TOPAMAX TABLETS 200MG

Active substance: TOPIRAMATE

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612 LEAFLET Topamax 20140715

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPAMAX TABLETS 200mg
(topiramate)
The name of your medicine is Topamax Tablets 200mg but will be
referred to as Topamax throughout the following leaflet.
Please note that information regarding other strengths 25mg, 50mg
and 100mg of Topamax Tablets may also be present in the below
leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.



Keep this leaflet. You may need to read it again

Topamax with food and drink



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

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.



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

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.

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

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

1

WHAT TOPAMAX IS AND WHAT IT IS USED FOR

Ask your doctor or pharmacist for advice before taking this
medicine.

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



WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPAMAX

Driving and using machines

to prevent migraine headaches in adults

2

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.

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

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

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

Talk to your doctor or pharmacist before taking Topamax if you:


have kidney problems, especially kidney stones, or are getting
kidney dialysis

If you take more Topamax than you should





See a doctor right away. Take the medicine pack with you

have a history of blood and body fluid abnormality (metabolic
acidosis)





have liver problems



have eye problems, especially glaucoma

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)



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)

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

It is important that you do not stop taking your medicine without first
consulting your doctor.



Do not take a double dose (two doses at the same time) to
make up for a forgotten dose

You should also talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topamax.

If you stop taking Topamax

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

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)

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

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



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)

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

Decreased or loss of sweating





Cold fingers and toes

Having thoughts of serious self-harm, trying to cause serious
self-harm



Feeling drunk



Learning disability

Uncommon (may affect up to 1 in 100 people)


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

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


Abnormally elevated mood



Loss of consciousness

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



Blindness in one eye, temporary blindness, night blindness



Lazy eye

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



Swelling in and around the eyes



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



Stuffy, runny nose or sore throat



Tingling, pain and/or numbness of various body parts



Sleepiness, tiredness



Inflammation of the liver, liver failure



Dizziness





Nausea, diarrhoea



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



Kidney disorder

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



Children and adolescents

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

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.



Shortness of breath



Cough

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.



Nose bleeds

Reporting of side effects



Fever, not feeling well, weakness



Vomiting, constipation, abdominal pain or discomfort,
indigestion, stomach or intestinal infection

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.



Dry mouth



Hair loss



Itching



Joint pain or swelling, muscle spasms or twitching, muscle
aches or weakness, chest pain

5

HOW TO STORE TOPAMAX





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Weight gain



Do not store above 25°C.



Keep the bottle tightly closed and store in original package to
protect the tablets 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.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

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

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)

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



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

What Topamax looks like and contents of the pack



Impaired, distorted, or no sense of smell



Unusual feeling or sensation that may precede a migraine or a
certain type of seizure

Topamax Tablets 200mg are round, salmon-coloured tablets
marked TOP on one side and 200 on the other.



Dry eye, sensitivity of the eyes to light, eyelid twitching, watery
eyes

What Topamax contains


Topamax Tablets 200mg contains 200mg of the active
ingredient topiramate.



Topamax also contains the following inactive ingredients:
lactose monohydrate, pregelatinized starch, carnauba wax,
microcrystalline cellulose, sodium starch glycollate, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol,
synthetic iron oxide (E172) and polysorbate 80.

Topamax Tablets 200mg are available in plastic bottles of 60
tablets.
Product Licence holder



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



Leaflet revision date: 15 July 2014

Bleeding gums, increased saliva, drooling, breath odour

Topamax is a registered trade mark of Johnson & Johnson, USA.



Excessive intake of fluids, thirst



Skin discolouration



Muscle stiffness, pain in side

Procured from within the EU and repackaged by the
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by either of the below manufacturers

Janssen Pharmaceutica N.V., Beerse, Belgium.



Cilag AG, Schaffhausen, Switzerland.

POM

PL 08747/0612

Topamax Tablets 200mg

612 LEAFLET Topamax 20140715

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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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