SEVELAMER HYDROCHLORIDE WAYMADE 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sevelamer Hydrochloride Waymade 800 mg Film-Coated Tablets

Sevelamer Hydrochloride

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 any 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Sevelamer Hydrochloride Waymade and what is it used for

Sevelamer Hydrochloride contains the active substance sevelamer. This active substance binds to phosphate from food in the digestive tract and in this way reduces phosphate levels in the blood.

Sevelamer Hydrochloride is indicated to control phosphate levels in the blood of adult patients with chronic kidney disease on hemodialysis or peritoneal dialysis.

Adult patients whose kidneys do not work and who are on hemodialysis or peritoneal dialysis cannot control the concentration of serum phosphate in the blood. Therefore, the amount of phosphate (your doctor will call this hyperphosphatemia) increases. The increase in serum phosphate levels can cause hard deposits in the body called calcifications. These deposits can harden your blood vessels and make it more difficult for blood to be pumped through the body. The increase in serum phosphate also can cause skin itching, red eyes, bone pain, and fractures.

Sevelamer Hydrochloride can be used with other medications, including calcium or vitamin D supplements, to control the development of renal bone disease.

2. What you need to know before you take Sevelamer Hydrochloride Waymade

Do not take Sevelamer Hydrochloride Waymade:

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

Consult your doctor while taking Sevelamer Hydrochloride Waymade:

if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal bleeding). These symptoms can be due to a serious intestinal inflammatory disease caused by the deposit of sevelamer crystals in the intestine. Contact your doctor, who will decide whether to continue treatment or not.

Warnings and precautions

Consult your doctor before taking Sevelamer Hydrochloride Waymade if you are in any of the following situations:

• if you are not undergoing dialysis treatment
• if you have swallowing problems
• if you have stomach or intestinal motility problems
• if you have symptoms of delayed emptying of stomach contents such as feeling full, nausea, and/or vomiting
• if you have prolonged diarrhea or abdominal pain (symptoms of intestinal inflammatory disease)
• if you have undergone major stomach or intestinal surgery.

Additional treatments:

Because you have kidney disease or are undergoing dialysis treatment, it may happen that:

• you have high or low calcium levels in your blood. Since Sevelamer Hydrochloride Waymade does not contain calcium, your doctor may prescribe calcium supplement tablets
• you have low vitamin D levels in your blood. For this reason, your doctor may monitor your vitamin D levels in your blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor will monitor these levels and prescribe vitamin supplements if necessary.

Treatment change:

When switching from another phosphate binder treatment to Sevelamer Hydrochloride Waymade, your doctor may consider it necessary to monitor your blood bicarbonate levels more closely, as Sevelamer Hydrochloride Waymade may decrease 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 with careful use of sterile techniques during bag changes.

You should inform your doctor immediately if you have any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal stiffness, constipation, fever, chills, nausea, or vomiting.

Additionally, you may undergo more thorough checks to detect problems with low levels of vitamins A, D, E, K, and folic acid.

Children and adolescents

The safety and efficacy of Sevelamer Hydrochloride Waymade in children (under 18 years) have not been established. Therefore, Sevelamer Hydrochloride Waymade is not recommended for use in this population.

Using Sevelamer Hydrochloride Waymade with other medicines

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

• Do not take Sevelamer Hydrochloride Waymade at the same time as ciprofloxacin (an antibiotic).
• You should consult your doctor if you are using medications for heart rhythm disorders or for epilepsy while taking Sevelamer Hydrochloride Waymade.
• Sevelamer Hydrochloride Waymade may reduce the effects of medications such as cyclosporin, mycophenolate mofetil, and tacrolimus (medicines used in transplant patients). Your doctor will advise you if you are taking these medications.
• In certain individuals taking levothyroxine (a thyroid hormone) and this medicine, an increase in thyroid-stimulating hormone (TSH) levels in the blood could be observed in very rare cases. Therefore, your doctor may monitor your TSH levels in the blood more closely.
• If you are taking medications such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or stomach ulcers, you should consult your doctor when taking this medicine.

Your doctor will periodically check for possible interactions between Sevelamer Hydrochloride Waymade and other medications.

