Dimethyl fumarate ranbaxy

Package leaflet: Information for the patient

Dimethyl fumarate Ranbaxy, 120 mg, hard enteric-coated capsules
Dimethyl fumarate Ranbaxy, 240 mg, hard enteric-coated capsules
Dimethylis fumaras
Please read all of 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dimethyl fumarate Ranbaxy is and what it is used for

What Dimethyl fumarate Ranbaxy is
Dimethyl fumarate Ranbaxy is a medicine containing the active substance dimethyl fumarate.
What Dimethyl fumarate Ranbaxy is used for
Dimethyl fumarate Ranbaxy is used to treat relapsing-remitting multiple sclerosis (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 episodes of neurological symptoms (called relapses). Symptoms vary between patients but usually include walking and balance difficulties, 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 Ranbaxy works
Dimethyl fumarate Ranbaxy appears to suppress the immune system from causing damage to the brain and spinal cord. This may also help slow the future progression of multiple sclerosis.

2. Important information before using Dimethyl fumarate Ranbaxy

When not to take Dimethyl fumarate Ranbaxy

• 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 or has been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Dimethyl fumarate Ranbaxy may have an adverse effect on white blood cell count, as well as on kidney and liver function. Before starting treatment with Dimethyl fumarate Ranbaxy, 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 Ranbaxy, the patient should discuss with the doctor if they have:

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

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Ranbaxy. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should inform the doctor 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 symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.

Rare but serious kidney dysfunction (Fanconi syndrome) has been reported during treatment with medicines containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin condition). If the patient notices increased urination, feels more thirsty and drinks more than usual, their muscles seem weaker, a bone fracture occurs, or they simply feel pain, they should seek medical advice 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 Ranbaxy with 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, 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 other similar non-steroidal anti-inflammatory drugs, including over-the-counter medicines), and medicines containing lithium;
• the use of certain vaccines (vaccines containing live organisms) during treatment with Dimethyl fumarate Ranbaxy may lead to the development of an infection and should therefore be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated organisms) should be administered.

Dimethyl fumarate Ranbaxy and alcohol
The patient should avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume) in quantities exceeding 50 mL within one hour of taking Dimethyl fumarate Ranbaxy, due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the gastric mucosa), 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 baby, 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 Ranbaxy should not be used during pregnancy unless the patient has discussed this with her doctor and the use of this medicine is considered necessary.

Breastfeeding
It is not known whether the active substance of Dimethyl fumarate Ranbaxy passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or the administration of Dimethyl fumarate Ranbaxy. 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 using machines
No effect of Dimethyl fumarate Ranbaxy on the ability to drive or operate machinery is expected.

Dimethyl fumarate Ranbaxy contains sodium, azorubine (E 122), and orange yellow (E 110)
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
This medicine contains azorubine and orange yellow FCF, which may cause allergic reactions.

3. How to take Dimethyl fumarate Ranbaxy

This medicine should always be taken exactly 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 used at the
usual maintenance dose.
Usual dose:
240 mg twice daily.
Dimethyl fumarate Ranbaxy 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 Ranbaxy should be taken with food – this will help reduce the very common
adverse reactions (listed in section 4).
Taking more than the recommended dose of Dimethyl fumarate Ranbaxy
If more capsules than recommended have been taken, you must inform your doctor immediately.
Adverse reactions similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Ranbaxy
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 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 Ranbaxy may reduce the number of lymphocytes (a type of white blood cells).
Low numbers 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 aware of 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-onset weakness or worsening of weakness on one side of the body; loss of coordination, vision disturbances, thinking or memory problems, confusion (disorientation), or 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 occurrence of any new symptoms while taking Dimethyl fumarate Ranbaxy, 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.

Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from the available data (frequency unknown). A very common adverse effect is sudden (flushing) redness of the face or body. If flushing 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 serious allergic reaction (anaphylaxis).

• You must stop taking Dimethyl fumarate Ranbaxy 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, skin burning or itching (flushing)
• loose stools (diarrhea)
• nausea
• stomach pain or cramps
• Taking the medicine with food may help reduce these adverse effects.

During treatment with Dimethyl fumarate Ranbaxy, ketone bodies, which are normally produced in the body, are very frequently detected in urine tests.
Talk to your doctor about 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 mucosa (gastritis)
• gastrointestinal disorders
• skin burning
• hot flushes, sensation of heat
• skin itching (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Adverse effects that may appear in blood or urine test results:

• low number of white blood cells (lymphopenia, leukopenia). Reduced white blood cell count may mean the body is less able to fight infections. In case of severe 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

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

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

Frequency not known (frequency cannot be estimated from the available data)

• 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 or red spots accompanied by severe pain
• runny nose (rhinitis)

Children (aged 13 years and older) 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 this medicine.

5. How to store Dimethyl fumarate Ranbaxy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate Ranbaxy contains
The active substance is dimethyl fumarate.
Dimethyl fumarate Ranbaxy 120 mg, hard enteric-coated capsules
Each enteric-coated hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate Ranbaxy 240 mg, hard enteric-coated capsules
Each enteric-coated hard capsule contains 240 mg of dimethyl fumarate.

Other ingredients are:
Capsule contents: microcrystalline cellulose, magnesium oxide, sodium croscarmellose, colloidal anhydrous silica, talc, magnesium stearate, triethyl citrate, sodium lauryl sulfate, copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, simethicone.
Capsule shell: gelatin, titanium dioxide (E 171), azorubine (E 122), orange-yellow FCF (E 110), patent blue V (E 131), quinoline yellow (E 104).
Printing ink for capsules: shellac, potassium hydroxide, black iron oxide (E 172), propylene glycol (E 1520).

What Dimethyl fumarate Ranbaxy looks like and contents of the pack
Dimethyl fumarate Ranbaxy 120 mg, hard enteric-coated capsules
Hard gelatin capsules with a white body and green cap, 21 mm in size, printed with “120 mg” on the body.

Dimethyl fumarate Ranbaxy 240 mg, hard enteric-coated capsules
Hard gelatin capsules with a green body and cap, 22 mm in size, printed with “240 mg” on the body.

Dimethyl fumarate Ranbaxy is packed in aluminium PVC/PE/PVDC blisters or perforated single-dose blisters.

Pack sizes:
[120 mg]
PVC/PE/PVDC aluminium blisters: cardboard boxes containing 14, 56, 60 and 196 hard enteric-coated capsules.
Perforated single-dose aluminium blisters with PVC/PE/PVDC: cardboard boxes containing 14 x 1 hard enteric-coated capsules.

[240 mg]
PVC/PE/PVDC aluminium blisters: cardboard boxes containing 14, 28, 56, 60, 120, 168 and 196 hard enteric-coated capsules.
Perforated single-dose aluminium blisters with PVC/PE/PVDC: cardboard boxes containing 56 x 1 hard enteric-coated capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Ludwika Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Strada Fabricii Nr 124
400632 Cluj-Napoca
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland: Dimethyl fumarate SUN 120 mg kovat enterokapselit
Dimethyl fumarate SUN 240 mg kovat enterokapselit
France: DIMETHYL FUMARATE SUN 120 mg, gélule gastro-résistante
DIMETHYL FUMARATE SUN 240 mg, gélule gastro-résistante
Spain: Fumarato de dimetilo Sun 120 mg cápsulas duras gastrorresistentes EFG
Fumarato de dimetilo Sun 240 mg cápsulas duras gastrorresistentes EFG
Germany: Dimethylfumarat Basics 120 mg magensaftresistente Hartkapseln
Dimethylfumarat Basics 240 mg magensaftresistente Hartkapseln
Norway: Dimethyl fumarate SUN
Sweden: Dimethyl fumarate SUN 120 mg hårda enterokapslar
Dimethyl fumarate SUN 240 mg hårda enterokapslar
Italy: Dimetilfumarato SUN