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1. STILLA DECONGESTIONANTE 50mg/100ml eye drops, solution
   1. What is STILLA DECONGESTIONANTE and what is it for
   2. What you need to know before using STILLA DECONGESTIONANTE
   3. How to use STILLA DECONGESTIONANTE
   4. Possible side effects
   5. How to store STILLA DECONGESTIONANTE
   6. Contents of the pack and other information
2. STILLA DECONGESTIONANTE 50 mg/100 ml eye drops, solution
   1. What is STILLA DECONGESTIONANTE and what is it for
   2. What you need to know before using STILLA DECONGESTIONANTE
   3. How to use STILLA DECONGESTIONANTE
   4. Possible side effects
   5. How to store STILLA DECONGESTIONANTE
   6. Contents of the pack and other information

STILLA DECONGESTIONANTE 50mg/100ml eye drops, solution

Tetrizoline hydrochloride
Read this leaflet carefully before using this medicine as it contains
important information for you.
Always use 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.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is STILLA DECONGESTIONANTE and what is it for

STILLA DECONGESTIONANTE is an eye drop containing the active ingredient tetrizoline, which
acts by decongesting the mucous membranes of the eyes, that is, it reduces their inflammation and
swelling.
STILLA DECONGESTIONANTE is used to relieve irritation, burning,
redness, itching of the eye due to allergic or physical causes (excessive
exposure to sunlight, snow glare, headlight glare during night driving in
cars, dust in work environments, video screens, smoke or pollen).

2. What you need to know before using STILLA DECONGESTIONANTE

Do not use STILLA DECONGESTIONANTE

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from glaucoma or other serious eye diseases.
• children under the age of 3 years

Warnings and precautions
Consult your doctor or pharmacist before using STILLA DECONGESTIONANTE.

• the medicine should be used with caution in individuals suffering from hypertension (high blood pressure), heart disorders, diabetes, hyperthyroidism, and in patients taking drugs known as MAO inhibitors (Tranylcypromine, Phenelzine, Pargilline).
• if there are infections, pus or foreign bodies in the eye; or if the eye has suffered mechanical, chemical and thermal damage (such as bruises, abrasions, contact with harmful substances), the medicine should be used under strict medical supervision.
• if symptoms persist or worsen after a short period of treatment, consult a doctor.
• in children, accidental oral intake can cause drowsiness, even profound drowsiness and muscle relaxation.
• allow 5 minutes to pass between using the eye drops and applying contact lenses.

For those who play sports: the product contains substances prohibited for doping. It is
forbidden to take it differently than indicated, according to the dosage schedule and route of
administration compared to those reported in this leaflet. Other medicines and STILLA DECONGESTIONANTE
No interactions with other medicines have been observed; however, inform your doctor or
pharmacist if you are taking, have recently taken or may take any other
medicine.

STILLA DECONGESTIONANTE with food, beverages and alcohol
This medicine does not interact with food, beverages or alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use STILLA DECONGESTIONANTE only if
absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
STILLA DECONGESTIONANTE does not impair the ability to drive vehicles or operate
machinery.

STILLA DECONGESTIONANTE contains:

• Boric acid (and borates): Do not administer to children under 2 years of age as this medicine contains boron and may compromise fertility in the future.
• Benzalkonium chloride: This medicine contains 0.03 mg of benzalkonium chloride per dose equivalent to 0.03 mg / 0.30 ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent superficial layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use STILLA DECONGESTIONANTE

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for individuals over 12 years of age is 1 or 2 drops per eye, to be instilled
2-3 times a day. The product should not be used for more than 4 consecutive days.

Use in children
In children between 3 and 12 years of age, the medicine should be used only as directed by a doctor. It should
not be used in children under 3 years of age.

5 ml bottle and 8 ml bottle
To open the bottle, apply slight pressure to the side edges at the
base of the cap (fig. 1) and lift simultaneously (fig. 2). To release the drops, apply moderate pressure to the walls of the dropper, holding the
bottle with the tip pointing downwards. To close the bottle, place the cap on the
dropper, press on the top of it until you feel it click into place.
After application, ensure the bottle is closed.
Fig 1 Fig 2

Do not exceed the recommended doses.

If you use more STILLA DECONGESTIONANTE than you should
The product, if used for a long period at excessive doses, may cause
toxic effects.
In case of ingestion/accidental intake of an excessive dose of the product, immediately notify
your doctor, or go to the nearest hospital.

Paediatric population
In children, if accidentally ingested, the medicine may cause drowsiness, even
deep drowsiness, and excessive muscle relaxation. Immediately notify your doctor, or go
to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, STOP usingSTILLA
DECONGESTIONANTE immediately: increased blood pressure, heart problems or increased
blood sugar. These effects only occur with very high doses. However, in these
cases, consult your doctor or the nearest hospital where you will be given appropriate and
specific treatment.
Other side effects that may occur with the use of STILLA
DECONGESTIONANTE are pupil dilation, increased pressure inside
the eye, nausea and headache. Rarely, hypersensitivity reactions may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system available on the Italian Medicines Agency website 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 STILLA DECONGESTIONANTE

Store at a temperature not exceeding 25°C.
After first opening: store for a maximum of 28 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What STILLA DECONGESTIONANTE contains
The active ingredient is tetrizoline hydrochloride.
The other ingredients are:

Eye drops bottle
Boric acid, sodium tetraborate, sodium chloride, benzalkonium chloride, methylene blue, water for
injections.

Description of the appearance of STILLA DECONGESTIONANTE and contents of the
pack

Eye drops bottle
Plastic bottle containing 5 or 8 ml of solution.

Marketing Authorisation Holder and Manufacturer
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 ROMA

Manufacturer
TUBILUX S.p.A.
Via Costarica 20/22
00040 Pomezia (Roma)

Health Education Notes
Situations such as: prolonged screen viewing, long car journeys at night
exposed to headlight glare, being in the sun in situations of high reflection (on the beach or
on the snow), being in an environment where there are elements in the air to which you are
hypersensitive, can cause burning and redness of the eyes. This irritation,
characterized by itching, tearing, photophobia, burning, foreign body sensation, can
be a manifestation of allergic conjunctivitis. The first precaution to take, for
prevention, is to avoid exposure to the conditions or substances (if known) that
trigger the symptoms; when this is not possible, the use of vasoconstrictor drugs can
be useful to control the symptoms and shorten their duration.

STILLA DECONGESTIONANTE 50 mg/100 ml eye drops, solution

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

• 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 a short period of treatment.

Contents of this leaflet:

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

1. What is STILLA DECONGESTIONANTE and what is it for

STILLA DECONGESTIONANTE is an eye drop containing the active ingredient tetrizoline, which acts
by decongesting the mucous membranes of the eyes, that is, it reduces inflammation and swelling.
STILLA DECONGESTIONANTE is used to relieve irritation, burning, redness, itching
of the eye due to allergic or physical causes (excessive exposure to sunlight, glare from
snow, headlights during night driving, dust in work environments, video screens, smoke or pollen).

2. What you need to know before using STILLA DECONGESTIONANTE

Do not use STILLA DECONGESTIONANTE

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from glaucoma or other serious eye diseases.
• children under the age of 3 years.

Warnings and precautions
Consult your doctor or pharmacist before using STILLA DECONGESTIONANTE.

• The drug must be used with caution in subjects suffering from hypertension (high blood pressure), heart disorders, diabetes, hyperthyroidism, and in patients taking drugs known as MAO inhibitors (Tranylcypromine, Phenelzine, Pargilline).
• If infections, pus or foreign bodies are present in the eye, or if the eye has suffered mechanical, chemical or thermal damage (such as contusions, abrasions, contact with harmful substances), the drug should be used under strict medical supervision.
• If symptoms persist or worsen after a short period of treatment, consult a doctor.
• In children, accidental oral intake may cause drowsiness, even profound, and muscle relaxation.
• The product is packaged in single sterile doses, each of which contains the amount of eye drops sufficient for one application to both eyes. The single-dose packaging protects the eye drops from any contamination, and ensures its sterility and stability without the need for preservatives, so it can also be used by contact lens wearers. Allow 5 minutes to pass between using the eye drops and applying contact lenses.

