Instructions for the medical use of the medicinal product

FRILAX

Tradename

Frilax, Фрилакс

International non-proprietary name

Sodium Picosulfate, Натрия Пикосульфат

Compound

Each tablet contains:

active substance: sodium Picosulfate BP ten mg

excipients : Q. S

Dosage form

Tablets.

Pharmacological properties

Mechanism of action

Picosulfuric acid, like sodium picosulfate, is contact laxative. Picosulfate sodium inhibits suction water and electrolytes and increase their secretion into the intestinal lumen 3. He hydrolyzed bacterial enzyme thick guts sulfatase 3 With active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane ( BHPM ), which acts directly on the colonic mucosa, stimulating peristalsis thick intestines.

Indications to application

Sodium picosulfate/oxide solution magnesium/citric acids used for cleaning bowels before surgery or certain procedures

ramie (such as colonoscopy, X-ray). It is a laxative that draws large amounts of water into the intestines and stimulates the colon. it causes watery chair (diarrhea).

Contraindications

• •         decline functions kidneys.
• •         diarrhea.
• •         high amount magnesium in blood.
• •         low amount sodium in blood.
• •         dehydration.
• •         appendicitis.
• •         blockage stomach or intestines.
• •         convulsions.

Special instructions and precautions

Special Warnings:

Long-term excessive use of Ferring's sodium picosulfate can lead to fluid and electrolyte imbalance and hypokalemia. Caution should be exercised in patients who have recently undergone gastrointestinal surgery. tract, a also at patients With kidney failure, heart disease, or inflammatory diseases intestines. Ferring sodium picosulfate should use with caution in patients taking drugs that may affect water and / or electrolyte balance, for example. diuretics, corticosteroids, lithium.

Precautionary measures:

Important, to your doctor carefully checked your progress or your child's progress on subject of any problems or unwanted effects, which _ may to be caused this medicine. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor right away if you or your child has decreased urination, dizziness, headache, or vomiting. These could be symptoms of losing too much liquids in body (dehydration). If you or your child experience severe bloating, bloating, or abdominal pain after the first dose, stop taking this medicine or delay the second doses before improvements your symptoms.

This medicine may cause fluid imbalance and electrolytes, what maybe lead to serious unwanted effects, including problems With cordial rhythm convulsions or Problems with kidneys. Your doctor must correct these imbalances before you or your child starts taking this medicine. Also drink plenty of clear liquids, prescribed doctor.

Do not drink alcohol with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or over-the-counter (OTC [OTC]) medicines, as well as herbal or vitamin supplements.

Side effect

MedDRA organ class Common (1/100 to 1/10) Uncommon (1/1000 to 1/100) Rare (1/10000 to 1/1000) Not known (cannot be estimated from the available data) Immune system disorders Hypersensitivity ( including y angio-neurotic edema and skin reactions) Gastrointestinal disorders Discomfort in stomach, pain in belly, spasms in stomach and diarrhea Nausea and vomiting Flatulence Nervous system disorders Headache, dizziness, dizziness and fainting.

Influence on the ability to drive vehicles and mechanisms Sodium picosulfate does not affect or has a slight effect on the ability to drive vehicles and work with mechanisms.

Interaction with other drugs

Concomitant use of diuretics or adrenocorticosteroids may increase the risk of electrolyte imbalance when taken excessive doses sodium picosulfate Ferring. electrolyte imbalance maybe lead to hypersensitivity to cardiac glycosides or an increased risk of lithium poisoning. Concomitant use of antibiotics may reduce the laxative effect of sodium picosulfate. Ferring. Picosulfate sodium Ferring can increase speed gastrointestinal transit. So the way absorption others oral medications (eg. antiepileptic, contraceptives, antidiabetics, antibiotics) change in flow period treatment.

Dosage and administration

For oral use.

Sodium picosulfate acts for approximately 6-12 hours; so it's best to take before bedtime. If your child has been prescribed sodium picosulfate, follow the instructions carefully as the doctor will adjust the dose in accordance With age and your needs child.

Overdose

Symptoms: When taking high doses, diarrhea, abdominal cramps and clinical significant the loss potassium and others electrolytes. Except Togo, reported about cases ischemia colonic mucosa in relation to picosulfate doses sodium, much higher than recommended for the routine treatment of constipation. Laxatives at chronic overdose can cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism and stones in kidneys. Damage renal tubules, metabolic alkalosis and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse.

Terms storage

Keep at temperature below 30 ° C protect from the world and moisture.

Keep out of the reach of children!

Best before date

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

Holiday conditions

Released by prescription.

Release form

2 blister Alu - Alu 10 tablets in a carton with insert. those. 2 x 10 tablets