ELIDEL 1% Krem

Treść ulotki

1. INSTRUCTIONS for medical use of the medicinal product PHENCAROL®(PHENCAROL)
   1. Composition
   2. Pharmaceutical form
   3. Main physical and chemical properties
   4. Pharmacotherapeutic group
   5. Pharmacological properties
   6. Clinical characteristics
   7. Shelf life
   8. Storage conditions
   9. Packaging
   10. Release category
   11. Manufacturer
   12. Manufacturer's location and address

INSTRUCTIONS for medical use of the medicinal product PHENCAROL^®(PHENCAROL)

Composition

active substance: chlorpheniramine; 1 tablet contains chlorpheniramine hydrochloride 25 mg; excipients: potato starch, sucrose, calcium stearate.

Pharmaceutical form

Tablets.

Main physical and chemical properties

Flat-cylindrical tablets of white or almost white color, with a facet.

Pharmacotherapeutic group

Antihistamines for systemic use.

ATC code R06A X31.

Pharmacological properties

Pharmacodynamics

Chlorpheniramine is a derivative of quinuclidylcarbinol, which reduces the effect of histamine on organs and systems. Chlorpheniramine is a competitive blocker of H1-receptors. Additionally, it activates the enzyme diamine oxidase, which breaks down approximately 30% of endogenous histamine. This explains the effectiveness of chlorpheniramine in patients who are insensitive to other antihistamines. Chlorpheniramine poorly penetrates the blood-brain barrier and has little effect on serotonin desamination processes in the brain, weakly affects monoamine oxidase activity. The antihistamine properties of chlorpheniramine are associated with the presence of a quinuclidine ring in its structure and the distance between the diphenylcarbinol group and the nitrogen atom. In terms of antihistamine activity and duration of action, chlorpheniramine surpasses dimedrol. Chlorpheniramine reduces the toxic effect of histamine, relieves or weakens its bronchoconstrictor effect and spasmodic effect on the smooth muscles of the intestine, has a moderate antiserotonin and weak anticholinergic effect, well-expressed antipruritic and desensitizing properties. Chlorpheniramine weakens the hypotensive effect of histamine and its effect on capillary permeability, does not directly affect cardiac activity and arterial pressure, does not have a protective effect in aconitine arrhythmias.

Chlorpheniramine does not suppress the central nervous system, but in case of individual increased sensitivity, a weak sedative effect is possible. The drug is slightly lipophilic, and its content in brain tissue is low (less than 0.05), which explains the absence of a suppressive effect on the central nervous system.

Pharmacokinetics

Chlorpheniramine is quickly absorbed from the gastrointestinal tract and is already present in the body's tissues after 30 minutes. The maximum concentration is reached after 1 hour.

Metabolites and the unchanged fraction of chlorpheniramine are mainly excreted in the urine, bile, and through the lungs within 48 hours.

Clinical characteristics

Indications

Pollinosis, food and drug allergy, other allergic diseases, acute and chronic urticaria, angioedema (Quincke's edema), hay fever, allergic rhinopathy, dermatoses (eczema, psoriasis, neurodermatitis, skin itching), as well as infectious-allergic reactions with a bronchospastic component.

Contraindications

Increased sensitivity to chlorpheniramine or to the excipients of the medicinal product.

Interaction with other medicinal products and other types of interactions

Phencarol^®does not enhance the suppressive effect of alcohol and sedatives on the central nervous system, has weak M-cholinoblocking properties, but with decreased motor activity of the gastrointestinal tract, the absorption of slowly absorbed medications may be enhanced (e.g., indirect anticoagulants - coumarins).

Special warnings and precautions for use

The drug should be prescribed with caution to patients with severe cardiovascular, gastrointestinal, renal, and hepatic diseases.

The drug contains sucrose, which should be taken into account in patients with diabetes.

Patients with rare hereditary diseases, such as fructose intolerance or sucrase-isomaltase insufficiency, should not use the drug.

Use during pregnancy or breastfeeding

There are no sufficient studies in animals to assess the impact of the medicinal product on pregnancy.

The drug is contraindicated during the first trimester of pregnancy. It is not recommended to use the drug during the second and third trimesters of pregnancy.

There are no data on the penetration of the drug into breast milk, so the use of Phencarol^®is contraindicated during breastfeeding.

Ability to affect the reaction rate when driving vehicles or using other mechanisms

Persons whose work requires rapid physical or mental reactions (drivers) should first establish individual sensitivity (through short-term use) to the sedative effect. If there is increased sensitivity, such persons should be especially careful when using the drug.

Method of administration and dosage

Phencarol^®should be taken orally immediately after meals.

A single dose for adults is 25-50 mg 2-4 times a day.

In case of pollinosis, a daily dose of less than 75 mg is ineffective. The maximum daily dose is 200 mg. The duration of the treatment course is 10-15 days.

For children over 12 years old, 25 mg 2-3 times a day. The duration of the treatment course is 10-20 days. If necessary, the treatment course can be repeated (after consulting a doctor).

If a dose is missed, the treatment course should be continued using the previously prescribed doses. If necessary, consult a doctor.

Children

The drug can be used in children over 12 years old.

For children under 12 years old, it is recommended to use the drug in a different dosage (Phencarol^®, 10 mg tablets).

Overdose

There have been no reports of overdose. A daily dose of up to 300 mg/day does not cause serious clinically significant side effects. High doses may cause dryness of the mucous membranes, headache, nausea, vomiting, epigastric pain, and dyspeptic symptoms.

Symptomatic treatment should be performed if necessary.

There is no specific antidote.

Side effects

From the nervous system: dizziness, headache.

Sometimes a weak sedative effect is possible, which manifests as weakness, drowsiness, slowing of response reactions.

From the gastrointestinal tract: dryness of the mucous membranes of the oral cavity, dyspeptic symptoms (nausea, vomiting, bitterness in the mouth), which usually pass when the dose is reduced or the drug is discontinued.

From the respiratory system, organs of the thoracic cavity, and mediastinum: sneezing, difficult breathing.

From the psyche: anxiety.

From the kidneys and urinary tract: proteinuria, interstitial nephritis.

From the musculoskeletal and connective tissue: joint pain.

From the organs of vision: lacrimation.

In persons with gastrointestinal diseases, the possibility of side effects increases.

If any undesirable effects occur, the use of the medicinal product should be discontinued and a doctor consulted.

Shelf life

5 years.

Storage conditions

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

Store in a place inaccessible to children.

Packaging

10 tablets in a blister pack. 2 blister packs in a cardboard box.

Release category

Without a prescription.

Manufacturer

JSC "Olainfarm" / AS "Olainfarm".

Manufacturer's location and address

5 Rupnicu street, Olaine, LV-2114, Latvia / 5 Rupnicu iela, Olaine, LV-2114, Latvija.