For those who play sports: attention, the product contains substances prohibited for doping. It is
forbidden to take it differently from the indication, dosage regimen and route of administration
than those reported in this leaflet.
Other medicines and STILLA DECONGESTIONANTE
No interactions with other medicines have been observed; however, inform your doctor or pharmacist
if you are taking, have recently taken or might take any other medicine.

STILLA DECONGESTIONANTE with food, beverages and alcohol
This medicine does not interact with food, beverages or alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use STILLA DECONGESTIONANTE only if absolutely
necessary and under the direct supervision of a doctor.

Driving and operating machinery
STILLA DECONGESTIONANTE does not impair the ability to drive vehicles or operate machinery.

STILLA DECONGESTIONANTE contains:
Boric Acid: Do not administer to children under 2 years of age as this medicine
contains boron and may compromise fertility in the future.

3. How to use STILLA DECONGESTIONANTE

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for individuals over 12 years of age is 1 or 2 drops per eye, to be instilled 2-3 times
a day. The product should not be used for more than 4 consecutive days.

Use in children
In children between 3 and 12 years of age, the medicine should only be used as directed by a doctor. It should not be
used in children under 3 years of age.

Single-dose containers of 0.3 ml

• 1) Detach the single ampoule by applying an upward and downward movement and pulling it towards you.

• 2) Gently tap the neck of the ampoule with your fingertip to avoid the presence of liquid near the opening.
• 3) To open the ampoule: gently rotate the cap on itself and remove the neck of the ampoule

• 4) Then instill the eye drops into the eye by repeatedly pressing the ampoule at the base to facilitate the descent of the liquid even in the presence of air bubbles.

Do not exceed the recommended doses.

If you use more STILLA DECONGESTIONANTE than you should
The product, if used for a long period at excessive doses, may determine toxic phenomena.
In case of ingestion/accidental intake of an excessive dose of the product, immediately notify your
doctor, or go to the nearest hospital.

Paediatric population
In children, if accidentally ingested, the medicine may determine drowsiness, even profound, and
excessive muscle relaxation. Immediately notify your doctor, or go to the nearest
hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, STOP usingSTILLA
DECONGESTIONANTE immediately: increased blood pressure, heart problems or increased
blood sugar. These effects only occur with very high doses. However, in these cases, consult your
doctor or the nearest hospital where they will provide appropriate and specific treatment.
Other side effects that may occur with the use of STILLA DECONGESTIONANTE are
pupil dilation, increased pressure inside the eye, nausea and headache.
Rarely, hypersensitivity reactions may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact
your doctor or pharmacist. You can also report side effects directly via the
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 STILLA DECONGESTIONANTE

Store at a temperature not exceeding 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What STILLA DECONGESTIONANTE contains
The active ingredient is tetrizoline hydrochloride.
The other ingredients are:

Eye drops single-dose containers
Glycerol, boric acid, sodium borate, polysorbate 80, water for injections.

Description of the appearance of STILLA DECONGESTIONANTE and contents of the pack

Eye drops single-dose containers
10 containers or 20 single-dose containers of 0.3 ml in plastic material, contained in sachets of
aluminium.

Marketing Authorisation Holder and Manufacturer
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 ROMA

Manufacturers
LABORATOIRE UNITHER 1 Rue De L’Arquerie
50200 Coutances – France

Health Education Notes
Situations such as prolonged focus on a video screen, driving for long periods at night while exposed to light
from headlights, staying in the sun where there is high glare (on the beach or in the snow), or staying in an environment
where there are elements in the air to which you are sensitive, can cause burning and
redness of the eyes, sometimes accompanied by tearing, difficulty looking at the light, or
foreign body sensation.
In these cases, the first precaution to take is to prevent exposure to the conditions or substances (if known) that trigger the symptoms. When this is not possible, the use of vasoconstrictor drugs may be useful to control the symptoms and shorten their duration.