DACRIOGEL 0.3% Ophthalmic gel

Зміст інструкції

1. DACRIOGEL 0.3 % Ophthalmic Gel
   1. What is DACRIOGEL and what is it used for
   2. What you need to know before you use DACRIOGEL
   3. How to use DACRIOGEL
   4. Possible side effects
   5. How to store DACRIOGEL
   6. Contents of the pack and other information
2. DACRIOGEL 0.3 % Ophthalmic Gel
   1. What is DACRIOGEL and what is it used for
   2. What you need to know before you use DACRIOGEL
   3. How to use DACRIOGEL
   4. Possible side effects
   5. How to store DACRIOGEL
   6. Contents of the pack and other information

DACRIOGEL 0.3 % Ophthalmic Gel

carbomer 974P
10 g tube
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 DACRIOGEL is and what it is used for
• 2. What you need to know before using DACRIOGEL
• 3. How to use DACRIOGEL
• 4. Possible side effects
• 5. How to store DACRIOGEL
• 6. Contents of the pack and other information

1. What is DACRIOGEL and what is it used for

DACRIOGEL contains the active ingredient carbomer 974P, which has a moisturizing and lubricating effect on the
surface of the eye.
DACRIOGEL is used for the treatment of all conditions characterized by insufficient or defective
hydration of the ocular surface, from red eye to dry eye.
See your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before you use DACRIOGEL

DO NOT use DACRIOGEL

• If you are allergic (hypersensitive) to carbomer or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Use DACRIOGEL only for application to the eyes.
• If you experience eye pain, changes in vision, eye irritation, persistent redness, or if the condition worsens or persists, stop treatment and consult your doctor.
• Do not use this medicine for prolonged treatments: after a short period of treatment without appreciable results, consult your doctor.
• Prolonged use of products for local use, such as DACRIOGEL, may give rise to sensitization phenomena (allergy); in this case, stop treatment and consult your doctor.
• Close the tube tightly after use and do not touch the ophthalmic tip, to avoid contaminating the product.

Children and adolescents up to 18 years:
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended dosage for
adults have been established by clinical experience, but data from clinical studies are not available.
In children, use DACRIOGEL if prescribed by a doctor, preferring the single-dose vial
formulation, without preservatives

Other medicines and DACRIOGEL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. If you are using other eye drops, gels or ointments, allow at least 5 minutes to pass between
the instillation of each medicine. Ophthalmic ointments and gels should be used last.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There are no data relating to the use of carbomer in pregnant women. However, effects are not expected
during pregnancy, as the amount of carbomer absorbed by the body should be
negligible. In addition, carbomer is an inactive substance that exerts a protective effect on the surface
of the eye
Dacriogel can be used during pregnancy.
Breastfeeding
It is not known whether carbomer or any of the other components are excreted in breast milk. However, effects on infants are not
expected, as the amount of carbomer absorbed by the body in breastfeeding women should be negligible. In addition, carbomer is an inactive substance that exerts a protective
effect on the surface of the eye.
Dacriogel can be used during breastfeeding.
Fertility
No data are available regarding the effect of this medicine on male or female fertility.

Driving and operating machinery
For a certain period of time after using DACRIOGEL, blurred vision may occur.
Do not drive or operate machinery until this effect has worn off.

DACRIOGEL contains approximately 0.0017 mg of benzalkonium chloride per drop equivalent to 0.05 mg/g.
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 reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the most superficial transparent 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 DACRIOGEL

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Use DACRIOGEL only for application to the eyes.

Recommended dose:instill one drop into the conjunctival sac up to 4 times a day.
The product can also be instilled more times a day, as judged by the doctor.
Do not exceed the recommended dose

Use in children and adolescents up to 18 years
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended dosage for adults have been established by clinical experience, but data from clinical studies are not available.

If you use more DACRIOGEL than you should
Given the characteristics of the product, toxic effects are not expected if you use more DACRIOGEL than you should, or even in case of accidental ingestion of the contents of a tube.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, DACRIOGEL can cause side effects, although not everybody gets them.
The side effects listed below have been detected with carbomer during clinical trials.
Very common side effects (may affect more than 1 in 10 people)

• Side effects on the eyes: blurred vision. Common side effects (may affect up to 1 in 10 people)
• Side effects on the eyes: eye discomfort, eyelid margin scabs, eye irritation. Uncommon side effects (may affect up to 1 in 100 people)
• Side effects on the eyes: periorbital edema (eye swelling), conjunctival edema (eye swelling), eye pain, eye itching, ocular hyperemia (eye redness), increased tearing.
• General side effects: contact dermatitis (skin inflammation).

Additional side effects detected during post-marketing experience, for which the frequency is not known.

• General side effects: hypersensitivity (allergy).

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 DACRIOGEL

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the tube and the package after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date stated refers to the product in intact packaging, correctly stored.
The product should not be used more than 15 days after first opening the container.
Medicines should not be disposed of via 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 DACRIOGEL contains

• The active ingredient is carbomer 974P. 1 gram of DACRIOGEL contains 3 mg of carbomer 974P.
• The other ingredients are: sorbitol, benzalkonium chloride, sodium hydroxide q.s. to pH 7.5, purified water q.s.

Description of the appearance of DACRIOGEL and contents of the pack
DACRIOGEL is a transparent and colorless gel. Each pack contains a 10 g plastic tube with an ophthalmic tip.

