Brunistill eye drops 20 bottles 0.5 ml 0.025

  • Bruschettini S.r.l.
  • 037448026

Brunistill is a drug based on the active ingredient ketotifen hydrogen fumarate (FU) - belonging to the category of Antiallergics and specifically Other antiallergics. Brunistill can be prescribed with SOP Recipe - non-prescription medicine. BRUNISTILL is indicated for the symptomatic treatment of seasonal allergic conjunctivitis.

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BRUNISTILL * COLL20FL 0,5ML0,025

Therapeutic indications

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

Dosage and method of use

Adults, seniors and children (over 3 years):one drop of eye drops into the conjunctival sac twice a day. The content of a single-dose container is sufficient for one administration in both eyes. 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.

Contraindications

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

Side effects

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,

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

Special warnings

No special precautions

Pregnancy and breastfeeding

No clinical data are available on the use of BRUNISTILL in 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 consecutive animal studies with 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 BRUNISTILL eye drops can therefore breastfeed.

Expiration and retention

Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

If you are using other medications for ocular use, you should leave at least 5 minutes between applications. 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.

Overdose

No cases of overdose have been reported. Oral intake of the contents of a single-dose container would be equivalent to 0.1 mg of ketotifen, which is 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.

Active principles

A single-dose container of 0.5 ml of solution contains:Active principle: ketotifen 125 mcg (as hydrogen fumarate), equal to 250 mcg / ml For excipients see 6.1.

Excipients

Glycerol (E422) Sodium Hydroxide Purified water.

037448026

Data sheet

Packaging
0 -025 mg / ml eye drops 20 single-dose containers
0,025 mg/ml collirio 20 contenitori monodose
Product Type
HUMAN DRUG
ATC code
S01GX08
ATC description
Ketotifen
Therapeutic Group
Antiallergic
Active principle
ketotifen hydrogen fumarate (FU)
Class
C.
Pharmaceutical form
eye drops
Type of Administration
ophthalmic
Container
pipette / single-dose containers
Quantity
20 pipette / single-dose container
Capacity
0 -5 milliliters
0.5 milliliters
Quantity of the Active Ingredient
, 25MG
-25MG
Recipe required
SOP - non-prescription medicine
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