Safinamid ELPEN: Uses, Dosage & Side Effects
A selective, reversible MAO-B inhibitor containing 50 mg safinamide, used as add-on therapy to levodopa for adults with mid-to-late stage Parkinson’s disease and motor fluctuations
Safinamid ELPEN is a film-coated tablet containing 50 mg of safinamide (as methanesulfonate), a selective and reversible monoamine oxidase type B (MAO-B) inhibitor. It is manufactured by ELPEN Pharmaceutical and prescribed as an add-on treatment to levodopa for adults with Parkinson’s disease who experience motor fluctuations. Safinamide increases dopamine levels in the brain and modulates glutamate release, helping to extend “on” time and reduce “off” periods. Safinamid ELPEN is taken once daily, with or without food, and requires a prescription.
Quick Facts: Safinamid ELPEN
Key Takeaways
- Safinamid ELPEN contains 50 mg of safinamide per film-coated tablet and is a selective, reversible MAO-B inhibitor with a dual mechanism of action – enhancing dopamine availability and modulating glutamate release to manage Parkinson’s disease motor fluctuations.
- It is used exclusively as an 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.
- Safinamid ELPEN 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.
- The recommended starting dose is 50 mg once daily taken orally with water, which may be titrated upward under medical supervision; patients with moderate hepatic impairment must not exceed 50 mg daily.
- Patients with certain retinal conditions (including albinism, retinal degeneration, uveitis, inherited retinopathy, or severe progressive diabetic retinopathy) must not take Safinamid ELPEN due to potential risk of retinal damage.
What Is Safinamid ELPEN and What Is It Used For?
Safinamid ELPEN is the brand name given by ELPEN Pharmaceutical Co. Inc. to its 50 mg film-coated tablets of safinamide. The active substance, safinamide, belongs to the pharmacological class of highly selective and reversible monoamine oxidase type B (MAO-B) inhibitors. Safinamide was originally developed by Newron Pharmaceuticals and received its first marketing authorisation in the European Union in 2015 under the name Xadago. Following patent expiry, generic and alternative branded formulations such as Safinamid ELPEN have become available in European markets, offering the same therapeutic efficacy with established bioequivalence to the originator product.
Parkinson’s disease is a progressive, chronic neurodegenerative disorder caused by the gradual loss of dopamine-producing neurons in the substantia nigra, a small but vital region deep within the brain that controls smooth, voluntary movements. As dopamine levels decline, patients develop the classical motor features of Parkinson’s disease: resting tremor, bradykinesia (slowness of movement), muscular rigidity, and postural instability. Non-motor symptoms – such as sleep disturbances, mood changes, autonomic dysfunction and cognitive changes – often accompany the motor manifestations and can significantly affect quality of life.
Levodopa, the metabolic precursor of dopamine, remains the most effective symptomatic therapy for Parkinson’s disease. However, as the disease progresses and levodopa is taken for several years, most patients develop motor complications. These include predictable or unpredictable “off” periods (when levodopa’s effect wears off before the next scheduled dose, leading to a return of Parkinsonian symptoms) alternating with “on” periods (when symptoms are well controlled). Some patients also experience involuntary movements known as dyskinesia during peak levodopa levels. Managing these motor fluctuations is a central clinical challenge, and adjunctive therapies such as safinamide play an important role.
Safinamide, the active substance in Safinamid ELPEN, has a distinctive dual mechanism of action that differentiates it from earlier MAO-B inhibitors such as selegiline and rasagiline. The 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 inhibiting MAO-B, safinamide reduces the degradation of dopamine, thereby increasing its availability in the striatum and enhancing the therapeutic effect of levodopa. Because safinamide’s MAO-B inhibition is reversible – unlike the irreversible inhibition produced by selegiline or rasagiline – enzyme function recovers more rapidly once the drug is eliminated.
The secondary mechanism of safinamide involves state-dependent blockade of voltage-gated sodium channels. At therapeutic concentrations, safinamide selectively inhibits sodium channels in their inactivated state, which limits pathological glutamate release from overactive neurons. Excessive glutamatergic signalling has been implicated in both the pathophysiology of Parkinson’s disease and the development of levodopa-induced dyskinesia. This non-dopaminergic, anti-glutamatergic effect may contribute to safinamide’s clinical benefit in managing motor complications without worsening troublesome dyskinesia, offering a differentiated therapeutic profile compared with purely dopaminergic add-on therapies.
Safinamid ELPEN 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. It is not approved as monotherapy or in early-stage disease. Pivotal randomized controlled trials of safinamide, including the SETTLE and Study 016/018 trials, demonstrated that add-on safinamide significantly increased daily “on” time without troublesome dyskinesia and reduced “off” time compared with placebo when added to optimised levodopa therapy, supporting its role in the practical management of motor fluctuations.
Unlike other MAO-B inhibitors, safinamide (the active ingredient in Safinamid ELPEN) combines dopaminergic enhancement (through reversible MAO-B inhibition) with non-dopaminergic glutamate modulation (through state-dependent sodium channel blockade). This dual approach helps control motor symptoms while potentially reducing the risk of worsening levodopa-induced dyskinesia – a therapeutic profile particularly relevant for patients in the mid-to-late stages of Parkinson’s disease.
What Should You Know Before Taking Safinamid ELPEN?
Before starting Safinamid ELPEN, it is essential that you and your prescribing doctor review your full medical history, current medications (including over-the-counter products, dietary supplements and herbal remedies), and any pre-existing conditions. Safinamide has clinically important contraindications and interactions that must be identified before the first dose. Always read the manufacturer’s patient information leaflet supplied with the medicine and keep it for future reference.
Contraindications
There are several situations in which Safinamid ELPEN must not be used. Understanding these absolute contraindications is central to patient safety.
- Hypersensitivity: Do not take Safinamid ELPEN if you are allergic to safinamide or any of the other ingredients in the tablets (including microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, titanium dioxide, iron oxides, or potassium aluminium silicate).
- Other MAO inhibitors: You must not take Safinamid ELPEN 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 between stopping one MAO inhibitor and starting another.
- 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: Safinamid ELPEN must not be used in patients with severe liver disease (Child-Pugh Class C), because safinamide is extensively metabolised 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 Safinamid ELPEN. 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 Safinamid ELPEN 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 Safinamid ELPEN before starting any other MAO inhibitor or pethidine.
Warnings and Precautions
Before and during treatment with Safinamid ELPEN, 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. Regular liver function monitoring may be recommended, and if liver function deteriorates during treatment the medicine may need to be stopped.
- Impulse control disorders: Patients and caregivers should be aware that compulsive behaviours 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 behaviours. 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 Safinamid ELPEN 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.
- Sudden sleep onset: Safinamid ELPEN can cause drowsiness and, rarely, sudden sleep onset without warning. If this occurs, you should not drive or operate machinery until the situation is reassessed with your doctor.
- Psychiatric history: In patients with a history of psychosis or significant psychiatric disorders, safinamide should be used with caution, as dopaminergic therapies may precipitate hallucinations or worsen existing psychiatric symptoms.
Pregnancy and Breastfeeding
Safinamid ELPEN should not be used during pregnancy. There are limited human data on the use of safinamide in pregnant women, and animal studies are insufficient to exclude 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.
Based on its pharmacological properties, safinamide is likely excreted in human breast milk. A risk to the breastfed infant cannot be excluded. Therefore, Safinamid ELPEN 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 Safinamid ELPEN 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
Safinamid ELPEN is not recommended for use in children and adolescents under 18 years of age. There are no safety or efficacy data on safinamide in this population, and Parkinson’s disease does not typically occur in pediatric patients.
How Does Safinamid ELPEN Interact with Other Drugs?
Drug interactions with Safinamid ELPEN fall into several categories: absolute contraindications involving serotonergic and MAO-related drugs, precautionary interactions with sympathomimetic agents and antidepressants, and pharmacokinetic interactions mediated through drug transporter proteins such as BCRP (breast cancer resistance protein) and OAT3 (organic anion transporter 3). Safinamide is primarily metabolized by amidase enzymes rather than cytochrome P450 isoforms, so it is less susceptible to the classic CYP-based interactions that affect many other medications. Nevertheless, several clinically important interactions require careful management.
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 |
Precautionary Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| SSRIs (e.g., fluoxetine, fluvoxamine, sertraline) | Theoretical risk of serotonin syndrome, particularly at high antidepressant 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 |
| Tricyclic antidepressants (e.g., amitriptyline) | Theoretical risk of serotonergic and noradrenergic reactions | Use with caution; clinical monitoring recommended |
| Rosuvastatin, pitavastatin, pravastatin | Safinamide inhibits BCRP and OAT3 transporters; potential increase in statin levels | Monitor for statin-related side effects such as muscle pain |
| Ciprofloxacin (fluoroquinolone antibiotic) | Potential increase in ciprofloxacin levels via BCRP inhibition | Use with caution; monitor for antibiotic side effects |
| Methotrexate, topotecan | Potential increase in plasma 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, repaglinide | 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 |
| Oral contraceptives | No clinically significant interaction observed | No dose adjustment needed; effective contraception required during treatment |
Because safinamide is primarily metabolised by amidase enzymes (non-CYP-dependent), it shows minimal interaction potential with medications that induce or inhibit cytochrome P450 isoforms. However, its metabolites can inhibit BCRP and 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 and may order laboratory tests if needed.
Always check with your doctor or pharmacist before starting any over-the-counter cold, flu or allergy medicine while taking Safinamid ELPEN. Products containing dextromethorphan, ephedrine, pseudoephedrine, or phenylephrine may be unsafe in combination. Herbal products such as St John’s Wort can also interact with serotonergic drugs and should be avoided unless approved by your doctor.
What Is the Correct Dosage of Safinamid ELPEN?
Always take Safinamid ELPEN exactly as your doctor has instructed. Do not change the dose without consulting your physician. Safinamid ELPEN is provided 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 minimise any potential impact on sleep. Swallow the tablet whole; do not crush, split or chew it.
Adults
Standard Dosing in Adults
Starting dose: 50 mg once daily, taken orally
Maintenance dose: Based on clinical response and tolerability, the prescriber may continue with 50 mg once daily or, where clinically appropriate and using a compatible strength of safinamide, increase the dose according to the official Summary of Product Characteristics.
Administration: Swallow whole with water; can be taken with or without food, preferably in the morning. Take at the same time each day.
Safinamid ELPEN is always used as an add-on to a stable dose of levodopa (alone or in combination with other anti-Parkinson medications). Your doctor will determine whether dose adjustments are appropriate based on your individual response and the overall balance of your Parkinson’s disease medications.
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): Safinamid ELPEN is contraindicated and must not be used
If you progress from moderate to severe hepatic impairment during treatment, Safinamid ELPEN must be discontinued immediately. Liver function tests may be performed periodically at your doctor’s discretion.
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 take into account your overall health status, kidney and liver function, concomitant medications, and risk of falls when determining the appropriate dose. Elderly patients may be more vulnerable to orthostatic hypotension, so rising slowly from sitting or lying positions is advisable.
Kidney Impairment
No dose adjustment is necessary in patients with kidney (renal) impairment. Safinamide is extensively metabolized in the liver before excretion, and kidney function does not significantly affect its clearance. Patients on renal replacement therapy (haemodialysis) should still follow the standard dosing schedule unless advised otherwise.
Children
Safinamid ELPEN 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.
Missed Dose
If you forget to take a dose of Safinamid ELPEN, do not take a double dose to make up for the missed one. If it is close to the time of your next scheduled dose, simply skip the forgotten dose and take the next dose at the usual time. If it is many hours until your next dose and you remember soon after the usual time, take the missed dose as soon as you remember, then resume your normal schedule. When in doubt, consult your pharmacist.
Overdose
If you have taken too many Safinamid ELPEN tablets, you may experience elevated blood pressure, anxiety, confusion, forgetfulness, drowsiness, dizziness, nausea, vomiting, dilated pupils or involuntary jerking movements. Contact your doctor, poison control centre or emergency services immediately, and bring the Safinamid ELPEN package with you. There is no specific antidote for safinamide overdose; treatment is supportive and symptomatic.
Stopping Treatment
Do not stop taking Safinamid ELPEN without first consulting your doctor. Abrupt discontinuation of Parkinson’s disease medications can lead to a worsening of symptoms and, rarely, to severe reactions such as neuroleptic malignant syndrome. Your doctor will advise you on how to discontinue the medication safely if needed. A washout period of at least 7 days is required after stopping Safinamid ELPEN before starting any MAO inhibitor or pethidine.
What Are the Side Effects of Safinamid ELPEN?
Like all medicines, Safinamid ELPEN 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. Frequencies are grouped using the standard Council for International Organizations of Medical Sciences (CIOMS) categories.
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, hyperthermia), or severe hypotension with fainting.
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
- 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, diarrhoea, abdominal pain
- Gastritis, flatulence, bloating, drooling, mouth ulcers
- Excessive sweating, generalised 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 authorised. This allows ongoing monitoring of the medicine’s benefit-risk balance. You can report side effects to your national pharmacovigilance authority (e.g., EMA in Europe, FDA MedWatch in the United States, or MHRA Yellow Card Scheme in the United Kingdom). Reporting side effects helps healthcare authorities identify new safety issues and improve the safe use of medicines for future patients.
How Should You Store Safinamid ELPEN?
Keep this medicine out of the sight and reach of children. Safinamid ELPEN should be stored according to the following conditions to ensure that the product remains safe and effective throughout its shelf life.
- Storage conditions: No special storage conditions are required. Store at room temperature (below 30 °C) in the original packaging, protected from excessive heat, humidity and direct sunlight.
- Packaging: Keep the tablets in the original blister pack until ready to use. The blister protects the medicine from moisture and light.
- Expiry date: Do not use Safinamid ELPEN 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.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.
- Travel: When travelling, keep Safinamid ELPEN in its original labelled packaging, along with your prescription, to avoid issues at customs or border control.
What Does Safinamid ELPEN Contain?
Active Substance
The active substance is safinamide. Each film-coated tablet of Safinamid ELPEN contains 50 mg of safinamide, present in the form of safinamide methanesulfonate (mesylate salt). Safinamide is a chemically stable small molecule specifically designed to provide highly selective and reversible inhibition of monoamine oxidase type B together with state-dependent sodium channel modulation.
Inactive Ingredients (Excipients)
The other ingredients typically present in safinamide film-coated tablets are:
- Tablet core: Microcrystalline cellulose, crospovidone (disintegrant), magnesium stearate (lubricant), colloidal anhydrous silica (glidant)
- Film coating: Hypromellose, macrogol, titanium dioxide (E171), iron oxides (E172) and/or potassium aluminium silicate (E555) as colouring and opacifying agents
If you have any known allergies to these excipients or have been told you are intolerant to certain sugars, consult your pharmacist before starting treatment. The full list of excipients specific to the Safinamid ELPEN product you have been prescribed is printed on the patient information leaflet supplied with the pack.
Appearance and Pack Sizes
Safinamid ELPEN is supplied as a 50 mg film-coated tablet. The tablets are packed in blisters and placed in a labelled outer carton. Pack sizes typically available include smaller starter packs and larger monthly supply packs; not all pack sizes may be marketed in all countries. Always check the carton and leaflet supplied by the pharmacy for the exact description of your pack.
Marketing Authorisation Holder and Manufacturer
Safinamid ELPEN is marketed by ELPEN Pharmaceutical Co. Inc., a European pharmaceutical company based in Greece. The product is authorised for use in the European Economic Area under national or decentralised procedures. For country-specific authorisation details, batch information, or supply questions, consult the outer packaging or contact the marketing authorisation holder via your pharmacist.
Frequently Asked Questions About Safinamid ELPEN
Safinamid ELPEN (safinamide) 50 mg is used to treat Parkinson’s disease in adults. It is specifically 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”). Safinamid ELPEN helps to extend “on” time and reduce “off” time.
Safinamid ELPEN and Xadago both contain the same active ingredient safinamide and belong to the same drug class (MAO-B inhibitors, ATC code N04BD03). Safinamid ELPEN is manufactured by ELPEN Pharmaceutical and is bioequivalent to the originator brand Xadago, which was originally developed by Newron Pharmaceuticals and marketed by Zambon. Both products are prescribed for the same indication – add-on therapy to levodopa in Parkinson’s disease with motor fluctuations. Your doctor or pharmacist can advise whether switching between brands is appropriate, and you should not switch between products without medical advice.
Safinamid ELPEN 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 and may offer a differentiated therapeutic profile for patients with motor fluctuations.
You should avoid taking Safinamid ELPEN 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 while on Safinamid ELPEN.
At the recommended 50 mg daily dose, Safinamid ELPEN 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 routinely required. You can generally follow a normal diet while taking Safinamid ELPEN. However, if you are unsure or have a sensitive blood pressure response, consult your doctor.
Safinamid ELPEN 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 attend scheduled eye examinations.
In the pivotal SETTLE trial, safinamide significantly increased daily “on” time without troublesome dyskinesia by approximately 1.4 hours compared with 0.6 hours for placebo (p < 0.001) and significantly reduced “off” time. In the long-term Study 016/018, the benefits were sustained over two years of treatment. Safinamide was also shown to improve motor function scores (UPDRS Part III) and quality-of-life measures. The drug’s dual mechanism may contribute to these benefits while minimising worsening of existing dyskinesia. Individual response to Safinamid ELPEN may vary.
There is no specific pharmacokinetic interaction described between alcohol and safinamide. However, alcohol can worsen drowsiness, dizziness and postural hypotension – side effects that may already occur with Safinamid ELPEN and Parkinson’s disease itself. Alcohol can also increase the risk of falls. It is generally advisable to drink alcohol only in moderation, if at all, while taking Safinamid ELPEN, and to discuss your individual alcohol intake with your doctor.
References
- European Medicines Agency (EMA). Safinamide – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- 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: indications, dose, interactions and side effects. Joint Formulary Committee; latest edition.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in neurology, movement disorders and clinical pharmacology.
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