Fosrenol 1000 mg chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

FOSRENOL 1000 mg chewable tablets

lanthanum

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Fosrenol is 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. How to store Fosrenol
6. Contents of the pack and other information

1. What Fosrenol is and what it is used for

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

Patients whose kidneys do not function properly are unable to control the level of phosphorus in the blood. As a result, blood phosphorus levels rise (your doctor may refer to this condition as hyperphosphatemia).

Fosrenol is a medicine that reduces the body's absorption of dietary phosphorus by binding to it in the digestive tract. 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 to 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

Consult your doctor or pharmacist before taking Fosrenol if you know 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 (bowel movement) (e.g., constipation and stomach complications due to diabetes)
• reduced liver or kidney function.

It is very important to chew Fosrenol tablets thoroughly and not to swallow them whole or incompletely chewed. This will reduce the risk of gastrointestinal adverse complications such as intestinal wall rupture, intestinal obstruction, or constipation (see section 4).

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

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

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

Taking Fosrenol with other medicines

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

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 antibiotics in the tetracycline or doxycycline group, you should not take these drugs within 2 hours before or after taking Fosrenol.

Oral fluoroquinolone antibiotics (including ciprofloxacin) are not recommended within 2 hours before or 4 hours after taking Fosrenol.

If you are taking levothyroxine (for underactive thyroid), you should not take this medicine within 2 hours before or after taking Fosrenol. Your doctor may wish to monitor your blood levels of thyroid-stimulating hormone (TSH) more closely.

Taking Fosrenol with food and drink

Fosrenol should be taken together with or immediately after meals. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Dizziness and vertigo (a sensation 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 operate machinery.

Fosrenol contains glucose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Fosrenol

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

You must take Fosrenol with food or immediately after eating. Adverse effects such as nausea and vomiting are more likely if you take Fosrenol before meals.

The tablets must be completely chewed and must not be swallowed whole. To aid chewing, the tablets may be crushed. It is not necessary to take additional liquid.

If you have difficulty chewing 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 among your meals). The number of tablets you take will depend on the following:

• your diet (the amount of phosphorus contained in the foods you eat)
• your blood phosphorus level.

Initially, the usual daily dose of Fosrenol is 1 tablet per meal (3 tablets per day).

Every 2–3 weeks, your doctor will check your blood phosphorus levels and may increase your dose until your blood phosphorus level is within the appropriate range for you.

Fosrenol works by binding to phosphorus from food in your intestine. It is very important to take Fosrenol with every meal. If you change your diet, inform your doctor, as you may need additional Fosrenol. Your doctor will advise you on 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 overdose may include nausea and headache.

If you have taken more Fosrenol than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91-562-0420, stating the name of the medicine and the amount taken.

If you forget to take Fosrenol

It is important that you take Fosrenol with every meal.

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

If you have any further questions about 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 everyone will experience 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 tenderness when touched). This side effect is rare (may affect up to 1 in 1,000 people).
• Intestinal obstruction (signs include: severe bloating, pain, swelling, or cramps in the abdomen, severe constipation). This side effect is uncommon (may affect up to 1 in 100 people).
• Contact your doctor if you develop a new or severe episode of constipation, as it may be an early sign of intestinal obstruction. Constipation is a common side effect (may affect 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 and abdominal cramps, or spasms of facial and foot muscles.

Uncommon side effects (may affect up to 1 in 100 people):

? Tiredness; feeling unwell; chest pain; weakness; swelling of hands and feet; body pain; dizziness; vertigo; burping; inflammation of the stomach and intestine (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders, inflammation of the oesophagus or mouth; soft stools; increases in certain liver enzymes, parathyroid hormone, aluminium, calcium, and blood glucose levels; increase or decrease in blood phosphate levels; thirst; weight loss; joint pain; muscle pain; weakness and loss of bone mass (osteoporosis); loss of appetite or increased appetite; laryngitis; hair loss; increased sweating; taste disturbances and increased white blood cell count.

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

• Presence of product residue in the gastrointestinal tract

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You may also report side effects directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date which is stated on the outer packaging and on the label of the bottle after EXP. The expiry date refers to the last day of the stated month.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosrenol

• The active substance is lanthanum (as hydrated lanthanum carbonate). Each chewable tablet contains hydrated lanthanum carbonate equivalent to 1000 mg of lanthanum.
• The other components are dextrates (hydrated), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Fosrenol is presented as a white, round, flat, chewable tablet with bevelled edges, marked "S405/1000" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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 Manufacturer is:

RB NL Brands B.V.
Schiphol Boulevard 207
1118BH, Schiphol
The Netherlands

Further information about this medicinal product is available upon request to 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: 04/2025

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