DIMETHYL FUMARATE SANDOZ PHARMACEUTICAL 240 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Dimethyl Fumarate Sandoz Pharmaceutical 120 mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Sandoz Pharmaceutical 240 mg hard gastro-resistant capsules EFG

dimethyl fumarate

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.

Contents of the pack

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

1. What Dimethyl Fumarate Sandoz Pharmaceutical is and what it is used for

What Dimethyl Fumarate Sandoz Pharmaceutical is

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

What Dimethyl Fumarate Sandoz Pharmaceutical is used for

Dimethyl fumarate is used to treat multiple sclerosis (MS) in patients from 13 years of age.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. 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 Sandoz Pharmaceutical works

This medicine 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 from MS.

2. What you need to know before you take Dimethyl Fumarate Sandoz Pharmaceutical

Do not take Dimethyl Fumarate Sandoz Pharmaceutical

• if you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6),
• if you suspect that you 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 you start taking dimethyl fumarate, your doctor will do a blood test to check your white blood cell count and to make sure your kidneys and liver are working properly. Your doctor will do regular blood tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Tell your doctorbefore you start taking dimethyl fumarate if you have:

• severe kidney disease,
• severe liver disease,
• a stomach or intestine 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 tell your doctor immediatelyif you suspect you have any symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or changes in vision) 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 that contains dimethyl fumarate in combination with other fumaric acid esters, which is used to treat psoriasis (a skin disease). If you notice that 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, tell your doctor as soon as possible so that this can be investigated further.

Children and adolescents

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

Other medicines and Dimethyl Fumarate Sandoz Pharmaceutical

Tell your doctor or pharmacistif 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 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 painkillers(such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines) and medicines that contain lithium,
• taking dimethyl fumarate and receiving certain types of vaccines (live vaccines) could cause you to get an infection and, therefore, should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Sandoz Pharmaceutical 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 spirits) for the first hour because alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people who are 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 in the fetus if used during pregnancy is limited. Do not use this medicine during pregnancy unless you have discussed it with your doctor and this medicine is strictly necessary.

Breastfeeding

It is not known if dimethyl fumarate passes into breast milk. Your doctor will inform you if you should stop breastfeeding, or if you should 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 is not expected to affect your ability to drive and use machines.

Dimethyl Fumarate Sandoz Pharmaceutical contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Dimethyl Fumarate Sandoz Pharmaceutical

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 Sandoz Pharmaceutical is taken by mouth.

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

Take Dimethyl Fumarate Sandoz Pharmaceutical with food, this helps to reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate Sandoz Pharmaceutical 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 ingested.

If you forget to take Dimethyl Fumarate Sandoz Pharmaceutical

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if it is at least 4 hours between doses. Otherwise, wait until the next 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

Dimethyl fumarate may lower your lymphocyte count(a type of white blood cell). A low lymphocyte count can increase the risk of infection, including a 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 will continue to monitor your lymphocytes during treatment, and you should be aware of any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a 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 changes in personality, 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. Also, inform your partner or caregivers about your treatment. It is possible that symptoms may arise that you are not aware of on your own.

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 or hivesandyou have any of the following 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 Sandoz Pharmaceutical 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 the presence of ketones, substances that are naturally produced by the body.

Tell your doctorabout 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),
• feeling sick (vomiting),
• indigestion (dyspepsia),
• inflammation of the stomach mucosa (gastritis),
• gastrointestinal disorders,
• burning sensation,
• hot flashes, feeling of heat,
• skin itching (pruritus),
• rash,
• red or pink patches on the skin accompanied by itching (erythema),
• hair loss (alopecia).

Side effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leucopenia) in blood. A decrease in white blood cells may make the body less able to fight infections. If you have a severe infection (such as pneumonia), tell your doctor immediately,
• proteins (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.

Not known(cannot be estimated from the available data)

• inflammation of the liver and increased liver enzymes (ALT or AST simultaneously with bilirubin),
• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain on the skin, 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 (13 years of age and older) 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Vigilance 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 Dimethyl Fumarate Sandoz Pharmaceutical

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 is the last day of the month stated.

Do not store above 30°C.

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. Container contents and additional information

Composition of Dimethyl Fumarate Sandoz Pharmaceutical

• The active ingredientis dimethyl fumarate.

Dimethyl Fumarate Sandoz Pharmaceutical 120 mg: each hard gastroresistant capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Sandoz Pharmaceutical 240 mg: each hard gastroresistant capsule contains 240 mg of dimethyl fumarate.

• The other components are:capsule content: sodium croscarmellose (E468), colloidal anhydrous silica (E551), sodium stearyl fumarate (E470A), methacrylic acid-methyl methacrylate copolymer (1:1); methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, talc (E553B), triethyl citrate (E1505), polysorbate 80 (E443), glycerol monostearate 40-55; capsule shell: gelatin (E441), titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133); capsule ink: shellac ~45% (20% esterified) (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28%.

Appearance of the product and container contents

Hard gastroresistant capsules

Dimethyl Fumarate Sandoz Pharmaceutical 120 mg are hard capsules with a white body and a light green cap with the imprint '120 mg' on the capsule body. Approximate size 19 mm long and 9 mm wide.

Dimethyl Fumarate Sandoz Pharmaceutical 240 mg are hard capsules of light green color with the imprint '240 mg' on the capsule body. Approximate size 23 mm long and 9 mm wide.

Dimethyl Fumarate Sandoz Pharmaceutical is presented in Al/PVC/PVDC blister packs or calendarized blisters or single-dose precut blisters.

Dimethyl Fumarate Sandoz Pharmaceutical 120 mg hard gastroresistant capsules EFG:

Container sizes: blisters with 14 or 28 hard gastroresistant capsules.

Calendarized blisters with 14 or 28 hard gastroresistant capsules.

Single-dose precut blisters with 14x1 hard gastroresistant capsules.

Dimethyl Fumarate Sandoz Pharmaceutical 240 mg hard gastroresistant capsules EFG:

Container sizes: blisters with 28, 56, 168 or 196 hard gastroresistant capsules.

Calendarized blisters with 28, 56, 168 or 196 hard gastroresistant capsules.

Single-dose precut blisters with 56x1 and 168x1 hard gastroresistant capsules.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LEK Pharmaceuticals d.d.

Verovškova ulica, 57

SLO-1526 Ljubljana

Slovenia

or

This medicinal product is authorized in the Member States of the European Union under the following names:

Date of the last revision of this prospectus:June 2024.

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.