This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use FOSRENOL 1000 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

FOSRENOL 1000mgchewabletablets

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 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 leaflet. See section 4.

Contents of the pack

What Fosrenol is and what it is used for
What you need to know before you take Fosrenol
How to take Fosrenol
Possible side effects
Storage of Fosrenol
Contents of the pack and other information

1. What Fosrenol is and what it is used for

Fosrenol is used to reduce high blood phosphate levels in adult patients with chronic kidney disease.

Patients 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 the blood (hypophosphataemia).

? if you have intestinal obstruction.

Warnings and precautions

Blank space with thin horizontal lines above and below

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 intestinal disease including ulcerative colitis or Crohn's disease
abdominal surgery or infection or inflammation of the abdomen/intestine (peritonitis)
stomach or intestinal ulcers
intestinal obstruction or slow intestinal 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 chewing completely. 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 your blood calcium levels. If the 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 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 tetracycline or doxycycline antibiotics, 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.

Since 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.

Blank space with thin horizontal lines above and below 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

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, ask 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.

The tablets should be chewed completely 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, inform 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 will take will depend on:

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

? your blood phosphate level.

Initially, the 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 the dose until your blood phosphate level is suitable for you.

Fosrenol works by binding to phosphate in your gut. It is very important to take Fosrenol with each meal. If you change your diet, inform your doctor as you may need to take extra Fosrenol. Your doctor will advise 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. 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 each meal.

If you miss a dose, take the next dose with the 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 medicine, 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 could be serious. If you experience any of the following side effects, contact your doctor immediately:

Rupture of the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting or abdominal pain on palpation). This side effect is rare (may affect up to 1 in 1000 people).
Intestinal obstruction (signs include: severe swelling, pain, oedema or abdominal cramps, severe constipation). This side effect is uncommon (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, 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 intestine (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders, 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; laryngeal inflammation; hair loss; increased sweating; taste disturbances 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 experience 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 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 other information

What Fosrenol contains

The active substance is lanthanum (as lanthanum carbonate hydrate). Each chewable tablet contains lanthanum carbonate hydrate equivalent to 1000 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 “S405/1000” on one side.

The tablets are supplied in plastic bottles of 20, 45 tablets, or a multipack: 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: [email protected]

The manufacturer is:

RB NL Brands B.V.

Schiphol Boulevard 207

1118BH, Schiphol

Netherlands

You can obtain further 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:

Germany, Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Norway, Netherlands, United Kingdom (Northern Ireland), Sweden	Fosrenol
Ireland, Italy, Malta	Foznol

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/)

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How much does FOSRENOL 1000 mg CHEWABLE TABLETS cost in Spain ( 2025)?

The average price of FOSRENOL 1000 mg CHEWABLE TABLETS in October, 2025 is around 271.9 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

Preventive consultations and check-up planning.
Medical advice and follow-up consultations.
Test interpretation and diagnostic guidance.
Structured support for undiagnosed complaints.
Second opinion on diagnoses and treatment plans.
Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
Post-operative recovery support and pain management.
Preconception counselling and postpartum support.
Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

FOSRENOL 1000 mg CHEWABLE TABLETS

Anna Biriukova

Svetlana Kolomeeva

Anna Biriukova

Svetlana Kolomeeva