DIMETHYL FUMARATE MACLEODS 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Dimethyl Fumarate Macleods 120mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Macleods 240mg 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 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 Macleods is and what it is used for
2. What you need to know before you take Dimethyl Fumarate Macleods
3. How to take Dimethyl Fumarate Macleods
4. Possible side effects
5. Storage of Dimethyl Fumarate Macleods
6. Contents of the pack and other information

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

What Dimethyl Fumarate Macleods is

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

What Dimethyl Fumarate is used for

Dimethyl Fumarate is used to treat multiple sclerosis (MS) in patients from 13years of age and older with relapsing-remitting MS.

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 persist.

How Dimethyl Fumarate 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 Macleods

Do not take Dimethyl Fumarate

• 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

Talk to your doctor or pharmacist before starting treatment with Dimethyl Fumarate.

Dimethyl Fumarate may affect your white blood cell count, kidneys, and liver. Before starting treatment with Dimethyl Fumarate, your doctor will perform a blood test to check your white blood cell count and to ensure that 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 doctorbefore starting treatment with this medicine 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 that you have any symptoms of shingles.

If you think that your MS is getting worse (e.g., weakness or changes in vision) or if 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, inform 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 because there is no data available for this age group.

Other medicines and Dimethyl Fumarate Macleods

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
• The use of Dimethyl Fumarate and the administration of certain types of vaccines (live vaccines) could cause you to become infected, and therefore, should be avoided. Your doctor will advise you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Macleods 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 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 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 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

This medicine is not expected to affect your ability to drive or use machines.

Dimethyl Fumarate Macleods 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 Macleods

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Starting dose: 120mg twice a day.

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

Usual dose: 240mg twice a day.

Dimethyl Fumarate is taken by mouth.

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 with food– this helps to reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate 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

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 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 white blood cell 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 white blood cell count during treatment, and you should remain alert to 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 can include new weakness 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 that 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 experience 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 hives 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 be a severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl Fumarate 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
• 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 white blood cell count (lymphopenia, leucopenia) in blood. A decrease in white blood cells can make the body more susceptible to infections. If you have a severe 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 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 (13years 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 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 Macleods

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 Macleods

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

microcrystalline cellulose (E460), sodium croscarmellose (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b), methacrylic acid - ethyl acrylate copolymer (1:1) type A, 30% dispersion (sodium lauryl sulfate and polysorbate 80), triethyl citrate, talc (E553b), methacrylic acid - 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 container contents

Dimethyl Fumarate Macleods 120 mg gastro-resistant capsules are size “0”, with a light green opaque cap and a white opaque body printed with “I 65” and “120 mg” in black ink, containing white to off-white film-coated mini-tablets and are available in blister packs (white opaque PVC/PE/PVdC aluminum 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 capsules are size “0”, with a light green opaque cap and a light green opaque body printed with “I 66” and “240 mg” in black ink, containing white to off-white film-coated mini-tablets and are available in blister packs (white opaque PVC/PE/PVdC aluminum 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 some 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 Member States of the European Economic Area under the following names

Date of the last revision of this leaflet:January 2024

Other sources of information

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/).