Patient Information Leaflet

Safinamide EG 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please 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 questions, ask 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 adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.
Contents of this leaflet

What Safinamide EG is and what it is used for
What you need to know before taking Safinamide EG
How to take Safinamide EG
Possible side effects
How to store Safinamide EG
Contents of the pack and other information

1. What Safinamide EG is and what it is used for

Safinamide EG is a medicine that contains the active substance safinamide. It works by increasing the level in the brain of a substance called dopamine, which is involved in the control of movement and is present in lower amounts in the brains of patients with Parkinson's disease. Safinamide EG is used to treat 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, Safinamide EG is added to a stable dose of the medicine called levodopa, used either alone or in combination with other Parkinson's disease medications.

2. What you need to know before taking Safinamide EG

Do not take Safinamide EG
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 (a strong analgesic).
You must wait at least 7 days after stopping treatment with Safinamide EG 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 could put you at risk of potentially damaging 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 Safinamide EG
if you have liver problems.
Patients and caregivers should be aware 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 buying syndrome.
When Safinamide EG is used together with levodopa, uncontrolled, jerky movements may occur or worsen.

Children and adolescents
Safinamide EG is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy data are not available in this population.

Other medicines and Safinamide EG
Inform 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 Safinamide EG:
cough or cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine;
medicines known as selective serotonin reuptake inhibitors (SSRIs), usually used in the treatment of anxiety disorders and certain personality disorders (e.g. fluoxetine or fluvoxamine);
medicines known as 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;
antibiotics belonging to the fluoroquinolone class such as ciprofloxacin;
medicines that act on the immune system such as methotrexate;
medicines for the treatment of metastatic cancer such as topotecan;
medicines for the treatment of pain and inflammatory conditions such as diclofenac;
medicines for the treatment of type 2 diabetes such as glibenclamide, metformin;
medicines for the treatment of viral infections such as aciclovir, ganciclovir.

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

Pregnancy
Safinamide EG must not be used during pregnancy or in women of childbearing potential who are not using adequate contraception.

Breastfeeding
Safinamide EG is likely to be excreted in breast milk. Safinamide EG must not be used during breastfeeding.

Driving and using machines
During treatment with safinamide, drowsiness and dizziness may occur; caution should be exercised when operating dangerous machinery or driving vehicles, until you are reasonably certain that Safinamide EG does not affect you negatively in any way.
Ask your doctor for advice before driving or using machinery.

3. How to take Safinamide EG

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

The recommended starting dose of Safinamide EG is one 50 mg tablet, which may be increased to one 100 mg tablet taken once daily, preferably in the morning, orally with water.
Safinamide EG 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 tell you if this applies to you.

If you take more Safinamide EG than you should
If you have taken too many Safinamide EG tablets, you may develop high blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea or vomiting, dilated pupils, or involuntary jerking movements. Contact your doctor immediately and bring the package of Safinamide EG with you.

If you forget to take Safinamide EG
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next dose at your usual time.

If you stop taking Safinamide EG
Do not stop treatment with Safinamide EG without first consulting your doctor.

If you have any questions about 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 everyone gets them.
Consult a doctor if you experience hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increased levels of the enzyme creatine kinase in the blood), serotonin syndrome (confusion, hypertension, muscle rigidity, hallucinations), or hypotension.

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 as monotherapy or in combination with other Parkinson’s disease medications):

Common (may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, somnolence, dizziness, headache, worsening of Parkinson’s disease, lens opacity of the eye, 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, decreased appetite, high levels of fats in the blood, increased appetite, high blood sugar levels, seeing things that are not there, feeling of sadness, 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, persistent abnormal muscle contraction, discomfort in the head, 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, sensation of dizziness, awareness of heartbeat, rapid heartbeat, irregular heartbeat, slowed heartbeat, high blood pressure, low blood pressure, enlarged and twisted veins, cough, breathing difficulty, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, stomach burning, flatulence, feeling of fullness, drooling, mouth ulcer, sweating, 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 sexual performance 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 impulses, clouding of consciousness, disorientation, distorted perception of images, reduced sexual interest, obsessive thoughts, feeling that someone is against you, premature ejaculation, uncontrollable urge to sleep, fear of social situations, suicidal thoughts, clumsiness, easy distractibility, loss of taste, weak/slow reflexes, pain radiating down the legs, persistent urge to move legs, drowsiness, eye abnormalities, progressive loss of vision due to diabetes, increased tear production, night blindness, strabismus, heart attack, hardening/narrowing of blood vessels, severely high blood pressure, chest tightness, difficulty speaking, difficulty/pain swallowing, peptic ulcer, nausea, stomach 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 urgency to urinate, increased urination, presence of pus cells in urine, urinary hesitation, prostate problems, breast pain, reduced effect of the medicine, drug intolerance, feeling cold, feeling unwell, fever, dryness of the skin, eyes and mouth, abnormalities in blood tests, heart murmur, 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Safinamide EG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after the word "Exp." The expiry date refers to the last day of that month.
This medicine does not require any 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 Safinamide EG contains
The active substance is safinamide.
Each film-coated tablet contains 50 mg or 100 mg of safinamide.
The other components are:
Tablet core: Microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate.
Tablet coating: Hypromellose (E464), Macrogol 6000 (E1521), Mica (E555), titanium dioxide (E171) and red iron oxide (E172).

Description of the appearance of Safinamide EG and the contents of the pack
Safinamide EG 50 mg appears as orange, round, film-coated tablets with a metallic sheen, marked with "MS" on one side and "18" on the other.
Safinamide EG 100 mg appears as orange, round, film-coated tablets with a metallic sheen, marked with "MS" on one side and "19" on the other.
Safinamide EG is packaged in blisters containing 14 x 1, 28 x 1, 30 x 1, 90 x 1 or 100 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturer
Pharmadox Healthcare Limited, Kw20a Kordin Industrial Park, Paola PLA 3000 - Malta

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
BE Safinamide EG 50 mg; 100 mg filmomhulde tabletten
DE Safinamid STADA Arzneimittel AG 50 mg; 100 mg Filmtabletten
LU Safinamide EG 50 mg; 100 mg comprimés pelliculés
IT Safinamide EG