Smecta® 3g powder for oral suspension

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Therapeutic indications

  • Treatment of acute diarrhea in children over 2 years of age, with oral rehydration, as well as in adults.
  • Symptomatic therapy of chronic diarrhea in adults.
  • Symptomatic therapy of pain associated with functional bowel disease in adults.

Dosage and method of administration

DosageTreatment of acute diarrhea

Children over 2 years of age: 4 sachets per day for 3 days, then 2 sachets per day for 4 days.

Adults: on average, 3 sachets are used per day, for 7 days. In practice, the daily dose may be doubled at the beginning of therapy.

Other indications

Adults: On average, 3 sachets are used per day.

If within 3 days from the start of the medication the symptoms do not subside or the symptoms worsen, the patient should contact his doctor.

Way of useOral use.

The contents of the sachet must be reconstituted immediately before administration.

Children:

Reconstitute the contents of the sachet in a bottle with 50 mL of boiled and cooled water and use during the day to drink or mix it well with semi-liquid food: soup, pureed fruit, pureed vegetables or baby porridge.

Adults:

Reconstitute the contents of the sachet in half a glass of water.

Contraindications

  • Hypersensitivity to diosmectite or any of the excipients listed in section 6.1.

 

Special warnings

The drug must be used with caution in patients with a history of chronic severe constipation.

Smecta should not be given to infants and children under 2 years of age. The reference therapy for acute diarrhea is oral rehydration solution.

In children over 2 years of age, treatment of acute diarrhea with Smecta should begin with the early use of an oral rehydration solution to prevent dehydration. Chronic use of Smecta should be avoided.

In adults, rehydration can be omitted, if not necessary.

The degree of rehydration, as well as the choice of method of rehydration (oral or intravenous), should be adapted to the intensity of diarrhea and the age of the patient in accordance with the clinical picture.

The patient should be informed about the need:

  • Rehydration with plenty of salty or sweet fluids, to replace fluid loss due to diarrhea (daily water intake requirement for adults is 2 liters)
  • Adherence to the intake of the following foods during diarrhea:
    • avoid raw and green vegetables, fruits, spicy food as well as frozen and cold food and drinks,
    • jesti grilovano meso i pirinač.Ovaj lek sadrži glukozu i saharozu.Pacijenti sa retkim naslednim oboljenjem intolerancije na fruktozu, glukozno-galaktoznom malapsorpcijom ili nedostatkom saharoza-izomaltaze, ne smeju koristiti ovaj lek.

      This medicine contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.

  • Taking into account the adsorbing properties of the drug Smecta, which can affect the resorption of drugs, simultaneous administration with other drugs is not recommended (after more than two hours, if possible).

     

    Pregnancy and breastfeeding

    Pregnancy

    There is no data or data on the use of diosmectite in pregnant women is limited (less than 300 pregnancies).

    The results of animal studies are insufficient to draw a definitive conclusion on reproductive toxicity.

    The use of Smecta during pregnancy is not recommended.

    Breastfeeding

    There is insufficient data on the use of Smecta during breastfeeding. The use of Smecta during breastfeeding is not recommended.

    Fertility

    The effect of this medicine on human fertility has not been studied.

     

    Vehicle management

    No studies have been conducted on the effect of this medicine on the ability to drive and use machines. However, the drug is expected to have no or negligible effect.

     

    Adverse effects

    The most commonly reported side effect during therapy is constipation, which occurs in approximately 7% adults and 1% children. If constipation occurs, the application of diosmectite should be stopped and, if necessary, restarted with a lower dose.

    The table below shows the side effects reported during clinical studies and in the post-marketing period. The frequency of side effects is classified as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), occasionally (≥ 1/1000 to < 1/100), rare (≥ 1/ 10000 to < 1/1000), very rare (< 1/10000), unknown (cannot be estimated from the available data).

    Adverse effects recorded during clinical studies and in the post-marketing period

    A class of organ system Frequency Adverse effect
    Gastrointestinal disorders Often* constipation
    periodically vomiting
    Tissue disorders skin and subcutaneous periodically* rash
    rarely* urticaria
    unknown angioedema, itching
    Disorders of the immune system unknown hypersensitivity

    * frequency estimated from frequency during clinical studies Adverse reaction reporting

    Reporting of suspected adverse reactions after obtaining a drug license is important. This enables continuous monitoring of the drug's benefit-risk ratio. Healthcare workers should report any suspicion of adverse reactions to this medicine to the Agency for Medicines and Medical Devices of Serbia (ALIMS):

    Agency for Medicines and Medical Devices of Serbia National Center for Pharmacovigilance

    Vojvode Stepe 458, 11221 Belgrade Republic of Serbia

    fax: +381 (0)11 39 51 131

    website: www.alims.gov.rs

    e-mail: nezeljene.reakciie@alims.gov.rs

     

    Overdose

    Overdose can lead to severe constipation.

    Pharmacological data

     

    Pharmacodynamics

    Pharmacotherapeutic group: Antidiarrheals, intestinal anti-inflammatory/anti-infective drugs; Other intestinal adsorbents ATC code: A07BC05Diosmectite has shown clinical pharmacological effects:

    • adsorbs intestinal gases in adults
    • restores mucus permeability in clinical studies conducted in children with gastroenteritis. Thanks to its layered structure and high plastic viscosity, diosmectite coats the mucous membrane of the gastrointestinal tract.

    The combined results of two double-blind, randomized studies involving 602 patients with acute diarrhea between the ages of 1 and 36 months, which compared the efficacy of Smecta with placebo, showed a significant reduction in the number of stools during the first 72 hours in the group of patients treated with the drug Smecta, along with oral rehydration.

     

    Pharmacokinetics

    Due to the structure of diosmectite, the drug Smecta remains on the luminal side of the intestinal epithelium. Smecta is not resorbed or metabolized.

    Diosmectite is excreted in the feces during the process of normal intestinal transit.

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