Ketoftil

Package leaflet: Information for the user

Ketoftil 0.5 mg/ml eye drops, solution

Ketotifene
Please read this leaflet carefully before 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, 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 improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Ketoftil is and what it is used for

Ketoftil contains the active substance ketotifene and belongs to a group of medicines called
antihistamine-antiallergic agents for ocular use.
Ketoftil is used to treat acute and chronic allergic inflammation (such as vernal, atopic and other types) of the eyes, including:

• conjunctivitis
• keratoconjunctivitis

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before using Ketoftil

Do not use Ketoftil

• if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before using Ketoftil.
This medicine may cause, upon application, a mild and temporary burning sensation.

Other medicines and Ketoftil
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are using Ketoftil together with other eye medicines, leave at least 5 minutes between each application.
Oral administration of ketotifen may enhance the effects of medicines that depress the central nervous system (such as tranquilizers, hypnotics), antihistamines (antiallergic medicines), and alcohol. Although these effects have not been observed with ketotifen eye drops, the possibility that they may occur cannot be ruled out.

Ketoftil with food, drinks and alcohol
Ketoftil may increase the effects of alcohol.

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

Pregnancy
There are no available data on the use of ketotifen during pregnancy. The use of Ketoftil during pregnancy should be limited to cases of clear medical necessity.

Breastfeeding
Ketoftil may be used during breastfeeding.

Fertility
There are no data available on the effects of ketotifen on human fertility.

Driving and using machines
At the beginning of treatment, Ketoftil may cause blurred vision or drowsiness and reduce reaction ability (particularly in sensitive individuals). Therefore, if this occurs, do not drive or operate machinery.

Ketoftil contains benzalkonium chloride
This medicine contains 1 mg of benzalkonium chloride, equivalent to 0.1 mg/mL.
Benzalkonium chloride can be absorbed by soft contact lenses and may cause discoloration. Remove your 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 any abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Ketoftil

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 conjunctival sac two or more times a day.
Instructions for using the multidose bottle:

• To open the bottle, press down on the closure cap and at the same time unscrew it.
• After use, close the bottle securely by screwing the cap tightly.

If you use more Ketoftil than you should
Cases of overdose have not been reported.
Oral ingestion of the content of the 10 ml multidose bottle corresponds to 5 mg of ketotifene.
No serious signs or symptoms have been reported after ingestion of doses up to 20 mg of ketotifene.
If you forget to use Ketoftil
Do not use a double dose to make up for the missed dose.
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:
Common (may affect up to 1 in 10 people)

• eye pain and/or irritation;
• corneal inflammation (punctate keratitis);
• damage to the corneal epithelium (punctate epithelial erosion).
  Uncommon (may affect up to 1 in 100 people)
• allergy (hypersensitivity);
• headache;
• blurred vision (particularly during eye drop instillation), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
• dry mouth;
• skin rash, eczema, and urticaria;
• drowsiness.
  Frequency not known (frequency cannot be estimated from the available data)
• hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling around the eye area, eyelid itching, and swelling);
• systemic allergic reactions including facial swelling (facial oedema), and in some cases associated with contact dermatitis;
• exacerbations of pre-existing allergic conditions such as asthma and eczema.

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 Ketoftil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The stated expiry date applies to the product when it is unopened and properly stored.
The medicine must be used within 30 days after first opening the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Ketoftil contains

• The active substance is ketotifene. 1 ml of solution contains 0.69 mg of ketotifen fumarate (equivalent to 0.5 mg of ketotifene). The other components are: sorbitol, benzalkonium chloride, TS-polysaccharide, water for injections.

Description of the appearance of Ketoftil and pack contents
Ketoftil is an eye drop solution.
The pack contains one 10 ml bottle with dropper.
Marketing Authorization Holder
POLIFARMA S.p.A. - Viale dell'Arte, 69 – 00144 Rome
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.

Package leaflet: Information for the user

Ketoftil 0.5 mg/ml eye drops, solution

Ketotifen
Please read this leaflet carefully before 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.
• 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 improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Ketoftil is and what it is used for

Ketoftil contains the active substance ketotifene and belongs to a group of medicines called antihistamine-
antiallergic agents for ocular use.
Ketoftil is used to treat acute and chronic allergic inflammation (such as vernal, atopic and other types) of the eyes, including:

• conjunctivitis;
• keratoconjunctivitis.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Ketoftil

Do not use Ketoftil

• if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before using Ketoftil.
This medicine may cause a mild and temporary burning sensation upon application.

Other medicines and Ketoftil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using Ketoftil together with other eye medications, wait at least 5 minutes between each application.
Oral administration (by mouth) of ketotifen may enhance the effects of central nervous system depressants (such as tranquilizers, hypnotics), antihistamine medicines (antiallergy drugs), and alcohol. Although these effects have not been observed with the use of ketotifen eye drops, the possibility that they may occur cannot be ruled out.

Ketoftil with food, drinks and alcohol
Ketoftil may increase the effects of alcohol.

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

Pregnancy
There are no available data on the use of ketotifen during pregnancy. The use of Ketoftil during pregnancy should be limited to cases of genuine medical need.

Breastfeeding
Ketoftil may be used during breastfeeding.

Fertility
There are no data available on the effects of ketotifen on human fertility.

Driving and using machines
At the beginning of treatment, Ketoftil may cause blurred vision or drowsiness and reduce reaction ability (especially in sensitive individuals). Therefore, if this occurs, do not drive or operate machinery.

3. How to use Ketoftil

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 conjunctival sac 2 or more times a day.

Instructions for using the single-dose container:

1. Separate the container from the strip.
2. Open the container by turning the cap counterclockwise.
3. Hold the container upside down over the eye and gently press with thumb and index finger until the drop comes out.
4. Dispose of the container after use, even if there is some medicine left.

1 2 3

If you use more Ketoftil than you should
Cases of overdose have not been reported.
Oral ingestion (by mouth) of the contents of the 0.5 ml single-dose container corresponds to 0.25 mg of ketotifene.
No serious signs or symptoms have been reported after ingestion of doses up to 20 mg of ketotifene.

If you forget to use Ketoftil
Do not use a double dose to make up for the forgotten 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 everybody gets them.
The following side effects have been reported:
Common (may affect up to 1 in 10 people)

• eye pain and/or irritation;
• inflammation of the cornea (punctate keratitis);
• damage to the corneal epithelium (punctate epithelial erosion).

Uncommon (may affect up to 1 in 100 people)

• allergy (hypersensitivity);
• headache;
• blurred vision (particularly during eye drop administration), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
• dry mouth;
• skin rash, eczema, urticaria;
• drowsiness.

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

• hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling around the eye area, eyelid itching, and swelling);
• systemic allergic reactions including facial swelling (facial oedema), and in some cases associated with contact dermatitis;
• exacerbations of pre-existing allergic conditions such as asthma and eczema.

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 Ketoftil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the
last day of that month.
The stated expiry date applies to the product if unopened and correctly stored.
Once the container is opened, the medicine should be used immediately. Any remaining solution must be
discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ketoftil contains

• The active substance is ketotifene. 1 ml of solution contains 0.69 mg of ketotifene fumarate (equivalent to 0.5 mg of ketotifene).
• The other components are: TS-polysaccharide, sorbitol, water for injections.

Description of the appearance of Ketoftil and contents of the pack
Ketoftil is an eye drop solution.
The pack contains 25 single-dose containers of 0.5 ml. The containers are arranged in strips of 5 units and enclosed in polyethylene-aluminium-polyester sachets.
Marketing Authorisation Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 – 00144 Rome
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.

Package leaflet: Information for the user

Ketoftil 0.5 mg/g ophthalmic gel

Ketotifen
Please read this entire leaflet carefully before 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, 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 improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Ketoftil is and what it is used for

Ketoftil contains the active substance ketotifene and belongs to a group of medicines called
antihistamine-anti-allergic ophthalmic preparations.
Ketoftil is used to treat acute and chronic allergic inflammation of the eye (such as seasonal, atopic, and other types), including:

• conjunctivitis
• keratoconjunctivitis

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Ketoftil

Do not use Ketoftil

• if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before using Ketoftil.
After application, Ketoftil may cause slight blurring of vision for a few minutes. If this occurs, do not drive or
operate machinery (see "Driving and use of machines").
This medicine may cause a mild and temporary burning sensation at the time of application.

Other medicines and Ketoftil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are using Ketoftil together with other eye medicines, wait at least 5 minutes between each application.
Oral administration (by mouth) of ketotifen may enhance the effects of central nervous system depressants
(such as tranquilizers, hypnotics), antihistamines (antiallergic medicines), and alcohol. Although these effects
have not been observed with ketotifen eye drops, the possibility that they may occur cannot be excluded.

Ketoftil with food, drinks and alcohol
Ketoftil may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
There are no data available on the use of ketotifen during pregnancy. The use of Ketoftil during pregnancy should
be limited to cases of clear medical necessity.

Breastfeeding
Ketoftil may be used during breastfeeding.

Fertility
There are no data available on the effects of ketotifen on human fertility.

Driving and use of machines
At the beginning of treatment, Ketoftil may cause blurred vision or drowsiness and reduce reaction ability (especially
in sensitive individuals). Therefore, if this occurs, do not drive or operate machinery.

Ketoftil contains benzalkonium chloride
This medicine contains 1 mg of benzalkonium chloride, equivalent to 0.1 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses
before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (affecting
the transparent outer layer of the eye). If you experience any unusual eye sensation, burning or pain after using this
medicine, consult your doctor.

3. How to use Ketoftil

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 1 drop into the conjunctival sac twice daily.

Instructions for use:

1. Open the tube by unscrewing the cap.
2. To ensure proper drop delivery, apply the gel holding the tube in a perpendicular, not oblique, position.
3. Close the tube by screwing the cap back on.

If you use more Ketoftil than you should
Cases of overdose have not been reported.
Oral intake (oral route) of the tube contents corresponds to 5 mg of ketotifene.
No serious signs or symptoms have been reported after ingestion of a dose up to 20 mg of ketotifene.

If you forget to use Ketoftil
Do not use a double dose to make up for the missed dose.
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 everybody will experience them.
The following side effects have been reported:
Common (may affect up to 1 in 10 people)

• eye pain and/or irritation;
• inflammation of the cornea (punctate keratitis);
• damage to the corneal epithelium (punctate epithelial erosion).

Uncommon (may affect up to 1 in 100 people)

• allergy (hypersensitivity);
• headache;
• blurred vision (particularly during gel application), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
• dry mouth;
• skin rash, eczema, urticaria;
• drowsiness.

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

• hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling around the eye area, eyelid itching and swelling);
• systemic allergic reactions including facial swelling (facial oedema), and in some cases associated with contact dermatitis;
• exacerbations of pre-existing allergic conditions such as asthma and eczema.

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 Ketoftil

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 stated expiry date applies to the product stored in its original intact packaging and kept under proper storage conditions.
The medicine must be used within 30 days after first opening the container.
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. Contents of the pack and other information

What Ketoftil contains

• The active substance is ketotifene. 1 g of gel contains 0,69 mg of ketotifene fumarate (equivalent to 0,5 mg of ketotifene).
• The other ingredients are: hydroxyethylcellulose, sorbitol, benzalkonium chloride, water for injections.

Description of the appearance of Ketoftil and contents of the pack
Ketoftil is an ophthalmic gel.
The pack contains a 10 g tube of gel with an ophthalmic tip.
Marketing Authorization Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 – 00144 Rome
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.