TOPIRAMATE SPRINKLE 15MG CAPSULES

Active substance: TOPIRAMATE

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S469 LEAFLET Topamax 20130213

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPAMAX SPRINKLE 15mg CAPSULES
(topiramate)
Your medicine is known as Topamax Sprinkle 15mg Capsules but
will be referred to as Topamax throughout the following leaflet.
Information for other strengths of Topamax also may be present in
this 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.

In this leaflet
1. What Topamax is and what it is used for

Pregnancy, breast-feeding and fertility
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.
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.
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 sucrose
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

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.

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



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 hard capsules may be swallowed whole or may be
opened and sprinkled on a teaspoon of soft food of any type.
Examples are applesauce, custard, ice cream, porridge,
pudding or yogurt. Drink fluids right after to make sure all of the
food and medicine mixture is swallowed



Hold the hard capsule upright so that you can read the word
“TOP”



Carefully twist off the clear portion of the capsule. You may find
it best to do this over the small portion of food onto which you
will be pouring the sprinkles



Sprinkle all of the capsule’s contents onto a spoonful of soft
food, taking care to see that the entire prescribed dosage is
sprinkled onto the food

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 (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)

Be sure to swallow the entire spoonful of the sprinkle/food
mixture immediately. Avoid chewing. Drink fluids immediately in
order to make sure all of the mixture is swallowed



Never store any medicine and food mixture for use at a later
time



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 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:

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).



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

Overdose can happen if you are taking other medicines together
with Topamax.



have a growth problem

If you forget to take Topamax



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:


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.

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



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

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:

Topamax with food and drink

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

You can take Topamax with or without food. Drink plenty of fluids
during the day to prevent kidney stones while taking Topamax.



Stuffy, runny nose or sore throat



Tingling, pain and/or numbness of various body parts



Sleepiness, tiredness



Dizziness



Nausea, diarrhoea



Weight loss

You should avoid drinking alcohol when taking Topamax.

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

Not known (frequency cannot be estimated from the available
data)



Dry mouth



Itching



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.
5 HOW TO STORE TOPAMAX


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your capsules above 25°C.



Keep the bottle tightly closed.



Do not use Topamax after the expiry date which is stated on the
carton and bottle label. The expiry date refers to the last day of
that month.



Capsules 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.

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)

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.



Hair loss







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

Product Licence holder



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

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



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)

POM PL No. 19488/0469



Flushing, feeling warm



Pancreatitis (inflammation of the pancreas)

Leaflet revision date: 13 February 2013



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 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



Increased acid level in the blood

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topamax contains


Each Capsule contains 15mg of the active ingredient,
topiramate.



Topamax also contains the following: sugar spheres (sucrose,
maize starch), povidone, and cellulose acetate. The capsule is
composed of gelatin and titanium dioxide (E171). The black
printing ink contains black iron oxide (E172), shellac and
propylene glycol.

What Topamax looks like and contents of the pack
The hard gelatine capsules have opaque white bodies, imprinted
’15 mg’ in black ink and clear caps imprinted ‘TOP’ in black ink. The
capsules contain white spheroids.
Topamax is available in white plastic bottles with a tamper evident
screw cap containing 60 capsules.

Manufacturer
This product is manufactured by either of the following
manufacturers:


Cilag AG, Hochstrasse 201, 2805 Schaffhausen, Switzerland



Janssen-Cilag SpA, Borgo San Michele – Latina, Italy.

Topamax is a registered trade mark of Johnson & Johnson, USA.
S469 LEAFLET Topamax 20130213

S469 LEAFLET Topiramate 20130213

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPIRAMATE SPRINKLE 15mg CAPSULES
Your medicine is known as Topiramate Sprinkle 15mg Capsules but
will be referred to as Topiramate throughout the following leaflet.
Information for other strengths of Topiramate also may be present
in this 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.

