Sevelamer Teva 800 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Sevelamer Teva 800 mg film-coated tablets
Sevelamer carbonate
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Sevelamer Teva is and what it is used for
- What you need to know before taking Sevelamer Teva
- How to take Sevelamer Teva
- Possible adverse effects
- How to store Sevelamer Teva
- Contents of the pack and other information
1. What Sevelamer Teva is and what it is used for
Sevelamer Teva contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the digestive tract and thereby reduces serum phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a blood-cleansing technique). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dial游戏副本
2. What you need to know before taking Sevelamer Teva
Do not take Sevelamer Teva:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- if you have low levels of phosphate in the blood (your doctor will check this for you)
- if you have intestinal obstruction
Warnings and precautions
Talk to your doctor or pharmacist before starting Sevelamer Teva if you are in any of the following situations:
- if you have difficulty swallowing
- if you have problems with gastrointestinal motility (movement of the stomach and intestines)
- if you frequently experience vomiting
- if you have active intestinal inflammation
- if you have undergone major surgery of the stomach or intestines
Contact your doctor while taking Sevelamer Teva:
- if you experience severe abdominal pain, stomach or intestinal disturbances, or blood in the stool (gastrointestinal bleeding). These symptoms may be due to a serious inflammatory bowel disease caused by deposition of sevelamer crystals in the intestine. Contact your doctor, who will decide whether you should continue treatment.
Additional treatments:
Due to your kidney condition or dialysis treatment, you may:
- have low or high levels of calcium in your blood. As this medicine does not contain calcium, your doctor may prescribe additional calcium supplements.
- have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood vitamin D levels and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor may monitor these levels and prescribe vitamin supplements as needed.
- have altered blood bicarbonate levels and increased acidity in the blood and other body tissues. Your doctor should monitor your blood bicarbonate levels.
Special note for patients on peritoneal dialysis:
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by carefully following sterile techniques during bag exchanges. You must inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal bloating, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
The safety and efficacy have not been studied in children (under 6 years of age). Therefore, the use of this medicine is not recommended in children under 6 years of age.
Use of Sevelamer Teva with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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Sevelamer Teva must not be taken at the same time as ciprofloxacin (an antibiotic).
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If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Sevelamer Teva.
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The effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer Teva. Your doctor will advise you if you are taking these medicines.
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A deficiency of thyroid hormone may occasionally occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer Teva. Therefore, your doctor may monitor your blood levels of thyroid-stimulating hormone (TSH) more closely.
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Medicines used to treat stomach acidity and gastroesophageal reflux, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," may reduce the effectiveness of Sevelamer Teva. Your doctor should monitor your blood phosphate levels.
Your doctor will regularly check for possible interactions between Sevelamer Teva and other medicines.
In some cases, Sevelamer Teva should be taken separately from another medicine. Your doctor may instruct you to take the other medicine either 1 hour before or 3 hours after taking Sevelamer Teva. Your doctor may also consider monitoring blood levels of the other medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The potential risk of Sevelamer Teva during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with Sevelamer Teva.
It is unknown whether Sevelamer Teva passes into breast milk and could affect your baby. Consult your doctor, who will decide whether you can breastfeed or not and whether treatment with Sevelamer Teva needs to be discontinued.
Driving and using machines
It is unlikely that Sevelamer Teva will affect your ability to drive or operate machinery.
Sevelamer Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Sevelamer Teva
Sevelamer Teva must be taken exactly as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.
The recommended starting dose of sevelamer tablets for adults and elderly patients is one to two 800 mg tablets with each meal, three times a day. If you are unsure, consult your doctor, pharmacist, or nurse.
Take sevelamer after a meal or with food.
The tablets must be swallowed whole. Do not crush, chew, or divide them.
Initially, your doctor will monitor your blood phosphorus levels every 2 to 4 weeks and may adjust the dose of sevelamer as necessary to achieve an appropriate phosphorus level.
Follow the diet prescribed by your doctor.
If you take more Sevelamer Teva than you should
In case of a possible overdose, you must contact your doctor immediately.
In the event of an overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Sevelamer Teva
If you miss a dose, skip it and take the next dose at the usual time with a meal. Do not take a double dose to make up for a missed dose.
If you stop taking Sevelamer Teva
Taking your sevelamer treatment regularly is important to maintain appropriate phosphate levels in your blood. Stopping sevelamer treatment may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping your sevelamer treatment, contact your doctor or pharmacist first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Constipation is a very common adverse effect (may affect more than 1 in every 10 patients). It may be an early symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.
Some adverse effects may be serious. If you experience any of the following adverse effects, seek medical attention immediately:
- Allergic reaction (symptoms include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (may affect up to 1 in every 10,000 patients).
- Intestinal obstruction has been reported (symptoms include: severe distension, abdominal pain, bloating or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).
- Perforation of the intestinal wall has been reported (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is unknown.
- Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, digestive or intestinal disturbances, blood in the stool [intestinal bleeding]) and deposition of crystals in the intestine. Frequency is unknown.
Other adverse effects reported in patients taking Sevelamer Teva:
Very common (may affect more than 1 in every 10 patients):
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in every 10 patients):
diarrhea, stomach pain, indigestion, flatulence
Frequency not known (cannot be estimated from available data):
Cases of itching, rash, and slow intestinal motility (movement) have been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sevelamer Teva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer packaging, following EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sevelamer Teva
The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
The other components are monohydrate lactose, colloidal anhydrous silica, zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
Appearance of the product and contents of the container
Sevelamer Teva are film-coated tablets, white to off-white, oval-shaped, with "SVL" printed on one side.
HDPE bottles with polypropylene screw caps.
Each bottle contains 30, 50 or 180 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid, Spain
Manufacturer
Synthon Hispania SL
Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat
Spain
Or
Merckle GmbH
Ludwig-Merckle-Str. 3, 89143 Blaubeuren
Germany
Or
Pliva Hrvatska d.o.o.
Prilaz Baruna Filipovica 25
10000 Zagreb
Croatia
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Sevelamercarbonat-ratiopharm 800 mg Filmtabletten
Austria: Sevelamer ratiopharm 800 mg - Filmtabletten
Spain: Sevelámero Teva 800 mg comprimidos recubiertos con película
France: SEVELAMER TEVA 800mg, comprimé pelliculé
Netherlands: Sevelameercarbonaat 800 mg Teva, filmomhulde tabletten
Sweden: Sevelamer Teva
Date of the most recent review of this leaflet: September 2021
“Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78865/P_78865.html
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