Patient Information Leaflet

Macleods Dimethyl Fumarate 120 mg Hard Gastrorresistant Capsules EFG

Macleods Dimethyl Fumarate 240 mg Hard Gastrorresistant Capsules EFG

Please read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section4.

What is Macleods Dimethyl Fumarate

Dimethyl Fumarate is a medication that containsdimethyl fumarateas the active ingredient.

What is dimethyl fumarate used for

Dimethyl fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13and 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 (exacerbations) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulties walking, balance problems, and visual problems (e.g., blurred vision or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How does dimethyl fumarate work

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

Do not take dimethyl fumarate

• if you are allergic to dimethyl fumarateor to any of the other ingredients of this medicine (listed in section6).
• if you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dimethyl fumarate.

Dimethyl fumarate may affect thenumber of white blood cells, thekidneysand theliver. Before starting to take dimethyl fumarate, your doctor will do a blood test to get a white blood cell count and check that your kidneys and liver are working properly. Your doctor will do blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting to take this medicine if you have:

• severerenal disease
• severehepatic disease
• gastrointestinal diseaseorintestinal disease
• severe infection (for example pneumonia)

You may experience herpes zoster (shingles) during treatment with dimethyl fumarate. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may 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, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, 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 old because there are no available data in this age group.

Other medicines and Dimethyl fumarate Macleods

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the body's immune system,includingchemotherapy, immunosuppressants,orother medicines used to treat MS
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine production),certaintypes of analgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medicines that containlithium
• The use of dimethyl fumarate and the administration of certain types of vaccines (live vaccines) may cause an infection, and therefore should be avoided. Your doctor will inform you if you should receive other types of vaccines (inactivated vaccines).

Dimethyl fumarate Macleods and alcohol

After taking dimethyl fumarate, avoid consuming more than a small amount (more than 50mL) of strong alcoholic beverages (with a volume of alcohol of more than 30%, such as spirits) during the first hour because alcohol may interact with this medicine. It may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breastfeeding

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

Pregnancy

The information on the effects of this medicine on the fetus if used during pregnancy is limited. Do not use dimethyl fumarate during pregnancy unless you have discussed this with your doctor and this 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 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 operating machinery

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

Dimethyl fumarate Macleods contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Initial dose: 120mg twice a day.

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

Usual dose: 240mg twice a day.

Dimethyl fumarate is taken orally.

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

Take dimethyl fumarate with food– it helps to reduce some very frequent adverse effects (listed in section4).

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 in section4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take dimethyl fumarate

Do not take a double doseto make up for the missed doses.

You can take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the next scheduled dose.

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

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

Severe side effects

Methylphenidate hydrochloride 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 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 cells throughout 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 medication that has worsened your immune system function.

The symptoms of PML may be similar to those of 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 changes in personality, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important to speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking methylphenidate hydrochloride. Also, inform your partner or caregivers about your treatment. New symptoms may arise of which you may not be aware.

• 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 (unknown frequency).

Flush (rubefaction) is a very common side effect. However, if the flush is accompanied by a red rash or hives and presents any of the following symptoms:

• swelling of the face, lips, mouth, or tongue(angioedema)
• whistling when breathing, difficulty breathing, or shortness of breath(dyspnea, hypoxia)
• dizziness or loss of consciousness(hypotension)

it may then constitute a severe allergic reaction (anaphylaxis).

• Stop taking methylphenidate hydrochloride and call your doctor immediately

Other side effects

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

• flushing of the face or body, feeling hot, 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 side effects.

While taking methylphenidate hydrochloride, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Consult your doctorabout how to treat 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 intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dispepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• sweating, feeling hot
• skin itching (pruritus)
• exanthema
• rosy or reddish patches accompanied by 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) inform your doctor immediately
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Rare(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of platelets in the blood

Unknown frequency(cannot be estimated from the available data)

• inflammation of the liver and increase in 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 the infection, followed by numbness, itching, or red spots with intense 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, p.eg, headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Macleods Dimethyl Fumarate

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

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

Macleods Dimethyl Fumarate 120mg gastro-resistant hard capsules are size “0”, greenish clear opaque cap and white opaque body printed with “I 65” and “120mg” in black ink, containing mini-compressions with a white to off-white film and are available in blister packs (white opaque PVC/PE/PVdC aluminum blisters)

Blister pack – containing 14 (1 x 14 capsules)

Unit dose blister pack – containing 14 x 1 (1 x 14 capsules)

Macleods Dimethyl Fumarate 240mg gastro-resistant hard capsules are size “0”, greenish clear opaque cap and greenish clear opaque body printed with “I 66” and “240mg” in black ink, containing mini-compressions with a white to off-white film 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)

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible person for manufacturing

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 with the following names

Last review date of this leaflet:January 2024

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).