MOVIPREP powder 2Sachets oral solution (A + B)

MOVIPREP powder 2Sachets oral solution (A + B) View larger

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indications:


  • Bowel preparation to endoscopic or radiological, Preparation for digestive endoscopy , find the composition and dosage of MOVIPREP powder oral solution 2Sachets (A + B) in our pharmacy online bio: sodium chloride

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For warnings, precautions for use and against-indications, please refer to the manual of MOVIPREP powder oral solution 2Sachets (A + B) without prescription. Description of MOVIPREP powder oral solution 2Sachets (A + B)

molecules:


  • 79949: MOVIPREP powder for oral solution in Bags A + B (ITEM -)

  • citral (Molecule - Excipients)

  • sodium chloride (Molecule - Active Substance)

  • potassium chloride (Molecule - Active Substance)

  • macrogol 3350 (Molecule - Active Substance)

  • xanthan gum (Molecule - Excipients)

  • maltodextrin (Molecule - Excipients)

  • sodium ascorbate (Molecule - Active Substance)

  • Lemon oil (Molecule - Excipients)

  • aspartame (Molecule - Excipient with known effect)

  • lemon aroma (Molecule - Excipients)

  • Glucose (Molecule - Excipient with known effect)

  • ascorbic acid (Molecule - Active Substance)

  • alpha-tocopherol (Molecule - Excipients)

  • anhydrous sodium sulfate (Molecule - Active Substance)

  • acesulfame potassium (Molecule - Excipients)

  • lime oil (Molecule - Excipients)

MOVIPREP powder for oral solution 2Sachets indication (A + B)

indications:


  • Bowel preparation to endoscopic or radiological, Preparation for digestive endoscopy , Directions for use and dosage of MOVIPREP powder oral solution 2Sachets (A + B) Presentation of MOVIPREP powder oral solution 2Sachets (A + B) Warnings Warning on drugs, the drug MOVIPREP powder 2Sachets oral solution (A + B) without order is not a product like any other. Read the package leaflet before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products. Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose. Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products. Pharmacovigilance: Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

MOVIPREP

Preparation for colon exams

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

MOVIPREP: powder for oral solution (lemon flavoring); box of 2 sachets A and 2 sachets B.
Refunded at 65%. - price: 9,22 euro (s).

Norgine Pharma Laboratory

COMPOSITION (summary)
p sachet A p sachet B
Macrogol (polyethylene glycol) 3 350 100 g
Anhydrous sodium sulfate 7.5 g
Sodium Chloride 2.691 g
Potassium chloride 1.015 g
aspartame +
Ascorbic acid 4.7 g
Sodium ascorbate 5.9 g

INDICATIONS (summary)
This medicine contains an osmotic laxative . It retains water in the intestine and causes diarrhea that empties the digestive tract.
It is used to purge the intestine before an endoscopic examination (colonoscopy) or radiological examination (barium enema).
CONTRAINDICATIONS (summary)
This treatment should not be used in the following cases:
  • disease responsible for a state of extreme fatigue,
  • serious illness, responsible for fragility or obstruction of the intestine,
  • deficit in G6PD ,
  • phenylketonuria (presence of aspartame).
WARNING (Contents)
In the elderly or frail elderly, it is sometimes preferable to carry out the preparation of the intestine in the hospital or in the clinic the day before the examination.
DRUG INTERACTIONS (summary)
Diarrhea caused by the administration of this preparation may decrease the absorption of many drugs. Ask your doctor for advice if you are following another treatment: a delay in the catch schedule may be necessary.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known: only your doctor can evaluate the possible risk of its use in your case.
DIRECTIONS FOR USE AND DOSAGE (summary)
Dissolve the contents of one sachet A and one sachet B in 1 liter of water (mineral or tap).
The solution obtained must then be drunk within 1 to 2 hours.

Usual dosage:

  • Adult over 18 years: 2 liters solution before the examination:
  • in one case, in the evening preceding the examination;
  • in 2 cases, 1 liter the night before and 1 liter early in the morning before the examination. The last drink should be taken at least 1 hour before the examination.
It is recommended to drink in addition 1 liter of other liquid: water, soup, soft drink, fruit juice ...
TIPS (summary)
The absorption of the prescribed volume is generally neither simple nor pleasant, but a correct intestinal preparation determines the quality of the examination which will be carried out by the doctor.
A light, low fiber diet (avoid fruits and vegetables) is usually followed in the days before the test.
POSSIBLE ADVERSE EFFECTS (summary)
Diarrhea, intense, corresponds to the desired effect and is not an undesirable effect.
Nausea, vomiting, bloating, anal irritation, sleep disorders.
Very rarely: allergic reaction ( urticaria , edema ...).


