Flogocyn

Patient Information Leaflet

Flogocyn 5 mg/ml eye drops, solution

chloramphenicol
10 ml bottle
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Flogocyn is and what it is used for

Flogocyn is an eye drop containing chloramphenicol, an antibiotic. An antibiotic is a medicine used
to treat many infections caused by bacteria.
Flogocyn is indicated for simple eye infections known as "acute bacterial conjunctivitis".
Acute bacterial conjunctivitis is also known as "red eye" because the white part of the affected eye
becomes red, and the eyelid becomes red and swollen. Mucus may also be present, which can make it difficult
to open the eye in the morning, and you may feel that the eye is irritated.
Consult your doctor if you feel worse after starting treatment or if you do not feel better after 2 days.

2. What you need to know before using Flogocyn

Do not use Flogocyn if:

• you are allergic to chloramphenicol or to any of the other ingredients of this medicine (listed in section 6).
• you or a member of your family has had blood disorders or bone marrow problems. These may include a severe reduction in red blood cells or a lowered normal blood cell count.
• the person needing to use the eye drops is under 2 years of age.
• you have a history of familial dyscrasia, a condition causing fatigue, bruising, and an increased risk of infections.

Warnings and precautions
Talk to your doctor or pharmacist before using Flogocyn if:

• your eye is painful (or irritated and swollen), or you feel pain and swelling around the eyes or face.
• you experience loss of vision, reduced or blurred vision, or see halos around lights.
• you are unable to open your eyes due to severe pain.
• your pupil (the black part inside the eye) appears abnormal—possibly blurred, not round, very large, or not changing size in bright light.
• your eye appears cloudy.
• you have had an eye infection in recent months.
• you have had glaucoma (high eye pressure).
• you have had "dry eye syndrome".
• you have an eye injury.
• you feel like there is something in your eye or that liquid has entered your eye.
• you have already used other eye drops or ointments.
• you have undergone eye surgery or laser treatment within the last 6 months.

Take particular care:

• If you develop a new eye infection during treatment, you should stop using the drops and consult your doctor.

If you wear contact lenses, consult your ophthalmologist/optician or your general practitioner before using this medicine.
You must not wear contact lenses during treatment. If you normally wear soft contact lenses, do not resume wearing them until at least 24 hours after completing treatment with Flogocyn.
Children and adolescents
The use of Flogocyn is not recommended in children under 2 years of age. Do not administer Flogocyn to a child unless prescribed by a doctor, and the child must be monitored by a doctor.
Other medicines and Flogocyn
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines not requiring a prescription.
Medicines that may interact with Flogocyn include:

• drugs that suppress bone marrow function.
• dietary supplements containing chymotrypsin.
• other eye drops or ophthalmic ointments.

Pregnancy and breastfeeding
Flogocyn must not be used during pregnancy, if you suspect you may be pregnant, are planning pregnancy, or while breastfeeding, unless otherwise directed by your doctor.
Pregnancy
If you discover you are pregnant during treatment, stop using Flogocyn and consult your doctor immediately.
Breastfeeding
Chloramphenicol has been detected in newborns/infants breastfed by women receiving treatment. Your doctor will decide whether to discontinue breastfeeding or avoid using Flogocyn, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.
Driving and using machines
Flogocyn may cause slight blurred vision after application. Wait until your vision returns to normal before driving or operating machinery.
Flogocyn contains phenylmercuric nitrate, which may cause allergic reactions.

3. How to use Flogocyn

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor.
The recommended dose is:
for adults and children over 2 years of age: 1 drop into the affected eye every 2 hours for the first 48 hours, and subsequently every 4 hours.
Do not take the medicine by mouth. Do not use this medicine in children under 2 years of age.
WHEN to use Flogocyn:
Treatment must be carried out exclusively during daytime hours.
Treatment should not last longer than 5 consecutive days, unless otherwise directed by a doctor.
HOW to use Flogocyn:

1. Wash your hands thoroughly before use.
2. Remove the outer cap. It may be easier to apply the eye drops in front of a mirror.
3. Tilt your head backward and pull down the lower eyelid to form a small pouch.
4. Hold the container between thumb and middle finger of the other hand, turn the container upside down close to the eye, taking care not to touch the eye with the dropper tip.
5. Apply sufficient pressure so that the container releases one or two drops. Flogocyn should be instilled into the space between the eyelid and the eye for the treatment of acute bacterial conjunctivitis.
6. Blink several times.
7. Instill an additional drop if you think you missed the eye.
8. Repeat the same procedure for the other eye if necessary.
9. Replace the outer cap on the container, taking care not to touch anything with the dropper tip, including eyes and fingers.
10. Wash your hands.

