Active ingredient
- safinamide methansulfonate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: EU/1/14/984/006, EU/1/14/984/007, EU/1/14/984/010, EU/1/14/984/001, EU/1/14/984/009, EU/1/14/984/002, EU/1/14/984/003, EU/1/14/984/008, EU/1/14/984/004, EU/1/14/984/005.
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.
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
Warnings and precautions
Talk to your doctor before taking Xadago
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:
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 via
United Kingdom
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 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
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
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in October 2018.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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