Dimethyl fumarate cipla

Package leaflet: Information for the user

Dimethyl Fumarate Cipla, 120 mg, hard enteric-coated capsules
Dimethyl Fumarate Cipla, 240 mg, hard enteric-coated capsules
dimethyl fumarate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

What Dimethyl Fumarate Cipla is
Dimethyl Fumarate Cipla is a medicine containing the active substance dimethyl fumarate.

What Dimethyl Fumarate Cipla is used for
Dimethyl Fumarate Cipla is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease that affects the central nervous system (CNS), including the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by recurring, periodic episodes of neurological symptoms (called relapses). Symptoms vary between individuals but usually include problems with walking and balance, and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some issues may persist.

How Dimethyl Fumarate Cipla works
Dimethyl Fumarate Cipla is thought to work by suppressing the immune system from causing damage to the brain and spinal cord. It may also help slow down the future progression of the disease.

2. Important information before using Dimethyl Fumarate Cipla

When not to take Dimethyl Fumarate Cipla:

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

Warnings and precautions
Dimethyl fumarate may have an adverse effect on the white blood cell count, as well as on kidney and liver function. Before starting treatment with Dimethyl Fumarate Cipla, 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 patient's white blood cell count decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.
Before starting treatment with Dimethyl Fumarate Cipla, the patient should consult a doctor if they have:

• 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, 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 signs of a rare brain infection called PML. PML is a serious condition that may lead to severe disability or death.
Rare but serious kidney disorders, known as Fanconi syndrome, have been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease). 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 consult their 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 Cipla and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, 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 Cipla may lead to infection; therefore, such vaccination should be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be given.

Use of Dimethyl Fumarate Cipla with alcohol
The consumption of high-strength alcoholic beverages (over 30% alcohol by volume) in amounts exceeding 50 ml within one hour of taking Dimethyl Fumarate Cipla should be avoided due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, thinks 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 data on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl Fumarate Cipla should not be used during pregnancy unless the patient has discussed this with her doctor and treatment is considered necessary.

Breastfeeding
It is not known whether the active substance of Dimethyl Fumarate Cipla passes into breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or the administration of Dimethyl Fumarate Cipla. 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 Cipla is not expected to affect the ability to drive or operate machinery.

Dimethyl Fumarate Cipla contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Dimethyl Fumarate Cipla

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

Starting dose: 120 mg twice daily.
This starting dose should be taken for the first 7 days, after which the medicine should be continued at the usual maintenance dose.

Usual maintenance dose: 240 mg twice daily.

Dimethyl Fumarate Cipla should be taken orally.
Each capsule must 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 Cipla should be taken with food – this helps to reduce the very common side effects (listed in section 4).

Taking more Dimethyl Fumarate Cipla than prescribed
If you take more capsules than recommended, you must inform your doctor immediately. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl Fumarate Cipla
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided that at least a 4-hour interval is maintained before the next scheduled dose. If it is too late, do not take the missed dose; 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Dimethyl Fumarate Cipla may reduce the number of lymphocytes, which are a type of white blood cell.
Low levels 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 observed after 1 to 5 years of treatment; therefore, your doctor should monitor your white blood cell count throughout the entire duration of treatment, and you should pay attention to the symptoms described below, which may indicate PML. The risk of developing 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, coordination problems, vision disturbances, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. For this reason, if you notice worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms while taking Dimethyl Fumarate Cipla, you should contact your doctor immediately. 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 (frequency unknown).
A very common adverse reaction is sudden ( paroxysmal ) redness of the face or body. If paroxysmal skin 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 Cipla and contact your doctor immediately
Other adverse reactions
Very common (may affect more than 1 in 10 people)

• redness of the face or a sensation of warmth, burning, or itching of the skin ( flushing ),
• loose stools (diarrhea) ,
• nausea,
• stomach pain or cramps.

→ Taking the medicine with food may help reduce the adverse reactions listed above
While taking Dimethyl Fumarate Cipla, 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 reactions. Your 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 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 ( flushing )
• hair loss ( alopecia )

Adverse reactions that may cause abnormal blood or urine test results

• Low white blood cell count ( lymphopenia, leukopenia ). A reduced white blood cell count 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 the urine;
• increased liver enzyme levels ( AlAT, AspAT ) in the blood.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions ( hypersensitivity )
• decreased platelet count

Rare (may affect up to 1 in 1,000 people)

• hepatitis and increased liver enzyme activity ( AlAT or AspAT together with bilirubin )

Unknown (frequency cannot be determined from available data)

• shingles, with symptoms such as: skin blisters, burning, itching, or 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,

• cold ( rhinitis ).

Children (aged 13 years and above) and adolescents
The adverse reactions listed above also apply to children and adolescents.
Some adverse reactions 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 of adverse reactions
If any adverse reactions occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website:
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dimethyl Fumarate Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Dimethyl Fumarate Cipla contains
The active substance is dimethyl fumarate.

• Dimethyl Fumarate Cipla, 120 mg: each hard enteric capsule contains 120 mg of dimethyl fumarate.
• Dimethyl Fumarate Cipla, 240 mg: each hard enteric capsule contains 240 mg of dimethyl fumarate.
• Other ingredients are:
• Capsule contents (enteric mini-tablets): sodium croscarmellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, microcrystalline cellulose, colloidal anhydrous silica, simethicone, 30% emulsion, talc (E 553), triethyl citrate (E 1505).
• Capsule shell: brilliant blue FCF (E 133), gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide black (E 172), purified water.
• Printing ink on the capsule (black ink): iron oxide black (E 172), potassium hydroxide (E 525), propylene glycol (E 1520), shellac (E 904).

What Dimethyl Fumarate Cipla looks like and contents of the pack
Dimethyl Fumarate Cipla, 120 mg, hard enteric capsules are opaque, green and white, with a linear black ink print reading "Cipla 120" and contain mini-tablets.
Dimethyl Fumarate Cipla, 120 mg, is available in packs containing 14 capsules in a cardboard box.
Dimethyl Fumarate Cipla, 240 mg, hard enteric capsules are opaque, green, with a linear black ink print reading "Cipla 240" and contain mini-tablets.
Dimethyl Fumarate Cipla, 240 mg, is available in packs containing 56, 168 or 196 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium
Tel.: +32(0)32910101 / +32(0)32910199

Manufacturer/Importer
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium

S & D Pharma CZ, spol. s r.o.
Theodor 28
273 08 Pchery (area PHARMOS a.s.)
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names: