Skip to Content

ZONISAMIDE FLYNN 50 MG HARD CAPSULES

Active substance(s): ZONISAMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package Leaflet: Information for the patient

Zonisamide Flynn
25mg hard capsule
Zonisamide Flynn
50mg hard capsule
Zonisamide Flynn
100mg hard capsule
Zonisamide
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor
or pharmacist.
n This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
n If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zonisamide Flynn is and what it is used for
2. What you need to know before you take
Zonisamide Flynn
3. How to take Zonisamide Flynn
4. Possible side effects
5. How to store Zonisamide Flynn
6. Contents of the pack and other information

1 What Zonisamide Flynn is and
what it is used for
This medicine contains the active substance
zonisamide and is used as an antiepileptic medicine.
Zonisamide Flynn is used to treat seizures that affect
one part of the brain (partial seizure), which may or
may not be followed by a seizure affecting all of the
brain (secondary generalisation).
Zonisamide Flynn may be used:
n On its own to treat seizures in adults.
n With other antiepileptic medicines to treat seizures
in adults, adolescents, and children aged 6 years and
above.

2 What do you need to know before you take
Zonisamide Flynn
DO NOT take Zonisamide Flynn:
If you:
n are allergic to zonisamide or any of the other
ingredients of this medicine (listed in section 6).
n are allergic to other sulphonamide medicines.
Examples include: sulphonamide antibiotics,
thiazide diuretics, and sulfonylurea antidiabetic
medicines.
Warnings and precautions
Zonisamide Flynn belongs to a group of medicines
(sulphonamides) which can cause severe allergic
reactions, severe skin rashes, and blood disorders,
which very rarely can be fatal (see section 4. Possible
side effects).
Serious rashes occur in association with
Zonisamide Flynn therapy, including cases of
Stevens-Johnson syndrome.
Talk to your doctor or pharmacist before taking
Zonisamide Flynn if you:

younger than 12 years old, as you may be at
greater risk of decreased sweating, heat stroke,
pneumonia and liver problems. If you are younger
than 6 years old, Zonisamide Flynn is not
recommended for you.
n are an older person, as your dose of Zonisamide
Flynn may need adjusting, and you may be more
likely to develop an allergic reaction, severe skin
rash, swelling of the feet and legs, and itchiness
when taking Zonisamide Flynn.
n suffer from liver problems, as your dose of
Zonisamide Flynn may need adjusting.
n suffer from kidney problems as your dose of
Zonisamide Flynn may need adjusting.
n have previously suffered from kidney stones, as you
may be at increased risk of developing more kidney
stones. Reduce the risk of kidney stones by
drinking sufficient water.
n live in a place or are on holiday in a place where the
weather is warm. Zonisamide Flynn can make you
perspire less, which can cause your body
temperature to increase. Reduce the risk of
overheating by drinking sufficient water and
keeping cool.
n 
are underweight, or have lost a lot of weight as
Zonisamide Flynn can cause you to lose more
weight. Tell your doctor as this may need to be
monitored.
If any of these applies to you, tell your doctor before
you take Zonisamide Flynn
n are

Children and adolescents
Talk to your doctor about the following risks:
Preventing overheating and dehydration
in children
Zonisamide Flynn can cause your child to sweat less
and overheat and if your child is not treated this
can lead to brain damage and death. Children are
most at risk especially in hot weather.

When your child is taking Zonisamide Flynn:
n Keep your child cool especially in hot weather.
n Your child must avoid heavy exercise especially
when the weather is hot.
n Give your child plenty of cold water to drink.
n Your child must not take these medicines:
carbonic anhydrase inhibitors (like topiramate
and acetazolamide) and anticholinergic agents
(like clomipramine, hydroxyzine,
diphenhydramine, haloperidol, imipramine and
oxybutynin).
If your child’s skin feels very hot with little or no
sweating, becomes confused, has muscle cramps, or
your child’s heartbeat or breathing becomes rapid:
n Take your child to a cool, shaded place.
n Sponge your child’s skin with cool (not cold)
water.
n Give your child cold water to drink.
n Seek urgent medical assistance.
n Body weight: You should monitor your child’s
weight every month and see your doctor as soon
as possible if your child is not gaining enough
weight. Zonisamide Flynn is not recommended for
children who are underweight or have a small
appetite, and should be used with caution in those
below 20kg.
n Increased acid level in the blood and kidney stones:
Reduce these risks by ensuring that your child
drinks enough water and is not taking any other
medicine which could cause kidney stones (see
Other medicines and Zonisamide Flynn). Your doctor
will monitor your child’s blood bicarbonate levels
and kidneys (see also section 4).
Do not give this medicine to children below the age
of 6 years because it is not known for this age group
whether the potential benefits are greater than
the risks.