If the eye is inflamed or has crusts, you should clean it with sterile water before using this eye drop. During treatment, you should not wear contact lenses.
Flogocyn is for external use only. In case of accidental or suspected ingestion of the product, contact your doctor or go to the nearest hospital immediately.
If you forget to use Flogocyn
Continue therapy with the next scheduled dose. Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use 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.
Possible side effects may include:

Very rare (may affect up to 1 in 10,000 people)
Immune system disorders

• In some patients, sensitization reactions may occasionally occur, such as angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis.

Blood disorders

• Severe reduction in the number of red blood cells (aplastic anaemia), which may cause weakness or breathlessness.
• Bone marrow suppression (a condition in which the bone marrow is unable to produce red blood cells), which may cause fever, joint pain, or infections.

Gray syndrome
This syndrome has been reported in newborns and children, manifesting as low blood pressure, vomiting, bluish discoloration of the lips, and grayish skin colouration.

Not known (frequency cannot be estimated from the available data)
Eye disorders

• Redness.
• Stinging or burning.
• Itching or irritation.
• Inflammation of the skin (dermatitis) around the eye.

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 Flogocyn

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month, provided the packaging is intact and the medicine has been properly stored.
After first opening the bottle, the medicine can be stored for 4 weeks.
Store in a refrigerator (2°C - 8°C) and protect from light.
Do not freeze.
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 Flogocyn contains

• The active substance is chloramphenicol.
• The other components are borax, boric acid, phenylmercuric nitrate, water for injectable preparations.

Description of the appearance of Flogocyn and contents of the pack
Polyethylene vial containing 10 ml of solution.
Marketing Authorization Holder:
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILAN, Italy
Manufacturer:
FARMIGEA S.p.A., Via G.B. Oliva 6/8 - 56121 Pisa, Italy

Patient Information Leaflet

Flogocyn 5 mg/ml eye drops, solution in single-dose containers

chloramphenicol
20 Single-dose containers of 0.5 ml
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, because it could be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Flogocyn is and what it is used for
8. What you need to know before using Flogocyn
9. How to use Flogocyn
10. Possible side effects
11. How to store Flogocyn
12. Contents of the pack and other information

1. What Flogocyn is and what it is used for

Flogocyn is an eye drop containing chloramphenicol, an antibiotic. An antibiotic is a medicine used to treat many infections caused by bacteria.
Flogocyn is indicated for simple eye infections known as "acute bacterial conjunctivitis". Acute bacterial conjunctivitis is also known as "red eye" because the white part of the affected eye becomes red, and the eyelid becomes red and swollen. There may also be mucus, which can make it difficult to open the eye in the morning, and you may feel eye irritation.
Consult your doctor if you feel worse after starting treatment or if you do not feel better after 2 days.

2. What you need to know before using Flogocyn

Do not use Flogocyn if:

• you are allergic to chloramphenicol or to any of the other ingredients of this medicine (listed in section 6).
• you or a family member has had blood disorders or bone marrow problems. These may include a severe reduction in red blood cells or a drop in normal blood cell counts.
• the person who needs to use the eye drops is under 2 years of age.
• you have a family history of aplastic anaemia, a condition causing fatigue, bruising, and increased risk of infections.

Warnings and precautions
Talk to your doctor or pharmacist before using Flogocyn if:

• your eye is painful (or irritated and swollen), or you feel pain and swelling around the eyes or face.
• you experience loss of vision, reduced or blurred vision, or see halos around lights.
• you are unable to open your eyes due to severe pain.
• your pupil (the black part in the center of the eye) appears abnormal—possibly blurred, not round, very large, or not changing size in bright light.
• your eye appears cloudy.
• you have had an eye infection in recent months.
• you have had glaucoma (high eye pressure).
• you have had "dry eye syndrome".
• you have an eye injury.
• you feel like there is something in your eye or that liquid has entered your eye.
• you have previously used other eye drops or ointments.
• you have undergone eye surgery or laser treatment within the past 6 months.

Take particular care:

• If you develop a new eye infection during treatment, you should stop using the drops and consult your doctor.

