powder for oral solution
macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride
What Vistaprep is and what it is used for
Vistaprep is a white powder used to prepare a solution to be swallowed. This medicine has a laxative effect (facilitates bowel movements).
Vistaprep is used for bowel cleansing in preparation for an examination of the large intestine ( colonoscopy ) in adults over 18 years of age.
Macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride found in Vistaprep may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Vistaprep
Do not take Vistaprep:
- if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride, saccharin sodium, orange flavoring, lemon-lime flavoring, anhydrous colloidal silicon dioxide, or any of the other ingredients of this medicine (listed in section 6).
- if you have an intestinal obstruction (obstruction in the intestine) or suspected intestinal obstruction, or if you have perforation (hole) in the intestinal wall or risk of having a perforation in the intestinal wall.
- if you have problems emptying your stomach or have a severe, severe inflammatory form of colitis (inflammation of the colon) and a severe, abnormally enlarged colon due to this colitis (toxic megacolon).
- if you have an impaired swallowing and vomiting reflex or suffer from a general feeling of weakness.
Vistaprep should not be given to patients with a reduced level of consciousness or patients who tend to choke or inhale liquids (aspiration).
Warnings and precautions
Contact your doctor:
- if you are older
- if you have reflux disease (heartburn, reflux esophagitis )
- if you have problems with your heart rhythm (SA block or sick sinus syndrome)
- if your heart is not pumping efficiently (a condition called heart failure ), and you feel discomfort when you do light to moderate exercise or when you rest
- if your kidneys and/or liver are not working effectively (reduced kidney and liver function)
- if you have kidney failure or liver disease
- if you are severely dehydrated
- if you have severe colitis ( inflammation of the colon), diverticulitis, or chronic inflammatory bowel disease
In these cases, Vistaprep can only be used under the supervision of a doctor who will check your salt and fluid balance.
If you experience sudden abdominal pain or rectal bleeding while taking Vistaprep for bowel cleansing, contact your doctor or seek medical attention immediately.
Children
There is insufficient experience of use in children. Vistaprep should therefore not be used in children.
Other medicines and Vistaprep
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take other medications just before, during, or up to 1 hour after you take Vistaprep, these medications may be washed out during the colonic lavage and/or may not be effective. If you must take other medications, ask your doctor in advance for advice and/or alternative treatment. This also applies to oral contraceptives (e.g. birth control pills ).
Macrogol 3350 can affect the results of tests done using intestinal fluids.
Vistaprep with food and drink
You should not eat any solid food 2-3 hours before drinking Vistaprep until after the examination has been completed.
Pregnancy, breastfeeding, and fertility
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.
There is no experience with the use of Vistaprep during pregnancy.
If you are pregnant, your doctor will carefully assess the benefits and risks of this medicine before using Vistaprep.
You can also take Vistaprep while breastfeeding if deemed necessary.
Driving ability and use of machinery
No special precautions are required.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Vistaprep contains sodium and potassium
This medicine contains 20 millimoles of potassium and 260 millimoles of sodium per 4 liters of Vistaprep solution.
This should be taken into account if you:
– have reduced kidney function
– have been prescribed a low-potassium diet
– have been prescribed a low-sodium (low-salt) diet.
How to take Vistaprep
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage for adults (over 18 years)
For a complete bowel movement, you must take 3 liters, up to a maximum of 4 liters, of Vistaprep solution. One sachet corresponds to 1 liter of solution.
Drink the solution in portions of 2-3 deciliters every 10 minutes, until you notice that the liquid from the rectum is clear or until you have drunk a maximum of 4 liters.
Take the solution over about 4 hours, generally on the day of the examination. You can take the entire required amount the night before the exam, or a small amount the night before the exam and the remaining amount on the morning of the exam. Consult your doctor about how to do this.
Duration of treatment
Vistaprep is intended for a single use before a planned bowel examination.
Preparation of the solution
Prepare the almost colorless and slightly cloudy solution immediately before use. The contents of a sachet are dissolved in 1 liter of lukewarm water. Prepare 3-4 liters of solution in this way. Since 1 sachet of Vistaprep corresponds to 1 liter of solution, you will need 3-4 sachets for 3-4 liters. You can put the prepared solution in the refrigerator to cool it down. The chilled solution tastes better to drink.
You must not add any other solutions or additives (especially sugar or flavorings that are not miscible with the Vistaprep solution) to the Vistaprep solution, as this may, among other things, lead to a change in the composition of salts in the blood. In addition, explosive gas mixtures can develop in the intestine when the added substances are broken down by intestinal bacteria.
