XADAGO

Package leaflet: Information for the patient

Xadago 50 mg film-coated tablets, 100 mg film-coated tablets

Safinamide
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet:

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 containing the active substance safinamide. It works by increasing the level in the
brain of a substance called dopamine, which is involved in movement control and is present at lower
levels 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 from an “ON”
state, in which they are able to move, to an “OFF” state, in which they have difficulty moving,
Xadago is added to a stable dose of the medicine called levodopa, used either as monotherapy or in
combination with other Parkinson's disease 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, tranylcypromine (e.g. for the treatment of Parkinson’s disease, depression or any other disorder).
  • meperidine (pethidine) (a strong painkiller). You must wait at least 7 days after stopping treatment with Xadago before starting treatment with MAO inhibitors or meperidine.
• if you have been told that you have severe liver problems.
• if you have an eye disorder that might put you at risk of damage to the retina (the light-sensitive layers at the back of the eye), e.g. albinism (lack of pigment in the skin and eyes), retinal degeneration (loss of cells from 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
Talk to your doctor before taking Xadago.

• If your doctor has told you that you have mildly or moderately reduced liver function.
• Patients and caregivers should be informed that, with other Parkinson’s disease medications, compulsive behaviours have been reported, such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour, and compulsive shopping syndrome.
• When Xadago is used together with levodopa, uncontrolled, sudden movements may occur or worsen.

Children and adolescents
Xadago is not recommended for use in children and adolescents under 18 years of age, because
there are no data on safety and efficacy in this population.

Other medicines and Xadago
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Ask your doctor for advice before taking any of the following medicines together with Xadago:

• other monoamine oxidase inhibitors (MAO inhibitors) (including herbal and natural products) (see section “Do not take Xadago”).
• meperidine (pethidine) (see section “Do not take Xadago”).
• cough or cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine.
• medicines called selective serotonin reuptake inhibitors (SSRIs), usually used in the treatment of anxiety disorders and certain personality disorders (e.g. fluoxetine or fluvoxamine).
• medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depressive disorder and other mood disorders, such as venlafaxine.
• medicines that are substrates of BCRP (breast cancer resistance protein) (e.g. rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac, or glyburide).

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

Pregnancy
There is no information on the use of Xadago in pregnant women, but animal studies indicate harmful effects on the foetus when administered during pregnancy. For this reason, Xadago must not be used during pregnancy or by women of childbearing potential who are not using adequate contraception.

Breastfeeding
Xadago is likely to be excreted in breast milk. Since adverse effects have been observed in rat pups, a risk to the breastfed infant cannot be excluded. XADAGO must not be used during breastfeeding.

Driving and using machines
Xadago does not affect or has a negligible effect on the ability to drive or use machines; however, caution should be exercised when operating dangerous machinery or driving vehicles until it is reasonably certain that Xadago does not have any adverse effects of any kind.
Ask your doctor for advice before driving or using machinery.

