MEDICATION GUIDE LANTHANUM CARBONATE CHEWABLE TABLETS (LAN-tha-num KAR-bo-nate)

Read this Medication Guide before you start taking lanthanum carbonate chewable tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about lanthanum carbonate chewable tablets?

Lanthanum carbonate chewable tablets may cause a bowel blockage, a hole in the bowel, or severe constipation, which can be serious, and sometimes lead to surgery or treatment in a hospital.

• You may have a higher risk of bowel blockage, a hole in the bowel, or severe constipation if you take lanthanum carbonate chewable tablets and have:
  • a history of surgery, ulcers or cancer in the stomach or bowel
  • a history of bowel blockage, or problems resulting in a decreased movement of food through your stomach and bowel (e.g., feeling full quickly after eating or constipation)
  • an infection or inflammation of the stomach/bowel (peritonitis)

Do not swallow lanthanum carbonate chewable tablets whole. Chew tablets completely before swallowing. If you cannot chew tablets completely, you may crush the tablets thoroughly before swallowing or discuss the oral powder formulation with your healthcare provider.

What are lanthanum carbonate chewable tablets?

Lanthanum carbonate chewable tablets are a prescription medicine used in people with end- stage renal disease (ESRD) to lower the amount of phosphate in the blood.

Who should not take lanthanum carbonate chewable tablets?

Do not take lanthanum carbonate chewable tablets if you:

• have blocked bowels
• have severe constipation

Lanthanum carbonate chewable tablets have not been studied in children and adolescents under 18 years of age.

What should I tell my healthcare provider before taking lanthanum carbonate chewable tablets?

Lanthanum carbonate chewable tablets may not be right for you. Before starting lanthanum carbonate chewable tablets, tell your healthcare provider if you:

• have a history of surgery, ulcers or cancer in the stomach or bowel
• have a history of a bowel blockage, constipation, or problems resulting in a decreased movement of food through your stomach and bowel especially if you also have diabetes
• have ulcerative colitis, Crohn’s disease or an infection or inflammation of the stomach/bowel (peritonitis)
• plan to have an X-ray of your stomach (abdomen)
• have any other medical conditions
• are pregnant, plan to become pregnant, or plant to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• antacids
• antibiotics
• thyroid medicine

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take lanthanum carbonate chewable tablets?

• Take lanthanum carbonate chewable tablets exactly as prescribed by your healthcare provider
• Your healthcare provider will tell you how much lanthanum carbonate chewable tablets to take
• Your healthcare provider may change your dose if needed
• Chewable tablets -Do not swallow tablets whole. Chew tablets completely before swallowing. If you cannot chew tablets completely, or if you have tooth disease, you may crush the tablets thoroughly before swallowing or discuss the oral powder formulation with your healthcare provider.
• Take lanthanum carbonate chewable tablets with or right after meals
• If you take an antacid medicine, take the antacid 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets
• If you take medicine for your thyroid (levothyroxine), take the thyroid medicine 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets
• If you take an antibiotic medicine, take the antibiotic 1 hour before or 4 hours after you take lanthanum carbonate chewable tablets

What are possible or reasonably likely side effects of lanthanum carbonate chewable tablets?

See “What is the most important information I should know about lanthanum carbonate chewable tablets?”

The most common side effects of lanthanum carbonate chewable tablets include:

• nausea
• vomiting
• diarrhea
• stomach pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of lanthanum carbonate chewable tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lanthanum carbonate chewable tablets?

• Store lanthanum carbonate chewable tablets between 20° to 25°C (68° to 77°F).

Keep lanthanum carbonate chewable tablets and all medicines out of the reach of children.

General information about lanthanum carbonate chewable tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lanthanum carbonate chewable tablets for a condition for which it was not prescribed. Do not give lanthanum carbonate chewable tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about lanthanum carbonate chewable tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lanthanum carbonate chewable tablets that is written for healthcare professionals.

For more information call Cipla Ltd. at 1-866-604-3268

What are the ingredients in lanthanum carbonate chewable tablets?

Active ingredient: lanthanum carbonate

Inactive ingredients: microcrystalline cellulose, guar gum, sucralose, hydroxypropyl cellulose, dextrates, colloidal silicon dioxide, stearic acid, magnesium stearate.

This Medication Guide has been approved by the US Food and Drug Administration.

Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788

Manufactured for:
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059

06/2023

SAP-21067067