ACTIFED DECONGESTANT*SPRAY 10ML

ACTIFED DECONGESTIONANTE LENITIVO 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 facilitating breathing. ACTIFED DECONGESTIONANTE 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 due to rhinitis (e.g., common cold) or sinusitis.

What you need to know before taking the medicine
Do not use ACTIFED DECONGESTIONANTE in the following cases:
- allergy to xylometazoline or any of the other ingredients of this medicine (listed in paragraph 6);
- high eye pressure, especially in the presence of narrow-angle glaucoma;
- chronic rhinitis (long-term nasal irritation) with scant or no secretion (rhinitis sicca);
- if you are being treated with monoamine oxidase inhibitors (MAOIs) or have taken MAO inhibitors in the previous 2 weeks;
- if you are being treated with other medicines that may increase blood pressure;
- if you have inflammation caused by hypersensitivity of the blood vessels in the nose;
- if you have inflammation associated with thinning of the nasal membranes with or without secretion;
- if you have recently undergone brain surgery through the nose or mouth.

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 (adrenaline-like products), as the use of ACTIFED DECONGESTIONANTE may cause insomnia, dizziness, tremor or uncontrollable spasms, irregular heartbeat or abnormal heart rhythm or increased blood pressure;
- heart problems, if you suffer from heart disease (such as Long QT Syndrome), vascular problems, hypertension;
- overactive thyroid, diabetes or other metabolic problems;
- adrenal gland disorders;
- enlarged prostate (prostatic hypertrophy).

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

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

Stop using the nasal spray and seek medical attention immediately if you experience the following symptoms, which could indicate an allergic reaction:
• difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat;
• severe skin itching, with red rash or lumps.

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).

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 the use of the product.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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.