DUSPATALIN RETARD 200 mg Kapsułki
Ocena recepty online
Lekarz przeanalizuje Twój przypadek i zdecyduje, czy wystawienie recepty jest medycznie uzasadnione.
Porozmawiaj z lekarzem o tym leku
Omów swoje objawy i opcje leczenia podczas szybkiej konsultacji online.
Jak stosować DUSPATALIN RETARD 200
Treść ulotki
- INSTRUCTIONS for medical use of the medicinal product DUSPATALIN® RETARD 200
- Composition
- Pharmaceutical form
- Main physical and chemical properties
- Pharmacotherapeutic group
- Pharmacological properties
- Clinical characteristics
- Method of administration and dosage
- Overdose
- Adverse reactions
- Shelf life
- Storage conditions
- Packaging
- Release category
- Manufacturer
- Manufacturer's location and address
INSTRUCTIONS for medical use of the medicinal product DUSPATALIN® RETARD 200
Composition
active substance: mebeverine hydrochloride; 1 capsule contains mebeverine hydrochloride 200 mg; excipients: magnesium stearate, methacrylic acid copolymer dispersion, talc, hypromellose, polyacrylate dispersion, glycerol triacetate; solid gelatin capsule (size No. 1): titanium dioxide (E 171), gelatin.
Pharmaceutical form
Prolonged-release capsules, hard.
Main physical and chemical properties
Opaque white hard gelatin capsules, size No. 1, with corresponding marking 245, containing granules from white to almost white color.
Pharmacotherapeutic group
Drugs used for functional gastrointestinal disorders. Synthetic anticholinergic drugs, esterified tertiary amines. Mebeverine. ATC code A03AA04.
Pharmacological properties
Pharmacodynamics
Mechanism of action and pharmacodynamic effects
Mebeverine is a myotropic spasmolytic with selective action on the smooth muscles of the gastrointestinal tract. It eliminates spasms without suppressing normal intestinal motility. Since this action is not mediated by the autonomic nervous system, typical anticholinergic side effects are absent.
Clinical efficacy and safety
The clinical efficacy and safety of various mebeverine formulations have been studied in over 1,500 patients. Significant relief of predominant symptoms of irritable bowel syndrome (such as abdominal pain, bowel habits) was usually observed in reference and controlled clinical trials.
All mebeverine formulations were generally safe and well-tolerated at the recommended dosage regimen.
Children
Clinical trials of tablet or capsule administration were conducted only in adults. Data on clinical efficacy and safety obtained from clinical trials and post-marketing experience with mebeverine suspension in patients aged 3 years and older demonstrated that mebeverine is an effective and safe medicinal product, well-tolerated.
Clinical trials of mebeverine suspension showed that the drug is effective in relieving symptoms of irritable bowel syndrome in children. Further open-controlled clinical trials of mebeverine suspension confirmed the efficacy of the drug.
Pharmacokinetics
Absorption
Mebeverine is rapidly and completely absorbed after oral administration in tablet form. Due to the prolonged release of the drug from the capsule, it can be taken twice a day.
Distribution
With repeated use of Duspatalin® Retard 200, no significant accumulation occurs.
Metabolism
Mebeverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave the ether bonds to form veratric acid and mebeverine alcohol. In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The half-life of DMCA at steady state is 5.77 hours. With repeated use of capsules (200 mg twice daily), Cmax for DMCA was 804 ng/mL, and tmax was approximately 3 hours. The relative bioavailability of prolonged-release capsules was optimal, with a mean ratio of 97%.
Excretion
Mebeverine is not excreted unchanged; it is completely metabolized, and its metabolites are excreted almost entirely. Veratric acid is excreted in the urine. Mebeverine alcohol is also excreted by the kidneys, partly as the corresponding carboxylic acid (CA) and partly as demethylcarboxylic acid (DMCA).
Children
Pharmacokinetic studies in children have not been conducted.
Clinical characteristics
Indications
Adults and children aged 10 years and older:
- Symptomatic treatment of abdominal pain and spasms, bowel disorders, and discomfort in the bowel area in irritable bowel syndrome;
- Treatment of gastrointestinal spasms of secondary genesis caused by organic diseases.
Contraindications
Hypersensitivity to the active substance or to any of the excipients of the drug, as specified in the "Composition" section.
Interactions with other medicinal products and other types of interactions
Interaction studies have not been conducted, except for the interaction with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between Duspatalin® Retard 200 and ethanol.
Special warnings and precautions for use
None.
Use during pregnancy or breastfeeding
Pregnancy
There are only very limited data on the use of mebeverine in pregnant women. Reproductive toxicity studies conducted in animals are insufficient. Duspatalin® Retard 200 is not recommended during pregnancy.
Breastfeeding
It is unknown whether mebeverine or its metabolites are excreted in human breast milk. Excretion of mebeverine in breast milk of animals has not been studied. Duspatalin® Retard 200 should not be used during breastfeeding.
