STILLERGY 0.05% + 0.3% Eye drops, solution

Зміст інструкції

1. STILLERGY 0.05% + 0.3% eye drops, solution
   1. What is STILLERGY eye drops and what are they used for?
   2. What you need to know before you use STILLERGY eye drops
   3. How to use STILLERGY eye drops
   4. Possible side effects
   5. How to store STILLERGY eye drops
   6. Contents of the pack and other information
2. STILLERGY 0.05% + 0.3% eye drops, solution
   1. What is STILLERGY eye drops and what are they used for
   2. What you need to know before you use STILLERGY eye drops
   3. How to use STILLERGY eye drops
   4. Possible side effects
   5. How to store STILLERGY eye drops
   6. Contents of the pack and other information

STILLERGY 0.05% + 0.3% eye drops, solution

Tetrizoline hydrochloride and Pheniramine maleate

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 has
told you to.

• 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. See section 4.

Contents of this leaflet:

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

1. What is STILLERGY eye drops and what are they used for?

STILLERGY is a medicine with decongestant and anti-allergic action for the eye. It is used for the
treatment of symptoms caused by irritation and congestion of the conjunctiva, i.e. the inner lining
of the eye.

2. What you need to know before you use STILLERGY eye drops

Do not use STILLERGY eye drops

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from closed-angle glaucoma.
• Do not administer STILLERGY eye drops to children under 3 years of age due to the presence of boric acid

Warnings and precautions
Talk to your doctor or pharmacist before using STILLERGY eye drops.
Do not mix with other medicines, therefore do not instill simultaneously with other eye drops.
If you have glaucoma, other eye diseases, or have damage due to mechanical, chemical or physical
agents (heat), or, in any case, present symptoms other than simple redness of the eye (such as eye
discharge/tearing or a feeling of a foreign body) you should use the medicine only as prescribed by a
doctor.
The passage of medicines administered to the eye into the blood is very variable. There is a
possibility that a sufficient amount of drug is absorbed to cause undesirable effects at the level of
organs, or interactions with other medicines taken. For this reason, if you suffer from thyroid
diseases, heart diseases, high blood pressure, diabetes, or if you are taking medicines known as MAOIs
(monoamine oxidase inhibitors used for the treatment of depression), you can use the medicine only
after consulting your doctor.
If you use the medicine at higher dosages and for periods longer than those recommended, you may have
an increased risk of side effects.
If during treatment you feel eye pain or changes in vision, or if your symptoms worsen or persist for
more than 3 days, you should stop applying the eye drops and consult your doctor. Excessive use of
decongestant drugs (which constrict peripheral blood vessels) can cause an increase in eye redness.
If you wear contact lenses, you can use the medicine only after consulting your doctor.
Contact lenses (especially soft ones) should not be worn during treatment with medicines administered
directly into the eye. Possible side effects are less frequent when using single-dose eye drops without
preservatives.
This medicine contains an antihistamine (against allergy) that can reduce the frequency of your
heartbeat and the production of tears.

Children
The medicine contains boric acid, for this reason it should not be administered to children under 3
years of age.

Other medicines and STILLERGY eye drops
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Due to the possible passage of the medicine into the blood, interactions with other drugs cannot be
excluded; in particular, if you are undergoing therapy with MAOIs (monoamine oxidase inhibitors), you
can use the medicine only after consulting your doctor.

STILLERGY eye drops with food and drink and alcohol.
No incompatibilities to report.

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 for advice before taking STILLERGY eye drops.

Driving and operating machinery
negligible ability to drive vehicles or operate machinery.

