about the product

Powder for preparation of an oral solution.

Component A: White to yellow powder with a characteristic lemon scent.

Component B: White to light brown powder.

Specifications

Name
Entrilax®-Pro
Dosage form
Powder for preparation of an oral solution
Nosological classification
Laxatives
INN
Ascorbic acid+Macrogol+Sodium Ascorbate+Sodium Sulfate+[Potassium Chloride+Sodium chloride]
Dosages
There is no dosage
ATC code
A06AD65
Active substance
Active ingredients of component A:
macrogol + sodium sulfate + sodium chloride + potassium chloride

Active ingredients of component B:
ascorbic acid + sodium ascorbate
Pharmacotherapeutic group
General therapy drugs

use

Always take the drug in full accordance with the leaflet or with the recommendations of your doctor or pharmacy employee. If in doubt, consult your doctor or a pharmacy employee.

Recommended dose:
The recommended dose is two liters of solution (see subsection "Route and (or) method of administration").

Before conducting a diagnostic examination (for example, endoscopic, X-ray and other intestinal examinations) and surgical intervention, it is necessary to undergo an important intestinal preparation process, which includes 3 stages:
1. Follow a special diet.
2. The choice of the drug intake regimen depending on the time of the study or operation.
3. Carrying out the intestinal cleansing process using the drug Entrilax-Pro.
Detailed information on each stage is provided below.

1. Compliance special the diet Power supply
3 days before the examination or surgery, it is important to follow a special diet.

Allowed: Forbidden:
All protein foods: All plant foods:
- boiled meat and poultry  - vegetables,
 (except sausage products), - fruits,
- low-fat fish varieties, - berries,
- low-fat fermented dairy products - greenery,
  products - cereals
 "eggs." - nuts,
- porridge,
 Jelly, sugar, honey. - bread.

Liquids: Liquids:
- transparent broths, - colored juices,
- tea without milk, - alcohol,
- coffee without milk, - carbonated drinks.
- compotes without berries,
- juice without pulp,
- non-alcoholic unpainted drinks, All products that are not included in the allowed list.
- water.

2. Choosing an admission scheme the drug Entrilax-Pro in depending on time carrying out research or operations

Before surgery, a single-stage evening regimen of Entrilax-Pro is used.

Before conducting a diagnostic study, it is necessary to choose the most appropriate regimen for taking Entrilax-Pro with your doctor, depending on the time of the procedure and your daily activity.

Time researches Admission scheme of the drug
08:00 – 10:00
The diet Power supply behind 3 of the day before carrying out researches:
according to the list of permitted products and liquids.
The diet Power supply behind 2 of the day before carrying out researches:
according to the list of permitted products and liquids.
The diet Power supply The day before of the day researches:
breakfast: according to the list of permitted products and liquids;
lunch and dinner: only allowed ones
transparent liquids.
Single-stage evening scheme*
Day The day before researches:
19:00 – 20:00 take the first liter of the drug solution;
21:00 – 22:00 take the second liter of the drug solution.
After each liter of the drug taken, you need to drink 500 ml of the allowed liquid.
10:00 – 14:00
The diet Power supply behind 3 of the day before carrying out researches:
according to the list of permitted products and liquids.
The diet Power supply behind 2 of the day before carrying out researches:
according to the list of permitted products and liquids.
Diet on the eve of the study day:
breakfast and light lunch before 1 p.m.: according to the list of permitted foods and liquids;
Dinner: only allowed clear liquids.
Two-stage scheme*
Day The day before researches:
20:00 – 21:00 take the first liter of the drug solution.
Day researches:
06:00 – 07:00 take the second liter of the drug solution.
After each liter of the drug taken, you need to drink 500 ml of the allowed liquid.
 14:00 – 19:00
Food ration 3 days before the event researches:
according to the list of permitted products and liquids.
Food ration 2 days before the event researches:
according to the list of permitted products and liquids.
The diet on the eve of the day researches:
breakfast, lunch and light dinner until 18:00: according to the list of permitted products and liquids.
In research day with morning:
only allowed clear liquids.
    Single-stage morning scheme*
Day researches:
08:00 – 09:00 take the first liter of the drug solution;
10:00 – 11:00 take the second liter of the drug solution.
After each liter of the drug taken, you need to drink 500 ml of the allowed liquid.

