Consumer medicine information

Prepkit-C Powder for oral solution

Macrogol 3350; Potassium chloride; Sodium sulfate; Ascorbic acid; Sodium chloride; Magnesium oxide; Citric acid; Sodium picosulfate

BRAND INFORMATION

Brand name

Prepkit-C Powder for oral solution

Active ingredient

Macrogol 3350; Potassium chloride; Sodium sulfate; Ascorbic acid; Sodium chloride; Magnesium oxide; Citric acid; Sodium picosulfate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Prepkit-C Powder for oral solution.

What is in this leaflet

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

It does not contain all the information that is known about Prepkit-C. 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 Prepkit-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 Prepkit-C is used for

Prepkit-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.

Prepkit-C produces watery stools or bowel motions within 2 to 3 hours after the first administration and may cause frequent loose bowel motions during the night.

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 Prepkit-C

When you must not take it

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

  • Any of the ingredients listed at the end of this leaflet
  • Any similar medicines to Prepkit-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 Prepkit-C if you have, or have had, any of the following medical conditions:

  • Gastrointestinal obstruction or blockage
  • Gastric retention
  • A hole in the stomach, large intestine or small intestine
  • Toxic megacolon, a type of bloating
  • A condition known as Paralytic Ileus where the small bowel doesn't work properly
  • Inflammation of the bowel
  • A body weight less than 20kg

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.

Ensure you receive adequate fluids during the administration of Prepkit-C

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

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

  • Ulcerative Colitis
  • Kidney problems
  • Heart problems
  • Diabetes
  • Dehydration
  • Phenylketonuria
  • Stoma
  • Undiagnosed stomach pain

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

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

Prepkit-C 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 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 condition
  • Iron medications
  • Other medicines that may affect electrolyte balance
  • Other bowel cleansing preparations

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

How to take Prepkit-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 box or in this leaflet, ask your doctor or pharmacist for help.

Prepkit-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 Prepkit-C.

How much to take

Prepkit-C 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.

Preparation for the procedure begins two days prior to the procedure by stopping all iron containing medication.

Dietary changes also occur two days prior to the procedure. Refer to the Patient Instructions on the back of this leaflet for details.

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

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.

Do not drink carbonated beverages.

Do not drink alcoholic beverages.

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

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

If you take too much (overdose)

Overdosage is unlikely as Prepkit-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 the Poisons Information Centre for any further information.

While you are taking Prepkit-C

Things you must do

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

Do not stop taking Prepkit-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 Prepkit-C.

Prepkit-C 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

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 Prepkit-C is finished.

If you get any side effects, do not stop taking Prepkit-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.

Nephrocalcinosis and renal impairment may occur following the use of this medicine.

Further information

Storage

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

Do not store Prepkit-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 Prepkit-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 composite pack containing a 70g sachet of white powder labelled Glycoprep-C, two 15.5g sachets of white powder labelled PicoPrep and a Consumer Medicine Information leaflet.

Ingredients

Each Prepkit-C carton contains the following products:

Glycoprep-C
Each sachet labelled Glycoprep-C contains a white powder for solution composed of macrogol 3350, sodium chloride, potassium chloride, sodium sulfate anhydrous, ascorbic acid, citric acid anhydrous, aspartame and lemon flavour.

PicoPrep
Each sachet labelled PicoPrep contains a white powder for solution composed of sodium picosulfate as the active. It also contains magnesium oxide, citric acid and aspartame.

Prepkit-C does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Prepkit-C does not contain any preservative.

Australian Registration Number

AUST L 210263

Sponsor

Supplied in Australia by:

Fresenius Kabi Australia Pty Ltd
964 Pacific Highway
Pymble NSW 2073
Ph: 1300 361 004

Supplied in New Zealand by:

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

® = Registered Trademark

This leaflet was prepared in August 2015.

BRAND INFORMATION

Brand name

Prepkit-C Powder for oral solution

Active ingredient

Macrogol 3350; Potassium chloride; Sodium sulfate; Ascorbic acid; Sodium chloride; Magnesium oxide; Citric acid; Sodium picosulfate

Schedule

S3

 

Name of the medicine

GlycoPrep-C.