GLOSSARY (summary)


G6PD
glucose-6-phosphate dehydrogenase deficiency, an enzyme normally present in the red blood cell. His congenital absence (deficiency) is responsible for a disease called favism; it prohibits the use of certain drugs.


osmotic laxative
Laxative to make stools more liquid by retaining water in the contents of the intestine. It is devoid of toxicity.


edema
Accumulation of water or lymph causing localized swelling.


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 22/08/2017

Name of the medicinal product

MOVIPREP, powder for oral solution

Macrogol 3350, anhydrous sodium sulfate, sodium chloride, potassium chloride

Ascorbic acid and sodium ascorbate

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

· Keep this leaflet. You might need to read it again.

· If you have any further questions, ask your doctor or pharmacist.

· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

What is in this leaflet?

1. What is Moviprep, powder for oral solution and in which cases it is used?

2. What information should be known before taking Moviprep powder for oral solution?

3. How to take Moviprep powder for oral solution?

4. What are the possible side effects?

5. How to store Moviprep powder for oral solution?

6. Package contents and other information.

1. WHAT IS MOVIPREP Powder for oral solution AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: A06AD.

Moviprep is a lemon flavored osmotic laxative. The box contains four sachets: two large sachets (sachet A) and two small sachets (sachet B). You must use the four bags for treatment.

Moviprep is indicated in adults in intestinal washing prior to any examination requiring a clean intestine (eg endoscopic or radiological exploration).

Moviprep works by emptying your intestines of their contents, so you should expect liquid stools.

2. BEFORE YOU TAKE MOVIPREP, powder for oral solution?

Never take Moviprep, powder for oral solution:

· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of Moviprep (mentioned in section 6).

· If you suffer from intestinal obstruction.

· If you suffer from intestinal perforation.

· If you have a gastric emptying disorder.

· If you have intestinal paralysis (often appears after abdominal surgery).

· If you are suffering from phenylketonuria (hereditary inability to use a specific amino acid). Moviprep is a source of phenylalanine.

· If your body does not produce enough glucose-6-phosphate dehydrogenase.

· If you are in a toxic megacolon condition (severe complication of acute colitis).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Moviprep powder for oral solution .

If you are fragile or suffer from severe clinical failure, you should be aware of the list of possible side effects listed in section 4. Contact your doctor or pharmacist if you are concerned.

Tell your doctor or pharmacist if you experience any of the following:

· If you need to thicken the liquids in order to swallow them.

· A tendency to regurgitate drinks, food or acid from the stomach.

· Renal disease.

· Heart failure or heart disease such as high blood pressure, irregular heartbeat or palpitations.

· Thyroid disease.

· Dehydration.

· Severe outbreaks of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Moviprep should not be administered unattended in patients with alertness.

Children and Youth

Moviprep is not recommended for children under 18 years of age.

Other medicines and Moviprep, powder for oral solution

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.

If you are taking other medicines, take them at least one hour before you ingest Moviprep or at least an hour later as they can be eliminated more quickly from the digestive tract and no longer exercise their therapeutic effect.

Moviprep, powder for oral solution with food and beverages

Do not take any more solid food from the moment you start taking Moviprep until the end of the test.

During the time you take Moviprep, you should continue to drink plenty of fluid. The fluid contained in Moviprep after reconstitution does not replace your usual water intake. Sufficient water intake must be maintained.

Pregnancy and breast feeding

There is no data on the use of Moviprep during pregnancy and lactation. Moviprep should only be used if your physician considers this to be essential. If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Moviprep does not affect your ability to drive or use machines.

Moviprep powder for oral solution contains aspartame (E951), sodium and potassium

This drug contains 56.2 mmol of absorbable sodium per liter. To be taken into account in patients controlling their sodium dietary intake.

This medicine contains 14.2 mmol of potassium per liter. To be taken into account in patients with renal insufficiency or in patients controlling their dietary intake of potassium.

This medicine contains aspartame, a source of phenylalanine, which can be dangerous for people with phenylketonuria.

