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ZONISAMIDE WAYMADE 25 MG HARD CAPSULES

Active substance(s): ZONISAMIDE / ZONISAMIDE

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Package leaflet: Information for the user
GB 724-9410-APIL

Zonisamide Waymade 25 mg hard capsules
Zonisamide Waymade 50 mg hard capsules
Zonisamide Waymade 100 mg 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 your 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.
What is in this leaflet
1. What Zonisamide Waymade is and what it is
used for
2. What you need to know before you take
Zonisamide Waymade
3. How to take Zonisamide Waymade
4. Possible side effects
5. How to store Zonisamide Waymade
6. Contents of the pack and other information

1. What Zonisamide Waymade is and
what it is used for
The name of your medicine is Zonisamide
Waymade 25 mg, 50 mg and 100 mg hard
capsules (referred to as Zonisamide Waymade in
this leaflet).
Zonisamide Waymade contains the active
substance zonisamide, and is used as an
antiepileptic medicine.
Zonisamide Waymade 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 Waymade 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.

2. What you need to know before you
take Zonisamide Waymade
Do not take Zonisamide Waymade:
If you:
• are allergic to zonisamide or any of the other
ingredients in this medicine (listed in section 6),
• are allergic to other sulphonamide medicines.
Examples include: sulphonamide antibiotics,
thiazide diuretics, and sulfonylurea antidiabetes
medicines.
Warnings and precautions
Zonisamide Waymade 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 therapy, including cases of
Stevens-Johnson syndrome.
Talk to your doctor or pharmacist before taking
Zonisamide Waymade:
• 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
Waymade is not recommended for you.
• if you are elderly, as your dose of zonisamide
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 Waymade
(see section 4 ‘Possible side effects’).
• if you suffer from liver problems, as your dose
of zonisamide may need adjusting.
• if you have eye problems such as glaucoma.
• if you suffer from kidney problems as your dose
of zonisamide 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
Waymade 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 Waymade 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 Waymade.
Children and adolescents
Talk to your doctor about the following risks:
Preventing overheating and dehydration in
children
Zonisamide 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 Waymade:
• 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
Waymade is not recommended for children
who are underweight or have a small appetite,
and should be used with caution in those below
20 kg.
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 section ‘Other medicines
and Zonisamide Waymade’). 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 Waymade
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other
medicines, including medicines obtained without a
prescription.






Zonisamide Waymade 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 Waymade 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,
which may require an adjustment of your dose
of Zonisamide Waymade.

Zonisamide Waymade with food and drink
Zonisamide Waymade 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 Waymade.
You must only take Zonisamide Waymade 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 Waymade.
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 Waymade 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 Waymade affects you in
this way.
Zonisamide Waymade 100 mg Capsules contain
Sunset yellow (E110) and Allura red (E129)
Zonisamide Waymade 100 mg hard capsules
contain a yellow colour called Sunset yellow
(E110) and a red colour called Allura red (E129),
which may cause allergic reactions.

3. How to take Zonisamide Waymade
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 Waymade on its
own
• The starting dose is 100 mg taken once a day.
• This may be increased by up to 100 mg at
intervals of two weeks.
• The recommended dose is 300 mg once a day.
When you take Zonisamide Waymade with
other antiepileptic medicines
• The starting dose is 50 mg daily taken in two
equal doses of 25 mg.
• This may be increased by up to 100 mg at
intervals of one to two weeks.
• The recommended daily dose is between 300
mg and 500 mg.
• 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.
Use in children (aged 6 to 11 years) and
adolescents (aged 12 to 17 years) weighing at
least 20 kg
• The starting dose is 1 mg per kg of body weight
taken once a day.
• This may be increased by 1 mg per kg of body
weight at intervals of one to two weeks.
• The recommended daily dose is 6 to 8 mg per
kg for a child with a body weight of up to 55 kg
or 300 to 500 mg for a child with a body weight
more than 55 kg (which ever dose is lower)
taken once a day.

Example: A child who weighs 25 kg sho
take 25 mg once a day for the first week
then increase the daily dose by 25 mg a
start of each week until a daily dose bet
150 to 200 mg is reached.

If you feel that the effect of Zonisamide Wa
is too strong or too weak, talk to your docto
pharmacist.





Zonisamide Waymade must be swallow
whole with water.
Do not chew the capsules.
Zonisamide Waymade can be taken onc
twice daily, as instructed by your doctor
If you take Zonisamide Waymade twice
take half the daily dose in the morning a
in the evening.

If you take more Zonisamide Waymade t
you should
If you may have taken more Zonisamide
Waymade than you should (or if somebody
has taken some of your medicine), tell a ca
(relative or friend), your doctor or pharmaci
immediately, or contact your nearest hospi
casualty department, taking your medicine
you.

You may become sleepy and could lose
consciousness. You might also feel sick, ha
sore stomach, muscle twitches, eye movem
feel faint, have a slowed heart beat, and re
breathing and kidney function. Do not try to

If you forget to take Zonisamide Wayma
• If you forget to take a dose, don't worry:
the next dose when it is due.
• Do not take a double dose to make up f
forgotten dose.

If you stop taking Zonisamide Waymade
Zonisamide Waymade is meant to be taken
long-term medicine. Do not reduce your do
stop your medicine unless your doctor tells
• If your doctor advises you to stop taking
Zonisamide Waymade, your dose will b
reduced gradually to lower the risk of m
seizures.

If you have any further questions on the us
product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause
effects, although not everybody gets them.

Zonisamide Waymade belongs to a group
medicines (sulphonamides) that can cause
allergic reactions, severe skin rashes, and
disorders, which very rarely can be fatal.

Serious side effects
Contact your doctor immediately if:
• you have difficulty breathing, a swollen
lips or tongue, or a severe skin rash as
symptoms may indicate that you are ha
severe allergic reaction.
• you have signs of overheating - high bo
temperature but little or no sweating, rap
heartbeat and breathing, muscle cramp
confusion.
• you have thoughts of harming or killing
yourself. A small number of people bein
treated with antiepileptics such as Zonis
Waymade have had thoughts of harmin
killing themselves.
• you have pain in your muscles or a feeli
weakness, as this may be a sign of abn
muscle breakdown which can lead to kid
problems.
• you get a sudden pain in your back or s
have pain on urinating (passing water) o
blood in your urine, as this may be a sig
kidney stones.
• you develop visual problems such as ey
or blurred vision while taking Zonisamid
Waymade.

Contact your doctor as soon as possibl
• you have an unexplained skin rash, as t
could develop into a more severe skin r
skin peeling.
• you feel unusually tired or feverish, have
throat, swollen glands, or find that you b
more easily, as this may mean you have
blood disorder.
• you have signs of increased acid level in
blood, headaches, drowsiness, shortnes
breath and loss of appetite. Your doctor
need to monitor or treat this.
Your doctor may decide that you should sto
Zonisamide Waymade.

The most common side effects of Zonisam
Waymade are mild. They occur during the
month of treatment and usually decrease w
continued treatment.

In children ages 6 – 17 years old, side effe
were consistent with those described below
the following exceptions: pneumonia, dehy
sweating decreased (common) and abnorm
enzymes (uncommon).

Very common side effects: may affect m
than 1 in 10 people
• agitation, irritability, confusion, depressi
• poor muscle coordination, dizziness, po
memory, sleepiness, double vision.
• loss of appetite, decreased blood levels
bicarbonate (a substance that prevents
blood from becoming acidic).

Common side effects: may affect up to 1
people
• difficulty sleeping, strange or unusual th
feeling anxious or emotional.
• slowed thoughts, loss of concentration,
abnormalities, abnormal skin sensation
and needles), tremor, involuntary movem
the eyes.
• kidney stones.
• skin rashes, itching, allergic reactions, f
tiredness, flu-like symptoms, hair loss.
• ecchymosis (a small bruise caused by b
leaking from broken blood vessels in the
• loss of weight, nausea, indigestion, stom
pains, diarrhoea (loose stools), constipa
• swelling of the feet and legs.

