Package leaflet: Information for the patient

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

  
  

  What is in this leaflet

  
  

  1. What Xadago is and what it is used for

  2. What you need to know before you take 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 that contains the active substance safinamide. It acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson’s disease. Xadago is used for the treatment of Parkinson’s disease in adults.

     
     

     In mid- to late-stage patients experiencing sudden switches between being “ON” and able to move and being “OFF” and having difficulties moving about, Xadago is added to a stable dose of the medicine called levodopa alone or in combination with other medicines for Parkinson’s disease.

     
     

  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 (MAO) inhibitors such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of Parkinson’s disease or depression, or used for any other condition).

  • Pethidine (a strong pain killer).

    You must wait at least 7 days after stopping Xadago treatment before starting treatment with MAO inhibitors or pethidine.

• If you have been told that you have severe liver problems

• If you have an eye condition which might put you at risk of potential damage to your retina (the light sensitive layers at the back of your eyes), e.g. albinism (lack of pigment in your skin and eyes), retinal degeneration (loss of cells from light sensitive layer at the back of the eye), or uveitis (inflammation inside of the eye), inherited retinopathy (inherited disorders of the vision), or severe progressive diabetic retinopathy (a progressive decrease of the vision due to diabetes).

  Warnings and precautions

  Talk to your doctor before taking Xadago

• If you have liver problems

• Patients and carers should be made aware that certain compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying have been reported with other medicines for Parkinson’s disease.

• Uncontrollable jerky movements may occur or worsen when Xadago is used together with levodopa.

  
  

  Children and adolescents

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

  
  

  Other medicines and Xadago

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

• Cold or cough remedies containing dextromethorphan, ephedrine or pseudoephedrine

• Medicines called selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluoxetine or fluvoxamine)

• Medicines called serotonin–norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine

• Medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin

• Fluoroquinolone antibiotic such as ciprofloxacin

• Medicines that affect the immune system such as methotrexate

• Medicines to treat metastatic carcinoma such as topotecan

• Medicine to treat pain and inflammation such as diclofenac

• Medicines to treat type 2 diabetes such as glyburide, metformin

• Medicines to treat virus infection such as aciclovir, 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 by women of childbearing potential not practicing adequate contraception.

  
  

  Breast Feeding

  Xadago is likely to be excreted in breast milk. Xadago should not be used during breast-feeding.

  
  

  Driving and using machines

  Somnolence and dizziness may occur during safinamide treatment; you should be cautious about operating hazardous machines or driving, until you are reasonably certain that Xadago does not affect you in any way.

  
  

  Ask your doctor for advice prior to driving or using machines.

  1. How to take Xadago

     
     

     Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

     
     

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

     
     

     If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.

     
     

     If you take more Xadago than you should

     If you have taken too many Xadago tablets, you may develop raised blood pressure, anxiety, confusion, forgetfulness, sleepiness, lightheadedness; feel sick or be sick; dilated pupils or develop involuntary jerky movements. Contact your doctor immediately and take the Xadago pack 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 time you normally take it.

     
     

     If you stop taking Xadago

     Do not stop taking Xadago without first talking to your doctor.

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

     
     

  2. Possible side effects

     
     

     Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

     
     

     The following side effects have been reported in patients at a mid- to late-stage of Parkinson’s disease (patients taking safinamide as add-on to levodopa alone or in combination with other medicines for Parkinson’s disease):

     
     

     Common (may affect up to 1 in 10 people): insomnia, difficulty in performing voluntary movements, feeling sleepy, dizziness, headache, worsening of Parkinson’s disease, clouding of the lens of the eye, fall in blood pressure when rising to a standing position, nausea, falling.

     
     

     Uncommon (may affect up to 1 in 100 people): urine infection, skin cancer, low iron in your blood, low white cell count, red blood cell abnormality, decreased appetite, high fat in blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusional state, mood swings , increased interest in sex, abnormal thinking and perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction, head discomfort, difficulty in speaking, fainting, memory impairment, blurring of vision, blind spot, double vision, aversion to light, disorders of the light sensitive layer at the back of your eye, redness of the eyes, increased pressure in the eye, sensation of room spinning, feeling of heart beating, fast heartbeat, irregular heartbeat, slowed heartbeat , high blood pressure, low blood pressure, veins that have become large and twisted, cough, difficult breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, burning stomach, wind, feeling full, drooling, mouth ulcer, sweating, itching, sensitive to light, redness of the skin, back pain, joint pain, cramps, stiffness, pain in legs or arms, muscle weakness, sensation of heaviness, increased urination at night, pain upon urination, difficulty in having sex in males, fatigue, feeling weak, unsteady walking,

     swelling of your feet, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat in your blood, increased sugar in your blood, abnormal ECG, liver function test abnormal, abnormal urine tests, blood pressure decreased, blood pressure increased, abnormal eye test, fracture of your foot.

