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BELADONNI EKSTRAKT

BELADONNI EKSTRAKT

About the medicine

How to use BELADONNI EKSTRAKT

INSTRUCTIONS for medical use of the medicinal product DIMETINDENE (DIMETINDENE)

Composition

active substance: dimetindene maleate; 1 g of gel contains dimetindene maleate 1 mg; excipients: benzalkonium chloride, disodium edetate, carbomer, sodium hydroxide solution 30%, propylene glycol, purified water.

Pharmaceutical form

Gel.

Main physical and chemical properties

Homogeneous, colorless or slightly yellowish, transparent or slightly opalescent gel.

Pharmacotherapeutic group

Antihistamine drugs for topical use.

ATC code D04A A13.

Pharmacological properties

Pharmacodynamics

Dimetindene maleate is a derivative of phenindamine, an antagonist of histamine at the level of H1-receptors. It has anti-allergic and anti-itching effects. Due to the active substance of the medicinal product - dimetindene maleate - after applying the gel to the skin, itching and irritation that accompany skin allergic reactions are reduced. The preparation also has local anesthetic properties and cools the skin when applied.

When applied topically, the gel, due to its specially designed base, quickly penetrates the skin and starts acting within a few minutes. The maximum effect is achieved within 1-4 hours.

Pharmacokinetics

The systemic bioavailability of the active substance is 10%.

Clinical characteristics

Indications

Skin itching, for example, with insect bites, non-extensive sun erythema, uncomplicated small skin burns, and allergic irritation of small skin areas.

Contraindications

Increased sensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions

No studies on the interaction of the medicinal product have been conducted; however, since the systemic absorption of dimetindene maleate when using the Dimetindene gel is extremely low, interaction with other medicinal products is unlikely.

Special warnings and precautions for use

The medicinal product contains benzalkonium chloride and propylene glycol, which can cause skin irritation.

The preparation cannot be used in case of known allergy to insect bites. In such cases, systemically acting preparations should be used.

It is recommended to avoid using the Dimetindene medicinal product when large areas of skin are affected, especially in children or adolescents.

During treatment with the preparation, it is recommended to avoid prolonged exposure to the sun on the affected skin areas.

Use during pregnancy or breastfeeding

Clinical data on the use of the medicinal product in pregnant women are not available. In animal studies, dimetindene maleate did not cause harmful effects (either direct or indirect) on the course of pregnancy, fetal development, and subsequent development of offspring. However, during pregnancy, it is not recommended to use Dimetindene, except in cases where the benefit of use outweighs the potential risk to the fetus. In such cases, the use of the preparation is possible only under the supervision of a doctor.

It is not recommended to apply Dimetindene to large areas of skin, especially damaged or inflamed skin. This also applies to women who are breastfeeding. In addition, women who are breastfeeding should not apply the gel to the nipples of the mammary glands.

Ability to influence the reaction rate when driving vehicles or operating other mechanisms

Dimetindene maleate, when used externally, does not affect the reaction rate while driving vehicles or working with other mechanisms.

Method of administration and dosage

Children under 2 years of age can use the medicinal product only under the supervision of a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed.

Adults and children over 2 years of age should apply the gel to the affected skin areas 2-4 times a day. If the skin condition does not improve after 7 days of using the preparation, it is necessary to consult a doctor.

Children

Children under 2 years of age can use the medicinal product only under the supervision of a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed.

Overdose

To date, there have been no reports of cases of overdose of the medicinal product. In case of accidental ingestion of a large amount of Dimetindene gel, it is necessary to immediately consult a doctor.

Some symptoms characteristic of overdose with H1-antihistamine drugs for systemic use may be observed: depression of the central nervous system, accompanied by drowsiness (mainly in adults), stimulation of the central nervous system and anticholinergic effect (especially in children and the elderly), including excitement, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, hyperemia of the face, urinary retention, fever, as well as possible arterial hypotension.

In case of overdose, it is necessary to take measures recommended by the medical institution according to the symptoms that occur.

Side effects

The most common side effects are minor and short-term reactions on the skin at the site of application. The medicinal product contains benzalkonium chloride and propylene glycol, which can cause skin irritation.

Possible side effects

  • From the skin and subcutaneous tissue: frequency unknown (cannot be determined based on available data) - dry skin, burning sensation of the skin, allergic reactions, including skin rash, itching, and swelling, allergic dermatitis, urticaria.

Reporting of suspected side effects

Reporting of side effects after registration of the medicinal product is of great importance. This allows monitoring the benefit/risk ratio of the use of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their authorized representatives, should report all cases of suspected side effects and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life

2 years.

Shelf life after first opening

3 months.

Storage conditions

Store at a temperature not exceeding 25 °C.

Store in a place inaccessible to children.

Packaging

30 g in a tube, 1 tube in a cardboard box.

Release category

Without a prescription.

Manufacturer

Lubnypharm PJSC.

Location of the manufacturer and address of the place of its activity

Ukraine, 37500, Poltava region, Lubny, Barvinkova street, 16.

Talk to a doctor online

Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.

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Doctor

Anna Moret

Dermatology18 years of experience

Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs.

Dr. Moret provides expert evaluation and treatment for:

  • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis.
  • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis.
  • Pediatric skin problems — from newborns to adolescents.
  • Sexually transmitted infections (STIs) and dermatovenereology.
  • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments.
  • Skin allergies and hypersensitivity reactions.
  • Mole checks, lesion evaluation, and skin cancer screening.
  • Skincare advice and personalised cosmeceutical routines.

Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology.

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Alina Tsurkan

Family medicine12 years of experience

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Andrei Popov

General medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including:

  • Chronic pain lasting more than 3 months.
  • Migraines and recurring headaches.
  • Neck, back, lower back, and joint pain.
  • Post-traumatic pain following injury or surgery.
  • Nerve-related pain, fibromyalgia, and neuralgia.
In addition to pain management, Dr. Popov helps patients with:
  • Respiratory infections (colds, bronchitis, pneumonia).
  • High blood pressure and metabolic conditions such as diabetes.
  • Preventive care and routine health check-ups.

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

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Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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