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TOPIRAMATE TEVA 300 MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE / TOPIRAMATE / TOPIRAMATE

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TEVA UK Ref:

231-30-87372-Z LEA TOPIRAMATE TEVA A/S TAB TUK

Version:

2

17 April 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Topiramate

Package leaflet: Information
for the patient
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet:
1. What 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 any other information
Pharma code 80

1

WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Topiramate belongs to a group of medicines called “anti-epileptic
medicines.” It is used:
• alone to treat seizures in adults and children over 6 years.
• with other medicines to treat seizures in adults and children
aged 2 years and above
• to prevent migraine headaches in adults.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Topiramate.
Topiramate with food, drink and alcohol
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.
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 or pharmacist for advice
before taking this medicine.
Your doctor will decide if you can take Topiramate. As with other
anti-epilepsy 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 benefits of using Topiramate for epilepsy during
pregnancy.
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.
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 lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.
Other expients with known effect
Topiramate 200 mg film-coated tablets: This medicinal product
contains allura red AC lake and may cause allergic reactions.

3

HOW TO TAKE TOPIRAMATE

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
• Take Topiramate exactly as prescribed. 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
• Topiramate tablets are to be swallowed whole. Avoid chewing the
TOPIRAMATE
tablets as they may leave a bitter taste.
• Topiramate can be taken before, during or after a meal. Drink
Do NOT take Topiramate:
plenty of fluids during the day to prevent kidney stones while
• if you are allergic to topiramate, 200 mg film-coated tablets: allura
taking Topiramate.
red AC lake, or any of the other ingredients of this medicine (listed
in section 6 ).
If you take more Topiramate than you should
• for migraine prevention if you are pregnant or you are able to
• See a doctor right away. Take the medicine pack with you.
become pregnant but you are not using effective contraception
• You may feel sleepy, tired, or less alert; lack coordination; have
(see section “Pregnancy and breast-feeding and fertility”for further
difficulty speaking or concentrating; have double or blurred vision;
information).
feel dizzy due to low blood pressure; feel depressed or agitated; or
have abdominal pain, or seizures (fits).
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Topiramate.
Overdose can happen if you are taking other medicines together with
Topiramate.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate if you:
If you forget to take Topiramate
• have kidney problems, especially kidney stones or are having
• If you forget to take a dose, take it as soon as you remember it.
kidney dialysis
However, if it is almost time for your next dose, skip the missed
• have a history of blood and body fluid abnormality (metabolic
dose and continue as usual. If you miss two or more doses, contact
acidosis)
your doctor.
• have liver problems
• Do not take a double dose (two doses at the same time) to make
• have eye problems, especially glaucoma
up for a forgotten dose.
• have a growth problem
If you stop taking Topiramate
• are on a high fat diet (ketogenic diet)
Do not stop taking this medicine unless told to do so by your doctor.
• are pregnant or could become pregnant (see section “Pregnancy
Your symptoms may return. If your doctor decides to stop this
and breast-feeding and fertility” for further information).
medication, your dose may be decreased gradually over a few days.
If you are not sure if any of the above apply to you, talk to your
If you have any further questions on the use of this medicine, ask
doctor or pharmacist before using Topiramate.
your doctor or pharmacist.
It is important that you do not stop taking your medicine without first
consulting your doctor.
POSSIBLE SIDE EFFECTS
You should also to talk to your doctor before taking any medicine
Like all medicines, this medicine can cause side effects, although not
containing topiramate that is given to you as an alternative to
everybody gets them.
Topiramate.
You may lose weight if you use Topiramate; so your weight should be Tell your doctor, or seek medical attention immediately if you have
the following side effects:
checked regularly when using this medicine. If you are losing too
much weight or a child using this medicine is not gaining enough
Very common (may affect more than 1 in 10 people)
weight, you should consult your doctor.
• Depression (new or worse)
A small number of people being treated with anti-epileptic medicines Common (may affect up to 1 in 10 people)
such as Topiramate have had thoughts of harming or killing
• Seizures (fits)
themselves. If at any time you have these thoughts, immediately
• Anxiety, irritability, changes in mood, confusion, disorientation
contact your doctor.
• Problems with concentration, slowness of thinking, loss of
memory, problems with memory (new onset, sudden change or
Other medicines and Topiramate
increased severity)
Tell your doctor or pharmacist if you are taking, have recently taken
• Kidney stone, frequent or painful urination
or might take any other medicines. Topiramate and certain other
medicines can affect each other. Sometimes the dose of some of
Uncommon (may affect up to 1 in 100 people)
your other medicines or Topiramate will have to be adjusted.
• Increased acid level in the blood (may cause troubled breathing
including shortness of breath, loss of appetite, nausea, vomiting,
Especially, tell your doctor or pharmacist if you are taking:
excessive tiredness, and fast or uneven heart beats)
• other medicines that impair or decrease your thinking,
concentration or muscle co-ordination (e.g. central nervous system- • Decreased or loss of sweating
• Having thoughts of serious self-harm, trying to cause serious
depressant medicines such as muscle relaxants and sedatives)
self-harm
• birth control pills. Topiramate may make your birth control pills
less effective.
Rare (may affect up to 1 in 1,000 people)
• Glaucoma – blockage of fluid in eye causing increased pressure in
Tell your doctor if your menstrual bleeding changes while you are
the eye, pain, or decreased vision
taking birth control pills and Topiramate.
Keep a list of all the medicines you take. Show this list to your doctor Other side effects include the following, if they get serious, please
tell your doctor or pharmacist:
and pharmacist before you start a new medicine.
Very common (may affect more than 1 in 10 people)
Other medicines you should discuss with your doctor or pharmacist
• Stuffy, runny nose or sore throat
include other anti-epileptic medicines, risperidone, lithium,
• Tingling, pain and/or numbness of various body parts
hydrochlorothiazide, metformin, pioglitazone, glyburide,
• Sleepiness, tiredness
amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine,
St. John’s Wort (Hypericum perforatum) (a herbal preparation used to • Dizziness
• Nausea, diarrhoea
treat depression).
• Weight loss

2

4

Top of page cut-off to middle of registration mark: 44 mm.

Topiramate Teva 25 mg Film-coated Tablets
Topiramate Teva 50 mg Film-coated Tablets
Topiramate Teva 100 mg Film-coated Tablets
Topiramate Teva 200 mg Film-coated Tablets
Topiramate Teva 300 mg Film-coated Tablets
Topiramate Teva 400 mg Film-coated Tablets

TEVA UK Ref:

231-30-87372-Z LEA TOPIRAMATE TEVA A/S TAB TUK

Version:

2

17 April 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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
• Cough
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion,
stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or twitching, muscle aches
or weakness, chest pain
• Weight gain.
Uncommon (may affect up to 1 in 100 people)
• Decrease in platelets (blood cells that help stop bleeding),
decrease in white blood cells that help to protect you against
infection, decrease in potassium level in the blood
• Increase in liver enzymes, increase in eosinophils (a type of white
blood cell) in the blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental
disorder (psychosis)
• Showing and/or feeling no emotion, unusual suspiciousness, panic
attack
• Problems with reading, speech disorder, problems with
handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or alertness
• Reduced or slow body movements, involuntary abnormal or
repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede a migraine or a
certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid twitching, watery
eyes
• Decreased or loss of hearing, loss of hearing in one ear
• Slow or irregular heartbeat, feeling your heart beating in your
chest
• Low blood pressure, low blood pressure upon standing
(consequently, some people taking 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
• 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

5

HOW TO STORE TOPIRAMATE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and bottle or blister after EXP. The expiry date refers to the last
day of that month.
Store below 30°C. Store in the original package in order to protect
from moisture.
Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.