Per 70 g sachet: macrogol 3350 (polyethylene glycol) 52.9 g, sodium chloride 2.6 g, potassium chloride 740 mg, anhydrous sodium sulfate 5.6 g, ascorbic acid 6.0 g.

PicoPrep.

Per 15.5 g sachet: sodium picosulfate 10 mg, magnesium oxide 3.5 g, anhydrous citric acid 12.0 g.

Excipients.

GlycoPrep-C.

This solution also contains anhydrous citric acid, aspartame and flavouring.

PicoPrep.

Aspartame 36 mg.

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.
Total sodium content 2.83 g.

PicoPrep.

Sodium picosulfate.

Molecular formula: C18H13NNa2O8S2,H2O. MW: 499.4. CAS: 10040-45-6 (anhydrous).

Heavy magnesium oxide.

Molecular formula: MgO. MW: 40.3. CAS: 1309-48-4.

Anhydrous citric acid.

Molecular formula: C6H8O7. MW: 192.1. CAS: 77-92-9.

Prepkit-C.

Prepkit-C is a combination kit containing one sachet of GlycoPrep-C 70 g powder for solution to produce one litre of solution and two sachets of PicoPrep 15.5 g powder for solution. They both contain dry white crystalline powders which, when dissolved in water, produce solutions with a lemon-like taste.

Pharmacology

For PicoPrep.

Sodium picosulfate is broken down by colonic bacteria to form the active compound bis(p-hydroxyphenyl)pyridyl-2-methane which is a contact laxative. The citric acid reacts with the magnesium oxide to form magnesium citrate, an osmotic laxative. This induces a watery stool or bowel motion, usually within 3 hours, which normally removes the bowel contents.

For GlycoPrep-C.

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 within 4 hours of commencing treatment. The water and included electrolytes are iso-osmotic with normal intestinal contents and help to reduce or prevent electrolytes or water loss.
The two products are used sequentially to ensure total removal of intestinal and colonic contents.

Indications

Prepkit-C is indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination (such as colonoscopy, barium enema X-ray examination), prior to intravenous pyelograms (IVP), or surgery).

Contraindications

Prepkit-C should not be used by patients with clinically significant renal impairment, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic megacolon, ileus, toxic colitis or whose bodyweight is less than 20 kg.

Precautions

Effects on fertility.

No reproductive studies have been performed.

Use in pregnancy.

It is not known whether either product can cause fetal harm or affect reproductive capacity. They should only be used if clearly needed.

Use in lactation.

No lactation studies has been performed.

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.

Genotoxicity.

No genotoxic studies have been performed.

Carcinogenicity.

No carcinogenic studies have been performed.

Effects on laboratory tests.

No data available.

Other.

Use with caution in patients with ulcerative colitis, impaired renal function, heart conditions, pre-existing electrolyte disturbances, congestive heart failure, diabetes, those with a stoma, patients taking other medicines that may affect electrolyte levels and elderly or debilitated patients.
Adequate hydration is very important for safe and effective use of the product, and that medications such as a diuretic may exacerbate volume depletion associated with bowel cleansing.
Patients with impaired gag reflex, who are unconscious or semiconscious, are prone to regurgitation or aspiration; and particularly those with nasogastric intubation; should be carefully observed during the administration of Prepkit-C.
Patients with kidney disease or impaired kidney function; using calcium channel blockers, diuretics or other medications that may affect electrolytes may need to be monitored.
Nephrocalcinosis and renal impairment may occur following use of oral sodium phosphate products in at risk or inappropriate patient groups.
There have been reports of skin reactions and rhinorrhoea attributed to macrogol which is contained in GlycoPrep-C.
PicoPrep is likely to cause transient hypovolaemia, hence adequate fluid intake or replacement should be ensured (see Dosage and Administration).
As PicoPrep contains aspartame, persons suffering from phenylketonuria need to be advised accordingly.
Both products may cause bloating, distension or abdominal pain. If this develops, the rate of administration should be slowed or temporarily ceased until the symptoms abate.

Information for patients.

