MOVIPREP powder for oral solution, 1 unit

Moviprep, powder. Indications: For bowel cleansing prior to clinical procedures to prepare the bowel for examination (endoscopy, X-ray).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Moviprep - Powder for oral solution
Active ingredients: Macrogol 3350, anhydrous sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after a few days, consult your doctor.

What this leaflet contains:

1. WHAT IS MOVIPREP AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING MOVIPREP?
3. HOW SHOULD MOVIPREP BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MOVIPREP BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS MOVIPREP AND WHAT IS IT USED FOR?

Moviprep is a lemon-flavored laxative in 4 sachets. One dose consists of two large sachets (###Sachet A###) and two small sachets (###Sachet B###). You need all four sachets for one dose. Moviprep is a medicine for adults used to cleanse the bowel before clinical procedures to prepare the bowel for examination (endoscopy, X-ray). Moviprep works by emptying the bowel. Therefore, an expected effect of using Moviprep is watery diarrhea.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVIPREP:

Do not take Moviprep if:

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of this medicine listed in section 6.
• if your intestine is not completely passable or if you suffer from a blockage (obstruction) in the digestive tract or from an intestinal obstruction (ileus).
• if you have a perforation in the wall of your digestive tract.
• if you suffer from a disorder of gastric emptying (e.g. gastric atony).
• if you suffer from intestinal paralysis (this can be a consequence of abdominal surgery).
• If you suffer from phenylketonuria (PKU). Phenylketonuria is an inherited metabolic disorder in which your body cannot process phenylalanine. Moviprep contains aspartame as a source of phenylalanine.
• if you suffer from glucose–%%%6–%%%phosphate–%%%dehydrogenase–%%% deficiency.
• if you suffer from acute dilation of the colon (toxic megacolon) as a result of chronic inflammatory bowel diseases such as ulcerative colitis.

Warnings and precautions:
If you are in poor general health or suffer from a serious illness, you should pay particular attention to the possible side effects listed in section 4. Please ask your doctor or pharmacist if you are not entirely sure.

You should inform your doctor about the following conditions before taking Moviprep:

• if you have difficulty or discomfort swallowing liquids and may need to thicken them%%%
• if you have a tendency for swallowed liquids, food, or stomach acid to reflux%%%
• if you suffer from kidney disease%%%
• if you suffer from heart failure, cardiovascular diseases including high blood pressure, irregular heart rhythms or palpitations
• if you suffer from a thyroid disorder%%%
• if you are dehydrated%%%
• if you are suffering from a severe acute flare-up of a chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Use in children:
Moviprep is not suitable for use in children and adolescents under 18 years of age.

In patients with impaired consciousness, Moviprep should only be used under medical supervision.

Taking Moviprep with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Take other medicines at least one hour before starting or at least one hour after finishing the Moviprep treatment, as otherwise they may be flushed out of the digestive tract and therefore not be effective.

Taking Moviprep with food and drink:
From the start of taking Moviprep until the end of the examination, you must not eat any solid food. You should continue to drink plenty of clear fluids while taking Moviprep. The fluid content of Moviprep does not replace your regular fluid intake.

Pregnancy and breastfeeding:
Since there are no data on the use of Moviprep during pregnancy or breastfeeding, Moviprep should only be used if your doctor considers it absolutely necessary. If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines:
Moviprep has no influence on the ability to drive or use machines.

Moviprep contains sodium, potassium, and a source of phenylalanine:
Moviprep contains 56.2 mmol of absorbable sodium per liter of ready-to-use solution. Take this into account if you are on a low-sodium diet. Moviprep contains 14.2 mmol of potassium per liter of ready-to-use solution. Take this into account if you have impaired kidney function or are on a low-potassium diet. Moviprep contains aspartame, a source of phenylalanine, and may be harmful if you have phenylketonuria.

3. HOW TO TAKE MOVIPREP?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for bowel preparation is a total of two liters of Moviprep solution, which is prepared as follows: One pack contains two clear outer bags, each containing two sachets: Sachet A and Sachet B. The contents of each pair of sachets (i.e., one Sachet A and one Sachet B) are dissolved together in water to make a 1-liter solution. One pack therefore makes two liters of ready-to-drink Moviprep solution.

Please read the following instructions carefully before using Moviprep. You need to know:

• when to take Moviprep%%%
• how to prepare Moviprep%%%
• how Moviprep is drunk%%%
• what effects can be expected.

When to take Moviprep:
Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Treatment with Moviprep must be completed before the start of the clinical examination.

For bowel preparation, Moviprep can be taken as a split dose or as a single dose, as described below:
For use if you are receiving general anesthesia:

1. Split dose: One liter of Moviprep the evening before and another liter of Moviprep early in the morning of the examination day. The intake of both Moviprep and any other clear liquid must be completed at least two hours before the start of the examination.
2. Single dose: Ingestion of two liters of Moviprep on the evening before the examination or ingestion of two liters of Moviprep on the morning of the examination. Ingestion of both Moviprep and any other clear liquid must be completed at least two hours before the start of the examination.

For procedures if you are not receiving general anesthesia:

1. Split dose: One liter of Moviprep the evening before and another liter of Moviprep early in the morning of the day the examination is to take place. The intake of both Moviprep and any other clear liquid must be completed at least one hour before the start of the examination.
2. Single dose: Two liters of Moviprep are taken the evening before the clinical procedure or two liters of Moviprep are taken on the morning of the examination. The Moviprep intake must be completed at least two hours before the examination begins. The intake of any other clear liquid must be completed at least one hour before the examination begins.

Important: You must not eat any solid food from the start of taking Moviprep until the examination is complete.

