ZADITEN OFTABAK COLL FL 5ML

ZADITEN OFTABAK 0.25 MG/ML COLLECTION

active ingredients

A ml contains 0.345 mg of ketotifene hydrogen smoked corresponding to 0.25 mg of ketotifene For the full list of excipients, see paragraph 6.1.

Excellent

Sodium glycerol (for pH regulation) Water for injectable preparations

Therapeutic indications

Syntomatic treatment of seasonal allergic conjunctivitis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Adults, elders and children (from 3 years): A drop of ZADITEN OFTABAK in the joint bag twice a day. Method of administration The patient must be instructed to: - before use, discard the first 5 drops. After the first time, it is no longer necessary to discard the first 5 drops; - wash your hands thoroughly before instillation; - to avoid contamination do not touch the eye or eyelids or any other surface with the end of the dropper; - close the eyelids and perform a nasolacrimal occlusion for 1-2 minutes. This will help to reduce systemic absorption; - close the bottle after use.

Conservation

This medicine does not require any special conservation conditions. For conditions of conservation after the first opening of the medicinal product, see paragraph 6.3.

Warnings

No special precaution.

Interactions

If ZADITEN OFTABAK is used in conjunction with other eye medicines, at least 5 minutes must be taken between the application of 2 medicines. Oral administration of ketotifen can enhance the effects of depressive drugs on SNC, antihistamines and alcohol. Although these phenomena have not been observed with collieries containing ketotifen, the possibility of such effects cannot be excluded.

Effects

Adverse reactions are classified according to the frequency using the following convention: very common: (≥1/10), common: (≥1/100 a Immune system disorders Not common: Hypersensitivity Diseases of the nervous system Not common: Cefa Pathologies of the eye City: Eye irritation, eye pain, pointed keratite, episode erosion of the corneal epithelium. Not common: Offused vision (during instillation), eye dryness, eyelid disorder, conjunctivitis, photophobia, conjunctive hemorrhage. Gastrointestinal diseases Not common: dry mouth Pathologies of skin and subcutaneous tissue Not common: rash, eczema, hives Systemic pathologies and conditions for administration Not common: Sleep Adverse reactions from post-marketing experience (non-known frequency): The following post-marketing events were observed: - hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, swelling of the eyes, itching and edema of the eyelids), systemic allergic reactions, including swelling / edema of the face (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as as asthma and eczema; - dizziness Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported. Oral intake of the content of a 5 ml bottle is equivalent to 1.25 mg ketotifen, equal to 60% of a daily oral dose recommended for a 3-year-old. Clinical results have not indicated severe signs or symptoms after ingestion of a dose of up to 20 mg of ketotifene.

Pregnancy There is no adequate data on the use of colliary ketotifen in pregnancy. Animal studies with toxic oral doses showed an increase in pre- and postnatal mortality, but did not show teratogenic effects. Systemic levels after eye administration are much lower than after oral use. It must be used caution in prescribing the medicine to pregnant women. Breastfeeding Although the data of animal studies after oral administration demonstrate the excretion in breast milk, it is unlikely that the topical administration in the woman can produce detectable amounts in breast milk. ZADITEN OFTABAK colliery can be used during breastfeeding. Fertility There is no data available on the effect of hydrogen ketotifen smoked on fertility.

Source: Farmadati