Dimethyl fumarate Macleods 120 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dimethyl fumarate Macleods 120 mg gastro-resistant hard capsules EFG

Dimethyl fumarate Macleods 240 mg gastro-resistant hard capsules EFG

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 you should not give it to others, 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.

Contents of the leaflet

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

1. What Fumarate de dimetilo Macleods is and what it is used for

What Fumarate de dimetilo Macleods is

Fumarate de dimetilo is a medicine that contains dimethyl fumarate as the active substance.

What fumarate de dimetilo is used for

Fumarate de dimetilo is used to treat relapsing-remitting multiple sclerosis (MS) in patients 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. Symptoms vary from patient to patient but usually include: difficulty walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How fumarate de dimetilo works

Dimethyl fumarate appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future progression of MS.

2. What you need to know before taking Fumarate de dimetilo Macleods

Do not take dimethyl fumarate

• if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
• if progressive multifocal leukoencephalopathy (PML), a rare brain infection, is suspected or has been confirmed.

Warnings and precautions

Talk to your doctor or pharmacist before starting dimethyl fumarate.

Dimethyl fumarate may affect the number of white blood cells, the kidneys, and the liver. Before starting treatment with dimethyl fumarate, your doctor will perform a blood test to check your white blood cell count and to ensure your kidneys and liver are functioning properly. Your doctor will carry out regular blood tests during treatment. If you experience a decrease in white blood cells during treatment, your doctor may consider additional testing or discontinuation of treatment.

Talk to your doctor before starting this medicine if you have:

• severe renal disease
• severe hepatic disease
• a stomach or intestinal disorder
• a serious 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 immediately if you suspect you have any symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or you notice new symptoms, speak to your doctor immediately, as these could be signs of a rare brain infection called PML. PML is a serious condition that can be fatal or cause 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 that you are urinating more frequently, feel unusually thirsty and drink more than normal, your muscles seem weaker, you experience bone fractures, or have general aches and pains, inform your doctor as soon as possible so these symptoms can be further investigated.

Children and adolescents

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

Other medicines and Fumarato de dimetilo Macleods

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

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis
• medicines that affect the body's immune system, including chemotherapies, immunosuppressants, or other medicines used to treat MS
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics (tablets that increase urine elimination), certain types of painkillers (such as ibuprofen or other similar non-steroidal anti-inflammatory drugs, and over-the-counter medicines), and medicines containing lithium
• The use of dimethyl fumarate together with certain types of vaccines (live vaccines) could lead to infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (inactivated vaccines) should be administered.

Taking Fumarato de dimetilo Macleods with alcohol

After taking dimethyl fumarate, avoid consuming more than a small amount (more than 50 mL) of strong alcoholic drinks (containing more than 30% alcohol by volume, such as spirits) for at least one hour, as alcohol may interact with this medicine. This may cause inflammation of the stomach (gastritis), especially in individuals prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether the active ingredient of dimethyl fumarate passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child against the benefits of treatment for you.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

Fumarato de dimetilo Macleods contains sodium

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

3. How to take Dimethyl fumarate Macleods

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

Starting dose: 120 mg twice daily.

Take this starting dose for the first 7 days, then switch to the maintenance dose.

Maintenance dose: 240 mg twice daily.

Dimethyl fumarate is taken orally.

The capsules must be swallowed whole, with some water. Do not split, crush, dissolve, suck, or chew the capsules, as this may increase certain adverse effects.

Take dimethyl fumarate with food – this helps reduce some of the very common adverse effects (listed in section 4).

If you take more dimethyl fumarate than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dimethyl fumarate

Do not take a double dose to make up for the missed dose.

You may take the missed dose if at least 4 hours remain until the next scheduled dose. Otherwise, wait until the time of your next dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse 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 a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can result in death or cause severe disability. PML has occurred after 1 to 5 years of treatment; therefore, your doctor must continue to monitor your white blood cells throughout treatment, and you should remain alert for any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that impaired your immune system function.

Symptoms of PML may resemble those of an MS relapse. Symptoms may include new weakness or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion, personality changes, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important that you contact your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with dimethyl fumarate. In addition, inform your partner or caregivers about your treatment. Symptoms may arise that you yourself do not notice.

• Call your doctor immediately if you experience any of these symptoms

Serious allergic reactions

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

Flushing of the face or body (rubefaction) is a very common adverse effect. However, if flushing is accompanied by a red rash or skin eruption and you experience 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 then indicate a serious allergic reaction (anaphylaxis).

• Stop taking dimethyl fumarate and call your doctor immediately

Other adverse effects

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

• flushing of the face or body, sensation of warmth, heat, burning sensation, or itching (rubefaction)

• loose stools (diarrhea)

• nausea or vomiting

• stomach pain or cramps

• Taking the medicine with food may help reduce the above adverse effects.

While being treated with dimethyl fumarate, urine tests may frequently show the presence of ketones, substances naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce your dose unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flushes, feeling of warmth
• skin itching (pruritus)
• rash
• itchy, rosy or reddish skin patches (erythema)
• hair loss (alopecia)

Adverse effects that may appear in blood or urine tests

• low white blood cell counts (lymphopenia, leukopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you develop a serious infection (such as pneumonia), inform 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 in blood platelets

Frequency not known (cannot be estimated from available data)

• inflammation of the liver and increased levels of liver enzymes (ALT or AST together 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 painful red rashes
• nasal discharge (rhinorrhea)

Children (aged 13 years and older) and adolescents

The adverse effects described above also apply to children and adolescents.

Some adverse 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Macleods

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

Do not use this medicine after the expiry date stated on the blister and outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Macleods

• The active substance is dimethyl fumarate. Each gastro-resistant hard capsule contains 120 mg or 240 mg of dimethyl fumarate.
• The other components are:

microcrystalline cellulose (E460), sodium croscarmellose (E468), colloidal anhydrous silica (E551), magnesium stearate (E470b), methacrylic acid and ethyl acrylate copolymer (1:1) type A, 30% dispersion (sodium lauryl sulfate and polysorbate 80), triethyl citrate, talc (E553b), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (sodium lauryl sulfate and polysorbate 80), gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), brilliant blue FCF (E133), shellac (E904), potassium hydroxide (E525).

Appearance of the product and pack contents

Dimethyl fumarate Macleods 120 mg gastro-resistant hard capsules are size “0”, with an opaque light green cap and an opaque white body printed in black ink with “I 65” and “120 mg”, containing white to off-white coated mini-tablets. They are available in blister packs (opaque white PVC/PE/PVdC aluminium blisters).

Blister pack – containing 14 (1 x 14 capsules)
Single-dose blister pack – containing 14 x 1 (1 x 14 capsules)

Dimethyl fumarate Macleods 240 mg gastro-resistant hard capsules are size “0”, with an opaque light green cap and an opaque light green body printed in black ink with “I 66” and “240 mg”, containing white to off-white coated mini-tablets. They are available in blister packs (opaque white PVC/PE/PVdC aluminium blisters).

Blister pack – containing 56 (4 x 14 capsules) and 168 (12 x 14 capsules)
Single-dose blister pack – containing 56 x 1 (4 x 14 capsules) and 168 x 1 (12 x 14 capsules)

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.
World Trade Center Barcelona
Moll de Barcelona, s/n,
08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzedz,
62-020, Poland

This medicinal product is authorized in the European Economic Area member states under the following names

Date of the most recent review of this leaflet: January 2024

Other sources of information

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