InfoCons Consumer Protection informs you – RIULVY – Package Leaflet

Before anything else

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.

ℹ️ 1. What RIULVY is and what it is used for

What RIULVY is RIULVY is a medicine that contains the active substance tegomil fumarate.

What RIULVY is used for

RIULVY is used to treat relapsing -remitting multiple sclerosis (MS) in patients aged 13 years and older.

MS is a long- term condition that affects the central nervous system (CNS), including the brain and the spinal cord. Relapsing- remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms. Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision). These symptoms may disappear complet ely when the relapse is over, but some problems may remain.

How RIULVY works

RIULVY seems to work by stopping the body’s defence system from damaging your brain and spinal cord. This may also help to delay future worsening of your MS.

⚠️ 2. What you need to know before you take RIULVY

Do not take RIULVY

• if you are allergic to tegomi l fumarate , related substances (called fumarates or fumaric acid esters) or any of the other ingredients of this medicine (listed in section 6).
• if you are suspected to suffer from a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

RIULVY may affect your white blood cell counts , your kidneys and liver . Before you start RIULVY, your doctor will do a blood test to count the number of your white blood cells and will 46 check that your kidneys and liver are working properly. Your doctor will test these periodically during treatment. If your number of white blood cells decreases during treatment, your doctor may consider additional tests or discontinue your treatment.

If you believe your MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away because these may be the symptoms of a rare brain infection called PML. PML is a serious condition that may lead to severe disability or death.

Talk to your doctor before taking RIULVY if you have:

• severe kidney disease
• severe liver disease
• a disease of the stomach or bowel
• a serious infection (such as pneumonia) Herpes zoster (shingles) may occur with RIULVY treatment. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of shingles.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease). If you notice you are passing more urine, ar e thirstier and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medicine to children below 13 years of age because no data are available in this age group.

Other medicines and RIULVY

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular:

• medicines that contain fumaric acid esters (fumarates) used to treat psoriasis;
• medicines that affect the body’s immune system including chemotherapy , immunosuppressants , or other medicines used to treat MS ;
• medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets ” (diuretics ), certain types of painkillers (such as ibuprofen and other similar anti – inflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium ;
• taking RIULVY with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided. Your doctor will advise whether other types of vaccines (non- live vaccines ) should be given.

RIULVY with alcohol Consumption of more than a small amount (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking RIULVY, as alcohol can interact with this medicine. This could cause inflammation of the stomach (gastritis ), especially in people already prone to gastritis.

Pregnancy and breast -feeding

Pregnancy

There is limited information about the effects of this medicine on the unborn child if used during pregnancy. Do not use the medicine if you are pregnant unless you have discussed this with your doctor and this medicine is clearly necessary for you .

Breast -feeding 47 It is not known whether the active substance of RIULVY passes into breast milk. Your doctor will advise whether you should stop breast -feeding, or stop using RIULVY. This involves balancing the benefit of breast -feeding for your child, and the benefit of therapy for you.

Driving and using machines

RIULVY is not expected to affect your ability to drive and use machines.

RIULVY contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium – free’.

💊 3. How to take RIULVY

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Starting dose:

The recommended starting dose is 174 mg twice a day.

Take this starting dose for the first 7 days, then take the regular dose.

Regular dose:

The recommended maintenance dose is 348 mg twice a day .

RIULVY is for oral use.

Swallow each capsule whole, with some water. Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.

Take RIULVY with food – it may help to reduce some of the very common side effects (listed in section 4).

If you take more RIULVY than you should

If you have taken too many capsules, talk to your doctor straight away . You may experience side effects similar to those described below in section 4.

If you forget to take RIULVY

If you forget or miss a dose, do not take a double dose.

You may take the missed dose if you leave at least 4 hours between the doses. Otherwise wait until your next planned dose.

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.

Serious side effects

PML and lower lymphocyte counts The frequency of PML cannot be estimated from the available data (not known).

