Powder for oral solution
Macrogol 3350, sodium sulfate, anhydrous, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate
What Movprep is and what it is used for
Movprep is a laxative with a lemon flavor that is divided into 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 is intended for adults to cleanse the bowel before an examination. Movprep works by emptying the contents of the intestines, so you can expect to have a watery stool.
What you need to know before using Movprep
Do not use Movprep
- 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 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 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 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 should not be given to patients with reduced consciousness without medical supervision.
If you experience sudden abdominal pain or rectal bleeding while taking Movprep for bowel cleansing, you should contact a doctor immediately or seek medical attention.
Children and young people
Movprep should not be taken by children and adolescents under 18 years of age.
Other medicines and Movprep
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 as they may otherwise be flushed through the gastrointestinal tract and thus have a worse effect.
Movprep 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 can counteract the effect of the thickener.
When taking Movprep, you must continue to take enough fluids. The fluid content of Movprep does not replace normal fluid intake.
Pregnancy, breastfeeding and fertility
There are no data from the use of Movprep during pregnancy or breastfeeding, and it should therefore only be used if your doctor considers 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 does not affect your ability to drive or use machines.
Movprep 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). 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). This should be considered by patients with renal impairment or patients on a controlled potassium diet.
Movprep contains a source of phenylalanine. It can be harmful to people with phenylketonuria.
How to use Movprep
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 solution.
Before taking Movprep, read the following instructions carefully. You need to know:
- when to use Movprep
- how to prepare the Movprep solution
- how to take Movprep
- what you can expect to happen
When to use Movprep
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 must be completed before the clinical 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 the night before and one liter of Movprep early in the morning before the examination. Ensure that the intake of Movprep 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 in the evening before the clinical examination or two liters of Movprep in the morning before the examination. Ensure that the intake of Movprep 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 in the evening before the examination and one liter of Movprep in the early morning before the examination. Ensure that the intake of Movprep 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 in the evening before the examination or two liters of Movprep in the morning before the examination. Ensure that taking Movprep 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 until the end of the study.
Preparation of Movprep
- 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. The Movprep solution should be clear or slightly cloudy. This can take up to 5 minutes.
How to take Movprep
Drink the first liter of Movprep 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 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 put to sleep, or
one hour before the examination if you are not to be anesthetized.
You can expect the following
When you start drinking the Movprep 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 is working. The watery stools will stop shortly after you have finished drinking.
If you follow these instructions, your gut 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 than you should
If you take more Movprep than you should, you may develop severe diarrhea, which may lead to dehydration. Drink plenty of fluids, especially fruit juices. If you have any further questions, ask your doctor or pharmacist.
If you forget to use Movprep
If you forget to take Movprep, take one 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 as a divided dose, you must end your Movprep 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 in the morning on the day of the study as a single dose, you must complete your Movprep 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.
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, stop the 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 (trying 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 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
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 sachets at room temperature (below 25 ° C).
After dissolving Movprep 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: | |
|---|---|
| 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 |
The other ingredients are lemon flavor (containing maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E) and the sweeteners aspartame (E 951) and acesulfame potassium (E 950). For further information, see section 2.
What the medicine looks like and contents of the pack
This package contains 2 transparent bags containing 2 sachets each: sachet A and sachet B. A set of sachets (A and B) should be dissolved in 1 liter of water.
Movprep 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
BV
Antonio Vivaldi Street 150
1083 HP Amsterdam
Netherlands
Manufacturer
Norgine Limited
New Road, Hengoed
Mid Glamorgan CF82 8SJ
United Kingdom
or
Norgine BV
Antonio Vivaldi Street 150
1083 HP Amsterdam
Netherlands
or
Sophartex
21 rue du Pressoir
28500 Vernouillet
France
This medicinal product is authorized under the European Economic Area under the names:
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and the United Kingdom: Moviprep
Sweden: Movprep