Side Effects

Like all medicines, LODALIS can cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking LODALIS: 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.

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 LODALIS.

Drugs that may interact with LODALIS 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 LODALIS and one of these medicines, your doctor may want to do tests to make sure that LODALIS 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 LODALIS. If necessary, your doctor may advise you to take vitamin supplements.

Proper Use of this medication

Before starting therapy with LODALIS, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.

Take LODALIS with a meal.

Usual dose:

Monotherapy:

The usual starting dose for LODALIS 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. The usual dose of LODALIS powder for oral suspension is one packet (3.75 g of colesevelam resin) a day with a meal.

Combination therapy:

The usual dose for LODALIS, 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 LODALIS dose either once a day or twice a day. The usual dose of LODALIS powder for oral suspension when used with a statin is one packet (3.75 g of colesevelam resin) a day with a meal. LODALIS 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.

In case of drug overdose, contact a health care practitioner, 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 LODALIS to make up for missed doses.