Normaze syrup 667 mg/ml 200 ml fl/pack card x1

Composition of the drug

The action of Normaze is explained by the presence of the main component - lactulose. It is a synthetic disaccharide obtained artificially. Lactulose does not occur naturally in nature. The small intestine does not know how to process it, so its aggressive environment does not have any effect on lactulose molecules. It enters unchanged into the large intestine and there it exerts its laxative effect.

Additional components of the drug are:

• propylene glycol;
• vanillin;
• water;
• flavoring

100 ml of the drug contains about 66 g of lactulose. Normaze bottles are sold in 200 ml volumes.

Normaze

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

INSTRUCTIONS for the use of the medicinal product for medical use

NORMASE®

Registration number: P N016189/01 Trade name: Normaze ® International nonproprietary name (INN): lactulose Dosage form: syrup Composition: 100 ml of the drug contains: active substance: lactulose solution (in terms of lactulose) - 66.7 g excipients : citric acid -0.05 g, creamy flavor (No. 7 bis) -0.06 g, purified water - up to 100 ml. Flavoring composition: propylene glycol, dihydrocoumarin, vanillin.

Description Transparent, colorless or light yellow with a brownish tint, syrupy liquid.

Pharmacotherapeutic group: laxative ATC code: A06AD11

Pharmacological properties Pharmacodynamics Has a hyperosmotic, hypoammonemic, laxative effect, stimulates intestinal motility, improves the absorption of phosphates and calcium salts. Under the influence of the drug, a change in the flora of the large intestine occurs (an increase in the number of lactobacilli), which leads to an increase in acidity in the lumen of the large intestine and stimulates its peristalsis. Along with this, the volume increases and the stool softens. As a result, the drug has a laxative effect without directly affecting the mucous membrane and smooth muscles of the large intestine. In hepatic encephalopathy or hepatic (pre)coma, the effect is associated with the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (for example, lactobacilli), the transition of ammonia to the ionic form due to acidification of the contents of the colon, bowel emptying due to a decrease in pH in the colon and the osmotic effect, as well as reducing nitrogen-containing toxic substances by stimulating bacteria that utilize ammonia for bacterial protein synthesis. Lactulose, as a prebiotic substance, enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, while inhibiting the growth of potentially pathogenic bacteria such as Clostridium and Escherichia coli, resulting in a more favorable balance of intestinal flora. Pharmacokinetics Absorption is low. After ingestion, it reaches the large intestine unchanged, where it is broken down by intestinal flora. Completely metabolized at doses up to 40-75 ml; at higher dosages it is partially excreted unchanged.

Indications for use - Constipation: regulation of the physiological rhythm of colon emptying. — Softening of stool for medical purposes (hemorrhoids, conditions after surgery on the colon and anus). — 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 glucose-galactose malabsorption should not use this drug.

With caution - patients with hepatic (pre)coma, with diabetes mellitus; - undiagnosed rectal bleeding; - colostomy, ileostomy.

Use during pregnancy and breastfeeding If necessary, Normaze ® can be used during pregnancy and breastfeeding.

Method of administration and dosage The drug is intended for oral administration. Lactulose solution can be taken either diluted or undiluted. It is necessary to immediately swallow the single dose taken without holding it in the mouth. All dosages must be selected individually. If a single daily dose is prescribed, it must be taken at the same time, for example, during breakfast. During laxative therapy, it is recommended to take a sufficient amount of fluid (1.5-2 liters, equal to 6-8 glasses) per day. Dosage for the treatment of constipation or for softening stool for medical purposes: The daily dose of lactulose can be taken once or divided into two using a measuring cup. The initial dose may be adjusted to the maintenance dose depending on the response to the drug. The therapeutic effect may appear 2-3 days after starting to take the drug.

The duration of treatment is from 4 weeks to 3-4 months. Dosage for the treatment of hepatic coma and precoma: Initial dose: 3-4 times a day, 30-45 ml. Then they switch to an individually selected maintenance dose so that soft stools are produced 2-3 times a day maximum.

Side effects In the first days of taking lactulose, flatulence may occur. As a rule, it disappears after a few days. If high doses are used for a long time in the treatment of hepatic encephalopathy, the patient may develop electrolyte imbalance due to diarrhea. Gastrointestinal disorders: Flatulence, abdominal pain, nausea, vomiting. When using high doses, diarrhea may occur. Other disorders: Water and electrolyte imbalance due to diarrhea.

