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609 LEAFLET Topamax 20170126



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

The name of your medicine is Topamax 25mg Film-coated Tablets
but will be referred to as Topamax throughout the following leaflet.
Please note that information regarding other strengths 50mg,
100mg and 200mg 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

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.
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.


What Topamax is and what it is used for


What you need to know before you take Topamax

Topamax contains lactose


How to take Topamax


Possible side effects


How to store Topamax

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


Contents of the pack and other information



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



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

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

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.
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.

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

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.
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.


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

Especially, tell your doctor or pharmacist if you are taking:


 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


Nausea, diarrhoea

Weight loss

Common (may affect up to 1 in 10 people)

Not known (frequency cannot be estimated from the available

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

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:

Decreased, loss of, or no sense of taste

Problems with concentration

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

Increased acid level in the blood

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

Having thoughts of serious self-harm


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

Decreased or increased appetite

Shortness of breath

Aggression, abnormal behaviour


Difficulty falling or staying asleep

Nose bleeds

Feeling of unsteadiness when walking

Fever, not feeling well, weakness

Not feeling well

Decrease in potassium level in the blood

Showing and/or feeling no emotion

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

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)

Dry mouth

Watery eyes

Hair loss

Slow or irregular heartbeat


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

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

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

Sensation of spinning (vertigo)



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

Uncommon (may affect up to 1 in 100 people)

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


Swollen glands in the neck, armpit, or groin

Feeling warm

Increased appetite

Learning disability

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

Slowed thinking, decreased wakefulness or alertness

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


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

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

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.

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

Do not use Topamax Tablets after the expiry date which is
stated on the carton, bottle 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.



What Topamax Tablets contain

Each film-coated tablet contains 25mg of topiramate.

Topamax also contains the following inactive ingredients:
Core tablets:
lactose monohydrate, pregelatinized starch, microcrystalline
cellulose, sodium starch glycollate, magnesium stearate

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

Topamax Tablets 25mg are round, white tablets marked TOP on
one side and 25 on the other.

Cold fingers and toes

Topamax Tablets 25mg are available in plastic bottles of 60 tablets.

Feeling drunk

Product Licence holder

 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

Film coating:
carnauba wax and Opadry White
The Opadry white contains:
hypromellose, titanium dioxide (E171), macrogol and
polysorbate 80.
What Topamax Tablets look like and contents of the pack

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 either of the below manufacturers

Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-2340
Beerse, Belgium.

Swelling in and around the eyes

Cilag AG, Schaffhausen, Switzerland.

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

Janssen-Cilag S.p.a, 04010 Borgo S. Michele, Latina, Italy

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

Discomfort in your arms or legs

Kidney disorder


PL 08747/0609

Topamax 25mg Film-coated Tablets

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.
Leaflet revision date: 26 January 2017
Topamax is a registered trade mark of Johnson & Johnson, USA.
609 LEAFLET Topamax 20170126

Expand Transcript

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.