LOVTELAR 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lovtelar 800 mgfilm-coated tablets

sevelamer carbonate

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.
• 1. 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 Lovtelar is and what it is used for
2. What you need to know before you take Lovtelar
3. How to take Lovtelar
4. Possible side effects

5 Storage of Lovtelar

1. Contents of the pack and further information

1. What Lovtelar is and what it is used for

Lovtelar contains sevelamer carbonate as the active substance. It binds to phosphate in the food in the digestive tract and thereby reduces the levels of phosphate in the blood.

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

• adult patients on dialysis (a technique for cleaning the blood). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a body membrane filters the blood);
• patients with chronic kidney disease (long-term) who are not on dialysis and have a serum (blood) phosphate level of 1.78 mmol/l or higher.

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

Increased levels of phosphate in the blood can lead to hard deposits in the body called calcifications. These deposits can harden in the blood vessels and make it more difficult for the blood to be pumped through the body.

Increased phosphate levels in the blood can also cause itching of the skin, red eyes, bone pain, and fractures.

2. What you need to know before you take Lovtelar

Do not take Lovtelar

• if you are allergic to the active substance or 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

Tell your doctor before you start taking Lovtelar if you are in any of the following situations:

• have difficulty swallowing
• have problems with stomach and intestinal motility
• have frequent vomiting
• have active intestinal inflammation
• have undergone major stomach or intestinal surgery

Tell your doctor while you are taking this medicine:

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

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 calcium supplements for you.
• have low levels of vitamin D in your blood. Therefore, your doctor may check 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 may monitor these levels and prescribe vitamin supplements as needed.
• have altered bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels in your blood.

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

Children

The safety and efficacy of this medicine have not been studied in children (under 6 years). Therefore, this medicine is not recommended for use in children under 6 years.

Other medicines and Lovtelar

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

• This medicine must 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 this medicine.

• The effects of medicines such as cyclosporin, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by this medicine. Your doctor will advise you if you are taking these medicines.

• A thyroid hormone deficiency may be observed in some individuals taking levothyroxine (used to treat low thyroid hormone levels) and Lovtelar. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in your blood more closely.

• Medicines for treating stomach acid and reflux in your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the effectiveness of this medicine. Your doctor should monitor your phosphate levels in your blood.

Your doctor will regularly check for interactions between this medicine and other medicines.

In some cases, when this medicine needs to be taken with another medicine, your doctor may tell you to take this medicine 1 hour before or 3 hours after taking the other medicine. Your doctor may also consider monitoring the levels of the other 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 this medicine during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with this medicine.

It is unknown whether this medicine passes into breast milk and may affect your baby. Consult your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

3. How to take Lovtelar

This medicine should be taken as directed by your doctor. The doctor will determine the dose based on your phosphate levels in the blood.

The recommended initial dose of this medicine for adults and elderly patients is one to two 800 mg tablets with each meal, three times a day. Consult your doctor, pharmacist, or nurse if you are unsure.

Take this medicine after a meal or with food.

The tablets should be swallowed whole. Do not crush, chew, or break them.

Initially, your doctor will check your phosphate levels in the blood every 2-4 weeks and may adjust the dose of this medicine as needed to achieve an adequate phosphate level.

Follow the diet prescribed by your doctor.

If you take more Lovtelar than you should

In case of a possible overdose, contact your doctor immediately.

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

If you forget to take Lovtelar

If you miss a dose, it should be omitted, so the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for forgotten doses.

If you stop taking Lovtelar

Taking your treatment with this medicine is important to maintain an appropriate level of phosphate in your blood.

Stopping treatment with this medicine could have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with this medicine, contact your doctor or pharmacist first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects can be serious. If you get any of the following side effects, seek medical attention immediately:

• Allergic reaction (signs include rash, hives, swelling, difficulty breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal obstruction has been reported (signs include: severe bloating, abdominal pain, swelling, or cramps, severe constipation). The frequency is unknown (cannot be estimated from the available data).
• Intestinal wall rupture has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness). The frequency is unknown.
• Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, digestive or intestinal disorders, blood in the stools [gastrointestinal bleeding]) and crystal deposition in the intestine. The frequency is unknown.

Other side effects have been reported in patients taking this medicine:

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 pain,
• indigestion,
• flatulence

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lovtelar

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 the letters "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Lovtelar

• The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.

The other ingredients are colloidal anhydrous silica, pregelatinized maize starch 1500, and magnesium stearate.

• The coating contains hypromellose 15cP (E464), HPMC 2910/Hypromellose 2910 5cP (E464), and acetylated monoglycerides FCC (E472a)
• The printing ink contains propylene glycol (E1520), brilliant blue FCF No.1 (E133), purified lacquer (E904)

Appearance and packaging

White to off-white, oval, biconvex film-coated tablets, approximately 21 mm in length, marked with "C800" on one side.

Lovtelar tablets are available in a cardboard box containing a white opaque HDPE bottle with a child-resistant polypropylene (PP) cap and an aluminium induction seal, containing 180 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pharmathen S.A.

Dervenakion 6

153 51 Pallini Attiki,

Greece

Manufacturer

Pharmathen International S.A.,

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi,

Greece

or

Pharmathen S.A.

Dervenakion 6

153 51 Pallini Attiki,

Greece

Date of last revision of this leaflet:February 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).