Movprep Orange | Macrogol 3350, sodium sulphate, anhydrous, sodium chloride, potassium chloride, ascorbic acid , sodium ascorbate | uses, dose and side effects

Movprep Orange is a laxative with an orange flavor that is distributed in 4 sachets. There are 2 large sachets ( sachet A) and 2 small sachets ( sachet B). You should use all of these for 1 treatment.

Movprep Orange is intended for adults to cleanse the bowel before an examination. Movprep Orange works by emptying the contents of the intestines, so you can expect to have a watery stool.

2. What you need to know before using Movprep Orange

Do not use Movprep Orange

if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6).
if you have blockages or obstructions in your intestines.
if you have holes in the intestinal wall.
if you have disorders in the emptying of the stomach.
if you have slow gastrointestinal motility (may often occur after abdominal surgery).
if you have phenylketonuria. It is a hereditary inability where the body can not metabolize a particular amino acid . Movprep Orange contains a source of phenylalanine.
if your body does not produce enough glucose -6-phosphate dehydrogenase.
if you suffer from toxic megacolon (a serious type of inflammation in the colon).

Warnings and cautions

If you have a bad general condition or a serious medical condition, you should pay special attention to any side effects listed in section 4. If you have any further questions, ask your doctor or pharmacist.

Talk to your doctor or pharmacist before using Movprep Orange if you suffer from any of the following:

a tendency to get ingested beverages or food, as well as acid reflux from the stomach, or if you have trouble swallowing (see also Movprep Orange with food and drink).
kidney disease
heart failure or heart disease including high blood pressure , irregular heartbeat or palpitations
thyroid disease
dehydration
acute relapse of inflammatory bowel disease ( Crohn’s disease or ulcerative colitis )

Movprep Orange should not be given to patients with reduced consciousness without medical supervision.

If you experience sudden abdominal pain or rectal bleeding while taking Movprep Orange for bowel cleansing, contact a doctor immediately or seek medical attention.

Children and young people

Moviprep Orange should not be taken by children and adolescents under 18 years of age.

Other medicines and Movprep Orange

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking other medicines, take them at least 1 hour before or 1 hour after Movprep Orange as they may otherwise be flushed through the gastrointestinal tract and thus have a worse effect.

Movprep Orange with food and drink

You should not eat solid food from the start of treatment until the end of the clinical trial.

If you need to thicken liquids to be able to swallow them safely, Movprep Orange can counteract the effect of the thickener.

When you take Movprep Orange, you must continue to take enough fluids. The liquid content of Movprep Orange does not replace regular fluid intake.

Pregnancy, breastfeeding and fertility

There are no data from the use of Movprep Orange during pregnancy or breastfeeding, and it should therefore only be used if your doctor deems it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Movprep Orange does not affect your ability to drive or use machines.

Movprep Orange contains sodium, potassium and a source of phenylalanine

This medicine contains 8.4 g sodium (the main component of table salt/table salt) per treatment. (One treatment consists of two liters of Movprep Orange). This corresponds to 420% of the recommended daily intake of sodium for an adult. This should be considered by patients on a controlled sodium diet. Only a proportion (up to (2.6 g) per treatment) of sodium is absorbed.

This medicine contains 1.1 g of potassium per treatment (One treatment consists of 2 liters of Movprep Orange). This should be considered by patients with renal impairment or patients on a low-potassium diet.

Movprep Orange contains a source of phenylalanine. It can be harmful to people with phenylketonuria.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Movprep Orange

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose is two liters of solution, which is prepared as follows:

The package contains two transparent bags containing two sachets each: sachet A and sachet B. A set of sachets (A and B) should be dissolved in water to make one liter of solution. This package is therefore sufficient to prepare two liters of Movprep Orange solution.

Before taking Movprep Orange, read the following instructions carefully. You need to know:

when to use Movprep Orange
how to prepare the Movprep Orange solution
how to take Movprep Orange
what you can expect to happen

When to use Movprep Orange

Always use this medicine exactly as described in this leaflet or as your doctor or nurse has told you. If you are not sure, talk to your doctor or nurse.

Treatment with Movprep Orange must be completed before the examination.

This course of treatment can be taken either as a divided dose or a single dose as indicated below:

For examinations that take place when you are anesthetized (with general anesthesia ):

Divided doses: one liter of Movprep Orange the night before and one liter of Movprep Orange early in the morning before the examination. Ensure that the intake of Movprep Orange as well as other clear drinks has been completed at least two hours before the start of the study.
Single dose: two liters of Movprep Orange in the evening before the examination or two liters of Movprep Orange in the morning before the examination. Ensure that the intake of Movprep Orange as well as other clear drinks has been completed at least two hours before the start of the study.

For examinations that take place without anesthesia (without general anesthesia ):

Divided doses: one liter of Movprep Orange in the evening before the examination and one liter of Movprep Orange in the early morning before the examination. Ensure that the intake of Movprep Orange as well as other clear drinks has been completed at least one hour before the start of the study.
Single dose: two liters of Movprep Orange in the evening before the examination or two liters of Movprep Orange in the morning before the examination. Ensure that the intake of Movprep Orange has been completed at least two hours before the start of the study. Ensure that the consumption of clear liquids has been completed at least one hour before the start of the examination.

Note! Do not eat solid food from the time you take Movprep Orange until the study is completed.

