Dimethil fumarate Reddi

Package Leaflet: Information for the Patient

Dimethyl Fumarate Reddy 120 mg Gastro-Resistant Hard Capsules

Dimethyl Fumarate Reddy 240 mg Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dimethyl Fumarate Reddy and what is it used for
• 2. Important information before taking Dimethyl Fumarate Reddy
• 3. How to take Dimethyl Fumarate Reddy
• 4. Possible side effects
• 5. How to store Dimethyl Fumarate Reddy
• 6. Contents of the pack and other information

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

What is Dimethyl Fumarate Reddy

Dimethyl Fumarate Reddy is a medicine containing dimethyl fumarate.

What is Dimethyl Fumarate Reddy used for

Dimethyl Fumarate Reddy is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 and over.

Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by recurring episodes of neurological symptoms (relapses). Symptoms vary from person to person, but usually include problems with walking and balance, and vision disturbances (e.g., blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How does Dimethyl Fumarate Reddy work

Dimethyl Fumarate Reddy seems to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimethyl Fumarate Reddy

When not to take Dimethyl Fumarate Reddy:

• - if you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6);
• - if you suspect or have been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl Fumarate Reddy may affect your white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Reddy, your doctor will check your white blood cell count and ensure that your kidneys and liver are working properly. These tests will be performed periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop the treatment.

Before taking Dimethyl Fumarate Reddy, you should consult your doctorif you have:

• - severe kidney disease
• - severe liver disease
• - stomach or intestinal disease
• - severe infection(e.g., pneumonia)

During treatment with dimethyl fumarate, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect any symptoms of shingles, such as blisters on the skin, burning, itching, or pain, you should immediately inform your doctor. If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or you develop new symptoms, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.

When taking dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney damage called Fanconi syndrome has been reported. If you notice that you are urinating more, feeling thirsty, and drinking more than usual, your muscles seem weaker, you have a bone fracture, or you simply feel pain, you should see your doctor as soon as possible to investigate these symptoms.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no data available for this age group.

Dimethyl Fumarate Reddy and other medicines

You should tell your doctor or pharmacistabout all medicines you are taking or have recently taken, as well as any medicines you plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis;
• medicines that affect the kidneys, including certain antibiotics(used to treat infections), diuretics(diuretics), some painkillers(such as ibuprofen and similar anti-inflammatory medicines, as well as over-the-counter medicines) and lithium;
• the use of certain vaccines ( live vaccines) during treatment with Dimethyl Fumarate Reddy may cause infection, so it should be avoided. Your doctor will advise whether to administer other types of vaccines ( killed vaccines).

Taking Dimethyl Fumarate Reddy with alcohol

You should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) in excess of 50 ml within an hour of taking dimethyl fumarate, due to the risk of interaction between alcohol and this medicine, which may lead to stomach inflammation (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. Dimethyl fumarate should not be taken during pregnancy unless you have discussed it with your doctor and the use of the medicine is necessary.
Breastfeeding
It is not known whether dimethyl fumarate passes into breast milk. Your doctor will advise whether to stop breastfeeding or taking dimethyl fumarate. The decision will be based on the assessment of the benefits of breastfeeding to the baby compared to the benefits of treatment for you.

Driving and using machines

You should not expect Dimethyl Fumarate Reddy to affect your ability to drive or use machines.

Dimethyl Fumarate Reddy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is considered "sodium-free".

3. How to take Dimethyl Fumarate Reddy

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor.

Initial dose: 120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the recommended dose should be taken.

Usual dose: 240 mg twice a day.

Dimethyl Fumarate Reddy should be taken orally.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
Dimethyl Fumarate Reddy should be taken with food– this will help alleviate very common side effects (listed in section 4)

Taking more Dimethyl Fumarate Reddy than prescribed

If you take more capsules than prescribed, you should immediately tell your doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl Fumarate Reddy

You should not take a double doseto make up for a missed dose.
A missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, you should not take the missed dose, but take the next dose at the usual time.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl Fumarate Reddy can cause side effects, although not everybody gets them.

Serious side effects

Dimethyl fumarate may lower the number of lymphocytes, a type of white blood cell. A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML may resemble a relapse of multiple sclerosis. They include weakness or increased weakness on one side of the body, coordination problems, vision disturbances, changes in thinking or memory, confusion (disorientation), or personality changes, speech difficulties, and communication problems lasting more than a few days. Therefore, if you experience a worsening of your multiple sclerosis symptoms or new symptoms while taking dimethyl fumarate, you should contact your doctor immediately.

If you experience any of the following symptoms, you should immediately contact your doctor

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown).
A very common side effect is sudden ( flushing) redness of the face or body.
If flushing of the skin is accompanied by a red rash or hives andany of the following symptoms:

• swelling of the face, lips, mouth, or tongue ( angioedema);
• wheezing, difficulty breathing, or shortness of breath ( dyspnea);
• dizziness or loss of consciousness ( hypotension), this may indicate a severe allergic reaction ( anaphylaxis).

You should stop taking Dimethyl Fumarate Reddy and immediately contact your doctor

Other side effects

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

• redness of the skin on the face or a feeling of increased body temperature, heat, burning, or itching of the skin ( flushing)
• diarrhea ( diarrhea)
• nausea ( nausea)
• stomach pain or cramps
• Taking the medicine with foodwill help alleviate the above side effects

During treatment with dimethyl fumarate, increased production of ketone bodies (substances normally produced in the body) is very commonly found in urine tests.
You should ask your doctorhow to deal with side effects. Your doctor may reduce the dose of the medicine. You should not reduce the dose of the medicine yourself unless your doctor advises you to do so.
Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines ( gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining ( gastritis)
• gastrointestinal disorders
• skin burning sensation
• hot flashes, feeling of heat
• itching ( pruritus)
• rash
• pink or red spots on the skin ( erythema)
• hair loss ( alopecia)

Side effects that may cause abnormal blood or urine test results

• low white blood cell count ( lymphopenia, leukopenia). A low white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (e.g., pneumonia), you should contact your doctor immediately;
• protein ( albumin) in the urine;
• increased liver enzyme activity ( ALT, AST) in the blood.

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

Unknown(frequency cannot be estimated from the available data)

• liver inflammation and increased liver enzyme activity ( ALT or AST together with bilirubin)
• shingles with symptoms such as blisters on the skin, burning, itching, or 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 and severe pain
• runny nose ( rhinitis)

Children (13 years and older) and adolescents

The above side effects also apply to children and adolescents.
Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dimethyl Fumarate Reddy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate Reddy contains

The active substance of the medicine is dimethyl fumarate.
Dimethyl Fumarate Reddy 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimethyl Fumarate Reddy 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 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).

What Dimethyl Fumarate Reddy looks like and contents of the pack

Dimethyl Fumarate Reddy 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 pack contains 14 or 56 gastro-resistant hard capsules.
Each single-dose blister pack contains 14 x 1 gastro-resistant hard capsules.
Dimethyl Fumarate Reddy 240 mg gastro-resistant hard capsules (size 0, approximately 21.4 mm) are green and have "RDY" printed on the cap and "430" on the body.
Each blister pack contains 14, 56, 112, 168, or 196 gastro-resistant hard capsules.
Each single-dose blister pack contains 56 x 1 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Manufacturer/Importer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Rual Laboratories S.R.L.
Building H 1st Floor Sector 3, Splaiul Unirii no 313
030138 Bucharest
Romania
Laboratori Fundacio Dau
Calle Lletra C De La Zona Franca 12-14
Poligono Industrial De La Zona Franca De Barcelona
08040 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 17.09.2024