Safinamide Doc Generici

Package leaflet: Information for the patient

SAFINAMIDE DOC Generici 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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, because it could 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 DOC Generici is and what it is used for
2. What you need to know before taking SAFINAMIDE DOC Generici
3. How to take SAFINAMIDE DOC Generici
4. Possible side effects
5. How to store SAFINAMIDE DOC Generici
6. Contents of the pack and other information

1. What SAFINAMIDE DOC Generici is and what it is used for

SAFINAMIDE DOC Generici 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
at lower levels in the brains of patients with Parkinson's disease. SAFINAMIDE DOC Generici is used for
the treatment of Parkinson's disease in adults.
In patients with moderate 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 DOC Generici
is added to a stable dose of the medicine called levodopa, used either as monotherapy or in combination with other
medicines for Parkinson's disease.

2. What you should know before taking SAFINAMIDE DOC Generici

Do not take SAFINAMIDE DOC Generici
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, tranilcypromine (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 DOC Generici 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 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), hereditary 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 DOC Generici:
if you have liver problems.
Patients and caregivers should be informed that with other medicines for Parkinson’s disease, certain compulsive behaviours have been reported, such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour, and compulsive shopping syndrome.
When SAFINAMIDE DOC Generici is used together with levodopa, involuntary, sudden movements may occur or worsen.

Children and adolescents
SAFINAMIDE DOC Generici 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 DOC Generici
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 DOC Generici:
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 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 gliburide, metformin;
medicines for the treatment of viral infections such as acyclovir, ganciclovir.

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

Pregnancy
SAFINAMIDE DOC Generici must not be used during pregnancy or by women of childbearing potential who are not using adequate contraception.

Breastfeeding
SAFINAMIDE DOC Generici is likely to be excreted in breast milk. SAFINAMIDE DOC Generici must not be used during breastfeeding.

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

3. How to take SAFINAMIDE DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The recommended starting dose of SAFINAMIDE DOC Generici 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 DOC Generici 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 advise you if this applies to you.
If you take more SAFINAMIDE DOC Generici than you should
If you have taken too many tablets of SAFINAMIDE DOC Generici, you may develop increased blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea or vomiting, dilated pupils, or involuntary jerking movements. Contact your doctor immediately and take the medicine pack with you.
If you forget to take SAFINAMIDE DOC Generici
Do not take a double dose to make up for the forgotten dose. Skip the missed dose and take the next dose at your usual scheduled time.
If you stop taking SAFINAMIDE DOC Generici
Do not stop treatment with SAFINAMIDE DOC Generici without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 alone 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, blurred lens of the eye, 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 of red blood cells, loss of appetite, high blood lipid 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, sustained abnormal 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, 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, generalised itching, skin redness, back pain, joint pain, cramps, stiffness, pain in the legs or arms, 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 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 of white blood cells, severe weight loss and weakness, increased potassium in the blood, uncontrollable urges, clouding of consciousness, disorientation, distorted perception of images, reduced interest in sex, 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, pain radiating down the legs, persistent urge to move the 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 in swallowing, peptic ulcer, vomiting, stomach bleeding, jaundice, hair loss, blisters, skin allergy, skin conditions, bruising, scaly skin, night sweats, skin pain, change in skin colour, psoriasis, scaly skin, inflammation of spinal joints due to an 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, hesitation in urination, prostate problems, breast pain, reduced effect of the medicine, drug intolerance, feeling of cold, feeling unwell, fever, dryness of the skin, eyes and mouth, abnormalities in blood tests, heart murmurs, abnormal cardiac tests, bruising/swelling after injury, 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 effect, including those not listed in this leaflet, please inform 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the 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 DOC Generici 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 iron oxide red (E172).

Description of the appearance of SAFINAMIDE DOC Generici and package contents
SAFINAMIDE DOC Generici 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 DOC Generici 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 DOC Generici is packaged in blisters containing 30 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.
Manufacturer
Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, PLA 3000 Paola, Malta.

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Safinamid Doc Generici 50 mg, 100 mg Filmtabletten
Italy SAFINAMIDE DOC Generici