Attributes
- Form
- Dosage mg
- Pack
- Description en
- DIMESTIL® EXTERNAL USE GEL 1 MG/G International Nonproprietary Name Dimetindene Dosage Form and Composition External use gel. 1 g of gel contains: Active substance - 1 mg dimetindene (as maleate); Excipients: propylene glycol, carbomer, sodium hydroxide, disodium edetate, benzalkonium chloride, purified water. Description Transparent, slightly opalescent gel, colorless, practically odorless. Pharmacotherapeutic Group Preparations for the treatment of itching (including antihistamines and anesthetics). Antihistamines for topical use. Pharmacological Properties Pharmacodynamics Mechanism of action and pharmacodynamic effects Dimetindene maleate is a histamine H1-receptor antagonist. It has a high affinity for these receptors. It significantly reduces the increased capillary permeability associated with immediate hypersensitivity reactions. When applied topically, dimetindene maleate also has local anesthetic properties. Dimetindene maleate is effective for itching of various origins, quickly relieving itching and irritation. The gel base promotes the penetration of the active substance into the skin. Pharmacokinetics Dimetindene maleate in gel form rapidly penetrates the skin and exerts an antihistamine effect within a few minutes. The effect reaches its maximum in 1-4 hours. In healthy volunteers, the systemic bioavailability of dimetindene maleate after external application is 10%. Indications for Use For short-term relief of skin itching associated with dermatoses, urticaria, insect bites, sunburn, and superficial burns. Method of Administration and Dosage Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. For external use. On intact skin. Apply a small amount to the affected area. Then, gently rub to promote the penetration of the medicine into the skin. Do not apply occlusive dressings. Do not apply to large areas of skin, damaged skin, or mucous membranes. Dimestil should be applied to irritated and itchy areas of the skin in adults, adolescents, and children in a thin layer, up to 3 times a day. If the patient does not feel better within 3 days of using Dimestil, or if their condition worsens, they should consult a doctor. Maximum duration of use without consulting a doctor: 7 days. Use in Children Avoid using the preparation on large areas of skin in newborns and infants. Dimestil should not be used in children under 1 month of age, especially premature infants. In children from 1 month to 2 years of age, Dimestil should be used under medical supervision. If you think the effect of the gel is too strong or too weak, consult your doctor or pharmacist. Contraindications Hypersensitivity to dimetindene or any of the excipients; second and third-degree burns. Children under 1 month of age, especially premature infants. Application to large areas of skin. Application to damaged skin. Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below are classified by organ system with their frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), unknown frequency (cannot be determined from available data). Skin and subcutaneous tissue disorders Uncommon: dry skin, burning sensation. Very rare: allergic dermatitis. If any of the listed side effects occur, as well as any side effects not listed in this leaflet, consult your doctor. Special Instructions In case of severe itching or irritation of large areas of skin, oral systemic therapy should be added to the use of dimetindene maleate. The patient should be advised to consult a doctor. Avoid prolonged exposure to sunlight on intensively treated skin areas. Do not use in newborns and infants on large areas of skin, especially if there is skin damage or inflammation. Excipients Each gram of Dimestil gel contains 0.05 mg of benzalkonium chloride. Benzalkonium chloride may cause skin irritation. Patients should not apply this medicinal product to the chest during breastfeeding, as the child may ingest it with breast milk. Since the absorption of benzalkonium chloride through the skin is minimal, no adverse effects on the mother are expected during pregnancy and breastfeeding. The preparation is not intended for use on mucous membranes. Each gram of Dimestil gel contains 150 mg of propylene glycol. Propylene glycol can cause skin irritation. Do not use propylene glycol at doses greater than 50 mg/kg per day in newborns under 4 weeks of age with open wounds or extensive areas of traumatized or damaged skin (e.g., burns) without prior consultation with a doctor or pharmacist. Pregnancy and Breastfeeding Pregnancy There is insufficient data on the use of dimetindene maleate during pregnancy. Animal studies have not revealed teratogenic effects of dimetindene maleate, direct or indirect effects on pregnancy, embryonic/fetal development, labor, or postnatal development. During pregnancy, Dimestil can be used only when the benefit to the mother outweighs the potential risk to the fetus and only on the recommendation of a doctor. Dimestil should not be used during pregnancy on large areas of skin, especially if there is skin damage or inflammation. Lactation Use on large areas of skin, especially in case of skin damage or inflammation, is not recommended during breastfeeding. Breastfeeding mothers should not apply the preparation to the nipples, as the child