Brunistill 0.025% 20×single-dose eye drops solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

BRUNISTILL is indicated in the symptomatic treatment of seasonal allergic conjunctivitis.

ACTIVE INGREDIENTS

A single-dose container of 0.5 ml of solution contains: Active ingredient: Ketotifen: 125 micrograms (as hydrogen fumarate), equal to 250 micrograms/ml. For the full list of excipients, see section 6.1.

EXCIPIENTS

Glycerol (E422), Sodium Hydroxide, Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance ketotifen or to any of the excipients listed in section 6.1.

DOSAGE

Dosage Adults, elderly and children (over 3 years): a drop of eye drops in the conjunctival sac twice a day. The contents of a single-dose container are sufficient for administration in both eyes. Method of administration Contents and container remain sterile until the original closure is opened. To avoid the risk of contamination, do not touch any surface with the tip of the container.

CONSERVATION

Store at a temperature not exceeding 25°C.

WARNINGS

No special precautions.

INTERACTIONS

If you are using other medicines for ocular use, you should leave at least 5 minutes between one application and another. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with BRUNISTILL, the possibility of such effects cannot be excluded.

SIDE EFFECTS

Adverse drug reactions from clinical trials (Table 1) are listed according to MedDRA classification. Within each systemic organ class, adverse drug reactions are classified by frequency with the most frequent first. Within each frequency grouping, reactions are presented in order of decreasing severity. The following side effects have been reported at the recommended dose: The frequency listed below is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10); uncommon (from ≥ 1/1000 <1/100); rare (from ≥ 1/10,000 to < 1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Eye disorders: - Adverse events: eye irritation, eye pain, punctate keratitis, punctate epithelial erosion. Frequency: Common.

Eye disorders: - Adverse events: blurred vision (during instillation), dry eye, eyelid disorders, conjunctivitis, photophobia, conjunctival hemorrhages. Frequency: Uncommon.

Nervous system disorders: - Adverse events: headache. Frequency: Uncommon.

Systemic disorders and conditions relating to the administration site - Adverse events: drowsiness. Frequency: Uncommon.

Skin and subcutaneous tissue disorders: - Adverse events: rash, eczema, urticaria. Frequency: Uncommon.

Gastrointestinal disorders: - Adverse events: dry mouth. Frequency: Uncommon.

Immune system disorders: - Adverse events: hypersensitivity. Frequency: Uncommon.

Adverse drug reactions from post-marketing experience (frequency not known). The following post-marketing events were also observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, eyelid pruritus and edema), systemic allergic reactions including facial swelling/edema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili".

OVERDOSE

No cases of overdose have been found. Oral intake of the contents of a single-dose container would be equivalent to 0.1 mg of Ketotifen, equal to 5% of a recommended daily oral dose for a 3-year-old child. Clinical results indicated no serious signs or symptoms following ingestion of a dose of up to 20 mg of ketotifen.

PREGNANCY AND BREASTFEEDING

Pregnancy No clinical data are available on the use of BRUNISTILL 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 used when prescribing the medicine to pregnant women. Breastfeeding Although data from consecutive animal studies following oral administration demonstrate the excretion of the active ingredient in breast milk, it is unlikely that topical administration in women can produce detectable quantities of active ingredient in breast milk. Mothers who use BRUNISTILL eye drops can therefore breastfeed. Fertility No data are available on the effect of ketotifen hydrogphen fumarate on fertility in humans.

EFFECTS ON DRIVING ABILITY

If a patient has blurred vision or drowsiness, he or she should refrain from driving vehicles and using machinery.