Fumarato de dimetilo accord 120 mg capsulas duras gastrorresistentes efg

Patient Information Leaflet

Methylphenidate Accord 120 mg Hard Capsules

Methylphenidate Accord 240 mg Hard Capsules

methylphenidate

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Dimethyl Fumarate Accord

Dimethyl Fumarate Accord is a medication that containsdimethyl fumarateas the active ingredient.

What is Dimethyl Fumarate Accord used for

Dimethyl Fumarate Accord is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13 years of age and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (exacerbations) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulties walking, balance problems, and visual problems (e.g., blurred vision or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How Dimethyl Fumarate Accord works

Dimethyl Fumarate Accord appears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future deterioration of MS.

Do not take Fumarato de dimetilo Accord

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

Warnings and precautions

Fumarato de dimetilo Accord may affect thenumber of white blood cells, thekidneysand theliver. Before starting Fumarato de dimetilo Accord, your doctor will make a blood test to get a white blood cell count and check that your kidneys and liver are working correctly. Your doctor will make periodic blood tests during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting to take Fumarato de dimetilo Accord if you have:

• severerenal disease
• severehepatic disease
• gastrointestinal diseaseorintestinal disease
• severe infection (for example pneumonia)

Herpes zoster (shingles) may occur during treatment with Fumarato de dimetilo Accord. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or visual changes) or notice the appearance of any new symptoms, speak directly with your doctor, as they may be symptoms of a rare brain infection called PML. PML is a serious disease that can cause death or severe disability.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine that contains dimethyl fumarate in combination with other fumaric acid esters, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not administer this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Fumarato de dimetilo Accord

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the body's immune system,including chemotherapy, immunosuppressants orother medicines used to treat MS.
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine elimination),certain types of analgesics(such as ibuprofen or other anti-inflammatory drugs, and over-the-counter medicines) and medicines that containlithium;
• the use of Fumarato de dimetilo Accord and the administration of certain types ofvaccines(attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Taking Fumarato de dimetilo Accord with alcohol

After taking Fumarato de dimetilo Accord, avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with a volume of alcohol of more than 30%, such as spirits) during the first hour because alcohol may interact with this medicine. It may cause stomach inflammation (gastritis), especially in people with a tendency to suffer from this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is limited information on the effects of this medicine on the fetus when used during pregnancy. Do not use Fumarato de dimetilo Accord during pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary.

Breastfeeding

It is unknown whether the active ingredient of Fumarato de dimetilo Accord passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or whether you should stop taking Fumarato de dimetilo Accord. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machinery

Fumarato de dimetilo Accord is not expected to affect your ability to drive and use machines.

Fumarato de dimetilo Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Initial Dose:

120 mg twice a day.

Take this initial dose for the first 7 days, then take the usual dose.

Usual Dose:

240 mg twice a day.

Dimethyl Fumarate Accord is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, or chew or suck on the capsules because some adverse effects may increase.

Take Dimethyl Fumarate Accord with food– it helps to reduce some very common adverse effects (listed in section 4).

If you take more Dimethyl Fumarate Accord than you should

If you take too many capsules,inform your doctor immediately. You may experience adverse effects similar to those described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Dimethyl Fumarate Accord

Do not take a double doseto compensate for the missed doses.

You can take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the next scheduled dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects

Fumarato de dimetilo Accord may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cells throughout treatment and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has worsened your immune system function.

The symptoms of PML may be similar to those of an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important to speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking Fumarato de dimetilo Accord.

Also, inform your partner or caregivers about your treatment. It is possible that symptoms may arise that you may not be aware of on your own.

→Call your doctor immediately if you experience any of these symptoms

Severe allergic reactions

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

Facial or body flushing (rubefaction) is a very common side effect. However, if the flushing is accompanied by a red rash or hives and you experience any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• whistling when breathing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

it may then constitute a severe allergic reaction (anaphylaxis).

→Stop taking Fumarato de dimetilo Accord and call your doctor immediately

Other side effects

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

• facial or body flushing
• sensation of heat, heat, burning sensation, or itching (rubefaction)
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

→Taking the medicine with food may help reduce the previous side effects

While taking Fumarato de dimetilo Accord, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Consult your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Frequent (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flashes, sensation of heat
• skin itching (pruritus)
• exanthema
• rosy or reddish patches accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia) in blood. A decrease in white blood cells may make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Poco frequent (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of platelets in the blood

Rare (may affect up to 1 in 1000 people)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin)

Unknown frequency(cannot be estimated from the available data)

• herpes zoster (shingles) with symptoms such as blisters, 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 the infection, followed by numbness, itching, or red patches with intense pain
• nasal secretion (rhinorrhea)

Children (13 years of age and older) and adolescents

The side effects described above also apply to children and adolescents.

Some side effects were reported more frequently in children and adolescents than in adults, for example, headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration datethat appears on the box and on each blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Dimethyl Fumarate Accord

• The active ingredientis dimethyl fumarate.

Dimethyl Fumarate Accord 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Accord 240 mg: each capsule contains 240 mg of dimethyl fumarate.

• Theothercomponents are:

Capule content (mini-compressed tablets with enteric coating): microcrystalline cellulose, talc, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, copolymer of methacrylic acid and methyl methacrylate (1:1), triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion at 30%,

Coating: gelatin, titanium dioxide (E171), Brilliant Blue FCF (E133), iron oxide black (E172), and iron oxide yellow (E172).

Capule printing (black ink): shellac (E904), iron oxide black (E172), potassium hydroxide (E525).

Appearance of the product and packaging content

Dimethyl Fumarate Accord 120 mg hard-gastrorresistant capsules are hard gelatin capsules size “0” (approximately 21.3 x 7.5 mm) with green cap and white body, engraved with “HR1” in black ink on the capsule body, and with content of mini-compressed tablets with enteric coating, round, biconvex, white, smooth on both sides.

Dimethyl Fumarate Accord 240 mg hard-gastrorresistant capsules are hard gelatin capsules size “0” (approximately 21.3 x 7.5 mm) with green cap and body, engraved with “HR2” in black ink on the capsule body, and with content of mini-compressed tablets with enteric coating, round, biconvex, white, smooth on both sides.

Capsules of 120 mg:

14 capsules in boxes with PVC/PE/PVDC-Alu blisters.

14x1 capsules in PVC/PE/PVDC-Alu unidose blister packs.

Capsules of 240 mg:

56 or 168 capsules in boxes with PVC/PE/PVDC-Alu blisters.

56x1 or 168x1 capsules in PVC/PE/PVDC-Alu unidose blister packs.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6aPlanta,

08039 Barcelona,

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU/ MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Τηλ: +30 210 74 88 821

Last review date of this leaflet:

The detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu/.