XADAGO 100 mg FILM-COATED TABLETS

2. What you need to know before you take Xadago

Do not take Xadago

• If you are allergic to safinamide or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAOIs), such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, or tranylcypromine (for example, for the treatment of Parkinson's disease or depression or other disorders).
• Pethidine (a strong painkiller).

You must wait at least 7 days between stopping treatment with Xadago and starting treatment with MAOIs or pethidine.

• If you have been diagnosed with severe liver disorders.

• If you have any eye disorders that may put you at risk of potential damage to the retina (the light-sensitive layers at the back of the eyes), such as albinism (lack of pigmentation in the skin or eyes), retinal degeneration (loss of cells in the light-sensitive layer at the back of the eye), uveitis (inflammation inside the eye), inherited retinopathy (inherited vision disorders), or severe progressive diabetic retinopathy (progressive loss of vision due to diabetes).

Warnings and precautions

Consult your doctor before starting to take Xadago.

• If you have liver problems.

• Patients and caregivers should be informed that some behavioral symptoms such as compulsions, obsessive thoughts, gambling, increased libido, hypersexuality, impulsive behavior, and compulsive shopping have been reported with other Parkinson's medicines.
• Involuntary muscle contractions or worsening of these may also occur when using Xadago with levodopa.

Children and adolescents

Xadago is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this population.

Taking Xadago with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Consult your doctor before taking the following medicines with Xadago:

• Cough and cold remedies that contain dextromethorphan, ephedrine, or pseudoephedrine.
• Medicines called selective serotonin reuptake inhibitors (SSRIs) that are usually used to treat anxiety disorders and some personality disorders (e.g., fluoxetine or fluvoxamine).
• Medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs), a type of antidepressant used in the treatment of major depression and other mood disorders, such as venlafaxine.

• Medicines for high cholesterol, such as rosuvastatin, pitavastatin, and pravastatin. Fluoroquinolone antibiotics, such as ciprofloxacin.

• Medicines that affect the immune system, such as methotrexate.
• Medicines for the treatment of metastatic carcinoma, such as topotecan.
• Medicines for the treatment of pain and inflammation, such as diclofenac.

• Medicines for the treatment of type 2 diabetes, such as gliburide and metformin.
• Medicines for the treatment of viral infections, such as aciclovir and ganciclovir.

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 for advice before taking this medicine.

Pregnancy

Xadago should not be used during pregnancy or in women of childbearing potential who are not using adequate contraception.

Breast-feeding

Xadago is likely to pass into breast milk. Xadago should not be used during breast-feeding.

Driving and using machines

During treatment with safinamide, drowsiness and dizziness may occur; patients should be cautious when using hazardous machinery or driving until they are reasonably certain that Xadago does not affect them in any way.

Before driving or using machines, ask your doctor for advice.

3. How to take Xadago

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor again.

The recommended starting dose of Xadago is one 50 mg tablet, which can be increased to one 100 mg tablet, once daily, preferably in the morning, by mouth with water. Xadago can be taken with or without food.

If you have moderate liver impairment, you should not take more than 50 mg per day. Your doctor will confirm if this applies to you.

If you take more Xadago than you should

If you have taken too many Xadago tablets, you may develop high blood pressure, anxiety, confusion, inattention, drowsiness, dizziness, nausea, or vomiting, dilated pupils, or develop involuntary muscle contractions. Contact your doctor immediately and take the Xadago packaging with you.

If you forget to take Xadago

Do not take a double dose to make up for forgotten doses. Skip the missed dose and take the next dose when it is normally due.

If you stop taking Xadago

Do not stop taking Xadago without consulting your doctor first.

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.

Seek medical attention in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, stiffness, high temperature, increased level of the enzyme creatine kinase in the blood), serotonin syndrome (confusion, high blood pressure, muscle stiffness, hallucinations), and hypotension.

The following side effects have been reported in clinical trials with placebo-controlled studies in patients with mid-to-advanced Parkinson's disease (patients taking safinamide as an add-on to levodopa alone or in combination with other anti-Parkinson's medicines):

Common(may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, drowsiness, dizziness, headache, worsening of Parkinson's disease, cataract, low blood pressure when standing up, nausea, and falls.

Uncommon(may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron levels in the blood, low white blood cell count, alteration of red blood cells, decreased appetite, high levels of fat in the blood, increased appetite, high blood sugar levels, seeing things that are not there, feeling sad, abnormal dreams, fear and anxiety, confusion, mood changes, increased interest in sex, abnormal perceptions and thoughts, agitation, sleep disorders, numbness, instability, loss of sensation, prolonged abnormal muscle contraction, headache, difficulty speaking, fainting, abnormal memory, blurred vision, blind spot, double vision, sensitivity to light, disorders of the light-sensitive layer at the back of the eye, redness of the eyes, increased eye pressure, feeling that the room is spinning, palpitations, rapid heart rate, irregular heart rate, slow heart rate, high blood pressure, low blood pressure, enlarged and twisted veins, cough, difficulty breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain, stomach upset, gas, feeling full, drooling, mouth ulcers, sweating, itching, sensitivity to light, redness of the skin, back pain, joint pain, cramps, stiffness, muscle pain, neck pain, joint pain, cyst in the joint, uncontrollable need to urinate (nocturia), increased urination, pus in the urine, difficulty urinating, prostate problems, breast pain, decreased effect of the medicine, intolerance to the medicine, feeling cold, feeling unwell, fever, dryness of the skin, eyes, or mouth, abnormal blood tests, abnormal heart tracing, abnormal kidney function tests, abnormal urine tests, decreased blood pressure, increased blood pressure, abnormal eye tests, fracture in the foot.

Rare(may affect up to 1 in 1,000 people): pneumonia, skin infection, sore throat, nasal allergy, tooth infection, viral infection, non-cancerous skin growths/disorders, white blood cell abnormalities, severe weight loss, high potassium levels in the blood, uncontrolled impulses, stupor, disorientation, misperception of images, decreased interest in sex, thoughts that cannot be shaken off, feeling of being persecuted, premature ejaculation, uncontrollable need to sleep, fear of social situations, suicidal thoughts, clumsiness, ease of distraction, loss of sense of taste, weak or slow reflexes, pain in the legs that radiates, uncontrollable urge to move the legs, feeling of sleep, eye abnormalities, progressive loss of vision due to diabetes, increased tearing, night blindness, crossed eyes, heart attack, constriction or narrowing of blood vessels, very high blood pressure, chest tightness, difficulty speaking, difficulty or pain when swallowing, gastroduodenal ulcer, nausea, stomach bleeding, yellowing of the skin and mucous membranes (jaundice), hair loss, blistering, skin allergy, skin disorders, bruising, scaly skin, night sweats, skin pain, skin discoloration, psoriasis, flaky skin, inflammation of the spine joints due to an autoimmune disease, back pain, joint inflammation, musculoskeletal pain, muscle pain, neck pain, joint pain, cyst in the joint, uncontrollable need to urinate (nocturia), increased urination, pus in the urine, difficulty urinating, prostate problems, breast pain, decreased effect of the medicine, intolerance to the medicine, feeling cold, feeling unwell, fever, dryness of the skin, eyes, or mouth, abnormal blood tests, abnormal heart tracing, abnormal kidney function tests, abnormal urine tests, decreased blood pressure, increased blood pressure, abnormal eye tests, fracture in the foot.

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xadago

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 carton after "EXP".

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Xadago contains

• The active substance is safinamide. Each tablet contains 50 or 100 mg of safinamide (as mesylate).
• The other ingredients are:

• Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, and anhydrous colloidal silica

• Tablet coating: hypromellose, macrogol (6000), titanium dioxide (E171), red iron oxide (E172), and mica (E555).

Appearance and packaging

Xadago 50 mg film-coated tablets are orange to copper-colored, round, biconvex with metallic luster, and 7 mm in diameter, marked with a "50" on one side of the tablet.

Xadago 100 mg film-coated tablets are orange to copper-colored, round, biconvex with metallic luster, and 9 mm in diameter, marked with a "100" on one side of the tablet.

Xadago is available in packs containing 14, 28, 30, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Zambon S.p.A.

Via Lillo del Duca 10

20091 Bresso (MI)

Italy

Tel: +39 02665241

Fax: +39 02 66501492

e-mail: [email protected]

Manufacturer

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 2

D- 73614 Schorndorf

Germany

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.