Patient leaflet - Dimethyl Fumarate Ascend 120 mg gastro-resistant hard capsules

1. What Dimethyl Fumarate Ascend is and what it is used for

What Dimethyl Fumarate Ascend is

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

What Dimethyl Fumarate Ascend is used for

Dimethyl Fumarate Ascend is 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.

How Dimethyl Fumarate Ascend works

Dimethyl Fumarate Ascend 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 Fumarate Ascend

Do not take Dimethyl Fumarate Ascend:

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 infection called progressive multifocal leukoencephalopathy (PML) or if PML has been conﬁrmed.

Warnings and precautions

Dimethyl Fumarate Ascend may aﬀect your white blood cell counts, your kidneys and liver. Before you start Dimethyl Fumarate Ascend, 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 tests or discontinue your treatment.

Talk to your doctor before taking Dimethyl Fumarate Ascend 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 Ascend 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 disability 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 psoriasis (a skin disease). If you notice you are passing more urine, are thirstier 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 investigated further.

Children and adolescents

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

Other medicines and Dimethyl Fumarate Ascend

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 chemotherapy, immunosuppressants, or other medicines used to treat MS;
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 anti-inﬂammatories and medicines purchased without a doctor's prescription) and medicines that contain lithium;
taking Dimethyl Fumarate Ascend 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 Ascend with alcohol

Consumption of more than a small amount (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 Ascend, 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

There is limited information about the eﬀects of this medicine on the unborn child if used during pregnancy. Do not use Dimethyl Fumarate Ascend if you are pregnant unless you have discussed this with your doctor and this medicine is clearly necessary for you.

Breast-feeding

It is not known whether the active substance of Dimethyl Fumarate Ascend passes into breast milk. Your doctor will advise whether you should stop breast-feeding, or stop using Dimethyl Fumarate Ascend. This involves balancing the beneﬁt of breast-feeding for your child, and the beneﬁt of therapy for you.

Driving and using machines

Dimethyl Fumarate Ascend is not expected to aﬀect your ability to drive and use machines.

Dimethyl fumarate contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per capsule, that is to say essentially 'sodium free'.

3. How to take Dimethyl Fumarate Ascend

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

If you take more Dimethyl Fumarate Ascend 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 Ascend

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.

4. Possible side eﬀects

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

Serious side eﬀects

Dimethyl Fumarate Ascend 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 physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as ^PTXXXX

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. 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 Ascend 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
(dyspnoea, hypoxia)
dizziness or loss of consciousness (hypotension)
then this may represent a severe allergic reaction (anaphylaxis)

Stop taking Dimethyl Fumarate Ascend 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 eﬀect above

Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Dimethyl Fumarate Ascend

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 (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

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

liver inﬂammation and increase in levels of liver
enzymes (ALT or AST in combination with bilirubin)

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

herpes zoster (shingles) with symptoms such as
blisters, burning, 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 numbness, 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 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.

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 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.

5. How to store Dimethyl Fumarate Ascend

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 medicinal product 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 Ascend contains

The active substance is dimethyl fumarate.

Dimethyl fumarate Ascend 120 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate

Dimethyl fumarate Ascend 240 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate

The other ingredients are siliciﬁed microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, methacrylic acid - methyl methacrylate copolymer (1:1), triethyl citrate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, FD & C BLUE 2, iron oxide yellow, titanium dioxide, gelatin, shellac, propylene glycol, black iron oxide.

What Dimethyl Fumarate Ascend looks like and contents of the pack

Dimethyl fumarate Ascend 120 mg gastro-resistant hard capsules

White to oﬀ white, enteric coated round shaped mini tablets ﬁlled in size "1" hard gelatin capsules, Opaque Green cap printed with "DMF" and Opaque white body printed with" 120" in black ink.

Dimethyl fumarate Ascend 240 mg gastro-resistant hard capsules

White to oﬀ white, enteric coated round shaped mini tablets ﬁlled in size "0" hard gelatin capsules, Opaque Green cap printed with "DMF" and Opaque green body printed with "240" in black ink.

Dimethyl Fumarate Ascend pack in

PVC-PVDC aluminium blister card of 14 capsules packed in cartons of 14 capsules (1 blister) and 70 capsules (5 blisters).
PVC-PVDC aluminium blister card of 28 capsules packed in cartons of 28 capsules (1 blister), 56 capsules (2 blisters), 112 capsules (4 blisters) and 168 capsules (6 blisters).
PVC-PVDC aluminium calendar blister (with sun/moon symbols) of 14 capsules packed in cartons of 14 capsules (1 blister), 28 capsules (2 blisters), 56 capsules (4 blisters), 70 capsules (5 blisters), 112 capsules (8 blisters) and 168 capsules (12 blisters).
PVC-PVDC aluminium blister of 14 capsules packed in cartons of 14 capsules (1 blister), 28 capsules (2 blisters), 56 capsules (4 blisters), 70 capsules (5 blisters), 112 capsules (8 blisters) and 168 capsules (12 blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ascend Laboratories (UK) Limited

Elsley Court 20-22

Great Titchﬁeld Street

London, W1W 8BE

United Kingdom.

Manufacturer