Consumer medicine information

Questran Lite

Colestyramine

BRAND INFORMATION

Brand name

Questran Lite

Active ingredient

Colestyramine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Questran Lite.

SUMMARY CMI

QUESTRAN® LITE

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 QUESTRAN LITE?

QUESTRAN LITE contains the active ingredient colestyramine. QUESTRAN LITE is used to reduce high levels of cholesterol in the blood, provide relief of pruritis (itching) and provide relief of diarrhoea caused by surgery or disease of the small bowel. For more information, see Section 1. Why am I using QUESTRAN LITE? in the full CMI.

2. What should I know before I use QUESTRAN LITE?

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

Talk to your doctor 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 QUESTRAN LITE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with QUESTRAN LITE 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 QUESTRAN LITE?

  • Your doctor will decide what dose you should receive.
  • The usual dose for adults is 12 to 16 g of QUESTRAN LITE per day.
  • QUESTRAN LITE must not be taken in its dry form; it must always be mixed with water, juice or other fluids before taking.

More instructions can be found in Section 4. How do I use QUESTRAN LITE? in the full CMI.

5. What should I know while using QUESTRAN LITE?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using QUESTRAN LITE.
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking QUESTRAN LITE.
  • If you become pregnant while taking this medicine, tell your doctor immediately.
  • Keep all of your doctor's appointments so that your progress can be checked.
Things you should not do
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not stop taking your medicine or lower the dosage, without checking with your doctor.
  • Do not take QUESTRAN LITE in its dry form. Always mix it with water or other fluids before you take it.
Driving or using machines
  • Be careful driving or operating machinery until you know how QUESTRAN LITE affects you.
Drinking alcohol
  • Avoid drinking large quantities of alcohol.
Looking after your medicine
  • Keep the sachets in a cool, dry place (below 30°C).
  • Do not store QUESTRAN LITE in the bathroom, near a sink, on a window sill or in the car.
  • Keep your tablets where children cannot reach it.

For more information, see Section 5. What should I know while using QUESTRAN LITE? in the full CMI.

6. Are there any side effects?

Tell your doctor as soon as possible if you notice any of the following: constipation, haemorrhoids, abdominal pain, flatulence (wind/gas), nausea, vomiting, heartburn, diarrhoea, anorexia (loss of appetite), indigestion, steatorrhoea, rash and irritation of the tongue, skin or anal area, changes in bowel motions, chest pain, headache, anxiety, dizziness or drowsiness.
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

QUESTRAN® LITE

Active ingredient(s): colestyramine

Consumer Medicine Information (CMI)

This leaflet provides important information about using QUESTRAN LITE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using QUESTRAN LITE.

Where to find information in this leaflet:

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

1. Why am I using QUESTRAN LITE?

QUESTRAN LITE contains the active ingredient colestyramine. QUESTRAN LITE belongs to a group of medicines called resins. It reduces the level of cholesterol in the blood by combining with bile in the small intestine to form an insoluble complex, which is then excreted in faeces.

The reduction of blood cholesterol levels helps to prevent blockages in the blood vessels to the heart which reduces the likelihood of angina (chest pain with heart disease) and heart attacks.

QUESTRAN LITE is used:

  • to reduce high levels of cholesterol in the blood and assist in the prevention of coronary heart disease. It also used as an accompanying therapy to your diet in order to reduce cholesterol
  • for the relief of pruritis (itching) associated with the flow of bile being partially blocked
  • for the relief of diarrhoea caused by surgery or disease of the small bowel.

QUESTRAN LITE may be used alone or in combination with other medicines.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is not addictive.

This medicine is only available with a doctor's prescription.

The safety and effectiveness of using QUESTRAN LITE in infants and children has not been established.

2. What should I know before I use QUESTRAN LITE?

Warnings

Do not use QUESTRAN LITE if:

  • you are allergic to any medicine containing colestyramine or any of the ingredients listed at the end of this leaflet. 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
    - rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
  • you have been diagnosed with complete biliary obstruction, where no bile is secreted into the intestine. A bile duct obstruction, also known as biliary obstruction, is where one of the ducts that carries bile from the liver to the intestine via the gallbladder becomes blocked.
  • the expiry date (EXP) printed on the pack has passed or 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 whether you should start taking this medicine, talk to your doctor.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes.
  • have or have had any medical conditions:
    - hypothyroidism
    - diabetes
    - nephrotic syndrome which is a kidney disorder that causes your body to excrete too much protein in your urine
    - liver problems
    - jaundice – yellowing of the skin and eyes
    - phenylketonuria (PKU)
    - blood problems – blood clotting associated with vitamin K deficiency
    - hyperchloraemic acidosis – too much chloride in the blood
    - constipation

If you have not told your doctor about any of the above, tell them before you start taking QUESTRAN LITE.

