Glycerine suppositories
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCERINE SUPPOSITORIES (GLYCERINESUPPOSITORIES)
Composition:
Active substance: glycerol;
1 suppository contains glycerol 0.88 g or 2.63 g;
Excipients: sodium carbonate decahydrate; stearic acid; macrogol 400.
Pharmaceutical form. Suppositories.
Main physicochemical properties: semi-transparent suppositories, almost colorless or with a slight yellowish tint, with a greasy surface, hygroscopic. A cup-shaped depression, air channel, slight cloudiness of suppositories, minor softening of the surface layer, and presence of condensation on the packaging are permitted.
Pharmacotherapeutic group.
Laxatives.
ATC code A06AX01.
Pharmacological properties.
Pharmacodynamics.
Pure glycerin has an irritant effect, which disappears when water (30–50%) is added, as well as vaseline or lanolin. When administered into the rectum, suppositories exert a mild irritant effect on the mucous membrane and reflexively stimulate defecation. When used in the form of rectal suppositories, glycerin facilitates the evacuation of fecal masses.
The effect of the medicinal product occurs within 5–30 minutes.
Pharmacokinetics.
After rectal administration, absorption is weak and the presence in the body is short-term.
Glycerin practically does not enter the systemic circulation and does not produce systemic adverse effects.
Clinical characteristics.
Indications. Constipation of various etiologies (when oral administration of drugs is not possible).
Contraindications.
Hypersensitivity to the components of the drug. Intestinal obstruction, renal failure, appendicitis, hemorrhage, diarrhea, acute hemorrhoids, anal fissures, inflammatory diseases, rectal tumors, undiagnosed abdominal pain, hemorrhagic rectocolitis.
Interaction with other medicinal products and other forms of interaction.
The drug may interact with other medicinal products.
Glycerin suppositories may weaken the effect of other drugs administered rectally. An interval of several hours should be observed.
Special precautions for use.
It is not recommended to use the suppositories for treatment courses longer than 1 week.
Use with caution in patients with impaired kidney function, allergies, nausea, or vomiting.
Hands should be thoroughly washed before and after administration of the suppositories.
Use during pregnancy or breastfeeding.
During pregnancy, the medicinal product should be used only if the expected benefit to the pregnant woman outweighs the potential risk to the fetus.
It is not known whether glycerin is excreted in breast milk; therefore, the physician may prescribe the drug only if the expected benefit to the breastfeeding woman outweighs the potential risk to the infant.
Ability to influence reaction speed when driving or operating machinery.
No effect.
Method of Administration and Dosage.
One suppository once daily, 15–20 minutes after breakfast.
The suppository is inserted into the rectum and retained there for at least 5 minutes, unless defecation occurs earlier. Residual suppository material is eliminated from the body together with feces. If necessary, the dose may be increased to two suppositories per day.
For adults and children aged 5 years and older: one suppository (containing 2.63 g of glycerin) once daily. For children under 5 years: one suppository (containing 0.88 g of gly游戏副本rin) once daily.
Children.
No restrictions.
Overdose.
Frequent loose stools. Resolves spontaneously after discontinuation of the drug.
Adverse reactions.
Some consequences and symptoms have been reported, which disappear after discontinuation of use, particularly rectal discomfort, irritation, burning, colic, and spasms. In rare cases, the medicinal product may cause hyperemia of the rectal mucosa, and in isolated cases – slight bleeding or mucus discharge.
Possible allergic reactions, pain, nausea, vomiting, gastrointestinal bleeding.
With prolonged use, irritation and unpleasant sensations in the rectum may occur; sometimes catarrhal proctitis.
Shelf life. 3 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
5 suppositories per strip, 1 or 2 strips per carton.
Prescription status. Over-the-counter.
Manufacturer. LLC "FARMEKS GROUP".
Manufacturer's address and place of business.
100, Shevchenko St., Boryspil, Kyiv region, Ukraine, 08301.
