Fosrenol (Lanthanum)
Fosrenol 500mg, 750 mg and 1000 mg chewable tablets
Lanthanum
1.What Fosrenol is and what it is used for
Fosrenol is used to lower the phosphate level in the blood of patients with chronic kidney disease.
Patients who have kidneys that do not work properly are not able to control the level of phosphate in the blood. The amount of phosphate in the blood then rises (your doctor will call this hyperphosphataemia).
Fosrenol is a drug which reduces the body’s absorption of phosphate from food by binding with it in your digestive tract. Phosphate which have bonded to Fosrenol cannot be absorbed through the intestinal wall.
2.Before you take Fosrenol
Do not take Fosrenol
- if you are allergic (hypersensitive) to lanthanum carbonate hydrate or any of the other ingredients of Fosrenol.
- if you have too little phosphate in your blood (hypophosphataemia).
Take special care with Fosrenol
If you know that you have or have had any of the following conditions, you should discuss this with your doctor before using Fosrenol:
acute peptic ulcer, ulcerative colitis, Crohn’s disease, bowel obstruction and reduced liver or kidney function.
If you have reduced kidney function your doctor may decide to check the level of calcium in your blood from time to time. If you have too little calcium, you may then be given extra calcium.
If you need to have an x-ray, please inform your doctor that you are taking Fosrenol as it may affect the results.
Taking other medicines
Fosrenol can affect how certain drugs are absorbed from your digestive tract. If you are taking chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), tetracycline or doxycycline antibiotics they should not be taken within 2 hours before or after taking Fosrenol.
It is not recommended that you take oral floxacin antibiotics (including ciprofloxacin) within 2 hours before or 4 hours after taking Fosrenol.
If you are taking levothyroxine (for an under-active thyroid) it should not be taken within 2 hours before or after taking Fosrenol. Your doctor may want to monitor the levels of thyroid-stimulating hormone (TSH) in your blood more closely.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Taking Fosrenol with food and drink
Fosrenol should be taken with, or immediately after food. The tablets should be chewed completely before swallowing. To aid in chewing the tablets may be crushed. Whole tablets should not be swallowed. Additional fluid is not necessary.
Pregnancy and breast-feeding
Fosrenol should not be taken during pregnancy. If you are, or could be pregnant, talk to your doctor before taking Fosrenol.
As it is not known whether the drug can be transferred to a child in breast-milk, you should not breast-feed whilst taking Fosrenol. If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Dizziness and vertigo are uncommon side effects reported by patients taking Fosrenol. If you experience these side effects it may affect your ability to drive or operate machinery.
3. How to take Fosrenol
Always take Fosrenol exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are not sure.
You should take Fosrenol with, or immediately after food. The tablets should be chewed completely before swallowing. To aid in chewing the tablets may be crushed. Whole tablets should not be swallowed. Additional fluid is not necessary.
Your doctor will tell you how many tablets you must take with each meal (your daily dose will be divided between meals). The number of tablets that you take will depend on:
• Your diet (the amount of phosphate in the food you eat)
• Your blood phosphate level
To start with, the daily dose of Fosrenol will usually be 1 tablet with each meal (3 tablets per day).
Every 2-3 weeks your doctor will check the level of phosphate in your blood and may increase your dose until the level of phosphate in your blood is acceptable.
Fosrenol works by binding phosphate from the food in your gut. It is very important to take Fosrenol at every meal. If you change your diet, contact 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 obtain advice. Symptoms of overdose may be nausea and headaches.
- If you forget to take Fosrenol
It is important to take Fosrenol with every meal.
If you forget to take your Fosrenol tablets, then take the next dose with your next meal. Do not take a double dose to make up for forgotten individual doses.
4. Possible side effects
Like all medicines, Fosrenol can cause side effects, although not everybody gets them.
Stomach effects are more likely if you take Fosrenol before your meal. You should always take it during or immediately after your food.
Common side effects (affects less than 1 in 10 people):
Nausea, vomiting, diarrhoea, stomach pain, constipation, heartburn, flatulence.
Hypocalcaemia (too little calcium in your blood) is also a common side effect; the symptoms of which can include tingling in the hands and feet, muscle and abdominal cramps or spasms of the facial and feet muscles.
Uncommon side effects (affects less than 1 in 100 people):
Tiredness; feeling of discomfort; chest pain, weakness; swollen hands and feet; body pain; dizziness; headache; vertigo; belching; inflammation of the stomach and intestines (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; tooth disorders; inflammation of the gullet or mouth; loose stools; increases in certain liver enzymes, parathyroid hormone; aluminium, calcium and glucose in the blood; increased or reduced phosphate level in the blood; thirst; weight decrease; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); lack of and increased appetite; inflammation of the larynx; loss of hair; itching; rash; increased sweating; taste disturbance and increased white blood cell count.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Fosrenol
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Fosrenol after the expiry date which is stated on the carton and the bottle label. The expiry date refers to the last day of that 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. Further Information
What Fosrenol contains
The active substance is 500mg 750mg or 1000mg lanthanum (as lanthanum carbonate hydrate).
The other ingredients are dextrates (hydrated), colloidal anhydrous silica and magnesium stearate.
What Fosrenol looks like and contents of the pack
Fosrenol is a white, round, bevelle-edged flat chewable tablet embossed with either ‘S405/500′ (500mg), ‘S405/750′ (750mg) or ‘S405/1000′ (1000mg) on one side of the tablet. The tablets are supplied in plastic bottles of 20, 45, 90, 100, or 200 tablets (500mg); 15, 30, 45, 75, 90, or 150 tablets (750 mg); and 10, 15, 30, 50, 90, or 100 tablets (1000mg).
Not all pack sizes may be marketed.
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