BETABIOPTAL 0,2% + 0,5% Ophthalmic ointment

Зміст інструкції

1. BETABIOPTAL 2mg/ml + 5mg/ml Eye Drops, Solution
   1. What is BETABIOPTAL and what is it used for
   2. What you need to know before you use BETABIOPTAL
   3. How to use BETABIOPTAL
   4. Possible side effects
   5. How to store BETABIOPTAL
   6. Contents of the pack and other information
2. BETABIOPTAL 2mg/g + 5 mg/g ophthalmic ointment
   1. What is BETABIOPTAL and what is it 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
3. BETABIOPTAL 2 mg/ml + 5 mg/ml Eye Drops, Suspension
   1. What is BETABIOPTAL and what is it used for
   2. What you need to know before you use BETABIOPTAL
   3. How to use BETABIOPTAL
   4. Possible side effects
   5. How to store BETABIOPTAL
   6. Contents of the pack and other information
4. BETABIOPTAL 1 mg/g + 2,5 mg/g ophthalmic gel
   1. What is BETABIOPTAL and what is it used for
   2. What you need to know before you use BETABIOPTAL
   3. How to use BETABIOPTAL
   4. Possible side effects
   5. How to store BETABIOPTAL
   6. Contents of the pack and other information

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

Betametasone + Chloramphenicol

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 BETABIOPTAL is and what it is used for
• 2. What you need to know before you use 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 is BETABIOPTAL and what is it used for

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

2. What you need to know before you use 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).

Tell your doctor before using BETABIOPTAL if you have or have had any of the following conditions:

• a) Increased eye pressure (Ocular hypertension);
• b) Acute eye infections caused by the Herpes simplex virus and most other viral diseases of the cornea in an acute ulcerative phase. Use is not recommended in viral infections of the cornea but may possibly be allowed only under the strict supervision of an ophthalmologist;
• c) Conjunctivitis with ulcerative keratitis even in the early stages;
• d) Eye infection caused by the tuberculosis bacterium;
• e) Eye infection caused by fungi (eye mycosis);
• f) Ocular infections with evident pus production such as purulent conjunctivitis and purulent blepharitis which may be masked or aggravated by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase pressure in the eye with the risk of progressive damage to the optic nerve (glaucoma),
• cause vision problems,
• promote cataracts,
• promote new eye infections.

During prolonged treatments, frequent checks of the internal eye pressure are advisable.
Continuous application of Betabioptal for more than a month without specialist supervision is not recommended.
If your eye condition is associated with thinning of the cornea and sclera, frequent checks by your doctor are advisable, as cases of corneal perforation caused by corticosteroids have been described.
Contact your doctor if you experience blurred vision or other visual disturbances.
In conjunction with prolonged topical applications of steroids and antibiotics, the development of microorganisms that are not sensitive (development of bacterial resistance) and a fungal infection of the cornea is more likely; if this should occur or no clinical improvement is noticed within a reasonable period of time, inform your doctor.
Do not use contact lenses if you have an eye infection.
Rare cases of reduction in the number of bone marrow cells (myeloplasia), including aplastic anemia, have been described following prolonged use of chloramphenicol for topical use in patients with pre-existing hematological diseases. For this reason too, the product should be used for short periods, unless specifically indicated by your doctor.

Children
Do not give Betabioptal to a child unless it has been prescribed by a doctor and the child must be regularly checked by a doctor.

Other medicines and BETABIOPTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data relating to the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct control of your doctor.
Breastfeeding
Chloramphenicol has been identified in newborns/infants breastfed by treated women.
Your doctor will have to decide whether to interrupt breastfeeding or avoid using BETABIOPTAL taking into consideration the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Driving and operating machinery
Betabioptal slightly alters the ability to drive vehicles or operate machinery, as it may blur your vision for a few minutes after application.

3. How to use BETABIOPTAL

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 for adolescents and adults, including the elderly, is 1 or 2 drops in the conjunctival sac, from 3 to 6 times a day, as prescribed by your doctor.
If using concomitant therapy with other eye drops, wait 10 to 15 minutes before subsequent
applications.

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 it has been prescribed by a
doctor and used under the direct supervision of a doctor.

If you use more BETABIOPTAL than you should
No cases of overdose have been reported.

