Safinamide Aurobindo

Patient Information Leaflet

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

Equivalent 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Safinamide Aurobindo 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 Aurobindo is used for
the treatment of Parkinson's disease in adults.
In patients with mid- to advanced-stage disease who experience sudden fluctuations from the "ON" state,
in which they are able to move, to the "OFF" state, in which they have difficulty moving,
Safinamide Aurobindo is added to a stable dose of the medicine called levodopa, either used alone or in
combination with other Parkinson's disease medicines.

2. What you need to know before taking Safinamide Aurobindo

Do not take Safinamide Aurobindo:

• 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 (MAOIs), such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for the treatment of Parkinson's disease, depression or any other disorder); = pethidine (a strong painkiller). You must wait at least 7 days after stopping treatment with Safinamide Aurobindo before starting treatment with MAO inhibitors or pethidine;
• if you have been told you have severe liver problems;
• if you have an eye disorder that could put you at risk of retinal damage (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 or pharmacist before taking Safinamide Aurobindo, especially:

• 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 shopping syndrome.
• When Safinamide Aurobindo is used together with levodopa, involuntary, jerky movements may occur or worsen.

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

Other medicines and Safinamide Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Ask your doctor for advice before taking any of the following medicines together with Safinamide Aurobindo:

• 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 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 acting 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 glibenclamide, metformin;
• medicines for the treatment of viral infections such as aciclovir, ganciclovir.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor before taking this medicine.

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

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

Driving and use of 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 Aurobindo does not affect you adversely in any way.
Ask your doctor for advice before driving or using machinery.

3. How to take Safinamide Aurobindo

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor.
The recommended starting dose of Safinamide Aurobindo 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 Aurobindo can 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 advise you if this applies to you.

If you take more Safinamide Aurobindo than you should
If you have taken too many Safinamide Aurobindo tablets, you may experience increased blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea or vomiting, dilated pupils, or develop involuntary jerky movements. Seek immediate medical attention and take the medicine pack with you.

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

If you stop taking Safinamide Aurobindo
Do not stop treatment with Safinamide Aurobindo without first talking to your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
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 everyone 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 as monotherapy or in combination with other Parkinson’s 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 upon standing, 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 in red blood cells, loss of appetite, high levels of fats in the blood, increased appetite, high blood sugar, seeing things that do not exist, 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, prolonged abnormal muscle contractions, headache, difficulty speaking, fainting, memory impairment, blurred vision, blind spots, double vision, light sensitivity, disturbances in 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, reflux, vomiting, dry mouth, diarrhoea, abdominal pain, heartburn, flatulence, feeling of fullness, drooling, mouth ulcer, sweating, generalized itching, sensitivity to light, skin redness, back pain, joint pain, cramps, stiffness, pain in arms or legs, muscle weakness, feeling of heaviness, increased nighttime urination, pain during urination, difficulty in achieving sexual intercourse in men, fatigue, feeling of weakness, unsteady gait, swelling of the feet, pain, sensation of warmth, 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 in white blood cells, severe weight loss and weakness, increased potassium levels in the blood, uncontrollable urges, 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, leg 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, stiffening/narrowing of blood vessels, severe high blood pressure, chest tightness, difficulty speaking, difficulty or pain when swallowing, peptic ulcer, vomiting urges, stomach bleeding, jaundice, hair loss, blisters, skin allergy, skin conditions, bruising, scaly skin, night sweats, skin pain, skin colour changes, psoriasis, scaly skin, inflammation of spinal joints due to autoimmune disorder, hip pain, joint swelling, musculoskeletal pain, muscle pain, neck pain, joint pain, cysts in joints, uncontrollable urgency to urinate, increased urination, presence of pus cells in urine, urinary hesitation, prostate problems, breast pain, reduced effect of the medicine, intolerance to the medicine, feeling of cold, feeling of malaise, fever, dryness of the skin, eyes and mouth, abnormalities in blood tests, fever, heart murmurs, abnormal cardiac tests, bruising/swelling after injuries, blockage of a blood vessel due to fat, head injuries, mouth injuries, skeletal injuries, gambling behaviour.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Aurobindo

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 requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What Safinamide Aurobindo contains

• The active substance is safinamide mesilate. Each film-coated tablet contains 50 mg of safinamide, equivalent to 65.9 mg of safinamide mesilate. Each film-coated tablet contains 100 mg of safinamide, equivalent to 131.8 mg of safinamide mesilate.
• The other components are: Tablet core: Microcrystalline cellulose (grade 200), crospovidone (type A), anhydrous colloidal silica, magnesium stearate. Tablet coating: Hypromellose 2910 (3 mPas & 6 mPas), potassium aluminum silicate/titanium dioxide/iron oxide, macrogol 6000, red iron oxide, titanium dioxide.

Description of the appearance of Safinamide Aurobindo and pack sizes
Film-coated tablet.
Safinamide Aurobindo 50 mg film-coated tablets
Orange, round, biconvex film-coated tablets of approximately 7.1 mm in diameter, marked with
“SA” on one side and “50” on the other side.
Safinamide Aurobindo 100 mg film-coated tablets
Orange, round, biconvex film-coated tablets of approximately 9.1 mm in diameter, marked with
“SA” on one side and “100” on the other side.
Blister packs: 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) Srl
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Safinamide Aurobindo
Portugal: Safinamida Generis Phar