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TOPAMAX 50MG TABLETS

Active substance(s): TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topamax® 50mg Tablets
(topiramate)
This product is available as the above but will be referred to as
Topamax throughout the remainder of this leaflet.
This product is available in multiple strengths.
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
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
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
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.
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.
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

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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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