What Dimethyl Fumarate SPC Delayed Release Capsules is

Dimethyl Fumarate SPC Delayed Release Capsules is a medicine that contains the active substance dimethyl fumarate.

What Dimethyl Fumarate SPC Delayed Release Capsules is used for

Dimethyl Fumarate SPC Delayed Release Capsules is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.

MS is a long-term condition that affects the central nervous system (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 patient, 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 SPC Delayed Release Capsules works

Dimethyl Fumarate SPC Delayed Release Capsules 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.

Do not take Dimethyl Fumarate SPC Delayed Release Capsules:

- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Dimethyl Fumarate SPC Delayed Release Capsules may affect your white blood cell counts, your kidneys and liver. Before you start Dimethyl Fumarate SPC Delayed Release Capsules, 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 interrupting your treatment

Talk to your doctor before taking Dimethyl Fumarate SPC Delayed Release Capsules if you have:

-  severe kidney disease

-  severe liver disease

-  a disease of the stomach or bowel

-  a serious infection (such as pneumonia)

Children and adolescents

Dimethyl Fumarate SPC Delayed Release Capsules should not be used in children and adolescents below 18 years old. The safety and effectiveness of Dimethyl Fumarate SPC Delayed Release Capsules in this age group are not known.

Other medicines and Dimethyl Fumarate SPC Delayed Release Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines, in particular:

-  medicines that contain fumaric acid esters (fumarates) used to treat psoriasis

-  medicines that affect the body’s immune system including other medicines used to treat MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).

-  medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar antiinflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium Taking Dimethyl Fumarate SPC Delayed Release Capsules 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 SPC Delayed Release Capsules 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 SPC Delayed Release Capsules, as alcohol can interact with this medicine. This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not use Dimethyl Fumarate SPC Delayed Release Capsules if you are pregnant unless you have discussed this with your doctor.

Breast-feeding

It is not known whether the active substance of Dimethyl Fumarate SPC Delayed Release Capsules passes into breast milk. Dimethyl Fumarate SPC Delayed Release Capsules should not be used during breast-feeding. Your doctor will help you decide whether you should stop breastfeeding, or stop using Dimethyl Fumarate SPC Delayed Release Capsules. This involves balancing the benefit of breast- feeding for your child, and the benefit of therapy for you.

Driving and using machines

The effect of Dimethyl Fumarate SPC Delayed Release Capsules on the ability to drive or use machines is not known. Dimethyl Fumarate SPC Delayed Release Capsules is not expected to affect your ability to drive and use machines.

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 SPC Delayed Release Capsules is for oral use

Swallow each capsule whole, with some water. Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.

Take Dimethyl Fumarate SPC Delayed Release Capsules with food – it may help to reduce some of the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate SPC Delayed Release Capsules 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 SPC Delayed Release Capsules 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 between 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious effects Moderately low to very low lymphocyte counts - Lymphocyte counts (a type of white blood cell) may be decreased for a long period of time. Having a low white blood cell count for a long period of time can increase your risk of infection, including a risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to 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 personality changes lasting for more than several days.

→ 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 (dyspnoea, hypoxia)

-  dizziness or loss of consciousness (hypotension) then this may represent a severe allergic reaction (anaphylaxis)

→ Stop taking Dimethyl Fumarate SPC Delayed Release Capsules and call a doctor straight away Very common side effects

These 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 Dimethyl Fumarate SPC Delayed Release Capsules.

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

Common side effects

These 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) 

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 side effects

These may affect up to 1 in 100 people:

-  Allergic reactions (hypersensitivity)

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)

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. By reporting side affects you can help provide more information on the safety of this medicine.

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.

Do not store above 30ºC.

Keep the blisters in the outer carton in order to protect from light.

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.