Eustamyl 0.05% Ketotifen Antiallergic eye drops 25 vials 0.5 ml

Ketotifen-based eye drops.

Therapeutic indications

Eustamyl is used in the treatment of acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature (spring, atopic and others).

Dosage and posology

The drug is taken according to the following doses and methods: 1 drop in the conjunctival sac 2 or more times a day, according to medical prescription.

The single-dose vials do not contain antimicrobial preservatives designed to preserve their sterility during use and therefore, once the container has been opened, the product contained in it must be used immediately; what may be left over must be thrown away.

Overdose

No cases of overdose have been reported. Oral intake of the contents of a single-dose container of 0.1 mg of ketotifen corresponds to 5% of a recommended daily oral dose for a 3-year-old child. Clinical results indicated no serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.

Contraindications

• Hypersensitivity to ketotifen or to any of the excipients.
• Generally contraindicated in pregnancy

Side effects

Adverse drug reactions from clinical trials (table 1) are listed according to MedDRA classification by organ and system classes. Within each system organ class, adverse drug reactions are ranked by frequency with the most frequent first. Within each frequency group, reactions are presented in order of decreasing severity. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): Very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1/1000 to <1/100); rare (> 1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).

- Disorders of the immune system

• Uncommon: Hypersensitivity

- Nervous system disorders

• Uncommon: Headache

- Eye disorders

• Common: Eye irritation, Eye pain, Punctate keratitis, Punctate epithelial erosion
• Uncommon: Blurred vision (during instillation), Dry eye, Eyelid disorders, Conjunctivitis, Photophobia, Conjunctival haemorrhages
• Rare: Slight burning, local irritation with hyperemia and blepharitis

- Gastrointestinal disorders

• Uncommon: Dry mouth

- Skin and subcutaneous tissue disorders

• Uncommon: Rash, Eczema, Urticaria

- General disorders and administration site conditions

• Uncommon: Somnolence

The following post-marketing events have also been observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, eyelid itching and edema), systemic allergic reactions including facial swelling / edema (in some cases associated contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.

Pregnancy and breastfeeding

There are no adequate data on the use of Eustamyl eye drops during pregnancy. Animal studies with toxic oral doses have shown an increase in pre - and postnatal mortality, but have not shown teratogenic effects. Systemic levels of ketotifen after ophthalmic application are much lower than those achieved after oral administration. However, caution should be exercised when prescribing the medicine to pregnant women.

Although data from animal studies following oral administration demonstrate excretion of the active substance in breast milk, topical administration in women is unlikely to produce detectable amounts of the active substance in breast milk. Mothers who use Eustamyl eye drops can therefore breastfeed.

There are no data on the effect of ketotifen fumarate on human fertility.

Special warnings

Eustamyl can cause a slight and fleeting burning sensation at the time of application.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Eustamyl 0.05% eye drops contain:

Active principle

Ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.

Excipients

Hydroxyethylcellulose; sorbitol; water for injections.