Filspari 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Filspari 200 mg film-coated tablets

Filspari 400 mg film-coated tablets

esparsentan

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. The final part of section 4 includes information on how to report these adverse reactions.

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• The package also contains a Patient Card. Please read it carefully, as it contains important safety information you should know before and during your treatment with Filspari.

Contents of the leaflet

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

1. What Filspari is and what it is used for

Filspari contains the active substance sparsentan. Filspari blocks the receptors of two hormones called endothelin and angiotensin, which are involved in the regulation of kidney function.

Filspari is used to treat primary immunoglobulin A nephropathy (IgAN) in adults with a urinary protein excretion of ≥1.0 g/day (or a urine protein/creatinine ratio of ≥0.75 g/g).

Primary IgAN is a disease caused by the immune system (the body's natural defenses) producing a defective form of an antibody called immunoglobulin A (IgA), which accumulates in clusters of tiny blood vessels in the kidney, called glomeruli, that are responsible for filtering the blood. This accumulation damages the glomeruli, causing blood and protein to leak into the urine.

Filspari blocks the receptors of two hormones, endothelin and angiotensin, which are involved in regulating processes in the kidney, such as inflammation, that contribute to the progression of kidney damage. By blocking these receptors, Filspari reduces the amount of protein leaking into the urine and therefore helps slow the progression of the disease.

2. What you need to know before taking Filspari

Do not take Filspari

• if you are allergic to sparsentan or any of the other ingredients of this medicine (listed in section 6)

• if you are pregnant, think you may be pregnant, or plan to become pregnant (see section 2 "Pregnancy and breastfeeding").

• if you are taking any of the following medicines used primarily in the treatment of high blood pressure:

• angiotensin receptor antagonists (such as irbesartan, losartan, valsartan, candesartan, telmisartan),

• endothelin receptor blockers (such as bosentan, ambrisentan, macitentan, sitaxentan), or

• renin inhibitors (such as aliskiren).

Warnings and precautions

Talk to your doctor or pharmacist before starting Filspari if:

• you have low blood pressure (hypotension). Low blood pressure may occur more frequently in elderly patients: your doctor may monitor your blood pressure during treatment and may adjust the dose of Filspari or stop treatment if necessary.
• you have reduced kidney function: your doctor may perform additional tests to monitor how well your kidneys are working (by measuring levels of creatinine and potassium in the blood).
• you experience swelling in your hands, ankles, or feet due to fluid retention: your doctor may prescribe an additional medicine to help remove fluid from your body or may adjust your dose of Filspari.
• you have liver problems: your doctor will perform blood tests before starting and regularly during treatment to check whether your liver is functioning properly and may stop treatment with Filspari if necessary. Signs that your liver may not be working properly include: nausea (feeling sick), vomiting, fever (high temperature), stomach pain (abdominal pain), jaundice (yellowing of the skin or whites of the eyes), dark-coloured urine, itching of the skin, lethargy or fatigue (unusual tiredness or exhaustion), flu-like syndrome (joint and muscle pain along with fever). If you notice any of these signs, tell your doctor immediately.

Children and adolescents

Filspari is not recommended for children under 18 years of age, as there are no studies conducted in this age group.

Other medicines and Filspari

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

Inform your doctor if you are taking medicines for the treatment of high blood pressure. Do not take Filspari if you are taking any of the following medicines: angiotensin receptor antagonists, endothelin receptor blockers, or renin inhibitors (medicines containing aliskiren) (see section 2 “Do not take Filspari”).

Talk to your doctor or pharmacist if you are taking any of the following medicines:

The concomitant use of Filspari with the following medicines may lead to more adverse effects:

• enalapril or lisinopril (or similar medicines called ACE inhibitors), commonly used to treat high blood pressure or for other reasons. Adverse effects may include low blood pressure when standing up from a lying or sitting position, high levels of potassium in the blood, and reduced kidney function.
• spironolactone or eplerenone (or similar medicines called mineralocorticoid receptor antagonists), commonly used to remove excess fluid or in the treatment of heart disease, as they may increase potassium levels in the blood.
• potassium supplements, potassium-sparing medicines (e.g., medicines that remove water from the body or diuretics), or salt substitutes containing potassium, as they may increase potassium levels in the blood.
• medicines used to treat fungal infections (such as itraconazole and fluconazole).
• medicines used to treat bacterial infections (such as clarithromycin and erythromycin).

