Consumer medicine information

Glycoprep-C Kit Combination pack

Potassium chloride; Macrogol 3350; Sodium sulfate; Sodium chloride; Citric acid; Magnesium carbonate hydrate; Bisacodyl

BRAND INFORMATION

Brand name

Glycoprep-C Kit Combination pack

Active ingredient

Potassium chloride; Macrogol 3350; Sodium sulfate; Sodium chloride; Citric acid; Magnesium carbonate hydrate; Bisacodyl

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Glycoprep-C Kit Combination pack.

What is in this leaflet

This leaflet answers some of the common questions people ask about Glycoprep-C Kit.

It does not contain all the available information that is known about Glycoprep-C Kit. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Glycoprep-C Kit against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Glycoprep-C Kit is used for

Glycoprep-C Kit is used for bowel cleansing in conjunction with intravenous pyelograms (IVP), x-ray examinations, surgery and colonoscopy.

The bowel needs to be clean before your doctor can examine it properly.

Glycoprep-C Kit produces watery stools or bowel motions within 2 to 3 hours after the first administration depending on your individual response.

This medicine belongs to a group of medicines called Bowel Preparations.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take Glycoprep-C Kit

When you must not take it

Do not take Glycoprep-C Kit if you have an allergy to:

  • Any of the ingredients listed at the end of this leaflet
  • Any similar medicines to Glycoprep-C Kit

Some symptoms of an allergic reaction may include:

  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Skin rash, itching or hives

Do not take Glycoprep-C Kit if you have, or have had, any of the following medical conditions:

  • Kidney failure or disease
  • Heart failure
  • Phenylketonuria - Glycoprep-C contains aspartame
  • Gastrointestinal blockage
  • Gastric retention - problems with food and fluid emptying from your stomach
  • Bowel perforation
  • Damage to the entire thickness of the intestinal wall
  • Severe distension in the colon
  • Blockage in the bowel
  • Active inflammatory bowel disease
  • A hole in the stomach, large intestine or small intestine
  • Toxic megacolon, very dilated large intestine
  • Toxic colitis severe inflammation of the large intestine
  • A condition known as Paralytic Ileus where the small bowel does not work properly
  • Nausea and vomiting
  • Severe dehydration
  • Appendicitis or inflammation of the appendix
  • A body weight less than 20kg.

Ensure you receive adequate fluids during the administration of Glycoprep-C Kit.

Do not take Glycoprep-C Kit after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure when you should start taking Glycoprep-C Kit, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • Inflammatory bowel disease
  • Kidney problems
  • Heart problems
  • Diabetes
  • Dehydration
  • Recent gastrointestinal surgery
  • Undiagnosed stomach pain
  • Ulcerative Colitis
  • Stoma - is surgically created when a portion of the small or large intestine is brought out onto the abdomen.

It may not be safe for you to take Glycoprep-C Kit if you have these conditions.

Caution should be exercised in “at risk” patients such as the elderly who are more at risk of dehydration as electrolyte depletion may occur, people with impaired kidney function, diabetes or heart condition. Consult your doctor before use.

Glycoprep-C Kit is not recommended in children as the safety and effectiveness in children has not been established.

Tell your doctor or pharmacist if you are pregnant, intend to become pregnant or are breast-feeding.

Glycoprep-C Kit is not generally recommended for use in pregnant women unless the benefits outweigh the risk to the unborn baby. Your doctor will discuss the benefits and possible risks with you.

Tell your doctor or pharmacist if you are diabetic.

The liquid diet recommended with this medication may affect your blood glucose levels and adjustment of your diabetic medication may be required.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

These include:

  • Iron medications
  • Medicines for heart conditions
  • Other bowel cleansing preparations or laxatives
  • Medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced (diuretics)
  • Bacitracin and benzylpenicillin.

These medicines may be affected by Glycoprep-C Kit, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Medications that are taken just before or during the course of Glycoprep-C Kit may not be absorbed. This is due to the increased movement in the digestive tract and the watery diarrhoea that is caused by Glycoprep-C Kit.

  • Birth control pills (Oral contraceptives)
  • Medicines used to treat infections (antibiotics)
  • Medicines for diabetes

Your doctor or pharmacist will have more information on medicines to be careful with or avoid while taking Glycoprep-C Kit.

How to take Glycoprep-C Kit

Patient instructions may be found on the carton and in the end of this consumer medicine information leaflet. In some circumstances, your doctor may choose to modify these dose instructions. Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the carton or in this leaflet, ask your doctor or pharmacist for help.

