Edermic

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EDERMIK (EDERMIK)

Composition:

Active substance: dimetindene maleate;

1 ml of drops (20 drops) contains dimetindene maleate (calculated as 100% dry substance) 1 mg;

Excipients: sodium hydrogen phosphate, dodecahydrate; citric acid, monohydrate; benzoic acid (E 210); disodium edetate; sodium saccharin; propylene glycol; purified water.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.
Antihistamines for systemic use. ATC code R06AB03.

Pharmacological Properties.

Pharmacodynamics.

Dimetindene maleate is a histamine antagonist at the H1-receptor level. At low concentrations, it exerts a stimulating effect on histamine methyltransferase, leading to histamine inactivation. It exhibits high affinity for H1-receptors and acts as a mast cell stabilizer. Dimetindene maleate has no effect on H2-receptors and possesses local anesthetic properties.

Dimetindene maleate is an antagonist of bradykinin, serotonin, and acetylcholine. It exists as a racemic mixture with R-(-)-dimetindene, which has more pronounced H1-antihistaminic activity.

Dimetindene maleate significantly reduces capillary hyperpermeability associated with immediate-type hypersensitivity reactions.

In combination with histamine H2-receptor antagonists, it almost completely suppresses all types of histamine effects on the circulatory system.

According to study data, the effect of a single 4 mg dose of dimetindene maleate in the form of drops on skin reactions persists up to 24 hours after administration.

Pharmacokinetics.

Systemic bioavailability of dimetindene in the form of drops is approximately 70%. After administration of the drops, maximum plasma concentration of dimetindene is reached within 2 hours.

At concentrations ranging from 0.09 to 2 µg/mL, plasma protein binding of dimetindene is approximately 90%. Metabolism of dimetindene involves hydroxylation and methoxylation reactions.

Its elimination half-life is nearly 6 hours. Dimetindene and its metabolites are excreted via the liver and kidneys.

Preclinical studies have not revealed any risk associated with the use of the drug at recommended doses. Dimetindene maleate showed no mutagenic or clastogenic properties.

Clinical characteristics.

Indications.

Symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and perennial allergic rhinitis, drug and food allergies.

Pruritus of various origins, except that associated with cholestasis. Pruritus in skin disorders with rashes, such as chickenpox. Insect bites.

An adjunctive agent in eczema and other pruritic dermatoses of allergic origin.

Contraindications.

Hypersensitivity to dimethindene maleate or to any other component of the medicinal product. Presence of duodenal or pyloric stenosis in the patient.

Contraindicated in children under 1 month of age, especially premature infants.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with drugs that depress the central nervous system (CNS), such as opioid analgesics, anticonvulsants, antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors), other antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, scopolamine, and ethanol, CNS depression may be enhanced, potentially leading to adverse effects or even life-threatening consequences.

Tricyclic antidepressants and anticholinergic drugs, such as bronchodilators, gastrointestinal spasmolytics, mydriatics, and urological antimuscarinic agents, may produce an additional antimuscarinic effect when administered concurrently with antihistamines, thereby increasing the risk of worsening glaucoma and urinary retention.

To minimize the risk of CNS depression or possible potentiation, concomitant use of procarbazine and antihistamines should be performed with caution.

Special precautions for use

As with other antihistamines, caution should be exercised when administering Edermik oral drops to patients with glaucoma, bladder neck contracture and/or urinary retention, including benign prostatic hyperplasia, as well as patients with chronic obstructive pulmonary diseases.

Like all H1-receptor antagonists and partially H2-receptor antagonists, this medication should be used with caution in patients with epilepsy. Antihistamines may cause excitation in young children.

The drug should be used with caution in elderly patients, in whom the risk of adverse reactions, including excitation and increased fatigue, is elevated. Avoid accidental misuse of the medication by elderly patients. The recommended dosage and duration of treatment must not be exceeded without a physician's recommendation.

The drug in drop form should be administered with caution to children under 1 year of age: the sedative effect may be accompanied by episodes of nocturnal apnea. In young children, antihistamines may cause excitation.

