Dimethyl fumarate reddy

Package leaflet: Information for the patient

Dimethyl fumarate Reddy 120 mg gastro-resistant hard capsules
Dimethyl fumarate Reddy 240 mg gastro-resistant hard capsules
Dimethylis fumaras
Please read this leaflet carefully before 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dimethyl fumarate Reddy is and what it is used for
2. What you need to know 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 Dimethyl fumarate Reddy is and what it is used for

What Dimethyl fumarate Reddy is
Dimethyl fumarate Reddy is a medicine containing dimethyl fumarate.
What Dimethyl fumarate Reddy is used for
Dimethyl fumarate Reddy is used to treat relapsing-remitting multiple sclerosis (in English:sclerosis multiplex, MS) in patients aged 13 years and older.
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 neurological worsening (called relapses). Symptoms vary between individuals but usually include walking and balance problems and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.
How Dimethyl fumarate Reddy works
Dimethyl fumarate Reddy appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the progression of the disease in the future.

2. Important information before using Dimethyl fumarate Reddy

When not to take Dimethyl fumarate Reddy:

• if the patient is allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6);
• if progressive multifocal leukoencephalopathy (PML), a rare brain infection, is suspected or has been confirmed in the patient.

Warnings and precautions
Dimethyl fumarate Reddy may have an adverse effect on white blood cell count, as well as on the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Reddy, the doctor will check the patient's white blood cell count and assess whether the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the white blood cell count decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.
Before starting treatment with Dimethyl fumarate Reddy, consult a doctor if the patient has:

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

Herpes zoster (shingles) may occur during treatment with dimethyl fumarate. In some cases, serious complications have occurred. If the patient suspects any symptoms of shingles, the doctor should be informed immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact the doctor immediately, as these may be signs of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
During treatment with dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin condition), rare but serious kidney disorders, including Fanconi syndrome, have been reported. If the patient notices increased urination, feels thirsty and drinks more than usual, their muscles seem weaker, bones break easily, or they experience pain, they should contact the doctor as soon as possible for further evaluation of these symptoms.

Children and adolescents
This medicine should not be given to children under 10 years of age, as data in this age group are not available.

Dimethyl fumarate Reddy and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• medicines containing fumaric acid esters used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium.
• Administration of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate Reddy may lead to the development of infection and should therefore be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be given.

Taking Dimethyl fumarate Reddy with alcohol
High-strength alcoholic beverages (containing more than 30% alcohol by volume) should be avoided in amounts exceeding 50 ml within one hour of taking dimethyl fumarate, due to the risk of interaction between alcohol and this medicine, which may cause gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate should not be taken during pregnancy unless the patient has discussed this with her doctor and treatment is considered necessary.

Breastfeeding
It is not known whether dimethyl fumarate passes into breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or the administration of dimethyl fumarate. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and operating machinery
Dimethyl fumarate Reddy is not expected to affect the ability to drive or operate machinery.

Dimethyl fumarate Reddy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Dimethyl fumarate Reddy

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Initial dose: 120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be continued at the recommended dose.
Usual dose: 240 mg twice daily.
Dimethyl fumarate Reddy should be taken orally.
Each capsule should be swallowed whole with water. Capsules must not be divided, crushed, dissolved, sucked, or chewed, as this may increase the risk of certain adverse reactions.
Dimethyl fumarate Reddy should be taken with food – this helps reduce the very common adverse reactions (listed in section 4).
Taking more Dimethyl fumarate Reddy than prescribed
If more capsules than recommended have been taken, you must immediately inform your doctor. Adverse reactions similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Reddy
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided there is at least a 4-hour interval before the next scheduled dose. If it is too late, the missed dose should not be taken; instead, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Dimethyl fumarate may reduce the number of lymphocytes, which are a type of white blood cell. A low number of white blood cells may 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; therefore, your doctor should monitor your white blood cell count throughout the entire treatment period, and you should be alert to the symptoms described below, which may indicate PML. The risk of PML may be higher if you have previously taken medicines that affect the immune system.

Symptoms of PML may resemble a relapse of multiple sclerosis. These include new or worsening weakness on one side of the body, loss of coordination, vision problems, changes in thinking or memory, confusion (disorientation), personality changes, speech problems, and communication difficulties lasting longer than a few days. For this reason, if you notice worsening of symptoms related to multiple sclerosis or any new symptoms while taking dimethyl fumarate, you should contact your doctor as soon as possible.

You should also talk to your partner or caregivers and inform them about your treatment. Symptoms may occur that you yourself may not be aware of.

• If any of the symptoms listed above occur, contact your doctor immediately

Severe allergic reactions

The frequency of severe allergic reactions cannot be determined from available data (unknown).

A very common adverse effect is sudden ( episodic ) redness of the face or body. If this episodic 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 may indicate a severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl fumarate Reddy and contact your doctor immediately

Other adverse effects

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

• redness of the face or sensation of increased body temperature, hot flushes, burning, or itching of the skin (episodic flushing)
• loose stools (diarrhea)
• nausea
• stomach pain or cramps

Taking the medicine with food may help reduce the above-mentioned adverse effects.

During dimethyl fumarate treatment, increased production of ketone bodies (substances normally produced in the body) is very commonly observed in urine tests.

Ask your doctor how to manage adverse effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.

Common (may occur in up to 1 in 10 people)

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

Adverse effects that may cause abnormal blood or urine test results:

• low number of white blood cells (lymphopenia, leukopenia). A reduced number of white blood cells may mean the body is less able to fight infections. If you develop a serious infection (e.g. pneumonia), contact your doctor immediately;
• protein (albumin) in urine;
• increased liver enzyme activity (AlaT, AspAT) in blood.

Uncommon (may occur in up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

Unknown (frequency cannot be estimated from available data)

• hepatitis and increased liver enzyme activity (AlAT or AspAT together with bilirubin)
• shingles, with symptoms such as skin blisters, burning, itching, or skin pain, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in the early stages of infection, followed by numbness, itching, red spots, and severe pain
• nasal congestion (rhinitis)

Children (aged 13 years and above) and adolescents

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

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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. Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps provide more information on the safety of the 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 specified month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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.
The other ingredients are: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30,
talc (E553b), magnesium stearate (E1505), copolymer of methacrylic acid and methyl methacrylate (1:1)
(E1205), sodium lauryl sulfate (E470a), triethyl citrate (E1505), dispersion 30% of copolymer of methacrylic acid and ethyl acrylate (1:1) (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, approx. 19.3 mm) are green and white with the imprint "RDY" on the cap and "429" on the body.
Each blister contains 14 or 56 gastro-resistant hard capsules.
Each blister divided into single doses contains 14 x 1 gastro-resistant hard capsules.
Dimethyl fumarate Reddy 240 mg gastro-resistant hard capsules (size 0, approx. 21.4 mm) are green with the imprint "RDY" on the cap and "430" on the body.
Each blister contains 14, 56, 112, 168 or 196 gastro-resistant hard capsules.
Each blister divided into single doses contains 56 x 1 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names: