TOPAMAX 25 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2013

GB-IE - AW_83813

Topamax® 25, 50, 100 and 200 mg film-coated tablets
Topiramate
Topamax is registered trademark

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.

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

1 What Topamax is and what it is used for
Topamax belongs to a group of medicines
called “antiepileptic medicines.” It is used:
• alone to treat seizures in adults and children
over age 6

• with other medicines to treat seizures in adults
and children aged 2 years and above
• to prevent migraine headaches in adults

2 What you need to know before you take Topamax
Do not take Topamax

• if you are allergic (hypersensitive) to topiramate
or any of the other ingredients of Topamax
(listed in section 6)
• for migraine prevention if you are pregnant,
or you are able to become pregnant but you
are not using effective contraception
(see section ‘pregnancy and breast-feeding’
for further information)
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before using
Topamax.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Topamax if you:
• have kidney problems, especially kidney
stones, or are getting kidney dialysis
• have a history of blood and body fluid
abnormality (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet)
• are pregnant or could become pregnant
(see section ‘pregnancy and breast-feeding’
for further information)
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
using Topamax.
It is important that you do not stop taking your
medicine without first consulting your doctor.
You should also talk to your doctor before taking
any medicine containing topiramate that is given
to you as an alternative to Topamax.
You may lose weight if you use Topamax so your
weight should be checked regularly when using
this medicine. If you are losing too much weight
or a child using this medicine is not gaining
enough weight, you should consult your doctor.
A small number of people being treated with
antiepileptic medicines such as Topamax have
had thoughts of harming or killing themselves.
If at any time you have these thoughts,
immediately contact your doctor.

Other medicines and Topamax

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Topamax and certain other
medicines can affect each other. Sometimes
the dose of some of your other medicines or
Topamax will have to be adjusted.
Especially, tell your doctor or pharmacist if you
are taking:
• other medicines that impair or decrease your
thinking, concentration, or muscle coordination
(e.g., central nervous system depressant
medicines such as muscle relaxants and
sedatives)
• birth control pills. Topamax may make your
birth control pills less effective

Tell your doctor if your menstrual bleeding
changes while you are taking birth control pills
and Topamax.
Keep a list of all the medicines you take.
Show this list to your doctor and pharmacist
before you start a new medicine.
Other medicines you should discuss with your
doctor or pharmacist include other antiepileptic
medicines, risperidone, lithium,
hydrochlorothiazide, metformin, pioglitazone,
glyburide, amitriptyline, propranolol, diltiazem,
venlafaxine, flunarazine, St. John’s wort
(Hypericum perforatum) (a herbal preparation
used to treat depression).
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
using Topamax.

Topamax with food and drink

You can take Topamax with or without food.
Drink plenty of fluids during the day to prevent
kidney stones while taking Topamax. You should
avoid drinking alcohol when taking Topamax.

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. Your doctor will decide if you can take
Topamax. As with other antiepilepsy medicines,
there is a risk of harm to the unborn child if
Topamax is used during pregnancy. Make sure
you are very clear about the risks and the benefits
of using Topamax for epilepsy during pregnancy.
You should not take Topamax for migraine
prevention if you are pregnant or you are able
to become pregnant and you are not using
effective contraception.
Mothers who breast-feed while taking Topamax
must tell the doctor as soon as possible if the
baby experiences anything unusual.
Ask your doctor or pharmacist for advice before
taking this medicine.

Driving and using machines

Dizziness, tiredness and vision problems may
occur during treatment with Topamax. Do not
drive or use any tools or machines without
talking to your doctor first.

Topamax contains lactose

If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3 How to take Topamax
Always take this medicine exactly as your doctor
has told you. Check with your doctor
or pharmacist if you are not sure.
• Your doctor will usually start you on a low dose
of Topamax and slowly increase your dose
until the best dose is found for you
• Topamax tablets are to be swallowed whole.
Avoid chewing the tablets as they may leave
a bitter taste
• Topamax can be taken before, during, or after
a meal. Drink plenty of fluids during the day to
prevent kidney stones while taking Topamax

If you take more Topamax than you
should

• See a doctor right away. Take the medicine
pack with you
• You may feel sleepy, tired, or less alert;
lack coordination; have difficulty speaking or
concentrating, have double or blurred vision;
feel dizzy due to low blood pressure; feel
depressed or agitated; or have abdominal pain,
or seizures (fits)
Overdose can happen if you are taking other
medicines together with Topamax.

