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TOPAMAX 25MG TABLETS

Active substance(s): TOPIRAMATE

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Package leaflet: Information for the user

Topamax® 25mg 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.

The name of your medicine is Topamax 25mg 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 50mg, 100mg
and 200mg Tablets.

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 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

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.

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
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.

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.

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

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

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.



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:
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 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)

5






6

How to store Topamax
Keep out of the sight and reach of children.
Do not store above 25°C.
Keep the container tightly closed.
Store in the original container in order to protect from
moisture.
Do not take the tablets after the expiry date which is
stated on the carton and bottle label after ‘Exp’. The
expiry date refers to the last day of that month.













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, 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:
 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 heartbeat
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 or
pharmacist. 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 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.






If the tablet becomes discoloured or shows any sign of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine
if your doctor tells you to.
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.

Contents of the pack and other information

What Topamax contains
The active substance in Topamax is topiramate. Each
tablet contains 25mg of topiramate.
The other ingredients are lactose monohydrate,
pregelatinised starch, microcrystalline cellulose,
carboxymethylated sodium starch (Type A), magnesium
stearate.
®
Tablet coating: OPADRY White and carnauba wax,
®
OPADRY contains: hypromellose, polyethylene glycol,
polysorbate 80, and as a colorant titanium dioxide (E171).
What Topamax looks like and contents of the pack
Topamax is white, round, film-coated tablet, 6mm in
diameter engraved with ‘TOP’ on one side and ‘25’ on the
other side.
Topamax is available in white plastic bottle with tamper
evident closure containing 60 tablets. In each bottle there
is a desiccant canister which should not be swallowed.
Manufactured by: Janssen Pharmaceutica N.V.,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
OR
Janssen-Cilag S.p.a., 04010 Borgo S. Michele, Latina,
Italy

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 25mg Tablets; PL 18799/0625

POM

Leaflet date: 25.01.2018
Topamax is a registered trademark of Janssen-Cilag.

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+ 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.

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