Fertility
Clinical data on the effect on male or female fertility are not available; however, available animal studies do not indicate a harmful effect of Duspatalin® Retard 200.
Ability to influence the reaction rate when driving vehicles or operating machinery
Studies on the effect on the ability to drive a car and work with mechanical devices have not been conducted. The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effect of mebeverine on the ability to drive a car and work with mechanical devices.
Method of administration and dosage
For oral administration.
Capsules should be taken with a sufficient amount of water (at least 100 mL). It is not recommended to chew, as the capsule coating is designed to ensure a prolonged release mechanism.
Adults and children aged 10 years and older should take 1 capsule twice a day (in the morning and evening).
The duration of use is not limited. If one or more doses are missed, the patient should take the next dose as scheduled. The missed dose(s) should not be taken in addition to the regular dose.
Special populations
Dosing studies in elderly patients, patients with impaired renal and/or hepatic function have not been conducted. Based on available post-marketing data, no specific risk has been identified for elderly patients, patients with impaired renal and/or hepatic function. Dose adjustment for these patient groups is not considered necessary.
Children
Duspatalin® Retard 200 should not be used in children under 3 years of age due to the lack of clinical data for this age group. Duspatalin® Retard 200, 200 mg capsules, should not be used in children aged 3 to 10 years due to the high content of the active substance.
Overdose
Symptoms. Theoretically, in case of overdose, central nervous system stimulation is possible. In cases of overdose, symptoms were absent or mild and usually resolved quickly. Overdose symptoms observed were of neurological or cardiovascular origin.
Treatment. A specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication with multiple drugs diagnosed within 1 hour of taking the medicinal product. Measures to reduce absorption are not necessary.
Adverse reactions
The following adverse reactions have been reported spontaneously during post-marketing use. The frequency cannot be accurately determined from the available data.
Allergic reactions were observed mainly, but not exclusively, on the skin.
Disorders of the skin and subcutaneous tissue:
- urticaria, angioedema, facial edema, rash.
Disorders of the immune system:
- hypersensitivity (anaphylactic reactions).
Shelf life
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C. Do not store at a temperature below 5 °C. Store in a place inaccessible to children.
Packaging
10 capsules in a blister pack, 3 blister packs in a carton, or 15 capsules in a blister pack, 1, 2, or 4 blister packs in a carton.
Release category
Prescription only.
Manufacturer
Mylan Laboratoires SAS/Mylan Laboratories SAS.
Manufacturer's location and address
Route de Belleville, Lieu dit Maillard, 01400, Chatillon-sur-Chalaronne, France.
Nie jesteś pewien, czy ten lek jest odpowiedni dla ciebie?
Omów swoje objawy i leczenie z lekarzem online.
Zacząłeś przyjmować lek i masz pytania?
Omów swoje objawy i leczenie z lekarzem online.
- Kraj rejestracji
- Postać farmaceutycznacapsules, 200 mg
- Kod ATCA03AA04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DUSPATALIN RETARD 200Postać farmaceutyczna: capsules, 200 mgSubstancja czynna: mebeverineProducent: АТ "КИЇВСЬКИЙ ВІТАМІННИЙ ЗАВОДWymaga receptyPostać farmaceutyczna: tablets, 135 mgSubstancja czynna: mebeverineProducent: Майлан Лабораторіз САСBez receptyPostać farmaceutyczna: capsules, capsules 200mgSubstancja czynna: mebeverineProducent: Евертоджен Лайф Саєнсиз ЛімітедWymaga recepty
Odpowiedniki DUSPATALIN RETARD 200 w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik DUSPATALIN RETARD 200 w Włochy
Odpowiednik DUSPATALIN RETARD 200 w Hiszpania
Odpowiednik DUSPATALIN RETARD 200 w Polska
Lekarze online w sprawie DUSPATALIN RETARD 200
Omów stosowanie DUSPATALIN RETARD 200, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
Uzyskaj receptę na DUSPATALIN RETARD 200 online
Wypełnij 2-minutowy formularz
Opisz swoje objawy, historię choroby i lek, o który prosisz.
Wybierz lekarza lub pozwól nam przydzielić
Wybierz specjalistę lub dopasujemy Cię do najbliższego dostępnego lekarza.
Lekarz analizuje Twój przypadek
Zazwyczaj w ciągu 30 minut. Może zadawać dodatkowe pytania przez czat.
Odbierz w dowolnej aptece
Recepta elektroniczna wysłana na Twój e-mail — ważna w całej Polsce.
Często zadawane pytania
DUSPATALIN RETARD 200 wymaga recepty w Ukraina. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DUSPATALIN RETARD 200 jest mebeverine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DUSPATALIN RETARD 200 jest produkowany przez Majlan Laboratoriz SAS. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie DUSPATALIN RETARD 200 jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić DUSPATALIN RETARD 200 w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (mebeverine) to m.in. АСПАЗМІН, ДУСПАТАЛІН, МЕБСІН РЕТАРД. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
