DIMETHYL FUMARATE SUN 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate SUN 120 mg Hard Gastro-Resistant Capsules EFG

Dimethyl Fumarate SUN 240 mg Hard Gastro-Resistant Capsules EFG

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 experience 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 Dimethyl Fumarate SUN and what is it used for
2. What you need to know before you take Dimethyl Fumarate SUN
3. How to take Dimethyl Fumarate SUN
4. Possible side effects
5. Storage of Dimethyl Fumarate SUN
6. Contents of the pack and other information

1. What is Dimethyl Fumarate SUN and what is it used for

Dimethyl Fumarate SUN is a medicine that contains dimethyl fumarateas the active substance.

What Dimethyl Fumarate SUN is used for

Dimethyl Fumarate is used to treat multiple sclerosis (MS) in patients from 13 years of age and older. MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. The symptoms vary from person to person but often include: difficulty walking, balance problems, and vision problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may remain.

How Dimethyl Fumarate SUN works.

Dimethyl Fumarate seems to work by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future disability in MS.

2. What you need to know before you take Dimethyl Fumarate SUN

Do not take Dimethyl Fumarate SUN

? If you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).

? If you are suspected to have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl Fumarate may affect your white blood cell count, kidneys, and liver. Before starting dimethyl fumarate, your doctor will perform a blood test to check your white blood cell count and ensure your kidneys and liver are working properly. Your doctor will perform regular blood tests during treatment. If you experience a decrease in white blood cell count during treatment, your doctor may consider additional tests or interrupt your treatment.

Talk to your doctor before starting dimethyl fumarate if you have:

? severe kidney disease

? severe liver disease

? a stomach or intestinal disease

? a severe infection (e.g., pneumonia)

Herpes zoster (shingles) may occur during treatment with dimethyl fumarate. In some cases, serious complications have occurred. You must inform your doctor immediatelyif you suspect you have any symptoms of shingles. If you think your MS is getting worse (e.g., weakness or vision changes) or you notice any new symptoms, talk to your doctor directly, as they could be symptoms of a rare brain infection called PML. PML is a serious disease that can cause death or severe disability.

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 urinating more, are thirstier, and drink more than usual, your muscles seem weaker, you break a bone, or simply have aches and pains, inform your doctor as soon as possible so this can be investigated further.

Children and adolescents

Do not give this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Dimethyl Fumarate SUN

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

? medicines containing 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), “diuretics”(pills that increase urine production), certain types of pain relievers(such as ibuprofen or similar anti-inflammatory drugs, and over-the-counter medicines), and medicines containing lithium;

? the use of dimethyl fumarate and the administration of certain types of vaccines (live attenuated vaccines) could cause you to become infected, and therefore should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate SUN with alcohol

After taking dimethyl fumarate, you should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with an alcohol content of more than 30%, such as liquor) for the first hour, as alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

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

Pregnancy

Information on the effects of this medicine when used during pregnancy is limited. Do not take dimethyl fumarate during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary for you.

Breastfeeding

It is not known whether the active substance of dimethyl fumarate passes into breast milk. Your doctor will inform you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

Dimethyl Fumarate SUN is not expected to affect your ability to drive or use machines. Dimethyl Fumarate SUN contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

Dimethyl Fumarate SUN contains azorubine and orange yellow S, which may cause allergic reactions.

3. How to take Dimethyl Fumarate SUN

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor again.

Starting dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Dimethyl Fumarate is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, suck, or chew the capsules, as this may increase some side effects.

Take Dimethyl Fumarate SUN with food– it helps reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate SUN than you should

If you take too many capsules, tell your doctor immediately. You may experience side effects similar to those described below in section 4.

In case of 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 Dimethyl Fumarate SUN. Do not take a double dose to make up for forgotten doses. You can take the forgotten dose if it is at least 4 hours until the next dose. Otherwise, wait until the next dose. If you have any other 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.

Serious side effects

Dimethyl Fumarate may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including the rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cell count during treatment, and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken any medicine that has weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The 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 difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while being treated with Dimethyl Fumarate SUN. Also, inform your partner or caregivers about your treatment. You may not notice symptoms that they can see.

? Call your doctor immediately if you have any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).

Facial or body redness (flushing) is a very common side effect. However, if the redness is accompanied by a rash andyou have any of these symptoms:

? swelling of the face, lips, mouth, or tongue (angioedema)

? wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)

? dizziness or loss of consciousness (hypotension) this could be a severe allergic reaction (anaphylaxis)

? Stop taking Dimethyl Fumarate SUN and call your doctor immediately

Other side effects

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

? facial or body redness, feeling of heat, heat, burning sensation, or itching (flushing)

? loose stools (diarrhea)

? nausea or vomiting

? stomach pain or cramps

? Taking the medicine with foodmay help reduce the above side effects. While being treated with dimethyl fumarate, it is common for urine tests to show ketones, substances that are naturally produced by the body.

