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.