SUMMARY CMI

Go-Kit™

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Go-Kit?

Go-Kit contains the active ingredients magnesium carbonate hydrate, citric acid and bisacodyl. Go-Kit is used for bowel emptying and cleansing in conjunction with barium meal, barium enema x-ray examination, air contrast examination, and prior to intravenous pyelograms (IVP).

For more information, see Section 1. Why am I using Go-Kit? in the full CMI.

2. What should I know before I use Go-Kit?

Do not use if you have ever had an allergic reaction to Go-Kit or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Go-Kit? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Go-Kit and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Go-Kit?

• It is important that you follow the instructions specifically given by the doctor, prescriber or pharmacist carefully and that you drink plenty of Recommended Clear Fluids.
• Your doctor, prescriber or pharmacist will have informed you of the dose that you should take it.

More instructions can be found in Section 4. How do I use Go-Kit? in the full CMI.

5. What should I know while using Go-Kit?

For more information, see Section 5. What should I know while using Go-Kit? in the full CMI.

6. Are there any side effects?

Tell your doctor, prescriber or pharmacist if you notice any of the following and they worry you: nausea, vomiting, stomach pain, stomach bloating or anal irritation. If the effects are severe, you may need medical treatment.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Go-Kit™

Active ingredient(s): bisacodyl, magnesium carbonate hydrate, citric acid

Consumer Medicine Information (CMI)

This leaflet provides important information about using Go-Kit. You should also speak to your doctor, prescriber or pharmacist if you would like further information or if you have any concerns or questions about using Go-Kit.

Where to find information in this leaflet:

1. Why am I using Go-Kit?
2. What should I know before I use Go-Kit?
3. What if I am taking other medicines?
4. How do I use Go-Kit?
5. What should I know while using Go-Kit?
6. Are there any side effects?
7. Product details

1. Why am I using Go-Kit?

Go-Kit contains the active ingredients magnesium carbonate hydrate, citric acid and bisacodyl. In solution, magnesium carbonate and citric acid combine to form magnesium citrate.

Go-Kit is used for bowel emptying and cleansing in conjunction with barium meal, barium enema x-ray examination, air contrast examination, and prior to intravenous pyelograms (IVP).

Magnesium citrate works by causing excess water to remain in your stool and stimulates bowel movements.

Bisacodyl works by being broken down by intestinal bacteria and then acting on the lining in your intestine to stimulate bowel movements.

This results in watery stool or bowel motions which removes the bowel contents and ensures the bowel is clean before the examination or procedure.

The bowel needs to be clean before the examination or procedure.

Go-Kit produces watery stools or bowel motions within 3 to 6 hours after the first administration and may cause frequent loose bowel motions depending on your individual response.

You should discuss with your doctor, prescriber or pharmacist what is going to happen before you have the examination or procedure. Your doctor or prescriber, however, may prescribe Go-Kit for another purpose.

Ask your doctor, prescriber or pharmacist if you have any questions about why this medicine has been prescribed for you or how you are to take it.

2. What should I know before I use Go-Kit?

Warnings

Do not use Go-Kit if:

• you are allergic to magnesium carbonate, citric acid, bisacodyl or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
  If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor, prescriber or pharmacist immediately or go to the Accident and Emergency department at the nearest hospital.
• you have severe dehydration
• you have or had appendicitis (an inflammation of the appendix)
• you have or had gastrointestinal obstruction (a blockage in the stomach or bowel)
• you have gastric retention (the stomach retains food and fluids)
• you have bowel perforation (a hole in the stomach, small intestine or large intestine)
• you have toxic megacolon (a poisonous and enlarged large bowel)
• you have ileus (a condition where the bowel does not work properly)
• you have toxic colitis (a poisonous and inflamed large bowel)
• you have a body weight less than 20 kg

Check with your doctor or pharmacist if you:

• have or had any other medical conditions including:
  - any stomach or bowel problems
  - Inflammatory bowel disease
  - kidney disease
  - impaired kidney function (the kidneys not working properly)
  - diabetes
  - electrolyte disturbances (blood chemicals)
  - heart conditions
  - stoma (a surgical opening from the large bowel through the lower abdomen or stomach to the outside)
• take any medicines for any other condition
• are allergic to any medicines, foods, dyes or preservatives
• are elderly

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

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Go-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.

Use in renal impairment

Patients with kidney disease or impaired renal function should be monitored.

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.

Use in Children

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

3. What if I am taking other medicines?

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

Some medicines may interfere with Go-Kit and affect how it works. These include:

• oral contraceptive pills (“the pill”)
• laxatives or other bowel cleansing preparations
• other medicines that may affect electrolyte balance
• antibiotics
• medicines for diabetes
• medicines for heart conditions

Go-Kit may affect any medication, taken orally, one hour before and after taking Go-Kit.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Go-Kit.

4. How do I use Go-Kit?

How much to take

• It is important that you follow the instructions specifically given by the doctor, prescriber or pharmacist carefully and that you drink plenty of Recommended Clear Fluids
  Instructions may differ from the information contained in this leaflet.
• Your doctor, prescriber or pharmacist will have informed you of the dose that you should take it.
• Do not exceed the recommended dosage.
• If you do not understand the instructions on the box or in this leaflet, ask your doctor, prescriber or pharmacist for help.
• Go-Kit will produce numerous bowel motions within a short period of time. Ensure you have toilet facilities within easy access from the time you start taking Go-Kit.
• Do not have any food after the first dose of Go-Kit. You must only consume the Recommended Clear Fluids while taking Go-Kit and until after the procedure.
• Recommended Clear Fluids include water, soups (e.g. strained chicken noodle soup), broth/bouillon, pulp-free fruit juices (apple, pear, white grape), black tea or coffee (no milk), electrolyte replacing drinks, nutritional supplements, carbonated beverages, clear cordials (lemon/lime), plain jelly, sorbet, boiled sweets, and gums/jubes. Sugar, salt, and sweetener can be used. No red or purple colouring. Barley sugar may be sucked if required.
• Do not drink alcoholic beverages.
• If you are diabetic, discuss your requirements, and your diet and dosage program with your doctor, prescriber or pharmacist before commencing.

When to take Go-Kit

• Go-Kit should be used as directed by your doctor, prescriber or pharmacist. It is important that you follow the instructions specifically given by your doctor, prescriber or pharmacist and that you drink plenty of Recommended Clear Fluids.
  Your doctor, prescriber or pharmacist will have informed you of the dose that you should take and when to take it.

An example of a regimen is detailed below:

1. One day prior to the examination (at approximately 12 pm or as advised by your doctor or prescriber), take the three Bisacodyl tablets with one full glass (approx. 250 mL) of water. Continue drinking Recommended Clear Fluids, at least a glass per hour.
2. In the evening of the same day (at approximately 6 pm or as advised by your doctor or prescriber), prepare the Magnesium Citrate sachet as per the instructions in “How to prepare Go-Kit” or if prepared earlier and chilled take the mixture out of the refrigerator. Drink the mixture completely. Continue drinking Recommended Clear Fluids, at least a glass per hour.

• REMEMBER you need to be close to toilet facilities whilst you are taking Go-Kit.
  Bowel movements may continue for several hours after the last dose of Go-Kit has been taken.
• It is important for you to take Go-Kit exactly as prescribed.
  If you forget to take a dose, contact your doctor or prescriber as soon as possible as the time of the examination may need to be changed.

How to prepare Go-Kit

• Slowly mix the entire contents of the Magnesium Citrate sachet in approximately 250 mL of warm water (not boiling). Be aware that the solution will be effervescent (fizz and bubble). Stir gently until the effervescence ceases. The solution will appear cloudy and may be hot. Allow solution to cool before drinking. You also have the option of chilling the prepared Magnesium Citrate mixture in the refrigerator for up to 24 hours prior to drinking.
• Swallow the bisacodyl tablets whole. Do not crush or chew the tablets.

If you use too much Go-Kit

If you think that you have used too much Go-Kit you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Go-Kit?

Things you should do

• Go-Kit can lead to dehydration and electrolyte disturbances. You must ensure that you drink the recommended amount of liquid to replace the fluid that may be lost during bowel emptying.
• If you are taking any other medicines, whether they require a prescription or not, talk to your doctor, prescriber or pharmacist before taking Go-Kit.
• Tell your doctor or prescriber if, for any reason, you have not taken Go-Kit exactly as prescribed.

Remind any doctor, prescriber or pharmacist you visit that you are using Go-Kit.

Things you should not do

• Do not give Go-Kit to anyone else, even if they have the same condition as you.
• Do not take any additional bowel preparation or laxative products unless otherwise stated by your doctor or prescriber.

Things to be careful of

• Because of the watery bowel motion caused by Go-Kit you should not plan any other activities until after the examination.
• It is most important that you take adequate fluids whilst using Go-Kit.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Go-Kit affects you.

