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Introduction About XAFINACT 100MG TABLET
XAFINACT 100MG TABLET contains Safinamide which belongs to the group of medicines called Monoamine oxidase type B (MAO-B) inhibitors. XAFINACT 100MG TABLET is used in the management of Parkinson’s disease, which is an age-related degenerative brain condition that cause unintended/uncontrollable movements in adults.
XAFINACT 100MG TABLET is also used to manage Parkinson’s disease in mid-late-stage patients when used with Levodopa or in combination with other anti-Parkinson’s disease.
XAFINACT 100MG TABLET is not recommended for use in patients allergic to Safinamide. It is also not recommended for use in patients suffering from eye condition (due to albinism, retinal degeneration, uveitis, inherited retinopathy), and/or severe liver problems.
Before taking XAFINACT 100MG TABLET, inform your doctor if you have kidney problems (such as renal impairment), and/or other liver problems (such as mild to moderate hepatic impairment).
XAFINACT 100MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. It is also not recommended for use in breastfeeding women as it may pass through breast milk.
XAFINACT 100MG TABLET is not recommended for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 75 years/above) after consulting the doctor.
The most common side effects of taking XAFINACT 100MG TABLET are insomnia (sleeplessness), difficulty in performing voluntary movements, feeling sleepy/dizzy/falling, headache, clouding of eye lens, drop in blood pressure (while raising to a standing position), and/or nausea. Consult your doctor if any of these side effects worsens.
Uses Of XAFINACT 100MG TABLET
- Manage Parkinson’s disease in adults
How XAFINACT 100MG TABLET Works
XAFINACT 100MG TABLET works by increasing the level of a substance called dopamine (responsible for the control of movement) in the brain which generally occurs in low levels in patient affected with Parkinson’s disease.
How to use XAFINACT 100MG TABLET
Take XAFINACT 100MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of XAFINACT 100MG TABLET
Common
- insomnia (sleeplessness)
- difficulty in performing voluntary movements
- feeling sleepy/dizzy/falling
- headache
- worsening of Parkinson’s disease
- clouding of the eye lens
- drop in blood pressure while raising to a standing position
- nausea
Uncommon
- urine infection
- skin cancer
- seeing things that are not there, feeling sad, abnormal dreams, fear, worry, confusion, mood swings
- increased interest in sex, abnormal thinking & perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction
- head discomfort, trouble speaking, memory impairment
- fainting
- blurred vision, blind spot, double vision, light sensitivity, disorders of the light sensitive layer at the back of your eye, red eyes, increased pressure in the eye
- sensation of room spinning, throbbing sensation, fast, slow or irregular heartbeat, high or low blood pressure, large and twisted veins
- cough, trouble breathing, runny nose
- constipation, heartburn, vomiting, dry mouth, diarrhoea, stomach pain, burning stomach, gas, feeling full, drooling, decreased or increased appetite
- mouth ulcer
- sweating, itching, red skin
- back/joint pain, cramps, stiffness, pain in legs/arms, muscle weakness
- sensation of heaviness
- increased urination at night, painful urination, trouble having sex in males
- extreme tiredness, feeling weak
- unsteady walking
- swelling of your feet
- pain
- feeling hot
- weight loss/gain
- foot fracture
Rare
- pneumonia, skin or tooth infection, viral infection
- sore throat, nasal allergy
- non-cancerous skin conditions/growth
- severe loss of weight
- uncontrollable urges, clouded consciousness, disorientation, wrong perception of images, reduced interest in sex, thoughts that you cannot get rid of, sensing that someone is out to get you
- premature ejaculation, uncontrollable urge to sleep, fear of social situations, suicidal thoughts, clumsiness, easy distraction
- loss of taste
- weak/slow reflexes
- scattering pain in the legs, continuous desire to move your legs
- feeling sleepy
- eye abnormalities, progressive weakening of vision due to diabetes, increased tears, night blindness, cross eyed
- heart attack, narrowing of blood vessel, tightening of the chest
- difficult/painful swallowing, peptic ulcer, retching, stomach bleeding
- jaundice
- loss of hair, blister, skin allergy, skin conditions, bruising, scaly skin, night sweats, painful skin, discoloration of the skin, psoriasis
- inflammation of spinal joints due to an autoimmune disorder
- pain in your sides, swelling of joints, musculoskeletal/muscular/neck/joint pain, cyst in the joint
- uncontrollable urge to urinate, increased urination, pus cells in urine, urinary hesitation
- prostate problem
- breast pain
- increased effect of the medicine, medicine intolerance
- feeling cold/unwell, fever
- dryness of skin, eye and mouth
- heart murmur
- bruising/swelling after injury
- blood vessel obstruction due to fat, head/mouth/skeletal injury
Stop taking XAFINACT 100MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- signs of hypertensive crisis (sudden severe increase in blood pressure) such as anxiety, blurred vision, seizures, and/or collapse
- signs of neuroleptic malignant syndrome (life threatening neurologic reaction to antipsychotic medicine) such as confusion, sweating, muscle rigidity, and/or high body temperature)
- serotonin syndrome (serious drug reaction) such as confusion, hypertension, stiff muscles, and/or hallucinations
- hypotension (low blood pressure)
How To Manage Side Effects
Nausea:
Take XAFINACT 100MG TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If you still feel nauseous, contact your doctor.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating – you don't have to eat or avoid any specific foods. Do not take any medicine for vomiting without your doctor's consultation. If vomiting does not get better, contact your doctor.
Constipation:
Eat plenty of fiber rich foods like fresh fruits, vegetables, cereals, and drink ample amount of water. Exercise more regularly. If you still feel constipated, contact your doctor.
Diarrhea:
Drink lots of fluids, like water or fruit juice to keep yourself hydrated. Check with your doctor before taking any medicine for diarrhea. If diarrhea does not get better, contact your doctor.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use alcohol-containing mouthwashes because they can make your mouth dry, use the one that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not get better.
Headache:
Drink plenty of water and get adequate rest. Try to be relaxed and stress free. Check with your doctor before taking any medicine for headache. If headache does not get better, consult your doctor.
Dizziness:
Lie down until dizziness is resolved, then get up slowly. Do not hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. If dizziness does not get better, consult your doctor.
Warning & Precautions
Pregnancy
XAFINACT 100MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. Women of childbearing potential should use effective contraceptive measures while taking XAFINACT 100MG TABLET. Consult your doctor before taking the medicine.
Breastfeeding
XAFINACT 100MG TABLET is not recommended for use in breastfeeding women as it is likely to be excreted in breast milk. Consult your doctor before taking the medicine.
Driving and Using Machines
Do not drive or operate machines if you feel excess sleepiness/dizzy after taking XAFINACT 100MG TABLET.
Kidney
XAFINACT 100MG TABLET should be used with caution in patients with kidney problems such as renal impairment. Consult your doctor before taking XAFINACT 100MG TABLET.
Liver
XAFINACT 100MG TABLET is not recommended for use if patients with severe liver problems. It should be used with caution in patients with mild to moderate hepatic impairment. Consult your doctor before taking XAFINACT 100MG TABLET.
Allergy
Do not take XAFINACT 100MG TABLET if you are allergic to Safinamide, and/or any other ingredients of this medicine.
Others
XAFINACT 100MG TABLET is not recommended for use if you:
- suffer from eye condition due to albinism (condition marked by lesser pigment in skin and eyes), retinal degeneration (loss of cells from light sensitive layer at the back of the eye), uveitis (inflammation of eye), inherited retinopathy (inherited vision disorders), and/or severe progressive diabetic retinopathy (progressive reduction of vision due to diabetes).
Use in Pediatrics:
XAFINACT 100MG TABLET is not recommended for use in children and adolescents (aged below 18 years) due to lack of data on safety and efficacy of the medicine. Consult your doctor before administering the medicine to the child.
Use in Geriatrics:
XAFINACT 100MG TABLET should be used with caution in elderly patients (aged 75 years/above). Consult your doctor before taking the medicine.
Interactions
A. Drug - Drug interactions:
Before taking XAFINACT 100MG TABLET, inform your doctor if you are taking any of the following medicines:
- monoamine oxidase (MAO) inhibitors (medicines used to manage depression) Ex. selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine
- pethidine (used to relieve severe pain)
- medicines used to manage cold/cough (Ex. dextromethorphan, ephedrine, pseudoephedrine)
- medicines used to manage anxiety and some personality disorders (Ex. fluoxetine, fluvoxamine)
- medicines used to manage major depression and other mood disorders (Ex. venlafaxine, duloxetine)
- medicines used in high cholesterol (Ex. rosuvastatin, pitavastatin, pravastatin)
- medicines used to manage bacterial infections (Ex. ciprofloxacin)
- medicines that affect the immune system (Ex. methotrexate)
- medicines used to manage metastatic carcinoma (Ex. topotecan)
- medicine used to manage pain and inflammation (Ex. diclofenac)
- medicines used to manage type 2 diabetes (Ex. glyburide, metformin)
- medicines used to manage viral infection (Ex. acyclovir, ganciclovir)
Overdosage:
If you or anyone else accidentally take too much of XAFINACT 100MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are raised blood pressure, anxiety, confusion, forgetfulness, sleepiness, lightheadedness, nausea, vomiting, dilated pupils, and/or involuntary jerky movements.
Synopsis
| Drug | : | Safinamide |
| Pharmacological Category | : | Monoamine oxidase type B (MAO-B) inhibitors |
| Therapeutic Indication | : | Parkinson’s disease |
| Dosage Forms | : | Tablet |
More Information
- Keep XAFINACT 100MG TABLET out of reach of children
- Store XAFINACT 100MG TABLET at room temperature
FAQs About XAFINACT 100MG TABLET
What is XAFINACT 100MG TABLET used for?
XAFINACT 100MG TABLET is used in the management of Parkinson’s disease, which is an age-related degenerative brain condition that cause unintended/uncontrollable movements in adults. It is also used to manage Parkinson’s disease in mid-late-stage patients when used with Levodopa or in combination with other anti-Parkinson’s disease.
What are the common side effects of taking XAFINACT 100MG TABLET?
The most common side effects of taking XAFINACT 100MG TABLET are insomnia (sleeplessness), difficulty in performing voluntary movements, feeling sleepy/dizzy/falling, headache, clouding of eye lens, drop in blood pressure (while raising to a standing position), and/or nausea. Consult your doctor if any of these side effects worsens.
How XAFINACT 100MG TABLET works?
XAFINACT 100MG TABLET works by increasing the level of a substance called dopamine (responsible for the control of movement) in the brain which generally occurs in low levels in patient affected with Parkinson’s disease.
How XAFINACT 100MG TABLET should be taken?
Take XAFINACT 100MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Can XAFINACT 100MG TABLET be used in pregnant women?
No, XAFINACT 100MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. Women of childbearing potential should use effective contraceptive measures while taking XAFINACT 100MG TABLET. Consult your doctor before taking the medicine.
References
1. Stoker TB, Greenland JC. Pharmacological treatment for Parkinson’s disease. Parkinson’s Disease: Pathogenesis and Clinical Aspects. Edition 2018. Page- 135 https://doi.org/10.15586/codonpublications.parkinsonsdisease.2018.ch7
2. Giossi, R., Carrara, F., Mazzari, M., Lo Re, F., Senatore, M., Schicchi, A., Corrù, F., Fittipaldo, V. A., Pani, A., Tramacere, I., Elia, A. E., & Scaglione, F. Overall Efficacy and Safety of Safinamide in Parkinson's Disease: A Systematic Review and a Meta-analysis. NIH National Library of Medicine. National center for biotechnology information. PMC PubMed Central. March 2021. [Accessed on 28th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004480/
3. Zambon S.p.A. Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 28th July 2022] https://www.medicines.org.uk/emc/files/pil.2159.pdf
Useful Diagnostic Tests
- Dopamine transporter (DAT) scan
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