All cases of adverse reactions should be reported to the manufacturer:
LLC "FARMEKS GROUP", 100, Shevchenko St., Boryspil, Kyiv region, Ukraine, 08301, tel. +38(044)391-19-19, fax: +38(044)391-19-18, or via the form on the website: http://www.pharmex.com.ua/farmakonadzor
**INSTRUCTION
for medical use of medicinal product
GLYCERIN SUPPOSITORIES
(GLYCERIN SUPPOSITORIES)**
Composition: Active ingredient: glycerol;
1 suppository contains glycerol 0.88 g or 2.63 g;
Excipients: sodium carbonate decahydrate; stearic acid; macrogol 400.
Pharmaceutical form. Suppositories.
Main physicochemical properties: suppositories are semi-transparent, almost colorless or with a slight yellowish tint, with a greasy surface, hygroscopic. A funnel-shaped depression, air core, cloudiness of suppositories, slight softening of the surface layer, or presence of condensate on the packaging may be observed.
Pharmacotherapeutic group.
Laxatives.
ATC code A06AX01.
Pharmacological properties.
Pharmacodynamics. Pure glycerin has an irritating effect, which disappears when water (30–50%), vaseline, or lanolin is added. When administered into the rectum, the suppositories exert a mild irritant effect on the mucous membrane and reflexively stimulate defecation.
When used as rectal suppositories, glycerin facilitates the evacuation of fecal masses.
The effect of the medicinal product occurs within 5–30 minutes.
Pharmacokinetics. After rectal administration, absorption is minimal and residence time in the body is short. Glycerin practically does not enter the systemic circulation and does not produce systemic adverse effects.
Clinical characteristics.
Indications. Constipation of various etiologies (when oral administration of drugs is not possible).
Contraindications.
Hypersensitivity to the components of the medicinal product. Intestinal obstruction, renal failure, appendicitis, bleeding, diarrhea, hemorrhoids in the stage of exacerbation, anal fissures, inflammatory diseases, tumors of the rectum, undiagnosed abdominal pain, hemorrhagic proctocolitis.
Interaction with other medicinal products and other types of interactions.
The product may interact with other medicinal products.
Glycerin suppositories may reduce the efficacy of other drugs administered rectally. An interval of several hours should be maintained.
Special precautions.
It is not recommended to use suppositories for more than 1 week.
Use with caution in patients with impaired renal function, allergies, nausea, or vomiting.
Hands should be thoroughly washed before and after administration of suppositories.
Use during pregnancy or breastfeeding.
During pregnancy, the medicinal product should be used only when the expected benefit to the pregnant woman outweighs the potential risk to the fetus.
It is unknown whether glycerin is excreted in breast milk; therefore, the product may be prescribed by a physician only when the expected benefit to the breastfeeding woman outweighs the potential risk to the infant.
Effect on ability to drive vehicles or operate machinery.
No effect.
Method of administration and dosage.
Administer 1 suppository once daily, 15–20 minutes after breakfast.
The suppository is inserted into the rectum and should be retained for at least 5 minutes, unless defecation occurs earlier. Residual suppository material is excreted from the body with feces. If necessary, the dose may be increased to 2 suppositories per day.
For adults and children over 5 years: 1 suppository (containing 2.63 g glycerol) once daily. For children under 5 years: 1 suppository (containing 0.88 g glycerol) once daily.
Children.
No restrictions.
Overdose.
Frequent loose stools. Symptoms resolve spontaneously after discontinuation of the drug.
Adverse reactions.
Some consequences and symptoms have been reported, which disappear after discontinuation of use, particularly rectal discomfort, irritation, burning, colic, and spasms. In rare cases, the medicinal product may cause hyperemia of the rectal mucosa, and in isolated cases – slight bleeding or mucus discharge.
Possible allergic reactions, pain, nausea, vomiting, gastrointestinal bleeding.
With prolonged use, irritation and unpleasant sensations in the rectum may occur; sometimes catarrhal proctitis.
Shelf life. 3 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
5 suppositories per strip, 1 or 2 strips per carton.
Prescription status. Over-the-counter.
Manufacturer. LLC "FARMEKS GROUP".
Manufacturer's address and place of business.
100, Shevchenko St., Boryspil, Kyiv region, Ukraine, 08301.