InfoCons Consumer Protection informs you – Sevelamer carbonate Winthrop – Package Leaflet

Before anything else

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Sevelamer carbonate Winthrop is and what it is used for

Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:

• adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood) ;
• adult patients with chronic (long- term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol /L.
• paediatric patients with chronic (long- term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician).

This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.

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 ski n, red eyes, bone pain and fractures.

⚠️ 2. What you need to know before you take Sevelamer carbonate Winthrop

Do not take Sevelamer carbonate Winthrop

• if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of phosphate in your blood (your doctor will check this for you)
• if you have bowel obstruction

Warnings and Precautions

Talk to your doctor before taking Sevelamer carbonate Winthrop :

• if you have problems with motility (movement) in your stomach and bowel 67 • if you have active inflammation of the bowel
• if you have undergone major surgery on your stomach or bowel.

Talk to your doctor while taking Sevelamer carbonate Winthrop :

• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystal deposit in your bowel. Contact your doctor who will decide on continuing the treatment or not.

Additional treatments :

Due to either your kidney condition or your dialysis treatment you may:

• develop low or high levels of calcium in your blood. Since this medicine does not contain calcium your doctor might prescribe additional calcium tablets.
• have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supple mental vitamins as necessary.
• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue. Your doctor should monitor the level of bicarbonate in your blood.

Special note for patients on peritoneal dialysis:

You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.

This risk can be reduced by careful adherence to sterile techniques during bag changes. You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.

Children

Do not give this medicine to children below the age of 6 years because because t he safety and efficacy in children (below the age of 6 years) have not been studied.

Other medicines and Sevelamer carbonate Winthrop

Tell your doctor if you are taking or have recently taken or might take any other medicines.

• Sevelamer carbonate Winthrop 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 carbonate Winthrop.
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop. 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 treat low thyroid hormone levels) and Sevelamer carbonate Winthrop. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Sevelamer carbonate Winthrop. Your doctor may monitor the phosphate level in your blood.

Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a regular basis.

68 In some cases where Sevelamer carbonate Winthrop 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 carbonate Winthrop intake . Your doctor may also consider monitoring the levels of that medicine in your blood.

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. The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Sevelamer carbonate Winthrop .

It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby.

Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Sevelamer carbonate Winthrop treatment.

Driving and using machines

Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines.

Excipients This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium -free’.

This medicine contains 25.27 mg propylene glycol in each 2.4 g sachet.

💊 3. How to take Sevelamer carbonate Winthrop

Always take this medicine exactly as your doctor has told you. He will base the dose on your serum phosphorus level.

For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.

Instead of water, the powder may be pre -mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Sevelamer carbonate Winthrop powder ( e.g. microwave) or add to hot foods or liquids.

The recommended starting dose of this medicine for adults and elderly is 2.4- 4.8g per day equally divided over three meals. The exact starting dose and regimen will be determined by your doctor. Check with your doctor, pharmacist or nurse if you are not sure.

Take Sevelamer carbonate Winthrop after your meal or with food .

If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.

Use in children and adolescents The recommended starting dose of Sevelamer carbonate Winthrop for children is based on their height and weight (used to calculate body surface area by your physician). For children, the powder is preferred, as tablets are not appropriate for this population. This medicine should not be given on an empty stomach and should be taken with meals or snacks. The exact starting dose and regimen will be determined by your doctor.

Initially, your doctor will check the levels of phosphorus in your blood every 2- 4 weeks and they may adjust the dose of Sevelamer carbonate Winthrop when necessary to reach an adequate phosphate level.

Follow the diet prescribed by your doctor.

If you take more Sevelamer carbonate Winthrop than you should

In the event of a possible overdose you should contact your doctor immediately.

If you forget to take Sevelamer carbonate Winthrop

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.

If you stop taking Sevelamer carbonate Winthrop

Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level in your blood. Stopping Sevelamer carbonate Winthrop would lead to important consequences such as calci fication in the blood vessels. If you consider stopping your Sevelamer carbonate Winthrop treatment, contact your doctor or pharmacist first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. P ossible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Constipation is a very common side effect. It can be an early symptom of a blockage in your intestine .In case of constipation, please inform your doctor or pharmacist if you experience it.

Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention: – Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may affect up to 1 in 10,000 people). – Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported. Frequency is not known.

• Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported. Frequency is not known.
• Serious i nflammation of the large bowel ( symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding] ) and crystal deposit in the intestine have been reported. Frequency is not known.

Other side effects have been reported in patients taking Sevelamer carbonate Winthrop :

Very common ( may affect more than 1 in 10 people )

• vomiting,
• upper abdominal pain,
• nausea.

Common ( may affect up to 1 in 10 people )

• diarrhoea,
• stomach ache ,
• indigestion,
• flatulence .

Not known (frequency cannot be estimated from the available data)

• cases of itching ,
• rash,
• slow intestine motility (movement) .

70 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 the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Sevelamer carbonate Winthrop

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the sachet and carton after “EXP”. The expiry date refers to the last day of that month.

The reconstituted suspension must be administered within 30 minutes of reconstitution.

This medicine 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.

📦 6. Contents of the pack and other information

What Sevelamer carbonate Winthrop contains

• The active substance is sevelamer carbonate. Each sachet contain s 2.4 g of sevelamer carbonate.
• The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and iron oxide yellow (E172).

What Sevelamer carbonate Winthrop looks like and contents of the pack

Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal. The sachets are packaged in an outer carton.

Pack size:

60 sachets per carton 90 sachets per carton Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie 82 Avenue Raspail 94250 Gentilly France

Manufacturer

Genzyme Ireland L imited IDA Industrial Park Old Kilmeaden Road Waterford Ireland ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140, Alcalá de Henares, Madrid, 28805, Spain 71 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder .

België/Belgique/Belgien/ Luxembourg/ Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Magyarország SANOFI -AVENTIS Zrt Tel: +36 1 505 0050 Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Malta Sanofi S.r.l.

Tel: +39 02 39394275 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Deutschland Sanofi -Aventis Deutschland GmbH Tel: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131 Norge sanofi -aventis Norge AS Tlf: + 47 67 10 71 00 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Österreich sanofi -aventis GmbH Tel: + 43 1 80 185 – 0 Ελλάδα Sanofi -Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 1600 Polska Sanofi Sp. z o.o.

Tel.: +48 22 280 00 00 España sanofi -aventis, S.A.

Tel: +34 93 485 94 00 Portugal Sanofi – Produtos Farmacêuticos, Lda..

Tel: +351 21 35 89 400 France Sanofi Winthrop Industrie Tél : 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 România Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 Hrvatska Swixx Biopharma d.o.o.

Tel: +385 1 2078 500 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00 Ireland sanofi -aventis Ireland Ltd T/A SANOFI Tel: +353 (0) 1 4035 600 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600 Ísland Vistor hf.

Sími: +354 535 7000 Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 300 72 Italia Sanofi S.r.l.

Tel: 800 536 389 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Κύπρος C.A. Papaellinas Ltd. Τηλ: +357 22 741741 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Sevelamer carbonate Winthrop (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/952).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.