Overdose Symptoms: abdominal pain and diarrhea. Treatment: discontinue the drug or reduce the dose and correct the water-electrolyte balance in case of large fluid loss due to diarrhea or vomiting. Interaction with other medicinal products Interaction studies with other medicinal products have not been conducted.

Special instructions If there is no therapeutic effect within several days, you should consult your doctor. Lactulose should be administered with caution to patients with lactose intolerance. Please note that Normaze ® may contain small amounts of bound sugars (for example, lactose, galactose, epilactose and fructose). The dosage usually used in the treatment of constipation does not require adjustment for patients with diabetes. When treating hepatic (pre)coma, higher doses of the drug are usually prescribed, which should be taken into account in patients with diabetes mellitus. Patients with rare congenital disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this drug. When treating children, laxatives should be used in exceptional cases and under medical supervision. It must be taken into account that during treatment, disorders of the emptying reflex may occur. Effect on the ability to drive a car and other mechanisms The use of the drug Normaze® does not affect or has an insignificant effect on the ability to drive a car and machines.

Release form: Syrup 667 mg/ml, 200 ml of the drug in a brown polyethylene terephthalate bottle, closed with a screw cap made of high-density polyethylene. The bottle, along with a plastic measuring cup and instructions for use, is 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 expiration date stated on the package.

Conditions for dispensing from pharmacies Without a prescription. Manufacturer / Marketing Authorization Holder L. Molteni and C. dei Fratelli Alitti Societa di Ezercizio S.p.A., Italy Strada Stratale 67, loc. Granatieri, 50018 Scadicci, Florence

A company authorized by the manufacturer to accept claims from buyers: Dr. Reddy's Laboratories LTD, 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1, tel. (+7495) 795 39 39, 783 29 01.

Operating principle of Normaze

Due to the fact that the human body does not have enzymes capable of digesting lactulose, the substance is not absorbed into the blood and enters unchanged into the lumen of the large intestine. Here the syrup becomes an excellent breeding ground for the proliferation of bifidobacteria and lactic acid bacteria. They jointly convert lactulose into three types of acids: lactic, formic and acetic. These three derivatives have a pronounced osmotic effect, that is, they are able to accumulate fluid in the intestine, which creates a certain pressure on its walls.

Natural fiber has a similar effect, so people who include vegetables, fruits and herbs in their daily diet do not experience constipation. Normaze accumulates salts in the intestinal lumen. And salt “attracts” liquid. The water moves to where there is a more concentrated saline solution. By increasing the volume of fluid in the large intestine, Normaze promotes an increase in the volume of feces, which presses on its walls, triggering peristalsis. Thanks to this simple mechanism, a laxative effect is achieved.

After taking a single dose of the drug, 1 to 2 days must pass before the effect of the substance appears. This is how long it takes lactulose to get from the small intestine to the large intestine and create pressure on its walls.

Normaze syrup 667 mg/ml 200 ml fl/pack card x1

Trade name: Normase International name: Lactulose

Release form: syrup (dark glass bottles) 200 ml /complete with measuring cup/

Ingredients: lactulose 66.7 g - 100 ml

Pharmacological group: laxative

Pharmacological group according to ATK: A06AD11 (Lactulose)

Pharmacological action: hypoazotemic, laxative, gastrointestinal motility accelerating,

Indications: Hepatic precoma and coma, hepatic encephalopathy, hyperammonemia, constipation (including chronic, with hemorrhoids, the need for surgery on the colon and/or anus), intestinal dysbiosis, enteritis caused by salmonella, shigella, salmonella carriage, syndrome putrefactive dyspepsia (in young children as a result of acute food poisoning), periodontal disease, pain syndrome after removal of hemorrhoids.

Dosage regimen: Orally, for hepatic coma, precoma, encephalopathy and hyperammonemia - 30-50 ml 3 times a day, the daily dose can be 90-190 ml, then in an individually selected maintenance dose (providing stool pH 5-5.5) 2- 3 times a day. For constipation - in the first 3 days, 15-45 ml, then - 10-30 ml. Children under 14 years old - 15 ml in the first 3 days, then 10 ml/day, up to 6 years old - 5-10 ml/day, infants - 5 ml/day. For salmonella enteritis - in the first 10-12 days, 15 ml 3 times a day, after a one-week break at the same dose 5 times a day, for periodontal disease - 15-30 ml/day.