RIULVY may lower lymphocyte counts (a type of white blood cell). Having a low white blood cell count can increase your risk of infection, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death.

48 PML has occurred after 1 to 5 years of treatment and so your physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine impairing the functionality of your body’s immune system.

The symptoms of PML may be similar to an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or speech and communication difficulties lasting for more than several days.

Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on treatment, it is very important that you speak to your doctor as soon as possible. Also speak with your partner or caregivers and inform them about your treatment. Symptoms might arise that you might not become aware of by yourself.  Call your doctor straight away if you experience any of these symptoms Severe allergic reactions The frequency of severe allergic reactions cannot be estimated from the available data (not known).

Reddening of the face or body (flushing ) is a very common side effect. However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:

• swelling of the face, lips, mouth or tongue (angioedema)
• wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia)
• dizziness or loss of consciousness (hypotension) then this may represent a severe allergic reaction (anaphylaxis)  Stop taking RIULVY and call a doctor straight away

Other side effects

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

• reddening of the face or body feeling warm, hot, burning or itchy (flushing)
• loose stools (diarrhoea)
• feeling sick (nausea)
• stomach pain or stomach cramps  Taking your medicine with food can help to reduce the side effects above Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking RIULVY.

Talk to your doctor about how to manage these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Common (may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (gastroenteritis )
• being sick (vomiting)
• indigestion (dyspepsia)
• inflammation of the lining of the stomach (gastritis )
• gastrointestinal disorder
• burning sensation
• hot flush, feeling hot
• itchy skin (pruritus )
• rash
• pink or red blotches on the skin (erythema )
• hair loss (alopecia) Side effects which may show up in your blood or urine tests
• low levels of white blood cells (lymphopenia, leucopenia) in the blood. Reduced white blood cells could mean your body is less able to fight an infection. If you have a serious infection (such as pneumonia), talk to your doctor immediately
• proteins (albumin ) in urine
• increase in levels of liver enzymes (ALT, AST) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity )
• reduction in blood platelets

Rare (may affect up to 1 in 1 000 people)

• liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin )

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

• herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
• runny nose (rhinorrhoea) Children (13 years of age and above) and adolescents The side effects listed above also apply to children and adolescents.

Some side effects were reported more frequently in children and adolescents than in adults, e.g, headache, stomach pain or stomach cramps, being sick (vomiting), throat pain, cough, and painful menstrual periods.

Reporting of side effects

If you get 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store RIULVY

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 or blister and the carton after “EXP”. The expiry date refers to the last day of that month.

For HDPE bottles: Do not swallow the desiccant canisters. Canister (s) should remain in the bottle until all capsules are administered.

For HDPE bottles: This medicine product does not require any special storage conditions.

For oPA/ Aluminium/PVC -Aluminium -blister s: Do not s tore above 30 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What RIULVY contains

• The active substance is tegomil fumarate.

RIULVY 174 mg: Each gastro -resistant hard capsule contains 174 .2 mg of tegomil fumarate.

RIULVY 348 mg: Each gastro -resistant hard capsule contains 348 .4 mg of tegomil fumarate.

• The other ingredients are microcrystalline cellulose (E461i) , croscarmellose sodium (E466) (essentially ‘ sodium -free’, refer to section 2) , talc, silica colloidal anhydrous, magnesium stearate (E470c) , talc, hypromellose (E464) , hydroxypropyl cellulose (E463) , triethyl citrate (E1505) , methacrylic acid – ethyl acrylate copolymer (1:1), poly(vinyl alcohol) (E1203) , macrogol, gelatin (E428) , titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172) , Shellac, potassium hydroxide , propylene glycol (E1520) .

What RIULVY looks like and contents of the pack

HDPE bottles RIULVY 174 mg gastro- resistant hard capsules are white opaque and light blue opaque and printed with ‘174’ and are available in packs containing 14 gastro- resistant hard capsules with one desic cant canister per bottle .

RIULVY 348 mg gastro- resistant hard capsules are light blue opaque and printed with ‘348’ and are available in packs containing 56 or 168 gastro- resistant hard capsules with two desiccant canisters per bottle.

Do not swallow the desiccant canister(s). oPA/Al uminium/PVC -Aluminium blister s RIULVY 174 mg gastro- resistant hard capsules are white opaque and light blue opaque and printed with ‘174’ and are available in packs containing 14 gastro- resistant hard capsules.

RIULVY 348 mg gastro- resistant hard capsules are light blue opaque and printed with ‘348’ and are available in packs containing 56 gastro- resistant hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69 08970 Sant Joan Despí – Barcelona Spain Tel: +34 93 475 96 00 E-mail: [email protected]

Manufacturer

Pharmadox Healthcare Ltd KW20A Kordin Industrial Park Paola PLA 3000 Malta 51 Delorbis Pharmaceuticals LTD 17 Athinon street, Ergates Industrial Area 2643 Ergates Lefkosia Cyprus Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69 08970 Sant Joan Despí – Barcelona Spain Tel: +34 93 475 96 00 E-mail: [email protected] For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Neuraxpharm Belgium Tél/Tel: +32 (0)2 732 56 95 Lietuva Neuraxpharm Pharmaceuticals, S.L.

Tel:+34 93 475 96 00 България Neuraxpharm Pharmaceuticals, S.L.

Teл.: +34 93 475 96 00 Luxembourg/Luxemburg Neuraxpharm France Tél/Tel: +32 474 62 24 24 Česká republika Neuraxpharm Bohemia s.r.o.

Tel:+420 739 232 258 Magyarország Neuraxpharm Hungary Kft.

Tel.: +36 (30) 542 2071 Danmark Neuraxpharm Sweden AB Tlf: +46 (0)8 30 91 41 (Sverige) Malta Neuraxpharm Pharmaceuticals, S.L.

Tel:+34 93 475 96 00 Deutschland neuraxpharm Arzneimittel GmbH Tel: +49 2173 1060 0 Nederland Neuraxpharm Netherlands B.V Tel: +31 70 208 5211 Eesti Neuraxpharm Pharmaceuticals, S.L.

Tel:+34 93 475 96 00 Norge Neuraxpharm Sweden AB Tlf: +46 (0)8 30 91 41 (Sverige) Ελλάδα Brain Therapeutics ΙΚΕ Τηλ: +302109931458 Österreich Neuraxpharm Austria GmbH Tel.: + 43 (0) 1 208 07 40 España Neuraxpharm Spain, S.L.U.

Tel: +34 93 475 96 00 Polska Neuraxpharm Polska Sp. z.o.o. Tel.: +48 783 423 453 France Neuraxpharm France Tél: +33 1.53.6 3.42.90 Portugal Neuraxpharm Portugal, Unipessoal Lda Tel: +351 910 259 536 Hrvatska Neuraxpharm Pharmaceuticals, S.L.

T +34 93 602 24 21 România Neuraxpharm Pharmaceuticals, S.L.

Tel: +34 93 475 96 00 52 Ireland Neuraxpharm Ireland Ltd.

Tel: +353 1 428 7777 Slovenija Neuraxpharm Pharmaceuticals, S.L.

T +34 93 475 96 00 Ísland Neuraxpharm Sweden AB Sími: +46 (0)8 30 91 41 (Svíþjóð) Slovenská republika Neuraxpharm Slovakia a.s.

Tel: +421 255 425 562 Italia Neuraxpharm Italy S.p.A.

Tel: +39 0736 980619 Suomi/Finland Neuraxpharm Sweden AB Puh/Tel: +46 (0)8 30 91 41 (Ruotsi/Sverige) Κύπρος Brain Therapeutics ΙΚΕ Τηλ: +302109931458 Sverige Neuraxpharm Sweden AB Tel: +46 (0)8 30 91 41 Latvija Neuraxpharm Pharmaceuticals, S.L.

Tel: +34 93 475 96 00

This leaflet was last revised in

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information RIULVY (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1947).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.