Talk to your doctor if you feel that the effect of Vistaprep is too strong or too weak.
If you have taken too much Vistaprep
Diarrhea or watery stools is the goal of treatment with Vistaprep, but if you have taken too much Vistaprep, you may have severe diarrhea. If this occurs, you should drink plenty of fluids and always consult your doctor.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Vistaprep
If you drink much less than the recommended amount, it may happen that the bowel does not empty completely and then the examination cannot be carried out as planned. Therefore, follow the dosage recommendation from your doctor or the recommendations in this leaflet.
If you stop taking Vistaprep
If you stop taking Vistaprep or end the treatment too soon, the bowel may not empty and the examination cannot be carried out as planned.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Special side effects or signs you should be aware of and what to do if you are affected:
All medicines can cause allergic reactions. However, serious allergic reactions are very rare. Stop taking Vistaprep and contact your doctor as soon as possible if you experience any of the following side effects:
- Allergic skin rashes
- Disturbances in blood circulation
- Respiratory distress
- The outbreak of sweating with nausea
The following side effects have also been reported:
Very common (may affect more than 1 in 10 users):
- Nausea, feeling bloated, gas formation
Common (may affect up to 1 in 10 users):
- Vomiting, stomach cramps, irritation around the anus
These side effects are largely due to consuming large amounts of liquid over a short period. If these symptoms occur in the stomach and intestines, you should take Vistaprep more slowly over some time or stop taking Vistaprep until the symptoms subside.
Uncommon (may affect up to 1 in 100 users):
- General malaise and insomnia
Very rare (may affect up to 1 in 10,000 users):
- Irregular or fast heart rhythm (heart rhythm disorders, tachycardia ) and accumulation of fluid in the lungs ( pulmonary edema ).
- Lowering the amount of calcium, potassium, and sodium in the blood, can give tangible signs of illness.
- Neurological symptoms (symptoms in the nervous system) as a result of an imbalance of salts in the blood. The neurological symptoms may range from mild confusion to generalized seizures.
- Hives ( urticaria ), runny nose, runny nose ( rhinorrhea ), or acute skin inflammation ( dermatitis ) of presumed allergic cause, anaphylactic shock ( acute and severe allergic reaction ).
Note:
There have been cases of vomiting followed by bleeding caused by ruptures in the esophagus (Mallory-Weiss syndrome). These cases have occurred after drinking solutions containing macrogol.
How to store Vistaprep
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the sachet after EXP and on the carton after EXP. The expiration date is the last day of the specified month.
Storage:
Powder: No special storage instructions.
Ready-made solution: Store at a maximum of 25°C for 3 hours or store in a refrigerator (2°C-8°C) for 48 hours.
Discard any remaining solution not used within 48 hours.
Contents of the packaging and other information
Contents declaration
The active substances (per sachet ) are:
| Macrogol 3350 | 105,000 grams |
| Sodium chloride | 2,800 grams |
| Sodium bicarbonate | 1.430 grams |
| Potassium chloride | 0.370 grams |
The content of electrolyte ions in a sachet after preparation of 1000 milliliters (1 liter) of solution corresponds to:
| Sodium | 65 millimoles/liter |
| Chloride | 53 millimoles/liter |
| Hydrogen carbonate | 17 millimoles/liter |
| Potassium | 5 millimoles/liter |
Other ingredients are:
Saccharin sodium, anhydrous colloidal silicon dioxide, orange flavoring (orange flavoring contains flavorings, flavorings, natural flavorings, glucose, maltodextrin, gum arabic (E414), alpha-tocopherol (E307)) and lemon-lime flavoring (lemon-lime flavoring contains natural flavorings, natural flavorings, maltodextrin, gum arabic (E414), citric acid (E330)).
Appearance and package sizes of the medicine
Vistaprep is a white powder for oral solution.
Vistaprep is available in packs of 4 and 64 sachets and in packs containing 12 cartons where each carton contains 4 sachets of powder for oral solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Allowed Pharma GmbH
Warmbier Str. 80
79618 Rheinfelden
Germany
The local representative of the Marketing Authorization Holder:
Tillotts Pharma AB
Gustavslundsvägen 135
167 51 Brake
Manufacturer
Klocke Pharma Service GmbH
Strassburger Str. 77
77767 Appenweier
Germany