Betabioptal

Package leaflet: Information for the patient

BETABIOPTAL 1 mg/g + 2.5 mg/g ophthalmic gel

Betamethasone + Chloramphenicol
Please read all of 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BETABIOPTAL is and what it is used for

BETABIOPTAL is a gel containing betamethasone, a corticosteroid with anti-inflammatory action, and chloramphenicol, an antibiotic.
BETABIOPTAL is indicated for the treatment of ocular infections when it is beneficial to combine the anti-inflammatory action of betamethasone.
If you do not feel better or feel worse, consult your doctor.

2. What you should know before using BETABIOPTAL

Do not use BETABIOPTAL

• if you are allergic to betamethasone or chloramphenicol, or to any of the other ingredients of this medicine (listed in section 6). Inform your doctor before using BETABIOPTAL if you are or have previously been affected by any of the following conditions:
  a) Elevated intraocular pressure (ocular hypertension);
  b) Acute viral infections of the eye caused by Herpes simplex virus and most other acute ulcerative viral corneal diseases, including ulcerative conjunctivitis with keratitis, even in the early stages. In viral corneal infections, use is not recommended but may exceptionally be allowed only under strict supervision by an ophthalmologist;
  c) Eye infection caused by the tuberculosis bacterium;
  d) Eye infection caused by fungi (fungal eye infections);
  e) Ocular infections with evident pus production, such as purulent conjunctivitis and purulent blepharitis, which may be masked or worsened by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase intraocular pressure, with risk of progressive optic nerve damage (glaucoma). However, the amount of betamethasone contained in BETABIOPTAL gel reduces the risk of glaucoma;
• cause vision problems;
• promote the development of cataracts;
• increase the risk of new ocular infections. During prolonged treatment, frequent monitoring of intraocular pressure is recommended. Continuous use of Betabioptal for longer than one month without specialist supervision is not recommended. If your eye condition is associated with thinning of the cornea and sclera, regular medical check-ups are necessary, as cases of corneal perforation due to corticosteroids have been reported. Contact your doctor if you experience blurred vision or other visual disturbances. With prolonged topical use of steroids and antibiotics, there is an increased risk of developing non-sensitive microorganisms (bacterial resistance) and fungal infections of the cornea. If this occurs, or if there is no clinical improvement within a reasonable time, inform your doctor. Do not wear contact lenses if you have an eye infection. Rare cases of reduced bone marrow cell production (bone marrow hypoplasia), including aplastic anemia, have been reported following prolonged topical use of chloramphenicol in patients with pre-existing blood disorders. For this reason, the product should be used only for short periods, unless otherwise directed by a physician.

Children
Do not administer BETABIOPTAL to a child unless specifically prescribed by a doctor, and the child must be regularly monitored by a physician.

For individuals engaged in sports activities:
This product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.

Other medicines and BETABIOPTAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Data on the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under direct medical supervision.

Breastfeeding
Chloramphenicol has been detected in newborns/infants breastfed by treated women.
Your doctor must decide whether to discontinue breastfeeding or avoid using BETABIOPTAL, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Driving and use of machines
BETABIOPTAL may slightly impair your ability to drive vehicles or operate machinery, as it may cause temporary blurred vision for a few minutes after application.

BETABIOPTAL gel contains thiomersal
It may cause allergic reactions.

3. How to use BETABIOPTAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adolescents and adults, including the elderly, is 1 application into the conjunctival sac, 2 to 3 times daily, according to medical prescription.
If you are using other eye drops at the same time, wait 10 to 15 minutes before applying the next product.

Use in children
The safety and efficacy of BETABIOPTAL in children under one year of age have not yet been established.
Do not administer BETABIOPTAL to children over one year of age unless prescribed by a doctor and used under direct medical supervision.

If you use more BETABIOPTAL than you should
Cases of overdose have not been reported.

If you forget to use BETABIOPTAL
Do not use a double dose to make up for the missed dose.

