Details for: APO-COLESEVELAM
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02494051 | APO-COLESEVELAM | COLESEVELAM HYDROCHLORIDE | 625 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- APO-COLESEVELAM may be prescribed on its own (called monotherapy) in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inadequate.
- APO-COLESEVELAM may be used together with a statin (called combination therapy) and the diet low in fat and cholesterol when patients are not appropriately controlled by the statin on its own.
What it does
Taking APO-COLESEVELAM helps to lower the level of cholesterol in your blood. Your doctor should only give you APO-COLESEVELAM if a diet low in fat and cholesterol did not work well enough on its own.
APO-COLESEVELAM works in your intestinal system by binding bile acids produced by your liver and carrying the bile acids out of your body with your feces. This prevents your body from recycling the bile acids from your intestines in the usual way. Without the recycling process, your liver has to make additional bile acids. Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.
When it should not be used
Do not take APO-COLESEVELAM
- if you are allergic (hypersensitive) to colesevelam or to any of the other ingredients of APO-COLESEVELAM
- if you have a blockage in your intestines or bile ducts (tubes that carry bile)
What the medicinal ingredient is
Colesevelam hydrochloride
What the non-medicinal ingredients are
APO-COLESEVELAM Tablets: Diacetylated Monoglycerides, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Silicon DiOxide.
What dosage form it comes in
Tablet 625 mgs
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use APO-COLESEVELAM talk to your doctor or pharmacist if:
- your triglyceride levels (a blood fat) are greater than 3.4 mmol/L
- you have difficulty in swallowing, or have a major stomach or intestinal disorder
- you are taking another medication called cyclosporine (a medicine used to suppress the immune system)
- you are taking antidiabetic treatments
- you are taking the oral contraceptive pill
- you are taking anticoagulant therapy
- you suffer from constipation, as APO-COLESEVELAM may induce or worsen this condition. This is especially important for patients with coronary heart disease and angina pectoris
- you are pregnant, planning on becoming pregnant or are breastfeeding
- you have any allergies to this drug or its ingredients or components of the container
Interactions with this medication
To ensure that the effectiveness of the following medications is not affected, it is important that you take the following medications at least 4 hours before taking APO-COLESEVELAM.
Drugs that may interact with APO-COLESEVELAM include:
- Anticoagulant therapy (medicines, such as warfarin, used to thin blood)
- Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
- Oral contraceptives (medicines to prevent pregnancy)
- Verapamil (a medicine used to treat high blood pressure)
- Antidiabetic medications (medicines, such as pioglitazone, repaglinide, glyburide metformin and insulin used to treat diabetes)
- Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy).
- Cyclosporine (a medicine used to suppress the immune system).
If you are going to take APO-COLESEVELAM and one of these medicines, your doctor may want to do tests to make sure that APO-COLESEVELAM does not interfere with these medicines.
Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking APO- COLESEVELAM. If necessary, your doctor may advise you to take vitamin supplements.
Proper use of this medication
Before starting therapy with APO-COLESEVELAM, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Take APO-COLESEVELAM with a meal.
APO-COLESEVELAM Tablets: Swallow the tablets with liquid.
Always take APO-COLESEVELAM exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you will be taking another medicine along with APO- COLESEVELAM it is possible that your doctor will advise you to take this other medicine at least 4 hours prior to taking APO-COLESEVELAM.
If you take a drug called cyclosporine, please ensure to take it with APO-COLESEVELAM in a consistent pattern over the day; either always together or always separate for a set number of hours.
Usual Dose
Monotherapy:
The usual starting dose for APO-COLESEVELAM is 3 tablets taken twice a day with meals or 6 tablets a day with a meal. Your doctor may increase your dose to a maximum of 7 tablets per day.
Combination therapy:
The usual dose for APO-COLESEVELAM, when used with a statin, is 4 to 6 tablets a day. The maximum recommended dose is 6 tablets per day. Your doctor may tell you to take the APO-COLESEVELAM dose either once a day or twice a day. APO-COLESEVELAM should be taken with a meal. The dosing of the statin should follow the instructions for that particular statin. The two medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Overdose
Please contact your doctor. Constipation or bloating could occur.
If you think you have taken too much APO- COLESEVELAM contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
You may take a missed dose with a later meal, but do not take a double dose of APO-COLESEVELAM to make up for missed doses.
Side effects and what to do about them
Like all medicines, APO-COLESEVELAM can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking APO-COLESEVELAM: Constipation, flatulence (gas), diarrhea, indigestion, muscle pain, abdominal pain, abnormal stools, feeling sick (nausea), headache, raised levels of triglycerides (fats) in your blood, raised levels of liver enzymes in your blood. You may notice that hemorrhoids get worse.
Side effects were usually mild or moderate in intensity.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| • Bowel obstructio n (abdomina l pain, cramps or distension, vomiting, fecal vomiting, constipatio n) | ✔ | ||
| • Difficulty swallowing | ✔ | ||
| • Fecal impaction (chronic constipatio n (sometime s with overflow diarrhea as liquid stool passes around the obstructio n), abdominal pain and bloating, loss of appetite) | ✔ | ||
| • Pancreatiti s (severe upper abdominal pain that radiates to the back, nausea, vomiting) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-COLESEVELAM, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children. Store at room temperature 15°C to 30°C. Protect from moisture.
Do not use after the expiry date.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO- COLESEVELAM:
- Talk to your doctor or pharmacist.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website. Find the Consumer Information on the manufacturer’s website, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last Approved: November 12, 2019