Sevelamer 800 mg. 180 tablets

What is Sevelamer Sandoz and what it is used for

Sevelamer Sandoz contains sevelamer carbonate as active substance. It binds with phosphate from food in the digestive tract and thus lowers serum phosphorus levels in the blood.

Patients whose kidneys do not function properly can not control the level of serum phosphorus in the blood. In this case, the amount of phosphate increases (your doctor will use the term hyperphosphatemia). Elevated levels of serum phosphorus may result in solid deposits in the body called calcifications. These deposits can "cure" the blood vessels and make it harder to push the blood in the body. Increased serum phosphorus may also lead to itchy skin, reddening of the eyes, bone pain and bone fractures.

2. What you need to know before taking Sevelamer Sandoz

Do not take Sevelamer Sandoz:

if you have low levels of phosphate in the blood (your doctor will check if this is the case);
if you have bowel obstruction;
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Sevelamer Sandoz if any of the following apply to you:

problems with swallowing;
problems with motility (spontaneous movement) of the stomach and intestines;
frequent vomiting;
active inflammation of the intestine;
you have had serious stomach or intestinal surgery.
The safety and efficacy of Sevelamer Sandoz have not been established in children (under the age of 18 years).
Therefore, the use of Sevelamer Sandoz in children is not recommended.

Additional treatments:
Because of your kidney disease or dialysis treatment, you may:

develop a condition with low or high levels of calcium in the blood. Since Sevelamer Sandoz does not contain calcium, your doctor may prescribe additional calcium tablets.
you have a small amount of vitamin D in the blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and, if necessary, prescribe additional vitamin D. If you do not take a multivitamin supplement, you may develop a condition with low levels of vitamins A, E, K and folic acid in the blood, so your doctor can monitor these levels and prescribe vitamin supplements if necessary.
Special note for dialysis patients:
You may develop a peritonitis (fluid infection in the abdomen) associated with your peritoneal dialysis. This risk can be reduced by careful adherence to sterile techniques when changing the bag. You should immediately inform your doctor if you experience new signs or symptoms of stomach discomfort, abdominal distension, abdominal pain, abdominal discomfort or abdominal cramps, constipation, fever, chills, nausea or vomiting. You should expect to be monitored more closely for problems with low levels of vitamins A, D, E, K and folic acid.

Other Drugs and Sevelamer Sandoz
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Sevelamer Sandoz should not be taken at the same time as ciprofloxacin (an antibiotic).

If you are taking medicines for heart rhythm problems or epilepsy, you should consult your doctor when taking Sevelamer Sandoz.

The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) can be reduced by Sevelamer Sandoz. Your doctor will give you advice if you are taking these medicines.

Thyroid hormone deficiency may occur rarely in certain subjects taking levothyroxine (used to treat low levels of thyroid hormone) and Sevelamer Sandoz. Your doctor may therefore monitor thyroid stimulating hormone levels more closely in your blood.
Your doctor may regularly check for interactions between Sevelamer Sandoz and other medicinal products.

Sevelamer Sandz with food and beverages
You should take Sevelamer Sandoz tablets during meals.

Fertility, pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine. It is not known whether Sevelamer Sandoz has an effect on the fetus.

Tell your doctor if you want to breast-feed your baby. It is not known whether Sevelamer Sandoz can pass into breast milk and influence your child.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. If your abilities are affected, do not drive or use tools or machines.

Sevelamer Sandoz contains lactose
Sevelamer Sandoz tablets contain lactose (milk sugar). Patients who are lactose intolerant or have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose
How to Store Sevelamer Sandoz

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the bottle and the outer carton after EXP.

This medicinal product does not require any special storage conditions.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Sevelamer Sandoz contains

The active substance is sevelamer carbonate. Each tablet contains 800 mg of sevelamer carbonate.
The other ingredients are: lactose monohydrate, silica, colloidal anhydrous, zinc stearate. Film coating contains hypromellose (E464), diacetylated monoglycerides.
What Sevelamer Sandoz looks like and what the package contains
Sevelamer Sandoz are oval, white to off-white, film-coated tablets with debossed 'SVL' on one side.

HDPE bottles with polypropylene cap.
Each bottle contains 180, 200 or 210 tablets.
Composite packages containing 1, 2 or 3 bottles are available.

HDPE bottles contain a desiccant. Do not remove this desiccant from the bottle.

Not all pack sizes may be marketed.

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