Soketol

Package leaflet: Information for the user

SOKETOL 0,5 mg/ml eye drops, solution

Ketotifene
Please read all of this leaflet carefully before you start using this medicine because 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 to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What SOKETOL is and what it is used for

SOKETOL contains the active substance ketotifene and belongs to a group of medicines called ophthalmic antihistamine-antiallergic agents.
SOKETOL is used for the local treatment of short- and long-term allergic inflammation of the eyes (such as vernal, 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 SOKETOL

Do not use SOKETOL

• 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 SOKETOL.
This medicine may cause, upon application, a mild and temporary burning sensation.

Other medicines and SOKETOL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are using SOKETOL together with other eye medications, wait 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 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.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might 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 SOKETOL during pregnancy should be limited to cases of clear medical necessity.
Do not use SOKETOL if you are pregnant unless your doctor considers it strictly necessary.

Breastfeeding
SOKETOL may be used during breastfeeding.

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

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

SOKETOL in the 10 ml multidose bottle contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove 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 outermost layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use SOKETOL

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 using the multidose bottle:

1. To open the bottle, unscrew the closure cap.
2. To avoid any contamination, do not let the dropper tip touch any surface, or come into direct contact with the eye.
3. After use, close the bottle by screwing the closure cap back on.

Instructions for using the single-dose container:

1. Separate the single-dose container from the strip.
2. Open the container by twisting the cap.
3. Hold the container upside down over the eye and press with thumb and index finger until the drops come out.
4. Discard the container after use, even if there is some medicine left.

If you use more SOKETOL than you should
No cases of overdose have been reported.
Oral ingestion (by mouth) of the contents of the 10 ml multidose bottle corresponds to 5 mg of ketotifene.
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 a dose up to 20 mg of ketotifene.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
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 application); dry eye; eyelid disorders; inflammation of the conjunctiva, the thin transparent layer covering the inner surface of the eyelids and the front part of the eye (conjunctivitis); eye discomfort caused by light (photophobia); bleeding of the conjunctiva (conjunctival haemorrhage);
• dry mouth;
• skin redness (rash);
• skin inflammation characterized by itching, redness, scaling, and skin elevations (eczema);
• sudden onset of skin rash and itching (urticaria);
• drowsiness.

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

• allergic reactions (hypersensitivity reactions), including local reactions (such as contact dermatitis, characterized by redness, scaling, small blisters, vesicles, superficial sores, and crusts; swelling around the eyes; eyelid itching and swelling);
• systemic allergic reactions affecting the whole body, such as facial swelling and fluid accumulation, sometimes associated with contact dermatitis;
• worsening of pre-existing allergic conditions such as asthma (an inflammatory disease of the airways characterized by breathing difficulty, wheezing, cough, and chest tightness) and eczema (skin inflammation characterized by itching, redness, scaling, and skin elevations).

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 SOKETOL

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 refers to the product in its original, unopened packaging, correctly stored.
10 ml multidose bottle
The medicine must be used within 28 days after first opening the bottle.
Single-dose containers
After first opening the aluminium pouch: use within 10 days.
Once the single-dose container has been opened, the medicine must be used immediately. Any remaining solution must be discarded.
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. Package contents and other information

What SOKETOL contains
10 ml multidose bottle

• 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: sorbitol (E420), benzalkonium chloride, hypromellose (E464), sodium hydroxide, purified water.

Single-dose containers

• 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: sorbitol (E420), hypromellose (E464), sodium hydroxide, purified water.

Description of the appearance of SOKETOL and contents of the pack
SOKETOL is an eye drop solution. It is available in multidose and single-dose presentations.
10 ml multidose bottle
The pack contains one 10 ml bottle with dropper.
Single-dose containers
The pack contains 30 single-dose containers of 0.5 ml, divided into 3 strips of 10 single-dose containers.
Each strip of 10 single-dose containers is packaged in a pouch.
Marketing Authorization Holder and Manufacturer
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera 26 - 80026 Casoria (NA)