FOSRENOL 750 mg ORAL POWDER

Introduction

Package Leaflet: Information for the Patient

FOSRENOL750mgoral powder

FOSRENOL1000mgoral powder

Lanthanum

Read the entire package leaflet carefully before starting to take/use this medicine, as it contains important information for you.

• Keep this package leaflet, as 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Fosrenol and what is it 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 further information

1. What is Fosrenol and what is it used for

Fosrenol is used to reduce the level of phosphorus in the blood of adult patients with chronic kidney disease.

Patients whose kidneys do not function properly cannot control the concentration of phosphorus in the blood. As a result, the amount of phosphorus in the blood increases (your doctor may refer to this condition as hyperphosphatemia).

Fosrenol is a medicine that reduces the absorption of phosphorus from food by the body, by binding to it in the digestive tract. The phosphorus bound to Fosrenol cannot be absorbed through the intestinal wall.

2. What you need to know before taking Fosrenol

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 a low level of phosphorus in the blood (hypophosphatemia)

• if you have intestinal obstruction.

Warnings and precautions

Talk to 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.

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

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

If you are going 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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

If you are taking levothyroxine (for low thyroid activity), do not take this medicine 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 how to take Fosrenol.

Pregnancy and breastfeeding

Fosrenol should not be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Since it is not known whether the medicine can pass into breast milk, you should not breastfeed while taking Fosrenol. If you are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dizziness and vertigo (a feeling of dizziness or 'spinning') are uncommon side effects 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 them before taking this medicine.

3. How to take Fosrenol

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Fosrenol oral powder should be mixed with a soft food (e.g. apple sauce or similar food) and swallowed immediately. No additional liquid is needed.

Do not open the sachet until the time of use. Mix the entire contents of the sachet with 1-2 tablespoons of soft food, making sure that the entire dose is mixed with the food. Make sure to swallow the mixture of oral powder and food immediately (within the next 15 minutes). Do not save any of the mixture of oral powder and food for later use.

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

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

? Your blood phosphorus level.

Before starting Fosrenol oral powder, your doctor may have used Fosrenol chewable tablets to find the right dose. Fosrenol chewable tablets come in different strengths, 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 phosphorus level and may increase the dose until your blood phosphorus level is acceptable, and regularly after that.

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

If you take more Fosrenol than you should

If you take too much Fosrenol, contact your doctor to assess the risk and receive advice. Symptoms of an overdose may be nausea and headache.

If you have taken more Fosrenol than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91-562-04-20, stating the medicine and the amount taken.

It is recommended to take the medicine packaging and package leaflet to the healthcare professional.

If you forget to take Fosrenol

It is important to take Fosrenol with each meal.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be serious. If you experience any of the following side effects, contact your doctor immediately:

• Intestinal wall rupture (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain on palpation). This side effect occurs rarely (may affect up to 1 in 1000 people).
• Intestinal obstruction (signs include: severe swelling, 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, it may be an early sign of intestinal obstruction. Constipation is a common side effect (may affect up to 1 in 10 people).

Other less serious side effects include the following:

.

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

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

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

? Heartburn and flatulence.

? Hypocalcemia (a level of calcium in the blood that is too low) is also a common side effect; symptoms may include tingling in hands and feet, muscle cramps, and spasms of facial and foot muscles.

Uncommon 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; gastrointestinal 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 phosphorus level in the blood; thirst; weight loss; joint pain; muscle pain; weakness and loss of bone mass (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 the available data):

• Presence of product residues in the digestive tract.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosrenol

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister label after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Fosrenol

• The active substance is lanthanum (as lanthanum carbonate hydrate). Each sachet contains lanthanum carbonate hydrate equivalent to 750 mg or 1000 mg of lanthanum.
• The other ingredients are dextrates (hydrated), colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging of the product

Fosrenol is presented as a white to off-white oral powder in a sachet.

The sachets are supplied in a carton of 90 units. (the outer carton contains 9 cartons of 10 sachets).

Marketing authorisation holder and manufacturer

The marketing authorisation holder is:

Takeda Pharmaceuticals International AG Ireland Branch

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

Dublin 2, D02 HW68, Ireland

Email: [email protected]

The manufacturer is:

Catalent Germany Schorndorf GmbH

Steinbeisstr. 1 and 2

Schorndorf, Baden-Wuerttemberg, 73614

Germany.

You can obtain further information on this medicine from the local representative of the marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this package leaflet: 04/2025.

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