Product Information for the Patient

Xadago 50 mg, Film-Coated Tablets

Xadago 100 mg, Film-Coated Tablets

Safinamida

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor.

• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor even if they are not listed in this product information. See section 4.

1. What you need to know before starting to take Xadago
2. How to take Xadago
3. Possible adverse effects
4. Storage of Xadago
5. Contents of the pack and additional information

Xadago is a medication whose active ingredient is safinamida. It acts to increase the level of a substance called dopamine in the brain, which participates in the control of movement and is present in reduced quantities in the brain of patients with Parkinson's disease. Xadago is used for the treatment of Parkinson's disease in adults.

In patients in the medium to advanced stage of the disease, who experience sudden changes between “ON”, with the ability to move, and “OFF”, with difficulty moving, Xadago is added to a stable dose of the medication called levodopa alone or in combination with other antiparkinsonian medications.

Do not take Xadago

• If you are allergic to safinamida or any of the other components of this medication (listed in section 6).
• If you are taking any of the following medications:

You should wait at least 7 days between the interruption of treatment with Xadago before starting treatment with MAO inhibitors or pethidine.

• If you have been diagnosed with severe liver disorders.

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

Warnings and precautions

Consult your doctor before starting to take Xadago.

• If you have liver problems.

• Inform patients and caregivers that some behavioral symptoms such as compulsion, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviors, and compulsive buying and spending have been reported with other medications for Parkinson's disease.
• Uncontrolled or worsening involuntary muscle spasms may also occur if Xadago is used with levodopa.

Children and adolescents

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

Taking Xadago with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Consult your doctor before taking the following medications with Xadago:

• Cough and cold medicines containing dextromethorphan, ephedrine, or pseudoephedrine.
• Medications called selective serotonin reuptake inhibitors (SSRIs) that are normally used to treatanxiety disordersand somepersonality disorders(e.g., fluoxetine or fluvoxamine).
• Medications called serotonin and norepinephrine reuptake inhibitors (SNRIs), a type of antidepressant medication used in the treatment of major depression and other mood disorders, such as venlafaxine.

• Medications for high cholesterol, such as rosuvastatin, pitavastatin, and pravastatin. Fluoroquinolone antibiotic, such as ciprofloxacin.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Xadago should not be used during pregnancy or in women of childbearing age who do not use an adequate contraceptive method.

Breastfeeding

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

Driving and operating machinery

During treatment with safinamida, drowsiness and dizziness may occur; patients should

exercise caution when using hazardous machinery or driving until they are sure that Xadago does not affect them in any way.

Before driving or operating machinery, consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor again.

The recommended starting dose of Xadago is one 50 mg tablet, which can be increased to one 100 mg tablet, once a day, preferably in the morning, taken orally 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 is your case.

If you take too much Xadago

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

If you forget to take Xadago

Do not take a double dose to make up for the missed dose. Skip the missed dose and take the next dose at your regular time.

If you interrupt treatment with Xadago

Do not stop treatment with Xadago without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

The following side effects have been indicated in controlled clinical studies with placebo in patients with medium to advanced Parkinson's disease (patients taking safinamide as an adjunct to levodopa alone or in combination with other antiparkinsonian medications):

Frequent(may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, feeling of sleepiness, dizziness, headache, worsening of Parkinson's disease, cloudy cornea, low blood pressure upon standing, nausea, and falls.

Infrequent(may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron level in the blood, low white blood cell count, alteration of red blood cells, decreased appetite, elevated blood lipid levels, increased appetite, elevated blood sugar levels, seeing things that are not there, feeling sad, abnormal dreams, fear, and worry, confusion, mood changes, increased interest in sex, abnormal perception and thoughts, agitation, sleep disorders, numbness, instability, loss of sensation, abnormal muscle contraction, headache, speech difficulty, fainting, abnormal memory, blurred vision, blind spot, double vision, light aversion, retinal layer disorders in the back of the eye, eye redness, increased intraocular pressure, feeling like the room is spinning, feeling strong heartbeats, rapid heartbeats, irregular heartbeats, slow heartbeats, high blood pressure, low blood pressure, varicose veins, cough, difficulty breathing, nasal discharge, constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain, acid reflux, gas, feeling full, drooling, mouth ulcers, sweating, generalized itching, light sensitivity, skin redness, back pain, joint pain, muscle cramps, stiffness, arm or leg pain, muscle weakness, feeling heavy, nocturia, dysuria, difficulty with sexual intercourse in men, fatigue, feeling weak, unstable gait, foot inflammation, pain, feeling hot, weight loss, weight gain, abnormal blood test results, elevated blood lipid levels, elevated blood sugar levels, abnormal electrocardiogram, abnormal renal function test, abnormal urine test results, decreased blood pressure, increased blood pressure, abnormal eye test, foot fracture.

Rare(may affect up to 1 in 1000 people): pneumonia, skin infection, sore throat, nasal allergy, dental infection, viral infection, non-cancerous skin growths/troubles, abnormal white blood cell abnormalities, severe weight loss, elevated potassium level in the blood, uncontrollable impulses, confusion, disorientation, incorrect image perception, decreased interest in sex, thoughts that cannot be escaped, feeling like someone is following you, premature ejaculation, uncontrollable need to sleep, fear of social situations, suicidal thoughts, clumsiness, distractibility, loss of taste, weak or slow reflexes, leg pain radiating, constant desire to move legs, feeling sleepy, eye abnormalities, progressive vision loss due to diabetes, increased tear production, night blindness, twisted gaze, heart attack, blood vessel constriction or narrowing, very high blood pressure, chest oppression, difficulty speaking, difficulty or pain swallowing, duodenal ulcer, nausea, gastric bleeding, yellow discoloration of skin and mucous membranes (jaundice), hair loss, blister formation, skin allergy, skin troubles, cardinals, scaly skin, night sweats, skin pain, skin discoloration, psoriasis, peeling skin, spinal cord joint inflammation due to autoimmune disease, back pain, joint inflammation, muscle and bone pain, muscle pain, neck pain, joint pain, joint cyst, uncontrollable need to urinate (urination), increased urination, pus in the urine, difficulty urinating, prostate problems, breast pain, decreased drug effect, drug intolerance, feeling cold, feeling unwell, fever, dry skin, eyes, or mouth, abnormal blood test results, heart murmur, abnormal cardiac tests, bruises or inflammation after trauma, blood vessel blockage due to fat, head trauma, oral injuries, skeletal injuries, bets.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendixVAppendixVBy reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after “CAD”.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Xadago

• The active ingredient is safinamide. Each tablet contains 50 or 100 mg of safinamide (as metansulfonate).
• The other components are:

Appearance of the product and contents of the package

The safinamide-coated tablets of 50 mg are orange to copper in color, round, bicongruous with metallic luster and 7 mm in diameter, marked with a “50” on one side of the tablet.

The safinamide-coated tablets of 100 mg are orange to copper in color, round, bicongruous with metallic luster and 9 mm in diameter, marked with a “100” on one side of the tablet.

Xadago is supplied in packages containing 14, 28, 30, 90 or 100 safinamide-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization 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]

Responsible for manufacturing

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 2

D- 73614 Schorndorf

Germany

ZambonS.p.A.

Via della Chimica,9

36100 Vicenza

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.