Preparation of Movprep Orange

Open a transparent bag and take out sachets A and B.
Pour the contents from BOTH sachets A and B into a 1-liter container.
Pour water into the vessel up to the 1 liter mark and stir until all the powder has dissolved. Movprep The orange solution should be clear or slightly cloudy. This can take up to 5 minutes.

How to take Movprep Orange

Drink the first liter of Movprep Orange Solution for 1-2 hours. Try to drink a glass every 10 -15 minutes.

When you are ready, prepare and drink the second liter of Movprep Orange solution that you prepared from the remaining sachets A and B.

During the treatment, it is recommended to drink an additional 1 liter of clear liquid to prevent you from becoming very thirsty and lacking fluids. Water, clear soup, fruit juice (without pulp), soft drink, tea, or coffee (without milk) are suitable.

These drinks can be taken no later than two hours before the examination if you are to be anesthetized, or

one hour before the examination if you are not to be anesthetized.

You can expect the following

When you start drinking the Movprep Orange solution, you must stay close to a toilet. Sooner or later, you will start getting watery stools. This is completely normal and shows that Movprep Orange works. The watery stools will stop shortly after you have finished drinking.

If you follow these instructions, your bowel will be clean and this will help you undergo a successful examination. You must allow the appropriate time after the last beverage to travel to the colonoscopy unit.

If you use more Movprep Orange than you should

If you take more Movprep Orange than you should, you can get severe diarrhea, which can lead to dehydration. Drink plenty of fluids, especially fruit juices. If you have any further questions, ask your doctor or pharmacist.f

If you forget to use Movprep Orange

If you forget to take Movprep Orange, take a dose as soon as you realize you have not taken it. If this is several hours after the time you took it, contact your doctor or pharmacist for advice. When taking Movprep Orange as a divided dose, you must end your Movprep Orange treatment at least 1 hour before your examination without anesthesia, or 2 hours before your examination with anesthesia.

If you are taking the full dose of Movprep Orange in the morning on the day of the study as a single dose, you must complete your Movprep orange intake at least two hours before the study.

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

Possible side effects

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

It is normal to get diarrhea while taking Movprep Orange.

Discontinue treatment and tell your doctor immediately if you experience any of the following side effects:

rash or itching
swelling of the face, ankles or other body part
palpitation
extreme fatigue
respiratory distress

These are symptoms of a severe allergic reaction.

If you do not have a bowel movement within 6 hours of taking Movprep Orange, stop treatment and contact your doctor immediately.

Other side effects include:

Very common side effects ( affects more than 1 user in 10) :

Abdominal pain, abdominal tension, fatigue, general malaise, tenderness around the rectum, nausea, and fever.

Common side effects ( affects up to 1 in 10 people) :

Hunger, sleep problems, dizziness, headache, vomiting, digestive problems, thirst, and chills.

Uncommon side effects ( affects up to 1 in 100 people) :

Feeling of discomfort, difficulty swallowing, and abnormal liver function values.

The following side effects have occurred occasionally but it is not known how often they occur as the frequency cannot be calculated from the available data:

Flatulence (flatulence), temporary high blood pressure, irregular heartbeat or palpitations, dehydration, nausea (attempts to vomit), very low levels of sodium in the blood that can cause seizures (seizures), and changes in salinity in the blood such as decreased calcium or bicarbonate, increased or decreased chloride and decreased phosphate. Potassium and sodium levels in the blood may also decrease.

These reactions usually occur only in connection with the treatment. If symptoms persist, consult your doctor.

Allergic reactions that may cause rash, itching, redness of the skin or hives, swollen hands, feet or ankles, headache, palpitations, and shortness of breath.

How to store Movprep Orange

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the sachets after EXP. Note that the different sachets do not necessarily have the same expiration date. The expiration date is the last day of the specified month.

Store Movprep Orange sachets at room temperature (below 25 ° C).

After dissolving Movprep Orange in water, the reconstituted solution can be stored (covered) at room temperature (below 25 ° C). The solution can alternatively be stored in a refrigerator (2 ° C-8 ° C). A ready-to-use solution should be used within 24 hours.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Dose bag A contains the following active substances: Show larger

Macrogol (also known as polyethylene glycol) 3350	100 g
Sodium sulfate, anhydrous	7,500 g
Sodium chloride	2,691 g
Potassium chloride	1,015 g

Dose bag B contains the following active substances:

Ascorbic acid	4,700 g
Sodium ascorbate	5,900 g

The concentration of electrolyte ions is as follows when both sachets are dissolved in up to 1 liter of solution:

Sodium	181.6 mmol / l (of which not more than 56.2 mmol is absorbable)
Chloride	59.8 mmol / l
Sulfate	52.8 mmol / l
Potassium	14.2 mmol / l
Ascorbate	29.8 mmol / l

Other ingredients are:

Orange flavor (containing natural flavors, maltodextrin, dextrose) and the sweeteners aspartame (E951) and acesulfame potassium (E950). For further information, see section 2.

What the medicine looks like and contents of the pack

This package contains 2 transparent bags containing 2 bags each: sachet A and sachet B. A set of sachets (A and B) should be dissolved in 1 liter of water.

Movprep Orange powder for oral solution is available in pack sizes of 1, 10, 40, 80, 160, and 320 single treatments. Hospital packaging with 40 disposable treatments. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Norgine BV

Antonio Vivaldi Street 150

1083 HP Amsterdam

Netherlands

Manufacturer

Norgine Limited

New Road, Hengoed

Mid Glamorgan CF82 8SJ

Sophartex

21 rue du Pressoir

28500 Vernouillet

France