Zonisep 50mg Capsule 10’S

INTRODUCTION

ZONISEP 50MG CAPSULE contains Zonisamide which belongs to a group of medicines called Antiepileptics. It is used to treat partial seizures (affecting one part of the brain), which may or may not be followed by secondary generalisation (a seizure affecting all of the brain).

Seizures are bursts of electrical activity that affect the functioning of the brain. During treatment with ZONISEP 50MG CAPSULE, your doctor might regularly monitor your weight and your child’s blood bicarbonate levels and kidneys. Drink sufficient water to keep yourself hydrated during ZONISEP 50MG CAPSULE treatment.

Before taking ZONISEP 50MG CAPSULE, inform your doctor if you have any liver, eye or kidney problems, are underweight or are staying in a place where the weather is warm. ZONISEP 50MG CAPSULE should be used in pregnant and breastfeeding women only if your doctor finds it necessary.

ZONISEP 50MG CAPSULE is not recommended for use in children (aged less than 6 years or underweight). The most common side effects of ZONISEP 50MG CAPSULE include agitation, irritability, confusion, depression, etc. Consult your doctor if any of the symptoms deteriorate.

USES OF ZONISEP 50MG CAPSULE

ZONISEP 50MG CAPSULE is used to treat:

Partial seizures, which may or may not be followed by secondary generalisation
HOW ZONISEP 50MG CAPSULE WORKS

ZONISEP 50MG CAPSULE works by supressing electrical activities of the brain by altering the synthesis, release and degradation of certain nerve chemicals (glutamate, gamma-aminobutyric acid (GABA), dopamine, serotonin and acetylcholine).

DIRECTIONS FOR USE

Always take ZONISEP 50MG CAPSULE as advised by your physician. Swallow with a glass of water and do not crush or chew it. The exact dose of ZONISEP 50MG CAPSULE will be decided by your physician depending upon your age, disease severity and body weight. Do not stop taking ZONISEP 50MG CAPSULE unless your doctor advises you to stop.

SIDE EFFECTS OF ZONISEP 50MG CAPSULE
COMMON
Agitation, irritability, confusion, depression
Disturbed muscle coordination, dizziness, poor memory, sleepiness, double vision
Loss of appetite, reduced blood levels of bicarbonate
Sleeping difficulty, unusual thoughts, feeling anxious or emotional
Disturbed thoughts, loss of concentration, speech problem, abnormal skin sensation, shakiness, involuntary movement of the eyes
Kidney stones
Skin rashes, itching, allergic reactions, tiredness, flu-like symptoms, fever, hair loss
Ecchymosis (a small bruise caused due to blood leakage from broken blood vessels in the skin)
Loss of weight, nausea, indigestion, stomach pains, diarrhoea, constipation
Swelling of the feet and legs
Pneumonia, dehydration, decreased sweating (in children 6-17 years old)
UNCOMMON
Anger, aggression
Vomiting
Gall bladder inflammation, gallstones
Urinary stones
Lung infection/inflammation, urinary tract infections
Low blood potassium levels, convulsions/seizures
Abnormal liver enzymes (in children 6-17 years old)
RARE
Lupus erythematosus (an autoimmune disease causing scaly red patches on the skin, particularly on the face)
Irregular heartbeat, heart failure, clot in lungs
Inflammation of bile duct, food pipe or intestines, vomiting blood, cholestatic jaundice, stool incontinence, mouth ulceration
Low red blood cells or platelets, purple spot due to bleeding into the skin
Low blood sugar or sodium levels
Uncontrollable, jerky or reduced muscle movement, facial paralysis, increased physical sensitivity, upward eyeball movements
Breathlessness, coughing up blood
Light sensitivity, eye inflammation
Increased protein in urine, involuntary urination, bladder pain or calculus
Breast enlargement in men, breast inflammation, heavy menstrual bleeding

Stop taking ZONISEP 50MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:

