Dicloftil

Package leaflet: Information for the patient

Dicloftil 0.1% eye drops, solution – 5 ml bottle

diclofenac
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, contact 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.

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 Dicloftil is and what it is used for

Dicloftil is an eye drop medication containing the active substance diclofenac. Dicloftil belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used to treat inflammatory conditions, possibly associated with pain, affecting the anterior segment of the eye, particularly following cataract surgery (reduction in transparency of a part of the eye called the crystalline lens).
If you do not notice any improvement or if your symptoms worsen, consult your doctor.

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 (NSAIDs) (acetylsalicylic acid, indometacin, etc.);
• if you have experienced asthma attacks, urticaria, or acute rhinitis after taking acetylsalicylic acid or other medicines that inhibit prostaglandin synthase;
• in children and adolescents under 14 years of age (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using Dicloftil.
If an infection is present or there is a risk of infection, appropriate treatment (e.g. antibiotics) should be administered concurrently with Dicloftil eye drops.
To ensure optimal absorption of the product, wait at least 5 minutes between the application of Dicloftil and any other eye medication.
Close the bottle immediately after use. The eye drops must not be used for more than 30 days after opening the bottle (see "How to store Dicloftil").
The dropper tip of the bottle remains sterile until first opening. Avoid contact with the eye or ocular tissues (eyelids, eyebrows, etc.) to prevent possible contamination.
In patients at increased risk of corneal diseases (the transparent front part of the eye), for example during treatment with corticosteroids (medicines used to treat a wide range of inflammatory conditions), and in patients with concomitant diseases such as rheumatoid arthritis (a chronic inflammatory disease affecting the joints), the use of diclofenac has been rarely associated with the development of ulcerative keratitis (inflammation and lesions of the cornea), corneal thinning, punctate keratitis (another form of corneal inflammation), epithelial disorders of the cornea (i.e. the outermost layer of the cornea), and corneal edema (swelling). Most patients who developed these complications had been treated for a very long time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be administered with caution when used concomitantly with topical corticosteroids (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
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Concomitant use of topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and topical corticosteroids in patients with significant pre-existing corneal inflammation may increase the risk of corneal damage; therefore, such use should be approached with caution.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Dicloftil must not be used during the last three months of pregnancy. Do not use Dicloftil during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies when diclofenac is used in the eye.

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

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

Driving and use of machinery
Patients experiencing scotomas (serious vision problems) should refrain from driving vehicles or operating 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 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.
This medicine contains boron and may impair fertility in the future. If you are pregnant, speak with your doctor before taking this medicine, as it contains boron, which may be harmful to your unborn child.

3. How to use Dicloftil

The recommended dose is 1 drop in the affected eye four times daily, or as prescribed by the physician.

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 have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 (frequency cannot be estimated from the available data)

• Eye redness (conjunctival hyperemia), inflammation of the membrane covering the white part of the eye and the inner surface of the eyelids (allergic conjunctivitis), red and swollen eyelids (eyelid erythema), eye allergy, swollen eyelids (eyelid edema), eyelid itching;
• Skin allergic reaction (urticaria), change in skin color and appearance associated with skin irritation or swelling (rash), inflammatory skin reactions (eczema), skin irritation (erythema), itching, increased allergic sensitivity to one or more substances (hypersensitivity);
• Cough, allergic 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 Dicloftil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dicloftil contains

• The active substance is diclofenac. 100 ml of solution contain 100 mg of sodium diclofenac (equivalent to 93.084 mg of diclofenac).
• The other components are: arginine, boric acid, borax, povidone, macrogol glycerol hydroxystearate, benzalkonium chloride, disodium edetate, water for injections.

Description of the appearance of Dicloftil and contents of the pack
Dicloftil is an ophthalmic solution.
The pack contains one 5 ml bottle.
Marketing Authorization Holder and Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Sole Distributor: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Roma

Patient information leaflet

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

diclofenac
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

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 Dicloftil is and what it is used for

Dicloftil is an eye drop solution containing the active substance diclofenac. Dicloftil belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used to treat non-infectious inflammatory conditions, possibly associated with pain, affecting the anterior segment of the eye, particularly following cataract surgery (reduction in 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 to 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, indomethacin, etc.);
• if after taking acetylsalicylic acid or other prostaglandin-synthetase inhibitors you have experienced asthma attacks, urticaria, or acute rhinitis;
• in children and adolescents under 14 years of age (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using Dicloftil.
During treatment with this medicine, do not wear soft contact lenses.
If an infection is present or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be administered concurrently with Dicloftil eye drops.
To ensure optimal absorption of the product, wait at least 5 minutes between the application of Dicloftil and any other eye medicine.
In patients at increased risk of corneal disease (the transparent front part of the eye), for example during treatment with corticosteroids (medicines used to treat a wide range of inflammatory conditions), and in patients with concomitant diseases such as rheumatoid arthritis (a chronic inflammatory disease affecting the joints), the use of diclofenac has been associated, in rare cases, with the development of ulcerative keratitis (inflammation and lesions of the cornea), corneal thinning, punctate keratitis (another form of corneal inflammation), corneal epithelial defects (i.e. defects in the outermost layer of the cornea), and corneal edema (swelling). Most patients who developed these complications had been treated for a very long time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be used with caution when administered concomitantly with topical corticosteroids (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
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
The concomitant use of topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and topical corticosteroids in patients with significant pre-existing corneal inflammation may increase the risk of corneal damage; therefore, such use should be approached with caution.
If you are undergoing another eye treatment at the same time, wait at least 5 minutes before applying another medicine.

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Dicloftil must not be used during the last three months of pregnancy. Do not use Dicloftil during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies when diclofenac is used in the eye.

Breast-feeding
Use of this medicine during breast-feeding is not recommended unless the expected benefits outweigh the potential risks.

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

Driving and using machines
Patients experiencing scotomas (serious vision problems) should refrain from driving vehicles or operating 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 unborn child.

3. How to use Dicloftil

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 is 1 drop into the affected eye four times daily, or as prescribed by the doctor.

Use in children and adolescents under 14 years of age: Insufficient data on efficacy and safety are available for children and adolescents under 14 years of age.
If you use more Dicloftil than you should
There is virtually no risk of adverse effects from accidental oral ingestion of this medicine, since a pack of 30 single-dose containers contains only 15 mg of sodium diclofenac, corresponding to approximately 9% of the maximum recommended daily dose of sodium diclofenac for adults administered orally.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 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 (frequency cannot be estimated from the available data)

• Eye redness (conjunctival hyperemia), inflammation of the membrane covering the white part of the eye and the inner surface of the eyelids (allergic conjunctivitis), red and swollen eyelids (eyelid erythema), eye allergy, swollen eyelids (eyelid edema), eyelid itching;

• Skin allergic reaction (urticaria), changes in skin color and appearance associated with skin irritation or swelling (rash), inflammatory skin reactions (eczema),
  skin irritation (erythema), itching, increased allergic-type sensitivity to one or more substances (hypersensitivity);

• Cough, allergic rhinitis (allergic cold);

• 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.

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 Dicloftil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original packaging, correctly stored.
Do not store the medicine at temperatures above 25°C.
The shelf life of single-dose containers after opening the sachet is 28 days.
Use Dicloftil immediately after opening the individual single-dose container. Discard the single-dose container and any remaining product immediately after use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dicloftil contains

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

Description of the appearance of Dicloftil and contents of the pack
Dicloftil is an eye drop solution.
Pack contains 30 single-dose containers of 0.5 ml each.
Marketing Authorization Holder and Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Sole Distributor: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Rome

Package leaflet: information for the user

Dicloftil 1 mg/ml eye drops, solution

Diclofenac
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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 Dicloftil is and what it is used for

Dicloftil is an ophthalmic solution containing the active substance diclofenac. Dicloftil belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used to treat non-infectious inflammatory conditions, possibly associated with pain, affecting the anterior segment of the eye, particularly following cataract surgery (reduction in 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, indomethacin, etc.);
• if after taking acetylsalicylic acid or other prostaglandin-synthase inhibitors you have experienced asthma attacks, urticaria, or acute rhinitis;
• 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.
During treatment, soft contact lenses must not be worn.
If an infection is present or there is a risk of infection, appropriate therapy (e.g. antibiotics) should be administered concurrently with Dicloftil eye drops.
To ensure optimal absorption of the product, leave an interval of at least 5 minutes between the application of Dicloftil and any other eye medication.
Close the bottle immediately after use. After use and before recapping the bottle, to avoid residual drops remaining on the tip and to ensure proper release of subsequent drops, it is recommended to shake the bottle once downwards with a firm wrist movement, allowing any residual drops to fall off.
During this procedure, take care not to touch the dropper tip.
The eye drops must not be used for more than 90 days after opening the bottle (see "How to store Dicloftil").
Avoid contact with the eye or ocular adnexa (eyelids, eyebrows, etc.) to prevent possible contamination.
In patients at increased risk of corneal disease (the transparent front part of the eye), for example during treatment with corticosteroids (medicines used to treat a wide range of inflammatory conditions), and in patients with concomitant diseases such as rheumatoid arthritis (a chronic inflammatory disease affecting the joints), the use of diclofenac has been associated, in rare cases, with the development of ulcerative keratitis (inflammation and lesions of the cornea) or corneal thinning, punctate keratitis (another form of corneal inflammation), corneal epithelial problems (i.e. the outermost layer of the cornea), and corneal edema (swelling). Most patients who developed these complications had been treated for a very long period of time.
Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac should be administered with caution when used concomitantly with topical corticosteroids (local use).
Particular caution is required in patients who are sensitive to silver.

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

Dicloftil with food, drinks and alcohol
No interaction effects are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Dicloftil must not be used during 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 required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies when diclofenac is used in the eye.

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

Fertility
This medicine contains boron and may impair fertility in the future.
If you are pregnant, speak with 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 operating machinery.

3. How to use Dicloftil

Use this medicine exactly as directed by your doctor or pharmacist.
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 in the direction indicated by the arrow.
• Remove the cap.
• Hold the bottle upside down over the eye and instill the desired amount, making sure afterwards that no residual drops remain on the tip.
• Replace the cap on the bottle.
• Screw the cap back in the opposite direction to opening.
• Close the bottle carefully after each use; to avoid residual drops remaining on the tip, shake them off decisively with a firm flick of the wrist before reclosing 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 use more Dicloftil than you should
If you apply too many drops, wash your eye(s) with clean water and apply the next dose at your usual time.
If you forget to use Dicloftil
Do not apply a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you stop treatment with Dicloftil
Dicloftil should be used according to the instructions provided by your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 more than 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 layers of the cornea)
• scotomas (defects in the visual field)

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 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 "Exp.". The expiry date refers to the last day of that month.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
Do not store the medicine at temperatures above 30°C.
The product should be used within 90 days after first opening the bottle.
Do not dispose of any medicine 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 Dicloftil contains

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

Description of the appearance of Dicloftil and contents of the pack
Dicloftil is presented as an eye drop solution.
The pack contains a 10 ml bottle with a Novelia dispenser that is preservative-free.
Marketing Authorization Holder and Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Selling Licensee: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Rome, Italy