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

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

4. Possible side effects

Like all medicines, BETABIOPTAL can cause side effects, although not everybody gets them.
Side effects have been listed below according to their frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to the onset of local irritation (burning or stinging sensation) and allergic reactions; treatment should 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 should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Development of adverse reactions due to systemic absorption is unlikely. However, in case of prolonged use or previous (anamnesis) quantitative or qualitative alteration of the
blood composition, the risk of reduction in the number of bone marrow cells (aplastic anemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor. You can also report side effects directly through 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 the first opening of 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 which is 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETABIOPTAL contains

• The active ingredients are Betamethasone sodium phosphate and Chloramphenicol
• The other ingredients 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 presented as a clear solution from colorless to slightly yellowish without
visible particles in ABAK bottle of 5 ml without preservative.

Marketing authorisation holder and manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milano

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

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

Betamethasone + Chloramphenicol

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 BETABIOPTAL is and what it is used for
• 2. What you need to know before you use 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 is BETABIOPTAL and what is it 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 useful to associate the anti-inflammatory action of betamethasone.
The ophthalmic ointment pharmaceutical form is particularly indicated for nighttime application or when the eye is protected by a bandage.
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 any of the other ingredients of this medicine (listed in section 6). Inform your doctor before using BETABIOPTAL if you have or have had any of the following conditions:
• a. increased eye pressure (intraocular hypertension);
• b. acute eye infections caused by the Herpes simplex virus and most other viral diseases of the cornea in an acute ulcerative stage, conjunctivitis with ulcerative keratitis even in the early stages. Use is not recommended in viral corneal infections but may possibly be allowed only under the strict supervision of an ophthalmologist;
• c. eye infection caused by the tuberculosis bacterium;
• d. eye infection caused by fungi (eye mycosis);
• e. eye infections with evident pus production such as purulent conjunctivitis and purulent blepharitis which may be masked or aggravated by corticosteroids.

Warnings and precautions
Long-term use of Betabioptal may:

• increase the pressure in the eye with the risk of progressive damage to the optic nerve (glaucoma),
• cause vision problems,
• promote cataracts,
• promote new eye infections. During prolonged treatments, frequent checks of the internal eye pressure are advisable. Continuous application of Betabioptal for more than one month is not recommended without specialist supervision.

If your eye condition is associated with thinning of the cornea and sclera, frequent checks by your doctor are appropriate, as cases of corneal perforation caused by corticosteroids have been described.
Contact your doctor if you experience blurred vision or other visual disturbances.
In connection with prolonged topical applications of steroids and antibiotics, the development of microorganisms that are not sensitive (development of bacterial resistance) and a fungal infection of the cornea is more likely; if this should occur or no clinical improvement is noticed within a reasonable period of time, inform your doctor.
Do not use contact lenses if you have an eye infection.
Rare cases of reduced numbers of bone marrow cells (myelodysplasia), including aplastic anemia, have been reported following prolonged use of chloramphenicol for topical use in patients with pre-existing hematological diseases. For this reason too, the product should be used for short periods, unless specifically indicated by your doctor.

Children
Do not give BETABIOPTAL to a child unless it has been prescribed by a doctor and the child must be regularly monitored by a doctor.

Other medicines and BETABIOPTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data relating to the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct control of your doctor.
Breastfeeding
Chloramphenicol has been identified in newborns/infants breastfed by treated women.
The doctor must decide whether to discontinue breastfeeding or avoid using BETABIOPTAL taking into consideration the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Driving and using machines
BETABIOPTAL slightly impairs the ability to drive and operate machines, as it may blur your vision for a few minutes after application.

BETABIOPTAL ointment contains p-hydroxybenzoic acid esters
May cause allergic reactions.

3. How to use BETABIOPTAL

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 for adolescents and adults, including the elderly, is 1 application into the
conjunctival sac, from 3 to 6 times a day, as prescribed by your doctor.
In case of concomitant therapy with other eye drops, wait 10 to 15 minutes before subsequent
applications.

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

If you use more BETABIOPTAL than you should
No cases of overdose have been reported.

