KETOFTIL 0.5 mg/ml Krople do oczu, roztwór

Treść ulotki

1. Ketoftil 0.5 mg/ml eye drops, solution
   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
2. Ketoftil 0.5 mg/ml eye drops, solution
   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
3. Ketoftil 0.5 mg/g ophthalmic gel
   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

Ketoftil 0.5 mg/ml eye drops, solution

Ketotifen

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 ketotifen and belongs to a group of medicines called
antihistamine-antiallergic for ophthalmic use.
Ketoftil is used to treat acute and chronic allergic inflammation (spring, atopic and
other) of the eyes such as:

• conjunctivitis
• keratoconjunctivitis

See 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 ketotifene or 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 taking, have recently taken or might take any other
medicines. If you are using Ketoftil together with other eye medicines, allow at least 5 minutes
between each application. Oral administration of ketotifene may enhance the effects of
medicines with a depressant action on the central nervous system (such as tranquilizers, hypnotics), antihistamines (antiallergics) and alcohol. Although these effects have not been observed with the use of ketotifene-based eye drops, the possibility that they may still occur cannot be ruled out.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may 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
No data are available on the use of ketotifene in pregnancy. The use of Ketoftil during pregnancy should be
limited to cases of actual necessity.
Breastfeeding
Ketoftil can be used during breastfeeding.
Fertility
No data are available regarding the effects of ketotifene on fertility in men.

Driving and operating machinery
Ketoftil, at the beginning of treatment, may cause blurred vision or drowsiness and reduce the ability
to react (especially in sensitive individuals). Therefore, if this should happen, do not drive vehicles and do not
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 lead to a change in
their color. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use Ketoftil

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The doserecommendedis 1 drop in the conjunctival sac 2 or more times a day.

Instructions for use of the multidose bottle:

• To open the bottle, press the closing cap and simultaneously unscrew it.
• After use, close the bottle tightly by screwing it on completely.

If you usemore Ketoftil than you should
Cases of overdose have not been reported.
Oral intake of the contents of the 10 ml multidose bottle is equivalent to 5 mg of ketotifen.
No serious signs or symptoms have been reported after ingestion of a dose up to 20 mg of ketotifen.

If you forget to use Ketoftil
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask 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;
• corneal inflammation (punctate keratitis);
• damage to the corneal epithelium (punctate erosion of the corneal epithelium). Uncommon(may affect up to 1 in 100 people)
• allergy (hypersensitivity);
• headache;
• blurred vision (particularly during the application of the eye drops), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
• dry mouth;
• skin rash, eczema and urticaria;
• drowsiness. Frequency not known(the frequency cannot be estimated from the available data)
• hypersensitivity reactions including local allergic reactions (predominantly contact dermatitis, swelling of the area around the eye, itching of the eyelid 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The medicine must be used within 30 days after the first opening of the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ketoftil contains

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

Description of the appearance of Ketoftil and package contents
Ketoftil is presented as eye drops, solution.
The package contains a 10 ml dropper bottle.

Marketing Authorisation Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 – 00144 Roma

Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.

Ketoftil 0.5 mg/ml eye drops, solution

Ketotifene

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 you use 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 ketotifen and belongs to a group of medicines called antihistamine-anti-allergic for ocular use.
Ketoftil is used to treat acute and chronic allergic inflammations (spring, atopic and
others) of the eyes such as:

• conjunctivitis;
• keratoconjunctivitis.

See 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 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 slight and temporary burning sensation.

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 medicines for the eyes, allow at least 5 minutes
between each application.
Oral administration (by mouth) of ketotifen may enhance the effects of medicines that depress the
central nervous system (such as tranquillizers, hypnotics), antihistamines (anti-allergy medicines) and
alcohol. Although these effects have not been observed with the use of ketotifen-based eye drops, the possibility
that they may still occur cannot be excluded.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
No data are available on the use of ketotifen in pregnancy. The use of Ketoftil during pregnancy should be
limited to cases of actual necessity.
Breastfeeding
Ketoftil can be used during breastfeeding.
Fertility
No data are available regarding the effects of ketotifen on fertility in men.

Driving and operating machinery
Ketoftil, at the beginning of treatment, may cause blurred vision or drowsiness and reduce the ability to
react (particularly in sensitive individuals). Therefore, if this should happen, do not drive vehicles and do not operate
machinery.

3. How to use Ketoftil

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The doserecommendedis 1 drop in the conjunctival sac 2 or more times a day.

Instructions for use of the single-dose container:

• 1) Separate the container from the strip.
• 2) Open the container by rotating the cap counterclockwise.
• 3) Hold the container upside down above the eye and press with your thumb and index finger until the drops come out.
• 4) Discard the container, even if some medicine remains after use.

