Name
ACTIFED SOOTHING DECONGESTANT 1 mg/50 mg/ml nasal spray, solution
Xylometazoline hydrochloride/Dexpanthenol


What it is and what it is used for
ACTIFED DECONGESTIONANTE contains xylometazoline, a substance that helps to constrict the blood vessels in the nose, reducing swelling of the nasal mucosa (the inner lining of the nose), and making breathing easier. ACTIFED DECONGESTIONANTE 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 due to rhinitis (e.g. cold) or sinusitis.


What you need to know before taking the medicine
Do not use ACTIFED DECONGESTANT in the following cases:
- allergy to xylometazoline or any of the other ingredients of this medicine (listed in section 6);
- high eye pressure, especially in the presence of narrow-angle glaucoma;
- chronic rhinitis (long-lasting nasal irritation) with little or no secretion (dry rhinitis);
- you are being treated with monoamine oxidase inhibitors (MAOIs) or have taken MAO inhibitors in the previous 2 weeks;
- you are taking other medicines that can increase blood pressure;
- there is inflammation caused by hypersensitivity of the blood vessels in the nose;
- there is inflammation associated with thinning of the nasal membranes with or without secretion;
- have recently had nasal or oral brain surgery.

This spray should not be used in children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before using this spray in the following cases:
- marked reaction to sympathomimetic agents (products similar to adrenaline), as the use of ACTIFED DECONGESTIONANTE may cause insomnia, dizziness, uncontrollable tremors or spasms, irregular heartbeat or abnormal heart rhythm or increased blood pressure;
- heart problems, suffer from heart disease (such as Long QT Syndrome), vascular problems, high blood pressure;
- overactive thyroid, diabetes or other metabolic problems;
- adrenal gland diseases;
- enlargement of the prostate (prostatic hypertrophy).

Continued use of the product for long periods may lead to worsening of congestion symptoms.


Possible side effects
Like all medicines, ACTIFED DECONGESTANT can cause side effects, although not everybody gets them.

Stop using the nasal spray and contact your doctor immediately if you experience any of the following symptoms that may 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 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 lining of the nose (nasal mucosa).

Uncommon (may affect up to 1 in 100 people):
• nosebleeds (epistaxis).

Rare (may affect up to 1 in 1,000 people):
• headache, increased blood pressure, nervousness, feeling unwell, dizziness, insomnia and palpitations;
• systemic allergic reactions and temporary vision changes.

Not known (frequency cannot be estimated from the available data):
• worsening of nasal congestion symptoms after stopping use of the product.

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: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.