Safinamide STADA: Uses, Dosage & Side Effects
A generic, selective and reversible MAO-B inhibitor (safinamide 50 mg) used as add-on therapy to levodopa for the treatment of mid-to-late stage Parkinson’s disease with motor fluctuations
Safinamide STADA is a generic medicinal product containing the active substance safinamide, a selective and reversible monoamine oxidase type B (MAO-B) inhibitor. It is used as an add-on treatment to levodopa for adults with mid-to-late stage Parkinson’s disease who experience motor fluctuations. Safinamide STADA 50 mg is bioequivalent to the reference medicine Xadago and works by increasing dopamine levels in the brain and modulating glutamate release, thereby extending “on” time and reducing “off” periods. It is taken orally once daily as a film-coated tablet, requires a prescription, and is regulated under the same marketing authorization standards as the originator product.
Quick Facts: Safinamide STADA
Key Takeaways
- Safinamide STADA is a generic version of safinamide, containing the same active substance as the reference medicine Xadago, and is bioequivalent in quality, safety, and efficacy as required by regulatory authorities.
- Safinamide is a selective, reversible MAO-B inhibitor with a dual mechanism of action – increasing dopamine levels in the brain and modulating glutamate release through state-dependent sodium channel blockade.
- It is used exclusively as add-on therapy to a stable dose of levodopa (alone or with other anti-Parkinson medications) in adults with mid-to-late stage disease experiencing “on-off” fluctuations.
- Safinamide STADA must never be combined with other MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine) or with pethidine; a 7-day washout is required between discontinuation and starting these drugs.
- Safinamide STADA is available as 50 mg film-coated tablets – the standard starting dose and the maximum dose allowed for patients with moderate hepatic impairment; it must not be used in severe hepatic impairment or in patients with specific retinal conditions.
What Is Safinamide STADA and What Is It Used For?
Safinamide STADA contains the active substance safinamide, which belongs to a class of medications known as monoamine oxidase type B (MAO-B) inhibitors. As a generic medicinal product, it has been developed and authorized to be therapeutically equivalent to the reference medicine Xadago (originally developed by Newron Pharmaceuticals and marketed by Zambon S.p.A.). Generic medicines contain the same active substance at the same strength and in the same pharmaceutical form as the originator; they must demonstrate bioequivalence through comparative pharmacokinetic studies before receiving marketing authorization. Safinamide STADA therefore offers the same clinical benefits as branded safinamide and is subject to the same regulatory standards for quality, safety, and efficacy.
Parkinson’s disease is a progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the substantia nigra, a region deep within the brain that plays a critical role in movement control. As dopamine levels decline, patients develop the hallmark motor symptoms: tremor at rest, bradykinesia (slowness of movement), rigidity, and postural instability. Levodopa, which is converted to dopamine in the brain, remains the most effective symptomatic treatment. However, as the disease progresses, patients often develop motor fluctuations – predictable or unpredictable periods where levodopa’s effect wears off (“off” periods) before the next dose is due, alternating with periods of good symptom control (“on” periods). Some patients also develop levodopa-induced dyskinesia, which are involuntary writhing or jerking movements that can be disabling.
Safinamide works through a dual mechanism of action that distinguishes it from other MAO-B inhibitors. Its primary action is the highly selective and reversible inhibition of MAO-B, the enzyme responsible for the metabolic breakdown of dopamine in the brain. By blocking this enzyme, safinamide reduces dopamine degradation and increases its availability in the striatum, thereby enhancing the effect of levodopa. Unlike selegiline and rasagiline (which are irreversible MAO-B inhibitors), safinamide’s inhibition of MAO-B is reversible, meaning the enzyme function recovers once the drug is eliminated from the body. This reversibility may be clinically advantageous in the event that MAO-B activity needs to be restored quickly.
The secondary mechanism involves state-dependent blockade of voltage-gated sodium channels. At therapeutic doses, safinamide selectively blocks sodium channels in their inactivated state, which inhibits pathological glutamate release from overactive neurons. Excessive glutamatergic activity has been implicated in both the pathophysiology of Parkinson’s disease and the development of levodopa-induced dyskinesia. This anti-glutamatergic effect may contribute to the observed clinical benefit of safinamide in managing motor complications without worsening troublesome dyskinesia – a potential advantage over purely dopaminergic add-on therapies.
Safinamide STADA is indicated for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of levodopa alone or in combination with other anti-Parkinson medications in mid-to-late stage fluctuating patients. Pivotal clinical trials of safinamide, including the SETTLE and Study 016/018 trials, demonstrated that safinamide significantly increased daily “on” time without troublesome dyskinesia and reduced “off” time compared with placebo when added to optimized levodopa therapy. Because Safinamide STADA is bioequivalent to the reference product, these clinical findings apply to it as well.
A generic medicine contains the same active substance in the same amount and pharmaceutical form as the reference (originator) medicine. It must demonstrate bioequivalence – meaning that the rate and extent of absorption into the bloodstream are comparable to the reference product within defined limits. Generics are authorized through established regulatory pathways (abridged applications to the European Medicines Agency or national authorities) and are subject to the same manufacturing quality standards as branded medicines. Switching between a reference medicine and its generic, or between different generics, is generally considered safe under medical supervision.
Unlike other MAO-B inhibitors, safinamide combines dopaminergic enhancement (through MAO-B inhibition) with non-dopaminergic glutamate modulation (through sodium channel blockade). This dual approach may help control motor symptoms while potentially reducing the risk of worsening levodopa-induced dyskinesia, offering a differentiated therapeutic profile for patients with motor fluctuations.
What Should You Know Before Taking Safinamide STADA?
Before starting Safinamide STADA, your doctor will review your full medical history, current medications, and any pre-existing conditions. It is essential to provide complete information about all prescription medicines, over-the-counter products, dietary supplements, and herbal remedies you are taking, as interactions with safinamide can be serious. The following section describes the most important contraindications and warnings.
Contraindications
There are several important situations in which Safinamide STADA must not be used. Understanding these absolute contraindications is essential for patient safety.
- Hypersensitivity: Do not take Safinamide STADA if you are allergic to safinamide or to any of the other ingredients in the tablets. The complete list of excipients is provided in the package leaflet and in the “What Does Safinamide STADA Contain?” section below.
- Other MAO inhibitors: You must not take Safinamide STADA if you are currently using any other monoamine oxidase inhibitor, including selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, or tranylcypromine (whether prescribed for Parkinson’s disease, depression, or any other condition). A washout period of at least 7 days is required after stopping Safinamide STADA before starting any MAO inhibitor, and vice versa.
- Pethidine (meperidine): Concurrent use of pethidine, a potent opioid analgesic, is strictly contraindicated due to the risk of serotonin syndrome and other serious adverse reactions.
- Severe hepatic impairment: Safinamide STADA must not be used in patients with severe liver disease (Child-Pugh Class C), as safinamide is extensively metabolized in the liver and its clearance is significantly reduced in these patients.
- Retinal conditions: Patients with eye conditions that pose a risk of potential retinal damage must not take Safinamide STADA. These include albinism (lack of pigment in the skin and eyes), retinal degeneration (progressive cell loss from the light-sensitive layer at the back of the eye), uveitis (inflammation inside the eye), inherited retinopathy (hereditary eye diseases), or severe progressive diabetic retinopathy (progressive vision loss caused by diabetes).
Combining Safinamide STADA with another MAO inhibitor can lead to a hypertensive crisis (dangerously high blood pressure) or serotonin syndrome (a potentially life-threatening condition characterized by confusion, high blood pressure, muscle rigidity, fever, and agitation). You must wait at least 7 days after stopping Safinamide STADA before starting any other MAO inhibitor or pethidine.
Warnings and Precautions
Before and during treatment with Safinamide STADA, speak to your doctor if any of the following apply:
- Liver problems: If you have any degree of hepatic impairment, your doctor should be informed. Patients with moderate hepatic impairment (Child-Pugh Class B) should not exceed 50 mg per day – which is the only strength in which Safinamide STADA is available. Regular liver function monitoring may be recommended, and the drug must be stopped if your liver disease progresses to the severe stage.
- Impulse control disorders: Patients and caregivers should be aware that compulsive behaviors have been reported with dopaminergic medications used in Parkinson’s disease. These may include pathological gambling, increased sexual urges, hypersexuality, compulsive spending or buying, binge eating, and obsessive-compulsive behaviors. If you or your caregiver notice any of these changes, inform your doctor promptly, as dose adjustment or treatment discontinuation may be necessary.