Contraindications: Hypersensitivity, undiagnosed rectal bleeding, colo-, ileostomy, suspected appendicitis, galactosemia, intestinal obstruction.

Side effects: Convulsions, flatulence, nausea, diarrhea, headache, dizziness, arrhythmias, myalgia, increased fatigue, weakness, and with long-term treatment - impaired water-electrolyte metabolism.

Pharmacodynamics: Has a hyperosmotic, laxative effect, stimulates intestinal motility, improves the absorption of phosphates and Ca2+ salts, and promotes the excretion of ammonium ions. Under the influence of the drug, Lactobacillus acidophilus, Lactobacillus bifidus multiply in the intestines, under the influence of which lactulose is broken down to form lactic acid (mainly) and partially formic and acetic acids. At the same time, the osmotic pressure increases and the pH in the lumen of the large intestine decreases, which leads to the migration of ammonia from the blood into the intestine, its ionization and retention, as well as an increase in the volume of feces and increased intestinal motility. The removal of bound ammonium ions occurs with the development of a laxative effect. The effect occurs 24-48 hours after administration (the delay is due to the passage of the drug through the gastrointestinal tract). Inhibits the formation and absorption of nitrogen-containing toxins in the proximal colon. Reduces the concentration of ammonium ions in the blood by 25-50%, reduces the severity of hepatic encephalopathy, improves mental state and normalizes the EEG. Reduces the proliferation of salmonella.

Pharmacokinetics: Absorption - low. Excretion by the kidneys is 3%.

Special instructions: With long-term use (more than 6 months), monitoring of the content of K+, Cl- and CO2 in plasma is necessary. For gastrocardial syndrome, doses should be gradually increased to avoid flatulence (which disappears on its own on the 2-3rd day of treatment). In elderly and debilitated patients taking lactulose for more than 6 months, it is recommended to periodically measure the level of electrolytes in the blood serum. If diarrhea occurs, treatment is discontinued. Carefully. Diabetes. Category of action on the fetus. B

Interaction: Antibiotics (neomycin) and antacids reduce the effect. Changes the pH-dependent release of enteric drugs. It is not recommended to take lactulose within 2 hours after taking other drugs.

Dispensed from pharmacies: Dispensed without a prescription

Drug registration number: P No. 016189/01

Date of registration (re-registration) of the drug: 01/28/2005

Indications for use of Normaze

Since Normaze is a laxative, it is prescribed for constipation. Due to its safety, the product can be used to normalize stool in preschool children and even infants.

Constipation is the absence of bowel movements for more than three days in a row. If we are talking about an adult, then pregnant women and the elderly most often suffer from constipation. Constipation is a common problem among expectant mothers because the fetus and growing uterus put pressure on the intestines, limiting blood supply and peristalsis. Normaze makes stool soft, which relieves a woman of pain when moving it to the exit and helps to gently cleanse the body of waste products.

Elderly people suffer from constipation due to the fact that at a certain age the intestines can no longer cope with their functions, its muscles lose their strength, which is why feces stagnate in the body. If it does not come out within three days, it can lead to intoxication.

Infants, particularly children aged 6 months and older, experience constipation. The culprit, as a rule, is improper feeding. If a baby is given porridge, during the preparation of which all proportions were violated, or when porridge is given more than once a day, the child may experience constipation, which is not associated with intestinal dysfunction or weak intestinal motility. Such constipation occurs because the stool lumps form too dense, and their volume, as a rule, exceeds the diameter of the baby's anal ring. In this case, Normaze syrup will also be a salvation.

It is important to remember that before you buy a Normaze baby, you need to assess its condition. When a child is cheerful, sleeps well, eats, drinks enough, is not capricious without obvious reason, but has not had a bowel movement for two or three days, this is not constipation. Infants can empty their intestines once every three days if everything they eat is almost completely digested. Therefore, if there are no complaints from the child, a laxative should not be given.

Normaze: instructions for use

When constipation is observed in a baby in the first year of life with real complaints from the child about his condition (crying, tucking up his legs, shrill and frequent screaming), give 5 ml of the drug per day at a time. You can add the product to formula or drink if the child does not yet know how to eat from a spoon.

When treating constipation in children aged 6 to 12 years, use a single dose of 15 ml. If necessary, you can use the product for 3 days in a row, gradually reducing the single dose to 10 ml.