may ingest it with breast milk. Experience with use during breastfeeding in humans is limited. Dimetindene maleate is excreted in rat milk, but low systemic absorption is expected after topical application. Fertility No effects on fertility were observed in animal studies. There are no studies in humans. Effect on Ability to Drive and Operate Machinery Dimestil does not affect the ability to drive vehicles and operate machinery. Interactions with Other Medicines Inform your doctor or pharmacist about all the medicines you are currently taking, have recently taken, or might take. Interaction studies have not been conducted. Interactions of dimetindene with other medicinal products and other forms of interaction are not expected due to the low systemic absorption of dimetindene. Overdose Symptoms With accidental ingestion of a large amount of the preparation or prolonged use on large areas of skin with increased absorption (occlusive dressings or application to damaged skin), symptoms characteristic of overdose of systemic H1-histamine receptor blockers may occur. Intoxication proceeds in 3 phases: sedation, excitation, coma with respiratory failure. In children, compared to adults, excitation and anticholinergic effects are more pronounced. Symptoms: sedative effect, fainting, dizziness, headache, tinnitus, partial pallor, but also red and swollen face, gastrointestinal symptoms, e.g.: constipation, diarrhea, vomiting, nausea, dry mouth, urinary retention, decreased or increased blood pressure, muscle tremors, increased or decreased reflexes, mydriasis, slow pupillary reaction, blurred vision. In newborns and infants, symptoms of the central nervous system: excitation, hallucinations, disorientation, ataxia, muscle tremors, fever, tonic-clonic seizures. In case of high doses: coma, cardiac arrest. Treatment A specific antidote is unknown. Standard emergency measures should be taken: for oral intake - administration of activated charcoal, saline laxatives; if necessary, measures to maintain the function of the cardiovascular and respiratory systems should be carried out. Stimulants are not required. Vasopressors may be used to treat hypotension. Storage Conditions Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children. Dispensing Conditions Pharmaceutical product group III, available without a prescription. Shelf Life 2 years. Packaging Primary packaging: Aluminum tube (30 g or 50 g) with an aluminum protective membrane on the neck and a conical device for piercing the membrane in a screw cap made of high-density polyethylene or polypropylene. Secondary packaging: 1 aluminum tube in a cardboard box with instructions for medical use.
- Active
- dimetindene
What is it?
DIMESTIL® EXTERNAL USE GEL 1 MG/G International Nonproprietary Name Dimetindene Dosage Form and Composition External use gel. 1 g of gel contains: Active substance - 1 mg dimetindene (as maleate); Excipients: propylene glycol, carbomer, sodium hydroxide, disodium edetate, benzalkonium chloride, purified water. Description Transparent, slightly opalescent gel, colorless, practically odorless. Pharmacotherapeutic Group Preparations for the treatment of itching (including antihistamines and anesthetics). Antihistamines for topical use. Pharmacological Properties Pharmacodynamics Mechanism of action and pharmacodynamic effects Dimetindene maleate is a histamine H1-receptor antagonist. It has a high affinity for these receptors. It significantly reduces the increased capillary permeability associated with immediate hypersensitivity reactions. When applied topically, dimetindene maleate also has local anesthetic properties. Dimetindene maleate is effective for itching of various origins, quickly relieving itching and irritation. The gel base promotes the penetration of the active substance into the skin. Pharmacokinetics Dimetindene maleate in gel form rapidly penetrates the skin and exerts an antihistamine effect within a few minutes. The effect reaches its maximum in 1-4 hours. In healthy volunteers, the systemic bioavailability of dimetindene maleate after external application is 10%. Indications for Use For short-term relief of skin itching associated with dermatoses, urticaria, insect bites, sunburn, and superficial burns. Method of Administration and Dosage Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. For external use. On intact skin. Apply a small amount to the affected area. Then, gently rub to promote the penetration of the medicine into the skin. Do not apply occlusive dressings. Do not apply to large areas of skin, damaged skin, or mucous membranes. Dimestil should be applied to irritated and itchy areas of the skin in adults, adolescents, and children in a thin layer, up to 3 times a day. If the patient does not feel better within 3 days of using Dimestil, or if their condition worsens, they should consult a doctor. Maximum duration of use without consulting a doctor: 7 days. Use in Children Avoid using the preparation on large areas of skin in newborns and infants. Dimestil should not be used in children under 1 month of age, especially premature infants. In children from 1 month to 2 years of age, Dimestil should be used under medical supervision. If you think the effect of the gel is too strong or too weak, consult your doctor or pharmacist. Contraindications Hypersensitivity to dimetindene or any of the excipients; second and third-degree burns. Children under 1 month of age, especially premature infants. Application to large areas of skin. Application to damaged skin. Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below are classified by organ system with their frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), unknown frequency (cannot be determined from available data). Skin and subcutaneous tissue disorders Uncommon: dry skin, burning sensation. Very rare: allergic dermatitis. If any of the listed side effects occur, as well as any side effects not listed in this leaflet, consult your doctor. Special Instructions In case of severe itching or irritation of large areas of skin, oral systemic therapy should be added to the use of dimetindene maleate. The patient should be advised to consult a doctor. Avoid prolonged exposure to sunlight on intensively treated skin areas. Do not use in newborns and infants on large areas of skin, especially if there is skin damage or inflammation. Excipients Each gram of Dimestil gel contains 0.05 mg of benzalkonium chloride. Benzalkonium chloride may cause skin irritation. Patients should not apply this medicinal product to the chest during breastfeeding, as the child may ingest it with breast milk. Since the absorption of benzalkonium chloride through the skin is minimal, no adverse effects on the mother are expected during pregnancy and breastfeeding. The preparation is not intended for use on mucous membranes. Each gram of Dimestil gel contains 150 mg of propylene glycol. Propylene glycol can cause skin irritation. Do not use propylene glycol at doses greater than 50 mg/kg per day in newborns under 4 weeks of age with open wounds or extensive areas of traumatized or damaged skin (e.g., burns) without prior consultation with a doctor or pharmacist. Pregnancy and Breastfeeding Pregnancy There is insufficient data on the use of dimetindene maleate during pregnancy. Animal studies have not revealed teratogenic effects of dimetindene maleate, direct or indirect effects on pregnancy, embryonic/fetal development, labor, or postnatal development. During pregnancy, Dimestil can be used only when the benefit to the mother outweighs the potential risk to the fetus and only on the recommendation of a doctor. Dimestil should not be used during pregnancy on large areas of skin, especially if there is skin damage or inflammation. Lactation Use on large areas of skin, especially in case of skin damage or inflammation, is not recommended during breastfeeding. Breastfeeding mothers should not apply the preparation to the nipples, as the child may ingest it with breast milk. Experience with use during breastfeeding in humans is limited. Dimetindene maleate is excreted in rat milk, but low systemic absorption is expected after topical application. Fertility No effects on fertility were observed in animal studies. There are no studies in humans. Effect on Ability to Drive and Operate Machinery Dimestil does not affect the ability to drive vehicles and operate machinery. Interactions with Other Medicines Inform your doctor or pharmacist about all the medicines you are currently taking, have recently taken, or might take. Interaction studies have not been conducted. Interactions of dimetindene with other medicinal products and other forms of interaction are not expected due to the low systemic absorption of dimetindene. Overdose Symptoms With accidental ingestion of a large amount of the preparation or prolonged use on large areas of skin with increased absorption (occlusive dressings or application to damaged skin), symptoms characteristic of overdose of systemic H1-histamine receptor blockers may occur. Intoxication proceeds in 3 phases: sedation, excitation, coma with respiratory failure. In children, compared to adults, excitation and anticholinergic effects are more pronounced. Symptoms: sedative effect, fainting, dizziness, headache, tinnitus, partial pallor, but also red and swollen face, gastrointestinal symptoms, e.g.: constipation, diarrhea, vomiting, nausea, dry mouth, urinary retention, decreased or increased blood pressure, muscle tremors, increased or decreased reflexes, mydriasis, slow pupillary reaction, blurred vision. In newborns and infants, symptoms of the central nervous system: excitation, hallucinations, disorientation, ataxia, muscle tremors, fever, tonic-clonic seizures. In case of high doses: coma, cardiac arrest. Treatment A specific antidote is unknown. Standard emergency measures should be taken: for oral intake - administration of activated charcoal, saline laxatives; if necessary, measures to maintain the function of the cardiovascular and respiratory systems should be carried out. Stimulants are not required. Vasopressors may be used to treat hypotension. Storage Conditions Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children. Dispensing Conditions Pharmaceutical product group III, available without a prescription. Shelf Life 2 years. Packaging Primary packaging: Aluminum tube (30 g or 50 g) with an aluminum protective membrane on the neck and a conical device for piercing the membrane in a screw cap made of high-density polyethylene or polypropylene. Secondary packaging: 1 aluminum tube in a cardboard box with instructions for medical use.