The effect of Filspari may be reduced by medicines such as:

• rifampicin, used to treat bacterial infections
• some medicines used to treat HIV infections such as efavirenz
• medicines used to treat epilepsy such as carbamazepine, phenytoin, phenobarbital
• St John’s wort (Hypericum perforatum), used for depression and other disorders
• corticosteroids such as dexamethasone, mainly used to treat inflammation

The effect of Filspari may be increased by medicines such as:

• boceprevir or telaprevir, used to treat hepatitis C
• conivaptan, used to treat low sodium levels in the blood
• some medicines used to treat HIV infections such as indinavir, lopinavir/ritonavir, nelfinavir, ritonavir
• nefazodone, used to treat depression
• medicines used to suppress the immune system and prevent transplant rejection, such as cyclosporine and tacrolimus

Taking Filspari with food and drinks

People prescribed Filspari must not eat grapefruit or drink grapefruit juice. This is because grapefruit and grapefruit juice may cause more adverse effects when taken together with Filspari.

Pregnancy and breastfeeding

Do not take Filspari if you are pregnant or plan to become pregnant. Filspari may harm the unborn baby.

If you could become pregnant, your doctor will ask you to take a pregnancy test before starting Filspari.

• If you could become pregnant, use a reliable method of contraception while taking Filspari and for one month after stopping treatment. Discuss this with your doctor.
• If you become pregnant or think you may be pregnant while taking Filspari or shortly after stopping treatment (within 1 month), tell your doctor immediately.

It is not known whether Filspari passes into breast milk. Do not breast-feed while taking Filspari. Discuss this with your doctor.

Driving and using machines

Filspari may cause adverse effects such as dizziness, which may mildly affect your ability to drive or operate machinery (see section 4). Wait until these effects have passed before driving or operating machinery.

Filspari contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

Filspari contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Filspari

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Recommended dose

The recommended starting dose is one 200 mg tablet once daily. After 14 days, your doctor will increase the dose to 400 mg (two tablets containing 200 mg of Filspari or one tablet containing 400 mg of Filspari) once daily, depending on your tolerability to Filspari.

How to take this medicine

Swallow the tablet whole to avoid the bitter taste. Take it with a glass of water.

If you take more Filspari than you should

If you have taken more tablets than prescribed by your doctor, you may experience signs and symptoms of low blood pressure.

If you have taken too many tablets, contact your doctor immediately.

If you forget to take Filspari

Skip the missed dose. Then take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you have any further questions about 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.

Very common (may affect up to 1 in 10 people):

• low blood pressure (hypotension)

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

• dizziness or feeling lightheaded when standing up or sitting down due to a drop in blood pressure (orthostatic hypotension),
• dizziness,
• high levels of potassium in the blood (hyperkalaemia),
• fluid accumulation in the body (oedema or swelling), especially in the ankles and feet,
• fatigue (tiredness),
• reduced kidney function (especially at the start of treatment; renal impairment),
• sudden kidney failure (especially at the start of treatment; acute kidney injury),
• increased levels of creatinine in the blood (a waste product from muscle breakdown eliminated by the kidneys),
• headache,
• changes in liver function, measured in blood tests.

Rare (may affect up to 1 in 100 people):

• low levels of red blood cells (anaemia).

Reporting of side effects

If you experience any type of side effect, please consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Filspari

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

Do not use this medicine after the expiry date stated on the carton and label after "CAD". The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Filspari

• The active substance is sparsentan: each Filspari 200 mg film-coated tablet contains 200 mg of sparsentan. Each Filspari 400 mg film-coated tablet contains 400 mg of sparsentan.
• The other components are: microcrystalline cellulose, lactose (see section 2, "Filspari contains lactose"), sodium starch glycolate (type A) (see section 2, "Filspari contains sodium"), colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E171).

Nature of the product and pack contents

Filspari 200 mg film-coated tablets are film-coated, oval-shaped tablets, white to off-white in colour, with the number "105" on one side. The tablet dimensions are approximately 13 mm × 7 mm.

Filspari 400 mg film-coated tablets are film-coated, oval-shaped tablets, white to off-white in colour, with the number "021" on one side. The tablet dimensions are approximately 18 mm × 8 mm.

Filspari 200 mg film-coated tablets are available in a bottle containing 30 film-coated tablets. Filspari 400 mg film-coated tablets are available in a bottle containing 30 film-coated tablets and in a multi-pack containing 90 film-coated tablets (3 packs of 30 film-coated tablets each).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Date of the latest revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.