Eustamyl

Package leaflet: Information for the patient

EUSTAMYL 0.5 mg/ml eye drops, solution

ketotifene fumarate
Please read all of this leaflet carefully before you start 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, 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 using the medicine.

Contents of this leaflet:

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

1. What EUSTAMYL is and what it is used for

EUSTAMYL contains the active substance ketotifene fumarate, which belongs to a class of medicines with antiallergic activity.
EUSTAMYL is used for local treatment of allergic inflammation (seasonal, atopic and other) of the eyes, both short- and long-term, such as:

• conjunctivitis
• keratoconjunctivitis.

Consult your doctor if you do not feel better or if you feel worse after using this medicine.

2. What you need to know before using EUSTAMYL

Do not use EUSTAMYL

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

Warnings and precautions
Talk to your doctor or pharmacist before using EUSTAMYL.
You must use EUSTAMYL only to treat the external part of the eye.
When applied to the eyes, EUSTAMYL may cause a slight and transient burning sensation.
Other medicines and EUSTAMYL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other eye medications, wait at least 5 minutes between each application.
Oral use of ketotifen may enhance the effects of medicines that depress the central nervous system (such as tranquilizers, used to treat anxiety and insomnia, and hypnotics, used to induce or facilitate sleep), antihistamines (medicines used for allergies), and alcohol. Although these effects have not been observed with ketotifen eye drops, the possibility cannot be completely ruled out.
EUSTAMYL and alcohol
Ketotifen may interact with alcohol, but this is unlikely due to the low systemic exposure following ocular administration of EUSTAMYL eye drops.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use EUSTAMYL during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Since it is unlikely that the medicine passes into breast milk, you may use EUSTAMYL during breastfeeding.
Fertility
There are no data available on the effects of this medicine on human fertility.
Driving and use of machinery
If you are particularly sensitive, EUSTAMYL may initially reduce your reaction ability.
If you experience blurred vision or drowsiness, do not drive or operate machinery.
EUSTAMYL multidose eye drop bottle contains benzalkonium chloride
EUSTAMYL multidose eye drop bottle contains the preservative benzalkonium chloride 0.01 g per 100 ml, equivalent to 0.001 g per 5 ml, which may 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 unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use EUSTAMYL

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 in the eye 2 or more times a day.

Multidose bottle of 10 ml
1- Unscrew the cap and the bottle is ready to use.
2- Close the bottle immediately after use.
3- To avoid any contamination, do not let the dropper tip touch any surface, nor make direct contact with the eye.
4- The eye drops must not be used more than 30 days after the first opening of the bottle.

Single-dose container of 0.5 ml
1- Separate a single-dose container.
2- To open the container, rotate the cap in one direction.
3- Gently squeeze the body of the container to instil one drop of solution onto the affected eye surface.

EUSTAMYL single-dose does not contain preservatives; after opening, discard it immediately after use, even if only partially used.

If you use more EUSTAMYL than you should
No overdose effects have been reported to date.

EUSTAMYL eye drops in multidose bottle
Oral ingestion of 1.25 mg of ketotifene, the active substance in EUSTAMYL, corresponds to 60% of the recommended daily oral dose for a 3-year-old child. With doses up to 20 mg of ketotifene, no serious signs or symptoms have been reported.

EUSTAMYL eye drops in single-dose container
Oral ingestion of 0.1 mg of ketotifene, the active substance in EUSTAMYL, corresponds to 5% of the recommended daily oral dose for a 3-year-old child. With doses up to 20 mg of ketotifene, no serious signs or symptoms have been reported.

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

If you stop using EUSTAMYL
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 were reported during clinical studies conducted with EUSTAMYL, according to the following frequency:

Common side effects (may affect up to 1 in 10 people):

• eye irritation;
• eye pain;
• inflammation with painful lesions of the cornea, the transparent membrane covering the front part of the eye (punctate keratitis);
• loss or damage of the surface skin of the cornea (corneal epithelium) with small, point-shaped erosions (punctate epithelial erosion);

Uncommon side effects (may affect up to 1 in 100 people):

• allergic reactions (hypersensitivity);
• headache;
• blurred vision during application of the eye drops;
• dry eye;
• eyelid disorders;
• inflammation of the conjunctiva, the transparent membrane lining the inner surface of the eyelids and the front part of the eye (conjunctivitis);
• discomfort in the eyes caused by light (photophobia);
• severe bleeding of the conjunctiva (conjunctival haemorrhage);
• dry mouth;
• skin redness (rash);
• skin inflammation characterized by itching, redness, peeling, and skin elevations (eczema);
• skin condition characterized by sudden onset of rash and itching (urticaria);
• drowsiness.

Rare side effects (may affect up to 1 in 1,000 people):

• mild burning sensation;
• local irritation with redness (hyperaemia) and inflammation of the eyelids (blepharitis).

Following the marketing of the medicine, the following side effects have been reported with the following frequency:

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

• allergic reactions (hypersensitivity reactions), including local reactions (such as contact dermatitis, characterized by redness, peeling, small blisters, vesicles, superficial wounds, and crusts appearing upon contact with certain substances; eye swelling; eyelid itching and edema, fluid accumulation with swelling) and those affecting the entire body (systemic reactions), such as facial swelling and fluid accumulation, often associated with contact dermatitis;
• worsening of pre-existing allergic conditions such as asthma (inflammatory disease of the airways characterized by breathing difficulty, wheezing, cough, and chest tightness) and eczema (skin inflammation characterized by itching, redness, peeling, and skin elevations).

If you follow the instructions provided, you reduce the risk of side effects.

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 the following website:
https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EUSTAMYL

Store at a temperature not exceeding 30°C.
For EUSTAMYL multidose bottle 10 ml, the shelf life after first opening is 30 days at a temperature not exceeding 30°C.
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 “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 EUSTAMYL contains

• The active substance is: ketotifene fumarate – 100 ml contain 0.069 g, equivalent to 0.05 g of ketotifene.
• The other components are:
  Multidose container: Glycerol; Benzalkonium chloride; Water for injections.
  Single-dose container: Hypromellose; Sorbitol; Water for injections.

Description of the appearance of EUSTAMYL and contents of the pack
Pack with multidose container: 1 10 ml dropper bottle made of polyethylene, with a child-resistant and non-intuitive closure cap.
Pack with single-dose containers: 25 single-dose units of 0.5 ml made of polyethylene. The containers are arranged in strips of 5 units and enclosed in pouches made of polyethylene-aluminum-polyester laminate.

Marketing Authorization Holder
VISUfarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome, Italy

Manufacturer:
FARMIGEA S.p.A.
Via G.B. Oliva, 8
56121 Ospedaletto – Pisa (Italy)