Dimethyl fumarate Qilu

Package leaflet: Information for the patient

Dimethylfumarate Qilu 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

Dimethylfumarate
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their
symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet

1. What Dimethylfumarate Qilu is and what it is used for
2. What you need to know before taking Dimethylfumarate Qilu
3. How to take Dimethylfumarate Qilu
4. Possible side effects
5. How to store Dimethylfumarate Qilu
6. Contents of the pack and other information

1. What Dimetilfumarato Qilu is and what it is used for

What Dimetilfumarato Qilu is
Dimetilfumarato Qilu contains the active substance dimethyl fumarate.
What Dimetilfumarato Qilu is used for
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease affecting the central nervous system (CNS), i.e. the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterised by repeated attacks (relapses) of symptoms affecting the nervous system. Symptoms vary from patient to patient but generally include difficulty walking, feelings of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when a relapse resolves, but some problems may persist.
How Dimetilfumarato Qilu works
This medicine appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future worsening of MS.

2. What you need to know before taking Dimetilfumarato Qilu

Do not take Dimetilfumarato Qilu
if you are allergic to dimethyl fumarate or to any of the other ingredients of this
medicine (listed in section 6).
if you suspect you have a rare brain infection called progressive multifocal
leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions
Dimetilfumarato Qilu may affect the number of white blood cells in your blood, your kidneys, and your liver.
Before starting this medicine, your doctor will perform a blood test to check your white blood cell count and to ensure that your kidneys and liver are functioning properly. Your doctor will carry out regular blood tests during treatment. If your white blood cell count decreases during treatment, your doctor may consider further investigations or discontinuation of therapy.

Contact your doctor before taking Dimetilfumarato Qilu if you have:
a serious kidney disease
a serious liver disease
a stomach or intestinal disease
a life-threatening infection (such as pneumonia)

During treatment with Dimetilfumarato Qilu, cases of herpes zoster infection (shingles) may occur. In some cases, life-threatening complications have occurred. If you suspect you have any symptoms of herpes zoster, you must inform your doctor immediately.

If you think your MS is worsening (for example, if you experience weakness or changes in vision) or if you notice new symptoms, contact your doctor immediately, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a life-threatening condition that may lead to severe disability or death.

With a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used for the treatment of psoriasis (a skin disease), a rare, life-threatening kidney disorder called “Fanconi syndrome” has been observed. If you notice that you are urinating more than usual, feel more thirsty and drink more than normal, experience increased muscle weakness, or have fractures or just pain, contact your doctor as soon as possible so that appropriate investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age, as there is no available data in this age group.

Other medicines and Dimetilfumarato Qilu
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:
medicines containing fumaric acid esters (fumarates) used for the treatment of psoriasis;
medicines that affect the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat MS;
medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, some types of painkillers (such as ibuprofen, other similar anti-inflammatory medicines, medicines purchased without a prescription), and medicines containing lithium;
taking this medicine together with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Qilu and alcohol
Consumption of more than a small amount (more than 50 mL) of strong alcoholic drinks (containing more than 30% alcohol by volume, such as spirits) should be avoided within one hour of taking Dimetilfumarato Qilu, as alcohol may interact with this medicine. This could cause stomach inflammation (gastritis), particularly in people who are already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Do not use this medicine during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary for you.

Breastfeeding
It is not known whether the active substance of this medicine passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimetilfumarato Qilu. This decision will take into account the benefit of breastfeeding for your child versus the benefit of treatment for you.

Driving and using machines
This medicine is not expected to affect your ability to drive or operate machinery.

Dimetilfumarato Qilu contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Dimetilfumarato Qilu

Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor.
Initial dose: 120 mg twice daily.
Take this initial dose for the first 7 days, then proceed to the regular dose.
Regular dose: 240 mg twice daily. Dimetilfumarato Qilu is for oral use.
Swallow each capsule whole with some water. Do not split, crush, dissolve, suck or chew the capsule, as this may increase certain side effects.
Take Dimetilfumarato Qilu with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimetilfumarato Qilu than you should
If you have taken too many capsules, contact your doctor immediately.
You may experience side effects similar to those described in section 4 below.
If you forget to take Dimetilfumarato Qilu
If you miss or forget a dose, do not take a double dose to make up for the missed dose.
You may take the missed dose if at least 4 hours will elapse between doses. Otherwise, wait until the next scheduled dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Dimetilfumarato Qilu may reduce levels of lymphocytes (a type of white blood cell). Having low levels of white blood cells can increase the risk of infections, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. Be sure to carefully observe any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair the function of the immune system.

Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include the onset or worsening of weakness on one side of the body, clumsiness, changes in vision, thinking, or memory, confusion or personality changes, or difficulty with language and communication lasting longer than a few days. Therefore, if you feel that your MS is worsening or if you notice any new symptoms during treatment with Dimetilfumarato Qilu, it is very important to contact your doctor as soon as possible. Also, inform your partner or caregiver about your treatment, as symptoms may arise that you might not notice yourself.

If you experience any of these symptoms, call your doctor immediately.

Severe allergic reactions

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

Flushing of the face or body (flushing) is a very common side effect. However, if flushing is accompanied by a red skin rash or hives and you have any of the following symptoms:

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

this may indicate a severe allergic reaction (anaphylaxis).

Stop taking Dimetilfumarato Qilu and call a doctor immediately.

Other side effects

Very common (may affect more than 1 in 10 people)

• flushing of the face or body, sensation of warmth, intense heat, burning, or itching (flushing)
• loose stools (diarrhea)
• feeling of imminent vomiting (nausea)
• stomach ache or stomach cramps

Taking the medicine with food may help reduce the above-mentioned side effects.

The presence of substances called ketones, which are naturally produced by the body, is very commonly detected in urine tests during treatment with Dimetilfumarato Qilu.

Contact your doctor for advice on how to manage these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal lining (gastroenteritis)
• feeling of illness (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal disorder
• burning sensation
• hot flush, feeling of warmth
• skin itching (pruritus)
• skin rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be detected in blood or urine tests:

• low levels of white blood cells (lymphopenia, leukopenia) in the blood. A reduced number of white blood cells may mean that you are not able to fight infections adequately. If you have a life-threatening infection (such as pneumonia), contact your doctor immediately
• protein (albumin) in the urine
• increased levels of liver enzymes (alanine aminotransferase, ALT and aspartate aminotransferase, AST) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduced platelet count in the blood

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

• inflammation of the liver and increased levels of liver enzymes (ALT or AST in combination with bilirubin)
• herpes zoster infection (shingles), with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the torso or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, red or itchy spots with severe pain
• runny nose (rhinorrhea)

Children (aged 13 years and older) and adolescents

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimetilfumarato Qilu

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 outer packaging after 'Exp.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Package contents and other information
What Dimetilfumarato Qilu contains
The active substance is dimethyl fumarate.
Dimetilfumarato Qilu 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Qilu 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other components are: silicified microcrystalline cellulose (a combination of microcrystalline cellulose and anhydrous colloidal silica), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, methacrylic acid–methyl methacrylate copolymer (1:1), sodium lauryl sulfate, triethyl citrate, methacrylic acid–ethyl acrylate copolymer (1:1) 30% dispersion, talc, dimethicone, gelatin, titanium dioxide (E171), Brilliant Blue FCF (E133), yellow iron oxide (E172), shellac, black iron oxide (E172), potassium hydroxide, propylene glycol, concentrated ammonia solution.

Description of the appearance of Dimetilfumarato Qilu and the contents of the pack
Dimetilfumarato Qilu 120 mg gastro-resistant hard capsules: green and white gastro-resistant hard capsules with capsule shell size 2 and length of 18.0 mm ± 1.0 mm, printed with “84 120 mg” in black ink, containing microtablets. They are available in unit-dose divisible blisters containing 14x1 capsules. One blister sheet is packaged in a laminated foil pouch inside a carton box.

Dimetilfumarato Qilu 240 mg gastro-resistant hard capsules: green gastro-resistant hard capsules with capsule shell size 0 and length of 21.7 mm ± 1.0 mm, printed with “85 240 mg” in black ink, containing microtablets. They are available in unit-dose divisible blisters containing either 56x1 or 168x1 capsules. Two blister sheets are packaged in a laminated foil pouch, with two pouches in a carton box containing 56x1 capsules, or six pouches in a carton box containing 168x1 capsules, respectively.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Marketing Authorization Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40,
8th Floor, 28046 - Madrid,
Spain

Manufacturer
KYMOS S.L.
Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès),
Cerdanyola del Vallès,
08290 Barcelona,
Spain

Eurofins Analytical Services Hungary Kft.
Anonymus utca 6.
Budapest, H-1045,
Hungary

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