DICLOFTIL 0.1% Krople do oczu, roztwór

Treść ulotki

1. Dicloftil 0.1% eye drops, solution – 5 ml bottle
   1. What is Dicloftil and what is it used for
   2. What you need to know before using Dicloftil
   3. How to use Dicloftil
   4. Possible side effects
   5. How to store Dicloftil
   6. Package contents and other information
2. Dicloftil 0.1% eye drops, solution - 30 single-dose containers of 0.5 ml
   1. What is Dicloftil and what is it used for
   2. What you need to know before using Dicloftil
   3. How to use Dicloftil
   4. Possible side effects
   5. How to store Dicloftil
   6. Package contents and other information
3. Dicloftil 1mg/ml eye drops, solution
   1. What is Dicloftil and what is it used for
   2. What you need to know before using Dicloftil
   3. How to use Dicloftil
   4. Possible side effects
   5. How to store Dicloftil
   6. Package contents and other information

Dicloftil 0.1% eye drops, solution – 5 ml bottle

diclofenac

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.
• Talk to your doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

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

1. What is Dicloftil and what is it used for

Dicloftil is an eye drop that contains the active ingredient diclofenac. Dicloftil belongs to a category of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used for the treatment of inflammatory conditions, possibly painful, not of an infectious nature,
affecting the anterior segment of the eye, particularly for cataract surgery (reduction of transparency of
a part of the eye called the lens).
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using Dicloftil

Do not use Dicloftil

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) (acetylsalicylic acid, indometacin, etc.).
• if you have had asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other medicines that inhibit prostaglandin-synthetase.
• in children and adolescents under 14 years of age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using Dicloftil.
In the presence, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) must be administered simultaneously with Dicloftil
eye drops.
For better absorption of the product, allow at least 5 minutes to pass between applying
Dicloftil and another medicine.
Close the bottle immediately after use. The eye drops should not be used for more than 30 days after opening
the bottle (see “How to store Dicloftil”).
The bottle nozzle remains sterile until opening, avoid contact with the eye or with the ocular appendages
(eyelids, eyebrows, etc.) due to the risk of possible contamination.
In patients who present an increased risk of corneal diseases (the transparent front part
of the eye), for example during the use of steroids (medicines used to treat a large number of
conditions that cause inflammation), and in patients with concomitant diseases such as rheumatoid arthritis
(a chronic inflammatory disease that affects the joints), the use of diclofenac has been associated, in rare cases,
with the appearance of ulcerative keratitis (inflammation and lesions of the cornea) or corneal thinning,
punctate keratitis (another form of corneal inflammation), problems with the corneal epithelium (i.e. the
most superficial layer of the cornea) and corneal edema (swelling). Most patients who have
presented these complications have been treated for a very long period of time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be administered with caution
in conjunction with topical steroids (for local use).

Children and adolescents
Do not administer this medicine to children and adolescents under 14 years of age (see “Do not
use Dicloftil”).

Other medicines and Dicloftil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The concomitant use of topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and topical steroids
in patients with significant pre-existing corneal inflammation may increase the risk of developing
corneal damage, therefore such use should be done with caution.

Pregnancy, breastfeeding and fertility

Pregnancy
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 taking this medicine.
Dicloftil should not be used if you are in the last 3 months of pregnancy. Do not use Dicloftil during the first 6
months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary
during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known whether the
same risk applies when diclofenac is used in the eye.

Breastfeeding
The use of this medicine is not recommended during breastfeeding unless the expected benefits outweigh the
potential risks.

Fertility
This medicine contains boron and may impair fertility in the future. If you are pregnant, talk to your doctor
before taking this medicine as it contains boron which may be harmful to your baby.

Driving and using machines
Patients with scotomas (serious vision problems) should refrain from driving vehicles or using
machinery.

Dicloftil contains benzalkonium chloride and boric acid
This medicine contains 0.005 mg of benzalkonium chloride per drop (with a theoretical drop volume of
approximately 50 µL) equivalent to 0.1 mg/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 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 any abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.
This medicine contains boron and may impair fertility in the future. If you are pregnant, talk to your
doctor before taking this medicine as it contains boron which may be harmful to your baby.

3. How to use Dicloftil

The doserecommendedis 1 drop in the affected eye four times a day, or as prescribed
by your doctor.

Use in children and adolescents under 14 years of age:there is insufficient data on efficacy
and safety in children and adolescents under 14 years of age.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of eye drops containing diclofenac:

• mild or moderate transient burning sensation and/or scotomata (serious vision problems) immediately after use of the eye drops;
• eye pain and blurred vision immediately after use of the eye drops;

Rare(may affect up to 1 in 1,000 people)

• hypersensitivity reactions with itching and redness;
• increased sensitivity to sunlight (photosensitivity);
• difficulty breathing (dyspnea) and worsening of asthma;
• thinning and ulcers (lesions) of the cornea.

Frequency not known(the frequency cannot be estimated from the available data)

• redness of the eye (conjunctival hyperemia), inflammation of the membrane lining the white part of the eye and the inner surface of the eyelids (allergic conjunctivitis), red and swollen eyelids (palpebral erythema), eye allergy, swollen eyelids (palpebral edema), itching of the eyelids;
• allergic skin reaction (urticaria), change in color and appearance of the skin associated with irritation or swelling of the skin (skin rash), inflammatory skin reactions

(eczema), skin irritation (erythema), itching, excessive allergic-type sensitivity to one or more
substances (hypersensitivity);

• cough, allergic cold (rhinitis);
• disorders and inflammation of the cornea (punctate keratitis, ulcerative keratitis, epithelial defects, corneal edema) usually after frequent use of the eye drops;
• burning sensation in the eyes.

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 Dicloftil

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 packaging after “Scad.”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store the medicine at temperatures above 25°C.
The product must be used within 30 days after the first opening of the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Dicloftil contains

• The active ingredient is diclofenac. 100 ml of solution contains 100 mg of diclofenac sodium (equivalent to 93.084 mg of diclofenac).
• The other ingredients are: arginine, boric acid, borax, povidone, macrogolglycerol ricinoleate, benzalkonium chloride,disodium edetate, water for injections.

Description of the appearance of Dicloftil and package contents
Dicloftil is presented as eye drops, solution.
The package contains a 5 ml bottle.

Marketing authorisation holder and manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Sales representative: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Roma

Dicloftil 0.1% eye drops, solution - 30 single-dose containers of 0.5 ml

diclofenac

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 any 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 get worse.

Contents of this leaflet:

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

1. What is Dicloftil and what is it used for

Dicloftil is an eye drop that contains the active ingredient diclofenac. Dicloftil belongs to a category of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used for the treatment of inflammatory conditions, possibly painful, that are not infectious,
affecting the anterior segment of the eye, particularly for cataract surgery (reduction of transparency of
a part of the eye called the lens).
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using Dicloftil

Do not use Dicloftil

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) (acetylsalicylic acid, indometacin, etc.);
• if you have had asthmatic attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other medicines that inhibit prostaglandin synthesis;
• in children and adolescents under the age of 14 (see “Children and adolescents”)

Warnings and precautions
Consult your doctor or pharmacist before using Dicloftil.
Do not wear soft contact lenses during treatment with this medicine.
In the presence, or if there is a risk, of infection, appropriate therapy (e.g. antibiotics) must be administered simultaneously with Dicloftil
eye drops.
For better absorption of the product, allow at least 5 minutes to pass between applying
Dicloftil and another medicine.
In patients who present an increased risk of corneal diseases (the transparent front part
of the eye), for example during the use of steroids (medicines used to treat a large number of
conditions that cause inflammation), and in patients with concomitant diseases such as rheumatoid arthritis
(a chronic inflammatory disease that affects the joints), the use of diclofenac has been associated, in rare cases,
with the appearance of ulcerative keratitis (inflammation and lesions of the cornea) or corneal thinning,
punctate keratitis (another form of corneal inflammation), defects of the corneal epithelium (i.e. the most superficial layer of the cornea) and corneal edema (swelling). Most patients who have
presented these complications have been treated for a very long period of time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be administered with caution
in conjunction with topical steroids (for local use).

Children and adolescents
Do not administer this medicine to children and adolescents under the age of 14 (see “Do not
use Dicloftil”).

Other medicines and Dicloftil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The concomitant use of topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and topical steroids
in patients with significant pre-existing corneal inflammation may increase the risk of developing
corneal damage, therefore such use should be done with caution.
If you are undergoing another eye treatment at the same time, wait at least 5
minutes before applying another medicine.

Pregnancy, breastfeeding and fertility

Pregnancy
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 taking this medicine.
Dicloftil should not be used if you are in the last 3 months of pregnancy. Do not use Dicloftil during the first 6
months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary
during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known whether
the same risk applies when diclofenac is used in the eye.

Breastfeeding
The use of this medicine is not recommended during breastfeeding unless the expected benefits outweigh the
potential risks

Fertility
This medicine contains boron and may impair fertility in the future. If you are pregnant, talk to your doctor
before taking this medicine as it contains boron which may be harmful to your baby.

Driving and using machines
Patients with scotomas (serious vision problems) should refrain from driving vehicles or using
machinery.

Dicloftil contains boric acid
This medicine contains boron and may impair fertility in the future.
If you are pregnant, talk to your doctor before taking this medicine as it contains boron which may
be harmful to your baby.

3. How to use Dicloftil

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended doseis 1 drop in the affected eye four times a day, or as prescribed by your doctor.

Use in children and adolescents under 14 years of age:there is insufficient data on efficacy and safety in children and adolescents under 14 years of age.

If you use more Dicloftil than you should
There is practically no risk of adverse effects due to accidental oral ingestion of this medicine
as a pack of 30 single-dose containers contains only 15 mg of diclofenac sodium, which corresponds to,
approximately, 9% of the maximum daily dose of diclofenac sodium recommended for adults by oral route.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of eye drops containing diclofenac:

• mild or moderate transient burning sensation and/or scotomas (serious vision problems) immediately after using the eye drops;
• eye pain and blurred vision immediately after using the eye drops;

Rare(may affect up to 1 in 1,000 people)

• hypersensitivity reactions with itching and redness;
• increased sensitivity to sunlight (photosensitivity);
• difficulty breathing (dyspnea) and worsening of asthma;
• thinning and ulcers (lesions) of the cornea.

Frequency not known(the frequency cannot be estimated from the available data)

• redness of the eye (conjunctival hyperemia), inflammation of the membrane lining the white part of the eye and the inner surface of the eyelids (allergic conjunctivitis), red and swollen eyelids (palpebral erythema), eye allergy, swollen eyelids (palpebral edema), itching of the eyelids;
• allergic skin reaction (urticaria), change in color and appearance of the skin associated with irritation or swelling of the skin (skin rash), inflammatory skin reactions (eczema),

skin irritation (erythema), itching, excessive allergic-type sensitivity to one or more substances
(hypersensitivity);

• cough, allergic cold (rhinitis);
• corneal disorders and inflammation (punctate keratitis, ulcerative keratitis, epithelial defects, corneal edema) usually after frequent use of the eye drops,
• burning sensation in the eyes.

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 Dicloftil

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 packaging after “Scad.”. The expiry
date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store the medicine at temperatures above 25°C.
The shelf life of the single-dose containers after opening the sachet is 28 days.
Use Dicloftil immediately after opening the single-dose container. Dispose of the single-dose container and
any remaining product immediately after use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dicloftil contains

• The active substance is diclofenac. 1 ml of eye drops contains 1 mg of sodium diclofenac.
• The other ingredients are: arginine, boric acid, borax, povidone, ricinoleic acid macrogolglycerides, disodium edetate, water for injections.

Description of the appearance of Dicloftil and contents of the pack
Dicloftil is presented as eye drops, solution.
The pack contains 30 single-dose containers of 0.5 ml.

Marketing Authorisation Holder and Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Distributor for sales: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Roma

Dicloftil 1mg/ml eye drops, solution

Diclofenac

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Dicloftil and what is it used for

Dicloftil is an eye drop that contains the active ingredient diclofenac. Dicloftil belongs to a category of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used for the treatment of inflammatory conditions, possibly painful, of a non-
infectious nature, affecting the anterior segment of the eye, particularly for cataract surgery (reduction of
transparency of a part of the eye called the lens).

2. What you need to know before using Dicloftil

Do not use Dicloftil

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other non-steroidal anti-inflammatory drugs (acetylsalicylic acid, indometacin, etc.);
• if you have had asthmatic attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other medicines that inhibit prostaglandin synthesis;
• in children and adolescents under 14 years of age (see “Children and adolescents”);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Dicloftil.
Contact lenses should not be worn during treatment.
In the presence, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be administered simultaneously with
Dicloftil eye drops.
For better absorption of the product, allow at least 5 minutes to pass between applying
Dicloftil and another medicine.
Close the bottle immediately after use. After use and before recapping the bottle, to avoid residual drops remaining on the tip and to ensure the release of subsequent drops, it is recommended to shake the
bottle once downwards with a firm wrist movement, allowing the residual drops to fall.
During the operation, it is recommended to be careful not to touch the tip of the dropper.
The eye drops should not be used for more than 90 days after opening the bottle (see “How
to store Dicloftil”).
Avoid contact with the eye or with the ocular appendages (eyelids, eyebrows, etc.) due to the risk of potential
contamination.
In patients who present an increased risk of corneal diseases (the transparent front part
of the eye), for example during the use of steroids (medicines used to treat a large number
of conditions that cause inflammation), and in patients with concomitant diseases such as rheumatoid arthritis
(a chronic inflammatory disease that affects the joints), the use of diclofenac has been associated, in rare
cases, with the appearance of ulcerative keratitis (inflammation and lesions of the cornea) or corneal thinning, punctate keratitis (another form of corneal inflammation), problems with the corneal epithelium
(i.e. the most superficial layer of the cornea) and corneal edema (swelling). Most of the
patients who have presented these complications have been treated for a very long period of time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be administered with caution
in conjunction with topical steroids (for local use).
Careful administration is required for patients who are sensitive to silver.

Children and adolescents
Do not give this medicine to children and adolescents under 14 years of age (see “Do not
use Dicloftil”).

Other medicines and Dicloftil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The concomitant use of topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and topical steroids
in patients with significant pre-existing corneal inflammation may increase the risk of
developing corneal complications, therefore such use should be done with caution.

Dicloftil with food, drinks and alcohol
No interactions have been reported.

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 taking this medicine.
Dicloftil should not be used if you are in the last 3 months of pregnancy. Do not use Dicloftil during the first 6
months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary
during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known whether the
same risk applies with diclofenac when used in the eye.

Breastfeeding
The use of this medicine is not recommended during breastfeeding unless the expected benefits
outweigh the potential risks.

Fertility
This medicine contains boron and may impair fertility in the future.
If you are pregnant, talk to your doctor before taking this medicine as it contains boron which may be
harmful to your baby.

Driving and using machines
Patients with scotomas (visual field defects) should refrain from driving vehicles or using
machinery.

3. How to use Dicloftil

Use this medicine following the instructions of your doctor or pharmacist exactly.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop in the affected eye four times a day, or as prescribed
by your doctor.

Instructions for use:

• Press the cap of the bottle and turn it in the direction indicated by the arrow.
• Remove the cap.
• Hold the bottle upside down over the eye and instill the desired amount, then check that no residual drops remain on the tip.
• Replace the cap on the bottle.
• Screw the cap back on in the opposite direction to opening.
• Close the bottle carefully after each use; to avoid residual drops remaining on the tip, let them fall with a decisive wrist movement before closing the bottle.

Use in children and adolescents under 14 years of age:insufficient data are available on efficacy
and safety in children and adolescents under 14 years of age.

If you take more Dicloftil than you should
If you apply an excessive number of drops, wash your eye(s) with clean water and apply the next dose at the
usual time.

If you forget to take Dicloftil
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you stop taking Dicloftil
Dicloftil must be used following the instructions provided by your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of eye drops containing diclofenac:

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

• eye irritation

Uncommon(may affect up to 1 in 1,000 people)

• eye pain
• eye itching
• ocular hyperemia (increased blood flow to the eye)
• blurred vision immediately after instillation of the eye drops

Rare(may affect up to 1 in 1,000 people)

• hypersensitivity reactions with itching and redness
• increased sensitivity to sunlight (photosensitivity)
• difficulty breathing (dyspnea) and worsening of asthma
• thinning and ulcers (lesions) of the cornea
• Corneal edema (fluid accumulation between the layers of the cornea)
• Scotomas (visual field defects)

Frequency not known(the frequency cannot be estimated from available data)

• burning sensation in the eyes immediately after using the eye drops
• redness of the eye (conjunctival hyperemia)
• inflammation of the membrane lining the white part of the eye and the inner surface of the eyelids (allergic conjunctivitis)
• red and swollen eyelids (palpebral erythema)
• eye allergy
• swollen eyelids (palpebral edema)
• eyelid itching
• corneal deficiencies (reduced number of corneal cells)
• allergic skin reaction (urticaria)
• change in skin color and appearance associated with skin irritation or swelling (rash)
• inflammatory skin reactions (eczema)
• skin irritation (erythema)
• itching
• cough
• allergic cold (rhinitis)
• corneal disorders and inflammation (punctate keratitis)
• Burning sensation in the eyes

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Dicloftil

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 packaging after “Scad.”. The expiry
date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store the medicine at temperatures above 30°C.
The product must be used within 90 days after the first opening of the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Dicloftil contains

• The active substance is diclofenac. 1 ml of Dicloftil 1 mg/ml eye drops, solution contains 1 mg of diclofenac sodium equivalent to 0.9308 mg of diclofenac.
• The other ingredients are: arginine, boric acid, borax, povidone, macrogolglycerol ricinoleate, disodium edetate, water for injections.

Description of the appearance of Dicloftil and package contents
Dicloftil is presented as eye drops, solution.
The package contains a 10 ml bottle with Novelia dropper which does not contain preservatives.

Marketing authorisation holder and manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Sales representative: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Rome, Italy