Cromicil-Solofarm, eye drops 2% 10 ml

Anti-allergic agent – stabilizer of mast cell membranes< br> < br> ATC: < section>

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

< section> Pharmacodynamics:< br> < br> < br> Antiallergic agent, prevents mast cell degranulation and the release from them of mediators of allergic reactions – histamine and leukotrienes (especially SRS-A). The mechanism of action is probably based on stabilization of mast cell membranes and blocking of calcium channels, which causes inhibition of mediator release. Cromoglycic acid blocks both early and late allergic reactions.

The drug has no antihistamine and vasoconstrictor action.

< section>Pharmacokinetics:< br>

Absorption through the ocular mucosa is negligible. Systemic bioavailability is less than 0.03%. The elimination half-life is 5-10 minutes. Binding with plasma proteins is 65%. It is not metabolized, excreted by the kidneys and through the intestine unchanged (approximately equal amounts within 24 hours after application).

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Indications

Active ingredient

Composition

Directions for use

The drug is most effective when used prophylactically. Noticeable clinical effect occurs after a few days or weeks of use.

The treatment starts with instillation of the drug 1 drop 2 times a day into both eyes; if necessary the dosage regimen can be changed to instillation of 1 drop 4 times a day into both eyes.

In case of seasonal allergic conjunctivitis treatment should be started immediately after the appearance of the first symptoms or used prophylactically before the pollen season. Treatment continues throughout the flowering season or longer if symptoms persist.

Instructions for Use

Wash hands thoroughly before applying the product. If the drop does not enter the conjunctival sac, repeat the injection. After an injection, close your eyes and do not blink or open them for about 2 minutes to allow time for the mucosa to better contact the product.

Performance of the tube dropper:

1. Open the bag, separate one tube dropper, and place the rest back in the bag.

2. Open the dropper tube (making sure the solution is at the bottom of the dropper tube, rotate and separate the valve).

3. Drip the desired amount into the eyes.

The dose contained in the dropper tube is sufficient for one injection in both eyes. The drip tube should be discarded after one use, even if there is still some left.

Special Instructions

Contraindications

Children’s age.

Side effects

The adverse effects listed below are according to the following frequency gradations of severity:

Very common: >1/10

Frequent: >1/100, < 1/10

Infrequent: >1/1000, < 1/100

Rare: >1/10000, <1/1000

Very rare: <1/10000

Frequency unknown: cannot be estimated from available data.

Unwanted drug reactions are presented in descending order of severity.

A visual organ disorders: very rare – quickly resolved impairment of visual clarity, transient sensation of burning, foreign body, dryness in the eye, conjunctival edema, lacrimation, meibomitis.

Others: very rare – allergic reactions (itching, mild conjunctival soreness, conjunctival injection), changes in taste sensation.

Pregnancy use

The safety of using the drug during pregnancy and breastfeeding has not been established; therefore, during this period the drug should be used with caution and only when the expected benefits to the mother outweigh the potential risk to the fetus and child.

The drug is excreted into the breast milk; discontinuation of breastfeeding should be considered during treatment with the drug.