Fosrenol 1000 mg oral powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

FOSRENOL 750 mg oral powder

FOSRENOL 1000 mg oral powder

lantano

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, consult 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 may 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 adverse 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 renal failure.

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

Fosrenol is a medicine that reduces the body's absorption of phosphorus from food 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 (e.g., constipation and stomach complications due to diabetes)

• reduced liver or kidney function.

If you have reduced kidney function, your doctor may decide to monitor your blood calcium levels periodically. If your calcium levels are too low, you may be given additional calcium.

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

If you are scheduled for a gastrointestinal endoscopy, inform your doctor that you are taking Fosrenol (lanthanum), as the endoscopist may detect lanthanum accumulation in the gastrointestinal 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 gastrointestinal tract. If you are taking chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), or antibiotics of the tetracycline or doxycycline group, you should not take these drugs 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 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 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Since it is unknown whether the medicine passes into 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 told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Fosrenol

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Oral powder Fosrenol must be mixed with a soft food (e.g., apple sauce or similar food) and then swallowed. There is no need to take additional liquid.

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

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

• Your diet (the amount of phosphate in the foods you eat)
• Your blood phosphorus level.

Before starting oral powder Fosrenol, your doctor may have used Fosrenol chewable tablets to determine the correct dose. Fosrenol chewable tablets are available in various strengths, allowing smaller dose increments. The initial dose of chewable tablets is usually 250 mg three times daily with meals. Your likely oral powder dose will be 750 or 1000 mg three times daily with meals. Every 2–3 weeks, your doctor will monitor your blood phosphorus level and may increase your dose until your blood phosphorus level becomes acceptable, and then regularly thereafter.

Fosrenol works by binding to dietary phosphorus 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 an excessive amount of Fosrenol, 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: 91-562-04-20, stating the medicine and the amount taken.

It is recommended to carry the medicine packaging and leaflet when consulting a healthcare professional.

If you forget to take Fosrenol

It is important to take Fosrenol with every meal.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Perforation of the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness when pressed). This adverse 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 adverse effect is uncommon (may affect up to 1 in 100 people).
• Contact your doctor if you experience a new or severe episode of constipation, as it may be an early sign of intestinal obstruction. Constipation is a common adverse effect (may affect 1 in 10 people).

Other less serious adverse effects include the following:

.

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

? Nausea, vomiting, diarrhoea, stomach pain, headache, itching, skin rash.

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

? Heartburn and flatulence.

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

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

? Fatigue; feeling unwell; chest pain; weakness; swelling of hands and feet; body pain; dizziness; vertigo; burping; inflammation of the stomach and intestines (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 glucose in the blood; increase or decrease in blood phosphate levels; thirst; weight loss; joint pain; muscle pain; weakness and loss of bone mass (osteoporosis); loss of appetite and increased appetite; inflammation of the larynx; 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 adverse effects

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

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 requires no special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines 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 lanthanum carbonate hydrate). Each sachet contains lanthanum carbonate hydrate corresponding to 750 mg or 1000 mg of lanthanum.
• The other components are dextrates (hydrated), anhydrous colloidal silicon dioxide, and magnesium stearate.

Nature and contents of the container

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

Sachets are supplied in a box of 90 units (the outer carton contains 9 boxes of 10 sachets each).

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:

Catalent Germany Schorndorf GmbH
Steinbeisstr. 1 und 2
Schorndorf, Baden-Wuerttemberg, 73614
Germany

Further information about this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Local representative:

Takeda Farmacéutica España S.A.
Calle Albacete, 5, planta 9ª,
Edificio Los Cubos
28027 Madrid
Spain
Tel: +34 91 790 42 22

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: 04/2025

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