COLONPREP KIT A Soluble Powders For Oral Administration. CONSUMER MEDICINE INFORMATION WARNING: Serious dehydration and/or electrolyte disturbances may occur in some “at risk” patients. Read the section headed "Before You Take Colonprep Kit A”

What Is In This Leaflet ? Please read this leaflet carefully before you start to use your medicine. Keep the leaflet because you may want to read it again. It answers some of the common questions people ask about COLONPREP KIT A. It does not contain all the information that is known about COLONPREP KIT A. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. If you have any concerns about taking this medicine, ask your doctor or pharmacist.

PRODUCT DESCRIPTION COLONPREP KIT A contains 1. one sachet of ColonLYTELY which contains a soluble powder. 2. two sachets of PICOLAX. Each sachet contains a soluble, effervescent powder. 3. this leaflet. INGREDIENTS Each sachet of ColonLYTELY contains the active ingredient sodium sulfate which is a saline purgative. It also contains the following ingedients: polyethylene glycol, sodium bicarbonate, sodium chloride and potassium chloride. Each sachet of PICOLAX contains the active ingredients sodium picosulfate 10mg, Magnesium carbonate and Citric acid (forming magnesium citrate in solution). PICOLAX also contains Acesulfame potassium, Lemon flavour Trusil, Silicon dioxide (colloidal) and Povidone. PICOLAX is used for bowel emptying and cleansing. When taken by mouth it cleanses the bowel rapidly by inducing bowel action.

WHAT IS COLONPREP KIT A USED FOR? COLONPREP KIT A is a means of cleansing the lower bowel in preparation for endoscopic, barium enema, X-ray or surgical gastrointestinal examination.

HOW DOES COLONPREP KIT A WORK? ColonLYTELY: The sodium sulfate works by increasing retention of water in the intestine which induces bowel movement while the other ingredients ensure there is no net loss or gain of ions from the bowel. PICOLAX: Sodium picosulfate is hydrolysed by colonic bacteria forming active ingredient bis(p-hydroxyphenyl)-2-pyridylmethane, a colonic stimulant, which increases the motility of the colon, thereby promoting bowel movement. ColonLYTELY and PICOLAX each usually produces a bowel movement within 3 hours, depending on dosage and individual response.

BEFORE YOU TAKE COLONPREP KIT A YOU MUST NOT TAKE COLONPREP KIT A IF YOU HAVE:
gastrointestinal obstuction (a stomach blockage)
gastric retention (stomach retaining it’s food)












bowel perforation (a hole in the large bowel) toxic colitis (a poisonous and inflamed bowel)

toxic megacolon (a poisonous and enlarged large bowel) ileus (a painful stoppage in the intestine) stoma (surgical opening from the large bowel through the lower abdomen or stomach to the outside). vomiting or severe abdominal pain. a sachet that is beyond the end of the month of the expiry date printed on the pack. Medicines may have no effect at all, or worse, an entirely unexpected effect if you take them after the expiry date. a sachet that is not intact. hypersensitivity to any of the ingredients.

TELL YOUR DOCTOR OR PHARMACIST IF
you are taking other medicines. Oral medication administered within one hour of taking ColonLYTELY or PICOLAX may be flushed from the gastrointestinal tract and not absorbed.
you have ever had a reaction to ColonLYTELY, PICOLAX or any of their ingredients (see Product Description).
you have any nausea, vomiting, or abdominal pain.
you have noticed a sudden change in bowel habits that has persisted over a period of two weeks,
you are breast feeding or are pregnant or likely to become pregnant.
you have any rectal bleeding.
you have kidney problems, heart problems or diabetes. Discuss this carefully with your doctor before taking this product. If you are diabetic, the liquid diet recommended with this medication may affect your glucose blood levels and adjustment of your insulin or oral antidiabetic medicine may be necessary. PICOLAX contains 0.96 mg of sodium per sachet which should be taken into account by those on a low sodium diet. (0.96mg sodium = 0.042mEq sodium). If you have not told your doctor or pharmacist about any of these things, tell them before you take any COLONPREP KIT A.