In some cases, Sevelamer Hydrochloride Waymade must be taken at the same time as another medication; your doctor may indicate that you take this medication 1 hour before or 3 hours after taking Sevelamer Hydrochloride Waymade or may consider monitoring the blood levels of that medication.

Pregnancy, breastfeeding, and fertility

The safety of Sevelamer Hydrochloride Waymade in pregnant or breastfeeding women has not been established. Sevelamer Hydrochloride Waymade should not be administered to pregnant or breastfeeding women unless clearly indicated.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Sevelamer Hydrochloride Waymade is unlikely to affect your ability to drive or use machines.

Sevelamer Hydrochloride Waymade tablets contain sorbitol

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking the medicine (or giving it to the child).

3. How to take Sevelamer Hydrochloride Waymade

Take this medicine exactly as your doctor has told you. Consult your doctor if you are not sure. He will indicate the dose you should take based on your serum phosphate levels. The recommended starting dose of Sevelamer Hydrochloride Waymade for adults and elderly patients (> 65 years) is one to two tablets 3 times a day with each meal.

Initially, your doctor will check your blood phosphate levels every 2-3 weeks and may adjust the dose of Sevelamer Hydrochloride Waymade as necessary (between 1 and 5 tablets of 800 mg per meal) to achieve an adequate phosphate level.

The tablets should be swallowed whole. They should not be crushed, chewed, or broken before administration.

Patients taking Sevelamer Hydrochloride Waymade should follow the diet and fluid intake prescribed by their doctor.

If you take more Sevelamer Hydrochloride Waymade than you should

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sevelamer Hydrochloride Waymade

If you miss a dose, it should be skipped, so you should take the next one when it is due and with a meal. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Since constipation, very rarely, could be an early symptom of intestinal obstruction, it is important to inform your doctor or pharmacist of this symptom before or during treatment with this medicine.

The following side effects have been reported in patients taking this medicine:

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

nausea, vomiting.

Common (may affect up to 1 in 10 patients):

diarrhea, indigestion, abdominal pain, constipation, flatulence.

Uncommon (may affect up to 1 in 100 patients):

increased blood acidity.

Rare (may affect up to 1 in 10,000 patients):

hypersensitivity.

Frequency not known (cannot be estimated from the available data):

Cases of itching, rash, abdominal pain, slow intestinal motility, inflammation of abnormally small bags (called diverticula) in the large intestine, intestinal obstruction (signs include: severe distension, abdominal pain, swelling, or cramps, severe constipation), rupture of the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness), and severe inflammation of the large intestine (symptoms include: severe abdominal pain, digestive or intestinal disorders, blood in the stool [intestinal bleeding]) and crystal deposits in the intestine have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevelamer Hydrochloride Waymade

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 carton and/or bottle after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer Hydrochloride Waymade

• The active substance is sevelamer hydrochloride. Each tablet contains 800 mg of sevelamer hydrochloride.
• The other ingredients are: Sorbitol (E 420), Hypromellose (E464), Crospovidone type B, Colloidal anhydrous silica, Magnesium stearate, Opadry white (Hypromellose (E464), Hydroxypropylcellulose (E 463), Macrogol 6000 (E 1521), Titanium dioxide (E171)).

Appearance of the product and pack size

Sevelamer Hydrochloride Waymade tablets are film-coated tablets, oval in shape, white to off-white in color, and bear the imprint “800” on one side and “SH” on the other. The tablets are packaged in high-density polyethylene bottles containing silica gel desiccant, with a child-resistant polypropylene cap and an induction seal. Do not ingest the desiccant.

The pack sizes are:

1 bottle of 30 tablets

1 bottle of 100 tablets

1 bottle of 180 tablets

Multiple pack containing 180 tablets (6 bottles of 30 tablets)

Multiple pack containing 360 tablets (2 bottles of 180 tablets)

Multiple pack containing 540 tablets (3 bottles of 180 tablets)

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Waymade B.V.

Herikerbergweg 88, Amsterdam

1101CM, Netherlands

Manufacturer:

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120, Vienna, Austria

or

Waymade B.V.,

Herikerbergweg 88, Amsterdam,

1101CM, Netherlands

Date of last revision of this leaflet:May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es