SAFINAMIDE 50 mg Film-Coated Tablets

Зміст інструкції

1. Safinamide Aurobindo 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Safinamide Aurobindo and what is it 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. Package Contents and Other Information

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

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Safinamide Aurobindo and what is it 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 the control of movement and is present
in lower quantities 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 disease in an intermediate to advanced stage who experience sudden shifts from the
state “ON”, in which they are able to move, to the state “OFF”, in which they have difficulty moving,
Safinamide Aurobindo is added to a stable dose of the medicine called levodopa in
monotherapy or in combination with other medicines for Parkinson's disease.

2. What you need to know before taking Safinamide Aurobindo

Do not take Safinamide Aurobindo:

• 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, isocarboxazide, tranylcypromine (e.g. for the treatment of Parkinson's disease or depression or for any other disorder); = pethidine (a potent painkiller). You must wait at least 7 days after stopping treatment with Safinamide Aurobindo before starting treatment with MAOIs or pethidine;
• if you have been told you have severe liver problems;
• if you have an eye condition that could put you at risk of 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) or uveitis (inflammation inside the eye), hereditary retinopathy (inherited vision disorders) or severe progressive diabetic retinopathy (a progressive decrease in 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 of patients should be informed that some compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive shopping syndrome have been reported with other medicines for Parkinson's disease.
• 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, because there are no safety and efficacy data in this population.

Other medicines and Safinamide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without 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 in the treatment of anxiety disorders and some personality disorders (e.g. fluoxetine or fluvoxamine);
• medicines called serotonin and 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;
• antibiotic of 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 states such as diclofenac;
• medicines for the treatment of type 2 diabetes such as gliburide, metformin;
• medicines for the treatment of viral infections such as acyclovir, ganciclovir.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Safinamide Aurobindo should not be used during pregnancy or by women of childbearing potential who are not using adequate contraception.
Breastfeeding
It is likely that Safinamide Aurobindo will be excreted in breast milk. Safinamide Aurobindo should not be used during breastfeeding.

Driving and using machines
During treatment with safinamide, drowsiness and dizziness may occur; caution should be exercised when using dangerous machinery or driving vehicles, until it is reasonably certain that Safinamide Aurobindo does not have any adverse effects of any kind.
Ask your doctor for advice before driving or using machines.

3. How to take Safinamide Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The recommended initial 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 both on an empty stomach or with food.
If you have moderately reduced liver function, you should not take more than 50 mg per day; your doctor will
tell you if this is the case.

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

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

If you stop taking Safinamide Aurobindo
Do not stop treatment with Safinamide Aurobindo without first talking to your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
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 everybody gets them.
Consult a doctor in case of hypertensive crises (very high blood pressure, collapse), malignant neuroleptic
syndrome (confusion, sweating, muscle rigidity, hyperthermia, increased levels of creatine kinase
enzyme in the blood), serotonin syndrome (confusion, hypertension, muscle rigidity, hallucinations) and
hypotension.
The following side effects have been reported in patients with Parkinson's disease in an intermediate to
advanced stage (patients treated with safinamide as add-on therapy to levodopa in monotherapy or in
combination with other medicines for Parkinson's disease):

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

Uncommon(may affect up to 1 in 100 people): urinary infection, skin tumor, low iron levels in the
blood, low number of white blood cells, red blood cell abnormalities, loss of appetite, high levels of
fats in the blood, increased appetite, high blood sugar, seeing things that are not there, feeling of
sadness, abnormal dreams, fear and worry, confused state, mood swings, increased interest in sex,
abnormal thoughts and perceptions, restlessness, sleep disorders, numbness, loss of balance, loss of
sensitivity, prolonged abnormal muscle contraction, headache discomfort, difficulty speaking, fainting,
memory impairment, blurred vision, blind spots, double vision, light sensitivity, disorders of the
photosensitive layer in the back of the eye, redness of the eyes, increased eye pressure, sensation of
dizziness, sensation of heartbeat, fast heartbeat, irregular heartbeat, slow heartbeat, high blood
pressure, low blood pressure, enlarged and tortuous veins, cough, difficulty breathing, runny nose,
constipation, reflux, vomiting, dry mouth, diarrhea, 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 legs or arms, muscle weakness, feeling of heaviness, increased
nighttime urination, pain during urination, difficulty having intercourse in men, fatigue, feeling of
weakness, unsteady walking, swelling of the feet, pain, feeling of warmth, weight loss, weight gain,
blood test abnormalities, high levels of fats in the blood, increased blood sugar, abnormal ECG, abnormal
liver function tests, urine test abnormalities, decreased blood pressure, increased blood pressure, abnormal
vision tests, foot fracture.

Rare(may affect up to 1 in 1,000): pneumonia, skin infection, sore throat, nasal allergy, dental
infection, viral infection, non-cancerous skin conditions/growths, white blood cell abnormalities, severe
weight loss and weakness, increased potassium in the blood, uncontrollable urges, loss of consciousness,
disorientation, misperception of images, reduced sexual interest, thoughts that you can't get rid of, feeling
that someone is against you, premature ejaculation, uncontrollable urge to sleep, fear of social situations,
thoughts of suicide, clumsiness, distractibility, loss of taste, weak/slow reflexes, pain radiating into the
legs, continuous desire to move the legs, feeling of sleepiness, eye abnormalities, progressive
worsening 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/pain
swallowing, peptic ulcer, vomiting, stomach bleeding, jaundice, hair loss, blisters, skin allergy, skin
conditions, bruising, scaly skin, night sweats, skin pain, skin color change, psoriasis, flaky skin,
inflammation of the spinal joints due to an autoimmune disorder, hip pain, joint swelling, musculoskeletal
pain, muscle pain, neck pain, joint pain, cysts in the joints, uncontrollable urge to urinate, increased
urination, emission of pus cells in the urine, urinary hesitation, prostate problems, breast pain, decreased
effect of the medicine, drug intolerance, feeling of cold, feeling unwell, fever, dry skin, eyes and mouth,
blood test abnormalities, fever, heart murmurs, 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 side effects not listed in
this leaflet. You can also report side effects directly through 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 which is stated on the box and blister after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Return any unused medicines to the
pharmacist. This will help protect the environment.

6. Package Contents and Other Information

What Safinamide Aurobindo contains

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

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Safinamide Aurobindo
Portugal: Safinamida Generis Phar