3. HOW TO TAKE MOVIPREP, powder for oral solution?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

The recommended dose is 2 liters of solution to be prepared in the following manner:

The box contains two transparent bags and each bag contains two sachets: one sachet A and one bag B. Each pair of sachets (sachet A and sachet B) is dissolved in water in order to obtain a liter of solution. The assembly will thus reconstitute two liters of solution Moviprep.

Before you take Moviprep, read the following instructions carefully.

You must know :

· When to take Moviprep?

· How to prepare Moviprep?

· How to take Moviprep?

· What you should expect with Moviprep

When to take Moviprep?

Always take this medication exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are unsure. Your treatment with Moviprep must be completely completed before the exam.

This preparation can be taken either in two steps or as a single dose as described below:

For examinations that require you to fall asleep (under general anesthesia):

1. In two instances: a liter of Moviprep ingested the night before the exam and a liter of Moviprep ingested early in the morning on the day of the exam. Ensure that the taking of Moviprep and any other clear fluid is stopped at least two hours before the start of the examination.

2. In single dose: two liters of Moviprep ingested the night before the exam or two liters of Moviprep on the morning of the exam. Ensure that the taking of Moviprep and any other clear fluid is stopped at least two hours before the start of the examination.

For exams that do not require you to fall asleep (without general anesthesia):

1. In two instances: a liter of Moviprep ingested the night before the exam and a liter of Moviprep ingested early in the morning on the day of the exam. Ensure that the take of Moviprep and any other clear fluid is stopped at least one hour before the start of the test.

2. In single dose: two liters of Moviprep ingested the night before the exam or two liters of Moviprep on the morning of the exam. Make sure that the plug of Moviprep is stopped at least two hours before the start of the test. Ensure that any other clear fluid is stopped at least one hour before the start of the test.

Important: Do not eat solid foods from the time you take Moviprep until the end of the test .

How to prepare Moviprep?

· Open a transparent bag and remove the sachets A and B.

· Pour at the same time 1 sachet A and 1 sachet B into a graduated container that can contain 1 liter.

·


Fill with water to the 1 L mark of the container. It is then necessary to mix until complete dissolution of the powder (this can take up to 5 minutes).

How to take Moviprep?

This reconstituted solution should be drunk over a period of one to two hours. It is advisable to drink a glass of solution every 10 or 15 minutes.

When the time comes, prepare and drink the second liter of Moviprep using the sachets A and B of the remaining bag.

During treatment, it is advisable to drink an extra liter of clear liquid to prevent any feeling of thirst or dehydration. Water, clear soup, fruit juice without pulp, non-alcoholic drinks, tea and / or coffee without milk can be consumed. This liter of extra liquid can be taken at any time during your preparation.

What you should expect with Moviprep

When you start to drink the preparation, it is important that you stay close to the toilet. At some point you will begin to evacuate stools more or less liquid. This is normal and indicates that the preparation is in the process of acting. The evacuation will stop shortly after finishing the preparation.

If you follow these instructions, your bowel will be clean and this will promote the success of the exam. Allow enough time between your last glass of liquid and the time of the appointment at the examination center.

If you take more Moviprep, powder for oral solution than you should have

Immediately consult your doctor or pharmacist.

If you take more Moviprep than required, you may have excessive diarrhea that can lead to dehydration. Drink plenty of liquid, including fruit juices. If you are concerned, contact your doctor or pharmacist.

If you forget to take Moviprep, powder for oral solution

If you forget to take Moviprep, take the prescribed dose as soon as you remember. If you have missed several hours, contact your doctor or pharmacist for advice. If you are taking Moviprep twice, it is important that you have taken the entire Moviprep preparation at least one hour before the examination (without general anesthesia) or two hours before the examination (with general anesthesia). If you take Moviprep once in the morning of the exam, it is important that you have finished taking the entire Moviprep preparation at least two hours before the exam.

If you have any further questions on the use of this medication, contact your doctor or pharmacist.

If you stop taking Moviprep, powder for oral solution

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Diarrhea is an expected effect when using Moviprep.

If you have any of the following side effects, stop taking the medicine and contact your doctor immediately:

· Rash (rash) or itching.

· Swelling of the face, ankles or other parts of your body.

· Palpitations.

· Extreme fatigue.

· Shortness of breath.

They are signs of a severe allergic reaction.

If you do not have a bowel movement within 6 hours of taking the first dose of Moviprep, stop taking it and contact your doctor immediately.

Other adverse reactions reported:

Very frequently (affecting more than 1 patient in 10): abdominal pain, abdominal distension, fatigue, general malaise (feeling unwell), anal pain, nausea and fever.

