Label: information for the patient

FOSRENOL750mgpolvooral

FOSRENOL1000mgpolvooral

lantano

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the label:

1.WhatisFosrenolyandwhatyouareallowedtotakeitfor

2.WhatarethesideeffectsofthemedicineFosrenol

3.HowtotakeFosrenol

4.Adverseeffects

5.Howtocontactus

6.Storageanddisposalofthemedicine

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Do not take Fosrenol

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting 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 or infection or inflammation of the abdomen/intestine (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.

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.

Inform your doctor if you are to have an X-ray, as Fosrenol may affect the results.

Inform your doctor if you are to have a gastrointestinal endoscopy, as the endoscopist may detect accumulation of lanthanum in the digestive tract.

Taking Fosrenol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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, do not take those 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), do not take that medication 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 medication.

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

Driving and operating machinery

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 machinery.

Fosrenol contains glucose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should take Fosrenol together or immediately after consuming food. Nausea and vomiting side effects are more likely if you take Fosrenol before meals.

Fosrenol oral powder must be mixed with a soft food (e.g., apple sauce or another similar food), and then swallowed. No additional liquid is required.

Do not open the package until the time of use. Mix the entire contents of the package with 1-2 tablespoons of soft food, making sure the entire dose is mixed with the food. Ensure you consume the oral powder and food mixture immediately (within 15 minutes). Do not store any amount of the oral powder and food mixture for later use.

Your doctor will indicate how many oral powder packets you should take with each meal (your daily dose will be divided between meals). The number of packets you will take will depend on:

?Your diet (the amount of phosphate in the foods you consume)

?Your blood phosphate level.

Before starting Fosrenol oral powder administration, your doctor may have used Fosrenol in chewable tablets to find the correct dose. Fosrenol chewable tablets are available in various concentrations, allowing for smaller dose increases. The initial dose of chewable tablets is usually 250 mg, three times a day with meals. Your oral powder dose is likely to be 750 or 1000 mg, three times a day with meals. Every 2-3 weeks, your doctor will check your blood phosphate level, and may increase the dose until your blood phosphate level is acceptable, and then regularly thereafter.

Fosrenol acts by binding to phosphate in your intestines. 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 instruct you on what to do in this case.

If you take more Fosrenol than you should

If you take an excessive amount of Fosrenol, contact your doctor to assess the risk and receive advice. 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: 91-562-04-20 indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Fosrenol

It is essential to take Fosrenol with each meal.

If you forgot to take Fosrenol, take the next dose with the next meal. Do not take a double dose to compensate for the missed doses.

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 (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain upon palpation). This side effect occurs rarely (may affect up to 1 in 1000 people).
• Intestinal obstruction (signs include: severe bloating, pain, edema, or abdominal cramps, severe constipation). This side effect occurs infrequently (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 (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, skin rash.

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

?Heartburn and flatulence.

?Hypocalcemia (excessively low calcium levels 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 bone mass loss (osteoporosis); loss of appetite or increased 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 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 prospectus.

You can also report them directly through 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 containers and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacisthow to dispose of the containers 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 sachet contains lanthanum carbonate hydrate corresponding to 750mg or 1000 mg of lanthanum.
• The other components are hydrated dextrates, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

Fosrenol is presented in the form of an oral powder, white to off-white in color, in a sachet.

The sachets are supplied in a box of 90units. (The outer box contains 9boxes of 10sachets).

Marketing Authorization Holder and Responsible Manufacturer

The Marketing Authorization Holder is:

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 Responsible Manufacturer is:

Catalent Germany Schorndorf GmbH

Steinbeisstr. 1 and 2

Schorndorf, Baden-Wuerttemberg, 73614

Germany.

Further information about this medicinal product can be obtained 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

Phone: +34 91 790 42 22

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet: 09/2023.

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