     
     

     Rare (may affect up to 1 in 1000 people): pneumonia, skin infection, sore throat, nasal allergy, tooth infection, viral infection, non-cancerous skin conditions/growth, white blood cell abnormalities, severe loss of weight and weakness, increased potassium in blood, uncontrollable urges, clouding of consciousness, disorientation, wrong perception of images, reduced interest in sex, thoughts that you cannot get rid of, feeling that someone is out to get you, premature ejaculation, uncontrollable urge to sleep, fear of social situations, thoughts of suicide, clumsiness, easily distracted, loss of taste, weak/slow reflexes, radiating pain in the legs, continuous desire to move your legs, feeling sleepy, eye abnormalities, progressive diminution of vision due to diabetes, increased tears, night blindness, cross eyed, heart attack, tightening/narrowing of blood vessel, severe high blood pressure, tightening of the chest, difficulty in speaking, difficulty in/painful swallowing, peptic ulcer, retching, stomach bleeding, jaundice, loss of hair, blister, skin allergy, skin conditions, bruising, scaly skin, night sweats, pain of skin, discolouration of the skin, psoriasis, flaky skin, inflammation of spinal joints due to an autoimmune disorder, pain in your sides, swelling of joints, musculoskeletal pain, muscular pain, neck pain, joint pain, cyst in the joint, uncontrollable urge to urinate, increased urination, passing of pus cells in urine, urinary hesitation, prostate problem, breast pain, drug effect decreased, drug intolerance, feeling cold, feeling unwell, fever, dryness of skin, eye and mouth, abnormal blood tests, heart murmur, abnormal heart tests, bruising/swelling after injury, blood vessel blockage due to fat, head injury, mouth injury, skeletal injury, gambling.

     
     

     Reporting of side effects

     the

     national

     reporting

     system

     listed

     in

     Appendix

     V

     If you get 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

     . By reporting side effects, you can help provide more information on the safety

     of this medicine.

     
     

  3. How to store 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 and blister after “EXP” The expiry date refers to the last day of that month.

     
     

     This medicine does not require any special storage conditions.

     
     

     Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

     
     

  4. Contents of the pack and other information What Xadago contains

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

• The other ingredients are:

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

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

What Xadago looks like and contents of the pack

Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.

Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.

Xadago is supplied 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

Email: info.zambonspa@zambongroup.com

Manufacturer

Catalent Germany Schorndorf GmbH Steinbeisstrasse 2

D- 73614 Schorndorf Germany

Zambon S.p.A.

Via della Chimica, 9 36100 Vicenza

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/ Luxembourg/Luxemburg Zambon N.V./S.A. Tél/Tel: + 32 2 777 02 00

France

Zambon France S.A.

Tél: + 33 (0)1 58 04 41 41

България/ Eesti/ Ireland/Ísland/Κύπρος/Latvija/ Malta/Polska/ România/ / United Kingdom (Northern Ireland) Zambon S.p.A.

Teл./Tel/Τηλ/Sími: + 39 02665241

Italia

Zambon Italia S.r.l. Tel: + 39 02665241

Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V. Tlf/Puh/Tel: + 47 815 300 30

Nederland

Zambon Nederland B.V. Tel: + 31 (0) 20 3085185

Deutschland/Österreich

Zambon GmbH

Tel: 00800 92626633

Portugal

Zambon - Produtos Farmacêuticos, Lda. Tel: + 351 217 600 952 / 217 600 954

España

Zambon, S.A.U.

Tel: + 34 93 544 64 00

Hrvatska/Slovenija SALUS, Veletrgovina, d.o.o. Tel: + 386 1 5899 100

Česká republika

Desitin Pharma spol. s r.o. Tel: + 420 222 245 375

Slovenská republika Desitin Pharma s.r.o. Tel: + 421 2 5556 3810

Ελλάδα

Innovis Pharma A.E.B.E.

Τηλ:+ 30 216 200 5600

Magyarország Richter Gedeon Nyrt. Tel.: +36 1 505 7032

Lietuva

UAB „Norameda“ Tel: + 370 5 2306499

This leaflet was last revised in .

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