PICOPREP POWDER EFFERVESCENT FOR SOLUTION INSIDE 16.1

Trade name of the drug:

PIKOPREP®

Dosage Form:

powder effervescent to prepare a solution for oral administration.

Composition:

1 bag contains:

active substances: anhydrous citric acid 12 g, Magnesium oxide 3.5 g, sodium picosulfate monohydrate 10.0 mg;

Excipients: potassium bicarbonate 0.5 g, sodium saccharinate dihydrate 0.06 g, orange flavor * 0.06 g

*The composition of the orange flavor includes dry orange extract, lactose, xanthine gum, Ascorbic acid ibutylhydroxyanisole (E320).

Description: white crystalline powder with a faint orange odor.

Description of the solution: white or white with a yellowish tinge opaque solution with a characteristic orange odor.

Pharmacotherapeutic group:

laxative

Pharmacological properties

Pharmacodynamics

The active ingredients of the drug Picoprep® sodium picosulphate, which has a local laxative effect in the colon, and magnesium citrate, which is formed from citric acid and magnesium oxide when the powder is dissolved, and acts as an osmotic laxative by retaining water in the colon. Intestinal cleansing is due to a powerful “scrubbing” effect in combination with stimulation of peristalsis,what is necessary for carrying out radiological or endoscopic (colonoscopy) studies and surgical procedures.

Pharmacokinetics

All active ingredients have a local action in the colon and are practically not absorbed.

Indications for use

Colon cleansing before radiographic or endoscopic (colonoscopy) examinations and surgical procedures.

The drug is not used as a regular laxative!

Contraindications

• hypersensitivity to one of the components of the drug,
• chronic heart failure
• dehydration,
• weakness of gastric motility,
• peptic ulcer and 12 duodenal ulcer,
• toxic colitis
• toxic megacolon,
• intestinal obstruction
• nausea and vomiting,
• severe renal impairment,
• rhabdomyolysis
• hypermagnesium,
• acute surgical abdominal conditions: acute appendicitis, diagnosed or suspected obstruction or perforation of the gastrointestinal tract,
• recent gastrointestinal surgery,
• lactose intolerance, lactase deficiency and glucose-galactose malabsorption,
• Pregnancy (I trimester),
• Children's age up to 9 years.

If you have one of these diseases, be sure to consult with your doctor before taking the drug.

Carefully

It should be used with caution in patients with impaired renal function, heart disease,inflammatory bowel diseases in patients taking drugs that affect the water and electrolyte balance (diuretics, corticosteroids, lithium drugs), in the elderly (65 years and older) and weakened patients, during breastfeeding, during pregnancy (II and III trimesters ), as well as in patients at risk of developing hypokalemia.

Use during pregnancy and during breastfeeding

Clinical data on the use of the drug Picoprep® during pregnancy are absent. But since sodium picosulphate has a stimulating effect on intestinal motility, it is not recommended to use the drug in the first place of pregnancy. Taking the drug during the II and III trimesters of pregnancy is possible only after a thorough assessment of the need and risks. Caution is prescribed during the breastfeeding period, although neither sodium picosulfate nor magnesium citrate does not penetrate into breast milk.

Dosage and administration

For oral administration. The day before the procedure is recommended to reduce the number of meals. In order to avoid dehydration while taking the drug Picoprep®It is recommended to observe drinking mode.

The contents of one sachet are dissolved in 150 ml of water, stirred for 2-3 minutes, cooled to an acceptable temperature and drunk.

Adults and children over 9 years old

If the procedure is scheduled for the first half of the day:

• The contents of the first sachet are taken after lunch or in the early evening (16 - 18 hours), drinking at least 5 glasses of 250 ml of water or clear liquid (water, non-carbonated soft drinks, tea, coffee, fruit juice without pulp).
• The contents of the second sachet take overnight (22 - 24 hours), drinking at least 3 glasses of 250 ml of water or clear liquid. The last glass can be drunk no later than 1 hour before the procedure.

If the procedure is scheduled for the afternoon:

• The contents of the first sachet are taken in the evening (at 17 - 21 hours) on the day preceding the procedure, drinking at least 5 glasses of 250 ml of water or a clear liquid.

• The contents of the second sachet are taken in the morning (5–9 hours before the procedure), drinking at least 3 glasses of 250 ml of water or clear liquid. The last glass can be drunk no later than 1 hour before the procedure.

Side effect

Adverse reactions after taking Picoprep® presented in the table:

If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects not mentioned in the instructions, notify your doctor.

Overdose

Overdose can lead to profuse diarrhea and, as a result, to dehydration. Measures should be taken to restore water and electrolyte balance.

Interaction with other drugs

Drug Picoprep® may affect the absorption of oral medications for continuous use (antiepileptic drugs, hypoglycemic drugs, oral contraceptives, antibiotics). For example, there are cases of epileptic seizures in connection with taking the drug Picoprep® against the background of previously compensated antiepileptic drugs for epilepsy. In such patients, the drug Picoprep®should be used with caution.

Simultaneous use of the drug Picoprep® with diuretics, corticosteroids or cardiac glycosides increases the risk of developing hypokalemia.

Simultaneous use of the drug Picoprep® with nonsteroidal anti-inflammatory drugs (NSAIDs), as well as with drugs that can cause the syndrome of inadequate secretion of antidiuretic hormone or salt-losing syndrome (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, antipsychotic drugs and carbamazepine) increases the risk of impaired serotonin reuptake inhibitors, antipsychotic drugs and Carbamazepine , increases the risk of water withdrawal inhibitors, antipsychotic drugs and carbamazepine, increases the risk of impaired water, serotonin reuptake inhibitors, antipsychotic drugs and carbamazepine, increases the risk of impaired water absorption serotonin reuptake inhibitors, antipsychotic drugs and carbamazepine, increases the risk of impaired water withdrawn serotonin reuptake inhibitors, antipsychotic drugs and carbamazepine, increases the risk of impaired water withdrawn serotonin reuptake inhibitors, antipsychotic drugs, and carbamazepine.

special instructions

The drug is not intended for use as a regular laxative.

In patients with signs of hyponatremia, it is necessary to take urgent measures to restore water and electrolyte balance.

The drug contains potassium bicarbonate, which should be taken into account in patients with a low potassium diet.

The composition of the orange flavoring drug Picoprep® lactose is included. Therefore, this drug is not recommended for patients with lactose intolerance , Lappa lactase deficiency or glucose-galactose malabsorption.

Patients with a significant reduction in renal function may increase plasma magnesium levels. In this case, you should use another drug.

Insufficient intake of water and electrolytes can cause a clinically significant deficiency in these components, especially in debilitated patients.

The period of preparation for bowel cleansing should not exceed 24 hours; a longer period increases the risk of impaired water and electrolyte balance.

Against the background of taking other powdered laxatives, the effectiveness of the drug Picoprep® going down.

Influence on ability to drive vehicles and mechanisms

In connection with the possibility of the development of side effects from the nervous system, caution should be exercised when driving and engaging in other potentially hazardous activities that require an increased concentration of attention and quickness of psychomotor reactions.

Release form

Powder effervescent for the preparation of oral solution.

16.1 g of powder in a four-layer (paper / polyethylene / aluminum foil / surlyn) bag. On 2 bags together with the application instruction in a pack cardboard.

Storage conditions

Store at a temperature not higher than 25aboutWITH.

Keep out of the reach of children.

Shelf life

3 years.

Do not apply after the expiration date.

Use immediately after opening the bag. The opened, but unused bag is subject to destruction.

Pharmacy sales terms

Over the counter.