- Involuntary movements (dyskinesia): Dyskinesia may occur or worsen when Safinamide STADA is taken together with levodopa. Your doctor may need to adjust the dose of levodopa or other Parkinson’s medications to manage these movements.
- Serotonin syndrome: Although safinamide is a selective MAO-B inhibitor, caution is advised when combining it with serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, or dextromethorphan). Watch for symptoms such as confusion, agitation, rapid heartbeat, high blood pressure, hyperthermia, muscle rigidity, and myoclonus.
- Elderly patients: No dose adjustment is required based on age alone, but clinical experience in patients above 75 years is limited. Extra vigilance for blood pressure changes, falls, and drug interactions is advisable in this group.
- Ophthalmic monitoring: Patients with pre-existing or family history of macular or retinal disease should be examined before and periodically during treatment, as a theoretical risk of retinal toxicity has been identified based on safinamide’s pharmacological properties.
Pregnancy and Breastfeeding
Safinamide STADA should not be used during pregnancy. There are limited data on the use of safinamide in pregnant women, and animal studies are insufficient to rule out potential harm to the developing fetus. Women of childbearing potential must use effective contraception during treatment. If you are pregnant, think you may be pregnant, or are planning to become pregnant, speak with your doctor before using this medicine.
Safinamide is likely excreted in breast milk based on its pharmacological properties. A risk to the breastfed infant cannot be excluded. Therefore, Safinamide STADA should not be used during breastfeeding. Your doctor will help you decide whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of therapy for you and the benefit of breastfeeding for your child.
Driving and Operating Machinery
Drowsiness and dizziness may occur during treatment with safinamide. You should exercise caution when driving, operating dangerous machinery, or performing other hazardous activities until you are reasonably certain that Safinamide STADA does not adversely affect your alertness or coordination. Parkinson’s disease itself can also impair driving ability, and the combination of the disease and its treatments may have additive effects on reaction time and attention. Consult your doctor before driving if you are uncertain.
Children and Adolescents
Safinamide STADA is not recommended for use in children and adolescents under 18 years of age. There are no data on the safety and efficacy of safinamide in this population, and Parkinson’s disease does not typically occur in pediatric patients.
How Does Safinamide STADA Interact with Other Drugs?
Drug interactions with Safinamide STADA fall into several categories: absolute contraindications involving serotonergic and MAO-related drugs, precautionary interactions with sympathomimetic agents and antidepressants, and pharmacokinetic interactions through drug transporter proteins. It is essential to tell your doctor about all medications, supplements, and herbal products you are taking before starting Safinamide STADA. Because the interaction profile is driven by the active ingredient safinamide, the same interaction considerations apply as for other safinamide-containing medicines such as the reference product Xadago.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, tranylcypromine) | Risk of hypertensive crisis and serotonin syndrome | Absolute contraindication – never combine; 7-day washout required |
| Pethidine (meperidine) | Risk of serotonin syndrome and severe adverse reactions | Absolute contraindication – never combine; 7-day washout required |
| Dextromethorphan (found in cough medicines) | Potential risk of serotonergic toxicity and psychosis | Avoid combination; use alternative cough treatments |
| Ephedrine / Pseudoephedrine (decongestants) | Potential risk of elevated blood pressure | Avoid combination; use alternative decongestants |
| Tricyclic antidepressants (amitriptyline, clomipramine, imipramine) | Risk of serotonergic toxicity and adverse cardiovascular events | Avoid combination; if required, use the lowest effective dose with close monitoring |
Precautionary Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| SSRIs (e.g., fluoxetine, fluvoxamine, sertraline) | Theoretical risk of serotonin syndrome at high doses | Use at the lowest effective SSRI dose; monitor for serotonin syndrome symptoms |
| SNRIs (e.g., venlafaxine, duloxetine) | Theoretical risk of serotonin syndrome | Use at the lowest effective SNRI dose; monitor closely |
| Rosuvastatin, pitavastatin, pravastatin | Safinamide inhibits BCRP and OAT3 transporters; potential increase in statin levels | Monitor for statin-related side effects (muscle pain, elevated creatine kinase) |
| Ciprofloxacin (fluoroquinolone antibiotic) | Potential increase in ciprofloxacin levels via BCRP inhibition | Use with caution; monitor for antibiotic side effects |
| Methotrexate, topotecan | Potential increase in drug levels via BCRP inhibition | Monitor closely; dose adjustment may be necessary |
| Diclofenac | Potential increase in diclofenac levels via OAT3 inhibition | Use with caution; monitor for NSAID side effects |
| Metformin, glyburide | Potential alteration in antidiabetic drug levels via transporter interactions | Monitor blood glucose; adjust diabetes medication if needed |
| Acyclovir, ganciclovir | Potential increase in antiviral drug levels via OAT3 inhibition | Monitor for antiviral side effects |
Safinamide is primarily metabolized by amidase enzymes (non-CYP-dependent), so it is less susceptible to the cytochrome P450-based drug interactions that affect many other medications. However, its metabolites can inhibit breast cancer resistance protein (BCRP) and organic anion transporter 3 (OAT3), which may increase the plasma levels of substrates of these transporters. Your doctor will consider these potential interactions when prescribing or adjusting your medications.
You should also inform your doctor about any herbal products you are taking. St John’s wort (Hypericum perforatum) has been associated with serotonergic effects and could theoretically increase the risk of serotonin syndrome when combined with safinamide; combined use is not recommended. Similarly, discuss any use of tyramine-rich dietary supplements with your prescriber. At standard therapeutic doses, safinamide is highly selective for MAO-B over MAO-A, so strict tyramine-restricted diets are not typically required, but unusual or high-dose exposure to tyramine should be avoided.
What Is the Correct Dosage of Safinamide STADA?
Always take Safinamide STADA exactly as your doctor has instructed. Do not change the dose without consulting your physician. Safinamide STADA is available as 50 mg film-coated tablets and is taken once daily by mouth with water. It can be taken with or without food, and it is generally recommended to take it in the morning to minimize any potential impact on sleep. Safinamide STADA is always used in combination with levodopa (alone or with other anti-Parkinson medications) – it is not indicated as monotherapy.
Adults
Standard Dosing in Adults
Starting dose: 50 mg once daily, taken orally
Maintenance dose: After 2–4 weeks, the physician may increase the daily dose to 100 mg (administered as two 50 mg tablets of Safinamide STADA taken together once daily) based on clinical need and tolerability
Maximum dose: 100 mg once daily
Administration: Swallow whole with water; can be taken with or without food, preferably in the morning
Dose adjustment of levodopa may be considered when Safinamide STADA is initiated, particularly if dyskinesia develops or worsens. Your doctor will determine the best balance between your Parkinson’s medications based on your individual response.
Hepatic Impairment
Dosing in Liver Impairment
Mild hepatic impairment (Child-Pugh A): No dose adjustment required
Moderate hepatic impairment (Child-Pugh B): Maximum dose is 50 mg once daily; do not exceed this dose
Severe hepatic impairment (Child-Pugh C): Safinamide STADA is contraindicated and must not be used
If you progress from moderate to severe hepatic impairment during treatment, Safinamide STADA must be discontinued immediately. Your doctor may order periodic liver function tests during long-term therapy.
Elderly Patients
No dose adjustment is required for elderly patients based on age alone. However, clinical experience with safinamide in patients over 75 years of age is limited. Your doctor will consider your overall health status, kidney and liver function, and other medications when determining the appropriate dose. Elderly patients may be more sensitive to the blood-pressure-lowering effects of Parkinson’s medications, so rising slowly from sitting or lying positions is recommended to prevent falls.
Kidney Impairment
No dose adjustment is necessary in patients with kidney (renal) impairment, including those with severe impairment. Safinamide is extensively metabolized in the liver before excretion, and renal function does not significantly affect its clearance. Safinamide has not been studied in patients on dialysis.
Children
Safinamide STADA is not recommended for use in children and adolescents under 18 years of age due to the absence of safety and efficacy data in this population. Parkinson’s disease in this age group is extremely rare and requires specialist evaluation.
Missed Dose
If you forget to take a dose of Safinamide STADA, do not take a double dose to make up for the missed one. Simply skip the forgotten dose and take your next dose at the usual time. Continue with your regular dosing schedule. If you miss several doses in a row, contact your doctor for advice before restarting, especially if your Parkinson’s symptoms have worsened during the break.
Overdose
If you have taken too many Safinamide STADA tablets, you may experience elevated blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea, vomiting, dilated pupils, or involuntary jerking movements. Contact your doctor or local poison control center immediately, and bring the Safinamide STADA package with you. There is no specific antidote; management is supportive and symptomatic.