Other medicines and Zonisamide Flynn
Tell your doctor or pharmacist if you are taking, have
recently taken or might take, any other medicines,
including medicines.
n Zonisamide Flynn should be used carefully in adults
when taken with medicines that can cause kidney
stones, like topiramate or acetazolamide. In
children, this combination is not recommended.
n Zonisamide Flynn could possibly increase your blood
levels of medicines like digoxin and quinidine, and
so a reduction in their dose may be required.
n Other medicines like phenytoin, carbamazepine,
phenobarbitone and rifampicin can decrease your
blood levels of Zonisamide Flynn, which may require
an adjustment of your dose of Zonisamide Flynn.
Zonisamide Flynn with food and drink
Zonisamide Flynn can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
If you are a woman of childbearing age you must use
adequate contraception while taking and for one
month after stopping Zonisamide Flynn.
You must only take Zonisamide Flynn during your
pregnancy if your doctor tells you to. Research has
shown an increased risk of birth defects in children of
women taking anti-epileptic medicines.
Do not breast-feed whilst taking, or for one month
after stopping Zonisamide Flynn.
There are no clinical data available on the effects of
Zonisamide Flynn on human fertility. Studies in
animals have shown changes in fertility parameters.

Driving and using machines
Zonisamide Flynn may affect your concentration,
ability to react/respond, and may make you feel
sleepy, particularly at the beginning of your treatment
or after your dose is increased. Be especially careful
while driving or operating machinery, if Zonisamide
Flynn affects you in this way.

3 How to take Zonisamide Flynn
Always take this medicine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The recommended adult dose
When you take Zonisamide Flynn on its own:
n The starting dose is 100mg taken once a day.
n This may be increased by up to 100mg at intervals
of two weeks.
n The usual dose is 300mg once a day.
When you take Zonisamide Flynn with other
antiepileptic medicines:
n The starting dose is 50mg daily taken in two equal
doses of 25mg.
n This may be increased by up to 100mg at intervals
of one to two weeks.
n The usual daily dose is between 300mg and 500mg.
n Some people respond to lower doses. The dose may
be increased more slowly if you experience side
effects, are an older person or if you suffer from
kidney or liver problems.
Use in children (aged 6 to 11 years) and adolescents
(aged 12 to 17 years) weighing at least 20kg:
n The starting dose is 1mg per kg of body weight
taken once a day.
n This may be increased by 1mg per kg of body
weight at intervals of one to two weeks.
n The usual daily dose is 6 to 8mg per kg for a child
with a body weight of up to 55kg or 300 to 500mg
for a child with a body weight more than 55kg
(which ever dose is lower) taken once a day.

Example: A child who weighs 25kg should take 25mg
once a day for the first week, and then increase the
daily dose by 25mg at the start of each week until a
daily dose between 150 to 200mg is reached.
If you feel that the effect of Zonisamide Flynn is too
strong or too weak, talk to your doctor or pharmacist.
n Zonisamide Flynn capsules must be swallowed
whole with water.
n Do not chew the capsules.
n Zonisamide Flynn can be taken once or twice daily,
as instructed by your doctor.
n It you take Zonisamide Flynn twice a day, take half
the daily dose in the morning and half in the evening.
If you take more Zonisamide Flynn than
you should
If you may have taken more Zonisamide Flynn than
you should, tell a carer (relative or friend), your
doctor or pharmacist immediately, or contact your
nearest hospital casualty department, taking your
medicine with you. You may become sleepy and
could lose consciousness. You might also feel sick,
have a sore stomach, muscle twitches, eye movement,
feel faint, have a slowed heartbeat, and reduced
breathing and kidney function. Do not try to drive.
If you forget to take Zonisamide Flynn
n If you forget to take a dose, don’t worry: take the
next dose when it is due.
n Do not take double the dose to make up for the
forgotten dose.
If you stop taking Zonisamide Flynn
n Zonisamide Flynn is meant to be taken as a
long-term medicine. Do not reduce your dose or
stop your medicine unless your doctor tells you to.
n If your doctor advises you to stop taking
Zonisamide Flynn your dose will be reduced
gradually to lower the risk of more seizures.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Zonisamide Flynn belongs to a group of medicines
(sulphonamides) that can cause severe allergic
reactions, severe skin rashes, and blood disorders,
which very rarely can be fatal.
Contact your doctor immediately if you:
n have difficulty breathing, a swollen face, lips or
tongue, or a severe skin rash as these symptoms
may indicate that you are having a severe
allergic reaction.
n have signs of overheating - high body temperature
but little or no sweating, rapid heartbeat and
breathing, muscle cramps, and confusion.
n have thoughts of harming or killing yourself. A
small number of people being treated with
anti-epileptics such as Zonisamide Flynn have had
thoughts of harming or killing themselves.
n have pain in your muscles or a feeling of weakness,
as this may be a sign of abnormal muscle
breakdown which can lead to kidney problems.
n get a sudden pain in your back or stomach, have
pain on urinating (passing water) or notice blood in
your urine, as this may be a sign of kidney stones.
Contact your doctor as soon as possible if you:
n have an unexplained skin rash, as this could develop
into a more severe skin rash or skin peeling.
n feel unusually tired or feverish, have a sore throat,
swollen glands, or find that you bruise more easily,
as this may mean you have a blood disorder.
n have signs of increased acid level in the blood
- headaches, drowsiness, shortness of breath and
loss of appetite. Your doctor may need to monitor
or treat this.
Your doctor may decide that you should stop using
Zonisamide Flynn.

