DIMETHYL FUMARATE DR. REDDYS 240 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate Dr. Reddys 120 mg Hard Gastro-Resistant Capsules EFG

Dimethyl Fumarate Dr. Reddys 240 mg Hard Gastro-Resistant Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dimethyl Fumarate Dr. Reddys and what is it used for
2. What you need to know before taking Dimethyl Fumarate Dr. Reddys
3. How to take Dimethyl Fumarate Dr. Reddys
4. Possible side effects
5. Storage of Dimethyl Fumarate Dr. Reddys
6. Package Contents and Additional Information

1. What is Dimethyl Fumarate Dr. Reddys and what is it used for

What is Dimethyl Fumarate Dr. Reddys

Dimethyl Fumarate Dr. Reddys is a medication that contains dimethyl fumarateas the active ingredient.

What is Dimethyl Fumarate Dr. Reddys used for

Dimethyl Fumarateis 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 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 ends, but some problems may persist.

How Dimethyl Fumarate Dr. Reddys works

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

2. What you need to know before taking Dimethyl Fumarate Dr. Reddys

Do not take Dimethyl Fumarate Dr. Reddys

• If you are allergic to dimethyl fumarateor any of the other ingredients of this medication (listed in section 6).
• If you are suspected to 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 starting dimethyl fumarate, your doctor will perform a blood test to obtain a white blood cell count and check that your kidneys and liver are functioning properly. Your doctor will perform periodic 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 dimethyl fumarate 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 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 medication 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, 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 medication to children under 10 years of age, as there is no data available for this age group.

Other medications and Dimethyl Fumarate Dr. Reddys

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medication, in particular:

• medications containing fumaric acid esters(fumarates) used to treat psoriasis;
• medications that affect the body's immune system, including chemotherapy, immunosuppressants, or other medications used to treat MS;
• medications that affect the kidneys, includingsome antibiotics(used to treat infections), diuretics(pills that increase urine production), certain types of pain relievers(such as ibuprofen or similar anti-inflammatory medications, and over-the-counter medications), and medications containing 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 indicate if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Dr. Reddys 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 liqueurs) for the first hour, as alcohol may interact with this medication. This may cause stomach inflammation (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

It is unknown whether the active ingredient 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

Dimethyl fumarate is not expected to affect your ability to drive or use machines.

Dimethyl Fumarate Dr. Reddys contains sodium

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

3. How to take Dimethyl Fumarate Dr. Reddys

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

Initial dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Dimethyl Fumarate is taken orally.

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

Take Dimethyl Fumarate Dr. Reddys with food– it helps reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate Dr. Reddys than you should

If you take too many capsules, inform 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 medication and the amount ingested.

If you forget to take Dimethyl Fumarate Dr. Reddys

Do not take a double dose to make up for forgotten doses. You can take the forgotten dose if at least 4 hours have passed between doses. Otherwise, wait until the next dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side 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 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 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 medication that has worsened the functioning of your immune system.

The symptoms of PML can 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 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 your MS is getting worse or if you notice any new symptoms while being treated with Dimethyl Fumarate Dr. Reddys. 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.

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 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).

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 medication 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 in 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), 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 of blood platelets

Frequency not known(cannot be estimated from the available data)

• inflammation of the liver and increased liver enzyme levels (ALT or AST simultaneously 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 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 side effects

If you experience any side effects, consult your doctor, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dimethyl Fumarate Dr. Reddys

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dimethyl Fumarate Dr. Reddys

The active ingredientis dimethyl fumarate.

Dimethyl Fumarate Dr. Reddys 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Dr. Reddys 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredientsare microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30, talc (E553b), magnesium stearate (E1505), methacrylic acid-methyl methacrylate copolymer (1:1) (E1205), sodium lauryl sulfate (E470a), triethyl citrate (E1505), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (E1205), polysorbate 80 (E433), gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide, and black iron oxide (E172).

Appearance and Package Contents

Dimethyl Fumarate Dr. Reddys 120 mg hard gastro-resistant capsules (size 1, approximately 19.3 mm) are green and white and are printed with "RDY" on the cap and "429" on the body.

Each blister pack contains 14 or 56 capsules.

Each single-dose blister pack contains 14 x 1 capsules.

Dimethyl Fumarate Dr. Reddys 240 mg hard gastro-resistant capsules (size 0, approximately 21.4 mm) are green and are printed with "RDY" on the cap and "430" on the body.

Each blister pack contains 14, 56, 112, 168, or 196 capsules.

Each single-dose blister pack contains 56 x 1 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

R PharmaI, S.A.

A osepTs, nº 38

08029 B Spain)

T: 93 355 49 16

Fax: 93 355 49 61

Manufacturer's Representative

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

or

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3

030138 Bucharest

Romania

or

Laboratori Fundacio Dau,

Calle Lletra C De La Zona Franca, 12-14,

Poligono Industrial De La Zona Franca De Barcelona,

Barcelona, 08040,

Spain.

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 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/