If you forget to take Topamax

• If you forget to take a dose, take it as soon
as you remember it. However, if it is almost
time for your next dose, skip the missed dose
and continue as usual. If you miss two or more
doses, contact your doctor
• Do not take a double dose (two doses at the
same time) to make up for a forgotten dose

If you stop taking Topamax

Do not stop taking this medicine unless told
to do so by your doctor. Your symptoms may
return. If your doctor decides to stop this
medication, your dose may be decreased
gradually over a few days.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor, or seek medical attention
immediately if you have the following side
effects:
Very common (may affect more than 1 in
10 people)
• Depression (new or worse)
Common (may affect up to 1 in 10 people)
• Seizures (fits)
• Anxiety, irritability, changes in mood,
confusion, disorientation
• Problems with concentration, slowness of
thinking, loss of memory, problems with
memory (new onset, sudden change or
increased severity)
• Kidney stone, frequent or painful urination
Uncommon (may affect up to 1 in
100 people)
• Increased acid level in the blood (may cause
troubled breathing including shortness of
breath, loss of appetite, nausea, vomiting,
excessive tiredness, and fast or uneven heart
beats)
• Decreased or loss of sweating
• Having thoughts of serious self-harm, trying to
cause serious self-harm

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Rare (may affect up to 1 in 1,000 people)
• Glaucoma – blockage of fluid in eye causing
increased pressure in the eye, pain, or
decreased vision
Other side effects include the following,
if they get serious, please tell your doctor
or pharmacist:
Very common (may affect more than 1 in
10 people)
• Stuffy, runny nose or sore throat
• Tingling, pain and/or numbness of various
body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss

© J-C 2013

GB-IE - AW_83813

4 Possible side effects (continued)
Common (may affect up to 1 in 10 people)
• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness,
itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger
• Difficulty falling or staying asleep
• Problems with speech or speech disorder,
slurred speech
• Clumsiness or lack of coordination, feeling of
unsteadiness when walking
• Decreased ability to complete routine tasks
• Decreased, loss of, or no sense of taste
• Involuntary trembling or shaking; rapid,
uncontrollable movements of the eyes
• Visual disturbance, such as double vision,
blurred vision, decreased vision, difficulty
focusing
• Sensation of spinning (vertigo), ringing in the
ears, ear pain
• Shortness of breath
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or
discomfort, indigestion, stomach or intestinal
infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or
twitching, muscle aches or weakness, chest pain
• Weight gain
Uncommon (may affect up to 1 in 100 people)
• Decrease in platelets (blood cells that help
stop bleeding), decrease in white blood cells
that help to protect you against infection,
decrease in potassium level in the blood
• Increase in liver enzymes, increase in
eosinophils (a type of white blood cell) in the
blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not
there, severe mental disorder (psychosis)
• Showing and/or feeling no emotion, unusual
suspiciousness, panic attack
• Problems with reading, speech disorder,
problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or
alertness
• Reduced or slow body movements, involuntary
abnormal or repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of
touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede
a migraine or a certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid
twitching, watery eyes
• Decreased or loss of hearing, loss of hearing
in one ear
• Slow or irregular heartbeat, feeling your heart
beating in your chest
• Low blood pressure, low blood pressure upon
standing (consequently, some people taking
Topamax may feel faint, dizzy, or may pass out
when they stand up or sit up suddenly)

• Flushing, feeling warm
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or wind, heartburn,
abdominal fullness or bloating
• Bleeding gums, increased saliva, drooling,
breath odour
• Excessive intake of fluids, thirst
• Skin discolouration
• Muscle stiffness, pain in side
• Blood in urine, incontinence (lack of control) of
urine, urgent desire to urinate, flank or kidney
pain
• Difficulty getting or keeping an erection, sexual
dysfunction
• Flu-like symptoms
• Cold fingers and toes
• Feeling drunk
• Learning disability
Rare (may affect up to 1 in 1,000 people)
• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness,
night blindness
• Lazy eye
• Swelling in and around the eyes
• Numbness, tingling and colour change (white,
blue then red) in fingers and toes when exposed
to the cold
• Inflammation of the liver, liver failure
• Stevens Johnson syndrome, a potentially lifethreatening condition that may present with
sores in multiple mucosal sites (such as the
mouth, nose, and eyes), a skin rash, and
blistering
• Abnormal skin odour
• Discomfort in your arms or legs
• Kidney disorder
• Increased acid level in the blood
Not known (frequency cannot be estimated
from the available data)
• Maculopathy is a disease of the macula,
the small spot in the retina where vision is
keenest. You should call your doctor if you
notice a change or decrease in your vision.
• Toxic epidermal necrosis, a life-threatening
condition related to, yet more severe than,
Stevens-Johnson syndrome, characterized by
widespread blistering and sloughing of the
outer layers of the skin (see rare side effects)
Children and adolescents
The side effects in children are generally similar
to those seen in adults. However, some side
effects are either seen more frequently in children
and/or can be more severe in children than in
adults. Side effects which may be more severe
include decreased or loss of sweating and
increase of the acid level in the blood. Side effects
which may occur more frequently in children
include upper respiratory tract illnesses.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