The most common side effects of Zonisamide Flynn
are mild. They occur during the first month of
treatment and usually decrease with continued
treatment. In children ages 6 – 17 years old, side
effects were consistent with those described below
with the following exceptions: pneumonia,
dehydration, sweating decreased (common) and
abnormal liver enzymes (uncommon).
Very common side effects: may affect
more than 1 in 10 people
n agitation, irritability, confusion, depression.
n poor muscle coordination, dizziness, poor memory,
sleepiness, double vision.
n loss of appetite, decreased blood levels of
bicarbonate (a substance that prevents your blood
from becoming acidic).
Common side effects: may affect
up to 1 in 10 people
n difficulty sleeping, strange or unusual thoughts,
feeling anxious or emotional.
n slowed thoughts, loss of concentration, speech
abnormalities, abnormal skin sensation (pins and
needles), tremor, involuntary movement of the eyes.
n kidney stones.
n skin rashes, itching, allergic reactions, fever,
tiredness, flu-like symptoms, hair loss.
n ecchymosis (a small bruise caused by blood leaking
from broken blood vessels in the skin).
n loss of weight, nausea, indigestion, stomach pains,
diarrhoea (loose stools), constipation.
n swelling of the feet and legs.
Uncommon side effects: may affect
up to 1 in 100 people
n anger, aggression, thoughts of suicide, suicide attempt.
n vomiting.
n gall bladder inflammation, gallstones.
n urinary stones.
n lung infection / inflammation, urinary tract
infections.
n low blood potassium levels, convulsions/seizures.

Very rare side effects: may affect
up to 1 in 10,000 people
n hallucinations, memory loss, coma, neuroleptic
malignant syndrome (inability to move, sweating,
fever, incontinence), status epilepticus (prolonged
or repeated seizures).
n breathing disorders, shortness of breath,
inflammation of the lungs.
n inflammations of the pancreas (severe pain in the
stomach or back).
n liver problems, kidney failure, increased blood levels
of creatinine (a waste product that your kidneys
should normally remove).
n severe rashes or skin peeling (at the same time you
may feel unwell or develop a fever).
n abnormal muscle breakdown (you may feel pain or
weakness in your muscles) which can lead to kidney
problems.
n swollen glands, blood disorders (reduction in the
number of blood cells, which can make infection
more likely and can make you look pale, feel tired
and feverish, and bruise more easily).
n decreased sweating, overheating.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme Website: www.
mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of
this medicine.

5 How to store Zonisamide Flynn
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which is
stated on the blister and the carton after EXP. The
expiry date refers to the last day of that month.

It is recommended to store the product below 30°C.
Do not use this medicine if you notice any damage to
the capsules, blister or carton or any visible signs of
deterioration in the medicine. Return the pack to
your pharmacist.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6 Contents of the pack and other information
What Zonisamide Flynn contains
The active substance is zonisamide.
Zonisamide Flynn 25mg hard capsules contain 25mg of
zonisamide. Zonisamide Flynn 50mg hard capsules
contain 50mg zonisamide. Zonisamide Flynn 100mg
hard capsules contain 100mg zonisamide.
n The other ingredients that are present in the
capsule contents are: Microcrystalline Cellulose,
Crospovidone, Hypromellose, Macrogol 3350, Sodium
Stearyl Fumarate.
n The capsule shell contains: Gelatin and Titanium
dioxide (E171). The 50mg capsule shell also contains:
Iron oxide black (E172). The 100mg capsule shell also
contains: Erythrosin (E127) and Patent blue V (E131).
What Zonisamide Flynn looks like and
contents of the pack
n Zonisamide Flynn 25mg hard capsules have a white
opaque body and a white opaque cap.
n Zonisamide Flynn 50mg hard capsules have a white
opaque body and a grey opaque cap.
n Zonisamide Flynn 100mg hard capsules have a
white opaque body and a red opaque cap
Zonisamide Flynn capsules are packaged in blister
packs supplied in boxes containing:
n 25mg: 14, 28, 56 and 84 hard capsules containing
white powder.

n 50mg:

14, 28, 56 and 84 hard capsules containing
white powder.
n 100mg: 28, 56, 84, 98 and 196 hard capsules
containing white powder.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland
The manufacturer is
Chanelle Medical
Loughrea
Co. Galway
Ireland
This medicinal product is authorised in the Member
States of the EEA under the following names:
TBA
This leaflet was last revised in 01/2016

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide