INTRODUCTION
FLUGESIC 800MG TABLET contains Eslicarbazepine which belongs to the group of medicines called Antiepileptics. It is used to treat epilepsy on its own (monotherapy) in adults with newly diagnosed epilepsy and with other antiepileptic medicines (adjunctive therapy) in adults, adolescents and children above 6 years of age (who are experiencing seizures that affect one part of the brain). These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Epilepsy is a central nervous system (neurological) disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behaviour, sensations and sometimes loss of awareness.
FLUGESIC 800MG TABLET is not recommended for use in patients allergic to Eslicarbazepine or who have heart rhythm disorders such as second- or third-degree heart block, severe liver or kidney disease.
Before taking FLUGESIC 800MG TABLET, inform your doctor if you had a history of seizures, have pacemaker (device to control heartbeat) and blood problems such as anaemia.
FLUGESIC 800MG TABLET should be used with caution in pregnant women only if it is clearly necessary and it is not recommended for use in breastfeeding women.
This medicine is not recommended for use in children (below 6 years) and can be used with caution in children and adolescents (from 6 to 18 years) after consulting the doctor.
The most common side effects of taking FLUGESIC 800MG TABLET are dizziness, sleepiness, sensation of being unsteady, floating, nausea, vomiting, headache and diarrhoea. Consult your doctor if any of the above side effects worsens.
USES OF FLUGESIC 800MG TABLET
Treats epilepsy
HOW FLUGESIC 800MG TABLET WORKS
FLUGESIC 800MG TABLET works by stabilizing hyperexcited nerve cells in brain by blocking the voltage gated sodium channels that reduces repetitive abnormal nerve cell activity in brain which results in preventing the occurrence of epilepsy or seizures.
DIRECTIONS FOR USE
Take FLUGESIC 800MG 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. Do not stop taking FLUGESIC 800MG TABLET unless your doctor advice you to stop.
SIDE EFFECTS OF FLUGESIC 800MG TABLET
COMMON
Dizziness
Sleepiness
Nausea
Vomiting
Headache
Diarrhoea
Double or blurred vision
Difficulty in concentration
Tiredness
Feeling low in energy
Shaking
Skin rashes
Decreased appetite
Troubled sleep
Ataxia (difficulty in movement coordination)
UNCOMMON
Signs of allergic reactions such as sneezing, itchy, runny or blocked nose, watering eye
Constipation
Seizures
Cold intolerance, low body temperature, large tongue, thin and brittle fingernails, or hair
Yellowing of the skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, dark urine (liver problems)
High blood pressure
Low blood pressure ?
Dehydration
Abnormal eye movements, fuzzy vision, or red eye
Suffering falls, clumsiness
Poor memory or forgetfulness
Crying, feeling depressed, nervous, confused, poor interest or emotion
Inability to speak, write or understand
Agitation
Attention-deficit or hyperactivity disorder (a neurobehavioral disorder of childhood)
Irritability
Mood swings or hallucinations
Nose bleeding
Chest pain
Tingling or numbness sensation felt in any part of your body
Migraine (severe headache)
Burning sensation
Abnormal senses of touch, smell
Hearing difficulty, ringing in the ears
Swelling in legs and arms
Abdominal disturbances such as heartburn, stomach upset, pain, bloating
Dry mouth
Dark stools
Swollen gums or toothache
Sweating
Dry skin, itching and skin changes such as red skin
Hair loss
Signs of urinary tract infection such as strong, persistent urge to urinate, burning sensation while urinating
Weight loss
Muscle pain and weakness
Signs of bone metabolism disorder such as aching pain, increased bone fractures, weakened muscles
Flushing
Pain in limbs, cold limbs
Slow or irregular heartbeat
Sedation
Signs of neurological movement disorder (condition marked by twisting, repetitive movements or abnormal postures) such as tremor, pain, cramping
Anxiety
RARE
Thoughts of suicide or hurting yourself
Signs of pancytopenia (low blood count of red cell, white cells, and platelets) such as weakness, dizziness, trouble breathing, fast heartbeat, and fever
Signs of agranulocytosis (deficiency of immune cells) such as fever, chills, weakness, sore throat, bleeding gums, and bone pain
Stop taking and consult your doctor immediately if you experience:
Rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue (signs of an allergic reaction)
HOW TO MANAGE SIDE EFFECTS
Dizziness:
Lie down until the dizziness passes and get up slowly. Do not bend down suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids. Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition persists for long or gets worsened.
Headache:
Consume lots of water and take rest. Do not skip meals. Do not strain your eyes for long durations, such as watching screen. Avoid taking alcohol. Consult your doctor if the condition persists for long or gets worsened.
Nausea and Vomiting:
Try to take FLUGESIC 800MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor and inform if symptom gets worse.
Diarrhoea:
Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult your doctor and inform them if the symptom gets worse.
Constipation:
Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.
WARNING & PRECAUTIONS
PREGNANCY
FLUGESIC 800MG TABLET should be used with caution in pregnant women only if it is clearly necessary. Consult your doctor before taking.
BREASTFEEDING
FLUGESIC 800MG TABLET is not recommended for use in breastfeeding women as it passes into the breast milk. Consult your doctor before taking.
DRIVING AND USING MACHINES
Do not drive or operate any machinery if you feel dizzy, drowsy and vision disturbances after taking FLUGESIC 800MG TABLET.
KIDNEY
FLUGESIC 800MG TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patient with mild kidney disease. Consult your doctor before taking.
LIVER
FLUGESIC 800MG TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with mild to moderate liver disease. Consult your doctor before taking.
ALLERGY
FLUGESIC 800MG TABLET is not recommended for use if you are allergic to Eslicarbazepine or to any other ingredients of this medicine. ?
HEART DISEASE
FLUGESIC 800MG TABLET is not recommended for use in patients with heart diseases such as heart rhythm disorder (second- or third-degree heart block). It should be used with caution in patients with heart failure or heart attack. Consult your doctor before taking the medicine.
OTHERS
Before taking FLUGESIC 800MG TABLET inform the doctor if you:
Suffer from seizures causing widespread electric discharge that involved both sides of the brain
Have blood problems such as anaemia, bleeding disorders like haemophilia
Have pacemaker (device to control heartbeat) problems
Use in pediatrics:
FLUGESIC 800MG TABLET is not recommended for use in children (below 6 years). It should be used with caution in children and adolescents (from 6 to 18 years of age). Your doctor will prescribe the right dose depending on your child?s age, body weight and disease condition. Consult your doctor before taking.
Use in geriatrics:
FLUGESIC 800MG TABLET should be used with caution in elderly patients (above 65 years). Consult your doctor before taking.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking FLUGESIC 800MG TABLET inform your doctor if you are taking any of the following medicine:
Carbamazepine, oxcarbazepine, phenytoin, and phenobarbital (used to treat seizures)
Hormonal contraceptives such as contraceptive pill Ex. estrogen and progestin
Simvastatin, rosuvastatin (used to lower blood cholesterol levels)
Warfarin (used to prevent blood clots)
Amitriptyline (used to treat depression)
Diuretics (used to treat high blood pressure and reduce sodium level in blood) such as chlorthalidone, hydrochlorothiazide, metolazone
Medicines used to treat heart diseases such as beta blockers (Ex. propranolol), antiarrhythmics (Ex. amiodarone, verapamil)
Overdosage:
If you or anyone else accidently takes too much of FLUGESIC 800MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are unsteady walking and muscle weakness on one side of the body.
SYNOPSIS
Drug :??
Eslicarbazepine
Pharmacological Category :??
Anti-epileptic drugs
Therapeutic Indication :??
Epilepsy
Dosage Forms :??
Tablet
MORE INFORMATION
Keep FLUGESIC 800MG TABLET out of reach of children
Store at room temperature
FAQs ABOUT FLUGESIC 800MG TABLET
What is FLUGESIC 800MG TABLET used for?
FLUGESIC 800MG TABLET is used in the treatment of epilepsy which is used as a monotherapy in adults with newly diagnosed epilepsy and as an adjunctive therapy with other antiepileptic medicines to treat partial seizure (seizures that affect one part of the brain) in adults, adolescents, and children (above 6 years of age) which is also used to reduce number of seizures experienced by an affected individual.
What is the side effects of FLUGESIC 800MG TABLET?
The most common side effects of taking FLUGESIC 800MG TABLET are dizziness, sleepiness, sensation of being unsteady, spinning, or floating, nausea, vomiting, headache, and diarrhoea. Consult your doctor before taking.
What if forget to take FLUGESIC 800MG TABLET?
If you forget to take FLUGESIC 800MG TABLET, take it as early as you remember and carry on as usual. Do not take a double dose to make up for a forgotten dose.
When can I stop taking FLUGESIC 800MG TABLET?
Do not stop taking FLUGESIC 800MG TABLET suddenly. If you do so, you might suffer more seizures. Your doctor will decide your duration of taking this medicine. Let your doctor decide when to stop your treatment with FLUGESIC 800MG TABLET. The dose will be given prescribed according to your health condition.
What if I accidently take more FLUGESIC 800MG TABLET than I should?
If you or anyone else accidently takes too much of FLUGESIC 800MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are unsteady walking and muscle weakness on one side of the body.
Can heart patients take FLUGESIC 800MG TABLET?
FLUGESIC 800MG TABLET is not recommended for use in patients with heart diseases such as heart rhythm disorder (second- or third-degree heart block). It should be used with caution in patients with heart failure or heart attack. Consult your doctor before taking the medicine.
REFERENCES
1.?Gerald G. Briggs,?Roger K. Freeman,?Craig V Towers, Alicia B Forinash. ?Drugs in Pregnancy and Lactation. Eleventh edition. 2017. Page 1727-1730.
2. Graciana L. Galiana, Angela C. Gauthier, Richard H. Mattson. Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. September 2017. [Assessed 21st June 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629137/
3.?Eugen Trinka?,?Elinor Ben-Menachem?,?Pedro A Kowacs?Christian Elger?,?Birgit Keller??Kurt L?ffler?,?Jos? Francisco Rocha?,?Patr?cio Soares-da-Silva?. Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. NIH National Library of Medicine. National Center for Biotechnology Information. PubMed.gov. Febraury 2018. [Assessed 21st June 2022]?https://pubmed.ncbi.nlm.nih.gov/29369348/
4. G.L. Pharma GmbH. Electronic Medicines Compendium (EMC). [Revised in April 2020] [Assessed 21st June 2022]?https://www.medicines.org.uk/emc/files/pil.13077.pdf
5. Sunovion Pharmaceuticals Canada Inc. Eslicarbazepine acetate. [Revised in July 2019] [Assessed 21st June 2022]?https://www.sunovion.ca/monographs/aptiom.pdf
USEFUL DIAGNOSTIC TESTS
Complete blood count
Liver and thyroid function test
EEG Electroencephalogram
Net Qty
1 N
Item Weight
17.5 g
Ingredient
ESLICARBAZEPINE 800MG
Hsn Code
30049069
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