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ZONISAMIDE ACTAVIS 100MG HARD CAPSULES

Active substance(s): ZONISAMIDE

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Children and adolescents

Talk to your doctor about the following risks:
Package leaflet: Information for the user

Zonisamide Actavis 25mg, 50mg
and 100mg Hard Capsules
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• 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.
• 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.
• The full name of this medicine is Zonisamide Actavis
25mg, 50mg and 100mg Hard Capsules but within the
leaflet it will be referred to as Zonisamide Capsules.

What is in this leaflet
1 What Zonisamide Capsules are and what they
are used for
2 What you need to know before you take
Zonisamide Capsules
3 How to take Zonisamide Capsules
4 Possible side effects
5 How to store Zonisamide Capsules
6 Contents of the pack and other information
1 What Zonisamide Capsules are and what they

are used for

Zonisamide Capsules contain the active substance zonisamide
and is used as an antiepileptic medicine.
Zonisamide Capsules are 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 Capsules may be used:
• On its own to treat seizures in adults.
• With other antiepileptic medicines to treat seizures in adults,
adolescents and children aged 6 years and above.

Preventing overheating and dehydration in children
Zonisamide Capsules 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 Capsules:
• Keep your child cool especially in hot weather
• Your child must avoid heavy exercise especially when the
weather is hot
• Give your child plenty of cold water to drink
• 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:
• Take your child to a cool, shaded place
• Sponge your child’s skin with cool (not cold) water
• Give your child cold water to drink
• Seek urgent medical assistance.
• 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
Capsules are not recommended for children who are
underweight or have a small appetite and should be used
with caution in those below 20kg.
• 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
Capsules). 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 Capsules

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
• Zonisamide Capsules 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.
• Zonisamide Capsules could possibly increase your blood
levels of medicines like digoxin and quinidine and so a
reduction in their dose may be required.
• Other medicines like phenytoin, carbamazepine,
phenobarbitone and rifampicin can decrease your blood
levels of Zonisamide Capsules, which may require an
adjustment of your dose of Zonisamide Capsules.

Zonisamide Capsules with food and drink

2 What you need to know before you take

Zonisamide Capsules can be taken with or without food.

Zonisamide Capsules

Pregnancy, breast-feeding and fertility

Do not take Zonisamide Capsules:

• if you are allergic to zonisamide or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to other sulfonamide medicines. Examples
include: sulfonamide antibiotics, thiazide diuretics and
sulfonylurea antidiabetes medicines.

Warnings and precautions

Zonisamide Capsules belong to a group of medicines
(sulfonamides) 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 Capsules therapy, including cases of
Stevens-Johnson syndrome.
Talk to your doctor or pharmacist before taking Zonisamide
Capsules
• if you are 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 Capsules are not recommended for you.
• if you are elderly, as your dose of Zonisamide Capsules 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 Capsules (see
section 4 Possible side effects).
• if you suffer from liver problems, as your dose of Zonisamide
Capsules may need adjusting.
• if you suffer from kidney problems as your dose of
Zonisamide Capsules may need adjusting.
• if you 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.
• if you live in a place or are on holiday in a place where
the weather is warm. Zonisamide Capsules 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.
• if you are underweight, or have lost a lot of weight as
Zonisamide Capsules 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 Capsules.

If you are a woman of childbearing age you must use
adequate contraception while taking and for one month after
stopping Zonisamide Capsules.
Tell your doctor immediately if you might be or are pregnant
or are planning to get pregnant. You must only take
Zonisamide Capsules during your pregnancy if your doctor
tells you to. Research has shown an increased risk of birth
defects in children of women taking antiepileptic medicines.
Do not breast-feed whilst taking or for one month after
stopping Zonisamide Capsules.
There are no clinical data available on the effects of zonisamide
on human fertility. Studies in animals have shown changes in
fertility parameters.

Driving and using machines

Zonisamide Capsules 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 Capsules affects you in this way.

3 How to take Zonisamide Capsules
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

The usual adult dose
When you take Zonisamide Capsules on its own:

• The starting dose is 100mg taken once a day.
• This may be increased by up to 100mg at intervals of two
weeks.
• The recommended dose is 300mg once a day.

When you take Zonisamide Capsules with other
antiepileptic medicines:

• The starting dose is 50mg daily taken in two equal doses of
25mg.
• This may be increased by up to 100mg at intervals of one to
two weeks.
• The recommended daily dose is between 300mg and
500mg.
• Some people respond to lower doses. The dose may be
increased more slowly if you experience side effects, are
elderly or if you suffer from kidney or liver problems.

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Zonisamide 25mg 50mg and 100mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAI8661

dimensions:

print proof no:

4

pharmacode:

origination date: 15.03.16
approved for print/date

min pt size:

190 x 380

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

18.03.16

Technical Approval

revised by:

jh

date sent:

supplier:

Dupnitsa

technically app. date: 17.03.16

15.03.16

Non Printing Colours
1.
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Use in children and adolescents
Use in children (aged 6 to 11 years) and adolescents
(aged 12 to 17 years) weighing at least 20kg:

• The starting dose is 1mg per kg of body weight taken once a
day.
• This may be increased by 1mg per kg of body weight at
intervals of one to two weeks.
• The recommended 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 Capsules is too strong
or too weak, talk to your doctor or pharmacist.
• Zonisamide Capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Capsules can be taken once or twice daily, as
instructed by your doctor.
• If you take Zonisamide Capsules twice a day, take half the
daily dose in the morning and half in the evening.
If you take more Zonisamide Capsules than you should
If you may have taken more Zonisamide Capsules 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 heart beat and reduced
breathing and kidney function. Do not try to drive.
If you forget to take Zonisamide Capsules
If you forget to take a dose, don’t worry: take the next dose
when it is due.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zonisamide Capsules
Zonisamide Capsules are meant to be taken as a long-term
medicine. Do not reduce your dose or stop your medicine
unless your doctor tells you to.
If your doctor advises you to stop taking Zonisamide Capsules
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 Capsules belong to a group of medicines
(sulfonamides) that can cause severe allergic reactions, severe
skin rashes and blood disorders, which very rarely can be fatal.

Contact your doctor immediately if you:

• 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.
• have signs of overheating - high body temperature but
little or no sweating, rapid heartbeat and breathing, muscle
cramps and confusion.
• have thoughts of harming or killing yourself. A small
number of people being treated with antiepileptics such
as Zonisamide Capsules have had thoughts of harming or
killing themselves.
• 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.
• 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:

• have an unexplained skin rash, as this could develop into a
more severe skin rash or skin peeling.
• 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.
• 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 Capsules.
The most common side effects of Zonisamide Capsules
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
• agitation, irritability, confusion, depression
• poor muscle coordination, dizziness, poor memory,
sleepiness, double vision
• 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
• difficulty sleeping, strange or unusual thoughts, feeling
anxious or emotional
• slowed thoughts, loss of concentration, speech
abnormalities, abnormal skin sensation (pins and needles),
tremor, involuntary movement of the eyes
• kidney stones

• skin rashes, itching, allergic reactions, fever, tiredness, flu-like
symptoms, hair loss
• ecchymosis (a small bruise caused by blood leaking from
broken blood vessels in the skin)
• loss of weight, nausea, indigestion, stomach pains,
diarrhoea (loose stools), constipation
• swelling of the feet and legs.

Uncommon side effects: may affect up to 1 in 100
people
• anger, aggression, thoughts of suicide, suicide attempt
• vomiting
• gall bladder inflammation, gallstones
• urinary stones
• lung infection / inflammation, urinary tract infections
• low blood potassium levels, convulsions/seizures.

Very rare side effects: may affect up to 1 in 10,000
people

• hallucinations, memory loss, coma, neuroleptic malignant
syndrome (inability to move, sweating, fever, incontinence),
status epilepticus (prolonged or repeated seizures)
• breathing disorders, shortness of breath, inflammation of
the lungs
• inflammations of the pancreas (severe pain in the stomach
or back)
• liver problems, kidney failure, increased blood levels of
creatinine (a waste product that your kidneys should
normally remove)
• severe rashes or skin peeling (at the same time you may feel
unwell or develop a fever)
• abnormal muscle breakdown (you may feel pain or
weakness in your muscles) which can lead to kidney
problems
• 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)
• decreased sweating, overheating.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 Capsules
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 carton and blister after EXP. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
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 protect
the environment.

6 Contents of the pack and other information

What Zonisamide Capsules contain

• The active substance is zonisamide. Zonisamide 25mg Hard
Capsules contain 25mg of zonisamide. Zonisamide 50mg
Hard Capsules contain 50mg zonisamide. Zonisamide
100mg Hard Capsules contain 100mg zonisamide.
• The other ingredients are:

Capsule content: Microcrystalline cellulose, magnesium
stearate.

Capsule shell: Gelatin, titanium dioxide (E171), sodium
laurilsulfate, purified water, black iron oxide (E172) (50mg
hard capsules).

Printing ink: Shellac, black iron oxide (E172) and potassium
hydroxide.
What Zonisamide Capsules look like and contents of the
pack
Zonisamide 25mg Hard Capsules: White to off-white
granular powder in hard capsules, size 4 (14.3mm x 5.31mm),
with a white to off‑white capsule body and a white to off-white
capsule cap. The cap is imprinted with “A730” in black ink.
Zonisamide 50mg Hard Capsules: White to off-white
granular powder in hard capsules, size 3 (15.9mm x 5.82mm),
with a white to off‑white capsule body and a grey capsule cap.
The cap is imprinted with “A735” in black ink.
Zonisamide 100mg Hard Capsules: White to off-white
granular powder in hard capsules, size 1 (19.4mm x 6.91mm),
with a white to off‑white capsule body and a white to off‑white
capsule cap. The cap is imprinted with “A740” in black ink.
Zonisamide Capsules are packaged in blisters supplied in
boxes containing:
• 25mg: 14 Hard Capsules
• 50mg and 100mg: 56 Hard Capsules
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str, Dupnitsa 2600, Bulgaria
This leaflet was last revised in March 2016.

If you would like a
leaflet with larger text,
please contact
01271 385257.

Continued top of next column
Actavis, Barnstaple, EX32 8NS, UK

AAAI8661

Zonisamide 25mg 50mg and 100mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAI8661

dimensions:

print proof no:

4

pharmacode:

origination date: 15.03.16
approved for print/date

min pt size:

190 x 380

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

18.03.16

Technical Approval

revised by:

jh

date sent:

supplier:

Dupnitsa

technically app. date: 17.03.16

15.03.16

Non Printing Colours
1.
2.
3.

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.

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