Consumer medicine information

GLYCOPREP-C

Sodium chloride; Potassium chloride; Ascorbic acid; Sodium sulfate; Macrogol 3350

BRAND INFORMATION

Brand name

Glycoprep-C Powder for oral solution

Active ingredient

Sodium chloride; Potassium chloride; Ascorbic acid; Sodium sulfate; Macrogol 3350

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using GLYCOPREP-C.

What is in this leaflet

This leaflet answers some common questions about Glycoprep-C. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Glycoprep-C 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 is used for

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

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

Glycoprep-C produces watery stools or bowel motions within about an hour after the first administration and after 4 hours should produce a clear discharge.

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

When you must not take it

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

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

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 if you have, or have had, any of the following medical conditions:

  • Phenylketonuria - Glycoprep-C contains aspartame
  • Gastrointestinal blockage
  • Gastric retention - problems with food and fluid emptying from your stomach
  • Bowel perforation
  • Toxic megacolon - very dilated large intestine
  • A condition known as Paralytic Ileus where the small bowel does not work properly
  • Toxic colitis - severe inflammation of the large intestine
  • Severe dehydration
  • A body weight less than 20kg

Ensure you receive adequate fluids during the administration of Glycoprep-C, particularly if you are elderly.

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

  • Ulcerative colitis
  • Kidney problems
  • Heart problems
  • Diabetes
  • Dehydration
  • Stoma - is surgically created when a portion of the small or large intestine is brought out onto the abdomen.
  • Undiagnosed stomach pain

It may not be safe for you to take Glycoprep-C 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.

Glycoprep-C 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 is not generally recommended for use in pregnant women unless the benefits outweigh the risk to the unborn baby. Your doctor or pharmacist 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 buy without a prescription from your pharmacy, supermarket or health food shop.

These include:

  • Medicines for heart conditions
  • Other medicines that may affect electrolyte balance
  • Other bowel cleansing preparations

These medicines may be affected by Glycoprep-C, 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 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.

These include:

  • Oral contraceptives (‘the pill’)
  • Antibiotics
  • Medicines for diabetes

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

How to take Glycoprep-C

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 back of the sachet or in this leaflet, ask your doctor or pharmacist for help.

Glycoprep-C 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.

How much to take

A total of 210g of Glycoprep-C will be required for the procedure. Three lots of 70g sachets can be prepared and used as required or one 210g sachet can be prepared at once and used instead.

How to take it

It should be prepared and taken according to the directions in this leaflet unless otherwise directed by your doctor.

When to take it

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

On the day before the procedure
Only drink recommended clear sugar free fluids. No food should be taken until after the procedure. Drink at least one glass (approx. 250mL) of clear fluids each hour to maintain hydration.

**Recommended clear sugar free fluids include water, soups (e.g. strained chicken noodle soup), broth/bouillon, fruit juices (apple, pear, white grape), black tea or coffee (no milk), electrolyte replacing drinks, cordials (lemon/lime), plain jelly (no red or purple colourings). Barley sugar may be sucked if required.

Do not drink carbonated beverages.

Do not drink alcoholic beverages.

Prepare the Glycoprep-C solution by dissolving the contents of three 70g sachets (each in 1 litre of water) using a suitable food grade container; or, by dissolving the contents of the 210g sachet in 3 litres of water using a suitable food grade container. Refrigerate if desired.

Commence drinking the prepared Glycoprep-C solution as directed by your doctor. Drink approximately one or two 250mL glasses of the prepared solution every 15-20 minutes until completed. Drink the mixture slowly but completely. If you become nauseated, reduce the rate of intake.

Continue drinking adequate clear fluids.

Nothing more should be taken 6 hours prior to the procedure.

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

The onset of diarrhoea is about 1 hour and should be complete in 4 hours.

If you take too much (overdose)

Overdose is unlikely as Glycoprep-C 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 your doctor or the Poisons Information Centre for any further information. Australia: 13 11 26. New Zealand: 0800 764 766

While you are using Glycoprep-C

Things you must do

Glycoprep-C 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 to anyone else, even if they have the same condition as you.

Do not stop taking Glycoprep-C 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.

Glycoprep-C helps most people that require bowel cleansing in preparation for a bowel examination, 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

Do not be alarmed by this list. You may not experience any side effects.

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

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

If you get any side effects, do not stop taking Glycoprep-C 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

Storage

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

Do not store Glycoprep-C 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 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 sachet containing 70g or 210g of a white to off white dry powder.

Ingredients

Each sachet labelled Glycoprep-C contains macrogol 3350, sodium sulfate, sodium chloride and potassium chloride as the active ingredients. It also contains citric acid, ascorbic acid, aspartame and lemon flavour.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Glycoprep-C is supplied in Australia by:

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

Glycoprep-C is supplied in New Zealand by:

Fresenius Kabi New Zealand Limited
60 Pavilion Drive
Airport Oaks, Auckland 2022
New Zealand
Freecall: 0800 144 892

Australian Registration Number

AUST R 20538

This leaflet was prepared in July 2015.

BRAND INFORMATION

Brand name

Glycoprep-C Powder for oral solution

Active ingredient

Sodium chloride; Potassium chloride; Ascorbic acid; Sodium sulfate; Macrogol 3350

Schedule

S3

 

Name of the medicine

Each 70 g or 210 g sachet contains macrogol 3350 (polyethylene glycol) 755.69 mg/g, sodium sulfate (anhydrous) 80.62 mg/g, sodium chloride 37.33 mg/g, potassium chloride 10.55 mg/g, citric acid 12.77 mg/g, ascorbic acid 85.16 mg/g, aspartame 5.11 mg/g and lemon flavour 12.77 mg/g.

