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Dimethyl fumarate Gastro-resistant hard Capsules
Dimethyl fumarate 120 mg Gastro-resistant hard Capsules
Dimethyl fumarate 240 mg Gastro-resistant hard Capsules
The name of your medicine is ‘Dimethyl fumarate 120 mg or 240 mg Gastro-resistant hard Capsules’ but in the rest of the leaflet it will be called ‘Dimethyl fumarate capsules’.
1. What Dimethyl fumarate capsules are and what they are used for
2. What you need to know before you take Dimethyl fumarate capsules
3. How to take Dimethyl fumarate capsules
4. Possible side effects
5. How to store Dimethyl fumarate capsules
6. Contents of the pack and other information
Dimethyl fumarate capsules contain the active substance dimethyl fumarate.
Dimethyl fumarate capsules are used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
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.
Dimethyl fumarate capsules seem 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.
Dimethyl fumarate capsules may affect your white blood cell counts, your kidneys and liver. Before you start Dimethyl fumarate 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 additional analytic measures or may discontinue your treatment.
Talk to your doctor before taking Dimethyl fumarate capsules if you have:
The warnings and precautions listed above also apply to children. Dimethyl fumarate capsules can be used in children and adolescents aged 13 years and above. No data are available in children below 10 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines, in particular:
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 capsules, as alcohol can interact with this medicine. This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
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.
Do not use Dimethyl fumarate capsules if you are pregnant unless you have discussed this with your doctor.
It is not known whether the active substance of this medicine passes into breast milk. Dimethyl fumarate capsules should not be used during breast-feeding. Your doctor will help you decide whether you should stop breast-feeding, or stop using Dimethyl fumarate capsules. This involves balancing the benefit of breast-feeding for your child, and the benefit of treatment for you.
The effect of this medicine on the ability to drive or use machines is not known. This medicine 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.
120 mg twice a day.
Take this starting dose for the first 7 days, then take the regular dose.
240 mg twice a day.
Dimethyl fumarate capsules are 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 capsules with food – it may help to reduce some of the very common side effects (listed in section 4).
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 or miss a dose, do not take a double dose.
You may take the missed dose provided 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.
Dimethyl fumarate capsules 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 occurred after 1 to 5 years of treatment and so your doctor should continue to check your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine reducing your body’s immune system.
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, or speech and communication 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 capsules 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.
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:
then this may represent a severe allergic reaction (anaphylaxis).
Stop taking Dimethyl fumarate capsules and call a doctor straight away.
Very common side effects
These may affect more than 1 in 10 people:
Taking your medicine with food can help to reduce the above side effects.
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking dimethyl fumarate.
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:
Side effects which may show up in your blood or urine tests:
Uncommon side effects
These may affect up to 1 in 100 people:
Not known (frequency cannot be estimated from the available data)
The side effects listed above also apply to children and adolescents.
Some side effects were reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or stomach cramps, being sick (vomiting), throat pain, cough, and painful menstrual periods.
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 reporting side effects 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.
This medicine does not require any special temperature storage conditions. Store in the original package 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.
Dimethyl fumarate 120 mg Gastro-resistant hard Capsules: green opaque cap and white opaque body, capsule shell size no. 0, length 21.4 mm, imprinted in black ink with “DMF 120” on the body containing white to off-white minitablets.
Dimethyl fumarate 240 mg Gastro-resistant hard Capsules: green opaque cap and body, capsule shell size no. 00, length 23.2 mm, imprinted in black ink with “DMF 240” on the body containing white to off-white minitablets.
Carton containing OPA/Alu/PVC//Alu blisters.
Dimethyl fumarate 120 mg Gastro-resistant hard Capsules: packs containing 14 gastro-resistant capsules.
Dimethyl fumarate 240 mg Gastro-resistant hard Capsules: packs containing 14, 56 or 168 gastro-resistant capsules.
Not all pack sizes may be marketed.
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This leaflet was last revised in October 2023