Description

1. What AOTOCOL-P is and what it is used for

This powder for oral solution is a lemon flavoured laxative. It is intended for adults to clean the bowel. This can also be used to clean the bowel, ready for examination. It works by emptying the contents of your bowels, so you should expect to have watery bowel movements.

2. What you need to know before you take AOTOCOL-P

Do not take this powder for oral solution

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of this product
• if you have an obstruction in your intestine (gut)
• if you have a perforated gut wall
• if you have a disorder of stomach emptying
• if you have paralysis of the gut (often occurs after an operation to the abdomen)
• if you suffer from phenylketonuria. This is a hereditary inability of the body to use a particular amino acid.
• if your body is unable to produce enough glucose-6-phosphate dehydrogenase
• if you have toxic megacolon (a severe complication of acute colitis)

Warnings and precautions

Talk to your doctor or pharmacist before taking this powder for oral solution if you have any of the following

• you need to thicken fluids in order to swallow them safely.
• a tendency to regurgitate swallowed drink, food or acid from the stomach.
• kidney disease.
• heart failure or heart disease including high blood pressure, irregular heartbeats or palpitations.
• thyroid disease · dehydration.
• acute flare of inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Other medicines and AOTOCOL-P.

If you are taking other medicines take them at least one hour before taking this powder for oral solution or at least one hour afterwards because they may be flushed through your digestive system and not work so well.

Pregnancy and breastfeeding

There are no data on the use of this powder during pregnancy or breastfeeding and it should only be used if considered essential by your doctor. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

This powder for oral solution does not affect your ability to drive or use machines.

3. How to take AOTOCOL-P (13.81 gm/sachet)

Adults, Adolescents & Elderly

Constipation: 1-3 sachets daily in divided doses, according to the individual response. Each sachet to be dissolved in125 ml boiled & cooled water.

Faecal Impaction: 8 sachets daily in divided doses. Dissolve each sachet in 125 ml of water or dissolve 8 sachets in 1 litre of water. To be consumed within 6 hrs.

Store reconstituted solution at 2°C – 8°C temp. in a refrigerator & covered. Drink 200 ml after every 10-15 minutes, so as to consume 1 litre in maximum of 1 hr duration. Normally the first bowel moment may occur after 1-2 hrs from the start of drinking.

How to take AOTOCOL-P (6.85 gm/sachet)

Chronic Constipation: Children 2-11 years of age.

Faecal Impaction: Children 5-11 years of age.

Contents of one sachet to be dissolved in 62.5 ml of water (a quarter of glass). Prepare one sachet at one time, if required store reconstituted solution at 2°C – 8°C temp. in refrigerator and covered.

When to take AOTOCOL-P (138.40 gm/pack)

For procedures conducted when you are put to sleep (using general anaesthesia):

1. Divided doses: one litre of this powder for oral solution in the evening before and one litre of this powder in the early morning of the day of the examination. Ensure consumption of this powder as well as any other clear fluids has finished at least two hours before the start of the examination.
2. Single dose: two litres of this powder in the evening before the examination or two litres of this powder in the morning of the examination. Ensure consumption of this powder as well as any other clear fluids has finished at least two hours before the start of the examination.

For procedures conducted without the need for putting you to sleep (without using general anesthesia):

1. Divided doses: one litre of this powder in the evening before and one litre of this powder in the early morning of the day of the examination. Ensure consumption of this powder as well as any other clear fluids has finished at least one hour before the start of the examination.
2. Single dose: two litres of this powder in the evening before the examination or two litres of this powder in the morning of the examination. Ensure consumption of this powder has finished at least two hours before the start of the examination. Ensure consumption of any clear fluids has finished at least one hour before the examination.

• Do not take any solid food from when you start to take this powder until after the examination

How to prepare this powder

• Add the contents of the bag to a measuring jug that holds 1 litre.
• Add water to make up to the one litre mark of the container and stir until all the powder has dissolved. This may take up to 5 minutes.

How to drink this powder

• Drink the solution of this powder over one to two hours. Try to drink a glassful (approx. 200 ml) every 10 – 15 minutes.
• During the course of this treatment, you are recommended to drink a further one litre of clear liquid to prevent you feeling very thirsty and becoming dehydrated. Water, clear soup, fruit juice (without pulp), soft drinks, tea or coffee (without milk) are all suitable. These drinks can be taken until two hours before the examination under general anesthesia at the latest and until one hour before the examination without general anesthesia at the latest.

What you should expect to happen

When you start drinking this solution, it is important that you stay close to a toilet. At some point, you will start to experience watery bowel movements. This is quite normal and indicates that the solution is working. The bowel movements will stop soon after you have finished drinking.

If you follow these instructions, your bowel will be clear, and this will help you to have a successful examination. You should allow sufficient time after your last drink to travel to the colonoscopy unit.

If you take more of this powder for oral solution than you should

If you take more of this powder for oral solution than you should, you may develop excessive diarrhea, which can lead to dehydration. Take generous amounts of fluid, especially fruit juices. If you are worried contact your doctor or pharmacist.

If you forget to take this powder for oral solution

If you forget to take this powder for oral solution, take the dose as soon as you realise you have not taken it. If this is several hours after the time when you should have taken it, contact your doctor or pharmacist for advice.

4. Possible side effects It is normal to get diarrhea when you take this powder for oral solution.

Stop your intake and tell your doctor immediately if you have any of the following side effects:

• rash or itching · swelling of your face, ankles or other part of your body
• palpitations · extreme fatigue · shortness of breath

These are symptoms of a severe allergic reaction.

If you do not have a bowel movement within 6 hours of taking this powder, stop the intake and contact your doctor immediately.

Other side effects include:

• Abdominal pain, abdominal distension, tiredness, feeling generally unwell, soreness of the anus, nausea and fever.
• Hunger, problems sleeping, dizziness, headache, vomiting, indigestion, thirst and chills.

5. How to store AOTOCOL-P Keep this product out of the sight and reach of children.

• Do not use this product after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of the month.
• Keep this powder for oral solution sachets at room temperature (below 25°C).
• After you have dissolved it in the water, the solution may be stored (keeping covered) at room temperature (below 25°C). It may also be stored in the fridge (2°C -8°C). Do not keep it for more than 24 hours.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.