Glycoprep-C Kit will produce numerous bowel motions within a short period of time. Ensure you have bathroom facilities within easy access from when you start to take Glycoprep-C Kit.

The success of your examination depends on the bowel being as clear as possible. Otherwise, the examination may need to be repeated. So it is important to take all the medicine and follow all your doctor's instructions.

How much to take

Glycoprep-C Kit contains only enough medication for one treatment.

The contents may be taken several hours apart on the day before the examination.

How to take it

The glycoprep-C and magnesium citrate sachets must be made up in water before drinking. The detailed instructions for reconstituting the sachets are in the carton.

Swallow the bisacodyl tablets whole.

Do not crush or chew the tablets.

Preparation for the procedure begins seven days prior to the procedure. Refer to the Patient Instructions on the back of this leaflet for details.

Glycoprep-C Kit is taken the day before the procedure unless otherwise stated by your doctor.

It is important that you follow the instructions specifically given by the hospital and that you drink plenty of clear fluids.

Recommended Clear Fluids:
Include water, strained fruit juice without pulp (apple, white grape, pineapple, pear), clear broth, tea or coffee without milk or cream, clear sugar-free cordials such as lemon or lime (no red or purple colourings), plain sugar-free jelly (no red or purple colourings) and clear ice blocks (no red or purple colourings).

Do not drink carbonated beverages.

Do not drink alcoholic beverages.

REMEMBER you need to be close to toilet facilities whilst you are taking Glycoprep-C Kit.

Bowel movements may continue for several hours after the last dose of Glycoprep-C Kit has been taken.

No food to be taken on the day of procedure.

No drink should be taken for six (6) hours prior to the procedure.

If you take too much (overdose)

Overdosage is unlikely as Glycoprep-C Kit contains only enough medication for one treatment.

However in the event of an overdose, dehydration is likely and immediate action should be taken to restore electrolyte balance with appropriate fluid replacement.

Contact the Poisons Information Centre for any further information.
Australia: 13 11 26
New Zealand: 0800 764 766

While you are taking Glycoprep-C Kit

Things you must do

Glycoprep-C Kit can lead to serious dehydration and electrolyte disturbances. You must ensure that you drink the recommended amount of liquid to replace the large amounts of fluid that may be lost during bowel emptying.

Ask your doctor or pharmacist to answer any questions you may have.

Things you must not do

Do not take any additional bowel preparation or laxative products.

Do not give Glycoprep-C Kit to anyone else, even if they have the same condition as you.

Do not stop taking Glycoprep-C Kit or lower the dose without checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Glycoprep-C Kit.

Glycoprep-C Kit helps most people that require bowel cleansing, but it may have unwanted side effects in a few people. All medicines can have some unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

The following is a list of possible side effects. Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Nausea (feeling sick)
  • Vomiting
  • Stomach pain
  • Stomach bloating
  • Anal irritation
  • Allergic reaction

Do not be alarmed by this list. You may not experience any of them.

If the effects are severe, you may need medical treatment.

However these side effects usually disappear when treatment with Glycoprep-C Kit is finished.

If you get any side effects, do not stop taking Glycoprep-C Kit without first talking to your doctor or pharmacist.

Other side effects not listed may also occur in some patients. Tell your doctor or pharmacist if you notice anything unusual that is making you feel unwell.

After using Glycoprep-C Kit

Storage

Keep Glycoprep-C Kit in a cool dry place where the temperature stays below 25°C.

Do not store Glycoprep-C Kit or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in the car on hot days.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking Glycoprep-C Kit or it has passed the expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

A carton containing a 210g sachet of white powder labelled Glycoprep-C, a 21.5g sachet of white powder labelled Magnesium Citrate and a blister pack of 3 yellow 5mg Bisacodyl tablets.

Ingredients

Each Glycoprep-C Kit contains the following products:

Each Bisacodyl tablet contains 5mg of bisacodyl as the active ingredient. It also contains:

Lactose, sucrose, gelatin, starch, calcium carbonate, silica-colloidal anhydrous, magnesium stearate, macrogol 6000 and quinoline yellow (104), methacrylic acid copolymer, cellulose microcrystalline, povidone, talc-purified, sodium starch glycolate A and antifoam AF emulsion QF 2587 (PI 1515).

Each sachet labelled Magnesium Citrate contains a white powder for solution, composed of the active ingredients magnesium carbonate - heavy 7.5g and citric acid anhydrous 14g which together forms magnesium citrate in solution.

Each sachet labelled Glycoprep-C contains a white powder for solution composed of macrogol 3350 (polyethylene glycol) 158.7g, sodium chloride 7.8g, potassium chloride 2.2g, sodium sulfate anhydrous 16.9g as the active ingredients. It also contains ascorbic acid, citric acid anhydrous, aspartame and lemon flavour QL58817.

Glycoprep-C Kit does not contain gluten, tartrazine or any other azo dyes.

Glycoprep-C Kit does not contain any preservative.

Australian Registration Number AUST R 20774

Supplier

Fresenius Kabi Australia Pty Limited
964 Pacific Highway
Pymble NSW 2073
Telephone: 1300 361 004

This leaflet was last updated in February 2016.

BRAND INFORMATION

Brand name

Glycoprep-C Kit Combination pack

Active ingredient

Potassium chloride; Macrogol 3350; Sodium sulfate; Sodium chloride; Citric acid; Magnesium carbonate hydrate; Bisacodyl

Schedule

S3

 

Name of the medicine

Glycoprep-C Kit is a composite pack containing the following.

Bisacodyl tablets.

Bisacodyl 5 mg.

Excipients.

Calcium carbonate, anhydrous colloidal silica, gelatin, lactose, macrogol 6000, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, purified talc, quinoline yellow, sodium starch glycolate A, starch, sucrose and antifoam AF emulsion QF 2587 (PI 1515).

Magnesium citrate sachet powder for solution.

Each 21.5 g sachet contains heavy magnesium carbonate 7.5 g and anhydrous citric acid 14 g, which together form a magnesium citrate solution when dissolved in water.

Glycoprep-C sachet powder for solution.

Each 210 g sachet contains macrogol 3350 (polyethylene glycol) 158.7 g, sodium chloride 7.8 g, potassium chloride 2.2 g and anhydrous sodium sulfate 16.9 g.

Excipients.

Ascorbic acid, anhydrous citric acid, aspartame and lemon flavour QL58817.

Description

Glycoprep-C.

Macrogol 3350.

Molecular formula: HOCH2 [CH2OCH2]m. CH2OH (where ‘m’ equals 45 to 70).

Sodium chloride.

Molecular formula: NaCl. MW: 58.44. CAS: 7647-14-5.

Potassium chloride.

Molecular formula: KCl. MW: 74.6. CAS: 7447-40-7.

Anhydrous sodium sulfate.

Molecular formula: Na2SO4. MW: 142.0. CAS: 7757-82-6.

Bisacodyl.

Chemical name: 4,4'-(pyridin-2-ylmethylene) diphenyl diacetate. Molecular formula: C22H19NO4. MW: 361.4. CAS: 603-50-9. A white or almost white crystalline powder. Bisacodyl is practically insoluble in water, soluble in acetone, sparingly soluble in ethanol (96 percent). It dissolves in dilute mineral acids.

Magnesium citrate.

Molecular formula: C6H6MgO7. MW: 214.41. A white crystalline powder. Magnesium citrate is made in situ from heavy magnesium carbonate and anhydrous citric acid when dissolved in water.

Magnesium carbonate.

Molecular formula: MgCO3. MW: 84.31. CAS: 546-93-0. Magnesium carbonate is a white powder practically insoluble in water. It dissolves in dilute acids with strong effervescence.

Anhydrous citric acid.

Molecular formula: C6H8O7. MW: 192.1. CAS: 77-92-9. Anhydrous citric acid is a white crystalline powder, colourless crystals or granules, very soluble in water and freely soluble in alcohol.

Pharmacology

Bisacodyl.

Bisacodyl is a stimulant laxative acting mainly in the large intestine. It acts locally in the gastrointestinal tract, stimulating the sensory nerve endings in the colonic mucosa to produce parasympathetic reflexes resulting in increased peristaltic contractions of the colon. Local axonic reflexes as well as segmental reflexes are initiated in the region of contact and contribute to the widespread peristaltic activity producing evacuation. For this reason bisacodyl may be used in patients with ganglionic blockage or spinal cord damage (e.g. paraplegia, poliomyelitis).

Pharmacokinetics.