DIRECTIONS FOR USE Follow all directions given by the doctor carefully. They may differ from the information contained in this leaflet.

FURTHER INFORMATION *Approved Clear Liquids are listed overleaf in the Patient Instruction Sheet. In case of accidental overdose or ingestion immediately contact a doctor or pharmacist or the Poisons Information Centre (telephone number 131126. This number is staffed 24 hrs a day, 7 days a week). If pain relief is needed, paracetamol only may be taken.

STORAGE Store COLONPREP KIT A in a cool, dry place where the temperature 0 stays below 30 C. Keep this, and all medicine, where young children cannot reach it. Do not store it, or any medicine, in the bathroom or near a sink. Heat and dampness causes medicines to deteriorate. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Do not leave medicine in the car on hot days.

SIDE EFFECTS All medicines can have side effects. Colonlytely or Picolax may cause unwanted side effects in some people. Tell your doctor or pharmacist if you do not feel well while you are taking Colonlytely or Picolax. For professional advice you may telephone 0403175339 during Office hours, Australian Eastern Standard Time. Common side effects of Colonlytely or Picolax are abdominal discomfort, vomiting, bloating or anal irritation. Side effects are usually transient and subside rapidly. Some side effects not listed may also occur in some patients. You may need medical treatment if you get some of the side effects. Do not take Colonlytely or Picolax if you think any of the ingredients listed might give you an allergy. Some of the symptoms of an allergic reaction might include an itchy skin rash, swelling of the face, lips or tongue, difficulty breathing, or faintness. However do not be alarmed by this list of possible side effects. You may not experience any of them. Tell your pharmacist if you don’t understand anything in this list.

HOW DO YOU KNOW IF THE PREP IS ADEQUATE?

When dissolving PICOLAX add the entire contents of one sachet slowly to approximately 250mL water in a jug. Stir until effervescence ceases. Gradually drink the mixture over 30 minutes. This is a single dose. This should be followed by as many 250mL glasses of water or Approved Clear Liquids* as desired in order to maintain hydration.

The stool should be watery in consistency. It does not have to be clear in colour like water since digestive juices will continue to tint the stool yellow and small flecks of debris are not a problem as long as the stool is not muddy or thick.

To prepare ColonLYTELY solution stir the powder into a one litre jug containing about two glasses of water. Stir briskly to dissolve. Add water to make up a 1 litre solution. Many have found that chilling the solution and drinking it through a straw improves tolerance.

Ask your pharmacist what to do with any medication you have left over.

DRINK PLENTY OF WATER prior to, during and after taking PICOLAX and ColonLYTELY. You should drink at least one 250mL glass of Approved Clear Liquids every hour (the more the better). Avoid excessive exercise so dehydration does not occur. A sachet should only be opened immediately before use. Do not exceed the recommended dose given in DIRECTIONS FOR USE. Please wear loose-fitting clothing and remain within easy reach of toilet facilities. Consider using a plastic cover sheet as a mattress protector for the bed. You should have someone with you to assist and to accompany you to and from the doctor.

DISPOSAL SPONSOR Dendy Pharmaceuticals Pty Ltd PO Box 3066, Dendy VIC 3186 Tel: 0403175339 Fax: 03 85184020 ABN 32 007 180 985 This leaflet was prepared Nov 2008 AUST R 54124 Doc. Code: 09055 ver 03.1 All enquires: [email protected]

Colonprep Kit A Patient Instruction Sheet FOR LOWER BOWEL PREPARATION FOR COLONOSCOPY, X-RAY, BARIUM ENEMA or OTHER ENDOSCOPIC EXAMINATION This Kit is made up of: (i) this leaflet (ii) two sachets of PICOLAX powder (iii) one sachet of ColonLYTELY powder The success of your examination depends on the bowel being as clear as possible, otherwise the examination may need to be repeated. The timing shown is a suggestion only. It may be varied by your doctor. Tick off each step as completed, and bring this sheet of paper with you when reporting for the examination. _________________________________________________________________________________________________________________________

TWO DAYS BEFORE EXAMINATION

Tick




Two days before the examination, begin this diet consisting of low fat and low fibre food and plenty of fluid.