* If necessary, the time of taking Entrilax-Pro can be adjusted depending on your daily activity and travel time to the clinic, observing the specified time intervals.

3. Carrying the process clearances the intestines with with help of the drug Entrilax-About

The package of Entrilax-Pro contains two sachets (sachets or sticks) A and two sachets (sachets or sticks) B, from which a solution is prepared for oral administration. Regardless of the patient's weight, the total dose of Entrilax-Pro for high-quality intestinal cleansing is 2 liters of the drug solution.

In case carrying out procedures under general anesthesia:
With two-stage, one–stage morning and one-stage evening dosing regimens, the intake of Entrilax-Pro and other liquids (according to the list of permitted ones - see above) must be stopped at least 2 hours, but no more than 4 hours before the start of the procedure.

In case carrying out procedures without anesthesia: With a two-stage dosing schedule, the intake of Entrilax–Pro and other liquids (according to the list of permitted ones - see above) must be stopped at least 1 hour, but no more than 4 hours before the start of the procedure.

With single-stage morning and single–stage evening dosing regimens, Entrilax-Pro should be discontinued at least 2 hours, but not more than 4 hours before the start of the procedure, and other liquids (according to the list of permitted ones - see above) should be discontinued at least 1 hour, but not more than 4 hours before the start of the procedure. an hour before the start of the procedure.

The criterion of readiness for diagnostic examination or surgical intervention is the appearance of a liquid transparent or almost transparent, slightly colored stool.

When taking the Entrilax-Pro solution at home, it is necessary to take into account the appropriate time interval for a trip to the clinic for the procedure. Frequent loose stools usually appear within 1 hour after the start of taking each liter of the Entrilax-Pro solution and end, as a rule, after 1-2 hours. During the period of taking the drug, the frequency of bowel movements may increase up to 12-15 times.

Patients with impaired renal function
If you have severe renal insufficiency (creatinine clearance <30 ml/min), care should be taken when taking this medication.

Patients with impaired renal function or patients who follow a controlled potassium diet should take into account that the drug contains 14.2 mmol of potassium per 1 liter of solution.

Route and (or) method of administration
The drug is intended for oral administration.

1) Preparation of the first liter of Entrilax-Pro solution:
The contents of one sachet (sachet or stick) are required A and one sachet (sachet or
stick) B completely dissolve in a small amount of non-carbonated drinking water
at room temperature, bring the volume of the solution with water to 1 liter and mix.


2) Preparation of the second liter of Entrilax-Pro solution:
Repeat the algorithm for preparing the drug solution from point 1 (see above) using
The remaining sachet (sachet or stick) A and a sachet (sachet or stick) B.
The prepared solution of Entrilax-Pro should be drunk within 1-2 hours.,
for example, 1 cup every 15-30 minutes.
important: while taking Entrilax-Pro, it is strongly recommended
additionally, use 1 liter of another liquid: non-carbonated water, broth
(clear, strained), fruit juice without pulp, soft drinks, tea without
milk (you can add sugar or honey).

Help

Package leaflet

The Entrilax-Pro preparation contains active ingredients: macrogol + sodium sulfate + sodium chloride + potassium chloride (in sachet A) and ascorbic acid + sodium ascorbate (in sachet B), which belong to the group of laxatives. Oral administration of an electrolyte solution based on macrogol increases peristalsis, causing moderate diarrhea, which results in rapid emptying of intestinal contents. Sodium sulfate and ascorbic acid have an osmotic effect that causes a laxative effect. Macrogol increases the volume of fecal matter, which leads to increased intestinal motility. The electrolytes included in the preparation, together with additional intake of fluids, prevent disruption of the water-electrolyte balance.