Marketing Authorisation Holder
Alcon Italia S.p.A.
Viale Giulio Richard 1/B
20143 Milano
Italy

Manufacturer
Alcon-Couvreur NV, 2870 PUURS, Belgium
Alcon Laboratories Belgium, 2870 Puurs-Sint-Amands, Belgium

DACRIOGEL 0.3 % Ophthalmic Gel

carbomer 974P
30 single-dose vials
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 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 DACRIOGEL is and what it is used for
• 2. What you need to know before using DACRIOGEL
• 3. How to use DACRIOGEL
• 4. Possible side effects
• 5. How to store DACRIOGEL
• 6. Contents of the pack and other information

1. What is DACRIOGEL and what is it used for

DACRIOGEL contains the active ingredient carbomer 974P, which has a moisturizing and lubricating effect on the
surface of the eye.
DACRIOGEL is used for the treatment of all conditions characterized by insufficient or defective
hydration of the ocular surface, from red eye to dry eye.
See your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before you use DACRIOGEL

DO NOT use DACRIOGEL

• If you are allergic (hypersensitive) to carbomer or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Use DACRIOGEL only for application to the eyes.
• If you experience eye pain, changes in vision, eye irritation, persistent redness, or if your condition worsens or persists, stop treatment and consult your doctor.
• Do not use this medicine for prolonged treatments: after a short period of treatment without appreciable results, consult your doctor.
• Prolonged use of products for local use, such as DACRIOGEL, may give rise to sensitization phenomena (allergy); in this case, stop treatment and consult your doctor.
• Instill the gel only if the single-dose vial is intact. Once the vial is opened, do not use the contents more than once and discard the excess product.

Children and adolescents up to 18 years:
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended dosage for
adults have been established by clinical experience, but data from clinical studies are not available.
DACRIOGEL single-dose vial does not contain preservatives and can be used in children if prescribed by a
doctor.

Other medicines and DACRIOGEL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. If you are using other eye drops, gels or ophthalmic ointments, allow at least 5 minutes to pass between
the instillation of each medicine. Ophthalmic ointments and gels should be used last.

Pregnancy, breastfeeding and fertility,
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.
Pregnancy
There are no data relating to the use of carbomer in pregnant women. However, effects are not expected
during pregnancy, as the amount of carbomer absorbed by the body should be
negligible. Furthermore, carbomer is an inactive substance that exerts a protective effect on the ocular
surface.
Dacriogel can be used during pregnancy.
Breastfeeding
It is not known whether carbomer or any of the other ingredients are excreted in breast milk. However, effects on infants are not
expected, as the amount of carbomer absorbed by the body in breastfeeding women should be negligible. Furthermore, carbomer is an inactive substance that exerts a protective effect on the ocular
surface.
Dacriogel can be used during breastfeeding.
Fertility
No data are available on the effect of this medicine on male or female fertility.

Driving and operating machinery
For a certain period of time after using DACRIOGEL, blurred vision may occur.
Do not drive or operate machinery until this effect has worn off.

3. How to use DACRIOGEL

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.
Use DACRIOGEL only for application to the eyes.

Recommended dose:instill one drop into the conjunctival sac up to 4 times a day.
The product may also be instilled more times a day, according to the doctor's judgement.
Do not exceed the recommended dose.

Use in children and adolescents up to 18 years
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended dosage for adults have been established by clinical experience, but data from clinical studies are not available.

If you use more DACRIOGEL than you should
Given the characteristics of the product, toxic effects are not expected if you use more DACRIOGEL than you should, or even in the event of accidental ingestion of the contents of a single-dose vial pack.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, DACRIOGEL can cause side effects, although not everybody gets them.
The side effects listed below have been detected with carbomer during clinical trials.
Very common side effects (may affect more than 1 in 10 people)

• Eye effects: blurred vision. Common side effects (may affect up to 1 in 10 people)
• Eye effects: eye discomfort, eyelid margin scabs, eye irritation. Uncommon side effects (may affect up to 1 in 100 people)
• Eye effects: periorbital edema (eye swelling), conjunctival edema (eye swelling), eye pain, eye itching, ocular hyperemia (eye redness), increased tearing.
• General side effects: contact dermatitis (skin inflammation).

Additional side effects detected during post-marketing experience, for which the frequency is not known.

• General side effects: hypersensitivity (allergy).

Reporting of side effects
If you get any side effects, talk to 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 DACRIOGEL

Keep this medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the vial and the package after “Expiry”.
The expiry date refers to the last day of that month.
The expiry date stated refers to the product in intact packaging, correctly stored.
Once the vial is opened, the contents must be used only once for a single patient: any excess product must be discarded.
Medicines should not be disposed of via drains 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 DACRIOGEL contains

• The active ingredient is carbomer 974P. 1 gram of DACRIOGEL contains: 3 mg of carbomer 974P.
• The other components are :sorbitol, sodium hydroxide q.s. to pH 7.5, purified water q.s.

Description of the appearance of DACRIOGEL and contents of the pack
DACRIOGEL is a transparent and colorless gel. Each pack contains 30 single-dose plastic vials
of 0.5 ml transparent.

Marketing Authorisation Holder
Alcon Italia S.p.A.
Viale Giulio Richard 1/B
20143 Milano
Italy

Manufacturer
Alcon-Couvreur NV, 2870 PUURS, Belgium
Alcon Laboratories Belgium, 2870 Puurs-Sint-Amands, Belgium