Normaz - instructions for use, doses, side effects, contraindications

Pharmacodynamics:Has a hyperosmotic, hypoammonemic, laxative effect, stimulates intestinal peristalsis, improves the absorption of phosphates and calcium salts.Under the influence of the drug changes the flora of the large intestine (increase in the number of lactobacilli), which leads to increased acidity in the lumen of the colon and stimulate peristalsis. Along with this, the volume increases and the feces softens. As a result, the drug has a laxative effect, without directly affecting the mucosa and the smooth musculature of the large intestine.

In hepatic encephalopathy and hepatic (pre) coma effect associated with inhibition of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g., lactobacillus), conversion of ammonia into the ionic form due to acidification of colon contents bowel owing to decrease in pH in the colon, the osmotic effect, as well as the reduction of nitrogen-containing toxic substances by stimulating bacteria that utilize ammonia for bacterial protein synthesis.

Lactulose as prebiotic substance enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, whereas it becomes possible to suppress the growth of potentially pathogenic bacteria such as Clostridium and Escherichia coli, which provides a more favorable balance of intestinal flora.

Pharmacokinetics:

Absorption is low. After ingestion, it reaches the large intestine in unchanged form, where it is split by intestinal flora. Completely metabolized at doses up to 40-75 ml; at a higher dosage, is partially excreted unchanged.

Indications:

- Constipation: regulation of the physiological rhythm of emptying the large intestine.

- Softening of the stool for medical purposes (hemorrhoids, conditions after surgery on the large intestine and in the anal area).

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

Contraindications:lactose intolerance;

- galactosemia;

- intestinal obstruction;

- Hypersensitivity to any component of the drug.

Patients with rare congenital disorders, such as galactose intolerance, lactase deficiency or malabsorption of glucose-galactose, should not use this medication.

Carefully:- Patients with hepatic (pre) coma, with sadiabetes mellitus;

- rectal bleeding nondiagnostirobathrooms;

- colostomy, ileostomy.

Pregnancy and lactation:If necessary, Normase® can be apply during pregnancy and during breastfeeding.

Dosing and Administration:

The drug is intended for oral administration.

A solution of lactulose can be taken in both diluted and undiluted form. It is necessary to immediately swallow the taken single dose, without delaying in the mouth. All dosages should be selected individually.

In the case of a single daily dose, it should be taken at the same time, for example, during breakfast.

During therapy with laxatives, it is recommended to take a sufficient amount of liquid (1.5-2 liters, which is 6-8 glasses) per day.

Dosage in the treatment of constipation or to soften the stool for medical purposes: The daily dose of lactulose can be taken once, or divided into two, using a measuring cup.

The initial dose can be adjusted to a maintenance dose, depending on the response to the drug. The therapeutic effect may appear 2-3 days after the start of the drug.

Age	Initial daily dose	Maintenance daily dose
Adults and teenagers	15-45 ml	10-30 ml
Children 7-14 years old	15 ml	10 -15 ml
Children 1-6 years old	5-10 ml	5-10 ml
Children under 1 year old	up to 5 ml	up to 5 ml

Duration of treatment from 4 weeks to 3-4 months.

Dosage in the treatment of hepatic coma and precoma:

Initial dose: 3-4 times a day for 30-45 ml.

Then they switch to an individually selected maintenance dose so that the soft stool is maximum 2-3 times a day.

Side effects:In the first days of taking lactulose, it is possible the appearance of flatulence. As a rule, it disappearsa few days later. In the case ofincreased doses for a long timeth time in the treatment of hepatic encephalitislobes in a patient may developof the water-electrolyte balance followingdiarrhea.

Disorders from the gastro-intestinal tract:

Flatulence, abdominal pain, nausea, vomiting.

When high doses are used,phenomenon of diarrhea.

Other violations:

Violations of the water-electrolyte balance due to diarrhea.

Overdose:Symptoms: abdominal pain and diarrhea.

Treatment: discontinuation of the drug or Dose reduction and correction of water-electrolyte balance in the case of large loss of fluid due to diarrhea or vomiting.

Interaction:

Studies on interactions with other drugs have not been conducted.

Special instructions:

In the absence of therapeutic effect for several days should consult with your doctor.

Lactulose should be administered with caution to patients with lactose intolerance.

It should be taken into account that Normase® can contain insignificant amounts of bound sugars (for example, lactose, galactose, epilactose and fructose).

Dosage, usually used in the treatment of constipation, does not require correction for patients with diabetes mellitus. In the treatment of hepatic (pre) coma, higher doses are usually prescribed, which should be taken into account in patients with diabetes mellitus. Patients with rare congenital disorders, such as galactose intolerance, Lappease lactase deficiency or glucose-galactose malabsorption, should not use this medication. In the treatment of children laxatives should be used in exceptional cases and under the supervision of a doctor. It must be taken into account that during the treatment there may be disorders of the emptying reflex.

Effect on the ability to drive transp. cf. and fur:

The use of Normase® does not affect or has little effect on the ability to drive and operate machinery.

Form release / dosage:Syrup 667 mg / ml 200 ml of the drug in the flbrown polyethylene terephthalate, forcovered with a screw cap made of polyethylenedensity. Vial with polyethylene measuring cup and instructions for use packed in a cardboard box.

Storage conditions:

Store at a temperature of 15 to 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N016189 / 01

Date of registration:03.12.2009

The owner of the registration certificate:L. Molteni and K. dei Fratelli Alitti Soetica di Ezerchicio SpAL. Molteni and K. dei Fratelli Alitti Soetica di Ezerchicio SpA Italy

Manufacturer: & nbsp

L.Molteni & C. dei F.Lli Alitti Societa di Esercizio, S.p.A. Italy

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp23.06.2014

Illustrated instructions

Instructions

Norma (Normase)