Entrilax-Pro is used in adults over the age of 18 to prepare for diagnostic examinations (for example, endoscopic, X-ray and other intestinal examinations) and surgical procedures requiring bowel movement.

If the laxative effect is not achieved, or you feel worse, you should consult a doctor.

If you think that you took more of the drug than you should have, or did not dilute the drug.
According to the instructions, if you have not drunk an additional amount of water or clear liquid, inform your doctor immediately and drink enough water or clear liquid to avoid dehydration. In this case, you may have
symptoms such as severe diarrhea and electrolyte disturbances (changes in blood salt levels
the body).

If you have any questions about taking the drug, contact your doctor or healthcare professional.
pharmacies.

Like all medications, Entrilax-Pro can cause undesirable reactions, but they do not occur in everyone.
Stop taking Entrilax-Pro and seek medical attention immediately.
assistance in case of occurrence of one of the following signs of serious
undesirable reactions:

The frequency is unknown (based on the available data, it is impossible to estimate):
• difficulty breathing, feeling of lack of air, feeling of pressure in the chest, skin rash, itching, swelling of the lips, tongue, face, sudden weakness (anaphylactic reactions);
• swelling of the face, neck and larynx, difficulty breathing and swallowing (angioedema).

Other possible adverse reactions that may occur when taking the drug Entrilax-Pro.

Very often (may occur in more than 1 person out of 10):
• abdominal pain, nausea, bloating, irritation in the anus;
• malaise, fever.

Often (may occur in no more than 1 person out of 10):
• Sleep disorders;
• dizziness;
• headache;
• vomiting;
• digestive disorders in the esophagus and stomach (dyspepsia);
• chills;
• thirst;
• Hunger.

Infrequently (may occur in no more than 1 person out of 100):
• difficulty swallowing;
• deviations from the norm of functional liver tests;
• discomfort.

The frequency is unknown (based on the available data, it is impossible to estimate):
• respiratory disorders (dyspnea);
• dehydration (dehydration), electrolyte disturbances, including decreased blood bicarbonate levels, increased blood calcium levels (hypercalcemia) and decreased blood calcium levels (hypocalcemia), decreased blood phosphate levels (hypophosphatemia), decreased blood potassium levels (hypokalemia) and decreased blood sodium levels (hyponatremia) and changes in blood chloride levels;
Seizures associated with severe hyponatremia (decreased blood sodium levels);
• short-term increase in blood pressure;
• abnormal heart rhythm (arrhythmia), rapid heartbeat;
• bloating (flatulence), vomiting;
• urticaria, itching, rash, redness of the skin (allergic skin reactions).

Do not take Entrilax-Pro if:
• You are allergic to macrogol, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate or any other components of the drug listed in section 6 of the leaflet;
• You have a gastric emptying disorder (gastroparesis);
• You have an intestinal obstruction;
• You have a through hole (perforation) in the wall of the gastrointestinal tract (GIT) or risk of perforation;
• You have a hereditary disease associated with impaired metabolism of amino acids, mainly phenylalanine (phenylketonuria) (due to the content of aspartame);
• You have a deficiency of glucose-6-phosphate dehydrogenase (due to the content of ascorbic acid in the composition);
• You have inflammatory diseases of the small and large intestine (including ulcerative colitis, Crohn's disease) or pathological enlargement of the colon (megacolon);
• You are unconscious.