Following oral administration, bisacodyl is converted to the active desacetyl metabolite bis(p-hydroxyphenyl)pyridyl-2-methane by intestinal and bacterial enzymes. Absorption from the gastrointestinal tract is minimal with enteric coated tablets or suppositories. The small amount absorbed is excreted in the urine as a glucuronide. Bisacodyl is mainly excreted in the faeces. When taken on an empty stomach, bisacodyl tablets will have an effect within 6 to 8 hours. When taken with food the effect of the tablets is exhibited within 10 to 12 hours.

Magnesium citrate.

Magnesium citrate is an osmotic laxative. Magnesium citrate is not significantly absorbed and acts by increasing the intestinal osmotic pressure thereby promoting retention of fluid within the bowel. Magnesium citrate draws water from the tissues into the small intestine. This stimulates the normal forward movement of the intestines (peristalsis), resulting in bowel movement within 3 to 6 hours.

Glycoprep-C.

A mixture of macrogol 3350 with electrolytes is used as an osmotic laxative to empty the bowel. Macrogol 3350 is not significantly absorbed and acts as an osmotic agent to induce watery diarrhoea usually within 1 hour after commencing treatment and which normally removes the bowel contents by about 4 hours after commencing treatment. The water and included electrolytes are iso-osmotic with normal intestinal contents and help to reduce or prevent electrolyte or water loss.

Indications

Glycoprep-C Kit is indicated for bowel cleansing in conjunction with intravenous pyelograms (IVP), abdominal X-ray examinations, surgery and colonoscopy.

Contraindications

Glycoprep-C Kit should not be used by patients with: clinically significant renal impairment; severe dehydration; acute abdominal conditions such as appendicitis, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic megacolon, paralytic ileus, toxic colitis; body weight is less than 20 kg; hypersensitivity to any of the ingredients; phenylketonuria (Glycoprep-C contains aspartame).

Precautions

Use with caution in patients with heart conditions, severe ulcerative colitis, inflammatory bowel disease (IBD), marked bloody diarrhoea, impaired renal function, pre-existing electrolyte disturbances, congestive heart failure, diabetes, those with a stoma and debilitated or elderly patients.
Patients with impaired gag reflex, who are semiconscious, are prone to regurgitation or aspiration should be carefully observed during the administration of Glycoprep-C Kit.
Glycoprep-C Kit is likely to cause transient hypovolaemia, hence adequate fluid intake or replacement should be ensured (see Dosage and Administration).
Patients with congestive heart failure should be monitored; as should patients using calcium channel blockers, diuretics or other medications that may affect electrolyte levels.
Patients with kidney disease or impaired renal function should also be monitored, as should those with pre-existing electrolyte disturbances.
There have been reports of skin reactions and rhinorrhea attributed to macrogol which is contained in Glycoprep-C Kit.
Glycoprep-C Kit may cause bloating, distension or abdominal pain. If this develops, the rate of administration should be slowed or temporarily ceased until the symptoms abate.
Nephrocalcinosis and renal impairment may occur following the use of this medicine.
Phenylketonurics are warned that this product contains phenylalanine.

Effects on fertility.

No fertility studies have been conducted.

Use in pregnancy.

It is not known whether Glycoprep-C Kit can cause foetal harm or affect reproductive capacity. Glycoprep-C Kit should only be used if the benefits clearly outweigh the risks.

Use in lactation.

No lactation studies have been conducted.

Paediatric use.

The safety and efficacy of Glycoprep-C Kit in children has not been established.

Use in the elderly.

Caution should be exercised in the elderly as dehydration and electrolyte depletion may occur. Elderly patients must receive adequate fluids during administration.

Genotoxicity.

No genotoxic studies have been conducted.

Carcinogenicity.

No carcinogenic studies have been conducted.

Interactions

Oral medication taken within one hour of the commencement of the administration of Glycoprep-C Kit, to one hour after completing its administration may be flushed from the gastrointestinal tract and not absorbed.
Sustained release preparations, or medicines with a short half-life or a narrow therapeutic window may need to be taken more than one hour before or after administration of Glycoprep-C.
The low dose contraceptive pill will not work when taken with Glycoprep-C as it needs as much time as possible in the gastrointestinal tract for absorption.
There is a possible reduction in the effect of bacitracin and benzylpenicillin when used in conjunction due to the macrogol content of Glycoprep-C.
Seven days prior to procedure stop taking all iron containing medications. Continue with other regular medications.
Glycoprep-C may potentially interact with medicines for heart conditions such as calcium channel blockers, diuretics or other medications that may affect electrolyte levels, and other bowel cleansing preparations or laxatives.
Glycoprep-C may potentially interact with medicines for diabetes and diabetic patients may require adjustment of their diabetic medication, as the recommended liquid diet may affect blood glucose levels.

Adverse Effects

Nausea, abdominal fullness and bloating are the most common adverse reactions. Abdominal cramps, vomiting and anal irritation occur less frequently.
These adverse effects are usually transient and subside rapidly.
Use can result in diarrhoea with excessive loss of water and electrolytes particularly in at risk patients, and/or where fluid intake is inadequate. Hypersensitivity reactions including angioedema and anaphylactoid reactions have been reported rarely.

Dosage and Administration

Information for patients.

Glycoprep-C Kit produces watery stools or bowel motions some 2 to 3 hours after the first administration. This action cleanses the bowel before the procedure. Patients should be warned that Glycoprep-C Kit will cause frequent loose bowel motions and there may also be a number of bowel actions during the night. Patients should ensure bathroom facilities are within easy access.
Glycoprep-C Kit should be prepared and taken according to the directions on the carton or as per the below dosage instruction.
The bisacodyl tablets should be taken whole and not crushed or chewed.
Glycoprep-C Kit contains aspartame. Patients suffering from phenylketonuria need to be advised accordingly.
It is important the patient follows the recommended dosing schedule and ensures an adequate intake of fluids.

Usual dosage (adult).

Not recommended in children.
Glycoprep-C Kit should be prepared and taken according to the directions unless otherwise directed by your doctor.
Preparation for the procedure begins seven (7) days before the procedure.

Directions.

Recommended clear fluids.

Recommended clear fluids which may be consumed whilst taking Glycoprep-C Kit include water, strained fruit juice without the pulp (apple, white grape, pineapple, pear), clear broth, tea or coffee without milk or cream, clear sugar free cordials such as lemon or lime (no red or purple colourings), plain sugar free jelly and clear ice blocks. Do not drink carbonated beverages. Do not drink alcoholic beverages.

7 days prior to procedure.

Stop taking all iron containing medication. Continue with other regular medications.

2 days prior to procedure.

1. Stop eating brown bread, red meat, cereals, vegetables and fruit. Do not have anything with seeds in it. Do not have any hard cheese.
2. You may eat eggs, steamed white fish, boiled chicken, cottage cheese, low fat plain yoghurt, white bread, white pasta, white rice, clear jelly, skim milk and well cooked pumpkin or peeled potato.

1 day prior to procedure.

1. No food or milk products allowed.
2. Drink only recommended clear fluids.
3. During the day drink at least one glass (approx. 250 mL) of clear fluids each hour to maintain hydration. Continue drinking recommended clear fluids until bedtime.
4. Prepare the magnesium citrate solution by dissolving the contents of the sachet in one glassful of hot water (approx. 250 mL) and refrigerate prior to use.
5. Prepare the Glycoprep-C solution by dissolving the contents of the 210 g sachet in three (3) litres of water and refrigerate prior to use.
6. At approximately 2 pm take the three (3) bisacodyl tablets with one full glass (approx. 250 mL) of water.
7. At approximately 5 pm drink the magnesium citrate solution which was previously prepared.
8. At approximately 7 pm commence drinking the Glycoprep-C solution which was previously prepared. Drink approximately 1 to 2 glasses every 15 to 20 minutes until completed. Drink the mixture slowly but completely. If you become nauseated, reduce the rate of intake.
9. Continue drinking adequate glasses of recommended clear fluids until bedtime.

On the day of procedure.

No food to be taken.
No drink should be taken for six (6) hours prior to the procedure.

Overdosage

Overdose is unlikely as the carton contains only enough medication for one treatment. However in the event of an overdose, dehydration may occur. Calcium, potassium, chloride and sodium levels should be carefully monitored and immediate corrective action should be taken to restore electrolyte balance with appropriate fluid replacements.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

Presentation

Combination pack (carton, AUST R 20774). Bisacodyl 5 mg tablets (yellow): 3's (blister pack) + magnesium citrate 21.5 g powder for solution (heavy magnesium carbonate 7.5 g + anhydrous citric acid 14 g; dry, white, effervescent, crystalline): 1's (sachet) + Glycoprep-C 210 g powder for solution (white, crystalline): 1 sachet.

Storage

Store in a dry place. Store below 25°C.

Poison Schedule

S3.