Kromofarm®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KROMOFARM® (CROMOFARM)

Composition:

Active substance: cromoglicic acid;

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

1 dose contains 2 mg of sodium cromoglicate;

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

Pharmaceutical form. Nasal spray.

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

Pharmacotherapeutic group.
Agents used in nasal diseases. Antiallergic agents, excluding corticosteroids. ATC code R01AC01.

Pharmacological Properties.

Pharmacodynamics.

An anti-allergic agent that prevents intracellular penetration of calcium ions, stabilizes basophil membranes, thereby inhibiting their degranulation, and consequently prevents the release of inflammatory mediators: histamine, bradykinin, leukotrienes, and other biologically active substances. This mechanism of action is universal for all mucous membranes (bronchi, nose, eyes, intestines). The drug protects against the effects of specific allergens (dust, pollen) and other irritating environmental factors.

Pharmacokinetics.

After intranasal administration, less than 7% of the dose is absorbed from the nasal cavity and enters the systemic circulation. The main factor ensuring the therapeutic effect of the drug is the concentration of sodium cromoglicate achieved in the target organ following local administration. The elimination half-life is 80 minutes.

Sodium cromoglicate is poorly soluble in lipids and therefore unable to penetrate biological membranes, including the blood-brain barrier.

Sodium cromoglicate is not metabolized. The drug is excreted from the body in equal amounts in urine and bile within 24 hours in unchanged form.

Clinical characteristics.

Indications.

Prophylaxis and treatment of seasonal or perennial allergic rhinitis.

Contraindications.

Hypersensitivity to sodium cromoglicate, benzalkonium chloride, or any of the other components of the drug; severe renal and/or hepatic insufficiency; nasal polyps.

Interaction with other medicinal products and other forms of interaction.

There are no data on negative drug interactions of sodium cromoglicate (in the form of nasal spray) with other drugs when used concomitantly. When including Cromofarm® in therapy together with antihistamines, beta-adrenergic agonists, glucocorticoids, and theophylline, the dosage of these agents may be reduced or they may be discontinued as recommended by a physician.

Special precautions for use.

To accelerate the onset of action, nasal decongestants may be used prior to application of Cromofarm® spray for 2–3 days. In some cases, combination with an antihistamine agent for a short period may be beneficial.

The patient should be advised about the necessity of regular use of the medication.

Accidental swallowing of the solution during spray application is safe and does not require any special measures.

The product should not be used if the integrity of the container is compromised or if the solution becomes cloudy.

Use during pregnancy or breastfeeding.

Teratogenic effects of the drug have not been observed during pregnancy. Available experience indicates no influence of sodium cromoglicate on fetal development. However, the drug should be used during pregnancy only when strictly necessary.

Sodium cromoglicate may pass into breast milk in small amounts, but adverse effects on the infant have not been reported with use at recommended doses. Nevertheless, the use of the spray during breastfeeding should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction speed when driving or operating machinery.

No effect is expected; however, in sensitive patients, adverse reactions from the central nervous system, such as dizziness, may occur.

Method of Administration and Dosage

Before use, hold the bottle of the medication in the palm of the hand to warm it to body temperature. The nose should be gently cleaned before administering the medication. During application, hold the bottle vertically with the nozzle pointing upwards. Before use, remove the protective cap, then insert the spray tip into the nostril and gently press with the fingers to administer the medication. A gentle nasal inhalation is recommended during spraying. After use, replace the protective cap on the bottle.

One spray of Cromopharm® nasal spray contains 2 mg of sodium cromoglicate (2.7 drops of the solution).

For adults and children aged 5 years and older: one spray into each nostril four times daily. If necessary, the frequency of administration may be increased for adults up to six times daily (one dose each time).

For seasonal allergic rhinitis, treatment should be initiated immediately upon the first symptoms or used prophylactically before patient exposure to a known allergen. After achieving the therapeutic effect, the intervals between doses may be gradually extended. Discontinuation should be performed gradually over a period of one week.

Duration of treatment depends on the type and severity of the disease.

Children. Due to lack of adequate data, sodium cromoglicate solution should not be administered to children under 5 years of age. Use in children aged 5 years and older is permitted only under medical supervision.

Overdose.

There are currently no reported cases describing symptoms following overdose with sodium cromoglicate.

Side effects.

Respiratory system: irritation or burning sensation of the nasal mucosa, sneezing, cough, rhinorrhea, mild dryness in the throat, difficulty breathing, nasal mucosal ulcers, epistaxis.

Nervous system: headache, dizziness, migraine.

Immune system: allergic reactions, hypersensitivity reactions, including pruritus, dyspnea, bronchospasm, angioedema of the face, lips, tongue, eyelids, anaphylactic reactions, arthralgia.

Skin: rash, urticaria, pruritus, exanthema.

Gastrointestinal tract: taste alteration, dysphagia, nausea, vomiting, abdominal pain, mucosal ulcers.

Cardiovascular system: arterial hypotension.

Other: lacrimation.

Shelf life.

3 years.

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

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

15 ml in a bottle. 1 bottle per carton.

Prescription status. Over-the-counter.

Manufacturer: JSC "Farmak".

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

74, Kyrylivska Street, Kyiv, 04080, Ukraine.