Special instructions and precautions
Before taking Entrilax-Pro, consult with your doctor or a pharmacy employee. It is especially important to inform if:
• You have a tendency to throw food into the respiratory tract (aspiration) or to passively throw food from the stomach or esophagus into the oral cavity;
• You have trouble swallowing;
• You have impaired consciousness;
• You have dehydration (signs of which may include dry mouth, thirst, headache, dizziness, urination less frequently than usual, extreme fatigue, palpitations, and confusion);
• You have severe heart failure;
• You have severe renal insufficiency (creatinine clearance <30 ml/min);
• You have severe acute inflammatory bowel disease;
• You have abdominal pain;
• You have heart failure or heart disease, including high blood pressure, irregular or rapid heartbeat;
• You have thyroid disease.

The drug will be administered to you under medical supervision if you are elderly, weakened or exhausted, if you are prone to throwing food into the respiratory tract (aspiration) or to passively throwing food from the stomach or esophagus into the oral cavity, if you have impaired consciousness or if the drug is administered to you through a nasogastric tube.

If you are weakened or have serious kidney or heart disease, or if you are at risk of changes in body salt levels (electrolyte disturbances), your doctor may decide to conduct special monitoring before and after the procedure.

If you experience swelling, shortness of breath, fatigue, or heart failure while using the drug, contact your doctor immediately.

If you experience symptoms such as severe flatulence, bloating, abdominal pain, or any other reactions that make it difficult to continue taking the drug, stop taking the drug and contact your doctor immediately.

If you experience symptoms such as sudden abdominal pain, rectal bleeding, nausea, vomiting, weakness, or fever while using the drug, contact your doctor immediately.

You should follow the instructions for using Entrilax-Pro exactly and drink as much water or clear liquid as you need to avoid dehydration.

Tell your doctor that you are taking, have recently taken, or may start taking any other medications.

Diarrhea caused by taking Entrilax-Pro can lead to significant malabsorption of other concomitantly administered medications.

If you are taking other medications orally (for example, medications to prevent pregnancy (oral contraceptives)), you should not take them an hour before, during, and an hour after taking Entrilax-Pro, as they can be eliminated from the gastrointestinal tract without being absorbed.

Entrilax-Pro can interact with starch-based food thickeners. Macrogol reduces the thickening effect of starch and dilutes drugs that should remain thick for patients with swallowing problems.

The holder of the registration certificate
Russian Federation
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640 25 28
Email: reception@promomed.pro
Manufacturer
Russian Federation
JSC "Biochemist"
Address: 15A Vasenko str., Saransk, Republic of Mordovia, 430030
Message about adverse reactions
Russian Federation
Federal Service for Healthcare Supervision
Address: 109012, Moscow, Slavyanskaya square, 4, building 1
Phone number: +7 800 550 99 03
Email: pharm@roszdravnadzor.gov.ru or npr@roszdravnadzor.gov.ru
Website: www.roszdravnadzor.gov.ru



If you are pregnant or breastfeeding, assume that you have become pregnant, or are planning pregnancy, consult your doctor before using the drug.
or a pharmacy employee.
Pregnancy
Entrilax-Pro should be taken only in cases where the intended benefit is
the risk to the mother exceeds the potential risk to the fetus.
Breastfeeding
Entrilax-Pro should be taken only in cases where the intended benefit is
the risk to the mother exceeds the potential risk to the child.

Do not give Entrilax-Pro to children aged 0 to 18 years, because the effectiveness of
and safety in this age group has not been established.

The drug Entrilax-Pro has no or negligible effect on the ability to drive vehicles and work with mechanisms. During the course of preparation for medical manipulations with Entrilax-Pro, it is recommended to refrain from driving vehicles and working with mechanisms (see the section "Possible adverse reactions").

Keep the medicine out of the reach of children.

Do not take the drug after the expiration date (shelf life) indicated on the carton after "Good before".

The expiration date is the last day of the given month.

Store at a temperature not exceeding 25 ° C. The reconstituted solution should be stored at a temperature of
not higher than 8 °C.

Do not dispose of the drug in the sewer. Ask the pharmacy employee how to dispose (destroy) drugs that are no longer needed. These measures will allow
protect the environment.