Medulac-Reb

BRAND NAME: Medulac-Reb

INTERNATIONAL NONPROPRIETARY NAME: Lactulose

DRUG FORM: Syrup

DESCRIPTION: clear, transparent to brownish-yellow colour viscous liquid

COMPOSITION

1 ml of syrup contains:

Active substance: lactulose – 667.0 mg

Excipients: purified water up to 1 ml.

PHARMACOTHERAPEUTIC GROUP

Drug products that affect the gastrointestinal tract (GIT) and metabolism. Osmotic laxatives.

ATC Code: A06AD11

PHARMACOLOGICAL PROPERTIES*:

When exposed to the intestinal flora in the colon, lactulose is transformed into low molecular weight organic acids. These acids help to reduce the pH in the lumen of the colon and increase the volume of intestinal contents through osmotic action. It stimulates colon peristalsis and normalizes the consistency of feces that helps to prevent constipation and restore the colon physiological rhythm. Lactulose, as a prebiotic substance, promotes the growth of bifidobacteria and lactobacilli, while the growth of opportunistic Clostridia and E. coli can be suppressed. It contributes to a favorable balance of the intestinal flora.

Lactulose is poorly absorbed after oral administration and reaches the colon in an unchanged form, then it undergoes metabolism by the intestinal flora. Completely metabolized at doses of 25-50g or 40-75 ml; at a higher dose it can be excreted in an unchanged form.

INDICATIONS FOR USE

- constipation: colon physiological rhythm regulation;

- stool softening - for medical purposes (hemorrhoids, post-surgery condition (colon and anus));

- hepatic encephalopathy: hepatic coma or precoma treatment and prevention.

CONTRAINDICATIONS:

- hypersensitivity to the active component or any of the drug product excipients.

- galactosemia;

- gastrointestinal tract obstruction, perforation or risk of perforation.

ADVERSE REACTION*

- Flatulence may occur in the first days of lactulose intake. It usually disappears in a few days. If the recommended doses are exceeded, pain in the abdomen and diarrhea may occur that requires dose reduction. In case the drug product has been taken at high doses for a long time, usually in hepatic encephalopathy treatment, the patient may develop electrolyte imbalance caused by diarrhea.

- Gastrointestinal tract disorders: very often - diarrhea; often - flatulence, abdominal pain, nausea, vomiting.

- Laboratory and instrumental data: infrequently – electrolyte imbalance due to diarrhea.

Children

When used in children, the similar drug product safety profile is expected compared to that used in adults.

For more detailed information on adverse reactions see the Instruction for Medical use.

DOSAGE AND ADMINISTRATION*:

For internal use

Lactulose solution can be taken both diluted and undiluted. It is necessary to immediately swallow the single dose, without keeping it in the mouth. All dosages should be chosen individually. In case of a single daily dose, it should be taken at the same point of time, for example, during breakfast. During therapy with laxatives it is recommended to take sufficient amount of fluid (1.5-2 liters, which is equal to 6-8 glasses) per day.

PRECAUTIONARY MEASURES*:

- in case of abdominal pain of unknown origin, before starting the treatment or no therapeutic effect a few days after the drug administration, it is necessary to consult a doctor;

- lactulose should be used with caution in patients with lactose intolerance;

- the dose usually used in treatment of constipation does not require adjustment for patients suffered from diabetes mellitus. In treatment of hepatic encephalopathy, higher doses of the drug are usually prescribed, which should be taken into account in patients with diabetes mellitus;

- continuous unadjusted doses and abuse can lead to diarrhea and disturbance of water and electrolyte balance;

- it should kept in mind that Medulac-Reb contains lactose, galactose and a small amount of fructose, therefore, patients with rare congenital disorders, such as galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption, should not be prescribed this drug.

Children

It must be taken into consideration that defecation disorder may occur during the treatment.

Ability to drive and operate machinery

Medulac-Reb intake has no / negligible effect on ability to drive or operate machinery.

Administration during pregnancy and breast-feeding period

Pregnancy

The drug product may be used during pregnancy.

Breast-feeding period

The drug may be used during breastfeeding.

INTERACTION WITH OTHER MEDICINAL PRODUCTS:

Studies on drugs interaction have not been carried out.

STORAGE AND SHELF LIFE

Store in a dark place at a temperature not above 25°C.

Keep out of reach of children!

3 years from the production date.

Not to be used after the expiration date.

PRESCRIPTION STATUS

Over the counter drug (OTC)

*For additional information see instructions for medical use.

Manufacturer Information

Foreign production and trade unitary enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, Smilovichi, Sadovaya St., 1, tel./fax: (+375) 17 240 26 35,

e-mail: rebpharma@rebpharma.by, http://www.rebpharma.by