Cromopharm®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CROMOFARM® (CROMOFARM)

Composition:

Active substance: cromoglicic acid;

1 ml of solution contains sodium cromoglicate, calculated as 100% dry substance, 20 mg;

Excipients: benzalkonium chloride; sodium chloride; disodium edetate; polysorbate 80; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-inflammatory and antiallergic agents. ATC code S01GX01.

Pharmacological properties.

Pharmacodynamics.

The active substance of Cromoharm® eye drops, sodium cromoglicate, stabilizes the membranes of mast cells after they have been exposed to antigens, thereby preventing degranulation and release of various inflammatory mediators.

In addition, sodium cromoglicate blocks calcium channels associated with IgE receptors, thus inhibiting calcium influx into mast cells, which prevents their degranulation. This mechanism of action is the same for all mucous membranes (bronchi, nose, eyes, and intestines).

Pharmacokinetics.

Sodium cromoglicate is poorly lipid-soluble and therefore unable to penetrate through most biological membranes, such as the blood-brain barrier. Achieving an optimal therapeutic effect does not require maintaining specific blood levels of the active substance. The therapeutic effect of sodium cromoglicate after local administration depends only on its concentration in the target organ.

The metabolism of sodium cromoglicate has not yet been studied. Sodium cromoglicate is excreted in bile and urine in approximately equal proportions.

Clinical characteristics.

Indications.

Acute and chronic allergic conjunctivitis, including seasonal keratoconjunctivitis.

Contraindications.

Hypersensitivity to the active substance or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Specific studies on drug interactions of the medicinal product have not been conducted.

When administering Cromopharm® together with other topical ophthalmic medicinal products, a 15-minute interval should be maintained between instillations.

Instructions for Use

In general, wearing contact lenses is not recommended in cases of allergic conjunctivitis. However, if an ophthalmologist allows a patient to wear contact lenses under exceptional circumstances, the lenses must be removed before instilling Cromopharm® eye drops and should not be reinserted earlier than 15 minutes after administration of the medication.

Cromopharm® contains benzalkonium chloride, which may cause eye irritation. Benzalkonium chloride may also cause discoloration of soft contact lenses.

During instillation of eye drops, care must be taken to avoid any contact between the dropper tip and the eye or skin.

Shelf life after opening the bottle: 28 days.

Use during pregnancy or breastfeeding.

Pregnancy

Although animal studies have not revealed any direct or indirect harmful effects of sodium cromoglicate on pregnancy, embryonic/fetal development, labor, or postnatal development, there are no clinical data on the use of the drug in pregnant women. Cromopharm® should be administered to pregnant women only with caution, after careful assessment of the benefits and risks of such use.

Breastfeeding

Since sodium cromoglicate passes into breast milk in very small amounts, toxic effects in breastfed infants are unlikely. However, for safety reasons, the drug should be used during breastfeeding only if the potential benefit of treatment to the mother outweighs the possible risks to the infant.

Ability to affect reaction speed when driving or operating machinery.

Transient blurred vision may occur immediately after administration of the medication. Therefore, patients should wait until vision clears before driving or operating machinery.

Method of Administration and Dosage.

For adults and children aged 4 years and older: instill 1 drop into each eye 4 times daily. In certain acute cases, the medication may be administered more frequently—1 drop up to 6–8 times daily. As symptoms improve, the frequency of instillation may be reduced, but treatment should be continued for as long as the patient remains in contact with allergens (pollen, household dust, mold spores, and food allergens).

Cromofarm® is intended for long-term therapy. Treatment with Cromofarm® should be continued until exposure to the allergen causing the disease has ceased.

For seasonal allergic conjunctivitis, treatment should be initiated immediately upon the first signs of symptoms or used preventively before pollen exposure begins.

Duration of treatment depends on the type and severity of the disease. In patients with renal impairment, monitoring of functional parameters is recommended; if necessary, the dose may be reduced.

Caution! Before first use, do not tightly screw on the cap. Prior to first use, screw the bottle cap on firmly until it clicks. This action causes the spike on the inner side of the cap to pierce the seal. Immediately before use, hold the bottle in the palm of the hand to warm the solution to body temperature. Unscrew and remove the cap, then instill the solution into the eye by gently pressing on the body of the bottle. After instillation, tightly screw the cap back on and store the medication according to the recommendations provided in the instructions.

During prolonged therapy, the therapeutic effect should be monitored regularly. After adequate clinical stabilization, the dose may be reduced at the discretion of the physician.

Children.

Cromofarm® is not recommended for children under 4 years of age.

Overdose.

As there are no reported cases of overdose, specific treatment methods are unknown.

Side effects.

In isolated cases, local reactions such as burning, foreign body sensation, chemosis, conjunctival hyperemia, irritation, lacrimation, transient blurred vision, and hypersensitivity reactions may occur. There have been rare reports of severe generalized anaphylactic reactions including bronchospasm associated with the use of sodium cromoglicate.

As a preservative, the product contains benzalkonium chloride, which may also cause adverse reactions such as allergic reactions or disturbances of taste sensation.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml in a bottle. 1 bottle per carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.