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Xadago 50mg and 100mg film-coated tablets

Last Updated on eMC 16-May-2016 View changes  | Profile Pharma Limited Contact details

Black Triangle icon This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/14/984/001, EU/1/14/984/002, EU/1/14/984/003, EU/1/14/984/004, EU/1/14/984/005, EU/1/14/984/006, EU/1/14/984/007, EU/1/14/984/008, EU/1/14/984/009, EU/1/14/984/010.



Xadago 50mg and 100mg film-coated tablets

Package leaflet: Information for the patient

Xadago 50 mg film-coated tablets

Xadago 100 mg film-coated tablets

Safinamide

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 (progressive diminution of the vision due to diabetes).

Warnings and precautions

Talk to your doctor before taking Xadago

  • If your doctor has told you that you have mild to moderately reduced liver function
  • 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:

  • Other monoamine oxidase (MAO) inhibitors (including medicinal and natural products) (see section “Do not take Xadago”)
  • Pethidine (see section “Do not take 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

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

There is no information from the use of Xadago in pregnant women, but animal studies indicate harmful effects on the foetus following administration during pregnancy. For this reason, 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. As adverse effects have been observed in rat pups, a risk for the breast-fed child cannot be excluded, Xadago should not be used during breast-feeding.

Driving and using machines

Xadago has no or negligible influence on the ability to drive and use machines; however 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.

3. 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 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; 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.

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 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

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL- Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:www.hpra.ie
E-mail: medsafety@hpra.ie

5. 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.

6. 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, polyethylene glycol 6000, titanium dioxide (E171), iron oxide (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 blisters 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

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

United Kingdon
Profile Pharma Limited
Tel: +44 (0) 800 1300 855

This leaflet was last revised in March 2016

Other sources of information

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

Company contact details

Profile Pharma Limited

Company image
Address

Suite 3 Ground Floor, Bicentennial Building, Southern Gate, Chichester, West Sussex, PO19 8EZ

Medical Information e-mail
Fax

+44(0)1243 859 001

Medical Information Direct Line

0800 0288 942

Out of Hours contact

0800 0288 942

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

safinamide methansulfonate

Legal categories

POM - Prescription Only Medicine

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