Filengia 0,5 mg Capsules

FILENGIA contains the active substance fingolimod. Fingolimod is a selective immunosuppressant and is used in adults to treat relapsing (returning) multiple sclerosis (MS) (characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the central nervous system.

FILENGIA does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

Do not take FILENGIA:

• if you are hypersensitive (allergic) to fingolimod or any of the other ingredients of FILENGIA (listed in section 6)
• if you are taking or have recently taken medicine for irregular heartbeat such as quinidine, procainamide, disopyramide, amiodarone or sotalol
• if, in the last 6 months, you have had heart attack, angina, stroke or warning of a stroke or certain types of heart failure
• if you have certain types of irregular or abnormal heartbeat (dysrhythmia), including patients in whom the electrocardiogram (ECG) shows prolonged QT interval before starting FILENGIA
• if you are pregnant or breastfeeding your baby
• if you can bear children and are not using effective contraception
• if you have a lowered immune response (due to an immunodeficiency syndrome, a disease or to medicines that suppress the immune system)
• if you have a severe active infection or active chronic infection such as hepatitis or tuberculosis
• if you have an active cancer
• if you have severe liver problems

Warnings and precautions:

Take special care with FILENGIA:

Tell your doctor before you start taking FILENGIA:

• if you have been told you have an abnormal electrocardiogram
• if you suffer from symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations)
• if you have a history of sudden loss of consciousness or fainting (syncope)
• if you have severe breathing problems during sleep (severe sleep apnoea)
• if you are taking or have recently taken medicines that slow your heart rate (beta blockers (such as atenolol), calcium channel blockers (such as verapamil, diltiazem), ivabradine, digoxin, anticholinesteratic medicines or pilocarpine)
• if you have low levels of potassium or magnesium in your blood as this can increase your risk for heart rhythm disorder
• if you plan to get vaccinated
• if you have never had chickenpox or have not been vaccinated against varicella zoster virus
• if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye (a condition known as macular oedema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems)
• if you have liver problems
• if you have high blood pressure that cannot be controlled by medicines
• if you have severe lung problems

Do not share medicines prescribed for you with any other person. Always take FILENGIA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of FILENGIA is one 0,5 mg capsule once a day by mouth. Do not exceed the recommended dose. Take one FILENGIA capsule (0,5 mg of fingolimod) once a day with a glass of water. FILENGIA capsules should always be swallowed intact, without opening them. FILENGIA can be taken with or without food. Taking FILENGIA at the same time each day will help you remember when to take your medicine.

Your doctor will tell you how long your treatment with FILENGIA will last. If you have the impression that the effect of FILENGIA is too strong or too weak, tell your doctor or pharmacist.

If you take more FILENGIA than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take FILENGIA:

Do not take a double dose to make up for forgotten individual doses.

If you stop taking FILENGIA:

Do not stop taking FILENGIA or change your dose without talking to your doctor first. FILENGIA will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. After stopping FILENGIA you may have to wait for 6 - 8 weeks before starting a new MS treatment. If you have stopped FILENGIA for 1 day or more during the first 2 weeks of FILENGIA treatment, if you stop for more than 7 days during weeks 3 and 4 of treatment, or if you stop taking FILENGIA for more than 2 weeks after your first month of FILENGIA treatment, the initial effect on your heart rate may occur again. When you restart FILENGIA treatment, your doctor may decide to monitor your heart rate and blood pressure every hour, to run ECG’s or to keep you under monitoring overnight. Do not restart FILENGIA after stopping it for more than two weeks without seeking advice from your doctor. Your doctor will decide whether and how you need to be monitored after stopping FILENGIA. Tell your doctor straight away if at any time you think your MS is getting worse after you have stopped treatment with FILENGIA. This could be serious.

FILENGIA can have side effects. Not all side effects reported for FILENGIA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FILENGIA, please consult your healthcare provider for advice.

If any of the following happens, stop taking FILENGIA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting (dizziness)

These are all very serious side effects. If you have them, you may have had a serious reaction to FILENGIA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• Bronchitis with symptoms such as cough with phlegm, chest pain, fever
• Gastroenteritis with symptoms such as vomiting, nausea, diarrhoea, fever
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain of the skin, typically on the upper body or the face. Other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
• a type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, although it can also take other forms
• depression and anxiety are known to occur with increased frequency in the MS population and have also been reported in paediatric patients treated with FILENGIA
• slow heartbeat (bradycardia), irregular heart rhythm

Less frequent side effects:

• pneumonia with symptoms such as fever, cough, difficulty breathing
• malignant melanoma (a type of skin cancer which usually develops from an unusual mole). Possible signs of melanoma include moles which may change size, shape, elevation or colour over time, or new moles. The moles may itch, bleed or ulcerate
• lymphoma (a type of cancer that affects the lymph system)

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 25 °C. Keep the capsule in the blister in the outer carton until required for use. Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).