If you stop using BETABIOPTAL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BETABIOPTAL may cause side effects, although not everyone experiences them.
The following is a list of possible side effects, grouped by frequency:
Very rare (may affect fewer than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to local irritations (burning or stinging sensation) and allergic reactions; treatment should be discontinued if these symptoms occur.
After prolonged use of corticosteroids, the risk of ocular hypertension should be considered.
Immune system disorders:
Transient allergic reactions are possible, including burning, rapid swelling of the skin and mucous membranes, urticaria, dermatitis; if such symptoms occur, discontinue treatment.
Not known (frequency cannot be estimated from the available data)
Eye disorders:
After prolonged use of corticosteroids, corneal thinning should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Systemic absorption leading to adverse reactions is unlikely. However, with prolonged use or in patients with a history of quantitative or qualitative blood composition abnormalities, the risk of reduced bone marrow cell count (aplastic anaemia) induced by chloramphenicol should be considered.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at the website http://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 BETABIOPTAL

Store in a refrigerator (2-8°C).
Store at a temperature not exceeding 25°C for a period of 28 days after first opening of the container.
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.
Do not use this medicine if you notice an intense yellow colouration.
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. Pack contents and other information

What BETABIOPTAL contains

• The active substances are betamethasone sodium phosphate and chloramphenicol.
• The other components are Macrogol 300, Polyvinyl alcohol, Carbomer, Disodium edetate, Thiomersal, Water for injections, Sodium hydroxide 1N.

Description of the appearance of BETABIOPTAL and pack contents
BETABIOPTAL is a gel.
It is available in a 5 g bottle.

Marketing Authorization Holder and Manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan, Italy

Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI), Italy

Patient Information Leaflet

BETABIOPTAL 2mg/g + 5 mg/g ophthalmic ointment

Betamethasone + Chloramphenicol
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BETABIOPTAL is and what it is used for

BETABIOPTAL is an ophthalmic ointment containing betamethasone, a corticosteroid with
anti-inflammatory action, and chloramphenicol, an antibiotic.
BETABIOPTAL is indicated for the treatment of ophthalmic infections when it is beneficial to combine
the anti-inflammatory action of betamethasone.
The ophthalmic ointment formulation is particularly suitable for nocturnal use or when the eye is protected by a dressing.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using BETABIOPTAL

Do not use BETABIOPTAL

• if you are allergic to betamethasone or chloramphenicol or to any of the other ingredients of this medicine (listed in section 6). Inform your doctor before using BETABIOPTAL if you have or have previously had any of the following conditions:
  a. high intraocular pressure (endocular hypertension);
  b. acute eye infections caused by the Herpes simplex virus and most other viral corneal diseases in the acute ulcerative phase, ulcerative keratoconjunctivitis even in the initial stage. In viral corneal infections, use is not recommended but may exceptionally be allowed only under strict supervision by an ophthalmologist;
  c. eye infection caused by the tuberculosis bacterium;
  d. eye infection caused by fungi (fungal eye infections);
  e. ocular infections with evident pus production such as purulent conjunctivitis and purulent blepharitis, which may be masked or worsened by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase eye pressure, with risk of progressive damage to the optic nerve (glaucoma),
• cause vision problems,
• promote cataract development,
• increase the risk of new ocular infections.
  During prolonged treatment, frequent monitoring of intraocular pressure is advisable. Continuous use of Betabioptal for longer than one month without specialist supervision is not recommended.

If your eye condition is associated with thinning of the cornea and sclera, regular medical check-ups are advisable, as cases of corneal perforation due to corticosteroids have been reported.
Contact your doctor if you experience blurred vision or other visual disturbances.
With prolonged topical use of steroids and antibiotics, there is an increased risk of developing non-sensitive microorganisms (bacterial resistance development) and fungal corneal infections. If this occurs or if no clinical improvement is observed within a reasonable time, inform your doctor.
Do not wear contact lenses if you have an eye infection.
Rare cases of reduced bone marrow cell count (medullary hypoplasia), including aplastic anemia, have been reported following prolonged topical use of chloramphenicol in patients with pre-existing hematological disorders. For this reason, the product should be used only for short periods, unless otherwise specifically directed by a physician.

Children
Do not administer BETABIOPTAL to a child unless prescribed by a doctor, and the child must be regularly monitored by a physician.

For athletes:
The product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.

Other medicines and BETABIOPTAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Data on the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under direct medical supervision.

Breastfeeding
Chloramphenicol has been detected in newborns/infants breastfed by treated women.
Your doctor must decide whether to discontinue breastfeeding or to avoid using BETABIOPTAL, taking into account the benefits of breastfeeding for the infant and the benefits of therapy for the mother.

Driving and using machines
BETABIOPTAL may slightly affect the ability to drive vehicles or operate machinery, as it may cause blurred vision for a few minutes after application.

BETABIOPTAL ointment contains parahydroxybenzoic acid esters
These may cause allergic reactions.

3. How to use BETABIOPTAL

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adolescents and adults, including the elderly, is 1 application into the
conjunctival sac, 3 to 6 times daily, according to medical prescription.
If you are using other eye drops at the same time, wait 10 to 15 minutes before applying the next
product.
Use in children
The safety and efficacy of BETABIOPTAL in children under one year of age have not yet been established.
Do not administer BETABIOPTAL to children over one year of age unless prescribed by a doctor and used under direct medical supervision.
If you use more BETABIOPTAL than you should
Cases of overdose have not been reported.
If you forget to use BETABIOPTAL
Do not use a double dose to make up for the missed dose.
If you stop using BETABIOPTAL
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BETABIOPTAL may cause side effects, although not everyone experiences them.
The side effects are listed below according to frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to local irritations (burning or stinging sensation) and allergic reactions; treatment must be discontinued if such symptoms occur.
After prolonged use of corticosteroids, the risk of ocular hypertension should be considered.

Immune system disorders:
Transient allergic reactions are possible, including burning, rapid swelling of the skin and mucous membranes, urticaria, dermatitis; if such symptoms occur, discontinue treatment.

Not known (frequency cannot be estimated from the available data)
Eye disorders:
After prolonged use of corticosteroids, thinning of the cornea, which may lead to perforation, should be considered.
Blurred vision has been reported.

Blood and lymphatic system disorders:
Systemic absorption leading to adverse reactions is unlikely. However, with prolonged use or in case of pre-existing (medical history) quantitative or qualitative alteration of blood composition, the risk of reduced bone marrow cell count (aplastic anaemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at the website: http://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 BETABIOPTAL

Store in the refrigerator (2° - 8° C).
After the first opening of the container, store at a temperature not exceeding 25°C for a period of 28 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice an intense yellow colouration.
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. Package contents and other information

What BETABIOPTAL contains

• The active substances are betamethasone and chloramphenicol.
• The other ingredients are Cetyl alcohol, Macrogol 300, Macrogol 1500, Macrogol 4000, Paraffin oil, Methyl p-hydroxybenzoate, Sodium ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Vaseline.

Description of the appearance of BETABIOPTAL and package contents
BETABIOPTAL is an ointment.
It is available in 5 g aluminium tubes.
Marketing Authorization Holder and Manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)

Patient information leaflet

BETABIOPTAL 2mg/ml + 5mg/ml Eye Drops, Solution

Betamethasone + Chloramphenicol
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BETABIOPTAL is and what it is used for
2. What you need to know before using BETABIOPTAL
3. How to use BETABIOPTAL
4. Possible side effects
5. How to store BETABIOPTAL
6. Package contents and other information

1. What BETABIOPTAL is and what it is used for

BETABIOPTAL is an eye drop formulation containing betamethasone, a corticosteroid with anti-inflammatory action,
and chloramphenicol, an antibiotic.
BETABIOPTAL is indicated for the treatment of ocular infections when it is beneficial to combine
the anti-inflammatory action of betamethasone.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using BETABIOPTAL

Do not use BETABIOPTAL

• if you are allergic to betamethasone or chloramphenicol, or to any of the other ingredients of this medicine (listed in section 6).

Inform your doctor before using BETABIOPTAL if you are or have previously been affected by any of the following conditions:

• a) Elevated intraocular pressure (endocular hypertension);
• b) Acute eye infections caused by the Herpes simplex virus and most other acute ulcerative viral diseases of the cornea. In viral corneal infections, use is not recommended but may exceptionally be allowed only under strict supervision by an ophthalmologist;
• c) Conjunctivitis with ulcerative keratitis, even in the initial phase;
• d) Eye infection caused by the tuberculosis bacterium;
• e) Eye infection caused by fungi (fungal eye infections);
• f) Ocular infections with evident pus production, such as purulent conjunctivitis and purulent blepharitis, which may be masked or worsened by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase intraocular pressure, with risk of progressive optic nerve damage (glaucoma),
• cause vision problems,
• promote cataract development,
• increase the risk of new ocular infections.

During prolonged treatment, frequent monitoring of intraocular pressure is recommended.
Continuous use of Betabioptal for longer than one month without specialist supervision is not advisable.
If your eye condition is associated with thinning of the cornea and sclera, regular medical check-ups are recommended, as cases of corneal perforation caused by corticosteroids have been reported.
Contact your doctor if you experience blurred vision or other visual disturbances.
With prolonged topical application of steroids and antibiotics, the development of non-sensitive microorganisms (bacterial resistance) and fungal corneal infections is more likely; if this occurs or if no clinical improvement is observed within a reasonable time, inform your doctor.
Do not wear contact lenses if you have an eye infection.
Rare cases of reduced bone marrow cell count (bone marrow hypoplasia), including aplastic anemia, have been reported following prolonged use of topical chloramphenicol in patients with pre-existing blood disorders. For this reason, the product should be used only for short periods, unless otherwise directed by a physician.
Children
Do not administer Betabioptal to a child unless specifically prescribed by a doctor, and the child must be regularly monitored by a physician.
For those engaged in sports activities:
This product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.
Other medicines and BETABIOPTAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Data on the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct supervision of your doctor.
Breastfeeding
Chloramphenicol has been detected in newborns/infants breastfed by treated women.
Your doctor will need to decide whether to discontinue breastfeeding or to avoid using BETABIOPTAL, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.
Driving and using machines
Betabioptal may slightly affect the ability to drive vehicles or operate machinery, as it may cause temporary blurred vision for a few minutes after application.

3. How to use BETABIOPTAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adolescents and adults, including the elderly, is 1 or 2 drops in the conjunctival sac,
3 to 6 times a day, according to medical prescription.
If you are using other eye drops at the same time, wait 10 to 15 minutes before applying the next product.

Use in children
The safety and efficacy of BETABIOPTAL in children under one year of age have not yet been established.
Do not administer BETABIOPTAL to children over one year of age unless prescribed by a doctor and used under direct medical supervision.

If you use more BETABIOPTAL than you should
Cases of overdose have not been reported.

If you forget to use BETABIOPTAL
Do not use a double dose to make up for the forgotten dose.

If you stop using BETABIOPTAL
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BETABIOPTAL may cause side effects, although not everyone experiences them.
The side effects are listed below according to frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to local irritations (burning or stinging sensation) and allergic reactions; treatment must be discontinued if such symptoms occur.
After prolonged use of corticosteroids, the risk of ocular hypertension should be considered.

Immune system disorders:
Transient allergic reactions are possible, including burning, rapid swelling of the skin and mucous membranes, urticaria, and dermatitis; if these symptoms occur, discontinue treatment.

Not known (frequency cannot be estimated from the available data)
Eye disorders:
After prolonged use of corticosteroids, thinning of the cornea, which may lead to perforation, should be considered.
Blurred vision has been reported.

Blood and lymphatic system disorders:
Systemic absorption leading to adverse reactions is unlikely. However, with prolonged use or in case of pre-existing (medical history) quantitative or qualitative blood composition abnormalities, the risk of reduced bone marrow cell count (aplastic anaemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at the website: http://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 BETABIOPTAL

Store in a refrigerator (2-8°C).
After first opening the container, store at a temperature not exceeding 25°C for a period of 21 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice an intense yellow colouration.
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 BETABIOPTAL contains

• The active substances are Betamethasone sodium phosphate and Chloramphenicol
• The other components are Macrogol 300, Macrogol 1500, Macrogol 4000, Boric acid, Borax, Polysorbate 80, Hypromellose, Water for injections

Description of the appearance of BETABIOPTAL and contents of the pack
BETABIOPTAL is a clear, colourless to slightly yellowish solution, free from visible particles, contained in a 5 ml ABAK bottle without preservative.
Marketing Authorisation Holder and Manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)

Patient Information Leaflet

BETABIOPTAL 2 mg/ml + 5 mg/ml Eye Drops, Suspension

Betamethasone + Chloramphenicol
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BETABIOPTAL is and what it is used for
2. What you need to know before using BETABIOPTAL
3. How to use BETABIOPTAL
4. Possible side effects
5. How to store BETABIOPTAL
6. Package contents and other information

1. What BETABIOPTAL is and what it is used for

BETABIOPTAL is an eye drop formulation containing betamethasone, a corticosteroid with anti-inflammatory action,
and chloramphenicol, an antibiotic.
BETABIOPTAL is indicated for the treatment of ocular infections when it is beneficial to combine
the anti-inflammatory action of betamethasone.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using BETABIOPTAL

Do not use BETABIOPTAL

• if you are allergic to betamethasone or chloramphenicol, or to any of the other ingredients of this medicine (listed in section 6). Inform your doctor before using BETABIOPTAL if you are or have previously been affected by any of the following conditions:
  a) Elevated intraocular pressure (ocular hypertension);
  b) Acute eye infections caused by the Herpes simplex virus and most other acute ulcerative viral corneal diseases. In viral corneal infections, use is not recommended but may exceptionally be allowed only under strict supervision by an ophthalmologist;
  c) Conjunctivitis with ulcerative keratitis, even in the initial phase;
  d) Eye infection caused by the tuberculosis bacterium;
  e) Eye infection caused by fungi (fungal eye infections);
  f) Ocular infections with evident pus production, such as purulent conjunctivitis and purulent blepharitis, which may be masked or worsened by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase intraocular pressure, with risk of progressive optic nerve damage (glaucoma);
• cause vision problems;
• promote cataract development;
• increase the risk of new ocular infections.
  During prolonged treatment, frequent monitoring of intraocular pressure is recommended. Continuous use of Betabioptal for longer than one month without specialist supervision is not advised. If your eye condition is associated with thinning of the cornea and sclera, regular medical check-ups are recommended, as cases of corneal perforation caused by corticosteroids have been reported. Contact your doctor if you experience blurred vision or other visual disturbances.
  With prolonged topical use of steroids and antibiotics, the development of non-sensitive microorganisms (bacterial resistance) and fungal corneal infections is more likely. If this occurs or if no clinical improvement is observed within a reasonable time, inform your doctor. Do not wear contact lenses if you have an eye infection.
  Rare cases of reduced bone marrow cell count (medullary hypoplasia), including aplastic anemia, have been reported following prolonged topical use of chloramphenicol in patients with pre-existing blood disorders. For this reason, the product should be used only for short periods, unless otherwise directed by a physician.

Children
Do not administer Betabioptal to a child unless specifically prescribed by a doctor, and the child must be regularly monitored by a physician.

For athletes:
This product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is prohibited.

Other medicines and BETABIOPTAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

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

Pregnancy
Data on the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct supervision of your doctor.

Breastfeeding
Chloramphenicol has been detected in newborns/infants breastfed by treated women.
Your doctor will need to decide whether to discontinue breastfeeding or to avoid using BETABIOPTAL, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Driving and operating machinery
Betabioptal may slightly impair your ability to drive or operate machinery, as it may cause temporary blurred vision shortly after application.

BETABIOPTAL eye drops contain thiomersal
It may cause allergic reactions.

3. How to use BETABIOPTAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adolescents and adults, including the elderly, is 1 or 2 drops into the
conjunctival sac, 3 to 6 times daily, according to medical prescription.
If you are using other eye drops at the same time, wait 10 to 15 minutes before applying the next drop.
Use in children
The safety and efficacy of BETABIOPTAL in children under one year of age have not yet been established.
Do not administer BETABIOPTAL to children over one year of age unless prescribed by a doctor and used under direct medical supervision.
If you use more BETABIOPTAL than you should
Cases of overdose have not been reported.
If you forget to use BETABIOPTAL
Do not use a double dose to make up for the missed dose.
If you stop using BETABIOPTAL
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, BETABIOPTAL may cause adverse effects, although not everyone experiences them.
The adverse effects listed below are categorized by frequency:
Very rare (may affect fewer than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to local irritations (burning or stinging sensation) and allergic reactions; treatment should be discontinued if such symptoms occur.
With prolonged use of corticosteroids, the risk of ocular hypertension should be considered.
Immune system disorders:
Transient allergic reactions are possible, including burning, rapid swelling of the skin and mucous membranes, urticaria, and dermatitis; if such symptoms occur, discontinue treatment.
Not known (frequency cannot be estimated from the available data)
Eye disorders:
With prolonged use of corticosteroids, thinning of the cornea, which may lead to perforation, should be considered.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Systemic absorption leading to adverse reactions is unlikely. However, with prolonged use or in patients with a history of quantitative or qualitative blood composition abnormalities, the risk of chloramphenicol-induced reduction in bone marrow cells (aplastic anaemia) should be considered.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor. You may also report adverse effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store BETABIOPTAL

Store in a refrigerator (2-8°C).
After the first opening of the container, BETABIOPTAL may be used for a maximum period of 15 days.
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.
Do not use this medicine if you notice an intense yellow colouration.
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 BETABIOPTAL contains

• The active substances are betamethasone and chloramphenicol.
• The other components are Macrogol 300, Macrogol 1500, Macrogol 4000, Boric acid, Borax, Polysorbate 80, Hypromellose, Thiomersal, Water for injections.

Description of the appearance of BETABIOPTAL and contents of the pack
BETABIOPTAL is a homogeneous white suspension after shaking.
It is available in a 5 ml dropper bottle.

Marketing Authorization Holder and Manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan

Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)