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TAJ PHARMA INDIA / Product / SEVELAMER CARBONATE TABLETS
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SEVELAMER CARBONATE TABLETS

Generic Name

Renaval


Brand Name

SEVELAMER CARBONATE


Dosage Form

Tablets


Strength and Dosage

400MG, 800 MG


Therapeutic Category

Anti hyperphosphatemic



Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


Sevelamer carbonate as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood. Patients who have kidneys that do not work properly are not able to control the level of serum phosphorus in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.



BEFORE YOU TAKE Sevelamer TABLETS

Do not take Sevelamer Tablets and tell your doctor if:
. you have low levels of phosphate in your blood (your doctor will check this for you)
. you have bowel obstruction
. 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 if any of the following applies to you:
. swallowing problems
. problems with motility (movement) in your stomach and bowel
. being sick frequently
. active inflammation of the bowel
. have undergone major surgery on your stomach or bowel.
The safety and efficacy in children (below the age of 18 years) has not been established. Therefore Sevelamer is not recommended for use in children.

Taking other medicines
Tell your doctor if you are taking or have recently taken or might take any other medicines. Sevelamer should not be taken at the same time as ciprofloxacin (an antibiotic). If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Sevelamer. The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer. Your doctor will advise you if you are taking these medicines. Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treatment low thyroid hormone levels) and Sevelamer. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely. Your doctor will check for interactions between Sevelamer and other medicines on a regular basis.

Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is unknown whether Sevelamer has any affect on unborn babies. Tell your doctor if you wish to breast-feed your baby. It is unknown whether Sevelamer may pass through breast milk and affect your baby. 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 you are affected, do not drive and do not use any tools or machines.


HOW TO TAKE SevelamerTABLETS

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.
Taking this medicine
• To remove a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil
. Do not remove the tablet from the blister until you are ready to take it
• Unless told otherwise, swallow your tablets whole with plenty of water
• Drink plenty of liquids such as water while taking this medicine
• If you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist.

You must take Sevelamer as prescribed by your doctor. They will base the dose on your serum phosphorus level.
The recommended starting dose of Sevelamer tablets for adults and the elderly (> 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.
The tablets must be swallowed whole . Do not crush, chew or break into pieces. In some cases where Sevelamer should be taken at the same time as another medicine , your doctor may advise you to take this medicine 1 hour before or 3 hours after Sevelamer intake, or they may consider monitoring the blood levels of that medicine. Your doctor will check the levels of phosphorus in your blood periodically and they may adjust the dose of Sevelamer . when necessary to reach an adequate phosphate level. If you take more RenavalTM than you should There are no reported overdoses in patients. In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Sevelamer

If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.


POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported in patients taking Sevelamer Very common (may affect more than 1 in 10 people):
. Vomiting
. constipation
. upper abdominal pain
. nausea
Common (may affect up to 1 in 10 people):
. Diarrhoea
. abdominal pain
. indigestion
. Flatulence
In clinical use, cases of itching, rash, slow intestine motility (movement)/blockages in the intestine and perforation in the intestine wall have been reported. Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist.

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via . By reporting side effects you can help provide more information on the safety of this medicine.


HOW TO STORE Sevelamer TABLETS

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the bottle and carton after the letters “EXP”. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment


FURTHER INFORMATION

What Sevelamer Tablets contain
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.
The tablet coating contains hypromellose (E464) and diacetylated monoglycerides

What Sevelamer Tablets look like and contents of the pack
RenavalTM are oval, white to off-white film-coated tablets with the inscription ‘SVL’ on one side. RenavalTM 800mg Tablets are available in blister packs of 30 tablets. Not all pack sizes may be marketed.

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

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