Stopping Treatment
Do not stop taking Safinamide STADA without first consulting your doctor. Abrupt discontinuation of Parkinson’s disease medications can lead to a worsening of symptoms or, in rare cases, to a neuroleptic malignant-like syndrome (characterized by fever, muscle stiffness, altered consciousness, and autonomic instability). Your doctor will advise you on how to discontinue the medication safely if needed, typically by gradual dose reduction where clinically appropriate.
What Are the Side Effects of Safinamide STADA?
Like all medicines, Safinamide STADA can cause side effects, although not everyone experiences them. The side effects listed below have been reported in patients with mid-to-late stage Parkinson’s disease who were taking safinamide as add-on therapy to levodopa alone or in combination with other anti-Parkinson medications. Because Safinamide STADA is bioequivalent to the reference safinamide product, the expected safety profile is the same.
Contact your doctor or seek emergency medical care immediately if you experience: hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, high body temperature, elevated creatine kinase levels), serotonin syndrome (confusion, high blood pressure, muscle rigidity, hallucinations), or severe hypotension (very low blood pressure). Also seek urgent care for any signs of an allergic reaction such as facial swelling, difficulty breathing, or widespread rash.
Very Common
May affect more than 1 in 10 people
- No very common adverse reactions have been identified for safinamide at the recommended therapeutic doses
Common
May affect up to 1 in 10 people
- Insomnia (difficulty sleeping)
- Dyskinesia (difficulty performing voluntary movements)
- Drowsiness (somnolence)
- Dizziness
- Headache
- Worsening of Parkinson’s disease symptoms
- Cataract (clouding of the eye lens)
- Orthostatic hypotension (blood pressure drops on standing)
- Nausea
- Falls
Uncommon
May affect up to 1 in 100 people
- Urinary tract infection, skin cancer (non-melanoma types)
- Low iron levels, low white blood cell count, abnormal red blood cells
- Decreased or increased appetite, high blood lipids, high blood sugar
- Hallucinations, depression, abnormal dreams, anxiety, confusion, mood swings
- Increased sexual interest, abnormal thoughts, restlessness, sleep disturbance
- Numbness, unsteadiness, loss of sensation, muscle spasms, speech difficulties
- Fainting, memory impairment, blurred vision, visual field loss, double vision
- Light sensitivity, eye redness, increased eye pressure, sensation of spinning
- Palpitations, rapid heart rate, irregular or slow heartbeat
- High or low blood pressure, varicose veins
- Cough, shortness of breath, runny nose
- Constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain
- Gastritis, flatulence, bloating, drooling, mouth ulcers
- Excessive sweating, generalized itching, photosensitivity, skin redness
- Back pain, joint pain, cramps, stiffness, limb pain, muscle weakness
- Increased nighttime urination, painful urination, erectile dysfunction
- Fatigue, weakness, unsteady gait, foot swelling, pain, feeling of warmth
- Weight loss or gain, abnormal blood tests, abnormal ECG, abnormal liver function 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 changes, abnormal white blood cells, severe weight loss
- Elevated potassium, uncontrollable urges, clouded consciousness, confabulation
- Decreased sexual interest, intrusive thoughts, paranoia, premature ejaculation
- Uncontrollable need to sleep, social phobia, suicidal thoughts
- Clumsiness, easily distracted, loss of taste, weak reflexes, radiating leg pain
- Restless legs syndrome, progressive diabetic retinopathy, increased tearing
- Night blindness, strabismus, heart attack, blood vessel constriction
- Severely elevated blood pressure, chest tightness, difficulty speaking or swallowing
- Peptic ulcer, retching, gastrointestinal bleeding, jaundice
- Hair loss, blisters, skin allergy, bruising, flaking skin, night sweats
- Skin pain, skin discoloration, psoriasis, spinal inflammation (autoimmune)
- Joint swelling, musculoskeletal pain, muscle pain, neck pain
- Urinary urgency, increased urination, pus cells in urine, hesitancy
- Prostate problems, chest pain, decreased drug effect, drug intolerance
- Cold sensation, general malaise, fever, dryness of skin, eyes and mouth
- Heart murmur, bruise or swelling after injury, fat embolism
- Head injury, mouth injury, skeletal injury, pathological gambling
It is important to report suspected side effects after the drug has been authorized. This allows ongoing monitoring of the medicine’s benefit-risk balance. You can report side effects to your national pharmacovigilance authority (e.g., EMA via the national competent authority in your country, FDA MedWatch in the United States, or MHRA Yellow Card Scheme in the United Kingdom). When reporting, include the brand name “Safinamide STADA” and the batch number, which helps regulators identify the specific product involved.
