Brunistill 0.025% 20×single-dose eye drops solution

Brunistill 0.025% 20×single dose eye drops solution is an ophthalmic solution in practical single-dose vials , ideal for the symptomatic treatment of seasonal allergic conjunctivitis . The active ingredient, ketotifen (0.025%), acts as an anti-allergic by blocking the mediators responsible for ocular allergic reactions, offering rapid relief from the main ocular symptoms such as itching, redness, tearing and burning. The formulation in single-dose eye drops guarantees maximum hygiene and practicality, reducing the risk of contamination and proving particularly suitable for those who use the product away from home or while traveling.

Brunistill is indicated for adults and children over 3 years of age and is distinguished by the absence of preservatives, making it suitable even for those with sensitive eyes or contact lens wearers (remove lenses before instillation and wait at least 15 minutes before reinserting them). The solution contains, in addition to ketotifen, glycerol, sodium hydroxide and purified water , to ensure comfort and tolerability during use. Each pack contains 20 single-dose containers of 0.5 ml each, sufficient for administration to both eyes.

Thanks to its targeted action against the symptoms of eye allergies , Brunistill 0.025% eye drops solution represents an effective and safe choice for those suffering from seasonal allergic conjunctivitis , ensuring rapid ocular well-being and prolonged protection during periods of greater exposure to allergens.

ACTIVE INGREDIENTS

Active ingredients contained in Brunistill 0.025% 20×single-dose eye drops solution - What is the active ingredient in Brunistill 0.025% 20×single-dose eye drops solution?

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

EXCIPIENTS

Composition of Brunistill 0.025% 20×single-dose eye drops solution - What does Brunistill 0.025% 20×single-dose eye drops solution contain?

Glycerol (E422), Sodium hydroxide, Purified water.

DIRECTIONS

Therapeutic indications Brunistill 0.025% 20×single-dose eye drops solution - Why is Brunistill 0.025% 20×single-dose eye drops solution used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Brunistill 0.025% 20×single-dose eye drops solution - When should Brunistill 0.025% 20×single-dose eye drops solution not be used?

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

DOSAGE

Quantity and method of taking Brunistill 0.025% 20×single-dose eye drops solution - How is Brunistill 0.025% 20×single-dose eye drops solution taken?

Dosage Adults, elderly and children (over 3 years): one drop of eye drops in the conjunctival sac twice a day. The contents of a single-dose container are sufficient for administration to 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

Storage Brunistill 0.025% 20×single-dose eye drops solution - How is Brunistill 0.025% 20×single-dose eye drops solution stored?

Store at a temperature not exceeding 25°C.

WARNINGS

Warnings Brunistill 0.025% 20×single dose eye drops solution - About Brunistill 0.025% 20×single dose eye drops solution it is important to know that:

No special precautions.

INTERACTIONS

Interactions Brunistill 0.025% 20×single-dose eye drops solution - Which medicines or foods can modify the effect of Brunistill 0.025% 20×single-dose eye drops solution?

If you are using other medications for ocular use, you should leave at least 5 minutes between one application and the other. 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

Like all medicines, Brunistill 0.025% 20×monodose eye drops solution can cause side effects - What are the side effects of Brunistill 0.025% 20×monodose eye drops solution?

Adverse drug reactions from clinical trials (Table 1) are listed according to MedDRA classification. Within each system organ class, adverse drug reactions are ranked by frequency with the most frequent first. Within each frequency grouping, reactions are presented in order of decreasing seriousness. The following undesirable 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 (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

MedDRA System Organ Classification	Adverse events	Frequency
Eye pathologies:	eye irritation, eye pain, punctate keratitis, punctate epithelial erosion	Common
	blurred vision (during instillation), dry eye, eyelid disorders, conjunctivitis, photophobia, conjunctival hemorrhages.	Uncommon
Nervous system disorders:	headache	Uncommon
Systemic disorders and conditions related to the administration site	drowsiness	Uncommon
Skin and subcutaneous tissue disorders:	rash, eczema, urticaria	Uncommon
Gastrointestinal disorders:	dry mouth	Uncommon
Immune system disorders:	hypersensitivity	Uncommon

Adverse drug reactions from post-marketing experience (frequency not known). The following post-marketing events have also been observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, eyelid itching and oedema), systemic allergic reactions including facial swelling/oedema (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 after authorisation of the medicinal product is important. It allows continued 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

Overdose Brunistill 0.025% 20×single-dose eye drops solution - What are the risks of Brunistill 0.025% 20×single-dose eye drops solution in case of overdose?

No cases of overdose have been reported. Oral ingestion of the contents of a single-dose container would be equivalent to 0.1 mg of Ketotifen, or 5% of a recommended daily oral dose for a 3-year-old child. Clinical results have not indicated serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Brunistill 0.025% 20×single-dose eye drops, solution.

Pregnancy There are no clinical data 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 any 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 medicinal product to pregnant women. Breastfeeding Although data from studies on animals following oral administration demonstrate the excretion of the active substance in breast milk, it is unlikely that topical administration in women can produce quantities of the active substance detectable in breast milk. Mothers using BRUNISTILL eye drops can therefore breast-feed. Fertility There are no data available on the effect of ketotifen hydrochloride fumarate on fertility in humans.

DRIVING AND USE OF MACHINERY

Taking Brunistill 0.025% 20×single-dose eye drops solution before driving or using machines - Does Brunistill 0.025% 20×single-dose eye drops solution affect driving or using machines?

If a patient experiences blurred vision or drowsiness, he or she should refrain from driving or operating machinery.