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TOPAMAX 200MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Topamax® 200mg Tablets
(topiramate)
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.
.

1. What Topamax is and what it is used for
Topamax belongs to a group of medicines called
‘anti-epileptic medicines.’ It is used:
alone to treat seizures in adults and children over
age 6

2. What you need to know before you take
Topamax
Do not take Topamax
if you are allergic to topiramate or any of the other
ingredients of this medicine (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:

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)

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

The name of your medicine is Topamax 200mg Tablets
but will be referred to as Topamax throughout this leaflet.
Please note that this leaflet also contains information
about other strengths such as Topamax 25mg, 50mg and
100mg Tablets.
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

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

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 anti-epileptic 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 and breast-feeding
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 discuss use of contraceptives with you,
as well as discussing whether Topamax is suitable for
you. As with other anti-epileptic 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.
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.
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.

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 (particularly in young
children who are exposed to high temperatures)
Having thoughts of serious self-harm, trying to cause
serious self-harm
Loss of part of the field of vision

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
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, abnormal behaviour
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
Cough
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 heart beat, 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)

5. How to store Topamax
Keep out of the sight and reach of children.
Do not store above 25°C. Keep in original package to
protect from moisture.
..

6

Contents of the pack and other information

What Topamax contains
The active substance in Topamax is topiramate. Each
tablet contains 200mg topiramate. The other ingredients
are: lactose hydrous, pregelatinised corn starch,
microcrystalline cellulose, sodium starch glycolate,
magnesium stearate, carnauba wax, hypromellose,
titanium dioxide, polyethylene glycol, polysorbate 80 and
synthetic iron oxide.
What Topamax tablets look like and contents of the
pack
Topamax are round, salmon-coloured tablets, engraved
with ‘TOP’ on one side and ‘200’ on the other. Topamax is
available in blister strips packs of 60 tablets.

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
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, characterised by widespread blistering and
sloughing of the outer layers of the skin (see rare side
effects)
Children
The side effects in children are generally similar to those
seen in adults, but the following side effects may be more
common in children than adults:
Problems with concentration
Increased acid level in the blood
Having thoughts of serious self-harm
Tiredness
Decreased or increased appetite
Aggression, abnormal behaviour
Difficulty falling or staying asleep
Feeling of unsteadiness when walking
Not feeling well
Decrease in potassium level in the blood
Showing and/or feeling no emotion
Watery eyes
Slow or irregular heart beat
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)
Sensation of spinning (vertigo)
Vomiting
Fever
Uncommon (may affect up to 1 in 100 people)
Increase in eosinophils (a type of white blood cell) in
the blood
Hyperactivity
Feeling warm
Learning disability
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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine

Do not use Topamax after the expiry date which is
stated on the label. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via waste water
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help protect the environment.
Manufactured by: Janssen Pharmaceutica N.V
Turnhoutseweg 30, 2340 Beerse, Belgium.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Topamax® 200mg Tablets, PL 18799/2144 POM
Leaflet date: 11.02.2016
Topamax is a registered trademark of Janssen-Cilag..

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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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