Xadago 100 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Xadago 50 mg, film-coated tablets

Xadago 100 mg, film-coated tablets

Safinamide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor.

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

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

Leaflet Contents

1. What Xadago is and what it is used for

2. What you need to know before taking Xadago

3. How to take Xadago

4. Possible side effects

5. How to store Xadago

6. Contents of the pack and other information

1. What Xadago is and what it is used for

Xadago is a medicine whose active substance is safinamide. It works by increasing the level of a substance called dopamine in the brain, which plays a role in movement control and is present in reduced amounts in the brains of patients with Parkinson's disease. Xadago is used for the treatment of Parkinson's disease in adults.

In patients with moderate to advanced stage disease who experience sudden fluctuations between "ON" periods, with ability to move, and "OFF" periods, with difficulty moving, Xadago is added to a stable dose of the medicine levodopa alone or in combination with other antiparkinsonian medicines.

2. What you need to know before taking Xadago

Do not take Xadago

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

• If you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAO inhibitors), such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, or tranylcypromine (for example, used to treat Parkinson’s disease, depression, or other disorders).

• Pethidine (a strong painkiller).

You must wait at least 7 days after stopping 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 potential damage to the retina (the light-sensitive layers at 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 at the back of the eye), uveitis (inflammation inside the eye), inherited retinopathy (inherited vision disorders), or severe progressive diabetic retinopathy (progressive vision loss due to diabetes).

Warnings and precautions

Talk to your doctor before starting to take Xadago.

• If you have liver problems.

• Patients and caregivers should be informed that behavioral symptoms such as compulsions, obsessive thoughts, gambling disorder, increased libido, hypersexuality, impulsive behaviors, and compulsive shopping or spending have been reported with other medicines used for Parkinson’s disease.

• Involuntary spasmodic movements may also occur or worsen when Xadago is used together with levodopa.

Children and adolescents

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

Taking Xadago with other medicines

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

• Cough and cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine.

• Medicines called selective serotonin reuptake inhibitors (SSRIs), usually used to treat anxiety disorders and certain personality disorders (e.g., fluoxetine or fluvoxetine).

• Medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), a type of antidepressant used to treat major depression and other mood disorders, such as venlafaxine.

• Medicines for high cholesterol, such as rosuvastatin, pitavastatin, and pravastatin. Fluoroquinolone antibiotic, 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 glibenclamide and metformin.

• Medicines for the treatment of viral infections, such as acyclovir and ganciclovir.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and using machines

Somnolence and dizziness may occur during treatment with safinamide; patients should exercise caution when operating dangerous machinery or driving until they are certain that Xadago does not affect them in any way.

Before driving or using machines, seek advice from your doctor.

3. How to take Xadago

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, consult your doctor again.

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

If you have moderate hepatic impairment, you must not take more than 50 mg per day. Your doctor will confirm whether 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, memory lapses, 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 forgotten doses. Skip the missed dose and take the next dose at your usual time.

If you stop taking Xadago

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

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

4. Possible adverse effects

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

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

The following adverse effects have been reported in placebo-controlled clinical studies in patients with mid- to advanced-stage Parkinson’s disease (patients taking safinamide as an add-on to levodopa alone or in combination with other antiparkinsonian medications):

Frequent (may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, drowsiness, dizziness, headache, worsening of Parkinson’s disease, lens opacity, low blood pressure upon standing, nausea, and falls.

Uncommon (may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron levels in blood, low white blood cell count, red blood cell abnormalities, decreased appetite, elevated blood fat levels, increased appetite, elevated 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, restlessness, sleep disorders, numbness, instability, loss of sensation, prolonged abnormal muscle contractions, headache, difficulty speaking, fainting, abnormal memory, blurred vision, blind spot, double vision, light sensitivity, disorders of the light-sensitive layer at the back of the eye, eye redness, increased intraocular pressure, sensation that the room is spinning, awareness of strong heartbeats, rapid heartbeat, irregular heartbeat, slow heartbeat, high blood pressure, low blood pressure, veins becoming enlarged and twisted, cough, breathing difficulty, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain, stomach acidity, gas, feeling of fullness, drooling, mouth ulcers, sweating, generalized itching, skin redness, lower back pain, joint pain, cramps, stiffness, pain in arms or legs, muscle weakness, feeling of heaviness, increased nighttime urination, pain during urination, difficulty with sexual performance in men, fatigue, feeling of weakness, unsteady gait, swelling of the feet, pain, sensation of heat, weight loss, weight gain, abnormal blood tests, increased blood fat levels, increased blood sugar levels, abnormal electrocardiogram, abnormal kidney function test, abnormal urine tests, decreased blood pressure, increased blood pressure, abnormal eye test, foot fracture.

Rare (may affect up to 1 in 1,000 people): pneumonia, skin infection, sore throat, allergic rhinitis, dental infection, viral infection, non-cancerous skin growths/disorders, white blood cell abnormalities, severe weight loss, increased potassium levels in blood, uncontrollable impulses, mental clouding, disorientation, misperception of images, decreased interest in sex, persistent intrusive thoughts, feeling persecuted, premature ejaculation, sudden uncontrollable urge to sleep, fear of social situations, suicidal thoughts, clumsiness, easy distractibility, loss of taste sensation, weak or slow reflexes, leg pain radiating outward, persistent urge to move legs, drowsiness, eye abnormalities, progressive vision loss due to diabetes, increased tear production, night blindness, strabismus, heart attack, blood vessel constriction or narrowing, very high blood pressure, chest tightness, difficulty speaking, difficulty or pain when swallowing, gastroduodenal ulcer, nausea, stomach bleeding, yellowing of skin and mucous membranes (jaundice), hair loss, blister formation, skin allergy, skin disorders, bruising, scaly skin, night sweats, skin pain, skin discoloration, psoriasis, peeling skin, inflammation of spinal joints due to autoimmune disease, back pain, joint inflammation, osteomuscular pain, muscle pain, neck pain, joint pain, joint cyst, uncontrollable urge to urinate (micturition), increased urination, pus in urine, difficulty urinating, prostate problems, breast pain, reduced drug effect, drug intolerance, feeling cold, feeling unwell, fever, dry skin, eyes or mouth, abnormal blood tests, heart murmur, abnormal cardiac tests, bruising or swelling after injury, blockage of blood vessels due to fat, head injury, oral injuries, skeletal injuries, gambling.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 the month indicated.

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 properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xadago

• The active substance is safinamide. Each tablet contains 50 or 100 mg of safinamide (as methanesulfonate).

• The other components are:

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

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

Appearance of the product and contents of the pack

Xadago 50 mg film-coated tablets are orange to copper-coloured, round, biconcave, with a metallic sheen 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-coloured, round, biconcave, with a metallic sheen and 9 mm in diameter, marked with a "100" on one side of the tablet.

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

Only some 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

More information on this medicine is available upon request by contacting the local representative of the Marketing Authorisation Holder:

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