FOSRENOL 750 mg CHEWABLE TABLETS

2. What you need to know before starting to take Fosrenol

Do not take Fosrenol

? if you are allergic to lanthanum carbonate hydrate or any of the other components of this medication (listed in section 6).

? if you have low phosphate levels in the blood (hypophosphatemia).

• if you have intestinal obstruction.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fosrenol if you know you have or have had any of the following conditions:

• stomach or intestinal cancer
• inflammatory intestinal disease, including ulcerative colitis or Crohn's disease
• abdominal surgery or infection or inflammation of the abdomen/intestine (peritonitis)

• gastric or intestinal ulcers
• intestinal obstruction or slow intestinal transit (e.g., constipation and stomach complications due to diabetes)

? reduced liver or kidney function.

It is very important to chew Fosrenol tablets well and not swallow them whole or without chewing completely. This will reduce the risk of adverse gastrointestinal complications such as intestinal wall rupture, intestinal obstruction, or constipation (see section 4).

If your kidney function is reduced, your doctor may decide to periodically check your blood calcium levels. If the level is too low, you may be given additional calcium.

If you need to have an X-ray, inform your doctor that you are taking Fosrenol, as it may affect the results.

If you need to have a gastrointestinal endoscopy, inform your doctor that you are taking Fosrenol (lanthanum) because the endoscopist may detect lanthanum accumulation in the digestive tract.

Taking Fosrenol with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Fosrenol may affect how certain medications are absorbed in the digestive tract. If you are taking chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), or tetracycline or doxycycline antibiotics, you should not take these medications within 2 hours before or after taking Fosrenol.

It is not recommended to take oral fluoroquinolone antibiotics (including ciprofloxacin) within 2 hours before or 4 hours after taking Fosrenol.

If you are taking levothyroxine (for low thyroid activity), you should not take this medication within 2 hours before or after taking Fosrenol. Your doctor may want to monitor your thyroid-stimulating hormone (TSH) levels more closely.

Taking Fosrenol with food and drinks

Fosrenol should be taken with or immediately after food. See section 3 for instructions on taking Fosrenol.

Pregnancy and breastfeeding

Fosrenol should not be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Since it is not known whether the medication can pass into breast milk, you should not continue breastfeeding while taking Fosrenol. If you are breastfeeding, consult your doctor or pharmacist before using any medication.

Driving and using machines

Dizziness and vertigo (a feeling of dizziness or "spinning") are rare adverse reactions that have been reported by patients taking Fosrenol. If you experience these symptoms, they may affect your ability to drive or use machines.

Fosrenol contains glucose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Fosrenol

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should take Fosrenol with or immediately after food. Adverse effects such as nausea and vomiting are more likely if you take Fosrenol before a meal.

The tablets should be chewed completely and not swallowed whole. To help with chewing, the tablets can be crushed. No additional liquid is needed.

If you have difficulty chewing the tablets, inform your doctor, as this medication is also available in oral powder form.

Your doctor will tell you how many tablets to take with each meal (your daily dose will be divided between meals). The number of tablets you take will depend on the following:

? your diet (the amount of phosphate in the food you eat)

? your blood phosphate level.

Initially, the daily dose of Fosrenol will normally be 1 tablet per meal (3 tablets per day).

Every 2-3 weeks, your doctor will check your blood phosphate levels and may increase the dose until your blood phosphate level is suitable for you.

Fosrenol works by binding to phosphate in your food in your intestine. It is very important to take Fosrenol with each meal. If you change your diet, inform your doctor, as you may need to take additional Fosrenol. Your doctor will advise you on what to do in this case.

If you take more Fosrenol than you should

If you take too many tablets, contact your doctor to assess the risk and receive advice. The symptoms of an overdose may be nausea and headache.

If you have taken more Fosrenol than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91-562-0420, indicating the medication and the amount taken.

If you forget to take Fosrenol

It is important to take Fosrenol with each meal.

If you forget to take the Fosrenol tablets, take the next dose with the next meal. Do not take a double dose to make up for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people will experience them.

Some adverse effects may be serious. If you experience any of the following adverse effects, consult your doctor immediately:

• Intestinal wall rupture (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain on palpation). This adverse effect occurs rarely (may affect up to 1 in 1000 people).
• Intestinal obstruction (symptoms include: severe swelling, pain, edema, or abdominal cramps, severe constipation). This adverse effect occurs infrequently (may affect up to 1 in 100 people).
• Contact your doctor if you experience a new or severe episode of constipation, as it may be an early sign of intestinal obstruction. Constipation is a frequent adverse effect (may affect up to 1 in 10 people).

Other less serious adverse effects include the following:

Very frequent adverse effects (may affect more than 1 in 10 people):

? Nausea, vomiting, diarrhea, stomach pain, headache, itching, rash.

Frequent adverse effects (may affect up to 1 in 10 people):

? Heartburn and flatulence.

? Hypocalcemia (low calcium levels in the blood) is also a frequent adverse effect; symptoms may include tingling in hands and feet, muscle cramps, and abdominal or facial muscle spasms.

Infrequent adverse effects (may affect up to 1 in 100 people):

? Fatigue; feeling unwell; chest pain; weakness; swelling of hands and feet; body pain; dizziness; vertigo; belching; stomach and intestinal inflammation (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders, esophageal or mouth inflammation; soft stools; increased levels of certain liver enzymes, parathyroid hormone; aluminum, calcium, and glucose in the blood; increased or decreased phosphate levels in the blood; thirst; weight loss; joint pain; muscle pain; weakness and bone loss (osteoporosis); loss and increased appetite; laryngeal inflammation; hair loss; increased sweating; taste disorders and increased white blood cell count.

Unknown (frequency cannot be estimated from available data):

• Presence of product residues in the digestive tract

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fosrenol

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fosrenol

• The active ingredient is lanthanum (as lanthanum carbonate hydrate). Each chewable tablet contains lanthanum carbonate hydrate equivalent to 750 mg of lanthanum.
• The other ingredients are dextrates (hydrated), colloidal silica anhydrous, and magnesium stearate.

Appearance of the product and package contents

Fosrenol is presented in the form of a white, round, flat, chewable tablet with beveled edges, marked with "S405/750" on one side.

The tablets are supplied in plastic bottles of 20, 45 tablets, or multiple packaging: 90 (2 bottles of 45) chewable tablets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower,

Dublin 2, D02 WH68, Ireland

Email: [email protected]

The manufacturer is:

RB NL Brands B.V.

Schiphol Boulevard 207

1118BH, Schiphol

Netherlands

You can request more information about this medication from the local representative of the marketing authorization holder.

Local representative:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Phone: +34 91 790 42 22

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this prospectus: 04/2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)