FOSRENOL 500 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

FOSRENOL 500mgchewabletablets

Lanthanum

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

Contents of the pack

1. What is Fosrenol and what is it used for
2. What you need to know before you take 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 high blood phosphate levels in adult patients with chronic kidney disease.

Patient with kidneys that do not work properly cannot control the level of phosphate in their blood. As a result, the amount of phosphate in the blood increases (your doctor may refer to this condition as hyperphosphataemia).

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

2. What you need to know before you take 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 low levels of phosphate in your blood (hypophosphataemia)

• if you have intestinal obstruction.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Fosrenol if you know that 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 abdominal infection or inflammation (peritonitis)
• stomach or intestinal ulcers
• intestinal obstruction or slow movement (e.g. constipation and stomach problems due to diabetes)

? reduced liver or kidney function.

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

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

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

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

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 how certain medicines are absorbed in the gut. 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 underactive thyroid), do not take this medicine within 2 hours before or after taking Fosrenol. Your doctor may want to monitor your blood thyroid stimulating hormone (TSH) levels more closely.

Taking Fosrenol with food and drink

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

Pregnancy and breast-feeding

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

As it is not known whether the medicine can pass to the child through breast milk, you should not breast-feed while taking Fosrenol. If you are breast-feeding, 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 some sugars, consult them before taking this medicine.

3. How to take Fosrenol

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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.

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

If you find it difficult to chew the tablets, tell your doctor as this medicine is also available as an oral powder.

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:

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

? your blood phosphate level.

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

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

Fosrenol works by binding to phosphate in your gut. It is very important to take Fosrenol with every 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 many tablets, contact your doctor to assess the risk and get 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, telephone: 91-562-0420 stating the medicine and the amount taken.

If you forget to take Fosrenol

It is important that you take Fosrenol with every meal.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious. If you experience any of the following side effects, tell 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, oedema or abdominal cramps, severe constipation). This side effect occurs uncommonly (may affect up to 1 in 100 people).
• Contact your doctor if you experience a new or severe episode of constipation, it can 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, diarrhoea, stomach pain, headache, itching, rash.

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

? Heartburn and flatulence.

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

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; inflammation of the stomach and gut (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental problems, inflammation of the oesophagus or mouth; soft stools; increased levels of certain liver enzymes, parathyroid hormone; aluminium, calcium and glucose in the blood; increased or decreased phosphate levels in the blood; thirst; weight loss; joint pain; muscle pain; weakness and loss of bone mass (osteoporosis); loss and increased appetite; inflammation of the larynx; hair loss; increased sweating; changes in taste and increased white blood cell count.

Not known (frequency cannot be estimated from the available data):

• Presence of product residues in the gut

Reporting of side effects

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

You can also report side effects directly via the Spanish Medicines Agency website: 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 after EXP. The expiry date refers to 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 to protect the environment.

Dispose of the packaging and any unused product in the pharmacy’s recycling bin

6. Contents of the pack and further information

Composition of Fosrenol

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

Appearance and packaging

Fosrenol is presented as a white, round, flat, chewable tablet with bevelled edges, marked with “S405/500” on one side.

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

Not all pack sizes may be marketed.

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: medinfoEMEA@takeda.com

The manufacturer is:

RB NL Brands B.V.

Schiphol Boulevard 207

1118BH, Schiphol

Netherlands

You can get more information on this medicine by contacting 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

Tel: +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 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/)