Vistaprep Powder For Oral Solution
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VistaPrep
powder for oral solution
Active substances: Macrogol 3350, potassium chloride, sodium chloride, sodium bicarbonate
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
-If you have any further questions, ask your doctor or pharmacist.
-If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What VistaPrep is and what it is used for
2. Before you use VistaPrep
3. How to use VistaPrep
4. Possible side effects
5. How to store VistaPrep
6. Further information
1. What VistaPrep is and what it is used for
VistaPrep is used to empty the intestines prior to examination or surgery of the intestines. Use of this medicine will cause diarrhoea and a watery stool, which rapidly empties the bowel.
2. Before you use VistaPrep Do not use VistaPrep:
• if you are allergic (hypersensitive) to macrogol 3350 or any of the other ingredients of VistaPrep (see Section 6)
• if you suffer from a blockage or obstruction in the intestines, or if you have a perforated intestine
• if you have a severe inflammation of the intestine or stomach, or if you have a severe complication of acute colitis (toxic megacolon), or severely active ulcerative colitis (hyperflorid colitis)
• if you have problems emptying your stomach
• if you have an acute or chronic ulcer in the stomach or intestines
• if you often swallow the wrong way (aspiration) or belch (regurgitation), or if you have a disturbed gag reflex
• if you have an unstable blood pressure (haemodynamic instability)
• if you have a general weakness
• in children younger than 12 years, due to insufficient data on safety
• in patients who are unconscious or semi-conscious.
Take special care with VistaPrep
Contact your doctor:
• if you are an elderly patient
• if you have reflux disease (‘heartburn’, reflux oesophagitis)
• if you have existing problems with your heart rhythm (SA block syndrome or sick sinus syndrome).
• if your heart does not pump efficiently (a condition called ‘heart failure’), and you have discomfort when performing light to moderate exercise or while resting
• if your kidneys and/or liver are not working efficiently (renal and hepatic insufficiency)
• if you have kidney failure or liver disease
• if you have severe dehydration
• if you have severe colitis, diverticulitis or chronic inflammatory bowel disease
In these cases VistaPrep can only be used under the supervision of a doctor who will check your electrolytes and fluid balance.
This medicine contains 20 mmol potassium and 260 mmol sodium per 4 litres of VistaPrep solution. This should be taken into consideration by patients on a controlled potassium or sodium diet. Patients with problems of heart and blood vessels, other than unstable blood pressure or heart failure, can use VistaPrep, but at a lower rate, as is described in section 3 ‘How to use VistaPrep’.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Oral medicines that have been taken several hours prior to drinking VistaPrep solution may be washed out from the gastrointestinal tract and may not be effective. This includes oral medication to treat diabetes and the contraceptive pill. Therefore, additional contraceptive precautions are necessary. In case of any essential oral medication, ask your doctor for an alternative.
Using VistaPrep with food and drink
Do not eat any solid food for at least 2 hours before you start drinking the VistaPrep solution. You may drink coffee, juice, and clear liquids such as water and tea. You may eat solid food again after the examination. In case surgery was performed, the doctor will inform you when you may eat again.
Pregnancy and breast-feeding
There is as yet very little experience with the use of VistaPrep during pregnancy and breast-feeding. VistaPrep can only be used after careful consideration by a physician of the risks and benefits. If you are pregnant or breastfeeding, contact your doctor or pharmacist before you take VistaPrep.
3. How to use VistaPrep
Always use VistaPrep exactly as your doctor has told you. If your doctor has not given any specific advice, please follow the instructions in this leaflet. You should check with your doctor if you have any questions.
The recommended dose for complete bowel cleansing is 4 litres of VistaPrep solution (this means 8 sachets of VistaPrep dissolved in 4 litres of water). Dissolve each sachet of VistaPrep (55.218 g) in half a litre (500 ml) of lukewarm tap water. You can also use boiled water that has cooled. Wait until the powder has completely dissolved before drinking the solution. The solution may be stored at room temperature for no longer than 3 hours; it may be stored in the refrigerator for up to 48 hours.
Drink one glass (200 - 300 ml) of the solution every 10 minutes until you start passing clear fluids or until you have finished drinking the full dosage of 4 litres of the solution. Start drinking the solution at least 4 hours before the start of the examination or the surgery of the intestines. Alternatively, you can drink the solution the evening before the procedure, or drink a portion of the solution the evening before the procedure and the rest during the morning of the clinical procedure.
Patients with problems of heart and blood vessels, must not take more than a quarter of a litre per hour. This means that taking the full dosage of 4 litres will take 16 hours. It is therefore better to start drinking the solution 24 hours before the start of the procedure.
For a more agreeable taste, you may cool the solution in the refrigerator. Do not add anything to the solution (such as sugar or flavouring), as this may have an influence on the effect of the solution. It is also possible that gas mixtures will develop in the intestines caused by bacteria digesting such added components.
If you use more VistaPrep than you should
If you take considerably more VistaPrep than prescribed, this may lead to heavy diarrhoea. If this happens, you should drink large amounts of water and consult your doctor.
If you forget to use VistaPrep
If you do not use the VistaPrep solution or if you use considerably less than instructed, your intestines will not be emptied sufficiently. You must inform your doctor as the examination cannot be performed as planned. Therefore, always follow the instructions of your doctor. If your doctor has not given any instructions, please follow the instructions in this package leaflet. If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, VistaPrep can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Very common:
You may feel bloated, nauseous, have flatulence and feel dizzy.
Common:
Common side effects are vomiting, abdominal pains, soreness around the anus.
Uncommon:
General indisposition and sleeplessness.
Very rare:
Allergic reactions, skin eruption. oedema, cardiac failure.
In very rare cases, vomiting after using lavage solutions that contained macrogol (which is one of the active substances of VistaPrep) have caused bleeding in the upper gastrointestinal tract (Mallory-Weiss syndrome).
Counter-measures
In most cases these symptoms result from drinking a large volume within a short period of time. In such cases, reduce the amount of VistaPrep you drink per hour or stop drinking temporarily until the symptoms subside. Please consult your doctor.
If you have an allergic reaction to VistaPrep or if you develop symptoms such as swollen ankles, shortness of breath, increasing fatigue, feeling very thirsty with a headache or cardiac failure, stop taking VistaPrep and consult your doctor.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store VistaPrep
Keep out of the reach and sight of children.
Do not use VistaPrep after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store the powder sachets above 25 °C.
Store in the original package.
Once the contents of the sachets have been dissolved in water, the solution may be stored at room temperature (below 25 °C) for no longer than 3 hours, or in the refrigerator (2-8 °C) for no longer than 48 hours.
6. Further information What VistaPrep contains
• The active substances are macrogol 3350 (52.5 g per sachet), potassium chloride (0.185 g), sodium chloride (1.400 g), sodium bicarbonate (0.715 g).
• The other ingredients are sodium saccharin (E954), orange and lemon fruit flavour and silica colloidal, anhydrous.
What VistaPrep looks like and contents of the pack
VistaPrep is a white powder for the preparation of an oral solution for bowel cleansing. The powder is packaged in sachets of approximately 55 grams.
VistaPrep is available in packages of 8 or 96 sachets. VistaPrep is also available in boxes of 8 or 32 packages, each with 96 sachets.
Marketing Authorisation Holder
Tillotts Pharma UK limited Wellingore Hall Wellingore
Lincolnshire LN5 0HX United Kingdom Telephone.
D/D: +44 1484 422 449
Manufacturer
Klocke Pharma-Service GmbH Strassburger Strasse 77 D-77767 Appenweier Germany
Telephone: +49(0)7805 / 401 201