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TOPAMAX 200MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

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612 LEAFLET Topamax 20171129

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPAMAX® 200mg FILM-COATED TABLETS
(topiramate)
The name of your medicine is Topamax 200mg Film-coated Tablets
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.


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

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 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 antiepileptic 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.

1

What Topamax is and what it is used for

2

What you need to know before you take Topamax

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

3

How to take Topamax

Driving and using machines

4

Possible side effects

5

How to store Topamax

6

Contents of the pack and other information

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

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 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.
Topamax may in rare cases cause high levels of ammonia in the
blood (seen in blood tests) which can lead to a change in brain
function, especially if you are also taking a medicine called valproic
acid or sodium valproate. Since this may be a severe condition, tell
your doctor immediately if the following symptoms occur (see also
section 4 ‘Possible side effects’):


difficulty thinking, remembering information, or solving problems



being less alert or aware



feeling very sleepy with low energy

At higher doses of Topamax, the risk of developing these symptoms
may increase.
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

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 (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



Difficulty thinking, remembering information, or solving
problems, being less alert or aware, feeling very sleepy with low
energy – these symptoms may be a sign of a high level of
ammonia in the blood (hyperammonemia), which can lead to a
change in brain function (hyperammonemic encephalopathy).

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

Tell your doctor if your menstrual bleeding changes while you are
taking birth control pills and Topamax.

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


Stuffy, runny nose or sore throat

Keep a list of all the medicines you take. Show this list to your
doctor and pharmacist before you start a new medicine.



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)

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.



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



Problems with concentration





Increased acid level in the blood

Decreased ability to complete routine tasks





Having thoughts of serious self-harm

Decreased, loss of, or no sense of taste





Tiredness

Involuntary trembling or shaking; rapid, uncontrollable
movements of the eyes



Decreased or increased appetite



Visual disturbance, such as double vision, blurred vision,
decreased vision, difficulty focusing



Aggression, abnormal behaviour



Difficulty falling or staying asleep



Sensation of spinning (vertigo), ringing in the ears, ear pain



Feeling of unsteadiness when walking

Shortness of breath



Not feeling well

Cough



Decrease in potassium level in the blood



Nose bleeds



Showing and/or feeling no emotion



Fever, not feeling well, weakness



Watery eyes



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



Slow or irregular heartbeat






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
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:



Dry mouth

Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)



Hair loss



Sensation of spinning (vertigo)



Itching



Vomiting



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



Fever

Uncommon (may affect up to 1 in 100 people)

 Weight gain
Uncommon (may affect up to 1 in 100 people)



Increase in eosinophils (a type of white blood cell) in the blood





Hyperactivity



Feeling warm

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

 Learning disability
Reporting of side effects



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

5

HOW TO STORE TOPAMAX



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Problems with reading, speech disorder, problems with
handwriting



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.
CONTENTS OF THE PACK AND OTHER INFORMATION

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 in UK via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting
side effects, you can help provide more information on the safety of
this medicine.



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

6



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



Slow or irregular heartbeat, feeling your heart beating in your
chest



Each Film-coated tablet contains 200mg of topiramate.



Topamax also contains the following inactive ingredients:



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)

What Topamax contains

Core tablets:
lactose monohydrate, pregelatinized starch, microcrystalline
cellulose, sodium starch glycollate, magnesium stearate,



Flushing, feeling warm

Film coating:



Pancreatitis (inflammation of the pancreas)

carnauba wax and Opadry Pink



Excessive passing of gas or wind, heartburn, abdominal
fullness or bloating

The Opadry Pink contains:



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

hypromellose, titanium dioxide (E171), macrogol, red iron oxide
(E172) and polysorbate 80.
What Topamax looks like and contents of the pack
Topamax 200mg Film-coated Tablets are round, salmon-coloured
tablets marked TOP on one side and 200 on the other.
Topamax 200mg Film-coated Tablets 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.
Manufacturer

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

This product is manufactured by either of the below manufacturers-



Abnormally elevated mood



Loss of consciousness






Blindness in one eye, temporary blindness, night blindness



Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-2340
Beerse, Belgium.
Cilag AG, Schaffhausen, Switzerland.
Janssen-Cilag S.p.a, 04010 Borgo S. Michele, Latina, Italy

POM

PL 08747/0612

Topamax 200mg Film-coated Tablets



Lazy eye

Leaflet revision date: 29 November 2017



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 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

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



Discomfort in your arms or legs

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



Kidney disorder

612 LEAFLET Topamax 20171129

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