Talk to your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

? inflammation of the intestinal mucosa (gastroenteritis)

? vomiting

? indigestion (dyspepsia)

? inflammation of the stomach mucosa (gastritis)

? gastrointestinal disorders

? burning sensation

? hot flashes, feeling of heat

? skin itching (pruritus)

? rash

? pink or red patches with itching on the skin (erythema)

? hair loss (alopecia)

Side effects that may appear in blood or urine tests

? low white blood cell count (lymphopenia, leucopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia), tell your doctor immediately ? protein (albumin) in urine

? increased liver enzymes (ALT, AST) in blood

Uncommon(may affect up to 1 in 100 people)

? allergic reactions (hypersensitivity)

? reduction of blood platelets

Rare(may affect up to 1 in 1000 people):

inflammation of the liver and increased liver enzyme levels (ALT or AST in combination with bilirubin).

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

? inflammation of the liver and increased liver enzyme levels (ALT or AST simultaneously with bilirubin)

? herpes zoster (shingles) with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with severe pain

? nasal discharge (rhinorrhea)

Children (from 13 years) and adolescents

. The side effects described 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 cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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. Storage of Dimethyl Fumarate SUN

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 blister and carton after ‘EXP’. The expiry date refers to the last day of the month stated.

Do not store above 30 °C.

Store the blister in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dimethyl Fumarate SUN.

The active ingredientis dimethyl fumarate.

Dimethyl Fumarate SUN 120 mg hard gastro-resistant capsules: each capsule contains 120 mg of dimethyl fumarate

Dimethyl Fumarate SUN 240 mg hard gastro-resistant capsules: each capsule contains 240 mg of dimethyl fumarate.

• The other excipients are:

Capsule content: microcrystalline cellulose, magnesium oxide, sodium croscarmellose, anhydrous colloidal silica, talc, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion, simethicone, sodium lauryl sulfate,

Capsule shell: gelatin, titanium dioxide (E171), azorubine (E122), yellow orange S (E110), patent blue V, quinoline yellow,

Capsule printing (black ink): shellac, potassium hydroxide, black iron oxide (E172), propylene glycol (E1520).

Appearance of the Product and Container Content:

Dimethyl Fumarate SUN hard gastro-resistant capsules of 120 mg.

Hard gelatin capsules with white body and green cap of 21 mm, with the inscription «120 mg» printed on the body.

Dimethyl Fumarate SUN hard gastro-resistant capsules of 240 mg.

Hard gelatin capsules with green body and cap of 22 mm, with the inscription «240 mg» printed on the body.

Dimethyl Fumarate SUN is presented in aluminum PVC/PE/PVDC blisters or perforated unit-dose blisters.

Package sizes:

[120 mg]:

Aluminum PVC/PE/PVDC blisters: boxes with 14, 56, 60 and 196 hard gastro-resistant capsules.

Perforated unit-dose aluminum PVC/PE/PVDC blisters: boxes with 14 x 1 hard gastro-resistant capsules.

[240 mg]:

Aluminum PVC/PE/PVDC blisters: boxes with 14, 28, 56, 60, 120, 168 and 196 hard gastro-resistant capsules.

Perforated unit-dose aluminum PVC/PE/PVDC blisters: boxes with 56 x 1 hard gastro-resistant capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Or

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Sweden: Dimethyl fumarate SUN 120 mg hard enteric capsules

(RMS) Dimethyl fumarate SUN 240 mg hard enteric capsules

Germany: Dimethylfumarat Basics 120 mg stomach-resistant hard capsules

Dimethylfumarat Basics 240 mg stomach-resistant hard capsules

Spain: Fumarate de dimetilo Sun 120 mg hard gastro-resistant capsules EFG

Fumarate de dimetilo Sun 240 mg hard gastro-resistant capsules EFG

France: DIMETHYL FUMARATE SUN 120 mg, gastro-resistant capsule

DIMETHYL FUMARATE SUN 240 mg, gastro-resistant capsule

Finland: Dimethyl fumarate SUN 120 mg hard enteric capsules

Italy: Dimetilfumarato SUN

Norway: Dimethyl fumarate SUN

Poland: Dimethyl fumarate Ranbaxy

Date of the last revision of this leaflet:February 2025

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