ACTIFED 1 mg /Ml Spray Do Nosa, Roztwór

Treść ulotki

1. ACTIFED DECONGESTIONANTE
   1. WHAT IS ACTIFED DECONGESTANT AND WHAT IS IT FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING ACTIFED DECONGESTANT
   3. HOW TO USE ACTIFED DECONGESTIONANTE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ACTIFED DECONGESTIONANTE
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

ACTIFED DECONGESTIONANTE

"1 mg/ml NASAL SPRAY, SOLUTION"
( xylometazoline hydrochloride)

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What ACTIFED DECONGESTIONANTE is and what it is used for
• 2. What you need to know before using ACTIFED DECONGESTIONANTE
• 3. How to use ACTIFED DECONGESTIONANTE
• 4. Possible side effects
• 5. How to store ACTIFED DECONGESTIONANTE
• 6. Contents of the pack and other information

1. WHAT IS ACTIFED DECONGESTANT AND WHAT IS IT 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 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 MAOIs in the previous 2 weeks
• you are being treated with other medicines that can increase blood pressure
• you have inflammation caused by hypersensitivity of the nasal blood vessels
• you have inflammation associated with thinning of the nasal membranes with or without secretion
• you have recently undergone surgery on the brain via the nasal or oral route. This spray should not be used in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist beforeusing this spray in the following cases:

• marked reaction to sympathomimetic agents (products similar to adrenaline), as the use of ACTIFED DECONGESTANT may cause insomnia, dizziness, tremor or uncontrollable spasms, irregular heartbeat or abnormal heart rhythm, or increased blood pressure.
• heart problems, suffer from a heart disease (such as Long QT syndrome), vascular problems, hypertension
• hyperthyroidism, diabetes or other metabolic problems
• adrenal gland disorders
• enlarged prostate (prostatic hypertrophy).

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

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 drugs, such as tricyclic or tetracyclic antidepressants or MAOIs, or if MAOIs have been taken in the last 2 weeks (see section “Do not use”);
• other medicines that can increase blood pressure.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, 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.
During breastfeeding, consult your doctor before using this medicine.
It is not known whether the active ingredient passes into breast milk.

Driving and using machines
ACTIFED DECONGESTANT has no known effects on the ability to drive vehicles or operate machinery.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

3. HOW TO USE ACTIFED DECONGESTIONANTE

Adults and children over 12 years of age.
Unless otherwise indicated by the doctor or pharmacist, it is recommended to administer
ACTIFED DECONGESTIONANTE into each nostril up to 3 times a day for a maximum of 7 days.

• 1. Remove the protective cap. Activate the bottle before use by pressing several times until a uniform spray of the solution is released (see Figure 1). At this point the inhaler is ready for use.
• 2. Hold the inhaler in a vertical position. Insert the nozzle into the nostril - do not spray outside the nose (see Figure 2).
• 3. Press once. Breathe in through the nose during vaporisation. Repeat the operation in the other nostril.
• 4. After use, replace the cap on the bottle.

To reduce the risk of infection, the bottle should 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 DECONGESTIONANTE than you should
Seek immediate medical advice, from your pharmacist or go to the nearest emergency room taking with you the

If you forget to use ACTIFED DECONGESTIONANTE
If you forget a dose, take it as soon as possible, but if the time for the next dose is near,
skip the missed dose and continue as normal. Do not take a double dose to make up for the
forgotten dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ACTIFED DECONGESTIONANTE may cause side effects, although not
everyone gets them.

Stop using the nasal spray and seek immediate medical attentionif 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 a red rash or swellings

Other side effects include:
Common(may affect up to 1 in 10 people):
a stinging or burning sensation in the nose and throat and dryness of the lining of the nose (nasal
mucosa).

Rare(may affect up to 1 in 1,000):

• headache, increased blood pressure, nervousness, feeling unwell, dizziness, insomnia and palpitations
• systemic allergic reactions and temporary changes in vision.

Not known(frequency cannot be estimated from available data):

• worsening of nasal congestion symptoms after stopping use of the product;
• nosebleeds.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE ACTIFED DECONGESTIONANTE

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 25°C.
Once the package is opened, DO NOT use ACTIFED DECONGESTIONANTE for more than 12 months.
Do not use ACTIFED DECONGESTIONANTE after the expiry date stated on the packaging.
Do not dispose of any medicine in drain water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ACTIFED DECONGESTANT contains
The active ingredientis xylometazoline hydrochloride, in the amount of 1 mg per millilitre of solution. Each
spray dose of ACTIFED DECONGESTANT (= 140 microlitres) contains 140 micrograms of
xylometazoline hydrochloride.
The other ingredientsare: sodium hyaluronate, sorbitol (E420), glycerol (E422), disodium hydrogen phosphate
dihydrate, disodium phosphate dihydrate, sodium chloride and water for injections.

Description of the appearance of ACTIFED DECONGESTANT and contents of the pack
The spray is a clear to slightly opalescent, colourless or slightly yellowish solution contained in
a white plastic bottle of 10 ml with a dosing pump.

Marketing Authorisation Holder
Johnson & Johnson S.p.A.
Via Ardeatina Km 23,500 – 00071 Santa Palomba, Pomezia (Roma)

Manufacturer responsible 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
Detailed and updated information on this medicinal product is available by scanning the QR Code
on the outer packaging with a smartphone. The information is also available on the Bank