Severe allergic reaction (difficulty breathing, swelling of face, lips or tongue, severe skin rash)
Signs of overheating (high body temperature, little or no sweating, rapid heartbeat and breathing, muscle cramps, confusion)
Thoughts of self-harm
Unusual muscle breakdown (muscle pain or weakness)
Kidney stones (sudden pain in back or stomach, pain on urinating, blood in urine)
Vision problems such as eye pain or blurred vision
Unexplained skin rash, leading to a more severe skin rash or peeling
Blood disorder (swollen glands, tiredness, sore throat, fever, easy bruising)
Increased blood acid levels (headache, feeling sleepy, shortness of breath, loss of appetite)
HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Take ZONISEP 50MG CAPSULE with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Drink lots of fluids, especially water. Have small sips if you feel sick. If symptoms persist, contact your doctor.

Diarrhea:

Drinking ample of water and other electrolyte balanced fluids (like diluted fruit juices, broths, sports drinks and caffeine-free sodas) will keep you hydrated throughout day. If the symptom persists, contact your doctor.

Constipation:

Have plenty of fiber rich foods like fresh fruits, vegetables, cereals and drink ample amount of water. Exercise more regularly. If symptom persists, contact your doctor.

Loss of appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you’re hungry. Eat a protein-rich or other healthy snack such as dried fruit and nuts. If appetite does not get better, contact your doctor.

Indigestion:

Keep your head and shoulders raised up while sleeping so that stomach acid won’t come up. Do not eat 3 to 4 hours before going to sleep and avoid tea, coffee, cola or alcohol. If symptom persists, contact your doctor.

Dizziness:

Lie down until dizziness gets better, then get up slowly. Don’t hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. If dizziness persists, consult your doctor.

Skin rash:

Avoid hot showers as it can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If symptom persists, contact your doctor.

Blurred vision:

Avoid driving or going outside on your own if you have blurred eyesight. Close your eyes for some time until your eyesight gets clear. Contact your doctor if your vision remains blur for a long period.

WARNING & PRECAUTIONS
PREGNANCY

ZONISEP 50MG CAPSULE should be used in pregnant women only if clearly necessary. Women of childbearing potential should take proper contraception till 1 month after stopping this treatment. Consult your doctor for advice.

BREASTFEEDING

ZONISEP 50MG CAPSULE should be used in breastfeeding women only if clearly necessary. Consult your doctor for advice.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel sleepy or if your concentration or ability to react/respond is affected after taking ZONISEP 50MG CAPSULE.

KIDNEY

ZONISEP 50MG CAPSULE should be used with caution in patients having kidney stones or other kidney problems. Consult your doctor for advice.

LIVER

ZONISEP 50MG CAPSULE should be used with caution in patients having liver problems. Consult your doctor for advice.

ALLERGY

Do not take ZONISEP 50MG CAPSULE if you are allergic to Zonisamide, other sulphonamide medicines (Ex. sulphonamide antibiotics, thiazide diuretics, sulfonylurea antidiabetes medicines) or any of the other ingredients of this medicine.

OTHERS

Before taking ZONISEP 50MG CAPSULE tell your doctor if you:

Have eye problems like glaucoma
Are staying in a place where the weather is warm
Are underweight or have lost a lot of weight

Use in Paediatrics:

ZONISEP 50MG CAPSULE is not recommended for use in children (aged less than 6 years, underweight or having a small appetite). ZONISEP 50MG CAPSULE should be used with caution in children (aged less than 12 years weighing below 20kg). Consult your child’s doctor for advice.

Use in Geriatrics:

ZONISEP 50MG CAPSULE should be used with caution in elderly patients. Consult your doctor for advice.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking ZONISEP 50MG CAPSULE, inform your doctor if you are taking any of the following medicines:

Phenytoin, carbamazepine, phenobarbitone, valproate, topiramate (medicines used to treat seizures)
Acetazolamide (used to treat eye problems like glaucoma)
Rifampicin (used to treat bacterial infections)
Digoxin, quinidine (used to treat irregular heartbeat and other heart problems)

Overdosage:

If you or anyone else accidentally take too much of ZONISEP 50MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are sleepiness, loss of consciousness, nausea, stomach pain, muscle twitches, eye movement, a slower heartbeat or reduced breathing.

SYNOPSIS
Drug :   Zonisamide
Pharmacological Category :   Antiepileptic
Therapeutic Indication :   Seizures
Dosage Forms :   Tablet, Capsule
MORE INFORMATION
Keep ZONISEP 50MG CAPSULE out of sight of children
Store ZONISEP 50MG CAPSULE at room temperature
FAQs ABOUT ZONISEP 50MG CAPSULE

Is there any special case that I should inform my doctor before taking ZONISEP 50MG CAPSULE?

Inform your doctor if you are a habitant of a place where the weather is warm. ZONISEP 50MG CAPSULE can make you perspire less, which can cause your body temperature to increase. The risk of overheating may be reduced by drinking sufficient water and keeping cool.

What will happen if I stop taking ZONISEP 50MG CAPSULE?

Do not stop taking ZONISEP 50MG CAPSULE without consulting your doctor even if you feel better as it may cause adverse effects. Pregnant women should not stop taking ZONISEP 50MG CAPSULE suddenly as it may lead to breakthrough seizures which may harm the unborn baby. If your doctor advises you to stop taking ZONISEP 50MG CAPSULE, your dose will be reduced gradually to reduce the risk of more seizures.

What if I miss a dose of ZONISEP 50MG CAPSULE?

If you miss a dose of ZONISEP 50MG CAPSULE, take it as soon as you remember. But skip that dose if it’s almost time for the next one. Do not take ZONISEP 50MG CAPSULE two times to make up for the missed dose.

Can ZONISEP 50MG CAPSULE use affect children?

ZONISEP 50MG CAPSULE can cause your child to sweat less and overheat, especially those living in hot weather. To avoid this, keep your child cool and make them avoid heavy exercise especially in hot weather. Give them plenty of cold water to drink and ask your doctor before giving them any other medicine. If your child’s skin feels very hot with little or no sweating, becomes confused, has muscle cramps or experience rapid heartbeat or breathing, take them to a cool, shaded place and sponge the skin with cool (not cold) water. Give your child cold water to drink and seek urgent medical assistance if symptoms do not resolve.

Can ZONISEP 50MG CAPSULE be taken in pregnancy?

You must only take ZONISEP 50MG CAPSULE during pregnancy if your doctor tells you to. If you are a woman of childbearing age, you must use proper contraception while taking ZONISEP 50MG CAPSULE and for one month after stopping it. If you are pregnant, think you may be pregnant or planning for pregnancy, you must tell your doctor straight away and discuss possible risks that ZONISEP 50MG CAPSULE might pose to your unborn baby.

REFERENCES

1. K.D. Tripathi. Antiepileptic Drugs. Essentials of Medical Pharmacology. 8th edition. 2019. Page 447.

2. Shang-Yeong Kwan. Yao-Chung Chuang, Chin-Wei Huang, Ta-Cheng Chen, Shuo-Bin Jou. Amitabh Dash. Zonisamide: Review of Recent Clinical Evidence for Treatment of Epilepsy. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. July 2015. [Accessed on 10th December 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6493109/

3. Eisai Inc. Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study). NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in May 2013] [Accessed on 10th December 2022]. https://clinicaltrials.gov/ct2/show/NCT00566254

4. Noucor Health S.A. Electronic Medicines Compendium (EMC). [Revised in July 2022] [Accessed on 10th December 2022]. https://www.medicines.org.uk/emc/files/pil.10067.pdf

5. Glenmark Pharmaceuticals Inc. Zonisamide. [Revised in September 2022] [Accessed on 10th December 2022]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe15e56e-8b86-4a65-825c-31d37dd81612&audience=professional

USEFUL DIAGNOSTIC TESTS
Complete Blood Count (CBC)
Electro-encephalograph (EEG)
Net Qty
1 N
Item Weight
17.5 g
Ingredient
ZONISAMIDE 50MG
Hsn Code
30049082
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