Safinamide Teva

Patient Information Leaflet

Safinamide Teva 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What Safinamide Teva is and what it is used for
2. What you need to know before taking Safinamide Teva
3. How to take Safinamide Teva
4. Possible side effects
5. How to store Safinamide Teva
6. Contents of the pack and other information

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

Safinamide Teva is a medicine containing the active substance safinamide. It works by increasing
the level in the brain of a substance called dopamine, which is involved in movement control and
is present in lower amounts in the brains of patients with Parkinson's disease. Safinamide Teva is
used for the treatment of Parkinson's disease in adults.
In patients with mid- to advanced-stage disease who experience sudden transitions from the "ON" state,
in which they are able to move, to the "OFF" state, in which they have difficulty moving,
Safinamide Teva is added to a stable dose of the medicine called levodopa alone.

2. What you should know before taking Safinamide Teva

Do not take Safinamide Teva

• 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 painkiller).
• You must wait at least 7 days after stopping treatment with Safinamide Teva before starting treatment with MAO inhibitors or meperidine.
• if you have been told you have severe liver problems.
• if you have an eye disorder that may put you at risk of retinal damage (the light-sensitive layers at the back of the eyes), 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 Teva

• if you have liver problems.
• Patients and caregivers should be informed 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 shopping syndrome.
• When Safinamide Teva is used together with levodopa, uncontrolled, jerky movements may occur or worsen.

Children and adolescents
Safinamide Teva is not recommended for use in children and adolescents under 18 years of age,
because there is no data on safety and efficacy in this population.
Other medicines and Safinamide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. Ask your doctor for advice before taking any of the following
medicines together with Safinamide Teva:

• cough or cold remedies containing dextromethorphan, ephedrine or pseudoephedrine.
• medicines called selective serotonin reuptake inhibitors (SSRIs), usually used to treat anxiety disorders and certain personality disorders (e.g. fluoxetine or fluvoxamine).
• medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used to treat major depressive disorder 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 carcinoma 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 glyburide, metformin.
• medicines for the treatment of viral infections such as aciclovir, ganciclovir.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before taking this medicine.
Pregnancy
Safinamide Teva must not be used during pregnancy or in women of childbearing potential who are not using adequate contraception.
Breastfeeding
Safinamide Teva is likely to be excreted in breast milk. Safinamide Teva must not be used during breastfeeding.
Driving and use of machinery
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 Teva does not affect you negatively in any way.
Ask your doctor for advice before driving or using machinery.

3. How to take Safinamide Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended starting dose of Safinamide Teva is one 50 mg tablet, which may be increased to one 100 mg tablet taken once daily, preferably in the morning, with a glass of water. Safinamide Teva may be taken with or without food.
If you have moderately impaired liver function, you must not take more than 50 mg per day; your doctor will advise you if this applies to you.

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

If you forget to take Safinamide Teva
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 Teva
Do not stop treatment with Safinamide Teva without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult a doctor if you experience hypertensive crises (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 alone or in combination with other Parkinson’s disease medications):

Common (may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, drowsiness, dizziness, headache, worsening of Parkinson’s disease, clouding of the eye lens, drop in blood pressure when standing up, nausea, falls.

Uncommon (may affect up to 1 in 100 people): urinary tract infection, skin tumours, low iron levels in the blood, low white blood cell count, abnormalities in red blood cells, loss of appetite, high blood fat levels, increased appetite, high blood sugar, 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, abnormal sustained muscle contraction, headache, 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, varicose veins, cough, breathing difficulty, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, stomach burning, flatulence, feeling of fullness, drooling, mouth ulcer, sweating, generalized 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, swollen feet, pain, feeling of warmth, weight loss, weight gain, abnormalities in blood tests, high blood fat levels, 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 in white blood cells, severe weight loss and weakness, increased potassium levels in the blood, uncontrollable impulses, clouding of consciousness, disorientation, distorted perception of images, reduced sexual interest, persistent thoughts that cannot be dismissed, feeling that someone is against you, premature ejaculation, uncontrollable urge to sleep, fear of social situations, suicidal thoughts, clumsiness, increased distractibility, loss of taste, weak/slow reflexes, leg pain radiating, persistent urge to move legs, drowsiness, eye abnormalities, progressive loss of vision due to diabetes, increased tearing, night blindness, strabismus, heart attack, stiffening/narrowing of blood vessels, severe high blood pressure, chest tightness, difficulty speaking, difficulty/painful swallowing, peptic ulcer, vomiting urges, 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 urge to urinate, increased urination, presence of pus cells in urine, urinary hesitation, prostate problems, breast pain, reduced effect of the medicine, drug intolerance, feeling of cold, feeling of malaise, fever, dryness of the skin, eyes and mouth, abnormalities in blood tests, fever, heart murmurs, abnormal heart 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 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 Teva contains

• The active substance is safinamide. Each tablet contains 50 mg or 100 mg of safinamide (as methanesulphonate).
• The other components are:
• Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, anhydrous colloidal silica.
• Tablet coating: hypromellose, macrogol (6000), titanium dioxide (E171), iron oxide red (E172), mica (E555).

Description of the appearance of Safinamide Teva and pack contents
Safinamide Teva 50 mg is presented as orange to copper-coloured, round, biconvex, film-coated tablets with a metallic glossy finish, approximately 6.6 mm in diameter, with the number “50” engraved on one side.
Safinamide Teva 100 mg is presented as orange to copper-coloured, round, biconvex, film-coated tablets with a metallic glossy finish, approximately 9.1 mm in diameter, with the number “100” engraved on one side.
Safinamide Teva is available in blisters containing 14, 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano, Italy

Manufacturer
Elpen
Pharmaceutical Co.
Inc. Marathonos Avenue
95, Pikermi, 190 09,
Greece
Elpen
Pharmaceutical Co.
Inc. Zapani, Block 1048,
Keratea, 190 01,
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Sweden Safinamid Teva
Germany Safinamid-ratiopharm 50 mg Filmtabletten
Safinamid-ratiopharm 100 mg Filmtabletten
Estonia Safinamide Teva
Spain Safinamida Teva 50 mg comprimidos recubiertos con película EFG
Safinamida Teva 100 mg comprimidos recubiertos con película EFG
Italy Safinamide Teva
Lithuania Safinamide Teva 50 mg plėvele dengtos tabletės
Safinamide Teva 100 mg plėvele dengtos tabletės
Latvia Safinamide Teva 50 mg apvalkotās tabletes
Safinamide Teva 100 mg apvalkotās tabletes