Skip to Content

ZONISAMIDE ARISTO 25 MG HARD CAPSULES

Active substance(s): ZONISAMIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the patient
Freifläche

Zonisamide Aristo 25 mg, 50 mg,
100 mg hard capsules

für
Laetus-Code

zonisamide
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.

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

1. What Zonisamide Aristo is and
what it is used for
Zonisamide Aristo contains the active substance
zonisamide, and is used as an antiepileptic
medicine. Zonisamide Aristo 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 Aristo 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 Aristo
Do not take Zonisamide Aristo: If you:
• are allergic to zonisamide or any of the other
ingredients in Zonisamide Aristo (listed in
section 6),
• are allergic to other sulphonamide medicines.
Examples include: sulphonamide antibiotics,
thiazide diuretics, and sulfonylurea
antidiabetes medicines.
Warnings and precautions
Zonisamide Aristo 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 Aristo therapy, including
cases of Stevens-Johnson syndrome.
Talk to your doctor or pharmacist before taking
Zonisamide Aristo 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
Aristo is not recommended for you.
• are elderly, as your dose of Zonisamide Aristo
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 Aristo (see
section 4 Possible side effects).
• suffer from liver problems, as your dose of
Zonisamide Aristo may need adjusting.
• suffer from kidney problems as your dose of
Zonisamide Aristo may need adjusting.
• 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.
• live in a place or are on holiday in a place
where the weather is warm. Zonisamide Aristo
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.
• are underweight, or have lost a lot of weight
as Zonisamide Aristo 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 Aristo.
Children and adolescents
Talk to your doctor about the following risks:
Preventing overheating and dehydration in
children
Zonisamide Aristo 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 Aristo:
• 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 Aristo
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 Other medicines).
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 Aristo
Please tell your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines, including medicines obtained
without a prescription.
• Zonisamide Aristo 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 Aristo 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 Aristo.
Zonisamide Aristo with food and drink
Zonisamide Aristo 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 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 Aristo.
Tell your doctor immediately if you might be, or
are pregnant, or are planning to get pregnant.
You must only take Zonisamide Aristo 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 Aristo.
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 Aristo 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 Aristo
affects you in this way.
Zonisamide Aristo 100 mg contains Ponceau
4 R (E124)
Ponceau 4 R (E124) may cause allergic reactions.

3. How to take Zonisamide Aristo
Always take Zonisamide Aristo 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 Aristo 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 Aristo 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 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 Aristo
is too strong or too weak, talk to your doctor or
pharmacist.
• Zonisamide Aristo capsules must be swallowed
whole with water.
• Do not chew the capsules.
• Zonisamide Aristo can be taken once or twice
daily, as instructed by your doctor.
• It you take Zonisamide Aristo twice a day, take
half the daily dose in the morning and half in
the evening.
If you take more Zonisamide Aristo than
you should
If you may have taken more Zonisamide
Aristo 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 Aristo
• If you forget to take a dose, don’t worry: take
the next dose when it is due.
• Do not take double the dose to make up for
the forgotten dose.
If you stop taking Zonisamide Aristo
• Zonisamide Aristo 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 Aristo 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, Zonisamide Aristo can cause
side effects, although not everybody gets them.
Zonisamide Aristo 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:
• 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
anti- epileptics such as Zonisamide Aristo 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 bloodheadaches, 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 Aristo.
The most common side effects of Zonisamide
Aristo 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.

GI582000-02/UK/1216

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
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 at: 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 Aristo
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.
This medicinal product does not require any
special storage conditions.
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 require. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Zonisamide Aristo contains
The active substance in Zonisamide Aristo is
zonisamide.
Zonisamide Aristo 25 mg hard capsules contain
25 mg zonisamide.
Zonisamide Aristo 50 mg hard capsules contain
50 mg zonisamide.
Zonisamide Aristo 100 mg hard capsules contain
100 mg zonisamide.
The other ingredients that are present
in the capsule contents are: cellulose,
microcrystalline, hydrogenated vegetable oil and
macrogolglycerol hydroxystearate.
The capsule shell contains: gelatin, titanium
dioxide (E171)
Additionally the 50 mg capsule shell contains
black iron oxide (E172).
Additionally the 100 mg capsule shell contains
Ponceau 4 R (E124) and quinolone yellow (E104).
What Zonisamide Aristo looks like and
contents of the pack
• Zonisamide Aristo 25 mg are white hard
gelatin capsules filled with white to off white
granules.
• Zonisamide Aristo 50 mg are hard gelatin
capsules with a white opaque body and grey
opaque cap and are filled with white to off
white granules.
• Zonisamide Aristo 100 mg are hard gelatin
capsules with a white opaque body and red
opaque cap and are filled with white to off
white granules.
Zonisamide Aristo 25 mg is available in blister
packs of 14 and 28 hard capsules.
Zonisamide Aristo 50 mg is available in blister
packs of 14, 28 and 56 hard capsules.
Zonisamide Aristo 100 mg is available in blister
packs of 28, 56 and 98 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This leaflet was last revised in November
2016.

50000180/1

+ 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.

Hide