Edermik oral drops may be used in children aged 1 month to 1 year only upon a physician's recommendation and when there are clear indications for antihistamine therapy. The recommended dose must not be exceeded.

Use during pregnancy or breastfeeding

Pregnancy. There are no clinical data on the use of the drug in pregnant women. Animal studies have shown no harmful effects (either direct or indirect) of the drug on the course of pregnancy, fetal development, or subsequent offspring development. However, the use of the drug during pregnancy is not recommended except when the expected benefit outweighs the potential risk to the fetus. In such cases, the drug may be used only under a physician's supervision.

Breastfeeding period. It is highly likely that dimethindene maleate is excreted into breast milk.

The use of the drug during breastfeeding is not recommended. If treatment is necessary, breastfeeding should be discontinued for the duration of therapy.

Ability to affect reaction speed when driving or operating machinery

Administration of Edermik may result in slowed psychomotor reactions, drowsiness, and dizziness. Therefore, patients should refrain from driving vehicles or operating machinery.

Method of Administration and Dosage

The duration of use of the medication without consulting a physician should not exceed 14 days.

Adults, children aged 12 years and older, and elderly patients

The recommended daily dose is 3–6 mg, divided into 3 doses – 20–40 drops three times daily. For patients prone to drowsiness, it is recommended to administer 40 drops at bedtime and 20 drops in the morning with breakfast.

Dose adjustment is not required for elderly patients.

Children

Administration of the medication is recommended only after prior consultation with a physician. For children aged 1 month to 1 year, use is allowed only after consultation with a physician. The recommended daily dose is 0.1 mg (i.e., 2 drops) per kilogram of body weight per day, divided into 3 doses.

20 drops = 1 mL = 1 mg of dimetindene maleate.

Edermik oral drops should not be exposed to high temperatures. They should be added directly to warm infant food immediately before feeding. If feeding the child with a spoon, the drops may be administered undiluted in a teaspoon. The drops have a pleasant taste.

Children

Do not administer to children under 1 month of age, especially premature infants. Oral drops Edermik should be used with caution in children under 1 year of age: the sedative effect may be accompanied by episodes of nocturnal apnea. In younger children, antihistamine agents may cause excitation.

Edermik oral drops may be used in children aged 1 month to 1 year only after consultation with a physician and when there are clear indications for antihistamine therapy. Do not exceed the recommended dose.

Overdose

In case of overdose with Edermik oral drops, as with other antihistamine agents, the following symptoms may occur: CNS depression, drowsiness (mainly in adults), CNS stimulation and antimuscarinic effects (especially in children and elderly individuals), including agitation, ataxia, tachycardia, hallucinations, convulsions, tremor, mydriasis, dry mouth, facial flushing, urinary retention, and fever. Subsequently, arterial hypotension, coma, and cardiopulmonary collapse may develop.

In case of overdose, measures recommended by a medical facility should be taken, depending on the symptoms that occur.

Adverse Reactions

The main adverse effect associated with the use of this medicinal product is drowsiness, particularly at the beginning of treatment. In very rare cases, allergic reactions may occur.

Possible adverse reactions:

Immune system

Rare: anaphylactic reactions, including facial swelling, pharyngeal swelling, rash; muscle spasms and shortness of breath.

Psychiatric disorders

Isolated cases: excitement.

Nervous system disorders

Very common: increased fatigue.

Common: drowsiness, nervousness.

Isolated cases: headache, dizziness.

Gastrointestinal disorders

Isolated cases: gastrointestinal disturbances, nausea, dryness of mouth and throat.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life: 2 years.

Storage conditions:

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

Keep out of reach and sight of children.

Packaging: 20 mL or 25 mL in a bottle. 1 bottle per carton.

Supply category: Over-the-counter (without prescription).

Manufacturer: JSC "Farmak".

Manufacturer's address and place of business:

74, Kyrylivska Street, Kyiv, 04080, Ukraine.