ADIFEMU 240 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adifemu, 120 mg, Gastro-Resistant Hard Capsules
3. Adifemu, 240 mg, Gastro-Resistant Hard Capsules
   1. Before Taking Adifemu, Read This Leaflet Carefully, as It Contains Important Information for You.
   2. Contents of the Pack
4. What is Adifemu and what is it used for
   1. What is Adifemu
   2. What is Adifemu used for
   3. Adifemu is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
   4. How Adifemu works
5. Important information before taking Adifemu
   1. When not to take Adifemu
   2. Warnings and precautions
   3. Children and adolescents
   4. Adifemu with other medicines
   5. Adifemu with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Adifemu contains sodium
6. How to take Adifemu
   1. Initial dose
   2. 120 mg twice a day.
   3. Usual dose
   4. 240 mg twice a day.
   5. Taking a higher dose of Adifemu than recommended
   6. Missing a dose of Adifemu
7. Possible side effects
   1. Severe side effects
   2. Severe allergic reactions
   3. Very common side effects
   4. Common side effects
   5. Uncommon side effects
   6. Children (13 years and older) and adolescents
   7. Reporting side effects
8. How to store Adifemu
9. Contents of the pack and other information
   1. What Adifemu contains
   2. What Adifemu looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Adifemu, 120 mg, Gastro-Resistant Hard Capsules

Adifemu, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Before Taking Adifemu, Read This Leaflet Carefully, as It Contains Important Information for You.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Adifemu and what is it used for
• 2. Important information before taking Adifemu
• 3. How to take Adifemu
• 4. Possible side effects
• 5. How to store Adifemu
• 6. Contents of the pack and other information

1. What is Adifemu and what is it used for

What is Adifemu

Adifemu is a medicine that contains the active substance dimethyl fumarate.

What is Adifemu used for

Adifemu is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

Multiple sclerosis is a long-term disease that affects the central nervous system (the brain and spinal cord). The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of symptoms (relapses) that can include problems with walking and balance, and vision problems (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may remain.

How Adifemu works

Adifemu seems to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Adifemu

When not to take Adifemu

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

(progressive multifocal leukoencephalopathy, PML).

Warnings and precautions

Adifemu may affect your white blood cell countand your kidneyand liverfunction. Before starting treatment with Adifemu, your doctor will check your white blood cell count and make sure your kidneys and liver are working properly. These tests will be repeated periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop treatment.

• severe kidney disease
• severe liver disease
• stomach or intestine disease
• severe infection(such as pneumonia).

During treatment with Adifemu, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of shingles, you should contact your doctor immediately. If your multiple sclerosis gets worse (for example, you get weakness or vision problems) or you get any new symptoms, you should contact your doctor right away, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can cause severe disability or death.

Children and adolescents

The above warnings and precautions also apply to children. Adifemu can be used in children and adolescents from 13 years of age. There is no experience with children under 10 years of age.

Adifemu with other medicines

Tell your doctor or pharmacistabout all medicines you are taking or have recently taken, and about any medicines you plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the immune system, including other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomid, alemtuzumab, ocrelizumab, or cladribine, and some medicines commonly used to treat cancer(rituximab or mitoxantrone);
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics(diuretics), certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines) and medicines containing lithium
• The use of certain vaccines (live vaccines) during treatment with Adifemu may cause infection, so it should be avoided. Your doctor will advise whether you should receive vaccines of another type (inactivated vaccines).

Adifemu with alcohol

You should avoid consuming high-percentage alcoholic beverages (more than 30% alcohol by volume) in amounts greater than 50 ml within one hour of taking Adifemu, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Adifemu should not be taken during pregnancy unless you have discussed it with your doctor.
Breastfeeding
It is not known whether the active substance of Adifemu passes into breast milk. Adifemu should not be taken during breastfeeding. Your doctor will help you decide whether to stop breastfeeding or stop taking Adifemu. The decision will be made based on the assessment of the benefit to the baby from breastfeeding compared to the benefit to you from treatment.

Driving and using machines

The effect of Adifemu on the ability to drive and use machines is not known. You should not expect Adifemu to affect your ability to drive and use machines.

Adifemu contains sodium

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

3. How to take Adifemu

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

Initial dose

120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the usual dose should be taken.

Usual dose

240 mg twice a day.

Adifemu should be taken orally.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase the risk of certain side effects.
Adifemu should be taken with food– this will help reduce the very common side effects (listed in section 4).

Taking a higher dose of Adifemu than recommended

If you have taken more capsules than recommended, you should contact your doctor immediately. Side effects similar to those described below in section 4 may occur.

Missing a dose of Adifemu

You should not take a double doseto make up for a missed dose.
A missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. In any other case, the next dose should be taken at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Adifemu may decrease the number of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

• If you experience any of the following symptoms, contact your doctor immediately

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown).
A very common side effect is sudden (flushing)redness of the face or body. If flushing of the skin is accompanied by a red rash or hives andany of the following symptoms:

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

it may indicate a severe allergic reaction (anaphylaxis).
→ Stop taking Adifemu and contact your doctor immediately

Very common side effects

These symptoms may occur in more than 1 in 10 people:

• redness of the skin of the face or a feeling of warmth, heat, burning, or itching of the skin (flushing)
• loose stools (diarrhea)
• nausea (nausea)
• stomach pain or cramps
• Taking Adifemu with foodwill help reduce the above side effects. During treatment with Adifemu, ketone bodies (substances normally produced by the body) are very commonly found in urine tests.

Ask your doctorhow to deal with these side effects. Your doctor may reduce the dose of Adifemu. You should not reduce the dose yourself unless your doctor advises you to.

Common side effects

These symptoms may occur in up to 1 in 10 people but not more often:

• inflammation of the lining of the intestine (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes, feeling of heat
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be seen in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that your body is less able to fight infection. If you get a severe infection (such as pneumonia), you should contact your doctor immediately;
• protein (albumin) in the urine;
• increased liver enzyme activity (ALT, AST) in the blood.

Uncommon side effects

These symptoms may occur in up to 1 in 100 people but not more often:

• allergic reactions (hypersensitivity)
• decreased platelet count

Frequency not known(frequency cannot be estimated from the available data)

• liver inflammation and increased liver enzyme activity (ALT or ASTtogether with bilirubin)
• shingles, with symptoms such as: blisters on the skin, 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 infection, and then numbness, itching, or red spots and severe pain
• runny nose (rhinitis)

Children (13 years and older) and adolescents

The above side effects also apply to children and adolescents.
Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adifemu

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 carton after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adifemu contains

The active substance is dimethyl fumarate.
Adifemu, 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Adifemu, 240 mg: each capsule contains 240 mg of dimethyl fumarate.
Other ingredientsare:
Capsule contents (gastro-resistant mini-tablets): microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion.
Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172).
Capsule printing (black ink): shellac (20% esterified), propylene glycol (E1520), black iron oxide (E172).

What Adifemu looks like and contents of the pack

Adifemu 120 mg is a hard gastro-resistant capsule with a light green cap and a white body, 21.4 ± 0.4 mm in length, 7.4 ± 0.4 mm in width, with “120” printed on the body in black ink, containing mini-tablets.
Adifemu 240 mg is a hard gastro-resistant capsule with a light green cap and a light green body, 21.4 ± 0.4 mm in length, 7.4 ± 0.4 mm in width, with “240” printed on the body in black ink, containing mini-tablets.
Pack sizes:
Adifemu, 120 mg, gastro-resistant hard capsules, are available in packs of 14, 28, 56, 84, 98 capsules.
Adifemu, 240 mg, gastro-resistant hard capsules, are available in packs of 14, 28, 56, 84, 98, or 168 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
e-mail: [email protected]
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes
Block No 5
69300 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
15351 Pallini, Attiki
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany
Adifemu 120 mg
Adifemu 240 mg
Czech Republic
Adifemu
Poland
Adifemu
Hungary
Adifemu 120 mg gastro-resistant hard capsule
Adifemu 240 mg gastro-resistant hard capsule
Slovakia
Adifemu 120 mg
Adifemu 240 mg

Date of last revision of the leaflet: