Universal reference book for medicines
Product name: FORTEZA ROMFARM (FORTESE ROMPHARM)

Active substance: macrogol

Type: Laxative preparation with osmotic properties

Manufacturer: SC ROMPHARM Company (Romania)
Composition, form of production and packaging
? Powder for the preparation of a solution for ingestion of white or almost white color, with an orange smell; The prepared 5% solution of the drug is a colorless liquid with a sweet orange flavor and an orange smell.
1 sachet
macrogol 4000 10 g
Excipients: sodium saccharinate, orange flavor.
10.5 g - sachets (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Osmotic laxative. A high-molecular substance, which is a long linear polymer, which by means of hydrogen bonds is capable of retaining water molecules. Increases the osmotic pressure and volume of the intestinal fluid, enhancing peristalsis. Increases the volume of chyme, prevents the loss of electrolytes with feces. It restores the reflex of evacuation, does not change the pH of the chyme. The laxative effect occurs 24-48 hours after oral administration. Prevents the violation of water-electrolyte balance.
PHARMACOKINETICS
It is not absorbed in the gastrointestinal tract and is not metabolized.
INDICATIONS
- Constipation (symptomatic treatment in adults and children over 12 years old).
DOSING MODE
The drug is used inside after dissolving the contents of the sachet in a glass of water.
The recommended dose for children over 12 years is 1 packet per day, for adults 1-2 packs per day, preferably in one morning. The action of Forteza Rhompharm manifests itself 24-48 hours after admission. Treatment of children should not exceed 3 months. Restoration of normal bowel activity, achieved through treatment, should be supported by a healthy lifestyle and diet.
SIDE EFFECT
During clinical trials, mainly minor and transient side effects were recorded, mainly associated with the gastrointestinal tract (GI tract):
- often (> 1/100, <1/10): bloating (may occur at the beginning of therapy and usually occurs after the dose is selected), abdominal pain, nausea, diarrhea;
- sometimes (> 1/1000, <1/100): allergic reactions.
- Very rarely (<1/10000): itching, hives, face swelling, Quincke's edema, cases of anaphylactic shock.
Side effects in children are the same as in adults.
CONTRAINDICATIONS
- dehydration;
- inflammatory and erosive-ulcerative lesions of the mucous membrane of the colon (including ulcerative colitis, Crohn's disease);
- intestinal perforation or perforation risk;
- intestinal obstruction (including spastic, obturation) or suspicion of intestinal obstruction;
abdominal pain of unclear etiology;
- Chronic heart failure;
- Children's age (up to 12 years);
- Hypersensitivity to the components of the drug,
With caution: pregnancy, lactation.
PREGNANCY AND LACTATION
Use with caution in pregnancy and during lactation.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
SPECIAL INSTRUCTIONS
Before starting treatment with Forteza Rompharm, you need to make sure that there is no organic pathology of the digestive tract. In the drug therapy of constipation, the drug should be considered as an addition to general hygiene measures and diet therapy (eating foods rich in plant fibers, a large amount of fluid, a physically active lifestyle and restoring a regular defecation reflex).
The duration of treatment should not exceed 3 months. If the patient's condition does not improve, contrary to diet therapy, it is necessary to look for another cause of dysfunction.
Very rare cases of hypersensitivity to drugs containing macrogol (polyethylene glycol) have been reported. Cases of anaphylactic shock have been reported.
Fortez Rompharm contains an artificial sweetener (sodium saccharinate), so it can be prescribed to patients with diabetes mellitus, as well as patients whose diet excludes galactose.
OVERDOSE
Symptoms: diarrhea.
Treatment: cancellation of the drug (diarrhea ceases on its own 1-2 days after cancellation).
Aspiration cases were recorded with the introduction of a large volume of polyethylene glycols and electrolytes through a gastroscopic probe. The risk of aspiration is increased in children with neurologic impairment of the swallowing function.
DRUG INTERACTION
Slows the absorption of concomitant medications. In case of simultaneous reception of Forteza Rompharm with other medicines, it is recommended to prescribe the drug 2 hours after their administration.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
In a dry place at a temperature of no higher than 25 ° C. In a place inaccessible to children. Shelf life - 3 years.
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