Xadago - Safinamide uses, dose and side effects

Xadago is a medicine that contains the active substance safinamide. It works by increasing the level of a substance called dopamine in the brain which is involved in movement control and is found in smaller amounts in the brain of patients with Parkinson’s disease. Xadago is used to treat Parkinson’s disease in adults.

In patients with mid- to late-stage disease who have “on” periods where they can move and “off” periods where they have difficulty moving, Xadago is used in addition to a stable dose of the drug levodopa alone or combination with other drugs against Parkinson’s disease.

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 inhibitors (MAOIs) such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (eg to treat Parkinson’s disease or depression, or used for any other disease).
- Pethidine (a strong pain reliever).
  Before starting treatment with MAOIs or pethidine, you must wait at least 7 days after finishing treatment with Xadago.
If you have been told that you have serious liver disease.
If you have an eye disease that could put you at risk of potential damage to your retina (the light-sensitive membrane at the back of the eye), e.g. albinism (lack of pigment in the skin and eyes), retinal atrophy (loss of cells from the light-sensitive layer at the back of the eye), or uveitis (an inflammation inside the eye, hereditary retinal disease (inherited eye diseases), or severe progressive diabetic retinopathy ( progressive vision reduction caused by diabetes ).

Warnings and precautions

Talk to your doctor before taking Xadago

If you have liver problems.
Patients and caregivers should be made aware that certain compulsive behaviors such as obsessions, obsessions, morbid gambling addiction, increased sexual desire, hypersexuality, impulsive behavior, and compulsive spending or buying have been reported with other drugs against Parkinson’s disease.
Uncontrollable jerky movements may occur or become worse when Xadago is used together with levodopa.

Children and young people

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

Other medicines and Xadago

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

Cold or cough medicines containing dextromethorphan, ephedrine, or pseudoephedrine.
Medicines called selective serotonin reuptake inhibitors ( SSRIs ) are commonly used to treat anxiety disorders and certain personality disorders (eg fluoxetine or fluvoxamine).
Medicines called serotonin-norepinephrine reuptake inhibitors ( SNRIs ) are used in the treatment of major depression and other mood disorders such as venlafaxine.
Medicines for high cholesterol such as rosuvastatin, pitavastatin, and pravastatinFluoroquinolone antibiotics such as ciprofloxacin
Medicines that affect the immune system such as methotrexate
Medicines to treat metastatic carcinoma such as topotecan
Medicines to treat pain and inflammation such as diclofenac
Medicines to treat type 2 diabetes such as glyburide, metformin
Medicines to treat viral infections such as aciclovir, ganciclovir

Pregnancy and breastfeeding

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

Pregnancy

Xadago should not be used during pregnancy or by women of childbearing potential without effective contraception.

Breast-feeding

Xadago is probably excreted in breast milk. Xadago should not be used during breastfeeding.

Driving ability and use of machinery

Drowsiness and dizziness may occur during treatment with safinamide: you should be careful about using dangerous machinery or driving until you are reasonably sure that Xadago will not affect you in any way.

Consult a doctor before driving or using machinery.

How to take Xadago

Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.

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

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

If you have taken too much Xadago

If you have taken too many Xadago tablets, you may develop high blood pressure , anxiety, confusion, forgetfulness, sleepiness, dizziness, feeling sick or vomiting, dilated pupils or developing involuntary jerky movements. Contact a doctor immediately and take the Xadago package with you.

If you forget to take Xadago

Do not take a double dose to make up for a missed dose . Do not take the missed dose and take the next dose at the same time as you normally take it.

If you stop taking Xadago

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

If you have further questions about this medicine, contact your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. Contact a doctor in case of hypertensive crisis (very high blood pressure , collapse), malignant neuroleptic syndrome (confusion, sweating, muscle stiffness, high body temperature, increased levels of creatine kinase in the blood), serotonin syndrome (confusion, high blood pressure , muscle stiffness, hallucinations) and low blood pressure .

The following side effects have been reported in patients with an intermediate to late stage of Parkinson’s disease (patients taking safinamide as add -on therapy to levodopa alone or in combination with other anti-Parkinson’s drugs ) :

Common (may affect up to 1 in 10 people): insomnia, difficulty in carrying out voluntary movements, sleepiness, dizziness, headache, worsening of Parkinson’s disease , clouding of the lens of the eye, blood pressure falling when standing up, nausea, tendency to fall .

Uncommon (may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron in your blood, low white blood cell count , abnormal red blood cells, decreased appetite, high blood fats, increased appetite, high blood sugar, seeing things that aren’t there, depressed mood, abnormal dreams, fear and anxiety, confusional states, mood swings, increased sex interest, abnormal thoughts and experiences, restlessness, sleep disturbance, numbness, unsteadiness, loss of sensation , persistent abnormal muscle contraction, head discomfort, difficulty speaking, fainting, impaired memory, blurred vision, loss of visual field, double vision, light sensitivity, diseases of the light-sensitive layer on the back of the eye, eye redness, increased pressure in the eye, feeling that the room is spinning, feeling that the heart is beating, fast heartbeat, irregular heartbeat, slow heartbeat, high blood pressure , low blood pressure , veins that become large and twisted, cough, shortness of breath, runny nose, constipation, acid reflux, vomiting,dry mouth , diarrhoea, abdominal pain, colic, gas, feeling of bloating, drooling, mouth ulcers, sweating, generalized itching , sensitivity to light, skin redness, back pain, joint pain, cramp, stiffness, pain in legs or arms, muscle weakness, feeling of heaviness, increased urination at night, pain during urination, difficulty having sex in men, fatigue, feeling weak, unsteady gait, foot swelling, pain, feeling warm, lower weight, higher weight, abnormal blood tests, high blood lipids, increased blood sugar, abnormal EKG , abnormal liver function test, abnormal urine test , 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, nasal allergy, tooth infection, viral infection, non-cancerous skin changes/skin growths, abnormal white blood cells , severe weight loss and weakness, increased potassium in the blood, uncontrollable cravings, clouded consciousness, confusion, misperception of images, decreased sexual interest, thoughts that you cannot get rid of, feeling that someone is after you, premature ejaculation, uncontrollable need to sleep, fear of social situations, suicidal thoughts, clumsiness, easily distracted, loss of sense of taste, weak/slow reflexes, radiating pain in the legs, constant need to move the legs, sleepiness, eye disturbances, progressiveimpaired vision due to diabetes , increased lacrimation, night blindness , wind blindness, heart attack, constriction/narrowing of blood vessels, severe high blood pressure , chest constriction, difficulty speaking, difficulty/painful swallowing, peptic ulcer, regurgitation, stomach bleeding, jaundice , hair loss, blisters, skin allergy, skin diseases, bruises, scaly skin, night sweats, skin pain, skin discoloration, psoriasis , flaky skin, inflammation of spinal joints due to autoimmune disease, pain in sides, swelling of joints, musculoskeletal pain, muscle pain, neck pain , joint pain, cystin the joint, uncontrollable need to urinate, increased urination, werecells in the urine, urinary hesitancy, prostate problems, chest pain, reduced drug effect, drug intolerance, feeling cold, general malaise, fever, dry skin, eyes and mouth, abnormal blood tests, heart murmurs , abnormal heart tests, bruising/swelling after injury, blockage of blood vessels due to fat, head injury, mouth injury, skeletal injury, gambling addiction.

How to store Xadago

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the carton and blister after “EXP”.

The expiration date is the last day of the specified month.

No special storage instructions.

Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substance is safinamide. Each tablet contains 50 mg or 100 mg of safinamide (as methanesulfonate).
Other ingredients are:
- Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, colloidal anhydrous silica.
- Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), red iron oxide (E172), potassium aluminum silicate (E555).

Appearance and package sizes of the medicine

Xadago 50 mg are orange- to copper-coloured, round, biconcave film-coated tablets with a diameter of 7 mm with a metallic luster surface and debossed with strength “50” on one side of the tablet.

Xadago 100 mg are orange- to copper-coloured, round, biconcave film-coated tablets of 9 mm in diameter with a metallic luster surface and debossed with strength “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

Phone: +39 02665241

Fax: +39 02 66501492

e‑mail: info.zambonspa@zambongroup.com

Manufacturer

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 2

D‑73614 Schorndorf,

Germany