3. How to take Xadago

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
The recommended starting dose of Xadago is one 50 mg tablet, which may be increased to one 100 mg tablet taken once daily orally with water. Xadago may be taken either on an empty stomach or with food.
If you have moderately impaired liver function, you must not take more than 50 mg per day; your doctor will advise you if this applies to you.
If you take more Xadago than you should
If you have taken too many Xadago tablets, you may develop increased blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea or vomiting, or involuntary jerking 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 a forgotten dose. Skip the missed dose and take the next dose at the same time as usual.
If you stop taking Xadago
Do not stop treatment with Xadago without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients with moderate to advanced Parkinson's disease (patients treated with safinamide as add-on therapy to levodopa either alone or in combination with other 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, clouding of the eye lens, drop in blood pressure when standing up, nausea, falls.
Uncommon (may affect up to 1 in 100 people): urinary tract infection, skin tumour, low iron levels in the blood, low white blood cell count, abnormalities of red blood cells, loss of appetite, high levels of fats in the blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusion, mood swings, increased interest in sex, abnormal thoughts and perceptions, restlessness, sleep disorders, numbness, loss of balance, loss of sensation, prolonged abnormal muscle contraction, headache, difficulty speaking, fainting, memory impairment, blurred vision, blind spots, double vision, light sensitivity, disorders of the light-sensitive layer at the back of the eye, eye redness, increased eye pressure, feeling of dizziness, awareness of heartbeat, rapid heartbeat, irregular heartbeat, slow heartbeat, high blood pressure, low blood pressure, varicose veins, cough, breathing difficulty, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, stomach burning, flatulence, feeling of fullness, drooling, mouth ulcer, sweating, generalized itching, light sensitivity, skin redness, back pain, joint pain, cramps, stiffness, pain in arms or legs, muscle weakness, feeling of heaviness, increased urination at night, pain during urination, difficulty in achieving sexual intercourse in men, fatigue, feeling of weakness, unsteady gait, swelling of the feet, pain, sensation of heat, weight loss, weight gain, abnormalities in blood tests, high levels of fats in the blood, increased blood sugar, abnormal ECG, abnormalities in liver function tests, abnormalities in urine tests, decreased blood pressure, increased blood pressure, abnormalities in vision tests, foot fracture.
Rare (may affect up to 1 in 1,000 people): pneumonia, skin infection, sore throat, nasal allergy, dental infection, viral infection, non-cancerous skin conditions/growths, abnormalities of white blood cells, severe weight loss and weakness, increased potassium in the blood, uncontrollable urges, clouding of consciousness, disorientation, distorted perception of images, reduced interest in sex, persistent thoughts that cannot be dismissed, feeling that someone is against you, premature ejaculation, uncontrollable urge to sleep, fear of social situations, suicidal thoughts, clumsiness, increased distractibility, loss of taste, weak/slow reflexes, leg pain radiating down the legs, persistent urge to move legs, feeling of sleepiness, eye abnormalities, progressive loss of vision due to diabetes, increased tearing, night blindness, squint, heart attack, stiffening/narrowing of blood vessels, severe high blood pressure, chest tightness, difficulty speaking, difficulty/painful swallowing, peptic ulcer, vomiting, gastrointestinal bleeding, jaundice, hair loss, blisters, skin allergy, skin conditions, bruising, scaly skin, night sweats, skin pain, skin colour change, psoriasis, scaly skin, inflammation of spinal joints due to autoimmune disorder, hip pain, joint swelling, musculoskeletal pain, muscle pain, neck pain, joint pain, joint cysts, uncontrollable urge to urinate, increased urination, presence of pus cells in urine, urinary hesitation, prostate problems, breast pain, reduced effect of the medicine, intolerance to the medicine, feeling cold, feeling unwell, fever, dryness of the skin, eyes and mouth, abnormalities in blood tests, fever, heart murmurs, abnormal cardiac tests, bruising/swelling after injury, blockage of a blood vessel due to fat, head injuries, mouth injuries, skeletal injuries, gambling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xadago

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xadago contains

• The active substance is safinamide. Each tablet contains 50 mg or 100 mg of safinamide (as methanesulphonate).
• The other components are:
• Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, anhydrous colloidal silica
• Tablet coating: hypromellose, polyethylene glycol 6000, titanium dioxide (E171), iron oxide (E172), mica (E555).

Description of the appearance of Xadago and package contents
Xadago 50 mg are round, biconvex, film-coated tablets, orange to copper-coloured, 7 mm in diameter, with a metallic sheen, marked "50" on one side.
Xadago 100 mg are round, biconvex, film-coated tablets, orange to copper-coloured, 9 mm in diameter, with a metallic sheen, marked "100" on one side.
Xadago is supplied in packs of 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/ France
Luxembourg/Luxemburg Zambon France S.A.
Zambon N.V./S.A. Tél: +33 (0)1 58 04 41 41
Tél/Tel: +32 2 777 02 00

България/Česká republika/Eesti/Ελλάδα/ United Kingdom
Hrvatska/Ireland/Ísland/Κύπρος/Latvija/ Profile Pharma Limited
Lietuva/Magyarország/Malta/Polska/ Tel: +44 (0) 800 0288 942
România/Slovenija/Slovenská republika
Zambon S.p.A. Italia
Teл./Tel/Τηλ/Sími: +39 02665241 Zambon Italia S.r.l.
Tel: +39 02665241

Danmark/Norge/Suomi/Finland/Sverige Nederland
Zambon Sweden, Filial of Zambon Nederland B.V. Zambon Nederland B.V.
Tlf/Puh/Tel: +47 815 300 30 Tel: +31 (0)33 450 4370

Deutschland/Österreich Portugal
Zambon GmbH Zambon - Produtos Farmacêuticos, Lda.
Tel: 00800 92626633 Tel: +351 217 600 952 / 217 600 954

España
Zambon, S.A.U.
Tel: +34 93 544 64 00

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.