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Active substance(s): TOPIRAMATE

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610 LEAFLET Topamax 20140724


Your medicine is known as Topamax Tablets 50mg but will be
referred to as Topamax throughout the following patient information

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).

Please note that information regarding other strengths 25mg,
100mg and 200mg of Topamax Tablets is also present in the below

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topamax.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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

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

Topamax with food and drink

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.


What Topamax is and what it is used for


What you need to know before you take Topamax


How to take Topamax


Possible side effects


How to store Topamax


Contents of the pack and other information

Ask your doctor or pharmacist for advice before taking this
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 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



Mothers who breast-feed while taking Topamax must tell the doctor
as soon as possible if the baby experiences anything unusual.

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


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

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

If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Topamax.

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)

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

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

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
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.

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


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)

Other medicines and Topamax

Anxiety, irritability, changes in mood, confusion, disorientation

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.

Problems with concentration, slowness of thinking, loss of
memory, problems with memory (new onset, sudden change or
increased severity)

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
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.

• 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

Rare (may affect up to 1 in 1,000 people)

Feeling drunk

Learning disability

Glaucoma – blockage of fluid in eye causing increased
pressure in the eye, pain, or decreased vision

Rare (may affect up to 1 in 1,000 people)

Other side effects include the following, if they get serious,
please tell your doctor or pharmacist:

Abnormally elevated mood

Very common (may affect more than 1 in 10 people)

Loss of consciousness

Blindness in one eye, temporary blindness, night blindness
Lazy eye

Stuffy, runny nose or sore throat

Tingling, pain and/or numbness of various body parts

Swelling in and around the eyes

Sleepiness, tiredness


Numbness, tingling and colour change (white, blue then red) in
fingers and toes when exposed to the cold

Nausea, diarrhoea

Inflammation of the liver, liver failure

Weight loss

Stevens Johnson syndrome, a potentially life-threatening
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

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


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

• Kidney disorder
Not known (frequency cannot be estimated from the available

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



Do not store your tablets above 25°C.

Store in the original package & keep the bottle tightly closed to
protect from moisture.

Do not use Topamax after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.

Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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


Restlessness, hyperactivity

What Topamax Tablets contain

Slowed thinking, decreased wakefulness or alertness

Reduced or slow body movements, involuntary abnormal or
repetitive muscle movements

Topamax Tablets 50mg contains 50mg of the active ingredient


Abnormal sense of touch; impaired sense of touch

Impaired, distorted, or no sense of smell

The other ingredients of Topamax are listed below.
Core tablet: Lactose Monohydrate, Pregelatinized Maize
Starch, Microcrystalline Cellulose, Sodium Starch Glycolate,
Magnesium Stearate.

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

Decreased or loss of hearing, loss of hearing in one ear

Slow or irregular heartbeat, feeling your heart beating in your

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

Film-coating: carnauba wax, Opadry Light Yellow.
Opadry Light Yellow contains Hypromellose 2910 E464,
Macrogol, Polysorbate 80 and as colourants Titanium Dioxide
E171, Iron Oxide yellow E172.
What Topamax Tablets look like and contents of the pack
Topamax Tablets 50mg are round, pale yellow tablets marked TOP
on one side and 50 on the other.
Topamax Tablets 50mg are available in plastic bottles of 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
This product is manufactured by

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340
Beerse, Belgium or

Cilag AG, Schaffhausen, Switzerland.

PL 08747/0610 Topamax Tablets 50mg

Leaflet revision date: 24 July 2014
Topamax is a registered trade mark of Johnson & Johnson, USA.
610 LEAFLET Topamax 20140724

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