The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
OSMOPREP 1500MG TABLETS
Osmoprep 1500 mg Tablets
Sodium phosphate monobasic monohydrate
Disodium phosphate anhydrous
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
What Osmoprep Tablets are and what they are used for
What you need to know before you take Osmoprep Tablets
How to take Osmoprep Tablets
Possible side effects
How to store Osmoprep Tablets
Contents of the pack and other information
1. What Osmoprep Tablets are and what they are used for
Osmoprep Tablets contains the active substances sodium phosphate monobasic monohydrate and
disodium phosphate anhydrous which belong to a group of medicines that are described as
purgatives (very strong laxatives). They are used to clean the bowels by causing large amounts of
water to be drawn into the bowel resulting in diarrhoea.
Osmoprep Tablets are used for cleansing the bowel before certain diagnostic procedures such as
2. What you need to know before you take Osmoprep Tablets
Do not take Osmoprep Tablets if you have:
an allergy (hypersensitivity) to sodium phosphate salts or to any of the other ingredients of this
medicine (listed in section 6).
been told that you have kidney failure or that your kidneys have been damaged by the
formation of phosphate crystals (phosphate nephropathy).
a problem with your thyroid gland known as primary hyperparathyroidism.
problems with your heart, heart failure or severe chest pains.
an accumulation of fluid in your abdomen (ascites).
bowel problems such as blockages or severe chronic constipation or problems with emptying
inflammatory bowel disease or an enlarged colon (megacolon) or bowel perforation.
ever undergone gastric bypass surgery.
hypomotility syndrome (hypothyroidism, scleroderma).
If you are under 18 years of age, or over 75 years of age.
You must not use any other laxatives, particularly those containing sodium phosphate, while you are
using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Osmoprep Tablets.
Before you start taking this medicine you should tell your doctor if you:
have any heart problems, such as, arrhythmias, cardiomyopathy, recent history of myocardial
infarction, cardiac surgery, including coronary artery bypass graft surgery
have ever had any problems with your kidneys.
have ever had any problems with your stomach or intestine (guts).
have ever had problems with the salts in your blood such as high / low levels of sodium or
phosphate, or low levels of calcium or potassium.
have ever suffered from fits (seizures).
have an underactive thyroid.
have low blood pressure.
are elderly or weak.
have hypertension (high blood pressure).
have been told you are dehydrated or you cannot drink a lot of liquid.
have been told you have syndrome of inappropriate ADH secretion (SIADH).
have stopped drinking alcohol after a period of excessive consumption.
take Benzodiazepines (such as valium, medicines used to treat anxiety)
take Diuretics (water tablets)
take Calcium channel blockers or ACE Inhibitors (medicines used for angina, heart conditions
or high blood pressure)
take Angiotensin receptor blockers (such as losartan, used to treat high blood pressure)
take NSAIDs (medicines used for pain relief such as ibuprofen)
take Tricyclic antidepressants (medicines used to treat depression)
Your doctor may ask you to have some blood tests before and after you take this medicine to check the
levels of salts (electrolytes) in your body.
Osmoprep Tablets can lead to excessive loss of fluid as diarrhoea. You must ensure that you drink the
recommended amount of clear liquid or water to replace the large amounts of fluid that may be lost
during bowel evacuation.
Children and adolescents
Do not give Osmoprep Tablets to children under 18 years of age
REMEMBER you need to be close to toilet facilities whilst you are taking Osmoprep Tablets as you can
expect to have frequent and watery stools. The medicine usually acts 30 minutes to 6 hours after taking the
tablets. If you have not had a bowel movement after 6 hours, do not take any more medicine and contact
your doctor immediately.
Other medicines and Osmoprep Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including those obtained without a prescription.
It may still be alright for you to use Osmoprep Tablets and your doctor will be able to decide what is
suitable for you.
In particular, please tell your doctor if you take or use any of the medicines mentioned below as their
effects may change:
Calcium channel blockers or ACE Inhibitors (medicines used for angina, heart conditions or
high blood pressure)
Diuretics (water tablets)
Lithium containing medicines (used to treat mental illness)
Medicines containing aluminium, calcium or magnesium salts (may reduce the absorption of
Vitamin D containing medicines (may increase phosphate absorption)
Medicines such as oral contraceptives, antibiotics, medicines used to treat diabetes and
medicines used to treat epilepsy (the effects of these medicines may be delayed or prevented)
NSAIDs (medicines used for pain relief such as ibuprofen)
Tricyclic antidepressants (medicines used to treat depression)
Benzodiazepines (such as valium, medicines used to treat anxiety)
Parathyroid hormone (used for treating osteoporosis)
Angiotensin receptor blockers (such as losartan, used to treat high blood pressure)
Medicines that alter the rhythm of your heart
DO NOT take any other laxatives, rectally administered medicines or other medication containing sodium
phosphate while taking Osmoprep Tablets.
Patients should not repeat taking this purgative agent for at least 7 days.
You may see undigested or partially digested Osmoprep Tablets or undigested tablets of other medications
in the watery diarrhoea stools.
Osmoprep Tablets with food and drink
Osmoprep Tablets should not be taken with food. On the day prior to colonoscopy you may have a light,
low fibre breakfast (coffee or tea with or without sugar, toast, butter or equivalent, fruit jelly or honey)
before 12 noon. After 12 noon you should only drink clear liquids such as water, any clear carbonated
(fizzy) drink with or without bicarbonate, light soup, diluted fruit juice with no pulp, black coffee and
weak tea before taking Osmoprep Tablets and while you are taking the tablets.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, you should only use Osmoprep Tablets if your doctor tells you to. If you are
breastfeeding your baby, you should not breastfeed whilst taking Osmoprep Tablets and not restart
breastfeeding until 24 hours after taking the last dose has passed.
Driving and using machines
This medicine may make you feel dizzy. If you are affected by this, you should not drive or use machines
until this feeling has gone.
Osmoprep Tablets contains 313 mg of sodium per tablet. This is to be taken into consideration by
patients on a controlled sodium diet.
3. How to use Osmoprep Tablets
Always use this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The tablets should be taken by mouth in the following manner.
Dosage for adults (over 18 years of age):
See the section above (Osmoprep Tablets with food and drink) for details of what you can eat before you
take these tablets.
The usual dose of Osmoprep Tablets is 32 tablets. The tablets are usually taken in the following manner:
The evening before the colonoscopy procedure, take 4 Osmoprep Tablets with 250 mL of water (or
another clear liquid) every 15 minutes until you have taken a total of 20 tablets.
The day of the colonoscopy procedure, (starting 3-5 hours before the procedure) take 4 Osmoprep Tablets
with at least a glass (250 mL) of water (or another clear liquid) every 15 minutes for a total of 12 tablets.
Osmoprep Tablets can make you dehydrated. It is important that you take this medicine and the quantities
of clear liquid as directed above, and drink as much clear liquid or water as you can to replace the large
amounts of fluid that may be lost during bowel evacuation.
A tablet check-off chart is provided below to help you make sure that you take all the tablets at the right
time. You should record the start date and the time you take each dose. After swallowing each dose you
should check-off the corresponding box for that dose. You should ensure that you have a clock or watch
nearby before you start taking Osmoprep Tablets.
First Dosing Regimen (To be taken the evening before the examination)
+ 15 min
+ 30 min
+ 45 min
+ 1 hr
Total = 20 tablets
Second Dosing Regimen (To be taken 3 to 5 hours before the examination)
+ 15 min
+ 30 min
Total = 12 tablets
If your examination is early morning, it is possible to take all of the tablets in the evening before the
procedure. You will need to start taking the tablets at least 4 and a half hours before you go to bed. For
example, if you are planning on going to bed at 11pm, you should take dose 1 at 6.30pm. So, at 6.30pm,
you would take 4 tablets with 250 mL of water (or another clear liquid), and repeat this every 15 minutes
until you have taken a total of 20 tablets. You must then wait 3 hours after dose 5 before starting the
second dosage regimen. With this example, you would take another 4 tablets at 10.30pm with 250 mL of
water (or another clear liquid) every 15 minutes until you have taken a total of 12 tablets. Your last dose
would be at 11pm.
First Dosing Regimen (To be taken at least 4 and a half hours before going to bed)
+ 15 min
+ 30 min
+ 45 min
+ 1 hr
Total = 20 tablets
Second Dosing Regimen (To be taken at least 3 hours after dose 5)
+ 15 min
+ 30 min
Total = 12 tablets
If you take more Osmoprep Tablets than you should
Contact a doctor immediately if you have taken more than the recommended dose of Osmoprep Tablets.
If you forget to take Osmoprep Tablets
Do not take a larger than normal dose of Osmoprep Tablets next time, but take your next dose of
Osmoprep Tablets as soon as you remember and continue taking the tablets every 15 minutes until you
have completed the course.
When you stop taking Osmoprep Tablets
Bowel movements may continue for several hours after your last dose of Osmoprep Tablets has been
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. If you get
any of the following symptoms after taking this medicine, you should contact your doctor
Rash or skin itching
Tightness or swelling of the throat, lips and face
Tingling of the lips and tongue
Seizures or loss of consciousness
Abnormal heart rhythm, muscle twitching or spasms
See your doctor as soon as possible if you notice any of the following:
Kidney failure and / or other problems with the kidneys (symptoms may include, weight gain,
swollen ankles, feet or hands, blood or protein in your urine, an increased need to urinate, weakness,
Electrolyte levels in your blood have changed (symptoms may include, feeling tired, thirsty, feeling
sick, tingles, weakness, irregular heartbeat)
The following side effects have also been reported:
Very common: (may affect more than 1 in 10 people)
Abdominal bloating, abdominal pain and nausea
Chills, feeling weak
Common: (may affect up to 1 in 10 people)
Headache, dizziness, vomiting
Ulcers in the lower gut (near your bottom). These clear up after treatment.
Superficial gastric erosions in your stomach, which may cause some pain or discomfort in this area.
These clear up after treatment.
Uncommon: (may affect more than 1 in 100 people)
Rare: (may affect up to 1 in 1,000 people)
Low magnesium level in your blood
Very rare: (may affect up to 1 in 10,000 people)
Low blood pressure
Kidney failure and / or other problems with the kidneys
If you are worried by any of these side effects, or they get worse or you get side effects not listed in
this leaflet, talk to your doctor or pharmacist.
5. How to store Osmoprep Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle.
Do not store above 25°C. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Osmoprep Tablets contains
The active substances of Osmoprep Tablets are 1102 mg of sodium phosphate monobasic monohydrate
and 398 mg of disodium phosphate anhydrous.
The other ingredients are macrogol 8000 and magnesium stearate.
What Osmoprep Tablets looks like and contents of the pack
Osmoprep Tablets are white to off-white oval tablets, with “SLX” printed on the left side and “102”
printed on the right side of the breakline. The reverse side of the tablets is unmarked.
Osmoprep Tablets are available in bottles containing 32 tablets. The bottle contains all the tablets you
need for a complete dose. The bottle also contains two desiccants, which should not be swallowed.
Marketing Authorisation Holder and Manufacturer
Laboratoires MAYOLY SPINDLER
6, Avenue de l’Europe – BP 51
78401 CHATOU CEDEX
Tel: +44 (0)1279 406759
This leaflet was last revised in: 02/2013
Marketing authorisation number: PL 19549/0001
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.