Dimethil fumarate Reddi

Leaflet attached to the packaging: patient information

Dimethyl fumarate Reddy 120 mg gastro-resistant hard capsules

Dimethyl fumarate Reddy 240 mg gastro-resistant hard capsules

Dimethyl fumarate

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 that contains 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, periodic worsening of neurological symptoms (called 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 the patient is allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6);
• - if the patient is suspected or confirmed to have a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl fumarate Reddy may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate Reddy, the doctor will check the patient's white blood cell count and ensure that the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the patient's white blood cell count decreases during treatment, the doctor may consider additional tests or discontinuation of treatment.

• - 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, severe complications have occurred. If the patient suspects any symptoms of shingles, they should immediately inform their doctor. If multiple sclerosis worsens (e.g., the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact their 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.

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

Tell your doctor or pharmacistabout all medicines you are taking, have recently taken, or might take, especially:

• medicines containing fumaric acid estersused 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), certain painkillers(such as ibuprofen and similar anti-inflammatory medicines, as well as over-the-counter medicines), and medicines containing lithium.
• Some vaccines ( live vaccines) should be avoided during treatment with Dimethyl fumarate Reddy, as they may cause infection. The doctor will advise on whether to administer other types of vaccines ( killed vaccines).

Using Dimethyl fumarate Reddy with alcohol

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 upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the patient has discussed it with their doctor and the use of the medicine is necessary.
Breastfeeding
It is not known whether dimethyl fumarate passes into breast milk. The doctor will advise the patient whether to stop breastfeeding or taking dimethyl fumarate. The decision will be made based on the assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and using machines

Dimethyl fumarate Reddy is not expected to affect the 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

Take this medicine always as directed by your doctor. In case of doubt, 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.
Swallow each capsule whole, with water. Do not divide, crush, dissolve, suck, or chew the capsules, as this may increase certain side effects.
Take Dimethyl fumarate Reddy with food– this will help alleviate very common side effects (listed in section 4)

Taking more Dimethyl fumarate Reddy than prescribed

In case of taking more capsules than prescribed, inform your doctor immediately. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl fumarate Reddy

Do not take a double doseto make up for a missed dose.
A missed dose can be taken later, provided a 4-hour interval is maintained before the next dose. If it is too late, do not take the missed dose, but take the next dose at the usual time.
In case of further doubts about taking this medicine, 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 the doctor should monitor the patient's white blood cell count throughout treatment, and the patient should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if the patient has taken immunosuppressive medicines in the past.

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

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 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).

Stop taking Dimethyl fumarate Reddy and contact your doctor immediately

Other side effects

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

• redness of the skin on the face or a feeling of warmth, 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, very common findings in urine tests include increased production of ketone bodies (substances normally produced by the body).
Ask your doctorhow to deal with side effects. The doctor may reduce the dose of the medicine. Do not reduce the dose 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
• burning sensation on the skin
• 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 the body is less able to fight infection. In case of severe infection (e.g., pneumonia), contact your doctor immediately;
• protein ( albumin) in the urine;
• increased liver enzyme activity ( AlaT, AspAT) 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 ( AlAT or AspAT together with bilirubin)
• shingles with symptoms such as: blisters on the skin, 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 and severe pain
• runny nose ( rhinitis)

Children (aged 13 and over) 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, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

Keep this medicine out of the 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl fumarate Reddy contains

The active substance 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 leaflet: 17.09.2024