Patient Information Leaflet

FOSRENOL 500 mg

tablet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
  If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What is FOSRENOL and what it is used for

2. What you need to know before taking FOSRENOL

3. How to take FOSRENOL

4. Possible side effects

5. Storage of FOSRENOL

6. Contents of the pack and additional information

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Do not take Fosrenol

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

?if you have low levels of phosphate in your blood (hypophosphatemia)

Warnings and precautions

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

• stomach or intestinal cancer
• inflammatory bowel disease, including ulcerative colitis or Crohn's disease
• abdominal surgery, infection, or inflammation (peritonitis)
• gastric or intestinal ulcers
• intestinal obstruction or slow intestinal transit (e.g., constipation and gastrointestinal 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 them completely. This will reduce the risk of adverse gastrointestinal complications such as intestinal perforation, intestinal obstruction, or constipation (see section 4).

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

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

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

Taking Fosrenol with other medicines

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

Fosrenol may affect how certain medicines are absorbed in the digestive tract. If you are taking chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), or tetracycline or doxycycline antibiotics, do not take those medicines 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), do not take that medicine within 2 hours before or after taking Fosrenol. Your doctor may want to monitor your blood levels of thyroid-stimulating hormone (TSH) more closely.

Taking Fosrenol with food and drinks

Fosrenol should be taken with food or immediately after eating 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machines

Dizziness and vertigo (a sensation 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 operate machines.

Fosrenol contains glucose

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

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

You should take Fosrenol together with or immediately after consuming food. Nausea and vomiting are more likely to occur if you take Fosrenol before eating.

The tablets must be chewed completely, and should not be swallowed whole. To aid in chewing, the tablets can be crushed. No additional liquid is required.

If you find it difficult to chew the tablets, inform your doctor as this medication is 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 will take will depend on the following:

?your diet (the amount of phosphorus in the foods you consume)

?your blood phosphorus level.

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

Every 2-3 weeks, your doctor will checkyour blood phosphorus concentrations and may increase the dose until your blood phosphorus level is suitable for you.

Fosrenol acts by binding to phosphorus in your food in your intestine. It is very important to take Fosrenol with each meal. If you modify your diet, inform your doctor, as you may need to take additional Fosrenol. Your doctor will advise you on what to do in such cases.

If you take more Fosrenol than you should

If you take too many tablets, contact your doctor to assess the risk and receive guidance. Symptoms of an overdose may include 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 essential 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 compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects could be serious. If you experience any of the following side effects, seek medical attention immediately:

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

Other less serious side effects include the following:

Frequent side effects (may affect more than 1 in 10 people):

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

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

?Heartburn and flatulence.

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

Rare side 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; inflammation of the stomach and intestines (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental problems, inflammation of the esophagus or mouth; soft stools; increases in certain liver enzymes, parathyroid hormone; aluminum, calcium, and glucose in the blood; increase or decrease in blood phosphorus levels; thirst; weight loss; joint pain; muscle pain; weakness and loss of bone mass (osteoporosis); loss of appetite; inflammation of the larynx; hair loss; increased sweating; alterations in taste and increased white blood cell count.

Unknown (frequency cannot be estimated from available data):

• Presence of product residues in the digestive tract

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directlythrough the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 that appears on the packaging and the label of the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacisthow to dispose of the packaging and the medicines that you no longer need. This way, you will help protect the environment.

Fosrenol Composition

• The active ingredient is lanthanum (as lanthanum carbonate hydrate). Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg of lanthanum.
• The other components are dextrates (hydrated), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the container

Fosrenol is presented in the form of a white, round, flat, beveled-edged, chewable tablet marked with “S405/500” on one side.

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder and manufacturer

The marketing authorization holderis:

Takeda Pharmaceuticals International AG Ireland Branch

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

Dublin 2, D02 HW68, Ireland

E-mail:[email protected]

The manufactureris:

RB NL Brands B.V.

Schiphol Boulevard 207

1118BH, Schiphol

Netherlands

You can request more information about this medication by contacting 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

Tel: +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) with the following names:

Last review date of this leaflet: 09/2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)