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

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

4. Possible side effects

Like all medicines, BETABIOPTAL can cause side effects, although not everybody gets them.
Side effects have been listed below according to their frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to the onset of local irritation (burning or stinging sensation) and allergic reactions; treatment should 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 (the frequency cannot be estimated from the available data)
Eye disorders:
After prolonged use of corticosteroids, thinning of the cornea should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Development of adverse reactions due to systemic absorption is unlikely. However, in case of prolonged use or previous (anamnestic) quantitative or qualitative alteration of blood composition, the risk of reduction in the number of bone marrow cells (aplastic anemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor. You can also report side effects directly through 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 the first opening of the container, you can use BETABIOPTAL for a maximum period of 28
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 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 colour.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETABIOPTAL contains

• The active ingredients are betamethasone and chloramphenicol
• The other ingredients are Cetyl alcohol, Macrogol 300, Macrogol 1500, Macrogol 4000, Petrolatum, p-Hydroxybenzoic acid esters, Petrolatum.

Description of the appearance of BETABIOPTAL and contents of the pack
BETABIOPTAL is presented as an ointment.
It is available in aluminium tubes of 5 g.

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)

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

Betametasone + Chloramphenicol

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 BETABIOPTAL is and what it is used for
• 2. What you need to know before you use 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 is BETABIOPTAL and what is it used for

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

2. What you need to know before you use BETABIOPTAL

Do not use BETABIOPTAL

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

Warnings and precautions
Long-term use of Betabioptal may:

• increase the pressure in the eye with the risk of progressive damage to the optic nerve (glaucoma),
• cause vision problems,
• promote cataracts,
• promote new eye infections. During prolonged treatments, frequent checks of the internal eye pressure are advisable. Continuous application of Betabioptal for more than one month without specialist supervision is not recommended. If your eye condition is associated with thinning of the cornea and sclera, frequent checks by your doctor are advisable, as cases of corneal perforation caused by corticosteroids have been described. Contact your doctor if you experience blurred vision or other visual disturbances. In connection with prolonged topical applications of steroids and antibiotics, the development of microorganisms that are not sensitive (development of bacterial resistance) and a fungal infection of the cornea is more likely; if this should occur or no clinical improvement is noticed within a reasonable period of time, inform your doctor. Do not use contact lenses if you have an eye infection. Rare cases of reduction in the number of bone marrow cells (myelodysplasia), including aplastic anemia, have been described following prolonged use of chloramphenicol for topical use in patients with pre-existing hematological diseases. For this reason too, the product should be used for short periods, unless explicitly indicated by the doctor.

Children
Do not give Betabioptal to a child unless it has been prescribed by a doctor and the child must
be regularly monitored by a doctor.

Other medicines and BETABIOPTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
Data relating to the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct control of your doctor.
Breastfeeding
Chloramphenicol has been identified in newborns/infants breastfed by treated women.
Your doctor will have to decide whether to interrupt breastfeeding or avoid using BETABIOPTAL
taking into consideration the benefit of breastfeeding for the child and the benefit of therapy for
the woman.

Driving and using machines
Betabioptal slightly alters the ability to drive vehicles or use machines, as it may
blur your vision for a few minutes after application.

BETABIOPTAL eye drops contains thiomersal
It may cause allergic reactions.

3. How to use BETABIOPTAL

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 for adolescents and adults, including the elderly, is 1 or 2 drops in the conjunctival
sac, from 3 to 6 times a day, as prescribed by your doctor.
In case of concomitant therapy with other eye drops, you must wait 10 to 15 minutes before the
subsequent applications.

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 it has been prescribed by a
doctor and used under the direct supervision of the doctor.

If you use more BETABIOPTAL than you should
No cases of overdose have been reported.

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

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

4. Possible side effects

Like all medicines, BETABIOPTAL can cause side effects, although not everybody gets them.
Side effects have been listed below according to their frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to the onset of local irritation (burning or stinging
sensation) and allergic reactions; treatment should 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 should occur, discontinue treatment.

Not known (frequency cannot be estimated from available data)
Eye disorders:
After prolonged use of corticosteroids, thinning of the
cornea should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Development of adverse reactions due to systemic absorption is unlikely. However, in case
of prolonged use or previous (anamnestic) quantitative or qualitative alteration of blood
composition, the risk of reduction of bone marrow cells (aplastic anemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor. You can also report side effects directly through the national reporting system at 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 the first opening of the container, you can use BETABIOPTAL 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 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 coloration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETABIOPTAL contains

• The active ingredients are betamethasone and chloramphenicol
• The other ingredients are Macrogol 300, Macrogol 1500, Macrogol 4000, Boric acid, Borax, Polysorbate 80, Hypromellose, Thiomersal, Purified water.