Example: A child who weighs 25 kg should
take 25 mg once a day for the first week, and
then increase the daily dose by 25 mg at the
start of each week until a daily dose between
150 to 200 mg is reached.
If you feel that the effect of Zonisamide Waymade
is too strong or too weak, talk to your doctor or
pharmacist.





Zonisamide Waymade must be swallowed
whole with water.
Do not chew the capsules.
Zonisamide Waymade can be taken once or
twice daily, as instructed by your doctor.
If you take Zonisamide Waymade twice a day,
take half the daily dose in the morning and half
in the evening.

If you take more Zonisamide Waymade than
you should
If you may have taken more Zonisamide
Waymade than you should (or if somebody else
has taken some of your medicine), 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 Waymade
• 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 Waymade
Zonisamide Waymade 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.
• If your doctor advises you to stop taking
Zonisamide Waymade, your dose will be
reduced gradually to lower the risk of more
seizures.

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.
• glaucoma, which is a blockage of fluid in the
eye causing increased pressure in the eye. Eye
pain, blurred vision or decreased vision may
occur and can be signs of glaucoma.
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 at: www.mhra.gov.uk/yellowcard

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

5. How to store Zonisamide Waymade

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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.
Do not store above 30°C.
Do not use 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.

Zonisamide Waymade 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.
Serious side effects
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.
• you have signs of overheating - high body
temperature but little or no sweating, rapid
heartbeat and breathing, muscle cramps, and
confusion.
• you have thoughts of harming or killing
yourself. A small number of people being
treated with antiepileptics such as Zonisamide
Waymade have had thoughts of harming or
killing themselves.
• you 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.
• you 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.
• you develop visual problems such as eye pain
or blurred vision while taking Zonisamide
Waymade.
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.
• you 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.
• you 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 Waymade.
The most common side effects of Zonisamide
Waymade 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.

Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer require.
These measures will help to protect
the environment.

6. Contents of the pack and
other information
What Zonisamide Waymade contain
The active substance in Zonisamide Waymade is
zonisamide.
Zonisamide Waymade 25 mg hard capsules
contain 25 mg zonisamide.
Zonisamide Waymade 50 mg hard capsules
contain 50 mg zonisamide.
Zonisamide Waymade 100 mg hard capsules
contain 100 mg zonisamide.
The other ingredients present in the capsule
contents are: microcrystalline cellulose,
hydrogenated vegetable oil, sodium laurilsulfate
and silica colloidal anhydrous.
The capsule shell contains: gelatin, titanium
dioxide (E171), shellac, propylene glycol and black
printing ink (contains: black iron oxide (E172),
shellac, propylene glycol, strong ammonia solution
(pH adjustment) and potassium hydroxide (pH
adjustment)).
Additionally the 100 mg capsule shell contains
Sunset yellow (E110) and Allura red (E129).
See Section 2 for important information about
the ingredients: Sunset yellow (E110) and
Allura red (E129).
What Zonisamide Waymade looks like and
contents of the pack
Zonisamide Waymade 25 mg hard capsules have
a size "4" white opaque body and a white opaque
cap and are imprinted with “I” on the cap and “22”
on the body in black ink.
Zonisamide Waymade 50 mg hard capsules have
a size "3" white opaque body and a grey opaque
cap and are imprinted with “I” on the cap and “21”
on the body in black ink.
Zonisamide Waymade 100 mg hard capsules
have a size "1" white opaque body and a red
opaque cap and are imprinted with “I” on the cap
and “20” on the body in black ink.
Zonisamide Waymade is packaged in blister packs
supplied in cartons containing:
25 mg:
14 capsules
50 mg:
56 capsules
100 mg:
56 capsules
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sovereign Medical, Sovereign House, Miles Gray
Road, Basildon, Essex SS14 3FR, UK
Manufacturer
Waymade Plc, Sovereign House, Miles Gray
Road, Basildon, Essex SS14 3FR, UK
This leaflet was last revised in: July 2017
PL 06464/3086
PL 06464/3087
PL 06464/3088

To request a copy of this leaflet in
Braille, large print or audio format,
contact the licence holder at the above
address or telephone: 01268 535200
(select option Medical Information) /
e-mail: info@waymade.co.uk

Expand Transcript

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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