☺

Not Allowed

Stop iron-containing medications, fibre (for example Metamucil) and constipation agents (for example Gastro-Stop, Imodium, Codeine, Lomotil). No fatty or oily foods. Do not eat red meat, brown bread, noodles, rice, cereals, milk, soy, fruit or vegetables. Do not have anything with seeds in it. Do not have yellow cheese, margarine or butter. No alcohol.

Allowed

You may eat cottage cheese, low-fat plain yoghurt, skim milk, white bread (plain or lightly toasted), boiled or poached eggs, steamed or microwaved white fish, boiled chicken, well cooked peeled pumpkin and peeled potato. You may add salt and pepper, to taste. You may have clear jelly and drink plenty of Approved Clear Liquids*.

ONE DAY BEFORE EXAMINATION No solid foods or milk products allowed. You may continue with your regular medication. Have only Approved Clear Liquids*. (refer to the list below for suggested Approved Clear Liquids*) Make up the sachet of ColonLYTLEY into a one litre solution following the “TO MAKE UP” instructions on the ColonLYTLEY sachet. Chill this solution, to your taste, in the refrigerator until required to drink. During the day drink at least one and a half litres of Approved Clear Liquids* in addition to the prepared solutions.


1st DOSE:

[ 5.00 p.m.] Add contents of ONE PICOLAX sachet slowly to approximately 250 mL water in a jug. Stir until effervescence ceases. Drink the solution gradually but completely. This should be followed by as many glasses of water or Approved Clear Liquids* as desired in order to maintain hydration (at least a glass every hour).


2nd DOSE:

[ 6.00 p.m.] Remove the made up ColonLYTLEY from the refrigerator. Follow the “INSTRUCTIONS FOR USE” on the ColonLYTLEY sachet. Over the next hour or more gradually drink a glass of the made up solution (approx. 250mL) every 15 minutes, followed by an Approved Clear Liquid. If you feel nausea or fullness, SLOW DOWN and take longer to drink the required amount completely. Many have found that chilling the solution and drinking it through a straw improves tolerance.


3rd DOSE:

[ 7.00 p.m.] Add contents of the second PICOLAX sachet slowly to approximately 250 mL water in a jug. Stir until effervescence ceases. Drink the solution gradually but completely. This should be followed by as many glasses of water or Approved Clear Liquids* as desired in order to maintain hydration (at least a glass every hour).

DAY OF EXAMINATION MORNING EXAMINATION

AFTERNOON EXAMINATION




From MIDNIGHT before the examination, nothing more to be taken by mouth until after the examination.




Appear for examination at scheduled time.




Drink only Approved Clear Liquids* for breakfast.





Nil by mouth from 6 hours before the examination. Appear for examination at scheduled time.

*APPROVED CLEAR LIQUIDS Water, clear salty fluids (eg: strained chicken noodle soup, a little Vegemite or Bonox in warm water, clear broth or bouillon.) Clear fruit juices (apple or pear) or clear cordials (lemon or lime) Black Tea or Coffee (no milk or whitener). Artificial sweeteners are permitted. Clear jelly, carbonated soft drinks, sports drinks, GastrolyteTM or LucozadeTM, no red or purple colourings. A hearty combination of these clear liquids (including 3 to 4 cups of clear soups) will give a variation in fluid intake. If doctor allows, sugar or honey is okay . You may suck barley sugar or equivalent. It is recommended you have ready, zinc cream or haemorrhoid cream. Apply early and often to prevent discomfort. Also the use of Baby Wipes (plain or aloe) may ease irritation. Individual responses to laxatives do vary. This preparation may cause multiple bowel movements. It usually induces frequent, loose bowel movements within only 2 to 3 hours of taking a dose. Please wear loose-fitting clothing and remain within easy reach of toilet facilities. You should have someone with you to assist and to accompany you to and from the doctor. If pain relief is needed, paracetamol only may be taken. For Professional Assistance with these instructions during Office hours, Aust. East. Standard Time, telephone: 0403175339 or email [email protected] This leaflet was prepared Nov 2008 Doc Code: 09056 Ver 02.1