Prepkit-C produces watery diarrhoea about an hour after the first administration. This action cleanses the bowel before examination. It should be prepared and taken according to the directions (see Dosage and Administration).
It is important that the patient follows the recommended dosing schedule and ensures an adequate intake of fluids.

Interactions

Oral medication taken within one hour of the commencement of the administration of Prepkit-C may be flushed from the gastrointestinal tract and not absorbed.
Because of the macrogol content of GlycoPrep-C there is a possible reduction in the effect of bacitracin and benzylpenicillin when used in conjunction.

Adverse Effects

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

Dosage and Administration

Preparation of solutions.

PicoPrep.

Dissolve the contents of the 15.5 g sachet in one full glass of warm water (approximately 250 mL). Please note that the solution may become hot. If preferred, chill before use in a refrigerator prior to use.

GlycoPrep-C.

Dissolve the contents of the 70 g sachet in one (1) litre of water using a suitable food grade container. Chill before use if preferred. The full litre of solution should be taken.

Usual dosage (unless otherwise directed by your doctor).

For oral use.

Prepkit-C produces watery diarrhoea that empties and cleanses the bowel before examination or surgery. It should be prepared and taken according to the directions. The onset of diarrhoea is in about three (3) hours.

Two days before the examination.

Stop all iron containing medicines but continue with regular medication.
Stop eating brown bread, cereals, vegetables and fruit.
Do not have any yellow cheese.
Eat boiled or poached egg, cottage cheese, low fat plain yoghurt, white bread, steamed white fish, boiled chicken, well cooked peeled pumpkin or well cooked peeled potato. Consume only clear jelly, skim milk and drink plenty of clear approved liquids* (see below).
In the evening, make up the sachet of GlycoPrep-C with one litre of water as above. Do not discard the empty sachet to ensure directions are followed completely.

One day before the examination.

During the day, drink at least one glass of clear fluid (plus preparation liquids) each hour. Keep drinking approved* clear fluids all day until bedtime.
Do not have solid foods or milk products.
*Approved clear fluids or liquids are: water, Bonox, clear salty fluids (e.g. strained chicken noodle soup), clear broth/ bouillon, clear fruit juices (apple, pear and grape), plain jelly, black tea or coffee (no milk), sports drinks, Lucozade, carbonated beverages, barley sugar, clear fruit cordials (clear lemon/ lime), (no red or purple colourings). (A good combination of these clear fluids, including 2-3 cups of strained chicken noodle soup, will give you a variation in fluid intake.)

Note.

Individual responses to laxatives 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. Please remain within easy reach of toilet facilities and do not plan to go out.

First dose (3.00 pm).

Add the entire contents of one sachet of PicoPrep to a glass of warm water (approximately 250 mL) and stir until dissolved. Chill for half an hour before drinking if preferred. Drink the mixture slowly but completely. This should be followed by adequate glasses of water or approved clear liquids* (see above), at least a glass per hour, in order to retain hydration throughout the body.

Second dose (6.00 pm).

Remove the made up GlycoPrep-C from the refrigerator as per instructions above. Try to drink a glass of the prepared solution about every 15 minutes. Total intake time should take approximately one (1) hour in duration. If you start to feel nauseated whilst drinking the preparation, slow down the rate of intake.

Third dose (9.00 pm).

Add the entire contents of one sachet of PicoPrep to a glass of warm water (approximately 250 mL) and stir until dissolved. Chill for half an hour before drinking if preferred. Drink the mixture slowly but completely. This should be followed by adequate glasses of water or approved clear liquids* (see above), at least a glass per hour, in order to retain hydration throughout the body.

On the day of the examination.

For a morning procedure.

From midnight last night, nothing more to be taken (nil) by mouth until after the examination.

For an afternoon procedure.

Drink only approved clear fluids* (see above), for breakfast.
Nothing (nil) by mouth 6 hours prior to the procedure.

Overdosage

In the event of overdosage, dehydration may occur. The 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

Combination kit.

GlycoPrep-C (powder for solution), 70 g: 1 (sachet); PicoPrep (powder for solution), 15.5 g: 2's (sachet); (AUST L 73250).

Storage

Store in a dry place below 25°C.

Poison Schedule

S3.