750 mg, 1,000 mg oral lanthanum powder

1. What Fosrenol is and what it is used for

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

In patients whose kidneys do not function normally, the kidneys cannot regulate blood phosphate levels. This causes the amount of phosphate in the blood to rise (doctors may call this hyperphosphatemia ).

Fosrenol is a drug that lowers the body’s uptake of phosphate from food by binding to it in the gastrointestinal tract. Phosphate bound to Fosrenol cannot be absorbed through the intestinal wall.

The lanthanum contained in Fosrenol may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

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 too little phosphate in your blood ( hypophosphatemia ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Fosrenol if you know you have, have had, or have had any of the following:

If you have impaired kidney function, your doctor may occasionally want to check the level of calcium in your blood. If you have too little calcium, you may need extra calcium.

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

Other medicines and Fosrenol

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 from the gastrointestinal tract. If you are taking chloroquine (for rheumatism and malaria ), ketoconazole (for fungal infections), antibiotics containing tetracycline or doxycycline, these medicines should not be taken within 2 hours before or after taking Fosrenol.

You should not take oral antibiotics containing floxacin (including ciprofloxacin ) within 2 hours before or 4 hours after taking Fosrenol.

If you are taking levothyroxine (due to an underactive thyroid gland ) it should not be taken within 2 hours before or after taking Fosrenol. Your doctor may want to check your thyroid-stimulating hormone ( TSH ) levels more closely.

Fosrenol with food and drink

Fosrenol should be taken with or without food. Instructions on how to take Fosrenol can be found in section 3.

Pregnancy and breastfeeding

Fosrenol should 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 if the medicine can be passed on to your baby through breast milk, you should not breast-feed while taking Fosrenol. If you are breast-feeding, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Dizziness and dizziness (a feeling of dizziness or that it “spins”) are less common side effects that have been reported by patients taking Fosrenol. If you experience these side effects, it may affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fosrenol contains glucose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Fosrenol

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

You should take Fosrenol with or immediately after a meal. If you take Fosrenol before a meal, you are more likely to get side effects such as nausea and vomiting.

Fosrenol oral powder is intended to be mixed with soft foods (eg apple puree or other similar foods) and then swallowed. Additional fluid is not necessary.

Do not open the sachet until it is to be used. Mix all the contents of the sachet with 1 2 tablespoons of soft food and make sure that the whole dose is mixed with the food. Make sure you eat a mixture of oral powder and soft foods immediately (within 15 minutes). Never save any mixture of oral powder and food for later use.

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

  • your diet (the amount of phosphate in the food you eat)
  • the level of phosphate in your blood.

Before you start taking Fosrenol oral powder, your doctor may have used your Fosrenol chewable tablet to find the right dose. Fosrenol chewable tablets are available in several strengths that allow for smaller dose increases. The starting dose of chewable tablets is usually 250 mg three times daily with meals. Your oral powder dose is likely to be 750 or 1,000 mg three times daily with meals. Your doctor will check the level of phosphate in your blood at 2-3 week intervals and may increase your dose until the level of phosphate in your blood is acceptable and then regularly.

Fosrenol works by binding phosphate from food to your gut. It is very important to take Fosrenol with every meal. If you change your diet, consult 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 then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Symptoms of overdose may include nausea and headache.

If you forget to take Fosrenol

You must take Fosrenol with every meal.

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

4. Possible side effects

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

Some side effects can be serious. Contact a doctor immediately if you get any of the following side effects:

  • Rupture of the intestinal wall (symptoms in the form of severe abdominal pain, chills, fever, nausea, vomiting, or tenderness in the abdomen). This is a rare side effect (may affect up to 1 in 1,000 people).
  • Blockage in the intestine (symptoms in the form of severe flatulence, abdominal pain, swelling or cramps, severe constipation). This is a less common side effect (may affect up to 1 in 100 people).
  • Contact your doctor if you experience the new-onset or worsening of constipation. It may be an early sign of a blockage in the gut. Constipation is a common side effect (may affect 1 in 10 people) .

Other minor side effects include the following:

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

Common side effects (may affect up to 1 in 10 users in 100):

  • heartburn, flatulence
  • Hypocalcaemia (too little calcium in the blood) is also a common side effect . Symptoms of hypocalcaemia may include tingling in the hands and feet, cramps in the muscles and abdomen, or spasms in the muscles of the face and feet.

Uncommon side effects (may affect up to 1 in 10 users in 1,000):

  • fatigue, discomfort, chest pain, weakness, swollen hands and feet, body aches, dizziness, dizziness, belching, inflammation of the stomach and intestines ( gastroenteritis ), indigestion, irritable bowel syndromedry mouth , dental disease, inflammation of the esophagus or oral cavity, loose stools, loose stools, of certain liver enzymes, parathyroid hormone, aluminum, calcium and glucose in the blood, elevated or decreased phosphate levels in the blood, thirst, weight loss, joint pain, muscle pain, weakening and decalcification of the skeleton (osteoporosis), decreased appetite, increased appetite, inflammation of the hair, increased sweating, taste changes and an increase in the number white blood cells .

5. How to store Fosrenol

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. The expiration date is the last day of the specified month.

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.

6. Contents of the packaging and other information

Content declaration

  • Each sachet contains 750 mg of lanthanum (as lanthanum carbonate hydrate).
  • Each sachet contains 1,000 mg of lanthanum (as lanthanum carbonate hydrate).
  • The other ingredients are dextrose (hydrogenated), anhydrous colloidal silica, and magnesium stearate.

What the medicine looks like and the contents of the pack

This medicine is available as a white to off-white, oral powder in a sachet .

The sachets are delivered in a carton with 90 sachets. (The outer carton contains 9 cartons with 10 sachets.)

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower,

Dublin 2, Ireland

Tel: +44 (0) 1256 894 959

Email: medinfoEMEA@shire.com

Manufacturer

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Tel: 08-731 28 00

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, the United Kingdom, the Czech Republic, Germany, Hungary, and Austria Fosrenol
Ireland, Italy, Malta Foznol

Muhammad Nadeem

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