STILLERGY contains:

• boric acid; borax: Do not administer to children under 2 years of age because this medicine contains boron and may compromise fertility in the future.
• benzalkonium chloride: This medicine contains 0.015 mg of benzalkonium chloride per single dose equivalent to 0.015 mg / 0.30 ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove the 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 outermost layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

3. How to use STILLERGY eye drops

Take this medicine exactly as described in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops 2-3 times a day. Do not exceed the recommended doses.
Do not use for more than 3-4 consecutive days, unless otherwise prescribed by your doctor.
Method of administration
Instill the medicine into the eye. After gently lowering the lower eyelid, let 1 drop of eye drops fall; avoid touching the surface of the eye with the dropper or with the single-dose container.
After application, keep your eyes closed for 1-2 minutes.
Instructions for use of the 5 and 8 ml Bottle
To open, you need to apply slight pressure on the side edges at the base of the cap (Fig.
1), and simultaneously lift the cap (Fig. 2). To allow the drops to flow out, apply moderate pressure on the walls of the dropper, holding the bottle with the tip pointing downwards.
To close the bottle, place the cap on the dropper and press on the top of it until you feel the click of the closure.

Use in children
The medicine cannot be used in children under 3 years of age; and may be used in pediatric age up to 12 years only after consulting a doctor.

If you take more STILLERGY eye drops than you should
If you instill more drops into the eye, consult your doctor.
Accidental ingestion of the medicine can cause, especially in more sensitive subjects (children, elderly, heart patients), undesirable effects such as drowsiness or dizziness of varying degrees, reduction of body temperature, decreased heart rate, decreased blood pressure, breathing difficulties and coma.
In case of accidental ingestion of the medicine, consult your doctor immediately, or go to the hospital.

If you forget to take STILLERGY eye drops
Do not take a double dose to make up for a missed dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects are: blurred vision, irritation of the
conjunctiva (the inner lining of the eye), burning of the eye, dilation of the pupil
(mydriasis). Occasionally: nausea, headache, increased blood pressure, weakness,
sweating, dizziness, altered heartbeat, tremors, insomnia, increased pressure
inside the eye.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 to provide more information on the safety
of this medicine.

5. How to store STILLERGY eye drops

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the package after Exp. The expiry
date refers to the last day of that month.
The medicine can no longer be used after 30 days from the first opening of the bottle.
Do not dispose of any medicine in 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 STILLERGY eye drops contain
The active ingredients are tetryzoline hydrochloride 0.5 mg; pheniramine maleate 3 mg, dissolved in 1 ml of
solution.
The other ingredients are boric acid, borax, benzalkonium chloride and water for injections.

Description of the appearance of STILLERGY eye drops and contents of the pack
5 and 8 ml plastic bottle (with a dropper, direct dispensing, applied to the bottle and
closing cap) contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer

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

ManufacturerTUBILUX S.p.A.
Via Costarica, 20/22
00071 Pomezia (Roma)
Secondary packaging, control and release also at:
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona

STILLERGY 0.05% + 0.3% eye drops, solution

Tetrizoline hydrochloride and Pheniramine maleate

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 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. See section 4.

Contents of this leaflet:

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

1. What is STILLERGY eye drops and what are they used for

STILLERGY is a medicine with decongestant and anti-allergic action for the eye. It is used for the
treatment of symptoms caused by irritation and congestion of the conjunctiva, i.e. the inner lining
of the eye.

2. What you need to know before you use STILLERGY eye drops

Do not take STILLERGY eye drops

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from closed-angle glaucoma.
• Do not administer STILLERGY eye drops to children under 3 years of age due to the presence of boric acid.

Warnings and precautions
Consult your doctor or pharmacist before using STILLERGY eye drops.
Do not mix with other medicines, therefore do not instill simultaneously with other eye drops.
If you suffer from glaucoma, other eye diseases, or have damage due to mechanical,
chemical or physical agents (heat), or, in any case, present symptoms other than simple redness of the eye
(such as eye discharge/tearing or a feeling of a foreign body), you should use the medicine
only under medical prescription.
The passage of medicines administered to the eye into the bloodstream is very variable. There is a
possibility that a sufficient amount of drug is absorbed to cause undesirable effects
at the level of organs, or interactions with other medicines taken. For this reason, if
you suffer from thyroid diseases, heart diseases, high blood pressure, diabetes, or if you are
taking medicines known as MAOIs (monoamine oxidase inhibitors used for the
treatment of depression) you can use the medicine only after consulting your doctor.
If you use the medicine at higher dosages and for periods longer than those recommended, you may have
an increased risk of side effects.
If during treatment you feel eye pain or changes in vision, or if your symptoms
worsen or persist for more than 3 days, you should stop applying the eye drops and consult
your doctor.
Excessive use of decongestant drugs (which constrict peripheral blood vessels) can cause an
increase in eye redness.
If you wear contact lenses, you can use the medicine only after consulting your doctor.
Contact lenses (especially soft ones) should not be worn during treatment
with medicines administered directly to the eye. Possible side effects are less
frequent when using single-dose eye drops without preservatives.
This medicine contains an antihistamine (against allergy) that can reduce the frequency of your
heartbeat and tear production.

Children
The medicine contains boric acid, therefore it should not be administered to children under 3
years of age.

Other medicines and STILLERGY eye drops
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Due to the possible passage of the medicine into the bloodstream, interactions with
other drugs cannot be ruled out; in particular, if you are undergoing therapy with MAOIs (monoamine oxidase inhibitors)
you can use the medicine only after consulting your doctor.

STILLERGY eye drops with food and drink and alcohol.
No incompatibilities to report.

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 for advice before using STILLERGY eye drops.

Driving and using machines
negligible ability to drive vehicles or use machinery.

STILLERGY contains:

• boric acid, borax: 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 STILLERGY eye drops

Take this medicine exactly as described in this leaflet or as instructed by your doctor. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1-2 drops 2-3 times a day. Do not exceed the recommended doses.
Do not use for more than 3-4 consecutive days, unless otherwise prescribed by your doctor.
Instructions for use of single-dose containers:

• 1) Separate the single container by applying an upward and downward movement, and pull towards yourself.
• 2) Gently tap the neck of the container with your fingertip to avoid the presence of liquid near the opening.
• 3) Gently rotate the cap on itself to open the container.

Instill the eye drops into the eye.
Press the container repeatedly at the base to facilitate the descent of the liquid, even in the presence of
air.
After gently lowering the lower eyelid, let 1 drop of eye drops fall; avoid
touching the surface of the eye with the dropper or with the single-dose container. After application
keep your eyes closed for 1-2 minutes.
The eye drops do not contain preservatives, therefore they must be used immediately after opening the
container, and any residue must no longer be used.
The amount of eye drops is sufficient for administration to both eyes.

Use in children
The medicine cannot be used in children under 3 years of age; and can be used in pediatrics up to 12 years of age only after consulting a doctor.

If you take more STILLERGY eye drops than you should
If you instill more drops into the eye, consult your doctor.
Accidental ingestion of the medicine can cause, especially in more sensitive subjects (children,
elderly, heart patients), undesirable effects such as drowsiness or dizziness of varying degrees, reduction
of body temperature, decreased heart rate, decreased
pressure, breathing difficulties and coma.
In case of accidental ingestion of the medicine, consult your doctor immediately, or go to
the hospital.

If you forget to take STILLERGY eye drops
Do not take a double dose to make up for a missed dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects are: blurred vision, irritation of the
conjunctiva (the inner lining of the eye), burning of the eye, dilation of the pupil
(mydriasis). Occasionally: nausea, headache, increased blood pressure, weakness,
sweating, dizziness, altered heartbeat, tremors, insomnia, increased pressure
inside the eye.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 to provide more information on the safety of this medicine.

5. How to store STILLERGY eye drops

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in 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 STILLERGY eye drops contain
The active ingredients are tetrizoline hydrochloride 0.5 mg; pheniramine maleate 3 mg, dissolved in 1 ml of
solution.
The other ingredients are boric acid, borax, polysorbate 80 and water for injections.

Description of the appearance of STILLERGY eye drops and contents of the pack
A pack of 20 single-dose containers of 0.3 ml.

Marketing Authorisation Holder and Manufacturer

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

ManufacturerA.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona
S.I.F.I. SpA
Via Ercole Patti, 36
95020 Lavinaio
Aci S.Antonio (CT)