Description

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.

Sodium sulfate.

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

Glycoprep-C.

Glycoprep-C powder for solution is a white crystalline powder. When dissolved in water it produces a solution.

Pharmacology

Macrogol 3350 is not significantly absorbed and acts as an osmotic agent to induce a 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 is indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal procedure (such as colonoscopy, barium enema X-ray examination), prior to intravenous pyelograms (IVP) or colonic surgery.

Contraindications

Glycoprep-C should not be used by patients with hypersensitivity to any of the ingredients, phenylketonuria, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic colitis, toxic megacolon, ileus, severe dehydration or whose bodyweight is less than 20 kg.

Precautions

Use with caution in patients with severe ulcerative colitis, those with a stoma, impaired renal function, pre-existing electrolyte disturbances, dehydration, undiagnosed stomach pain, congestive heart failure, diabetics and in the elderly.
Patients with impaired gag reflex; who are semi-unconscious; who are prone to regurgitation or aspiration; and particularly those with nasogastric intubation; should be carefully observed during the administration of Glycoprep-C.
Patients with congestive heart failure; pre-existing electrolyte disturbances; kidney disease or impaired renal function; using calcium channel blockers; diuretics or other medications which may affect electrolyte levels; may need to be monitored.
There have also been reports of skin reactions and rhinorrhea attributed to macrogol which is contained in Glycoprep-C.
Glycoprep-C may cause bloating, distension or abdominal pain, especially if administered by nasogastric tube. If this develops, the rate of administration should be slowed or temporarily ceased until the symptoms abate.

Carcinogenesis, mutagenicity, impairment of fertility.

No carcinogenic or reproductive studies have been performed.

Use in pregnancy.

It is not known whether Glycoprep-C can cause foetal harm or affect reproductive capacity. Glycoprep-C should only be used if clearly needed.

Paediatric use.

The safety and efficacy 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.

Interactions

Oral medication taken within one hour of the commencement of the administration of Glycoprep-C, 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.

Adverse Effects

Nausea, abdominal fullness and bloating are the most common reactions.
Abdominal cramps, vomiting and anal irritation occur less frequently.
These adverse reactions are usually transient and subside rapidly.

Dosage and Administration

For oral use.

Glycoprep-C is usually taken the day before the procedure. This may be varied if considered appropriate by the doctor.

Guidance for clinicians/ doctors.

Glycoprep-C can be taken in the evening prior to the procedure (if a morning procedure) or on the morning of the procedure (if an afternoon procedure).

One day before the procedure.

Patients should fast until after the procedure. Patients should only drink recommended clear sugar free fluids. During the day, patients should drink at least one glass (approx. 250 mL) of fluids each hour to maintain hydration. Solid foods or milk products should not be taken.
** Recommended clear sugar free fluids: water, soups (e.g. strained chicken noodle soup), broth/ bouillon, fruit juices (apple, pear, white grape), black tea or coffee (no milk), electrolyte replacing drinks, cordials (lemon/ lime), plain jelly (no red or purple colourings). Barley sugar may be sucked if required.
The patient should not drink carbonated or alcoholic beverages.
Glycoprep-C produces a watery diarrhoea which empties and cleanses the bowel before procedure or surgery. It should be prepared and taken according to the directions. The onset of diarrhoea is about 1 hour and should be complete in 4 hours.

Preparation of solution.

The contents of the 70 g sachet should be dissolved in 1 litre of water using a suitable food grade container; or, the contents of the 210 g sachet should be dissolved in 3 litres of water using a suitable food grade container. The solution may be chilled if desired.

Usual dosage.

Glycoprep-C is usually taken orally but may be given by nasogastric tube to patients who are unwilling or unable to drink it.
A total of 210 g of Glycoprep-C will be required for the procedure. Three lots of 70 g sachets can be prepared and used as required or one 210 g sachet can be prepared at once and used instead.
The patient should fast for 2 hours before starting to take Glycoprep-C and only take clear fluids until after the procedure.
One or two 250 mL glasses of the prepared solution should be taken every 15-20 minutes. The recommended dosing intake rate is from 1.2 litres to 1.8 litres per hour. If nausea is experienced, the rate of intake of Glycoprep-C solution should be reduced. Lavage is complete when the faecal discharge is clear.
No food should be taken for 2 hours prior to commencing dosing. Only clear fluids are allowed during the interval between commencing the Glycoprep-C preparation and 6 hours prior to the procedure.

For nasogastric intubation.

Infuse the prepared solution at a rate of 20 to 30 mL/minute.
It is important that the patient follow the recommended dosing schedule.

Note.

Individual responses to laxatives may vary. The preparation may cause multiple bowel movements and usually induces frequent loose bowel movements within 2 to 3 hours of taking the first dose. Patients should be advised to remain within easy reach of toilet facilities and not plan to go out.

Overdosage

In the event of overdosage, dehydration may ensue.
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.

Presentation

Powder for reconstitution (dry, white crystalline, lemon flavour): 70 g, 210 g (sachets).

Storage

Store in a cool dry place below 25°C.

Poison Schedule

S3.