Frequently (can affect up to 1 in 10 patients): feeling hungry, sleep disorders, dizziness, headache, vomiting, indigestion, thirst and chills.

Uncommonly (which can affect up to 1 in 100 patients): discomfort, difficulty in swallowing and changes in liver function parameters.

The following adverse reactions have been reported, but their frequency is unknown because it can not be estimated from the available data: flatulence (gas), transient increase in blood pressure, irregular heartbeat or palpitations, dehydration, (which may go as far as vomiting), very low levels of sodium in the blood, which may be complicated by seizures, and changes in blood electrolyte levels such as decreased bicarbonates, increased or decreased calcium, increased or decreased chlorine , decrease in phosphate. Potassium and sodium levels in the blood may also decrease.

These reactions usually occur only during treatment. If these persist, consult your doctor.

Allergic reactions can cause a rash, itching, redness of the skin and urticaria, swelling of the hands, feet or ankles, headaches, palpitations and shortness of breath.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE MOVIPREP Powder for oral solution?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the outer packaging after '' EXP ''. The expiry dates of the different pouches may differ between them. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 25 ° C.

After reconstitution, keep in a closed container for 24 hours at a temperature not exceeding 25 ° C or in the refrigerator (between 2 ° and 8 ° C).

Any solution not used within 24 hours after reconstitution should be discarded.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MOVIPREP contains, powder for oral solution

· Packet A contains the following active substances:

Macrogol 3350 ................................................ .................................................. ................. 100 g

Anhydrous sodium sulfate .............................................. ................................................. 7,500 g

Sodium Chloride ............................................... .................................................. ......... 2.691 g

Potassium chloride............................................... .................................................. 1,015 g

· Packet B contains the following active substances:

Ascorbic acid................................................ .................................................. ........... 4,700 g

Sodium ascorbate ............................................... .................................................. ...... 5,900 g

· The concentration of electrolytes after dissolution of a sachet A and a sachet B in one liter of water:

Sodium................................................. ..... 181.6 mmol / L (of which at most 56.2 mmol is absorbable)

Sulfate................................................. .................................................. 52.8 mmol / L

Chloride................................................. .................................................. 59.8 mmol / L

Potassium................................................. .................................................. 14.2 mmol / L

Ascorbate ................................................. .................................................. 29.8 mmol / L

· The other components are:

Lemon flavor (maltodextrin, citral, lemon essential oil, lime essential oil, xanthan gum, vitamin E), aspartame (E951) and acesulfame potassium (E950) as sweeteners. For more information, see section 2.

What MOVIPREP, powder for oral solution and contents of the pack

This medicinal product is in the form of a box containing two transparent bags, each containing one sachet A and one sachet B. One sachet A and one sachet B must be dissolved together in one liter of water.

There are packs of 1, 10, 40, 80, 160 and 320 boxes and a hospital presentation of 40 boxes.

Not all pack sizes may be marketed.

Marketing Authorization Holder

NORGINE BV

HOGEHILWEG 7

1101 CA AMSTERDAM ZO

NETHERLANDS

Marketing Authorization Operator

NORGINE SAS

2 RUE JACQUES DAGUERRE

92500 RUEIL-MALMAISON

Maker

NORGINE LIMITED

NEW ROAD, TIR-Y-BERTH,

HENGOED, MID GLAMORGAN, CF82 8SJ

WALES

UK

Or

HELSINN BIREX PHARMACEUTICALS LTD

Damastown

Mulhuddart

DUBLIN 15

IRELAND

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and United Kingdom: Moviprep.

Sweden: Movprep.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

The following information is intended only for healthcare professionals.

Moviprep should be administered with caution in fragile patients or those with severe clinical disorders such as:

· Swallowing disorders or tendency to inhalation or regurgitation,

· Disorders of alertness,

· Severe renal impairment (creatinine clearance <30 mL / min),

· Heart failure (NYHA grade III or IV),

· Patients at risk of arrhythmia; for example those treated for cardiovascular disease or those with thyroid disease,

· dehydration,

· Severe outbreaks of inflammatory bowel disease.

Dehydration or anomalies of the electrolyte balance should be corrected before using Moviprep.

Patients with alertness, patients undergoing inhalation or regurgitation should be carefully monitored during administration and especially if this is done by nasogastric tube.

Moviprep should not be administered to unconscious patients.

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