Patient leaflet - Colestyramine powder for oral suspension
1. What Colestyramine Powder is and what it is used for
Colestyramine Powder is a sachet containing 4 g of the active ingredient colestyramine. Colestyramine belongs to a group of medicines called bile acid binding resins. Colestryramine Poweder is used to lower your body's level of cholesterol (a type of fat). Colestyramine works in the digestive tract to absorb the cholesterol-containing bile acids, which then pass out through the body in the faeces.
Colestryramine Poweder may also be used to help stop some types of diarrhoea or itching.
2. What you need to know before you take Colestyramine Powder
Do not take Colestyramine Powder:
if you are allergic to colestyramine or any of the other ingredients of this medicine
(listed in Section 6)
- if you have a an illness which results in complete blockage of your bile duct (e.g. gall stones). Check with your doctor if you are unsure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colestyramine Powder if:
- you are in a long-term treatment with high doses of Colestyramine Powder as it may reduce the body’s ability to absorb fat-soluble vitamins from your diet (e.g. Vitamin A, D and K). Your doctor may suggest you take a vitamin supplement.
you are in long term treatment there may be disturbances of the acid-base balance
(“hyperchloraemic acidosis” or acidic blood) especially in children and smaller patients or if you have a kidney disorder
- this medicine is being given to a child where there is a family history of high blood cholesterol levels. An additional supplement of folic acid may be advised.
Children
This medicine is not suitable for children under 6 years of age.
Other medicines and Colestyramine Powder
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
If you are taking any other medicines, it is important that they are taken at a different time to your dose of Colestyramine Powder.
Any other medicines should be taken at least 1 hour before you take your dose of Colestyramine Powder or 4 – 6 hours after you have taken your dose of Colestyramine Powder. This is because Colestyramine Powder may change the effects of other medicines by stopping them from working so well and Colestyramine Powder preparations can stay in the digestive system and can stop other medicines from being absorbed by the body.
Colestyramine Powder with food, drink and alcohol
It is recommended that your alcohol intake is kept within the recommended guidelines as advised by your doctor, as alcohol can increase your cholesterol level.
If you have been prescribed this medicine to reduce your cholesterol levels, it is recommended that you follow a low-fat diet as advised by your doctor.
Pregnancy and breast-feeding
If you are pregnant or breast‑feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. Driving and using machines
Colestyramine Powderhas not been shown to impair your ability to drive or use machinery.
Colestyramine Powder contains aspartame, propylene glycol and Sunset Yellow (E1l0) This medicine contains 50 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains 300 mg propylene glycol (as alginate) in each sachet. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If your child that is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
This medicine contains Sunset Yellow (E110) which may cause allergic reactions.
3. How you take Colestyramine Powder
Always take Colestyramine Powder exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
To lower cholesterol levels and to manage diarrhoea
The recommended dose is is 3-6 sachets a day. This can be taken in single or divided doses up to 4 times a day.
To relieve itching
The recommended dose is 1-2 sachets each day.
Children aged 6 to 12 years
The dose to be given depends on the child's weight, which your doctor will work out for you.
Children under 6 years of age
This medicine is not recommended for children under 6 years of age.
Do not use Colestyramine Powder if you suffer from exudative or bloody diarrhoea. How to make up the sachets
- 1. The contents of one sachet should be sprinkled evenly on to 150 ml (4-6 fluid oz) of water, skimmed milk or fruit juice. It may may also be mixed in thin soups or pulpy fruits (e.g. apple sauce or fruit smoothies).
- 2. Allow to stand for 1 or 2 minutes.
- 3. Once the powder has soaked into the liquid, stir or shake it to mix in thoroughly. Do not take this medicine in its dry form. It could cause you to choke. Colestyramine Powder should be taken at mealtimes, but if you are taking any other medicines, it is important that they are taken at a different time to your dose of Colestyramine Powder (see information above “Other medicines and Colestyramine Powder”).
If you take more Colestyramine Powder than you should
Go to your nearest hospital Casualty Department or tell your doctor immediately. Take the empty container and any remaining sachets with you.
If you forget to take Colestyramine Powder
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose if it is almost time for your next dose.
If you stop taking Colestyramine Powder
You should not suddenly stop taking Colestyramine Powder.
Discontinuing Colestyramine Powder may pose a hazard to you if a potentially toxic drug such as digitalis (a medicine for heart failure) has been administered in such a way that it has an adequate effect while taking cholestyramine. In addition, oral blood thinners may have an increased effect after Colestyramine Powder has been deposited. Talk to your doctor before you stop taking Colestyramine Powder.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effect seen is constipation. This is very common (may affect more than 1 in 10 people). To minimise this effect, you will usually start with a low dose and increase it slowly until you are taking the full number of sachets as prescribed by your doctor. This side effect usually reduces over time.
Other side effects include:
Uncommon side effects (may affect up to 1 in 100 people)
- bloatedness,
- wind (flatulence),
- feeling sick (nausea) or vomiting,
- diarrhoea,
- heartburn,
- anorexia, weight loss or gain,
- indigestion (dyspepsia),
- problems with your body’s ability to absorb food correctly leading to grey, bulky or smelly stools (steatorrhea),increased tendency to bleed, which may also be seen with vitamin D, vitamin K or vitamin A deficiency (which may rarely result in night blindness),
- increased level of chloride in the blood (hyperchloremic acidosis) especially in children and patients with renal dysfunction,
- thin or brittle bones (osteoporosis),
- rash, itching, irritation of skin, tongue or around the anus.
Rare side effects (may affect up to 1 in 1,000 people)
- reports of obstruction of the intestine have been seen.
Side effects occurring in unknown number of patients
- anaemia,
- oedema,
- acute abdominal pain combined with nausea/vomiting with general feeling of illness (acute abdominal symptom complex), belching,
- joint inflammation, backage,
- storage of calcium in the gall bladder, abnormal smelling urine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Colestyramine Powder
Keep this medicine out of the sight and reach of children.
Store in a dry place, below 30°C.
Do not use this medicine after the expiry date which is stated on the carton and sachet after ‘EXP’. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Colestyramine Powder contains
The active substance is Colestyramine. The other ingredients are: Aspartame powder, Propylene glycol alginate, Colloidal silicon dioxide, Citric acid anhydrous, Sunset Yellow (E110) and Orange flavour.
What Colestyramine Powder looks like and contents of the pack
Sachets are packed in cartons of 30, 50, 60 or 180. The medicine is orange flavoured. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage, Herts, SG1 4QT, United Kingdom
Manufacturer
*Pharmascience International Limited, 1 Lampousas street, CY-1095, Nicosia, Cyprus
This leaflet was last revised in October 2024
*Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL