TOPAMAX TABLETS 200MG

Active substance: TOPIRAMATE

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612 LEAFLET Topamax 20121201

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPAMAX 200mg TABLETS
(topiramate)
The name of your medicine is Topamax 200mg 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.

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.



Keep this leaflet. You may need to read it again



If you have any further questions, ask your doctor or pharmacist

Pregnancy, breast-feeding and fertility



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.

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 decide if you can take
Topamax. As with other antiepilepsy 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.

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

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.
Ask your doctor or pharmacist for advice before taking this
medicine.

6. Contents of the pack and other information
Driving and using machines
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

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPAMAX

3. HOW TO TAKE TOPAMAX

Do not take Topamax

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



if you are allergic (hypersensitive) to topiramate or any of the
other ingredients of Topamax (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.



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

Warnings and precautions

If you take more Topamax than you should

Talk to your doctor or pharmacist before taking Topamax if you:



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)



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 breastfeeding’ 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:




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)

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)

Common (may affect up to 1 in 10 people)

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.



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)



Skin discolouration



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)



Muscle stiffness, pain in side





Blood in urine, incontinence (lack of control) of urine, urgent
desire to urinate, flank or kidney pain

Decreased or loss of sweating





Difficulty getting or keeping an erection, sexual dysfunction

Having thoughts of serious self-harm, trying to cause serious
self-harm



Flu-like symptoms



Cold fingers and toes



Feeling drunk



Learning disability

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

Rare (may affect up to 1 in 1,000 people)
Other side effects include the following, if they get serious,
please tell your doctor or pharmacist:



Abnormally elevated mood



Loss of consciousness

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



Blindness in one eye, temporary blindness, night blindness



Stuffy, runny nose or sore throat





Lazy eye

Tingling, pain and/or numbness of various body parts





Swelling in and around the eyes

Sleepiness, tiredness





Dizziness

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



Nausea, diarrhoea



Inflammation of the liver, liver failure



Weight loss



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



Increased acid level in the blood

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



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



Nose bleeds



Fever, not feeling well, weakness



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



Dry mouth



Hair loss



Itching

5. HOW TO STORE TOPAMAX



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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Weight gain



Do not store your tablets above 25°C.



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.



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 and adolescents
The side effects in children are generally similar to those seen in
adults. However, some side effects are either seen more frequently
in children and/or can be more severe in children than in adults.
Side effects which may be more severe include decreased or loss
of sweating and increase of the acid level in the blood. Side effects
which may occur more frequently in children include upper
respiratory tract illnesses.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

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



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.



Increase in liver enzymes, increase in eosinophils (a type of
white blood cell) in the blood





Swollen glands in the neck, armpit, or groin

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.



Increased appetite



Elevated mood

6. FURTHER INFORMATION



Hearing, seeing, or feeling things that are not there, severe
mental disorder (psychosis)

What Topamax contains



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



What Topamax looks like and contents of the pack

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

Topamax Tablets 200mg are round, salmon-coloured tablets
marked TOP on one side and 200 on the other.



Fainting



Abnormal sense of touch; impaired sense of touch



Impaired, distorted, or no sense of smell

Topamax Tablets 200mg are available in plastic bottles of 28 and
60 tablets. Topamax Tablets 200mg are also available in blister
packs of 28 tablets



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)



Topamax Tablets 200mg contains 200mg of the active
ingredient topiramate.



Topamax also contains the following inactive ingredients:
lactose monohydrate, pregelatinized starch, carnauba wax,
microcrystalline cellulose, sodium starch glycollate, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol,
synthetic iron oxide (E172) and polysorbate 80.

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
This product is manufactured by either of the below manufacturers

Janssen-Cilag Farmaceutica Lda, Rua Consiglieri Pedroso
69A/B, Queluz de Baixo, 2745 Bacarena, Portugal.



Janssen Pharmaceutica N.V., Beerse, Belgium.



Cilag AG, Schaffhausen, Switzerland.



Flushing, feeling warm



Pancreatitis (inflammation of the pancreas)

Leaflet revision date: 01 December 2012



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

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



Bleeding gums, increased saliva, drooling, breath odour



Excessive intake of fluids, thirst

POM

PL 08747/0612

Topamax 200mg Tablets

612 LEAFLET Topamax 20121201

612 LEAFLET Topiramate 20121201

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPIRAMATE 200mg TABLETS
(topiramate)

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).

The name of your medicine is Topiramate 200mg Tablets but will be
referred to as Topiramate throughout the following leaflet.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topiramate.

Please note that information regarding other strengths 25mg, 50mg
and 100mg of Topiramate Tablets may also be present in the below
leaflet.

Topiramate with food and drink

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Drink plenty of fluids during the day to prevent kidney stones while
taking Topiramate. You should avoid drinking alcohol when taking
Topiramate.

You can take Topiramate with or without food.



Keep this leaflet. You may need to read it again



If you have any further questions, ask your doctor or pharmacist

Pregnancy, breast-feeding and fertility



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.

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 decide if you can take
Topiramate. As with other antiepilepsy medicines, there is a risk of
harm to the unborn child if Topiramate is used during pregnancy.
Make sure you are very clear about the risks and the benefits of
using Topiramate for epilepsy during pregnancy.

What is in this leaflet
1. What Topiramate is and what it is used for
2. What you need to know before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate

You should not take Topiramate 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 Topiramate must tell the
doctor as soon as possible if the baby experiences anything
unusual.

6. Contents of the pack and other information

Ask your doctor or pharmacist for advice before taking this
medicine.

1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Driving and using machines

Topiramate belongs to a group of medicines called “antiepileptic
medicines.” It is used:

Dizziness, tiredness and vision problems may occur during
treatment with Topiramate. Do not drive or use any tools or
machines without talking to your doctor first.



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
TOPIRAMATE
Do not take Topiramate


if you are allergic (hypersensitive) to topiramate or any of the
other ingredients of Topiramate (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 Topiramate.

Topiramate 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 TOPIRAMATE
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 Topiramate
and slowly increase your dose until the best dose is found for
you



Topiramate tablets are to be swallowed whole. Avoid chewing
the tablets as they may leave a bitter taste



Topiramate can be taken before, during, or after a meal. Drink
plenty of fluids during the day to prevent kidney stones while
taking Topiramate

Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate 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 eye problems, especially glaucoma



have a growth problem



are pregnant or could become pregnant (see section
‘pregnancy and breastfeeding’ for further information)

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)

are on a high fat diet (ketogenic diet)





have liver problems



If you take more Topiramate than you should

Overdose can happen if you are taking other medicines together
with Topiramate.
If you forget to take Topiramate


It is important that you do not stop taking your medicine without first
consulting your doctor.

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



You should also talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topiramate.

Do not take a double dose (two doses at the same time) to
make up for a forgotten dose

If you stop taking Topiramate

You may lose weight if you use Topiramate 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.

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.

A small number of people being treated with antiepileptic medicines
such as Topiramate have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.

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

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topiramate.

4. POSSIBLE SIDE EFFECTS
Other medicines and Topiramate
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Topiramate and certain other
medicines can affect each other. Sometimes the dose of some of
your other medicines or Topiramate will have to be adjusted.

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:

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

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







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. Topiramate may make your birth control pills
less effective

Tell your doctor if your menstrual bleeding changes while you are
taking birth control pills and Topiramate.
Keep a list of all the medicines you take. Show this list to your
doctor and pharmacist before you start a new medicine.

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)



Skin discolouration



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)



Muscle stiffness, pain in side





Blood in urine, incontinence (lack of control) of urine, urgent
desire to urinate, flank or kidney pain

Decreased or loss of sweating





Difficulty getting or keeping an erection, sexual dysfunction

Having thoughts of serious self-harm, trying to cause serious
self-harm



Flu-like symptoms



Cold fingers and toes



Feeling drunk



Learning disability

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

Rare (may affect up to 1 in 1,000 people)
Other side effects include the following, if they get serious,
please tell your doctor or pharmacist:



Abnormally elevated mood



Loss of consciousness

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



Blindness in one eye, temporary blindness, night blindness



Stuffy, runny nose or sore throat





Lazy eye

Tingling, pain and/or numbness of various body parts





Swelling in and around the eyes

Sleepiness, tiredness





Dizziness

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



Nausea, diarrhoea



Inflammation of the liver, liver failure



Weight loss



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



Increased acid level in the blood

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



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



Nose bleeds



Fever, not feeling well, weakness



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



Dry mouth



Hair loss



Itching

5. HOW TO STORE TOPIRAMATE



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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Weight gain



Do not store your tablets above 25°C.



Do not use Topiramate after the expiry date which is stated on
the carton and blister strip. The expiry date refers to the last day
of that month.



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 and adolescents
The side effects in children are generally similar to those seen in
adults. However, some side effects are either seen more frequently
in children and/or can be more severe in children than in adults.
Side effects which may be more severe include decreased or loss
of sweating and increase of the acid level in the blood. Side effects
which may occur more frequently in children include upper
respiratory tract illnesses.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

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



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.



Increase in liver enzymes, increase in eosinophils (a type of
white blood cell) in the blood





Swollen glands in the neck, armpit, or groin

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.



Increased appetite



Elevated mood

6. FURTHER INFORMATION



Hearing, seeing, or feeling things that are not there, severe
mental disorder (psychosis)

What Topiramate contains



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



What Topiramate looks like and contents of the pack

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

Topiramate Tablets 200mg are round, salmon-coloured tablets
marked TOP on one side and 200 on the other.



Fainting



Abnormal sense of touch; impaired sense of touch



Impaired, distorted, or no sense of smell

Topiramate Tablets 200mg are available in plastic bottles 28 and 60
tablets. Topiramate Tablets 200mg are also available in blister
packs of 28 tablets



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 Topiramate may feel faint,
dizzy, or may pass out when they stand up or sit up suddenly)



Flushing, feeling warm



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



Bleeding gums, increased saliva, drooling, breath odour



Excessive intake of fluids, thirst

Topiramate Tablets 200mg contains 200mg of the active
ingredient topiramate.



Topiramate also contains the following inactive ingredients:
lactose monohydrate, pregelatinized starch, carnauba wax,
microcrystalline cellulose, sodium starch glycollate, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol,
synthetic iron oxide (E172) and polysorbate 80.

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
This product is manufactured by either of the below manufacturers

Janssen-Cilag Farmaceutica Lda, Rua Consiglieri Pedroso
69A/B, Queluz de Baixo, 2745 Bacarena, Portugal.



Janssen Pharmaceutica N.V., Beerse, Belgium.



Cilag AG, Schaffhausen, Switzerland.

Pancreatitis (inflammation of the pancreas)





POM

PL 08747/0612

Topiramate 200mg Tablets

Leaflet revision date: 01 December 2012
612 LEAFLET Topiramate 20121201

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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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