How Should You Store Safinamide STADA?
Proper storage of medicines helps maintain their safety and effectiveness. Follow these instructions for Safinamide STADA:
- Storage conditions: No special storage conditions are required. Store at room temperature, in a dry place away from direct sunlight and moisture (avoid bathroom cabinets, as humidity can affect tablet integrity).
- Packaging: Keep the tablets in the original blister pack until ready to use. The blister provides protection from light and humidity and preserves drug stability through the labeled expiration date.
- Expiry date: Do not use Safinamide STADA after the expiry date which is stated on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month. Expired medicines may be less effective or, in some cases, harmful.
- Keep out of reach of children: Store in a location that is inaccessible to children and pets. Accidental ingestion by a child, even of a single tablet, can be dangerous and requires immediate medical assessment.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use – most pharmacies operate a medicine return scheme. These measures help to protect the environment and prevent diversion.
- Travel: When traveling, keep Safinamide STADA in its original packaging, and carry a copy of your prescription. Extreme temperatures (for example inside a hot car) should be avoided.
What Does Safinamide STADA Contain?
Active Substance
The active substance is safinamide. Each film-coated tablet contains 50 mg of safinamide, present in the tablet as safinamide methanesulfonate (commonly referred to as safinamide mesylate). Safinamide methanesulfonate is the salt form used to improve solubility and bioavailability; the dose is always expressed in terms of safinamide base.
Inactive Ingredients (Excipients)
The tablet core and film coating include standard excipients used in film-coated tablets. Typical excipients for safinamide 50 mg film-coated tablets include:
- Tablet core: Microcrystalline cellulose, crospovidone (type A), magnesium stearate, and colloidal anhydrous silica. These components act as diluents, disintegrants, lubricants, and glidants to ensure consistent tablet manufacture and uniform drug release.
- Film coating: Hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene glycol) 6000, titanium dioxide (E171), and iron oxide pigments (E172) that give the tablet its characteristic color. A mica-based pigment (such as potassium aluminium silicate, E555) may be included to provide a metallic sheen on the film.
If you have known allergies to any excipient (for example tartrazine, lactose, or specific colorants), check the current package leaflet for Safinamide STADA in your country before starting treatment. Patients with very rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should confirm with their pharmacist whether the formulation is suitable.
Appearance and Pack Sizes
Safinamide STADA 50 mg tablets are typically orange to copper-colored, round, biconvex film-coated tablets with a diameter of approximately 7 mm, consistent with the appearance of other authorized safinamide 50 mg products. Pack sizes commonly include 14, 28, 30, 90, or 100 film-coated tablets, supplied in aluminum/PVC or aluminum/aluminum blister strips. Not all pack sizes may be marketed in every country, and local packaging may differ. Always check the carton before use to confirm you have received the correct medicine and strength.
Marketing Authorization
Safinamide STADA is marketed by STADA Arzneimittel AG, a German multinational pharmaceutical company with a long-standing portfolio of generic and specialty medicines distributed across Europe and worldwide. The product is authorized under applicable national and European generic procedures, referencing the originator safinamide dossier. Consult the package leaflet supplied with your pack for the full marketing authorization holder and manufacturer details in your country.
Frequently Asked Questions About Safinamide STADA
Safinamide STADA (safinamide 50 mg) is used to treat Parkinson’s disease in adults. It is a generic version of safinamide prescribed as an add-on therapy to a stable dose of levodopa (alone or in combination with other Parkinson’s medications) in patients with mid-to-late stage disease who experience motor fluctuations – periods when they can move well (“on”) alternating with periods of difficulty moving (“off”). By adding Safinamide STADA, physicians aim to extend “on” time and reduce “off” time.
Yes. Safinamide STADA is a generic medicinal product that contains the same active substance (safinamide) in the same pharmaceutical form and strength as the reference medicine Xadago. Before approval, generic medicines must demonstrate bioequivalence to the reference product through comparative pharmacokinetic studies, and they are manufactured under the same good manufacturing practice (GMP) standards. Clinical efficacy, safety profile, contraindications, interactions, and dosing recommendations therefore apply equally to both products.
Safinamide (the active substance in Safinamide STADA) has a unique dual mechanism of action. Like selegiline and rasagiline, it inhibits MAO-B to increase dopamine levels. However, unlike those drugs (which are irreversible inhibitors), safinamide’s MAO-B inhibition is reversible. Additionally, safinamide modulates glutamate release through state-dependent sodium channel blockade, which may help control motor symptoms without worsening levodopa-induced dyskinesia. This non-dopaminergic mechanism sets it apart from other MAO-B inhibitors.
You should avoid taking Safinamide STADA with cold or cough medicines containing dextromethorphan, ephedrine, or pseudoephedrine, as these may interact with safinamide. Dextromethorphan (a common cough suppressant) can cause serotonergic toxicity when combined with MAO-B inhibitors. Ephedrine and pseudoephedrine (decongestants) may raise blood pressure. Always check the ingredients of over-the-counter medications and consult your doctor or pharmacist before taking any cold or cough remedies.
At the recommended doses of 50–100 mg daily, safinamide is a highly selective MAO-B inhibitor and does not significantly inhibit MAO-A (the enzyme involved in tyramine metabolism). Therefore, unlike older, non-selective MAO inhibitors, no special dietary restrictions regarding tyramine-containing foods (such as aged cheese, cured meats, or fermented products) are required. You can follow a normal diet while taking Safinamide STADA. However, if you are unsure about a specific food or supplement, consult your doctor or pharmacist.
Safinamide STADA is contraindicated in patients with pre-existing retinal conditions such as albinism, retinal degeneration, uveitis, inherited retinopathy, or severe progressive diabetic retinopathy, because there is a theoretical risk of retinal damage based on safinamide’s pharmacological properties. In clinical trials, cataract was reported as a common side effect. Other uncommon visual side effects include blurred vision, double vision, light sensitivity, and visual field loss. Report any changes in vision to your doctor promptly, and consider periodic ophthalmologic monitoring as advised by your physician.
In most cases, switching between the reference medicine and a bioequivalent generic such as Safinamide STADA is safe and straightforward when done under medical supervision. Because the products contain the same active substance at the same dose and form, no dose adjustment is usually required. You should, however, inform your doctor and pharmacist about the switch so that any changes can be recorded in your medical notes and so that you can be counseled about any differences in tablet appearance or packaging. Do not switch medicines without first discussing it with your prescriber.
References
- European Medicines Agency (EMA). Safinamide – Summary of Product Characteristics for the reference medicinal product (Xadago). Last updated 2025. Available from: EMA EPAR.
- European Medicines Agency (EMA). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr**). Committee for Medicinal Products for Human Use; 2010.
- U.S. Food and Drug Administration (FDA). Safinamide (Xadago) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Schapira AH, Fox SH, Hauser RA, et al. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial (SETTLE). JAMA Neurol. 2017;74(2):216–224. doi:10.1001/jamaneurol.2016.4467.
- Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations (Study 016). Mov Disord. 2014;29(2):229–237. doi:10.1002/mds.25751.
- Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease (Study 018). Mov Disord. 2014;29(10):1273–1280. doi:10.1002/mds.25961.
- National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance TA533: Safinamide for treating Parkinson’s disease. Published 2018.
- Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and Movement Disorder Society Evidence-Based Medicine Review: Update on Treatments for Motor Symptoms of Parkinson’s Disease. Mov Disord. 2018;33(8):1248–1266. doi:10.1002/mds.27372.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Cattaneo C, Sardina M, Bonizzoni E. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post Hoc Analyses of Studies 016 and SETTLE. J Parkinsons Dis. 2016;6(1):165–173. doi:10.3233/JPD-150700.
- Tsuboi Y, Hattori N, Yamada T, et al. Long-term safety and efficacy of safinamide as add-on therapy in levodopa-treated Japanese patients with Parkinson’s disease with wearing-off. J Neurol Sci. 2020;415:116891. doi:10.1016/j.jns.2020.116891.
- British National Formulary (BNF). Safinamide – Drug Monograph. Joint Formulary Committee. London: BMJ Group and Pharmaceutical Press; current edition.
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