How to prepare Moviprep:

• Open one of the transparent outer bags and remove bags A and B.
• Pour the contents of BOTH bags into a measuring cup that can hold one liter of liquid.
• Add water to the 1-liter mark in the container and stir until the powder is completely dissolved and the Moviprep solution is clear or slightly cloudy. This process may take up to five minutes.

How to take Moviprep:
Drink the first liter of Moviprep within one to two hours. Try to drink a glass of Moviprep every 10 to 15 minutes. Then prepare the second liter of Moviprep solution from sachets A and B of the remaining outer pouch. Drink this solution in the same way. You should drink another liter of clear fluids during this time to avoid excessive thirst and dehydration. Suitable drinks include water, clear broths, fruit juices (without pulp), soft drinks, tea, or coffee (without milk). You can drink these beverages at any time.

What to expect when using Moviprep:
As soon as you start taking Moviprep, you should stay close to a toilet. You will soon experience watery bowel movements. This is perfectly normal and indicates that the Moviprep solution is working. The urge to defecate will subside soon after you have drunk all of the solution. If you follow these instructions, your bowel will be cleansed, and you will be helping to ensure the examination is successful. Please allow sufficient time for your journey to your colonoscopy after taking the last dose.

Please talk to your doctor or pharmacist if you feel that the effect of Moviprep is too strong or too weak.

If you have taken more Moviprep than you should:
If you have taken more Moviprep than you should, you may experience severe diarrhea, which can lead to dehydration. Drink plenty of fluids, especially fruit juices. If you are concerned, contact your doctor or pharmacist.

If you forget to take Moviprep:
If you forget to take Moviprep, take it as soon as you remember. However, if several hours have passed since the scheduled time, contact your doctor or pharmacist.

If you are taking Moviprep as a split dose, it is important that you complete the Moviprep preparation at least one hour before the examination (without general anesthesia) or two hours before the examination (with general anesthesia). If you are taking the entire Moviprep as a single dose on the morning before the examination, it is important that you complete your Moviprep preparation at least two hours before the examination.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Moviprep can cause side effects, although not everyone will experience them. Diarrhea is a normal effect of Moviprep. If you experience any of the following symptoms, stop taking Moviprep and consult your doctor immediately:

• Skin rash or itching
• Swelling of the face, ankles, or other body parts
• heart palpitations
• very severe fatigue
• Shortness of breath.

These could be symptoms of a severe allergic reaction. If you do not have a bowel movement within six hours of taking Moviprep, stop taking it and contact your doctor immediately.

Other side effects:
Very common – may affect more than 1 in 10 people:
abdominal pain, bloating (abdominal distension), fatigue, general feeling of being unwell, anal irritation, nausea, and fever.

Common – may affect up to 1 in 10 people:
hunger, difficulty sleeping, dizziness, headache, vomiting, indigestion, thirst, and muscle tremors/chills.

Uncommon – may affect up to 1 in 100 people:
discomfort, difficulty swallowing, and altered liver function test results.

The following side effects have occasionally been observed, but their frequency is not known as it cannot be estimated from the available data:
bloating (flatulence), temporary increase in blood pressure, irregular heartbeat or palpitations, dehydration, nausea (squeamish retching to vomiting), very low blood sodium levels, which may trigger seizures, and changes in blood salt concentrations, such as decreased bicarbonate, increased or decreased calcium, increased or decreased chloride, and decreased phosphate. Blood potassium and sodium levels may also be decreased. These reactions usually only occur during use; however, if they persist, talk to your doctor. Allergic reactions may cause skin rash, itching, reddening of the skin or hives, swollen hands, feet, or ankles, headache, palpitations, and shortness of breath.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOVIPREP?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachets after ###EXP###. Please note that the expiry dates on sachet A and sachet B may differ. The expiry date refers to the last day of that month.

Storage conditions:
Store Moviprep sachets at room temperature (below 25°C). The ready-to-use Moviprep solution, reconstituted with water, can be stored (in a sealed container) at room temperature (below 25°C). It can also be stored in a refrigerator (2°C - 8°C).

Note regarding shelf life after opening or preparation:
The reconstituted Moviprep solution must not be used if more than 24 hours have passed since preparation.

Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Moviprep contains:

• Sachet A contains the following active ingredients: Macrogol (polyethylene glycol) 3350 100 g, Anhydrous sodium sulfate 7.500 g, Sodium chloride 2.691 g, Potassium chloride 1.015 g.
• Sachet B contains the following active ingredients: Ascorbic acid 4.700 g, sodium ascorbate 5.900 g.
• One liter of a solution prepared from both bags has the following electrolyte ion concentrations: sodium 181.6 mmol/l (of which a maximum of 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 flavouring (contains maltodextrin, citral, lemon oil, limonene oil, xanthan gum, vitamin E), aspartame (E 951) and acesulfame – potassium (E 950) as sweeteners.

For further information, see section 2.

What Moviprep looks like and contents of the pack:
One pack of Moviprep consists of two clear outer bags, each containing two sachets (###Sachet A### and ###Sachet B###). Two sachets (A and B) are dissolved together in one liter of water. Moviprep is available in pack sizes of 1, 10, 40, 80, 160, and 320 single-dose packs. A hospital pack contains 40 single doses. Not all pack sizes may be marketed.

Pharmaceutical company and manufacturer:
Norgine BV,
Antonio Vivaldistraat 150,
1083 HP Amsterdam,
Netherlands.

Distributed by:
Norgine GmbH,
Im Westpark 14,
35435 Wettenberg, Germany.

MOVIPREP powder for oral solution, 1 unit