If you wear contact lenses, consult your ophthalmologist/optician or your doctor before using this medicine.
You must not wear contact lenses during treatment. If you normally wear soft contact lenses, do not resume wearing them until at least 24 hours after completing treatment with Flogocyn.
Children and adolescents
The use of Flogocyn is not recommended in children under 2 years of age. Do not administer Flogocyn to a child unless prescribed by a doctor, and the child must be monitored by a doctor.
Other medicines and Flogocyn
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including medicines that do not require a prescription.
Medicines that may interact with Flogocyn include:

• drugs that suppress bone marrow function.
• dietary supplements containing chymotrypsin.
• other eye drops or ophthalmic ointments.

Pregnancy and breastfeeding
Flogocyn must not be used during pregnancy, if you suspect you are pregnant or are planning to become pregnant, or while breastfeeding.
Pregnancy
If you discover you are pregnant during treatment, stop using Flogocyn and contact your doctor immediately.
Breastfeeding
Flogocyn must not be used during breastfeeding.
Driving and using machines
Flogocyn may cause slight blurred vision after application. Wait until your vision returns to normal before driving or operating machinery.

3. How to use Flogocyn

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor.
The recommended dose is:
for adults and children over 2 years of age: 1 drop into the affected eye every 2 hours for the first 48 hours, and then every 4 hours thereafter.
Do not take this medicine by mouth. Do not use this medicine in children under 2 years of age.

WHEN to use Flogocyn:
Treatment must be carried out exclusively during daylight hours.
Treatment should not last longer than 5 consecutive days, unless otherwise directed by your doctor.

HOW to use Flogocyn:

11. Wash your hands thoroughly before use.
12. Separate the single-dose container from the strip.
13. Open by twisting the top part of the single-dose container. It may be easier to apply the eye drops while looking into a mirror.
14. Tilt your head backward and pull down the lower eyelid to form a small pouch.
15. Hold the single-dose container between your thumb and middle finger of the other hand, turn it upside down close to the eye, taking care not to touch the eye with the dropper tip.
16. Apply sufficient pressure so that the container releases one or two drops. Flogocyn should be instilled into the space between the eyelid and the eye for the treatment of acute bacterial conjunctivitis.
17. Blink a few times.
18. Instill an additional drop if you think you missed the eye.
19. Repeat the same procedure for the other eye, if necessary.
20. Discard the container and any remaining solution after use.
21. Wash your hands.

If the eye is inflamed or has crusts, wash it with sterile water before using this eye drop. During treatment, do not wear contact lenses.
Flogocyn is for external use only. In case of accidental ingestion or suspected intake of the product, contact your doctor or go to the nearest hospital immediately.

If you forget to use Flogocyn
Continue treatment with the next scheduled dose. Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use 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. Possible side effects may include:

Very rare (may affect up to 1 in 10,000 people)

Immune system disorders

• Occasional hypersensitivity reactions may occur in some patients, such as angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis.

Blood disorders

• Severe reduction in red blood cell count (aplastic anaemia), which may cause weakness or shortness of breath.
• Bone marrow suppression (a condition in which the bone marrow is unable to produce blood cells), which may lead to fever, joint pain or infections.

Gray syndrome

This syndrome has been reported in neonates and children, characterized by low blood pressure, vomiting, bluish discoloration of the lips and grayish skin tone.

Not known (frequency cannot be estimated from the available data)

Eye disorders:

• Redness
• Stinging or burning
• Itching or irritation
• Skin inflammation (dermatitis) around the eye.

Reporting of side effects

If you experience any side effect, 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.

7. How to store Flogocyn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month in the original unopened package, when properly stored.
The product must be used immediately after opening; discard any unused solution remaining after opening.
After the first opening of the aluminium foil pouch, the medicine must be used within 2 months; after this period, any remaining medicine should be disposed of.
Store in the refrigerator (2°C - 8°C) and protect from light.
Do not freeze.
After the first opening of the aluminium foil pouch, store any remaining single-dose containers in the original packaging (aluminium pouch and cardboard carton) to protect the medicine from light.
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.

8. Package Contents and Other Information

What Flogocyn contains
The active substance is chloramphenicol.
The other components are: borax, boric acid, water for injections.
Description of the appearance of Flogocyn and the contents of the pack
Single-dose containers made of low-density polyethylene with a volume of 0.5 ml.
Each package contains 20 single-dose containers divided into four aluminium pouches, each containing a strip of 5 single-dose containers.
Marketing Authorization Holder:
Thea Farma - Via Tiziano, 32 - 20145 Milano
Manufacturer:
FARMIGEA S.p.A., Via G.B. Oliva 6/8 - 56121 Pisa, Italy