Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Glycoprep. 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 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 is used for

Glycoprep 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 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

When you must not take it

Do not take Glycoprep if you have an allergy to:

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

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

• 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 doesn’t 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, particularly if you are elderly.

Do not take Glycoprep 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, 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 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 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 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 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:

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

These medicines may be affected by Glycoprep, 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 may not be absorbed. This is due to the increased movement in the digestive tract and the watery diarrhoea that is caused by Glycoprep.

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.

How to take Glycoprep

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 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.

How much to take

Glycoprep contains only enough medication for one treatment.

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 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 solution by dissolving the contents of the 200g sachet in 3 litres of water and refrigerate if desired.

Commence drinking the prepared Glycoprep 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. 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 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 further information.
Australia: 13 11 26
New Zealand: 0800 764 766

While you are using Glycoprep

Things you must do

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

Do not stop taking Glycoprep 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.

Glycoprep 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 of side effects.

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

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

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

Storage

Keep Glycoprep in a cool dry place where the temperature stays below 30°C.

Do not store Glycoprep 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 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 200g of a white to off-white dry powder.

Ingredients

Each sachet labelled Glycoprep contains macrogol 3350, sodium chloride, potassium chloride, sodium sulfate and sodium bicarbonate as the active ingredients. This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Glycoprep is supplied in Australia by:

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way Mount Kuring-gai NSW 2080
Ph:1300 732 001

Glycoprep 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 on 12 April 2012

Published by MIMS July 2020

Name of the medicine

Each 200 g sachet contains macrogol 3350 (polyethylene glycol) 856.92 mg/g, sodium chloride 22 mg/g, potassium chloride 11.25 mg/g, sodium sulfate (anhydrous) 84.51 mg/g and sodium bicarbonate 25.32 mg/g.

Description

The active ingredients are:
macrogol 3350 has a chemical formula of HOCH₂ [CH₂OCH₂]m. CH₂OH (where 'm' equals 45 to 70);
sodium chloride has a chemical formula of NaCl, a MW of 58.44 and a CAS No. 7647-14-5;
potassium chloride has a chemical formula of KCl, a MW of 74.6 and a CAS No. 7447-40-7;
sodium sulfate has a chemical formula of Na₂SO₄, a MW of 142.0 and a CAS No. 7757-82-6;
sodium bicarbonate has a chemical formula of NaHCO₃, a MW of 84.0 and a CAS No. 144-55-8.
Glycoprep powder for solution is a white crystalline powder packed in a sachet containing 200 g. When dissolved in water it produces a solution.
Each 200 g sachet contains macrogol 3350 (polyethylene glycol) 856.92 mg/g, sodium chloride 22 mg/g, potassium chloride 11.25 mg/g, sodium sulfate (anhydrous) 84.51 mg/g and sodium bicarbonate 25.32 mg/g.

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 electrolytes or water loss.

Indications

Glycoprep 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 should not be used by patients with hypersensitivity to any of the ingredients, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic colitis, toxic megacolon, ileus, severe dehydration or whose body weight 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-conscious; who are prone to regurgitation or aspiration; and particularly those with nasogastric intubation; should be carefully observed during the administration of Glycoprep.
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.
Glycoprep 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.

Use in pregnancy.

Paediatric use.

Use in the elderly.

Interactions

Oral medication taken within one hour of the commencement of the administration of Glycoprep, 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.
The low-dose contraceptive pill will not work when taken with Glycoprep 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.

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.

On the day before the procedure.

Preparation of solution.

Usual dosage.

For nasogastric intubation.

Note.

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

Sachet containing 200 g of dry powder.

Storage

Store in a cool dry place below 30°C.

Poison Schedule

Australia: S3 - Pharmacist Only Medicine.