTIFED DECONGESTANT in the following cases:
- Allergy to xylometazoline or any of the other components of this medicine;
- Elevated eye pressure, especially in the presence of narrow-angle glaucoma
- Chronic rhinitis (long-lasting nasal irritation) with little or no discharge (dry rhinitis);
- You are being treated with monoamine oxidase inhibitors (MAOIs) or taking MAO inhibitors within the previous 2 weeks;
- You are being treated with other medicines that can raise your blood pressure;
- There is an "inflammation caused by hypersensitivity of the blood vessels of the nose;
- There is an "inflammation associated with thinning of the nasal membranes with or without secretion;
- You have recently undergone nasal or oral brain surgery.
This spray should not be used in children under 12 years of age.
Precautions
What you need to know before taking Actifed Decongesionante
Talk to your doctor or pharmacist before using this spray in the following cases:
- Marked reaction to sympathomimetic agents (adrenaline-like products), as the use of ACTIFED DECONGESTANT may cause insomnia, dizziness, tremor or uncontrollable spasms, irregular heartbeat or abnormal heart rhythm or increase in blood pressure.
- Heart problems, vascular problems, hypertension.
- Overactivity of the thyroid gland, diabetes or other metabolic problems.
- Pathologies of the adrenal glands.
- Enlarged prostate (prostatic hypertrophy).
Continued use of the product for long periods can lead to worsening of symptoms from
congestion.
Interactions
Which drugs or foods can modify the effect of Actifed Decongestant?
Contact 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 been taking MAOIs within the last 2 weeks (see "Do not use" section);
- Other medicines which can increase blood pressure.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.
Warnings
It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
ACTIFED DECONGESTANT should not be used during pregnancy as its action on the fetus is not fully known.
While breastfeeding, consult your doctor before using this medicine.
It is not known whether the active substance is transferred into breast milk.
Driving and using machines
ACTIFED DECONGESTANT has no known effects on the ability to drive or use machines.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose and Method of Use
How to use Actifed Decongestant and Dosage
Adults and children over 12 years old
Unless otherwise indicated by the doctor or pharmacist, we recommend a "delivery of ACTIFED DECONGESTANT in each nostril up to 3 times a day for a maximum of 7 days.
- Remove the protective cap. Activate the bottle before use by pressing several times until a homogeneous spray of the solution comes out. The inhaler is now ready for use.
- Hold the inhaler upright. Insert the nozzle into the nostril - do not spray out of the nose.
- Press once. Breathe through your nose at the time of vaporization. Repeat the operation in the other nostril.
- After use, put the cap back on the bottle.
To reduce the risk of infections, the bottle should not be used by more than one person and the spout should be cleaned after each use.
DO NOT use this spray on children under 12 years of age.
If you forget to use ACTIFED DECONGESTANT
If you miss a dose, take it as soon as possible, but if it is near the time for your next dose, skip the missed dose and continue as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose
What to do if you have taken an overdose of Actifed Decongestant
Contact your doctor, pharmacist or the nearest emergency room immediately, taking the medicine or its package leaflet with you.
Side effects
What are the Unwanted Effects of Actifed Decongestant
Like all medicines, ACTIFED DECONGESTANT can cause side effects, although not everybody gets them.
Stop using the nasal spray and seek immediate medical attention if any of the following symptoms appear which could indicate an allergic reaction:
- Difficulty breathing or swallowing, swelling of the face, lips, tongue or throat;
- Severe itchy skin, with red rash or bumps.
Other side effects include:
Common (may affect up to 1 in 10 people):
- Tingling or burning sensation in the nose and throat and dryness of the inner lining of the nose (nasal mucosa).
Rare (may affect up to 1 in 1,000 people):
- Headache, increased blood pressure, nervousness, feeling sick, dizziness, sleeplessness and palpitations;
- Systemic allergic reactions and temporary changes in vision.
Not known (frequency cannot be estimated from the available data):
- Worsening of symptoms of nasal congestion after discontinuing use of the product;
- Nose bleeding.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Once the package is opened, DO NOT use ACTIFED DECONGESTANT for more than 12 months.
Do not use ACTIFED DECONGESTANT after the expiry date stated on the package.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and Pharmaceutical Form
What Actifed Decongestant contains
The active ingredient is xylometazoline hydrochloride, in the amount of 1 mg per milliliter of solution. Each spray-dose of ACTIFED DECONGESTANT (= 140 microliters) contains 140 micrograms of xylometazoline hydrochloride.
The other ingredients are: sodium hyaluronate, sorbitol (E420), glycerol (E422), sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride and water for injections.
Other Information
Description of the appearance of ACTIFED DECONGESTANT and contents of the pack
The spray is a clear to slightly opalescent, colorless or slightly yellowish solution contained in a 10 ml white plastic bottle with a dosing pump.
Further information on Actifed Decongesionante is available in the Summary of Product Characteristics available on the Official Website of the Italian Medicines Agency
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in February 2019.
The information present may not be up-to-date. For a correct use of this information, see the page: Disclaimer and Useful Information. For the most up-to-date version, access to the website of the Italian Medicines Agency (AIFA) is recommended.
