ROMFALAK

Active material: Lactulose
When ATH: A06AD11
CCF: Laxatives osmotic properties. Gipoammoniemicheskoe means
When CSF: 11.08.03
Manufacturer: S.C. ROMPHARM Company S.R.L. (Romania)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Syrup clear, slightly viscous, no visible particles, with a sweet taste.

270 g (200 ml) – plastic bottles (1) complete with a measured spoon 2-sided – packs cardboard.

Pharmacological action

It has hyperosmotic, gipoammoniemicheskoe, laxative effect, stimulates peristalsis, improves the absorption of calcium and phosphates. Under the influence of the drug changes the flora of the colon (increase in the number of lactobacilli), which leads to increased acidity in the lumen of the colon and stimulate peristalsis. Along with this increased volume and softening of stools. As a result, the drug has a laxative effect, without impacting directly on the mucosa and colonic smooth muscles. Under the action of the drug migration occurs ammonia from the blood into the intestine, reduce the formation of nitrogen-containing toxic substances in its proximal part, and, respectively, their absorption in poloyveny.

The action comes after 24-48 h after administration (due to the latency of the passage of the drug through the gastrointestinal tract).

It has the ability to inhibit the growth of Salmonella in the large intestine. It does not reduce the absorption of vitamins and is not addictive.

Pharmacokinetics

Absorption – low, is output through the intestine intact (excretion by the kidneys 3%).

Indications for use of the drug

• chronic constipation;
• Regulation stool hemorrhoids, need surgery on the colon and in the anal area, postoperatively;
• pechenochnaya coma and coma;
• hepatic encephalopathy;
• ammoniemia;
• dysbiosis;
• salmonellosis (except generalized forms);
• gnilosnoy dyspepsia syndrome in infants as a result of food poisoning.

Dosage regimen

Inside, after meal.

Dose picked individually.
Usually, the dose may be reduced after 2 days of depending on the needs of the patient. The drug is best taken 1 time / in the morning while eating. The dose is increased in the case, if during 2 days of the drug is observed improvement of the patient.

For constipation: adults – first 3 the day on 15-40 ml /, then – by 10-25 ml. Children over 6 years – first 3 the day on 15 ml /, then – by 10 ml; 1-6 years – by 5-10 ml /, to 1 year – 5 ml / Duration of treatment – from 4 weeks before 3-4 months.

In the treatment of hepatic coma, precoma and encephalopathy: the initial dose – 3 by 30-60 ml. Then move on to individually tailored maintenance dose as, to soft chair was the maximum 2-3 Treatment can last up to 3 months and more.

When dysbacteriosis and salmoneteze: adults – by 15-30 ml 3-5 time /, older children 8 years – 45 ml /, from 5 to 8 years – 25 ml /, from 1 to 5 years – 15 ml /, to 1 year – 5-15 ml / Duration of treatment – 10-12 days, refresher courses- 3 times at weekly intervals.

In the postoperative period: adults – by 10-30 ml 3, older children 1 year – by 5-10 ml 2-3, to 1 year – by 5 ml 2-3 The drug is prescribed by 18-24 h after surgery for 3-5 days.

Side effect

Convulsions, flatulence, nausea, diarrhea, headache, dizziness, Arrhythmia, myalgia, fatigue, weakness.

Long-term treatment – disruption of water and electrolyte metabolism.

Contraindications

• galactose or fructose intolerance;
• galactosemia;
• bowel obstruction;
• suspected appendicitis;
• rectal bleeding;
• column, ileostomy;
• hypersensitivity.

Carefully – diabetes.

Pregnancy and lactation

Romfalak can be used during pregnancy and lactation (breast-feeding) on indications.

Cautions

With long-term use of the drug (more 6 months) should regularly monitor the level of potassium, chlorine and carbon dioxide in the blood plasma.

When gastrocardiac syndrome should gradually increase the dose, to avoid flatulence (which disappears on its own in the 2-3 day treatment).

In elderly and debilitated patients, taking Romfalak more 6 months, It recommended to periodically measure the level of electrolytes in serum.

When the diarrhea treatment cancel.

If constipation persists for a few days of taking the drug, or the resumption of constipation after stopping treatment, seek medical advice.

Overdose

Symptoms: stomach ache, nausea, diarrhea, loss of electrolytes.

Treatment: discontinuation of the drug.

Drug Interactions

Antibiotics and antacids reduce the effect of Romfalaka.

Changes of pH-dependent release enteric medicaments.

Do not take for Romfalak 2 hours after administration of other drugs.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

Keep out of reach of children, dry, protected from light, at a temperature no higher than 25 ° C. Shelf life – 3 year. Do not use beyond the expiration date, on the package.