Dacriogel

Package leaflet: Information for the patient

DACRIOGEL 0.3% Ophthalmic Gel

carbomer 974P
10 g tube
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 would like more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms 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 DACRIOGEL is and what it is used for

DACRIOGEL contains the active substance carbomer 974P, which has moisturizing and lubricating properties for 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.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before using 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 ocular application.
• 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 noticeable improvement, consult your doctor.
• Prolonged use of locally applied products, such as DACRIOGEL, may lead to sensitization (allergic reactions); in such cases, discontinue treatment and consult your doctor.
• Close the tube carefully after use and do not touch the eye tip to avoid contaminating the product.

Children and adolescents up to 18 years of age:
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended adult dosage have been established based on clinical experience, but no data from clinical trials are available.
In children, use DACRIOGEL only if prescribed by a doctor, preferably using the preservative-free single-dose vial formulation.

Other medicines and DACRIOGEL
Inform 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, wait at least 5 minutes between each medication. Ophthalmic ointments and gels should be used last.

Pregnancy, breastfeeding, and fertility

Pregnancy
There are no data on the use of carbomer in pregnant women. However, no adverse effects are expected during pregnancy, since the amount of carbomer absorbed systemically should be negligible. Furthermore, carbomer is an inactive substance that provides protective effects on the ocular surface.
DACRIOGEL may be used during pregnancy.

Breastfeeding
It is not known whether carbomer or any of the other ingredients are excreted in breast milk. However, no effects on breastfed infants are expected, since the amount of carbomer absorbed systemically in breastfeeding women should be negligible. In addition, carbomer is an inactive substance that exerts a protective effect on the ocular surface.
DACRIOGEL may be used during breastfeeding.

Fertility
There are no data available on the effect of this medicine on male or female fertility.

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

DACRIOGEL contains approximately 0.0017 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use DACRIOGEL

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.
Use DACRIOGEL only for ocular application.
Recommended dose: instill one drop into the conjunctival sac up to four times a day.
The product may also be administered more frequently, according to the physician's judgment.
Do not exceed the recommended dose.
Use in children and adolescents up to 18 years of age
The safety and efficacy of DACRIOGEL in children and adolescents at the adult recommended dosage have been established based on clinical experience, although data from clinical trials are not available.
If you use more DACRIOGEL than you should
Due to the characteristics of the product, toxic effects are not expected if you use more DACRIOGEL than recommended, nor in case of accidental ingestion of the contents of a tube.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DACRIOGEL may cause side effects, although not everybody gets them.
The side effects listed below have been observed with carbomer during clinical studies.

Very common side effects (may affect more than 1 in 10 people)

• Eye-related side effects: blurred vision.

Common side effects (may affect up to 1 in 10 people)

• Eye-related side effects: eye discomfort, eyelid margin crusting, eye irritation.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye-related side effects: periorbital edema (swelling around the eyes), conjunctival edema (swelling of the eyes), eye pain, eye pruritus (itching), ocular hyperemia (eye redness), increased lacrimation (excessive tearing).
• General side effects: contact dermatitis (skin inflammation).

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

• General side effects: hypersensitivity (allergy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 below 25°C.
Do not use this medicine after the expiry date stated on the tube and the carton after “Exp.”.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original packaging, stored correctly.
The product must not be used more than 15 days after first opening the container.
Medicines must 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. Package contents and other information

What DACRIOGEL contains

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

Description of the appearance of DACRIOGEL and pack contents
DACRIOGEL is a transparent, colourless gel. Each package contains a 10 g plastic tube with an ophthalmic tip.
Marketing Authorization Holder
Alcon Italia S.p.A.
Viale Giulio Richard 1/B
20143 Milan
Italy
Manufacturer
Alcon-Couvreur NV, 2870 Puurs, Belgium
Alcon Laboratories Belgium, 2870 Puurs-Sint-Amands, Belgium

Package leaflet: information for the patient

DACRIOGEL 0.3% Ophthalmic Gel

carbomer 974P
30 single-dose containers
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 to do.

• 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, 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 DACRIOGEL is and what it is used for

DACRIOGEL contains the active substance carbomer 974P, which has moisturizing and lubricating effects 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.
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before using 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 ocular application.
• 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 treatment: after a short period of treatment without noticeable improvement, consult your doctor.
• Prolonged use of locally applied products, such as DACRIOGEL, may lead to sensitization (allergy); if this occurs, discontinue treatment and consult your doctor.
• Instill the gel only if the single-dose vial is intact. Once the vial has been opened, do not use its contents more than once and discard any remaining product.

Children and adolescents up to 18 years of age:
The safety and efficacy of DACRIOGEL in children and adolescents at the dosage recommended for adults have been established based on 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
Inform 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, wait at least 5 minutes between the instillation of each medication. Ophthalmic ointments and gels should be used last.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
There are no data regarding the use of carbomer in pregnant women. However, effects during pregnancy are not expected, as the amount of carbomer absorbed systemically should be negligible. Moreover, carbomer is an inactive substance that provides protective action on the ocular surface.
DACRIOGEL may 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 breastfed infants are not expected, as the amount of carbomer absorbed systemically in breastfeeding women should be negligible. Moreover, carbomer is an inactive substance that provides protective action on the ocular surface.
DACRIOGEL may be used during breastfeeding.

Fertility
There are no data available on the effect of this medicine on male or female fertility.

Driving and using machines
For a certain period after using DACRIOGEL, blurred vision may occur. Do not drive or operate machinery until this effect has disappeared.

3. How to use DACRIOGEL

Use this medicine 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 ocular application.
Recommended dose: instill one drop into the conjunctival sac up to four times a day.
The product may also be administered more frequently, according to the physician's judgment.
Do not exceed the recommended dose.
Use in children and adolescents under 18 years of age
The safety and efficacy of DACRIOGEL in children and adolescents at the recommended adult dosage have been established based on clinical experience, but data from clinical trials are not available.
If you use more DACRIOGEL than you should
Due to the characteristics of the product, toxic effects are not expected if you use more DACRIOGEL than recommended, nor in case of accidental ingestion of the contents of a single-dose vial.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DACRIOGEL may cause side effects, although not everybody experiences them.
The side effects listed below have been reported with carbomer during clinical studies.

Very common side effects (may affect more than 1 in 10 people)

• Eye disorders: blurred vision.

Common side effects (may affect up to 1 in 10 people)

• Eye disorders: eye discomfort, eyelid margin crusting, eye irritation.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye disorders: periorbital oedema (swelling around the eyes), conjunctival oedema (swelling of the eyes), eye pain, eye pruritus, ocular hyperaemia (redness of the eyes), increased lacrimation.

General side effects:

• Contact dermatitis (skin inflammation).

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

• General disorders: hypersensitivity (allergy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 below 25°C.
Do not use this medicine after the expiry date stated on the vial and on the carton after “Expiry”.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging and correctly stored.
After opening the vial, the contents must be used only once for a single patient: any unused portion must be discarded.
Medicines must not be disposed of 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 DACRIOGEL contains

• The active substance 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, colourless gel. Each pack contains 30 single-dose plastic ampoules of 0.5 ml.
Marketing Authorization 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