PATIENT INFORMATION
MoviPrep®
(moo-vee-prep)
(polyethylene glycol 3350, sodium sulfate, sodium chloride,
potassium chloride, sodium ascorbate, and ascorbic acid for oral solution)
Read this Medication Guide and Instructions for Use
before your colonoscopy and again before you start taking MoviPrep.
What is the most important information I should know
about MoviPrep?
MoviPrep and other bowel preparations can cause
serious side effects, including:
- Serious loss of body fluid (dehydration) and changes
in blood salts (electrolytes) in your blood. These changes can cause:
- abnormal heartbeats that can cause death.
- seizures. This can happen even if you have never had a
seizure.
- kidney problems.
Your chance of having fluid loss and changes in body
salts with MoviPrep is higher if you:
- have heart problems.
- have kidney problems.
- take water pills (diuretics), high blood pressure
medicine, or non-steroidal anti-inflammatory drugs (NSAIDS).
Tell your healthcare provider right away if you have
any of these symptoms of serious loss of body fluid (dehydration) while taking
MoviPrep:
- vomiting
- urinating less often than normal
- dizziness
- headache
See “What are the possible side effects of MoviPrep?”
for more information about side effects .
What is MoviPrep?
MoviPrep is a prescription medicine used by adults to
clean the colon before a colonoscopy. MoviPrep cleans your colon by causing you
to have diarrhea (loose stools).
Cleaning your colon helps your healthcare provider see
the inside of your colon more clearly during your colonoscopy.
It is not known if MoviPrep is safe and effective in
children.
Who should not take MoviPrep?
Do not take MoviPrep if your healthcare provider has told
you that you have:
- a blockage in your intestine (bowel obstruction).
- an opening in the wall of your stomach or intestine
(bowel perforation).
- problems with food and fluid emptying from your stomach
(gastric retention).
- a problem with food moving too slowly through your
intestines (ileus).
- a very dilated intestine (toxic megacolon).
- an allergy to any of the ingredients in MoviPrep. See the
end of this leaflet for a complete list of ingredients in MoviPrep.
What should I tell my healthcare provider before
taking MoviPrep?
Before taking MoviPrep, tell your healthcare provider about
all of your medical conditions, including if you:
- have problems with serious loss of body fluid
(dehydration) and changes in blood salts (electrolytes).
- have heart problems.
- have seizures or take medicines for seizures.
- have kidney problems or take medicines for kidney
problems.
- have stomach or bowel problems, including ulcerative
colitis.
- have problems with swallowing, gastric reflux, or if you
inhale food or fluid into your lungs when eating or drinking (aspirate).
- have a condition called glucose-6-phosphate dehydrogenase
(G6PD) deficiency that destroys red blood cells.
- are withdrawing from alcohol or benzodiazepines.
- have phenylketonuria (PKU). MoviPrep contains
phenylalanine.
- are allergic to any of the ingredients in MoviPrep.
- are pregnant or plan to become pregnant. It is not known
if MoviPrep will harm your unborn baby. Talk to your healthcare provider if you
are pregnant.
- are breastfeeding or plan to breastfeed. It is not known
if MoviPrep passes into your breast milk. You and your healthcare provider
should decide if you will take MoviPrep while breastfeeding.
Tell your healthcare provider about all the medicines
you take, including prescription and non-prescription medicines,
vitamins, and herbal supplements. MoviPrep may affect how other medicines work.
Do not take medicines by mouth 1 hour before or after the start of
MoviPrep. Especially tell your healthcare provider if you take:
- medicines to treat a blood salt (electrolyte) imbalance.
- medicines for blood pressure or heart problems.
- medicines for seizures (antiepileptics).
- medicines for kidney problems.
- water pills (diuretics).
- non-steroidal anti-inflammatory drugs (NSAID).
- laxatives. Do not take other laxatives while taking
MoviPrep.
- medicines for depression or other mental health problems.
Ask your healthcare provider or pharmacist for a list of
these medicines if you are not sure if you are taking any of the medicines
listed above.
Know the medicines you take. Keep a list of them to show
your healthcare provider and pharmacist when you get a new medicine.
How should I take MoviPrep?
See the “Instructions for Use ” for
dosing instructions. You must read, understand, and follow these
instructions to take MoviPrep the right way.
- Take MoviPrep exactly as your healthcare provider tells
you to take it. Your healthcare provider will tell you to take the Two-Day
Split-Dosing regimen option or the One-Day Evening Only Dosing regimen option.
- On the day before the procedure, you can have breakfast,
followed by a light lunch (no solid foods), and dinner of clear soup with or
without plain yogurt, or plain yogurt only. You must finish dinner at least 1
hour before the start of the first MoviPrep dose.
- Drink only clear liquids before, during, and after you
take MoviPrep, until 2 hours before your colonoscopy to help prevent fluid loss
(dehydration).
- Do not eat solid food while taking MoviPrep until after
your colonoscopy.
- Do not eat or drink alcohol, milk, anything colored red
or purple or any other foods with pulp.
- It is important for you to drink the additional amount of
clear liquids listed in the Instructions for Use .
- You may have stomach-area (abdomen) bloating after your
first dose of MoviPrep.
- If you have severe stomach-area (abdomen) discomfort or
bloating, stop drinking MoviPrep for a short time or wait a longer time between
each dose of MoviPrep until your stomach-area symptoms improve. If your
stomach-area discomfort or bloating continues, tell your healthcare provider.
- If you take too much MoviPrep, call your healthcare
provider.
What are the possible side effects of MoviPrep?
MoviPrep can cause serious side effects, including:
- Changes in certain blood tests. Your healthcare
provider may do blood tests after you take MoviPrep to check your blood for
changes. Tell your healthcare provider if you have any symptoms of too much
fluid loss, including:
- vomiting
- heart problems
- seizures
- dizziness
- kidney problems
- dry mouth
- feel faint, weak or lightheaded especially when you stand
up (orthostatic hypotension)
- Ulcers of the bowel or bowel problems (ischemic colitis):
Tell your healthcare provider right away if you have severe stomach-area
(abdomen) pain or rectal bleeding.
- Serious allergic reactions. Symptoms of a serious
allergic reaction may include:
- skin rash
- raised red patches on your skin (hives)
- kidney problems
- swelling of the face, lips, tongue and throat
- itching
The most common side effects of MoviPrep include:
- anal discomfort
- sleep problems
- vomiting
- thirst
- chills
- indigestion
- nausea
- hunger
- dizziness
- stomach-area (abdomen pain or bloating)
- discomfort
These are not all the possible side effects of MoviPrep.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store MoviPrep?
- Store MoviPrep that has not been mixed with water at room
temperature, between 68° to 77°F (20° to 25°C).
- Store MoviPrep that has been mixed with water in an
upright position in the refrigerator.
- MoviPrep should be taken within 24 hours after it has
been mixed with water.
Keep MoviPrep and all medicines out of the reach of
children.
General information about the safe and effective use
of MoviPrep.
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use MoviPrep for a condition
for which it was not prescribed.
Do not give MoviPrep to other people, even if they are
going to have the same procedure you are. It may harm them.
This Medication Guide summarizes the most important
information about MoviPrep. If you would like more information, talk with your
healthcare provider. You can ask your pharmacist or healthcare provider for
information that is written for healthcare professionals.
For more information, call 1-800-321-4576 or go to
www.MoviPrep.com.
What are the ingredients in MoviPrep?
Active ingredients:
Pouch A: polyethylene glycol (PEG) 3350, sodium sulfate,
sodium chloride, potassium chloride.
Pouch B: ascorbic acid and sodium ascorbate.
Inactive ingredients:
Pouch A: aspartame, acesulfame potassium, and lemon
flavoring.
Instructions for Use
MoviPrep
(polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride,
sodium ascorbate, and ascorbic acid for oral solution)
There are two different options for taking MoviPrep. Your
healthcare provider will tell you to take the Two-Day Split-Dosing Regimen
option or the One-Day Evening Only Dosing Regimen option.
Important Information on MoviPrep:
- water
- clear fruit juices without pulp including apple, white
grape, or white cranberry
- strained limeade or lemonade
- coffee or tea (do not use any dairy or non-dairy creamer)
- clear broth
- clear soda
- gelatin (without added fruit or topping, no red or
purple)
- popsicles (without pieces of fruit or pulp, no red or
purple)
- Mixing Container that comes with MoviPrep
- One Pouch A
- One Pouch B
- Lukewarm water
- On the day before the colonoscopy you can eat breakfast
followed by a light lunch (no solid foods). For dinner you may have a clear
soup with or without plain
- yogurt, or plain yogurt only.
- You must finish eating at least 1 hour before you start
taking MoviPrep.
- You must take the first dose between 10 to 12 hours
before the second dose. The second dose must be taken at least 3 ½ hours before
the colonoscopy.
- After you start taking MoviPrep you can only drink clear
liquids.
- On the day before the colonoscopy you can eat breakfast
followed by a light lunch. For dinner you may have a clear soup with or without
plain yogurt, or plain yogurt only.
- You must finish eating at least 1 hour before you start
taking MoviPrep.
- You must take the first dose 3 ½ hours before bedtime the
evening before the colonoscopy.
- After you start taking MoviPrep you can only drink clear
liquids.
- Take the second dose 1 ½ hours after starting Dose 1.
- You must drink all of the Dose 1 and Dose 2 of MoviPrep
with either dosing regimen option. Make sure you finish Dose 2 at least 2 hours
before your colonoscopy.
- After completing Dose 2, it is important that you drink
additional clear liquids (including water), but you must stop drinking all
liquids at least 2 hours before your colonoscopy.
- MoviPrep must be mixed with water. Do not add any other
ingredients to MoviPrep.
- After you start taking MoviPrep, you can only drink clear
liquids (no solid foods) until after your colonoscopy. Examples of clear
liquids include:
- water
- clear fruit juices without pulp including apple, white
grape, or white cranberry
- strained limeade or lemonade
- coffee or tea (do not use any dairy or non-dairy creamer)
- clear broth
- clear soda
- gelatin (without added fruit or topping, no red or
purple)
- popsicles (without pieces of fruit or pulp, no red or purple)
- Drink plenty of clear liquids before, during, and after
you take MoviPrep, up until 2 hours before your colonoscopy, to help prevent
fluid loss (dehydration).
- Do not eat or drink anything within 2 hours before
your colonoscopy.
- Do not eat or drink alcohol, milk, anything
colored red or purple or containing pulp.
- Do not take other laxatives while taking MoviPrep.
- Do not take any medicines by mouth (oral) within 1
hour before or after starting each dose of MoviPrep.
- Do not eat and solid food while taking ModiPrep until
after your colonoscopy. To take each dose of ModiPrep, you will need.
- Mixing Container that comes with MoviPrep
- One Pouch A
- One Pouch B
- Lukewarm water
- For the Two-Day Split-Dosing Regimen:
- On the day before the colonoscopy you can eat breakfast
followed by a light lunch (no solid foods). For dinner you may have a clear
soup with or without plain yogurt, or plain yogurt only.
- You must finish eating at least 1 hour before you start
taking MoviPrep.
- You must take the first dose between 10 to 12 hours
before the second dose. The second dose must be taken at least 3 ½ hours before
the colonoscopy.
- After you start taking MoviPrep you can only drink clear
liquids.
- For the One-Day Evening Only Dosing Regimen:
- On the day before the colonoscopy you can eat breakfast
followed by a light lunch. For dinner you may have a clear soup with or without
plain yogurt, or plain yogurt only.
- You must finish eating at least 1 hour before you start
taking MoviPrep.
- You must take the first dose 3 ½ hours before bedtime the
evening before the colonoscopy.
- After you start taking MoviPrep you can only drink clear
liquids.
- Take the second dose 1 ½ hours after starting Dose 1.
Two-Day Split-Dosing Regimen Dosing Instructions
Dose 1 - Take this dose the evening before your
colonoscopy (10 to 12 hours before Dose 2):
Step 1: Empty the contents of one Pouch A and one Pouch B
into the Mixing Container that comes with MoviPrep.
Step 2: Add lukewarm water to the Fill Line on the Mixing
Container. You will need at least 32 ounces.
Step 3: Mix to completely dissolve the medicine from
Pouch A and Pouch B into the lukewarm water. To mix the solution, stir the
medicine in the Mixing Container with a spoon, or close the lid and shake.
Step 4: Drink one 8 oz. (ounce) glass of the solution
every 15 minutes. Be sure to drink all of the solution in the Mixing Container.
It should take about 1 hour to drink all the liquid.
If you feel like you have severe stomach pain or
discomfort you can stop taking MoviPrep for a short period of time and then
continue taking it or you can take smaller sips of MoviPrep so that you space
out your dose longer than 1 hour. If you still have severe stomach pain, call
your healthcare provider.
Step 5: Refill the Mixing Container with 16 oz. (at least
halfway to Fill Line and enough for two 8 oz. glasses) of a clear liquid and
drink all of this liquid before you go to bed.
Dose 2 - Take this dose the next morning on the day of
your colonoscopy (start at least 3 ½ hours before your colonoscopy):
Step 1: Repeat steps 1 through 4 from Dose 1 of the Split-Dose (2-Day) instructions.
Step 2: Fill the Mixing Container with 16 oz. (at least halfway to Fill Line and enough for two 8 oz. glasses) of a clear liquid and drink all of this liquid at least 2 hours before your colonoscopy.
Step 3: Drink only clear liquids up to 2 hours before
your colonoscopy or as prescribed by your healthcare provider. Then stop
drinking liquids until after your colonoscopy.
One-Day Evening Only Dosing Regimen Instructions
Dose 1 (take at least 3 ½ hours before bedtime the
evening before your colonoscopy):
Step 1: Empty the contents of one Pouch A and one Pouch B
into the Mixing Container that comes with MoviPrep.
Step 2: Add lukewarm water to the Fill Line on the Mixing
Container. You will need at least 32 ounces.
Step 3: Mix to completely dissolve the medicine from
Pouch A and Pouch B into the lukewarm water. To mix the solution, stir the
medicine in the Mixing Container with a spoon, or close the lid and shake.
Step 4: Drink one 8 oz. (ounce) glass of the solution
every 15 minutes. Be sure to drink all of the solution in the Mixing Container.
It should take about 1 hour to drink all the liquid.
If you feel like you have severe stomach pain or
discomfort you can stop taking MoviPrep for a short period of time and then
continue taking it or you can take smaller sips of MoviPrep so that you space
out your dose longer than 1 hour. If you still have severe stomach pain, call
your healthcare provider.
Dose 2 (take about 1 ½ hours after starting Dose 1):
Step 1: Repeat Steps 1 through 4 from Dose 1 of the Evening Only (1-Day) instructions.
Step 2: After you complete steps 1 through 4, fill the Mixing Container again to the Fill Line with
clear liquid and drink all of this liquid before you go to bed.
Step 3: Drink only clear liquids up to 2 hours before
your colonoscopy or as prescribed by your healthcare provider. Then stop
drinking liquids until after your colonoscopy.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.