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BIOGLICEROL 1g - glycerol suppositories

NAME OF THE MEDICINAL PRODUCT

BIOGLICEROL
Czopki glicerolowe
(Suppositoria Glyceroli)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

  • Glycerin – 0.91 g
  • For excipients see the list of excipients.

PHARMACEUTICAL FORM

Suppositories, 1 g

CLINICAL PARTICULARS

Indications for use

BIOGLICEROL is used in constipation as an agent to ease evacuation.

Dosage and method of administration

  • The product is recommended for children under 6 years.
  • 1 - 2 suppositories are most often used, per rectum, overnight.

Contraindications

Do not use in rectal neoplastic diseases.

Special warnings and precautions for use

None.

Interactions with other medicinal products and other types of interactions

Have not been observed.

Pregnancy and lactation

The product can be used in pregnant and breast feeding women.

Effects on ability to drive and use machines

BIOGLICEROL has no effect on the ability to drive or use machines

Undesirable effects

BIOGLICEROL is generally well tolerated. Irritation of the rectum after use of the suppository is possible.

Overdose

The consequences of an overdose have not been reported.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: laxative medicinal products, ATC code: A06AX

Pharmacokinetic properties

  • Components of the suppositories are not absorbed. The active component of the suppositories - glycerin, acts as an osmotic laxative.
  • After the introduction of a suppository into the rectum evacuation occurs within 15 to 60 minutes.
  • The activity of BIOGLICEROL consists of the development of the ease of movement and density of the faecal mass. The mechanism of activity in some individuals also includes the development of local stimulation of peristalsis.

Preclinical safety data

Pharmacopoeial product safe in use.

PHARMACEUTICAL DATA

List of excipients

  • Anhydrous sodium carbonate
  • Stearic acid

Pharmaceutical incompatibilities

Does not apply.

Shelf life

18 months

Special precautions for storage

  • Store under 20°C.
  • Protect from moisture.
  • Keep away from children.
  • Do not use the product after the expiry date given on the package.

Nature and contents of package

  • 1 blister pack with 5 suppositories each, 1 g each, in a cardboard box.
  • 2 blister packs with 5 suppositories each, 1 g each, in a cardboard box.

Instructions for use and handling and disposal of medicinal product

  • Remove a suppository from the blister pack and introduce deep into the rectum.
  • Any unused product or waste material should be disposed of in accordance with local regulations.