Dimethyl fumarate Dr. Reddy's 240 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dimethyl fumarate Dr. Reddy's 120 mg gastro-resistant hard capsules EFG
Dimethyl fumarate Dr. Reddy's 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

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

1. What Fumarate Dimethyl Dr. Reddy's is and what it is used for

Fumarate Dimethyl Dr. Reddy's is a medicine that contains the active substance dimethyl fumarate (INN: Dimethyl fumarate). It is used to treat adults with relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening symptoms (relapses) followed by periods of recovery (remission).

What is Dimethyl fumarate Dr. Reddy's

Dimethyl fumarate Dr. Reddy's is a medicine that contains dimethyl fumarate as the active substance.

What Fumarato de dimetilo Dr. Reddys is used for

Fumarato 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 commonly 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 Dr. Reddys works

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

2. What you need to know before starting Fumarate of dimethyl Dr. Reddys

Do not take Dimethyl fumarate Dr. Reddy's

• If you are allergic to dimethyl fumarate or to any of the other ingredients of this medicine (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 establish your white blood cell count and to check that your kidneys and liver are functioning properly. Your doctor will carry out periodic blood tests during treatment. If you experience a decrease in white blood cells during treatment, your doctor may consider additional testing or interrupt your treatment.

Consult your doctor before starting dimethyl fumarate if you have:

• severe renal disease
• severe hepatic disease
• a stomach or intestinal disease
• 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 any new symptoms, speak directly with your doctor, as these could be symptoms of a rare brain infection called PML. PML is a serious condition that can lead to death or 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 condition). If you notice that you are urinating more, are more thirsty and drinking more than usual, your muscles seem weaker, you experience a bone fracture, or simply have aches and discomforts, inform your doctor as soon as possible so this can be further investigated.

Children and adolescents

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

Other medicines and Dimethyl fumarate Dr. Reddys

Inform 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 chemotherapy, 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 anti-inflammatory drugs, and over-the-counter medicines), and medicines containing lithium;
• using dimethyl fumarate and receiving certain types of vaccines (attenuated vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether you should receive other types of vaccines (inactivated vaccines).

Taking Dr. Reddy's Dimethyl fumarate 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 volume of over 30%, such as spirits) within the first hour, as alcohol may interact with this medicine. It may cause stomach inflammation (gastritis), especially in individuals predisposed 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.

Pregnacy

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 this with your doctor and the medicine is clearly necessary in your case.

Breastfeeding

It is unknown whether the active substance 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 use of machines

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

Dimethyl fumarate Dr. Reddy's contains sodium

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

3. How to take Dimethyl fumarate Dr. Reddy's

Always follow exactly your doctor's instructions for taking this medicine. If you are unsure, consult your doctor again.

Starting dose: 120 mg twice daily.

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

Recommended dose: 240 mg twice daily.

Dimethyl fumarate is taken orally.

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

Take Dr. Reddy's Dimethyl Fumarate with food—this helps reduce some of the very common side effects (listed in section 4).

If you take more Fumarato de dimetilo Dr. Reddys 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 telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dimethyl fumarate Dr. Reddy's

Do not take a double dose to make up for missed doses. You may take the missed dose if there are at least 4 hours between doses. Otherwise, wait until the time of your next scheduled 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 may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Dimethyl fumarate may decrease your lymphocyte count (a type of white blood cell in the blood). 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 to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that impaired the function of your immune system.

The symptoms of PML may be similar to 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; confusion or personality changes; or difficulty speaking and communicating, which may persist for more than several days. Therefore, it is very important that you speak with 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 Dr. Reddys. In addition, inform your partner or caregivers about your treatment. Symptoms may arise of which you may not be personally 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 (frequency not known).

Facial or body redness (rubor) is a very common adverse effect. However, if redness is accompanied by a red rash or hives and 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 severe allergic reaction (anaphylaxis).

? Stop taking Dimethyl fumarate Dr. Reddys and call the doctor immediately

Other adverse effects

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

• redness of the face or body, feeling of warmth, heat, burning sensation or itching (flushing)
• 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, it is common for urine tests to show the presence of ketones, substances that are naturally produced in the body.

Consult your doctor on 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
• red or rosy spots accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Adverse effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leucopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you have 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 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 (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 reactions

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

5. Storage of Dimethyl fumarate Dr. Reddy's

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 the outer carton after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Dr. Reddy's

The active substance is dimethyl fumarate.

Dimethyl fumarate Dr. Reddy's 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl fumarate Dr. Reddy's 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other ingredients are microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30, talc (E553b), magnesium stearate (E1505), methacrylic acid and methyl methacrylate copolymer (1:1) (E1205), sodium lauryl sulfate (E470a), triethyl citrate (E1505), methacrylic acid and 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 of the product and contents of the pack

Dimethyl fumarate Dr. Reddy's 120 mg gastro-resistant hard capsules (size 1, approximately 19.3 mm) are green and white, with “RDY” printed on the cap and “429” on the body.

Each blister contains 14 or 56 capsules.

Each single-dose blister contains 14 x 1 capsules.

Dimethyl fumarate Dr. Reddy's 240 mg gastro-resistant hard capsules (size 0, approximately 21.4 mm) are green, with “RDY” printed on the cap and “430” on the body.

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

Each single-dose blister contains 56 x 1 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Phone: 93 355 49 16

Fax: 93 355 49 61

Manufacturer responsible

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 Bucuresti

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 review of this leaflet: June 2024

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/