5 How to store Topamax
• Keep out of the sight and reach of children
• Do not use Topamax after the expiry date
which is on the blister/bottle/carton. The expiry
date refers to the last day of that month
• Do not store above 25°C. Store the tablets
in the original package (blister or bottle) to protect
from moisture. Keep the bottle tightly closed
to protect the tablets from moisture

• 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 Topamax contains

The active substance is topiramate.
Each Topamax film-coated tablet contains 25,
50, 100 or 200 mg of topiramate.
The other ingredients of Topamax are listed
below.
Core tablet:
Lactose Monohydrate, Pregelatinized Maize
Starch, Microcrystalline Cellulose, Sodium
Starch Glycolate (Type A), Magnesium Stearate.
Film-coating:
OPADRY® White, Yellow, Pink1, Carnauba Wax.
1OPADRY contains Hypromellose, Macrogol,
Polysorbate 80 and as colourants Titanium
Dioxide E171 (all strengths), Iron Oxide yellow
E172 (50 and 100 mg), and iron oxide red E172
(200 mg)

What Topamax looks like and
contents of the pack

Description of the product
25 mg: White round tablets, 6 mm in diameter,
“TOP” on one side, “25” on the other.
50 mg: Light yellow round tablets, 7 mm in
diameter, “TOP” on one side, “50” on the other.
100 mg: Yellow round tablets, 9 mm in diameter,
“TOP” on one side, “100” on the other.
200 mg: Salmon round tablets, 10 mm in
diameter, “TOP” on one side, “200” on the other.
Opaque plastic bottle with tamper-evident
closure containing 20, 28, 30, 50, 56, 60, 100 or
200 (2 x 100) tablets. In each bottle there
is a desiccant canister which should not be
swallowed.
Blister pack of an aluminium/aluminium foil in
strips. Pack sizes of 10, 20, 28, 30, 50, 56, 60,
100 or 200 (2 x 100) tablets.
Individual (alu/alu) blister strips are packed
inside a folding box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm
Way, High Wycombe, Bucks HP12 4EG, UK
Topamax film-coated tablets are made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
Janssen-Cilag S.p.A., 04010 Borgo S. Michele,
Latina, Italy
OR
McGregor Cory Limited, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

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This medicinal product is authorised in the
Member States of the EEA under the
following names:
Austria
Topamax – Filmtabletten
Belgium
Topamax tabletten
Bulgaria
TOPAMAX
Cyprus
TOPAMAX tabs
Czech Republic Topamax
Denmark
Topimax
Estonia
TOPAMAX
Finland
Topimax tabletti,
kalvopäällysteinen
France
EPITOMAX, COMPRIME
PELLICULE
Germany
Topamax
25<50><100><200> mg
Filmtabletten
Greece
TOPAMAC
Hungary
Topamax film-coated tablet
Iceland
Topimax filmuhúðaðar töflur
Ireland
Topamax Tablets
Italy
TOPAMAX compresse rivestite
con film, 60 compresse
Latvia
Topamax coated tablets
Lithuania
Topamax
Luxembourg
Topamax comprimés
Malta
Topamax
Netherlands
Topamax, filmomhulde
tabletten
Norway
Topimax Tabletter filmdrasjert
Poland
Topamax tabletki powlekane
Portugal
Topamax
Romania
TOPAMAX tablets
Slovak Republic Topamax
Slovenia
TOPAMAX filmsko oblozene
tablete
Spain
TOPAMAX Comprimidos
recubiertos
Sweden
Topimax tabletter,
filmdragerade
United Kingdom Topamax Tablets

For information in large
print, tape, CD or Braille,
telephone 0800 7318450
(UK) or 1800 709122 (IRE).
This leaflet was last revised in April 2013.

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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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