C.B. Fleet Co. Australia | Fleet Phospho-Soda

FLEET PHOSPHO-SODA BUFFERED SALINE MIXTURE (known as FLEET PHOSPHO-SODA)

If you are having an operation or x-ray of the bowel or colonoscopy, please read all of these instructions at least two days before your examination.

If you have any questions or are not sure of anything, ask your doctor or pharmacist.

WHAT IS FLEET PHOSPHO-SODA?

FLEET PHOSPHO-SODA is a liquid for oral use (to be taken by mouth) which comes in a 45mL bottle. Each 5mL of FLEET PHOSPHO-SODA contains:

• Sodium phosphate monobasic 2.4 g
• Sodium phosphate dibasic 0.9 g (900mg)

It also contains purified water, glycerol, saccharin sodium (sweetener), sodium benzoate (preservative) and ginger-lemon flavouring.

The Australian Register number of FLEET PHOSPHO-SODA is AUST R 43656.

WHAT IS FLEET PHOSPHO-SODA USED FOR?

FLEET PHOSPHO-SODA is used as part of a bowel cleansing procedure before x-ray of the bowel, colonoscopy (looking into the bowel with an instrument) or before a bowel operation.

FLEET PHOSPHO-SODA is approved for the above uses. However, your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

HOW DOES FLEET PHOSPHO-SODA WORK?

FLEET PHOSPHO-SODA produces bowel actions which cleanse the bowel. It usually works within 30 minutes, although it may take as long as six hours.

WARNING: Serious dehydration and/or electrolyte disturbances may occur in some 'at risk' patients. Read the section, "BEFORE YOU TAKE FLEET PHOSPHO-SODA" (below) and, if you think you could be at risk, discuss With your doctor and do not take this product without his/her approval.

BEFORE YOU TAKE FLEET PHOSPHO-SODA

Do not take FLEET PHOSPHO-SODA if you:

• Are of advanced age
• Have faecal impaction (hard, solidified bowel motions)
• Have paralytic ileus (non-functioning small bowel)
• Have bowel obstruction (stoppage)
• Have hypomotility (low movement of the intestines)
• Have Hirschsprung's disease/congenial megacolon (large bowel which was present from birth)
• Have imperforate anus (the natural opening of the anus is closed)
• Have ascitic conditions (fluid around the stomach)
• Have severe kidney disease
• Have heart failure
• Have an altered sense of smell or taste
• Do not drink much liquid
• Have nausea (feel sick)
• Are vomiting
• Have abnormal (stomach) pain.

Do not give to children under 12 years of age.

Tell your doctor if you are pregnant or breast-feeding. Tell your doctor if you are in poor general health, suffer from a heart or kidney condition, are taking diuretics (medicines which increase the volume of urine), have a colostomy or if you are on a low salt diet. If you are elderly, tell the doctor your age. He or she may need to check if it is safe for you to take FLEET PHOSPHO-SODA. It is very important that you drink more liquids, before and after taking FLEET PHOSPHO-SODA.

INTERACTIONS WITH OTHER MEDICINES

FLEET PHOSPHO-SODA may interact with diuretics (used to increase the volume of urine), lithium preparations (used to treat depression) and some other medicines which may affect electrolyte (salts in the body) levels. Therefore, tell your doctor of all medicines you are taking, including non-prescriptive medicines as well as prescription medicines, before taking FLEET PHOSPHO-SODA. Do not take FLEET PHOSPHO-SODA at the same time as taking polyethylene glycol bowel cleansing products.

If you are diabetic, the liquid diet recommended with this medication may affect your glucose blood levels and adjustment of your insulin or oral anti-diabetic medicine may be necessary.

WILL FLEET PHOSPHO-SODA AFFECT YOUR ABILITY TO DRIVE?

FLEET PHOSPHO-SODA will not affect your ability to drive or operate machinery. However, it will be impractical for you to do so, as you will need to stay close to a toilet until the purgative effect is complete!

HOW TO TAKE FLEET PHOSPHO-SODA

FLEET PHOSPHO-SODA is not to be taken by children under 12 years of age.