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

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

Your doctor can discuss with you the risks and benefits involved.

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 and QUESTRAN LITE may interfere with each other. These include:

  • thyroid and thyroxine preparations
  • warfarin, a medicine used to prevent blood clots
  • chlorothiazide, a diuretic which is used to help you excrete more urine
  • tetracyclines, antibiotics which fight bacterial infections
  • phenobarbital (phenobarbitone), a medicine used to treat epilepsy
  • digitalis
  • aldosterone antagonists, a diuretic which is used to help you excrete more urine
  • inorganic iron
  • estrogenic drugs

Do not stop taking QUESTRAN LITE if you have been taking a medicine with toxic side effect such as digitalis while you are using QUESTRAN LITE as this could be hazardous to your health.

These medicines may be affected by QUESTRAN LITE, or affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid, while taking this medicine.

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

4. How do I use QUESTRAN LITE?

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, ask your doctor or pharmacist for help.

How much to take

Adults

  • Maintenance or on-going therapy: 12 to 16 g of colestyramine resin equivalent to 14.1 to 18.8g of QUESTRAN LITE per day.

Children and Infants

  • No dosage regimen has been established for children. Your doctor will start therapy in a child with small doses and adjust the dose, depending on the child's response to initial therapy.

How to take it

QUESTRAN LITE must not be taken in its dry form; it must always be mixed with water, juice or other fluids before taking.

  • add the contents of the 4g sachet to 100 to 150 mL of water or fruit juice
  • mix immediately by stirring vigorously
  • continue to stir until the mixture is even (the powder will not dissolve)
  • drink the entire mixture immediately, rinse the container and drink the rinse to ensure that you have taken the full dose

Make sure you use the full amount of water and ensure that it is well mixed before you drink it.

You can mix QUESTRAN LITE with thin soups or pulpy fruits with a high water content e.g. pureed apple or crushed pineapple. If care is taken you can mix it with carbonated drinks.

When to take QUESTRAN LITE

Take your medicine at about the same time each day.

Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take your medicine.

If you are taking other medicines, you must take them one hour before taking QUESTRAN LITE or four to six hours after taking QUESTRAN LITE.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to use QUESTRAN LITE

If it is almost time for your next dose, skip the dose that you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of getting an unwanted side effect.

If you are not sure of what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much QUESTRAN LITE

If you think that you have used too much QUESTRAN LITE, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, 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 QUESTRAN LITE?

Things you should do

  • If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking QUESTRAN LITE.
  • Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking QUESTRAN LITE.
  • If you become pregnant while taking this medicine, tell your doctor immediately.
  • Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you should not do

  • Do not take QUESTRAN LITE to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not stop taking your medicine or lower the dosage, without checking with your doctor.
  • Do not take QUESTRAN LITE in its dry form. Always mix it with water or other fluids before you take it.

Driving or using machines

Be careful driving or operating machinery until you know how QUESTRAN LITE affects you.

As with other medicines QUESTRAN LITE may cause dizziness, light-headedness, drowsiness or tiredness in some people.

Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Avoid drinking large quantities of alcohol.

If you drink alcohol, your dizziness or light-headedness may be worse.

Large quantities of alcohol may increase your chance of QUESTRAN LITE causing liver problems.

Things that would be helpful for lowering your cholesterol levels

A healthy diet and reduction in your weight is recommended before using QUESTRAN LITE for cholesterol reduction.

Looking after your medicine

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

Do not store QUESTRAN LITE or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

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.

Getting rid of any unwanted medicine

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

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking QUESTRAN LITE.

This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Less serious side effects

Less serious side effectsWhat to do
  • constipation
  • haemorrhoids

The above list includes the more common side effects of your medicine.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

Serious side effects

Serious side effectsWhat to do
  • abdominal pain
  • flatulence (wind/gas)
  • nausea
  • vomiting
  • heartburn
  • diarrhoea
  • anorexia (loss of appetite)
  • indigestion
  • steatorrhoea (the presence of excess fat in the faeces. Stools may be bulky and difficult to flush, have a pale and oily appearance and can be especially foul-smelling)
  • rash and irritation of the tongue, skin or anal area
  • changes in bowel motions
  • chest pain
  • headache
  • anxiety
  • dizziness
  • drowsiness

The above list includes serious side effects that may require medical attention.