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

Marketing Authorisation Holder and Manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milano

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

BETABIOPTAL 1 mg/g + 2,5 mg/g ophthalmic gel

Betametasone + Chloramphenicol

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 their symptoms are the same as yours, as it could 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 BETABIOPTAL is and what it is used for
• 2. What you need to know before you use 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 is BETABIOPTAL and what is it 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 ophthalmic infections when it is useful to combine
the anti-inflammatory action of betamethasone.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you use BETABIOPTAL

Do not use BETABIOPTAL

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

Warnings and precautions
Long-term use of Betabioptal may:

• increase the pressure in the eye with the risk of progressive damage to the optic nerve (glaucoma). However, the amounts of betamethasone contained in BETABIOPTAL gel reduce the risk of glaucoma,
• cause vision problems,
• promote cataracts,
• promote new eye infections. During prolonged treatments, frequent checks of the internal eye pressure are advisable. Continuous application of Betabioptal for more than one month without specialist supervision is not recommended. If your eye condition is associated with thinning of the cornea and sclera, frequent checks by your doctor are advisable, as cases of corneal perforation caused by corticosteroids have been described. Contact your doctor if you experience blurred vision or other visual disturbances. In connection with prolonged topical applications of steroids and antibiotics, the development of microorganisms that are not sensitive (development of bacterial resistance) and a fungal infection of the cornea is more likely; if this should occur or if no clinical improvement is noticed within a reasonable period of time, inform your doctor. Do not use contact lenses if you have an eye infection. Rare cases of reduction in the number of bone marrow cells (myelodysplasia), including aplastic anemia, have been described following prolonged use of chloramphenicol for topical use in patients with pre-existing hematological diseases. For this reason too, the product should be used for short periods, unless explicitly indicated by the doctor.

Children
Do not give BETABIOPTAL to a child unless it has been prescribed by a doctor and the child
must be regularly monitored by a doctor.

Other medicines and BETABIOPTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
Data relating to the use of betamethasone in pregnant women are limited.
Do not use BETABIOPTAL during pregnancy unless under the direct control of your doctor.
Breastfeeding
Chloramphenicol has been identified in newborns/infants breastfed by treated women.
The doctor must decide whether to interrupt breastfeeding or avoid using BETABIOPTAL taking into
consideration the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Driving and using machines
BETABIOPTAL slightly alters the ability to drive vehicles or use machinery, as
it may blur your vision for a few minutes after application.

BETABIOPTAL gel contains thiomersal
It may cause allergic reactions.

3. How to use BETABIOPTAL

Use this medicine following exactly the instructions of 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 in the conjunctival sac, 2 to 3 times a day, as prescribed by your doctor.
In case of concomitant therapy with other eye drops, wait 10 to 15 minutes before subsequent
applications.

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

If you use more BETABIOPTAL than you should
No cases of overdose have been reported.

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

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

4. Possible side effects

Like all medicines, BETABIOPTAL can cause side effects, although not everybody gets them.
Side effects have been listed below according to their frequency:

Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to the onset of local irritation (burning or stinging sensation) and allergic reactions; treatment should 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 available data)
Eye disorders:
After prolonged use of corticosteroids, thinning of the cornea should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
Development of adverse reactions due to systemic absorption is unlikely. However, in case of prolonged use or previous (anamnestic) quantitative or qualitative alteration of the blood composition, the risk of reduction in the number of bone marrow cells (aplastic anemia) induced by chloramphenicol should be considered.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor. You can also report side effects directly through the national reporting system at 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 the 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 which is 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 colour.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETABIOPTAL contains

• The active ingredients are betamethasone sodium phosphate and chloramphenicol
• The other ingredients are Macrogol 300, Polyvinyl alcohol, Carbomer, Disodium edetate, Thiomersal, Purified water, 1N Sodium hydroxide.

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

Marketing authorisation holder and manufacturer
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milano

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