SEVELAMER MYLAN PHARMA

Package leaflet: Information for the user

Sevelamer Mylan Pharma 800 mg film-coated tablets

Sevelamer carbonate
Read this entire leaflet carefully before 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 others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

1. What Sevelamer Mylan Pharma is and what it is used for
2. What you need to know before taking Sevelamer Mylan Pharma
3. How to take Sevelamer Mylan Pharma
4. Possible side effects
5. How to store Sevelamer Mylan Pharma
6. Contents of the pack and other information

1. What Sevelamer Mylan Pharma is and what it is used for

Sevelamer Mylan Pharma contains sevelamer carbonate as the active substance. This binds to phosphate
from food within the digestive tract, thereby reducing serum phosphate levels in the blood.
Sevelamer Mylan Pharma is used to control hyperphosphataemia (high levels of phosphate in the
blood) in:

• adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
• patients with chronic kidney disease who are not on dialysis and have a serum phosphate level equal to or greater than 1.78 mmol/l.

Sevelamer Mylan Pharma should be used together with other treatments, such as calcium and vitamin
D supplements, to prevent the development of bone disease.
Elevated serum phosphate levels can cause hard deposits in the body called calcifications. These
deposits can stiffen blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased serum phosphate levels may cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking Sevelamer Mylan Pharma

Do not take Sevelamer Mylan Pharma if:

• you have low levels of phosphate in your blood (your doctor will monitor this).
• you have intestinal 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 Mylan Pharma if any of the following apply to you:

• problems with swallowing.
• problems with motility (movement) in the stomach and intestines.
• frequent vomiting.
• active inflammation of the intestine.
• you have undergone major surgical procedures on the stomach or intestines.

Children and adolescents
The safety and efficacy in children (under 18 years of age) have not been studied. Therefore, the use of
Sevelamer Mylan Pharma is not recommended in children.

Additional treatments:
Due to your kidney problems or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since Sevelamer Mylan Pharma does not contain calcium, your doctor may prescribe additional calcium tablets.
• have low levels of vitamin D in your blood. Consequently, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in your blood, and therefore your doctor may monitor these levels and prescribe vitamin supplements as needed.

Special note for patients undergoing peritoneal dialysis:
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis.
This risk can be reduced by strictly following aseptic techniques when changing bags. You must inform your doctor immediately if you experience new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting. You should expect more careful monitoring if problems related to low levels of vitamin A, D, E, K, and folic acid occur.

Other medicines and Sevelamer Mylan Pharma
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Sevelamer Mylan Pharma must not be taken at the same time as ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm disorders or for epilepsy, you should consult your doctor when taking Sevelamer Mylan Pharma.
Sevelamer Mylan Pharma may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system). Your doctor will advise you on how to proceed if you are taking these medicines.
In rare cases, in some individuals taking levothyroxine (used to treat low thyroid hormone levels) together with Sevelamer Mylan Pharma, a deficiency in thyroid hormones has been observed. Therefore, your doctor may monitor your thyroid-stimulating hormone levels more closely.
If you are taking medicines for heartburn, gastro-oesophageal reflux disease (GORD), or gastric ulcers, such as omeprazole, pantoprazole, or lansoprazole, you should consult your doctor when taking Sevelamer Mylan Pharma.
Your doctor will regularly check for possible interactions between Sevelamer Mylan Pharma and other medicines.
In some cases where Sevelamer Mylan Pharma must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Mylan Pharma, or may consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. It is not known whether Sevelamer Mylan Pharma has effects on the fetus.
Inform your doctor if you intend to breastfeed. It is not known whether Sevelamer Mylan Pharma passes into breast milk and may affect the baby.

Driving and using machines
It is unlikely that Sevelamer Mylan Pharma will affect your ability to drive or use machinery.

Sevelamer Mylan Pharma contains lactose
Sevelamer Mylan Pharma contains lactose (a milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Sevelamer Mylan Pharma

You must take Sevelamer Mylan Pharma exactly as prescribed by your doctor.
Your doctor will determine the dose based on your serum phosphorus level.
The recommended starting dose of Sevelamer Mylan Pharma tablets for adults and elderly patients (over 65 years of age) is one or two 800 mg tablets taken with each meal, three times daily.
The tablets must be swallowed whole. Do not crush, chew, or break the tablets.
In some cases, when Sevelamer Mylan Pharma must be taken concomitantly with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Mylan Pharma, or may consider monitoring blood levels of that medicine.
Your doctor will periodically check your blood phosphorus levels and may adjust the dose of Sevelamer Mylan Pharma as necessary to achieve an appropriate phosphate level.

If you take more Sevelamer Mylan Pharma than you should
In case of potential overdose, contact your doctor immediately.

If you forget to take Sevelamer Mylan Pharma
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 the missed dose.

4. Possible side effects

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

Tell your doctor or pharmacist as soon as possible if you experience any of the following:

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

• Constipation, which may be an early sign of intestinal blockage

Very rare (may affect up to 1 in 10,000 people):

• Severe allergic reactions, including swelling of the face, lips, tongue or throat, causing difficulty in breathing or swallowing

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

• Severe abdominal pain, with blood in the stool or vomit, which may be symptoms of intestinal wall perforation
• Constipation, which may be an early symptom of intestinal blockage

Other side effects reported by patients during treatment with sevelamer carbonate:

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
• Abdominal pain
• Indigestion
• Flatulence

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

• Itching
• Rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevelamer Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sevelamer Mylan Pharma contains

• The active substance is sevelamer carbonate. Each tablet contains 800 mg of sevelamer carbonate.
• The other components are monohydrate lactose, silica (anhydrous colloidal), and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

Description of the appearance of Sevelamer Mylan Pharma and package contents
Sevelamer Mylan Pharma 800 mg film-coated tablets are white to off-white, oval-shaped tablets,
imprinted with the letters 'SVL' on one side. The tablets are approximately 20 mm in length and 7 mm in width.
The tablets are packed in high-density polyethylene bottles with a polypropylene cap, containing a desiccant. Do not remove the desiccant from the bottle.
Each bottle contains 180, 200 or 210 tablets.
Packages containing 1, 2 or 3 bottles are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturers:
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain

Mylan Hungary Kft
Mylan utca 1
H-2900 Komárom
Hungary

This medicinal product is authorized in the EEA Member States under the following names:
Czech Republic Sevelamer Carbonate Mylan 800 mg, potahované tablety
Denmark Sevelamer carbonat Mylan
France Sevelamer Mylan Pharma 800 mg, comprimés pelliculés
Germany Sevelamercarbonat Mylan 800 mg Filmtabletten
Greece Sevelamer/Mylan
Ireland Sevelamer Carbonate 800mg Film-coated tablets
Italy Sevelamer Mylan Pharma
Netherlands Sevelameercarbonaat Mylan 800 mg, filmomhulde tabletten
Norway Sevelamer Mylan 800 mg filmdrasjerte tabletter
Portugal Sevelâmero Mylan
Spain Sevelámero Mylan Pharmaceuticals 800 mg comprimidos recubiertos con película
Sweden Sevelamer Mylan 800 mg filmdragerade tabletter
Slovakia Sevelamer Carbonate Mylan 800 mg, filmom obalené tablety
United Kingdom Sevelamer carbonate 800 mg Film-coated Tablets