Renvela 800 mg film coated tablets – Summary of Product Characteristics (SmPC) – (emc)

Renvela 800 mg film coated tablets are a crucial medication for managing elevated serum phosphate levels in patients, particularly those undergoing dialysis or suffering from chronic kidney disease (CKD). This article delves into the summary of product characteristics, including uses, dosage, side effects, and other essential details.

What are the uses of Renvela 800 mg film coated tablets?

Renvela 800 mg film coated tablets are primarily used to treat hyperphosphatemia in adults with chronic kidney disease. The medication effectively reduces phosphate absorption from the diet, which is vital for patients on dialysis. By binding dietary phosphate, Renvela helps maintain appropriate serum phosphate levels, preventing complications associated with elevated phosphate.

This medication is also beneficial for children over six years old who experience similar conditions. Its formulation allows for significant clinical benefits, as clinical trials have demonstrated a marked reduction in serum phosphate levels compared to placebo treatments.

In addition to its primary use, Renvela may help manage phosphate levels that are often unregulated in patients with CKD, thereby contributing to a more stable and controlled health condition.

What is the recommended dosage for Renvela 800 mg film coated tablets?

The recommended dosage for Renvela 800 mg film coated tablets generally ranges from 2.4 g to 4.8 g daily. This dosage is usually administered in three separate doses with meals, allowing for optimal absorption and effectiveness. The actual dosage may be adjusted based on the patient’s individual serum phosphate levels.

Patients should begin with the initial recommended dosage and then have their phosphate levels monitored regularly. Adjustments may be made every two to four weeks based on these levels to ensure that phosphate is maintained within the target range.

It is essential for patients to adhere to the prescribed regimen. Non-compliance with the recommended dosage may lead to ineffective treatment and the potential for increased phosphate levels in the blood.

What are the side effects of Renvela 800 mg film coated tablets?

Like any medication, Renvela 800 mg film coated tablets can cause side effects. Common side effects may include nausea, vomiting, and constipation. These gastrointestinal issues can be bothersome but are often manageable with dietary adjustments or supportive care.

More serious side effects include the risk of gastrointestinal obstruction. Patients should be aware of the symptoms of bowel obstruction, such as abdominal pain, severe constipation, or bloating, and should seek medical attention if these occur.

Furthermore, Renvela can bind to fat-soluble vitamins, which may lead to deficiencies if not monitored. Patients should discuss vitamin supplementation with their healthcare provider to avoid potential deficiencies in vitamins A, D, E, and K.

How does Renvela 800 mg film coated tablets work?

Renvela 800 mg film coated tablets contain sevelamer carbonate, which works by binding dietary phosphate in the gastrointestinal tract. This binding process prevents phosphate absorption into the bloodstream, effectively lowering serum phosphate levels.

By inhibiting the absorption of phosphate, Renvela helps to manage the complications associated with hyperphosphatemia, such as cardiovascular issues and bone disease in patients with CKD. Its action is essential for maintaining healthy phosphate levels, thus promoting overall well-being.

The mechanism by which Renvela operates emphasizes its importance in the treatment of patients undergoing dialysis. By regularly monitoring serum phosphate levels and adjusting the dosage as necessary, healthcare providers can ensure the effectiveness of Renvela in managing hyperphosphatemia.

What are the contraindications of Renvela 800 mg film coated tablets?

Renvela 800 mg film coated tablets are contraindicated in certain situations. Patients with a known hypersensitivity to sevelamer or any other ingredient in the formulation should avoid using this medication. Additionally, those with bowel obstruction or hypophosphatemia should not take Renvela, as it may exacerbate these conditions.

Patients with swallowing difficulties should also exercise caution. If a patient is unable to swallow tablets whole, alternative methods of administration or different formulations should be considered.

It’s essential for healthcare providers to evaluate each patient’s medical history and current health status before prescribing Renvela to ensure its safe and effective use.

How should Renvela 800 mg film coated tablets be stored?

Proper storage of Renvela 800 mg film coated tablets is crucial for maintaining their efficacy. The tablets should be kept in a cool, dry place away from direct sunlight and moisture to prevent degradation of the medication.

It is advisable to store Renvela at room temperature, typically between 20°C to 25°C (68°F to 77°F), ensuring that it is out of reach of children and pets. Regularly check the expiration date and properly dispose of any expired medications.

For patients, adhering to these storage guidelines is vital to ensure that they receive the full therapeutic benefits of Renvela when it is prescribed.

Related questions about Renvela 800 mg film coated tablets

What is Renvela 800 mg film coated tablet?

Renvela 800 mg film coated tablets are a prescription medication designed to manage hyperphosphatemia in patients with chronic kidney disease. Containing sevelamer carbonate, they function by binding dietary phosphate to minimize its absorption. This helps maintain healthier serum phosphate levels, crucial for individuals undergoing dialysis.

What is the classification of Renvela 800 mg?

Renvela is classified as a phosphate binder. It falls under the category of medications used to control phosphate levels in patients with chronic kidney disease or those on dialysis. Its active ingredient, sevelamer carbonate, is specifically designed to reduce phosphate absorption from the diet.

What is the difference between Renvela and sevelamer?

Renvela contains sevelamer carbonate, while sevelamer hydrochloride is a different formulation of the same active ingredient. The key difference lies in the formulation; Renvela is often preferred due to its lower acidity and potentially fewer gastrointestinal side effects. Both medications aim to achieve the same therapeutic effect in managing phosphate levels.

Who is the manufacturer of Renvela 800 mg?

Renvela 800 mg is manufactured by Genzyme Corporation, a subsidiary of Sanofi. The company is known for its commitment to producing high-quality medications for patients with various medical conditions, including chronic kidney disease.

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