RESTAFOS 800 MG FILM-COATED TABLETS

2. What you need to know before you take Restafos

Do not take Restafos if:

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

Warnings and precautions

Consult your doctor or pharmacist before starting Restafos if you are in any of the following situations:

• problems swallowing. Your doctor may prefer to prescribe a powder for oral suspension available on the market
• problems with stomach and intestinal motility
• you vomitfrequently
• active intestinal inflammation
• you have undergone major stomach or intestinal surgery

Consult your doctor while taking Restafos:

• 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 inflammatory bowel 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 calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets
• have low vitamin D levels in your blood. Therefore, your doctor may monitor your vitamin D blood levels 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 onperitoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced with careful observation of sterile techniques during bag changes. You should inform your doctor immediately if you experience any new signs or symptoms of discomfort, swelling, pain, sensitivity, or abdominal stiffness, constipation, fever, chills, nausea, or vomiting.

Children

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

Other medicines and Restafos

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

Restafos should not be taken at the same time as ciprofloxacin(an antibiotic).

If you are taking medicines for heart rhythm problems or epilepsy, you should consult your doctor when taking Restafos.

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

A low thyroid hormone level may be observed in some people taking levothyroxine(used to treat low thyroid hormone levels) and sevelamer carbonate. 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 sevelamer carbonate. Your doctor should monitor your phosphate levels in your blood.

Your doctor will check for interactions between Restafos and other medicines on a regular basis.

In some cases, when Restafos must be taken with another medicine, your doctor may tell you to take that medicine 1 hour before or 3 hours after taking Restafos.Your doctor should 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 Restafos during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with Restafos.

It is unknown whether Restafos is excreted in 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 Restafos.

Driving and using machines

Restafos is unlikely to affect your ability to drive or use machines.

Restafos contains lactose monohydrate

This medicine contains monohydrate (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Restafos

Restafos should be taken as directed by your doctor. The doctor will determine the dose based on serum phosphate levels.

The recommended initial dose of Restafos tablets for adults and elderly patients is one to two 800 mg tablets with each meal, 3 times a day.Consult your doctor, pharmacist, or nurse if you are unsure.

Take Restafos 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 blood phosphate levels every 2-4 weeks and may adjust the dose of Restafos as needed to achieve an adequate phosphate level.

Follow the diet prescribed by your doctor. Patients taking Restafos should follow the diets prescribed for them.

If you take more Restafos than you should

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

If you forget to take Restafos

In the event that you forget to take 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 Restafos

Taking your treatment with Restafos is important to maintain an appropriate phosphate level in your blood. Stopping treatment with Restafos would have significant consequences, such as calcification in blood vessels. If you consider stopping your treatment with Restafos, contact your doctor or pharmacist first.

If you have any further questions on the use of this product, 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 (it can affect more than 1 in 100 patients). 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 (it can affect up to 1 in 10,000 patients).
• Intestinal obstruction has been reported (signs include: severe distension, 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 pain or tenderness). The frequency is unknown.
• Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, stomach or intestinal disorders, blood in the stool [intestinal bleeding]) and crystal deposition in the intestine. The frequency is unknown.

Other side effects have been reportedin patients taking Restafos:

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

• vomiting, upper abdominal pain, nausea

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

• diarrhoea, stomach pain, indigestion, flatulence

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

• cases of itching, rash, slow intestinal motility

Reporting of side effects

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

5. Storing Restafos

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 blister after the letters “EXP”. The expiry date refers to 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 other information

Composition of Restafos

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

Appearance and packaging

Restafos are white to off-white, oval, film-coated tablets with “SVL” engraved on one side.

HDPE bottles with polypropylene caps.

Each bottle contains 180, 200, or 210 tablets.

Packs containing 1, 2, or 3 bottles are available.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

SPA Società Prodotti Antibiotici S.p.A.

Via Biella, 8

20143 Milano

Italy

Manufacturer

Synthon Hispania S.L.

C/ Castelló nº1. Polígono Las Salinas, 08830 Sant Boi de Llobregat

Barcelona. Spain

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

SPA Farma Ibérica S.L.U.

Carrer de Roc Boronat, 147

08018 Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark: Sevelamercarbonat Zentiva

Spain: Restafos 800 mg film-coated tablets

United Kingdom (Northern Ireland): Sevelamer carbonate

Date of last revision of this leaflet:June 2022

“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/”