PATIENT INFORMATION

LESCOL® XL(lĕs-cŏl)

(fluvastatin)

extended-release tablets, for oral use

You must read and follow all instructions before using LESCOL XL.

Read this Patient Information before you start taking LESCOL XL and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about LESCOL XL, ask your doctor or pharmacist.

What is LESCOL XL?

LESCOL XL is a prescription medicine “that contains the cholesterol lowering medicine, fluvastatin.”

LESCOL XL is used in adults with heart disease (coronary artery disease) to:

• •lower the need for heart and blood vessel procedures to improve flow to the heart, called coronary revascularization.
• •slow the buildup of too much cholesterol in the arteries of the heart.

LESCOL XL is used along with diet to lower the level of:

• •low-density lipoprotein cholesterol (LDL-C) or “bad” cholesterol in adults with hyperlipidemia (high levels of fat in the blood)
• •LDL-C in adults and children 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes high levels of LDL, who require 80 mg of fluvastatin daily.

The safety and effectiveness of LESCOL XL has not been established in children younger than 10 years of age with heterozygous familial hypercholesterolemia (HeFH) or in children with other types of hyperlipidemia (high levels in fat in the blood) other than HeFH.

Do not take LESCOL XL if you:

• •have liver problems (acute liver failure or decompensated cirrhosis)
• •are allergic to fluvastatin or any of the ingredients in LESCOL XL. See the end of this Patient Information leaflet for a complete list of ingredients in LESCOL XL.

Before you take LESCOL XL, tell your healthcare provider about all of your medical conditions, including if you:

• •have muscle aches or weakness
• •drink more than 2 glasses of alcohol daily
• •have diabetes
• •have a thyroid problem
• •have kidney problems
• •are pregnant or plan to become pregnant. If you become pregnant while taking LESCOL XL, stop taking LESCOL XL and call your healthcare provider.
• •are breastfeeding or plan to breastfeed. It is not known if LESCOL XL passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take LESCOL XL. You should not breastfeed while taking LESCOL XL

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any new medicines. Tell your healthcare provider who prescribes LESCOL XL if another healthcare provider increases the dose of another medicine you are taking.

LESCOL XL may affect the way other medicines work, and other medicines may affect how LESCOL XL works. Especially tell your healthcare provider if you take:

• •warfarin (a medicine used to reduce blood clotting)
• •glyburide (a medicine used to treat diabetes)
• •phenytoin (a medicine used to treat epilepsy)

Taking LESCOL XL with certain medicines can also increase the risk of muscle problems. Especially tell your healthcare provider if you take:

• •gemfibrozil (a medicine used to lower triglycerides)
• •cyclosporine (a medicine used to suppress the immune system)
• •fluconazole (a medicine used to treat fungal infections)
• •fibrates or niacin
• •colchicine

Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take LESCOL XL?

• •Take LESCOL XL exactly as your healthcare provides tells you to take it.
• • Do not change your dose or stop taking LESCOL XL without talking to your healthcare provider.
• •Take LESCOL XL tablets 1 time each day, at any time of the day. LESCOL XL can be taken with or without food.
• •LESCOL XL tablets must be swallowed whole with a liquid. Do not break, crush or chew LESCOL XL tablets. Tell your healthcare provider if you cannot swallow tablets whole. You may need fluvastatin capsules or a different medicine instead of LESCOL XL tablets.
• •While taking LESCOL XL, continue to follow your cholesterol-lowing diet and exercise as your healthcare provider told you to.
• •In case of overdose, get medical help or contact a Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

What are the possible side effects of LESCOL XL?

LESCOL XL may cause serious side effects, including:

• • Muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death.

Tell your healthcare provider right away if you have:

• •unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take LESCOL XL.
• •muscle problems that do not go away even after your healthcare provider has advised you to stop taking LESCOL XL. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. Your chances of getting muscle problems are higher if you:
• oare taking certain other medicines while you take LESCOL XL
• oare 65 years of age or older
• ohave thyroid problems (hypothyroidism) that are not controlled
• ohave kidney problems
• • Liver problems. Your healthcare provider should do blood tests to check your liver before you start taking LESCOL XL, and if you have symptoms of liver problems while you take LESCOL XL. Call your healthcare provider right away if you have the following symptoms of liver problems:
• ofeel tired or weak
• oloss of appetite
• oright sided upper belly pain
• odark amber colored urine
• oyellowing of your skin or the whites of your eye
• • Increase in blood sugar (glucose) levels. LESCOL XL may cause an increase in your blood sugar levels.

The most common side effects of LESCOL XL include:

• •flu-like symptoms
• •sinus infection
• •upset stomach and stomach pain
• •urinary tract infections
• •bronchitis
• •nausea

These side effects are usually mild and may go away. The following additional side effects have been reported with LESCOL XL:

• •memory loss and confusion

Talk to your healthcare provider or pharmacist if you have side effects that bother you or does not go away.

These are not all the possible side effects of LESCOL XL. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store LESCOL XL?

• •Store LESCOL XL at room temperature 68°F to 77°F (20°C to 25°C). Protect from light.
• • Keep LESCOL XL out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.

General information about safe and effective use of LESCOL XL.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use LESCOL XL for a condition for which it was not prescribed. Do not give LESCOL XL to other people, even if they have the same medical condition you have; it may harm them.

You can ask your pharmacist or healthcare provider for information about LESCOL XL that is written for health professionals.

What are the ingredients in LESCOL XL?

Active Ingredient: fluvastatin

Inactive Ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide.

For more information go to www.sandoz.com or call 1-800-525-8747.

Manufactured by

Pfizer Ireland Pharmaceuticals

Newbridge, Ireland for

Sandoz Inc., Princeton, NJ 08540

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2023