The effects of Go-Kit on a person's ability to drive and use machines were not assessed.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol will cause dehydration when used with Go-Kit and should be avoided.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store below 25°C in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

If you prefer to have your bowel preparation chilled, cover the mixture and place in a refrigerator prior to drinking for no more than 24 hours.

Keep it where young children cannot reach it.

When to discard your medicine

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

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

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

However, these side effects usually disappear when treatment with Go-Kit is finished.

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

Tell your doctor, prescriber or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription. It is a Pharmacist-Only Medicine.

What Go-Kit contains

Go-Kit is a medicine kit containing:

• a blister pack of three Bisacodyl 5 mg Tablets and
• one Magnesium Citrate 21.5 g sachet

Bisacodyl 5 mg Tablets

Magnesium Citrate 21.5 g Sachet

Do not take this medicine if you are allergic to any of these ingredients.

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

What Go-Kit looks like

Go-Kit is a medicine kit containing a blister pack of three yellow Bisacodyl 5 mg Tablets and a Magnesium Citrate 21.5 g sachet containing an effervescent white crystalline powder (AUST R 200381).

Who distributes Go-Kit

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

This leaflet was prepared in May 2021.

Published by MIMS November 2021

1 Name of Medicine

Bisacodyl tablets.

Magnesium citrate sachet.

2 Qualitative and Quantitative Composition

Go-Kit is a medicine kit containing:
Three (3) yellow bisacodyl 5 mg tablets. Each bisacodyl tablet contains bisacodyl 5 mg, as the active ingredient.
One (1) magnesium citrate 21.5 g sachet. Each sachet contains magnesium carbonate hydrate 7.2 g and citric acid 14.3 g, as the active ingredients.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Bisacodyl tablets.

Magnesium citrate sachet.

4 Clinical Particulars

4.1 Therapeutic Indications

Go-Kit is indicated for bowel emptying and cleansing in conjunction with barium meal, barium enema x-ray examination, air contrast examination, and prior to intravenous pyelograms (IVP).

4.2 Dose and Method of Administration

The bisacodyl 5 mg tablets should be taken whole and not crushed or chewed.

Prior to the procedure.

Preparation of the solution.

Recommended dosing regimen.

Bisacodyl tablets (taken at 12:00 PM)

Magnesium citrate sachet (taken at 6:00 PM).

Appendix I.

Recommended clear fluids.

4.3 Contraindications

Go-Kit should not be used by patients with acute abdominal conditions such as appendicitis, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic megacolon, toxic colitis, ileus, body weight less than 20 kg, severe dehydration, or hypersensitivity to any of the ingredients.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Oral medication, especially those medicines with a sustained release, short half-life or a narrow therapeutic window, taken within one hour of the commencing Go-Kit to one hour after completing its administration, may be flushed from the gastrointestinal tract and not absorbed.
The low-dose contraceptive pill will not work when taken with Go-Kit as it needs as much time as possible in the gastrointestinal tract for absorption.
Go-Kit administration 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.
Go-Kit administration 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Nausea, vomiting and anal irritation are the most common reactions. These adverse effects are usually transient and subside rapidly.
Bisacodyl may cause abdominal discomfort such as colic or cramps.
Prolonged use of Go-Kit may result in dehydration and electrolyte disturbances (see Section 4.3; Section 4.4).
Hypersensitivity reactions including angioedema and anaphylactoid reactions have been reported rarely.

Reporting suspected adverse effects.

4.9 Overdose

In the event of overdosage, 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 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Bisacodyl.

Magnesium citrate.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Bisacodyl.

Distribution.

Metabolism.

Bisacodyl.

Excretion.

Bisacodyl.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Bisacodyl.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C in a dry place. To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary, the solution may be stored for up to 24 hours in the refrigerator at 2-8°C.

6.5 Nature and Contents of Container

Go-Kit is presented as a medicine kit packed in an outer carton containing:
one (1) blister pack of three (3) yellow Bisacodyl 5 mg Tablets and;
one (1) Magnesium Citrate 21.5 g sachet containing a white crystalline powder.
The Australian registration number is AUST R 200381.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Bisacodyl.

Magnesium citrate.

Magnesium carbonate hydrate.

Citric acid.

CAS number.

7 Medicine Schedule (Poisons Standard)

Australia: S3 - Pharmacist Only Medicine.

Summary Table of Changes