Fortese Rompharm (Powder) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

A06AD15 (Macrogol)

Active Substance

Macrogol (Rec.INN registered by WHO)

Dosage Form

Fortese Rompharm

Powder for oral solution 10 g: sachets 10.5 g 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution white or almost white in color, with an orange odor; the prepared 5% solution of the drug is a colorless liquid with a sweet orange taste and an orange odor.

Excipients: sodium saccharin, orange flavor.

10.5 g – sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Osmotic laxative. Polyethylene glycol with a molecular weight of 4000.

The laxative effect develops due to the ability to increase the volume of intestinal contents, due to the fluid contained in it, which leads to increased peristalsis.

Pharmacokinetics

Not absorbed from the gastrointestinal tract and not metabolized.

Indications

Symptomatic treatment of constipation.

Preparation for diagnostic examinations (endoscopic, radiological) and surgical interventions on the colon.

ICD codes

Dosage Regimen

Administer orally or via a nasogastric tube.

For symptomatic constipation in adults and adolescents over 15 years of age, take 1 to 3 sachets daily in divided doses.

Dissolve the contents of each sachet in approximately 125 mL of water immediately before use.

For bowel preparation before diagnostic or surgical procedures, follow the specific regimen prescribed by the physician.

Adjust the daily dose based on individual response; the effective dose is the lowest dose producing a soft stool.

For pediatric use, administer strictly according to age-appropriate formulations and dosages.

Maintain adequate fluid intake during therapy.

If no improvement occurs after two weeks of use, re-evaluate the clinical situation.

Adverse Reactions

From the digestive system frequently – abdominal bloating, abdominal pain, nausea, diarrhea; rarely – vomiting, urgent urge to defecate and fecal incontinence, irritation of the perianal area.

From the metabolism frequently – electrolyte imbalance (hyponatremia, hypokalemia) and/or dehydration, especially in elderly patients.

Allergic reactions frequency unknown – skin itching, urticaria, skin rash, facial edema, angioedema, anaphylactic shock, erythema, fulminant and acute pulmonary edema (after administration of a balanced macrogol solution with electrolytes via a nasogastric tube).

Contraindications

Hypersensitivity to the drug, dehydration, severe chronic heart failure; presence of a malignant tumor or other disease of the colon accompanied by extensive damage to the intestinal mucosa; gastric ulcer, erosive-ulcerative lesions of the colon mucosa (including ulcerative proctocolitis, Crohn’s disease); severe inflammatory bowel diseases or toxic megacolon combined with symptomatic stenosis, perforation or risk of hollow organ perforation, intestinal obstruction (including spastic, obstructive); impaired gastric emptying (including gastroparesis), abdominal pain of unclear etiology; childhood – depending on the dosage form.

With caution in renal impairment, heart failure; in patients with impaired swallowing reflex, reflux esophagitis; in patients with concomitant diuretic therapy; in patients prone to developing water-electrolyte imbalance, including hyponatremia and hypokalemia; in patients with neurological disorders, in bedridden patients and/or patients with impaired motor functions, in patients prone to aspiration, and/or in a semi-conscious state; in elderly patients.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Renal Impairment

It should be used with caution in patients with renal impairment.

Pediatric Use

It can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the macrogol drug leaflets regarding contraindications for the use of specific macrogol dosage forms in children of different ages.

Geriatric Use

It should be used with caution in elderly patients.

Special Precautions

Elderly patients with various concomitant diseases are recommended to use Macrogol under the supervision of medical personnel.

Caution is required when using the drug D-Forject in patients with inflammation of the intestinal mucosa, including the rectum.

Macrogol should be used with caution and only under the supervision of medical personnel in patients prone to aspiration, in bedridden patients, in patients with neurological disorders and/or in patients with impaired motor functions due to the risk of developing aspiration pneumonia. In such patients, Macrogol should be administered in a sitting position and via a nasogastric tube.

Patients in a semi-conscious state should be under close supervision during the administration of macrogol. If symptoms of abdominal pain or bloating appear, the rate of macrogol administration should be reduced or administration should be suspended until these symptoms disappear.

Drug Interactions

Diarrhea caused by taking macrogol can lead to impaired absorption of other simultaneously taken drugs. In this case, the effectiveness of drugs with a narrow therapeutic index or a short half-life may be reduced. The patient should inform the doctor who prescribed Macrogol about all simultaneously taken drugs.

The interval between taking macrogol and other drugs should be at least 2 hours.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.