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
6. Contents of the pack and other information
1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR
Topiramate belongs to a group of medicines called “antiepileptic
medicines.” It is used:


with other medicines to treat seizures in adults and children
aged 2 years and above



WHAT YOU NEED TO KNOW BEFORE YOU TAKE
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.
Ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
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.
Topiramate contains sucrose
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 hard capsules may be swallowed whole or may be
opened and sprinkled on a teaspoon of soft food of any type.
Examples are applesauce, custard, ice cream, porridge,
pudding or yogurt. Drink fluids right after to make sure all of the
food and medicine mixture is swallowed



Hold the hard capsule upright so that you can read the word
“TOP”



Carefully twist off the clear portion of the capsule. You may find
it best to do this over the small portion of food onto which you
will be pouring the sprinkles



Sprinkle all of the capsule’s contents onto a spoonful of soft
food, taking care to see that the entire prescribed dosage is
sprinkled onto the food



Be sure to swallow the entire spoonful of the sprinkle/food
mixture immediately. Avoid chewing. Drink fluids immediately in
order to make sure all of the mixture is swallowed



Never store any medicine and food mixture for use at a later
time



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

to prevent migraine headaches in adults

2.

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.

alone to treat seizures in adults and children over age 6



Pregnancy, breast-feeding and fertility

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.
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

If you take more Topiramate than you should





See a doctor right away. Take the medicine pack with you

have a history of blood and body fluid abnormality (metabolic
acidosis)





have liver problems



have eye problems, especially glaucoma

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 a growth problem



Overdose can happen if you are taking other medicines together
with Topiramate.

are on a high fat diet (ketogenic diet)



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

If you forget to take Topiramate


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

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



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

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

If you stop taking Topiramate

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using 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.
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.
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.
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. 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.
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 Topiramate.
Topiramate with food and drink
You can take Topiramate with or without food. Drink plenty of fluids
during the day to prevent kidney stones while taking Topiramate.
You should avoid drinking alcohol when taking Topiramate.

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



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

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)



Abnormal skin odour



Discomfort in your arms or legs



Kidney disorder



Stuffy, runny nose or sore throat



Tingling, pain and/or numbness of various body parts



Sleepiness, tiredness

 Increased acid level in the blood
Not known (frequency cannot be estimated from the available
data)



Dizziness





Nausea, diarrhoea

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)

 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



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

5. HOW TO STORE TOPIRAMATE



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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your capsules above 25°C.



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



Keep the bottle tightly closed.



Shortness of breath





Nose bleeds



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

Fever, not feeling well, weakness





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

Capsules 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.



Dry mouth





Hair loss



Itching

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.



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

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topiramate contains


Each Capsule contains 15mg of the active ingredient,
topiramate.



Topiramate also contains the following: sugar spheres (sucrose,
maize starch), povidone, and cellulose acetate. The capsule is
composed of gelatin and titanium dioxide (E171). The black
printing ink contains black iron oxide (E172), shellac and
propylene glycol.



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



What Topiramate looks like and contents of the pack

Elevated mood



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

The hard gelatine capsules have opaque white bodies, imprinted
’15 mg’ in black ink and clear caps imprinted ‘TOP’ in black ink. The
capsules contain white spheroids.



Showing and/or feeling no emotion, unusual suspiciousness,
panic attack

Topiramate is available in white plastic bottles with a tamper evident
screw cap containing 60 capsules.



Problems with reading, speech disorder, problems with
handwriting

Product Licence holder



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



This product is manufactured by either of the following
manufacturers:

Impaired, distorted, or no sense of smell





Cilag AG, Hochstrasse 201, 2805 Schaffhausen, Switzerland

Unusual feeling or sensation that may precede a migraine or a
certain type of seizure



Janssen-Cilag SpA, Borgo San Michele – Latina, Italy.



Dry eye, sensitivity of the eyes to light, eyelid twitching, watery
eyes

POM PL No. 19488/0469



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



Pancreatitis (inflammation of the pancreas)



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

Manufacturer

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



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

 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 life-threatening
condition that may present with sores in multiple mucosal sites
(such as the mouth, nose, and eyes), a skin rash, and blistering

Leaflet revision date: 13 February 2013
S469 LEAFLET Topiramate 20130213

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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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