1 2 3

If you usemore Ketoftil than you should
No cases of overdose have been reported.
Oral administration (by mouth) of the contents of the 0.5 ml single-dose container is equivalent to 0.25 mg of ketotifen.
No serious signs or symptoms have been reported after ingestion of a dose of up to 20 mg of ketotifen.

If you forget to use Ketoftil
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask 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;
• corneal inflammation (punctate keratitis);
• damage to the corneal epithelium (punctate erosion of the corneal epithelium).

Uncommon(may affect up to 1 in 100 people)

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

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

• hypersensitivity reactions including local allergic reactions (predominantly contact dermatitis, swelling of the area around the eye, itching of the eyelid 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Scad”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Once the container is opened, the medicine must be used immediately. Any remaining medicine must be
discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketoftil contains

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

Description of the appearance of Ketoftil and contents of the pack
Ketoftil is presented as eye drops, solution.
The pack contains 25 single-dose containers of 0.5 ml. The containers, in strips of 5 units, are
contained in polithene-aluminium-polyester sachets.

Marketing Authorisation Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 – 00144 Roma

Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.

Ketoftil 0.5 mg/g ophthalmic gel

Ketotifen

Read this leaflet carefully before using this medicine as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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. Contents of the pack and other information

1. What Ketoftil is and what it is used for

Ketoftil contains the active ingredient ketotifen and belongs to a group of medicines called

antihistamines- anti-allergic for ocular use.
Ketoftil is used to treat acute and chronic allergic inflammation of the eyes (spring, atopic and
other) such as:

• conjunctivitis
• keratoconjunctivitis

See 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 ketotifene or 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.
Ketoftil, after application, may cause slight blurred vision for a few minutes. If this
occurs, do not drive vehicles or use machinery (see “Driving and operating machinery”).
This medicine may cause a slight and temporary burning sensation upon 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 medicines for the eyes, allow at least 5 minutes between
each application.
Oral administration (by mouth) of ketotifene may enhance the effects of medicines that depress
the central nervous system (such as tranquilizers, hypnotics), antihistamines (antiallergics) and
alcohol. Although these effects have not been observed with the use of ketotifene-based eye drops, the possibility
that they may still occur cannot be ruled out.

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

Pregnancy, breastfeeding and fertility
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
No data are available on the use of ketotifene in pregnancy. The use of Ketoftil during pregnancy should be
limited to cases of actual necessity.
Breastfeeding
Ketoftil can be used during breastfeeding.
Fertility
No data are available regarding the effects of ketotifene on fertility in men.

Driving and operating machinery
Ketoftil, at the beginning of treatment, may cause blurred vision or drowsiness and reduce your ability
to react (especially in sensitive individuals). Therefore, if this happens, do not drive vehicles and do not
use machinery.

Ketoftil contains benzalkonium chloride
This medicine contains 1 mg of benzalkonium chloride equivalent to 0.1 mg/g
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their color. Remove your contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent superficial layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use Ketoftil

Use this medicine following 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 doserecommendedis 1 drop into the conjunctival sac 2 times a day.

Instructions for use:

• 1) Open the tube by unscrewing the cap.
• 2) To obtain better dripping, apply the gel holding the tube in a perpendicular position and not at an angle.
• 3) Close the tube by screwing on the cap.

If you usemore Ketoftil than you should
Cases of overdose have not been reported.
Oral administration (by mouth) of the tube contents is equivalent to 5 mg of ketotifen.
No serious signs or symptoms have been reported after ingestion of a dose up to 20 mg of ketotifen.

If you forget to use Ketoftil
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 erosion of the corneal epithelium).

Uncommon(may affect up to 1 in 100 people)

• allergy (hypersensitivity);
• headache;
• blurred vision (particularly during application of the gel), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
• dry mouth;
• skin rash, eczema, urticaria;
• drowsiness. Frequency not known(the frequency cannot be estimated from available data)
• hypersensitivity reactions including local allergic reactions (predominantly contact dermatitis, swelling around the eye, itching of the eyelid 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Scad.” The expiry
date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The medicine must be used within 30 days after the first opening of the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ketoftil contains

• The active ingredient is ketotifen. 1 g of gel contains 0.69 mg of ketotifen fumarate (equivalent to 0.5 mg of ketotifen).
• The other ingredients are: hydroxyethylcellulose, sorbitol, benzalkonium chloride,water for injectable preparations.

Description of the appearance of Ketoftil and package contents
Ketoftil is presented as an ocular (ophthalmic) gel.
The package contains a tube of 10 g of gel with a tip for ocular (ophthalmic) use.

Marketing Authorisation Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 – 00144 Roma

Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa.