TOPIRAMATE SPRINKLE 25MG CAPSULES

Active substance: TOPIRAMATE

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S165 LEAFLET Topamax 20130205

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

TOPAMAX SPRINKLE 25mg CAPSULES
(topiramate)
Your medicine is known as Topamax Sprinkle 25mg Capsules but
will be referred to as Topamax throughout the following leaflet.
Information for other strengths of Topamax i.e. 15mg and 50mg
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.

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

1

What Topamax is and what it is used for

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

4

Possible side effects

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

5

How to store Topamax



6

Contents of the pack and other information

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

What is in this leaflet

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

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



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)

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:



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).



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.
If you forget to take Topamax



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 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 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 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:



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

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


Stuffy, runny nose or sore throat



Abnormal skin odour



Tingling, pain and/or numbness of various body parts



Discomfort in your arms or legs



Sleepiness, tiredness



Kidney disorder



Dizziness



Increased acid level in the blood



Nausea, diarrhoea



Weight loss

Common (may affect up to 1 in 10 people)

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)



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

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.



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

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.



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

5 HOW TO STORE TOPAMAX



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





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Shortness of breath





Do not store your capsules above 25°C.

Nose bleeds





Keep the bottle tightly closed.

Fever, not feeling well, weakness





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

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.



Dry mouth





Hair loss



Itching

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.



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



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.



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

6 FURTHER INFORMATION
What Topamax contains


Each Capsule contains 25mg of the active ingredient,
topiramate.



Topamax also contains the following: sugar spheres (maize
starch, sucrose), povidone, cellulose acetate, gelatin, titanium
dioxide (E171) and black printing ink (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



Elevated mood

What Topamax looks like and contents of the pack



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





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

Topamax Sprinkle 25 mg capsules are small, white to off-white
spheres in hard gelatin capsules with a white opaque body
marked ‘25mg’ and clear cap marked ‘TOP’.





Problems with reading, speech disorder, problems with
handwriting

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

Product Licence holder



Restlessness, hyperactivity

Procured from within the EU and repackaged by the Product



Slowed thinking, decreased wakefulness or alertness



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

Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer



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)



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

These products are manufactured by Janssen-Cilag S.p.a., 04010
Borgo S. Michele, Latina, Italy.
POM

PL No. 19488/0165

Leaflet revision date: 05 February 2013
Topamax is a registered trade mark of Johnson & Johnson, USA.
S165 LEAFLET Topamax 20130205

S165 LEAFLET Topiramate 20130205

Topiramate Capsules with food and drink
PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPIRAMATE SPRINKLE 25mg CAPSULES
(topiramate)

You can take Topiramate Capsules with or without food. Drink
plenty of fluids during the day to prevent kidney stones while taking
Topiramate Capsules.
You should avoid drinking alcohol when taking Topiramate
Capsules.
Pregnancy, breast-feeding and fertility

Your medicine is known as Topiramate Sprinkle 25mg Capsules but
will be referred to as Topiramate Capsules throughout the following
leaflet.
Information for other strengths of Topiramate Capsules i.e. 15mg
and 50mg 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.

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 Capsules. As with other antiepilepsy medicines, there is
a risk of harm to the unborn child if Topiramate Capsules is used
during pregnancy. Make sure you are very clear about the risks and
the benefits of using Topiramate Capsules for epilepsy during
pregnancy.
You should not take Topiramate Capsules 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 Capsules 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.

What is in this leaflet

Driving and using machines

1

What Topiramate Capsules is and what it is used for

2

What you need to know before you take Topiramate
Capsules

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

3

How to take Topiramate Capsules

Topiramate Capsules contains sucrose

4

Possible side effects

5

How to store Topiramate Capsules

6

Contents of the pack and other information

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

1 WHAT TOPIRAMATE CAPSULES IS AND WHAT IT IS USED
FOR
Topiramate Capsules belong 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



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
Capsules 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”

alone to treat seizures in adults and children over age 6



3 HOW TO TAKE TOPIRAMATE CAPSULES

to prevent migraine headaches in adults

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE CAPSULES
Do not take Topiramate Capsules


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

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

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



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

Talk to your doctor or pharmacist before taking Topiramate
Capsules if you:



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



have kidney problems, especially kidney stones, or are getting
kidney dialysis





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

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

If you take more Topiramate Capsules than you should



have liver problems



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



have eye problems, especially glaucoma





have a growth problem



are on a high fat diet (ketogenic diet)



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

Warnings and precautions

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topiramate Capsules.
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
Topiramate Capsules.
You may lose weight if you use Topiramate Capsules 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 Capsules have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.

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


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 Topiramate Capsules
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.

Other medicines and Topiramate Capsules

4 POSSIBLE SIDE EFFECTS

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

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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 Capsules 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 Capsules.
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 Capsules.

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



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

Stuffy, runny nose or sore throat



Abnormal skin odour

Tingling, pain and/or numbness of various body parts



Discomfort in your arms or legs



Sleepiness, tiredness



Kidney disorder



Dizziness



Nausea, diarrhoea



Weight loss

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)



Common (may affect up to 1 in 10 people)

 Increased acid level in the blood
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.



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

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.



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

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.



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



5 HOW TO STORE TOPIRAMATE

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





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Shortness of breath





Do not store your capsules above 25°C.

Nose bleeds





Keep the bottle tightly closed.

Fever, not feeling well, weakness





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

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.



Dry mouth





Hair loss



Itching

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.



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



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.

 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



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

6 FURTHER INFORMATION
What Topiramate contains


Each Capsule contains 25mg of the active ingredient,
topiramate.



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



Swollen glands in the neck, armpit, or groin



Increased appetite



Elevated mood

What Topiramate looks like and contents of the pack



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





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

Topiramate Sprinkle 25 mg capsules are small, white to offwhite spheres in hard gelatin capsules with a white opaque
body marked ‘25mg’ and clear cap marked ‘TOP’.





Problems with reading, speech disorder, problems with
handwriting

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

Product Licence holder



Restlessness, hyperactivity

Procured from within the EU and repackaged by the Product



Slowed thinking, decreased wakefulness or alertness



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

Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



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 Topiramate Capsules 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



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

Manufacturer
These products are manufactured by Janssen-Cilag S.p.a., 04010
Borgo S. Michele, Latina, Italy
POM

PL No. 19488/0165

Leaflet revision date: 05 February 2013
S165 LEAFLET Topiramate 20130205

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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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