FRILAX [Sodium Picosulfate] 5 mg/5 ml Oral syrup

Instructions for the medical use of the medicinal product

FRILAX

Tradename

Frilax, Фрилакс

International non-proprietary name or generic name

Sodium Picosulphate, Натрия Пикосульфат

Composition

Each 5 ml of syrup contains Sodium Picosulphate BP 5 mg; flavored syrup base q.s.

Dosage form

Syrup for oral administration.

Pharmacological properties

Laxative. Under the action of intestinal microorganisms, it is hydrolyzed with the formation of an active form, which causes irritation of the receptors of the intestinal mucosa and an increase in its peristalsis. Promotes the accumulation of water and electrolytes in the large intestine, which leads to the stimulation of the act of defecation, reducing the time of evacuation and soſtening of the stool.

Indications for use

•           constipation caused by atony and hypotension of the colon (including in old age, in bedridden patients, aſter operations, aſter childbirth and during lactation);

•           constipation caused by medication;

•           to regulate the stool with hemorrhoids, proctatitis, anal fissures (to soſten the consistency of feces);

•           diseases of the gallbladder, irritable bowel syndrome with a predominance of constipation;

•           constipation caused by intestinal dysbacteriosis, diet disorders.

Contraindications

•           intestinal obstruction or obstructive bowel disease;

•           acute diseases of the abdominal organs or severe pain in the abdomen, which may be accompanied by nausea, vomiting, fever, including appendicitis;

•           acute inflammatory bowel disease;

•           severe dehydration;

•           hypokalemia;

•           renal failure;

•           I trimester of pregnancy;

•           hypersensitivity to the components of the drug.

Method of administration and dosage

For oral use, at bedtime.

Shake the bottle well before using the syrup.

Special instructions and precautions Before using the drug, consult a doctor!

Prolonged excessive use of Frilax can lead to water and electrolyte imbalance and hypokalemia. Caution should be exercised when used in patients who have recently undergone gastrointestinal surgery, as well as in patients with renal insufficiency, heart disease or inflammatory bowel disease. Frilax should be used with caution in patients taking drugs that may affect fluid and electrolyte balance, such as diuretics, corticosteroids, lithium. Use with caution in elderly patients. The drug can cause fluid and electrolyte imbalances, which can lead to serious unwanted effects, including heart rhythm problems, seizures, or kidney problems. When taking the drug, you should drink more liquid.

Aſter opening the bottle, use the syrup within 2,5 months.

Interaction with other medicinal products

With simultaneous use with broad-spectrum antibiotics, it is possible to reduce the laxative effect of sodium picosulfate. Simultaneous use with diuretics, with corticosteroids may lead to an increased risk of electrolyte disturbances.

The electrolyte imbalance that occurs while taking high doses of sodium picosulfate can lead to a deterioration in the tolerability of cardiac glycosides when they are used simultaneously.

Side effect

From the digestive system: dyspepsia, flatulence, nausea, vomiting, dry mouth, flatulence, cramps and pain in the abdomen, diarrhea.

From the nervous system: headache, dizziness, fainting, drowsiness, fatigue, convulsions.

From the immune system: allergic reactions, angioedema, allergic dermatitis.

From the skin and subcutaneous tissues: skin rash, urticaria, itching.

From the side of metabolism: increased excretion of potassium, sodium and other electrolytes, dehydration.

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: when taking high doses, diarrhea, dehydration, lowering of arterial pressure, disturbance of water and electrolyte balance, hypokalemia, convulsions are possible. Chronic overdose can lead to chronic diarrhea, hypokalemia, secondary hyperaldosteronism, and urolithiasis.

Treatment:    gastric    lavage,    correction    of water and electrolyte imbalance, antispasmodics, symptomatic therapy.

Storage conditions

Store in a dry and dark place, at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use aſter the expiry date stated on the packaging.

Vacation conditions

Dispensed without a prescription.

Release form

100 ml bottle, measuring syringe with instructions for use in a cardboard box.