Tell your doctor as soon as possible if you notice any of the following serious side effects.

Tell your doctor 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What QUESTRAN LITE contains

Active ingredient
(main ingredient)		850 mg per gram of colestyramine.
Other ingredients
(inactive ingredients)
  • aspartame
  • citric acid
  • colloidal anhydrous silica
  • orange juice flavour 059107 AGEP0551 (ARTG PI No: 1291)
  • propylene glycol alginate
  • xanthan gum
Potential allergensaspartame

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

What QUESTRAN LITE looks like

QUESTRAN LITE is a cream coloured, fine powder. It is available in sachets containing 4 g of cholestyramine. There are 50 sachets in the box. (AUST R 11971).

Who distributes QUESTRAN LITE

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in May 2022.

QUESTRAN® is a Viatris company trade mark

QUESTRAN LITE_cmi\May22/00

Published by MIMS June 2022

BRAND INFORMATION

Brand name

Questran Lite

Active ingredient

Colestyramine

Schedule

S4

 

1 Name of Medicine

Colestyramine.

2 Qualitative and Quantitative Composition

Questran Lite is a powder for oral solution containing 850 mg per gram of colestyramine as the active ingredient. The 4.7 g sachet contains 4 g of colestyramine and the 9.4 g sachet contains 8 g of colestyramine.

Excipients of known effect.

Aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Questran Lite is a cream coloured, fine, dispersible powder.

4 Clinical Particulars

4.1 Therapeutic Indications

1. Reduction of serum cholesterol levels and prevention of coronary heart disease. Questran Lite is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins). Questran Lite may be useful to lower elevated cholesterol that occurs in patients with combined hypercholesterolemia and hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.
2. Relief of pruritus associated with partial biliary obstruction. Patients with primary biliary cirrhosis may exhibit elevated serum cholesterol as part of their disease. When colestyramine is used to treat the pruritus of partial biliary obstruction, it may lower serum cholesterol levels, produce no change, or cause rapid escape from a temporary lowering to pretreatment levels or rebound.
3. Relief of diarrhoea following ileal resection or ileal disease (cholerrhoeic enteropathy).

4.2 Dose and Method of Administration

Adults.

Usual maintenance therapy: 12 to 16 g of colestyramine equivalent to 14.1 to 18.8 g Questran Lite per day (without regard to meals), is usually effective.

Children.

Dosage in infants and children has not been established. Begin therapy with small doses. Subsequent adjustment should be made according to clinical response or laboratory results and the benefit/risk ratio.

Use for cholesterol lowering.

Define the type of hyperlipoproteinaemia.
A trial of diet, weight reduction, etc., should be undertaken before therapy with Questran Lite. Baseline cholesterol levels should be established, and the patient should be monitored both clinically and with serum cholesterol levels. Failure of cholesterol to fall or a significant rise in triglyceride level are indications to discontinue the medication.
Begin with 4 g colestyramine in the morning or evening, increasing to the required maintenance dose over 2 to 4 weeks. If the patient takes more than 24 g colestyramine daily, they should be observed for increased side effects.

Preparation.

Questran Lite should be taken mixed with water, juice or highly fluid foods.
When mixing individual sachets for immediate use, place the contents of a 4 g sachet of Questran Lite on the surface of 100 to 150 mL water or fruit juice (200 to 300 mL for an 8 g sachet of Questran Lite).
Mix immediately by stirring vigorously. Continue stirring or shaking until mixture is even. After dosing, rinse the container to ensure full dose.
Alternatively, Questran Lite may be mixed with highly fluid soups, pulpy fruits with a high moisture content (e.g. apple puree or crushed pineapple), or if care is taken to avoid excessive foaming, a carbonated beverage.
In all patients presenting with a diarrhoea induced by bile acid malabsorption, a response should be seen within 3 days. If this is not the case, alternative therapy should be initiated.

Instructions to the patient.

Patients should be advised as to the method of administration (see Section 4.2 Dose and Method of Administration).
Patients should be advised to take other drugs at least one hour before or four to six hours after taking Questran Lite.

4.3 Contraindications

Hypersensitivity to any of the components of Questran Lite.
Complete biliary obstruction where no bile is secreted into the intestine.

