Stilla decongestant
Italy
Table of Contents
Package leaflet: Information for the patient
STILLA DECONGESTANT 50mg/100ml eye drops, solution
Tetrahydrozoline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What STILLA DECONGESTANT is and what it is used for
- What you need to know before using STILLA DECONGESTANT
- How to use STILLA DECONGESTANT
- Possible side effects
- How to store STILLA DECONGESTANT
- Contents of the pack and other information
1. What STILLA DECONGESTIONANTE is and what it is used for
STILLA DECONGESTIONANTE is an eye drop containing the active substance tetrizoline, which acts by decongesting the eye mucous membranes, thereby reducing inflammation and swelling.
STILLA DECONGESTIONANTE is used to relieve eye irritation, burning, redness, and itching caused by allergic or physical factors (excessive exposure to sunlight, snow glare, dazzling headlights during night driving, dust in the workplace, 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 substance or to any of the other ingredients of this medicine (listed in section 6).
- if you have glaucoma or other serious eye diseases.
- children under 3 years of age
Warnings and precautions
Talk to your doctor or pharmacist before using STILLA DECONGESTIONANTE.
- this medicine should be used with caution in patients with hypertension (high blood pressure), heart disorders, diabetes, hyperthyroidism, or in patients taking medications known as MAO inhibitors (Tranylcypromine, Phenelzine, Pargyline).
- if there are infections, pus, or foreign bodies in the eye; or if the eye has suffered mechanical, chemical, or thermal damage (such as contusions, abrasions, contact with harmful substances), this medicine should be used under strict medical supervision.
- if symptoms persist or worsen after a short period of treatment, consult a doctor.
- accidental oral intake in children may cause drowsiness, even profound, and muscle relaxation.
- wait at least 5 minutes between using the eye drops and inserting contact lenses.
For those engaged in sports activities: the product contains substances prohibited for doping.
Any use differing from the indication, dosage regimen, or route of administration specified in this
package leaflet is prohibited.
Other medicines and STILLA DECONGESTIONANTE
No interactions with other medicines have been reported; however, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
STILLA DECONGESTIONANTE with food, drinks and alcohol
This medicine does not interact with food, drinks or alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use STILLA DECONGESTIONANTE only if strictly necessary and under direct medical supervision.
Driving and using machines
STILLA DECONGESTIONANTE does not impair the ability to drive 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, which may impair 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 may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.
3. How to use STILLA DECONGESTIONANTE
Use this medicine exactly as stated in this leaflet or as directed 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 in each eye, administered
2–3 times daily. The product must not be used for more than 4 consecutive days.
Use in children
In children between 3 and 12 years of age, this medicine should be used only as directed by a doctor.
It must not be used in children under 3 years of age.
5 ml bottle and 8 ml bottle
To open the bottle, apply slight pressure on the side edges at the base of the cap (Fig. 1) and simultaneously lift (Fig. 2).
To dispense the drops, apply moderate pressure on the sides of the dropper while holding the bottle with the tip pointing downward.
To close the bottle, place the cap back on the dropper and press down on the top until you hear a clicking sound indicating closure.
After each use, ensure that the bottle is properly closed.
Fig 1 Fig 2
Do not exceed the recommended doses.
If you use more STILLA DECONGESTIONANTE than you should
Prolonged use of this product at excessive doses may lead to toxic effects.
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Paediatric population
In children, accidental ingestion of the medicine may cause drowsiness, even profound drowsiness, and excessive muscular relaxation.
Contact your doctor immediately or go to the nearest hospital.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following symptoms, STOP using STILLA DECONGESTIONANTE IMMEDIATELY: increased blood pressure, heart disturbances, or elevated blood glucose levels. These effects occur only at very high doses. However, in such cases, consult your doctor or go to the nearest hospital, where you will be given appropriate and specific treatment.
Other side effects that may occur with the use of STILLA DECONGESTIONANTE include pupil dilation, increased intraocular pressure, nausea, and headache. Hypersensitivity reactions may rarely occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 STILLA DECONGESTIONANTE
Store below 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 stated on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What STILLA DECONGESTIONANT contains
The active substance is tetrizoline hydrochloride.
The other components are:
Eye drops bottle
Boric acid, sodium tetraborate, sodium chloride, benzalkonium chloride, methylene blue, water for
injections.
Description of the appearance of STILLA DECONGESTIONANT and package contents
Eye drops bottle
Plastic bottle containing 5 or 8 ml of solution.
Marketing Authorization 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 viewing of a video screen, long night driving with exposure to headlights, being in the sun under conditions of high reflection (on the beach or on snow), or being in an environment containing airborne substances to which you are hypersensitive, may cause eye burning and redness. This irritation, characterized by itching, tearing, photophobia, burning, and foreign body sensation, may be a sign of allergic conjunctivitis. The first preventive measure to take is to avoid exposure to conditions or substances (if known) that trigger symptoms; when this is not possible, the use of vasoconstrictor medications may be helpful in controlling symptoms and shortening their duration.
Patient information leaflet
STILLA DECONGESTIONANTE 50 mg/100 ml eye drops, solution
Tetrahydrozoline hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.
Contents of this leaflet:
- What STILLA DECONGESTIONANTE is and what it is used for
- What you need to know before using STILLA DECONGESTIONANTE
- How to use STILLA DECONGESTIONANTE
- Possible side effects
- How to store STILLA DECONGESTIONANTE
- Contents of the pack and other information
1. What STILLA DECONGESTIONANTE is and what it is used for
STILLA DECONGESTIONANTE is an eye drop containing the active substance tetrizoline, which acts by decongesting the eye mucous membranes, thereby reducing inflammation and swelling.
STILLA DECONGESTIONANTE is used to relieve eye irritation, burning, redness, and itching caused by allergic or physical factors (excessive exposure to sunlight, glare from snow, bright headlights during night driving, dust in the workplace, 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 substance or to any of the other ingredients of this medicine (listed in section 6).
- if you have glaucoma or other serious eye diseases.
- children under 3 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using STILLA DECONGESTIONANTE.
- This medicine should be used with caution in patients suffering from hypertension (high blood pressure), heart disorders, diabetes, hyperthyroidism, and in patients taking medications known as MAO inhibitors (Tranylcypromine, Phenelzine, Pargyline).
- If there are infections, pus or foreign bodies in the eye, or if the eye has suffered mechanical, chemical or thermal damage (such as contusions, 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.
- Accidental oral ingestion in children may cause drowsiness, even profound, and muscle relaxation.
- The product is packaged in single sterile doses, each containing enough eye drops for one application to both eyes. The single-dose container protects the eye drops from any contamination and ensures sterility and stability without the need for preservatives; therefore, it can also be used by contact lens wearers. Wait 5 minutes between using the eye drops and inserting contact lenses.
For athletes: caution, the product contains substances prohibited for doping.
It is forbidden to take this product in a way different from the indication, dosage regimen and route of administration
described in this package leaflet.
Other medicines and STILLA DECONGESTIONANTE
No interactions with other medicines have been reported; however, inform your doctor or pharmacist
if you are taking, have recently taken, or might take any other medicines.
STILLA DECONGESTIONANTE with food, drinks and alcohol
This medicine does not interact with food, drinks or alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use STILLA DECONGESTIONANTE only if clearly needed and under direct medical supervision.
Driving and using machines
STILLA DECONGESTIONANTE does not impair the ability to drive or operate machinery.
STILLA DECONGESTIONANTE contains:
Boric Acid: Do not administer to children under 2 years of age, as this medicine contains boron, which may impair fertility in the future.
3. How to use STILLA DECONGESTIONANTE
Use this medicine exactly as stated in this leaflet or as directed 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, administered 2–3 times daily. The product must not be used for longer than 4 consecutive days.
Use in children
In children between 3 and 12 years of age, this medicine should only be used on medical advice. It must not be used in children under 3 years of age.
Single-dose containers of 0.3 ml
- Detach the individual vial with a downward motion, pulling it towards you.
- Gently tap the neck of the vial with the fingertip to prevent any liquid from remaining near the opening.
- To open the vial: gently twist the cap on itself and remove the neck of the vial.
- Instill the eye drops into the eye by repeatedly squeezing the base of the vial to facilitate the flow of liquid, even in the presence of air bubbles.
Do not exceed the recommended doses.
If you use more STILLA DECONGESTIONANTE than you should
If used for prolonged periods and at excessive doses, this product may cause toxic effects.
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Paediatric population
In children, accidental ingestion of the medicine may cause drowsiness, even profound, and excessive muscular relaxation. Contact your doctor immediately or go to the nearest hospital.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following symptoms, STOP using STILLA DECONGESTIONANTE immediately: increased blood pressure, heart disturbances, or increased blood sugar levels. These effects occur only with very high doses. However, in such cases, consult your doctor or go to the nearest hospital, where you will receive appropriate and specific treatment.
Other possible side effects with the use of STILLA DECONGESTIONANTE include pupil dilation, increased intraocular pressure, nausea, and headache.
Hypersensitivity reactions may rarely occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the following 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 DECONGESTIONANT
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.
6. Package contents and other information
What STILLA DECONGESTIONANT contains
The active substance is tetrizoline hydrochloride.
The other components are:
Eye drops, single-dose containers
Glycerol, boric acid, sodium borate, polysorbate 80, water for injections.
Description of the appearance of STILLA DECONGESTIONANT and package contents
Eye drops, single-dose containers
10 or 20 single-dose containers of 0.3 ml in plastic, contained in aluminium sachets.
Marketing Authorization 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 viewing of a video screen, driving for long periods at night with exposure to headlights, being in the sun where there is high reflection (on the beach or on snow), or being in an environment containing airborne substances to which you are sensitive, may cause eye burning and redness, sometimes accompanied by tearing, difficulty tolerating light, or a sensation of foreign body in the eye.
In these cases, the first measure to take is to prevent exposure to conditions or substances (if known) that trigger symptoms. When this is not possible, the use of vasoconstrictor medications may be helpful in controlling symptoms and shortening their duration.