Patient leaflet - Dimethyl Fumarate Pharmathen 240 mg gastro-resistant hard capsules

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

What Dimethyl fumarate Pharmathen is

Dimethyl fumarate Pharmathen is a medicine that contains the active substance dimethyl fumarate.

What Dimethyl fumarate Pharmathen is used for

Dimethyl fumarate Pharmathen is used to treat relaps-ing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

MS is a long-term condition that affects the central nervous sys-tem (CNS), including the brain and the spinal cord. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms. Symptoms vary from patient to pa-tient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g., blurred or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.

How Dimethyl fumarate Pharmathen works

Dimethyl fumarate Pharmathen seems to work by stopping the body’s defence system from damaging your brain and spinal cord. This may also help to delay future worsening of your MS.

2. What you need to know before you take Dimethyl fu-marate Pharmathen

Do not take Dimethyl fumarate Pharmathen

if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
If you are suspected to suffer from a rare brain infec-tion called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl fumarate Pharmathen may affect your white blood cell counts, your kidneys and liver. Before you start Dimethyl fumarate Pharmathen, your doctor will do a blood test to count the number of your white blood cells and will check that your kidneys and liver are working properly. Your doctor will test these periodically during treatment. If your number of white blood cells decreases during treatment, your doctor may consider additional test or discontinue your treatment.

Talk to your doctor before taking Dimethyl fumarate Pharma-then if you have:

severe kidney disease
severe liver disease
a disease of the stomach or bowel
a serious infection (such as pneumonia)

Herpes zoster (shingles) may occur with Dimethyl fumarate Pharmathen treatment. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of shingles.

If you believe your MS is getting worse (e.g., weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away because these may be the symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe dis-ability or death.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psori-asis (a skin disease). If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be inves-tigated further.

Children and adolescents

Do not give this medicine to children below 10 years of age be-cause no data are available in this age group.

Other medicines and Dimethyl fumarate Pharmathen Tell your doctor or pharmacist if you are taking, have re-cently taken or might take any other medicines, in particular:

medicines that contain fumaric acid esters (fumarates) used to treat psoriasis
medicines that affect the body’s immune system includ-ing chemotherapy, immunosuppressants, or other med-icines used to treat MS;
medicines that affect the kidneys including some an-tibiotics (used to treat infections), “water tablets” (diuret-ics), certain types of painkillers (such as ibuprofen and other similar anti-inflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium
taking Dimethyl fumarate Pharmathen with certain types of
vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided. Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Dimethyl fumarate Pharmathen with alcohol Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30 % alcohol by volume, e.g., spirits) should be avoided within an hour of taking Dimethyl fumarate Pharmathen, as alcohol can interact with this medicine. This could cause inflammation of the stomach (gastritis), espe-cially in people already prone to gastritis.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be preg-nant or are planning to have a baby, ask your doctor or pharma-cist for advice before taking this medicine.
Pregnancy
Do not use Dimethyl fumarate Pharmathen if you are pregnant unless you have discussed this with your doctor.
Breast-feeding
It is not known whether the active substance of Dimethyl fu-marate Pharmathen passes into breast milk. Your doctor will ad-vise whether you should stop breast-feeding or stop using Dimethyl fumarate Pharmathen. This involves balancing the ben-efit of breast-feeding for your child, and the benefit of therapy for you.
Driving and using machines
The effect of Dimethyl fumarate Pharmathen on the ability to drive or use machines is not known. Dimethyl fumarate Phar-mathen is not expected to affect your ability to drive and use machines.

3. How to take Dimethyl fumarate Pharmathen

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Starting dose

120 mg twice a day.

Take this starting dose for the first 7 days, then take the regular dose.

Regular dose

240 mg twice a day.

Dimethyl fumarate Pharmathen is for oral use.

Swallow each capsule whole, with some water. Do not di-vide, crush, dissolve, suck or chew the capsule as this may in-crease some side effects.

Take Dimethyl fumarate Pharmathen with food – it may help to reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl fumarate Pharmathen than you should

If you have taken too many capsules, talk to your doctor straight away. You may experience side effects similar to those described below in section 4.

If you forget to take Dimethyl fumarate Pharmathen If you forget or miss a dose, do not take a double dose. You may take the missed dose if you leave at least 4 hours be-tween the doses. Otherwise wait until your next planned dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Dimethyl fumarate Pharmathen may lower lymphocyte counts (a type of white blood cell). Having a low white blood cell count can increase your risk of infection, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has oc-curred after 1 to 5 years of treatment and so your physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any poten-tial symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine impairing the functionality of your body’s immune system.

The symptoms of PML may be similar to an MS relapse. Symp-toms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or speech and communica-tion difficulties lasting for more than several days. Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on Dimethyl fumarate Pharmathen treatment, it is very important that you speak to your doctor as soon as possible. Also speak with your partner or caregivers and inform them about your treatment. Symptoms might arise that you might not become aware of by yourself.

→ Call your doctor straight away if you experience any of these symptoms

Severe allergic reactions

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

Reddening of the face or body (flushing) is a very common side effect. However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:

swelling of the face, lips, mouth or tongue (angioedema)
wheezing, difficulty breathing or shortness of breath (dysp-noea, hypoxia)
dizziness or loss of consciousness (hypotension)

then this may represent a severe allergic reaction (anaphylaxis)

→ Stop taking Dimethyl fumarate Pharmathen and call a doctor straight away

Other side effects

Very common: may affect more than 1 in 10 people:

reddening of the face or body, feeling warm, hot, burning or itchy (flushing)
loose stools (diarrhoea)
feeling sick (nausea)
stomach pain or stomach cramps

→ Taking your medicine with food can help to reduce the side effects above.

Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Di-methyl fumarate Pharmathen.

Talk to your doctor about how to manage these side effects. Your doctor may reduce your dose. Do not reduce your dose un-less your doctor tells you to.

Common: may affect up to 1 in 10 people:

inflammation of the lining of the intestines (gastroenteritis)
being sick (vomiting)
indigestion (dyspepsia)
inflammation of the lining of the stomach (gastritis)
gastrointestinal disorder
burning sensation
hot flush, feeling hot
itchy skin (pruritus)
rash
pink or red blotches on the skin (erythema)
hair loss (alopecia)

Side effects which may show up in your blood or urine tests

low levels of white blood cells (lymphopenia, leucopenia) in the blood. Reduced white blood cells could mean your body is less able to fight an infection. If you have a serious infection (such as pneumonia), talk to your doctor immediately
proteins (albumin) in urine
increase in levels of liver enzymes (ALT, AST) in the blood

Uncommon: may affect up to 1 in 100 people:

allergic reactions (hypersensitivity)
reduction in blood platelets

Not known (frequency cannot be estimated from the available data)

liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
herpes zoster (shingles) with symptoms such as blisters, burn-ing, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numb-ness, itching or red patches with severe pain
runny nose (rhinorrhoea)

Children (13 years of age and above) and adolescents The side effects listed above also apply to children and adoles-cents.

Some side effects were reported more frequently in children and adolescents than in adults, e.g, headache, stomach pain or stom-ach cramps, being sick (vomiting), throat pain, cough, and painful menstrual periods.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By re-porting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimethyl fumarate Pharmathen

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

Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate Pharmathen contains

The active substance is dimethyl fumarate.

Dimethyl fumarate Pharmathen 120 mg: Each capsule contains 120 mg of dimethyl fumarate.

Dimethyl fumarate Pharmathen 240 mg: Each capsule contains 240 mg of dimethyl fumarate.

The other ingredients are microcrystalline cellulose (E460), croscarmellose sodium (E468), talc (E553b), silica colloidal an-hydrous (E551), magnesium stearate (E470b), triethyl citrate (E1505), methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – ethyl acrylate copolymer (1:1) disper-sion 30 %, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac (E904), isopropyl alco-hol, propylene glycol (E1520), N-Butyl alcohol NF, ammonium hydroxide (E527) and black iron oxide (E172).

What Dimethyl fumarate Pharmathen looks like and contents of the pack

Dimethyl fumarate Pharmathen 120 mg gastro-resistant hard capsules are οpaque light green cap – opaque white body and printed with “120” in black ink on the body and are available in packs containing 14 capsules.

Dimethyl fumarate Pharmathen 240 mg gastro-resistant hard capsules are opaque light green cap – opaque light green body and printed with “240” in black ink on the body and are available in packs containing 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen S.A., 6 Dervenakion str., 15351 Pallini Attiki, Greece

Manufacturer:

Pharmathen International S.A., Industrial Park Sapes, Rodopi

Prefecture, Block No 5, Rodopi 69300, Greece