4.4 Special Warnings and Precautions for Use

General.

Colestyramine should not be taken in its dry form. It must always be mixed with water or other fluids before ingesting.
Experience in infants and children is limited and a practical dosage schedule has not been established. The effects of long-term drug administration as well as its effects in maintaining lowered cholesterol levels in paediatric patients are unknown.
Questran Lite should be used with caution in patients with phenylketonuria. Questran Lite powder contains 16.8 mg phenylalanine per 4 g dose of colestyramine.
Before instituting therapy with Questran Lite, diseases contributing to increased blood cholesterol such as hypothyroidism, diabetes mellitus, nephrotic syndrome, dysproteinemias and obstructive liver disease should be looked for and specifically treated.
In addition, prior to instituting therapy with Questran Lite, an attempt should be made to control serum cholesterol by appropriate dietary regimen, weight reduction and the treatment of any underlying disorder which might be the cause of the hypercholesterolemia. Serum cholesterol levels should be determined frequently during the first few months of therapy and periodically thereafter. A favourable trend in cholesterol reduction should occur during the first month of Questran Lite therapy. The therapy should be continued to sustain cholesterol reduction. Serum triglyceride levels should be measured periodically to detect whether significant changes have occurred.

Vitamin supplements.

Because it sequesters bile acids, colestyramine may interfere with normal fat absorption and may prevent absorption of fat soluble vitamins such as A, D and K. If colestyramine is to be given for a long time, supplementary vitamins A and D should be given daily in a water miscible form or parenterally.

Bleeding tendencies.

Chronic use of colestyramine resin may be associated with increased bleeding tendency due to hypoprothrombinaemia associated with a vitamin K deficiency. This will usually respond to parenteral vitamin K, and recurrences can be prevented by oral dosage of vitamin K. Increased prothrombin time may be a hazard with anticoagulants which depress prothrombin. Reduction of serum or red cell folate has been reported, and treatment with folic acid should be considered in these cases.

Concomitant medication.

Since colestyramine may bind other drugs given concurrently, the interval between administration of colestyramine and other medicaments should be as great as feasible. Other drugs should be taken at least one hour before or four to six hours after colestyramine to avoid impeding their absorption.

Fat digestion.

Questran Lite in large doses may (24 g/day) interfere with normal fat digestion.
Serum triglyceride levels should be checked periodically.

Hyperchloraemic acidosis.

There is a possibility that prolonged use of colestyramine, because it is the chloride form of a resin, may lead to hyperchloraemic acidosis, especially in younger children and smaller patients where the relative dosage may be higher.
Hyperchloraemic acidosis has been reported in two elderly female patients who had received colestyramine in conjunction with spironolactone. Caution is advised if the simultaneous administration of colestyramine and aldosterone antagonists is intended.

Constipation.

Colestyramine may produce or severely worsen pre-existing constipation. In patients with constipation, dosage of colestyramine should be reduced to avoid the possibility of impaction. In patients for whom Questran Lite is to be used as a cholesterol lowering agent, gastrointestinal dysfunction should be evaluated before using this preparation. In these patients, efforts should be made to avert severe constipation and its inherent problems, especially in those with clinically symptomatic coronary artery disease.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

Serum cholesterol levels should be determined frequently during the first few months of therapy and periodically thereafter. Serum triglyceride levels should be measured periodically to detect whether significant changes have occurred.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Since colestyramine is an anion exchange resin, Questran Lite may have a strong affinity for acidic materials; it may also absorb neutral or basic materials to some extent. Therefore, colestyramine resin may delay or reduce the absorption of concomitantly dosed medicaments such as phenylbutazone, warfarin, chlorothiazide (acidic), as well as tetracycline, phenobarbital (phenobarbitone), thyroid and levothyroxine preparations, digitalis and inorganic iron.
Discontinuation of colestyramine could be hazardous to health if a potentially toxic drug such as digitalis had been titrated to a maintenance level while the patient was taking colestyramine resin.
Questran Lite may interfere with the pharmacokinetics of drugs (e.g. estrogens) that undergo enterohepatic recirculation.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
The physiological hyperlipidaemia of pregnancy does not require treatment.
Use of colestyramine in pregnancy, lactation or by women of childbearing age requires that potential benefits of therapy be weighed against possible hazards to mother and child. The known interference with absorption of fat soluble vitamins may be detrimental even in the presence of supplementation. Safety of use of colestyramine resin by pregnant women has not been established.
 See Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy.

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)

More common.

Constipation is the major single complaint and may be severe and occasionally accompanied by faecal impaction and/or haemorrhoids with or without bleeding.
Predisposing factors for most of these complaints in patients treated to lower cholesterol levels are high dose (more than 24 g colestyramine daily) and old age (more than 60 years). Most instances of constipation are mild, transient and controlled with standard treatment. Some patients require a temporary decrease in dosage or discontinuation of therapy.

Less common.

Gastrointestinal.

Abdominal discomfort (pain and distension), flatulence, nausea, vomiting, heartburn, diarrhoea, anorexia, dyspepsia and steatorrhoea.

Haematological.

Bleeding tendencies (hypoprothrombinaemia) due to vitamin K deficiency, as well as vitamin A (one case of night blindness reported) and D deficiencies.

Skin and mucosa.

Rash and irritation of the skin, tongue and perianal area.

Other.

Hyperchloraemic acidosis, osteoporosis. Occasional calcified material has been observed in the biliary duct including calcification of the gall bladder in patients to whom colestyramine has been given. However, this may be a manifestation of the patient's liver disease and not drug related.
One patient experienced biliary colic on each of three occasions which he took Questran Lite. One patient diagnosed as acute abdominal symptom complex was found to have a "pasty mass" in the transverse colon on X-ray.
Rare reports of intestinal obstruction have been received postmarketing, including two deaths in paediatric patients.

Other events not necessarily drug related.

Gastrointestinal.

Rectal bleeding, black stools, haemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccoughs, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation.

Laboratory test changes.

Liver function abnormalities.

Haematological.

Increased or decreased prothrombin time, ecchymosis, anaemia.

Cardiovascular.

Claudication, xanthomas of hands and fingers, angina, arteritis, thrombophlebitis, myocardial infarction, myocardial ischaemia, increased postprandial angina.

Hypersensitivity.

Urticaria, asthma, wheezing, shortness of breath.

Musculoskeletal.

Backache, muscle and joint pains, arthritis.

Neurological.

Headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paraesthesia.

Eye.

Arcus juvenilis, uveitis.

Renal.

Haematuria, dysuria, burnt odour to urine, diuresis.

Miscellaneous.

Weight loss, weight gain, increased libido, swollen glands, oedema, dental bleeding, dental caries, chest pain.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

One case of overdosage with Questran Lite has been reported in a patient taking 150% of the maximum recommended daily dosage for several weeks. No ill effects were observed.
Should overdosage occur, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
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.

Cholesterol is the major, and probably the sole precursor of bile acids. A major portion of the bile acids secreted into the intestine with the bile is reabsorbed and returned to the liver via the portal circulation in an enterohepatic cycle. Only very small amounts of bile acids are found in normal serum.
Colestyramine combines with bile acids in the intestine to form an insoluble complex which is excreted in the faeces. This process results in a continuous, though partial, removal of bile acids from enterohepatic circulation by preventing their reabsorption. Besides bile acids, some other anions are strongly bound to the resin, but cations or neutral compounds are usually less firmly bound.
The increased loss of bile acids due to colestyramine administration leads to increased oxidation of cholesterol to bile acids, a decrease in beta lipoprotein or low density lipoprotein in plasma and a decrease in serum cholesterol levels. Although in man colestyramine produces an increase in hepatic synthesis of cholesterol, plasma cholesterol levels fall. Apparently, this fall is secondary to an increased clearance of cholesterol rich lipoproteins from plasma. Serum triglyceride levels may increase or remain unchanged in patients treated with colestyramine.
Colestyramine is insoluble in water and is not absorbed from the gastrointestinal tract. It is not affected by digestive enzymes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Questran Lite contains the following excipients: aspartame, citric acid, colloidal anhydrous silica, orange juice 059107 AGEP0551 (ARTG PI No: 1291), propylene glycol alginate and xanthan gum.

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 30°C.

6.5 Nature and Contents of Container

Container type: sachet (Al laminated with PE/paper).
Pack size: 4 g x 50 sachets and 8 g x 50 sachets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 11971 - Questran Lite colestyramine 850 mg/g powder sachet.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Colestyramine is the chloride salt of a basic anion exchange resin.
Chemical name: [4-[3-(4-ethylphenyl)butyl]phenyl]-trimethylazanium.
Molecular formula: C21H30ClN.
Molecular weight: 341.92.

CAS number.

11041-12-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes