DIMFORDA 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimforda 120 mg Hard Gastro-Resistant Capsules EFG

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

1. What is Dimforda and what is it used for

Dimforda is a medicine that contains dimethyl fumarateas the active substance.

What Dimforda is used for

Dimforda 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: difficulties in walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may remain.

How Dimforda works

Dimforda 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 Dimforda

Do not take Dimforda

• 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 calledprogressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimforda may affect your white blood cell count,kidneysand liver.Before starting Dimforda, your doctor will perform a blood test to check your white blood cell count and 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.

Consult your doctorbefore starting Dimforda 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 Dimforda. In some cases, serious complications have occurred. You should inform your doctor immediately if 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 progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause death or severe disability.

A rare but serious kidney disorder (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 pains 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 of age because there is no data available for this age group.

Other medicines and Dimforda

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 of the body,including chemotherapy, immunosuppressants,or other medicines used to treat MS
• medicines that affect the kidneys, includingsome 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 Dimforda and the administration of certain types of vaccines (live 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 Dimforda with alcohol

After taking Dimforda, 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 Dimforda during pregnancy unless you have discussed it with your doctor and this medicine is clearly necessary for you.

Breastfeeding

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

Driving and using machines

Dimforda is not expected to affect your ability to drive and use machines.

Dimforda contains sodium

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

3. How to take Dimforda

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

Dimforda is taken orally.

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

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

If you take more Dimforda 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 Dimforda

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 other 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

Dimforda 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 will continue to monitor your white blood cells 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 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 that your MS is getting worse or if you notice any new symptoms while being treated with Dimforda. 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 hivesand 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 Dimforda 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 Dimforda, it is common for urine tests to show the presence of ketones, substances that are naturally produced by the body.

Consult 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 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 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

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 (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 Surveillance 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 Dimforda

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.

This medicine does not require any special storage conditions.

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 Content and Additional Information

Composition of Dimforda

• The active ingredientis dimethyl fumarate.

Dimforda 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimforda 240 mg: each capsule contains 240 mg of dimethyl fumarate.

• The other componentsare microcrystalline cellulose (E460i), sodium croscarmellose (E468), talc (E553b), silicified microcrystalline cellulose (E460i) anhydrous colloidal silica, magnesium stearate, triethyl citrate (E1505), methacrylic acid-methyl methacrylate copolymer (1:1) (E1207), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (E1207), sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide (E172), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), shellac (E904), propylene glycol, 28% ammonium hydroxide (E527).

Product Appearance and Container Content

Dimforda 120 mg hard gastro-resistant capsules are hard gelatin capsules with an opaque white body and a pale green opaque cap, with an approximate external diameter of 7.6 mm and a total closed length of 21.7 mm, with the imprint "120 mg", which contains white to off-white enteric-coated mini-tablets, and are marketed in containers containing 14 capsules.

Dimforda 240 mg hard gastro-resistant capsules are hard gelatin capsules with an opaque pale green body and an opaque pale green cap, with an approximate external diameter of 7.6 mm and a total closed length of 21.7 mm, with the imprint "240 mg", which contains white to off-white enteric-coated mini-tablets, and are marketed in containers containing 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Bausch Health Poland Sp. z o.o.

Ul. Przemyslowa 2

35-959 Rzeszów

Poland

Bausch Health Poland Sp. z o.o.

Ul. Kosztowska 21

41-409 Myslowice

Poland

This medicinal product is authorized in the Member States of the European Economic Areawith the following names:

Date of the last revision of thisleaflet: 05/2024

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/