BEFORE A BOWEL OPERATION, X-RAY OF THE BOWEL OR COLONOSCOPY:

In the instruction "clear liquids" are mentioned. "Clear liquids consist of the following:

• Water
• Strained fruit juices without pulp or seeds (apple, white grapes, orange)
• Clear broth
• Coffee or tea (without milk or non-dairy whitener)
• All of the following that are not coloured red or purple
• Carbonated or non-carbonated soft drinks
• Fruit flavoured cordials
• Clear ice blocks

On the day before, drink only the above mentioned "clear liquids" for breakfast, lunch and dinner and in between times. Do not eat or drink solid foods, milk or milk products!

The intake of "clear liquid" is an essential part of the regimen.

FLEET PHOSPHO-SODA should not be used for children under 12 years of age. For adults and children over 12 years of age, the dose consists of one 45mL, bottle OF FLEET PHOSPHO-SODA and repeated 10 to 12 hours later as follows:

IF YOU ARE HAVING A COLONOSCOPY MID MORNING OR LATER, FOLLOW THE STEPS BELOW OR AS PRESCRIBED BY YOUR DOCTOR.

At 7 p.m. in the evening of the day before the examination, add the first 45mL bottle of FLEET PHOSPHO-SODA to half a glass (125 mL) of cool water and drink. Then drink one full (250mL) glass of "clear liquid". Before going to bed, drink at least three more full glasses of "clear liquid" or more, if desired.

At 7 a.m. (or at least 3 hours before you leave for your appointment) in the morning of the day of your examination, add the second 45mL bottle of FLEET PHOSPHO- SODA TO 125mL of cool water and drink. Follow with at least four full (250mL) glasses of "clear liquid".

Arrive for your colonoscopy at the scheduled time.

IF YOU ARE HAVING AN EARLY MORNING COLONOSCOPY, follow THE STEPS BELOW OR AS PRESCRIBED BY YOUR DOCTOR.

At 7 a.m. in the morning of the day before the examination, add the first 45mL bottle of FLEET PHOSPHO-SODA to half a glass (125mL) of cool water and drink. Then drink one full (250mL) glass of "clear liquid" or more, if desired.

At 7 p.m. in the evening before the day of your examination, add the second 45mL bottle of FLEET PHOSPHO-SODA to 125mL of cool water and drink. Follow with at least four full (250mL) glasses of "clear liquid".

Arrive for your colonoscopy on the next day, at the scheduled time.

IF YOU ARE HAVING AN X-RAY OF THE BOWEL, SIMILAR INSTRUCTIONS TO THE COLONOSCOPY INSTRUCTIONS WILL APPLY: YOUR DOCTOR WILL INFORM YOU OF THE EXACT INSTRUCTIONS.

IF YOU ARE HAVING AN OPERATION ON THE BOWEL, YOU WILL BE GIVEN YOUR DOSES OF FLEET PHOSPHO-SODA IN THE HOSPITAL UNDER MEDICAL AND NURSING SUPERVISION.

In some cases, your doctor may decide to modify the above dosage instructions. If this occurs, and you have questions, ask your doctor.

WHAT IF YOU TAKE TOO MUCH (OVERDOSE)?

Serious side effects may occur, if more than the recommended dose is taken. If you have taken too much, immediately telephone your doctor or Poisons Information Centre for advice, or go to the casualty department of your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

FURTHER INFORMATION

Do not use FLEET PHOSPHO-SODA to treat any other complaints unless your doctor says so. Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

WHAT SIDE EFFECTS DOES FLEET PHOSPHO-SODA HAVE?

People react differently to purgatives. FLEET PHOSPHO-SODA may cause a number of diarrhoea-like bowel movements. This is a result of its bowel cleansing action. It often works as soon as 30 minutes although it may take up to 6 hours to work. Therefore, stay close to a toilet during the treatment!

Rarely, it may cause nausea, vomiting, abdominal pain, bloating, fatigue, anal irritation, allergic reactions with or without rash, hunger and sleep loss. It may also cause temporary decrease in the volume of the blood and changes in the amounts of salts in the blood, which, in healthy and fit people, return to normal in 24 hours. Tell your doctor or pharmacist if any of the above side-effects or any other side- effects, are troubling you while taking FLEET PHOSPHO-SODA.

HOW SHOULD FLEET PHOSPHO-SODA BE STORED?

Store FLEET PHOSPHO-SODA below 25° C and keep it out of reach of children. Do not use FLEET PHOSPHO-SODA after the expiry date (EXP) printed on the Label.

WHERE TO GO FOR FURTHER INFORMATION

This is not all the information on FLEET PHOSPHO-SODA. Your doctor and pharmacist have more. Check with them, if you need further information.