Adults are given 15-40 ml at a time once a day. The next day, the dose is reduced to 10-25 ml.

In all cases, the syrup is taken after meals, once a day, without exceeding the recommended volume. The duration of continuous use usually does not exceed 3 days.

Normaze

Normaze (active ingredient - lactulose) is a laxative drug. It has a hyperosmotic and hypoammonemic effect, stimulates intestinal peristalsis, improves the absorption of phosphates and calcium salts. Under the influence of normase, the bacterial microflora of the large intestine changes (in particular, an increase in the number of lactic acid bacteria), as a result of which the acidity increases and the peristalsis of the large intestine is stimulated. In addition to this, the volume of feces increases while their consistency softens. All of the above together has a laxative effect without affecting the mucous membrane or smooth muscles of the colon. Under the influence of normase, ammonia penetrates from the blood into the digestive tract, while the formation of nitrogen-containing toxic compounds in the proximal intestine is suppressed and their absorption into the vena cava system is reduced. The action of normase can develop quickly or with a delay of 24-48 hours. The drug is endowed with the ability to inhibit the growth of salmonella in the large intestine. At the end of the brief description of the pharmacological characteristics of normase, it should be noted that it does not reduce the absorption of vitamins and does not contribute to the development of tolerance (which is a very important property for a laxative drug).

Normaze is practically not absorbed in the gastrointestinal tract, which is actually not necessary, because the area where his forces are applied is precisely the intestines. The latter is also involved in the excretion of the drug, leaving only 3% of the administered amount to the kidneys. Normaze is available in the form of syrup. The optimal time to take it is after a meal. Adult patients suffering from constipation should take 15-40 ml of syrup per day at the initial stage of pharmacotherapy, and then, after the so-called. “saturating” period - 10-25 ml per day. Children over 6 years of age are prescribed 15 ml per day, after which the dose is reduced to 10 ml per day. Children aged 1 to 6 years are recommended to take 5-10 ml per day. The smallest dose is recommended for children under 1 year of age - 5 ml per day.

The duration of the medication course should fit into the chronological “backlash” between 1 and 3-4 months. Hepatic precoma and coma, encephalopathy and hyperammonemia require higher doses of normase - 30-60 ml three times a day. Subsequently, the dose is adjusted in such a way as to obtain 2-3 bowel movements per day with soft stool consistency. The medication course can last 3 or more months. After surgical interventions, adult patients are prescribed 10-30 ml three times a day, children over 1 year old - 5-10 ml 2-3 times a day, under 1 year old - 5 ml 2-3 times a day. The drug should be taken 18-24 hours after surgery for 3-5 days. During long-term drug courses (more than six months), it is necessary to regularly monitor the presence of potassium, chlorine and carbon dioxide ions in the blood plasma. In case of gastrocardial syndrome (a complex of cardiac disorders that occurs after eating), the dose of the drug should be increased gradually to avoid increased gas formation. When Normaza is taken together with antibacterial drugs and antacids, the effectiveness of the latter decreases. Lactulose, the active ingredient in Normaze, alters the pH-dependent release of enteric-soluble drugs, so their intake should be separated from Normaze by at least two hours.

Normaze passed all the clinical trials that befell him with honor. Some of them were carried out in our country. Thus, at the base of the clinic of SSMU named after S.R. Mirotvortseva (Saratov) conducted a study of the effectiveness of Normaze in children suffering from chronic constipation. As a result, after two weeks of therapy, the frequency and consistency of stool returned to normal in 85% of children, and signs of fecal intoxication stopped in 100% of small patients. Individual intolerance to the drug (nausea, vomiting) was noted in only one child.

Normaze: reviews

Patients who use Normaze as a laxative note its mild and delicate effect. There is no spasmodic pain in the abdominal area, the body is cleansed easily, without discomfort. If you do not exceed the specified dosage, there will be no problems with bowel movements.

Exceptions may be situations when the patient has intolerance to galactose and fructose. In this case, taking the syrup will cause flatulence, abdominal pain and other unpleasant symptoms.

However, doctors recommend resorting to lactulose in a hopeless situation. For normal intestinal function, it is extremely important to follow a diet and include vegetables, fruits, and dill in your daily diet. Don't eat fast food on the go. In addition, it is important to remain physically active and drink enough fluids. Then there will be no problems with stool and you will not have to resort to laxatives.