6

CONTENT OF THE PACK AND OTHER INFORMATION

What Topiramate Teva contains
The active substance is topiramate.
Topiramate 25 mg film-coated tablets: Each film-coated tablet
contains 25 mg topiramate.
Topiramate 50 mg film-coated tablets: Each film-coated tablet
contains 50 mg topiramate.
Topiramate 100 mg film-coated tablets: Each film-coated tablet
contains 100 mg topiramate.
Topiramate 200 mg film-coated tablets: Each film-coated tablet
contains 200 mg topiramate.
Topiramate 300 mg film-coated tablets: Each film-coated tablet
contains 300 mg topiramate.
Topiramate 400 mg film-coated tablets: Each film-coated tablet
contains 400 mg topiramate.
The other ingredients are lactose monohydrate, pregelatinised maize
starch, microcrystalline cellulose, sodium starch glycolate (type A),
colloidal anhydrous silica, magnesium stearate, titanium dioxide
(E171),
Topiramate 25 mg film-coated tablets, Topiramate 300 mg film-coated
tablets and Topiramate 400 mg film-coated tablets: macrogol 4000,
polydextrose and hypromellose
Topiramate 50 mg film-coated tablets: macrogol 3350, polyvinyl
alcohol, talc and yellow iron oxide (E172)
Topiramate 100 mg film-coated tablets: macrogol 4000, polydextrose,
hypromellose, yellow iron oxide (E172), black iron oxide (E172)
Topiramate 200 mg film-coated tablets: macrogol 4000, polydextrose,
hypromellose, red iron oxide (E172), allura red AC lake (E129) and
indigo carmine lake (E132)
What Topiramate Teva looks like and contents of the pack
Film-coated tablet
Topiramate 25mg film-coated tablets: White to off-white, film-coated,
capsule-shaped tablet debossed “T25” on one side and plain on the
other.
Topiramate 50mg film-coated tablets: Light yellow, film-coated,
capsule-shaped tablet scored and debossed “T” and “50” on either
side of the score on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 100mg film-coated tablets: Yellow, film-coated,
capsule-shaped tablet scored and debossed “T” and “100” on either
side of the score on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 200mg film-coated tablets: Salmon, film-coated,
capsule-shaped tablet scored and debossed “T” and “200” on either
side of the score on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 300mg film-coated tablets: White to off-white,
film-coated, capsule-shaped tablet scored and debossed “T” and
“300” on either side of the score on one side, and plain on the other
side. The tablet can be divided into equal halves.
Topiramate 400mg film-coated tablets: White to off-white,
film-coated, capsule-shaped tablet scored and debossed “T” and
“400” on either side of the score on one side and plain on the other
side. The tablet can be divided into equal halves.
Pack sizes:
Topiramate Teva 25 mg film-coated tablets
Blisters: 10, 20, 28, 30, 50, 56, 60, 100 and 120 film-coated tablets.
Bottles: 60 film-coated tablets.
Topiramate Teva 50 mg/100 mg/ 200 mg film-coated tablets
Blisters: 10, 20, 28, 30, 50, 56, 60, 100, 120 and 200 film-coated
tablets.
Bottles: 60 film-coated tablets.
Topiramate Teva 300 mg/400 mg film-coated tablets
Blisters: 10, 28, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Bottles: 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne,
East Sussex, BN22 9AG, United Kingdom.
This leaflet was last revised in March 2015
PL 00289/1053-8

87372-Z
323 x 200

20 July 2015

2
Version:

PAGE 1: FRONT FACE

Topiramate Teva 25 mg Film-coated Tablets
Topiramate Teva 50 mg Film-coated Tablets
Topiramate Teva 100 mg Film-coated Tablets
Topiramate Teva 200 mg Film-coated Tablets
Topiramate Teva 300 mg Film-coated Tablets
Topiramate Teva 400 mg Film-coated Tablets
Topiramate

Package leaflet:
Information for the patient

TEVA UK Ref:

231-30-87218-ZA LEA TOPIRAMATE TEVA A/S TAB TUK
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What 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 any other information

1

WHAT TOPIRAMATE IS AND WHAT IT IS
USED FOR

Topiramate with food, drink and alcohol
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.
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 or pharmacist for advice before
taking this medicine.
Your doctor will decide if you can take Topiramate.
As with other anti-epilepsy 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 benefits of using
Topiramate for epilepsy during pregnancy.
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.
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 lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
Other expients with known effect
Topiramate 200 mg film-coated tablets: This
medicinal product contains allura red AC lake and
may cause allergic reactions.

Topiramate belongs to a group of medicines called
“anti-epileptic medicines.” It is used:
• alone to treat seizures in adults and children over
HOW TO TAKE TOPIRAMATE
6 years.
• with other medicines to treat seizures in adults
Always take this medicine exactly as your doctor or
and children aged 2 years and above
pharmacist has told you. Check with your doctor or
• to prevent migraine headaches in adults.
pharmacist if you are not sure.
WHAT YOU NEED TO KNOW BEFORE YOU • Take Topiramate exactly as prescribed. Your
doctor will usually start you on a low dose of
TAKE TOPIRAMATE
Topiramate and slowly increase your dose until
the best dose is found for you.
Do NOT take Topiramate:
• Topiramate tablets are to be swallowed whole.
• if you are allergic to topiramate, 200 mg
Avoid chewing the tablets as they may leave a
film-coated tablets: allura red AC lake, or any of
bitter taste.
the other ingredients of this medicine (listed in
• Topiramate can be taken before, during or after a
section 6 ).
meal. Drink plenty of fluids during the day to
• for migraine prevention if you are pregnant or
prevent kidney stones while taking Topiramate.
you are able to become pregnant but you are not
using effective contraception (see section
If you take more Topiramate than you should
“Pregnancy and breast feeding and fertility”for
• See a doctor right away. Take the medicine pack
further information).
with you.
• You may feel sleepy, tired, or less alert; lack
If you are not sure if the above applies to you, talk
coordination; have difficulty speaking or
to your doctor or pharmacist before using
concentrating; have double or blurred vision; feel
Topiramate.
dizzy due to low blood pressure; feel depressed
Warnings and precautions
or agitated; or have abdominal pain, or seizures
Talk to your doctor or pharmacist before taking
(fits).
Topiramate if you:
Overdose can happen if you are taking other
• have kidney problems, especially kidney stones
medicines together with Topiramate.
or are having kidney dialysis
• have a history of blood and body fluid
If you forget to take Topiramate
abnormality (metabolic acidosis)
• If you forget to take a dose, take it as soon as you
• have liver problems
remember it. However, if it is almost time for
• have eye problems, especially glaucoma
your next dose, skip the missed dose and
• have a growth problem
continue as usual. If you miss two or more
• are on a high fat diet (ketogenic diet)
doses, contact your doctor.
• are pregnant or could become pregnant (see
• Do not take a double dose (two doses at the
section “Pregnancy and breast-feeding and
same time) to make up for a forgotten dose.
fertility” for further information)
If you stop taking Topiramate
If you are not sure if any of the above apply to you, Do not stop taking this medicine unless told to do
talk to your doctor or pharmacist before using
so by your doctor. Your symptoms may return. If
Topiramate.
your doctor decides to stop this medication, your
dose may be decreased gradually over a few days.
It is important that you do not stop taking your
medicine without first consulting your doctor.
If you have any further questions on the use of this
You should also to talk to your doctor before taking medicine, ask your doctor or pharmacist.
any medicine containing topiramate that is given to
POSSIBLE SIDE EFFECTS
you as an alternative to Topiramate.
You may lose weight if you use Topiramate; so your Like all medicines, this medicine can cause side
weight should be checked regularly when using
effects, although not everybody gets them.
this medicine. If you are losing too much weight or
Tell your doctor, or seek medical attention
a child using this medicine is not gaining enough
immediately if you have the following side effects:
weight, you should consult your doctor.
Very common (may affect more than 1 in 10
A small number of people being treated with
people)
anti- epileptic medicines such as Topiramate have
• Depression (new or worse)
had thoughts of harming or killing themselves. If at
Common (may affect up to 1 in 10 people)
any time you have these thoughts, immediately
• Seizures (fits)
contact your doctor.
• Anxiety, irritability, changes in mood, confusion,
Other medicines and Topiramate
disorientation
Tell your doctor or pharmacist if you are taking,
• Problems with concentration, slowness of
have recently taken or might take any other
thinking, loss of memory, problems with
medicines. Topiramate and certain other medicines
memory (new onset, sudden change or increased
can affect each other. Sometimes the dose of some
severity)
of your other medicines or Topiramate will have to
• Kidney stone, frequent or painful urination
be adjusted.
Uncommon (may affect up to 1 in 100 people)
Especially, tell your doctor or pharmacist if you are
• Increased acid level in the blood (may cause
taking:
troubled breathing including shortness of breath,
• other medicines that impair or decrease your
loss of appetite, nausea, vomiting, excessive
thinking, concentration or muscle co-ordination
tiredness, and fast or uneven heart beats)
(e.g. central nervous system-depressant
• Decreased or loss of sweating
medicines such as muscle relaxants and
• Having thoughts of serious self-harm, trying to
sedatives).
cause serious self-harm
• birth control pills. Topiramate may make your
Rare (may affect up to 1 in 1,000 people)
birth control pills less effective.
• Glaucoma – blockage of fluid in eye causing
Tell your doctor if your menstrual bleeding changes
increased pressure in the eye, pain, or decreased
while you are taking birth control pills and
vision
Topiramate.
Other side effects include the following, if they get
Keep a list of all the medicines you take. Show this
serious, please tell your doctor or pharmacist:
list to your doctor and pharmacist before you start
Very common (may affect more than 1 in 10
a new medicine.
people)
Other medicines you should discuss with your
• Stuffy, runny nose or sore throat
doctor or pharmacist include other anti-epileptic
• Tingling, pain and/or numbness of various body
medicines, risperidone, lithium,
parts
hydrochlorothiazide, metformin, pioglitazone,
• Sleepiness, tiredness
glyburide, amitriptyline, propranolol, diltiazem,
• Dizziness
venlafaxine, flunarizine, St. John's wort (Hypericum
• Nausea, diarrhoea
perforatum) (a herbal preparation used to treat
• Weight loss
depression).
Common (may affect up to 1 in 10 people)
If you are not sure if any of the above apply to you,
• Anaemia (low blood count)
talk to your doctor or pharmacist before using
• Allergic reaction (such as skin rash, redness,
Topiramate.
itching, facial swelling, hives)

3

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231-30-87218-ZA LEA TOPIRAMATE TEVA A/S TAB TUK TEVA UK Ref:

PAGE 2: REAR FACE






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
• Cough
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or
discomfort, indigestion, stomach or intestinal
infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or
twitching, muscle aches or weakness, chest pain
• Weight gain
Uncommon (may affect up to 1 in 100 people)
• Decrease in platelets (blood cells that help stop
bleeding), decrease in white blood cells that help
to protect you against infection, decrease in
potassium level in the blood
• Increase in liver enzymes, increase in eosinophils
(a type of white blood cell) in the blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not
there, severe mental disorder (psychosis)
• Showing and/or feeling no emotion, unusual
suspiciousness, panic attack
• Problems with reading, speech disorder,
problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or
alertness
• Reduced or slow body movements, involuntary
abnormal or repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of
touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede a
migraine or a certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid
twitching, watery eyes
• Decreased or loss of hearing, loss of hearing in
one ear
• Slow or irregular heartbeat, feeling your heart
beating in your chest
• Low blood pressure, low blood pressure upon
standing (consequently, some people taking
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
• 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
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5

HOW TO STORE TOPIRAMATE

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and bottle or blister
after EXP. The expiry date refers to the last day of
that month.
Store below 30°C. Store in the original package in
order to protect from moisture.
Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

CONTENT OF THE PACK AND OTHER
INFORMATION

What Topiramate Teva contains
The active substance is topiramate.
Topiramate 25 mg film-coated tablets: Each
film-coated tablet contains 25 mg topiramate.
Topiramate 50 mg film-coated tablets: Each
film-coated tablet contains 50 mg topiramate.
Topiramate 100 mg film-coated tablets: Each
film-coated tablet contains 100 mg topiramate.
Topiramate 200 mg film-coated tablets: Each
film-coated tablet contains 200 mg topiramate.
Topiramate 300 mg film-coated tablets: Each
film-coated tablet contains 300 mg topiramate.
Topiramate 400 mg film-coated tablets: Each
film-coated tablet contains 400 mg topiramate.
The other ingredients are lactose monohydrate,
pregelatinised maize starch, microcrystalline
cellulose, sodium starch glycolate (type A),
colloidal anhydrous silica, magnesium stearate,
titanium dioxide (E171),
Topiramate 25 mg film-coated tablets, Topiramate
300 mg film-coated tablets and Topiramate 400 mg
film-coated tablets: macrogol 4000, polydextrose
and hypromellose
Topiramate 50 mg film-coated tablets: macrogol
3350, polyvinyl alcohol, talc and yellow iron oxide
(E172)
Topiramate 100 mg film-coated tablets: macrogol
4000, polydextrose, hypromellose, yellow iron
oxide (E172), black iron oxide (E172)
Topiramate 200 mg film-coated tablets: macrogol
4000, polydextrose, hypromellose, red iron oxide
(E172), allura red AC lake (E129) and indigo carmine
lake (E132)
What Topiramate Teva looks like and contents of
the pack
Film-coated tablet
Topiramate 25mg film-coated tablets: White to
off-white, film-coated, capsule-shaped tablet
debossed “T25” on one side and plain on the other.
Topiramate 50mg film-coated tablets: Light yellow,
film-coated, capsule-shaped tablet scored and
debossed “T” and “50” on either side of the score
on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 100mg film-coated tablets: Yellow,
film-coated, capsule-shaped tablet scored and
debossed “T” and “100” on either side of the score
on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 200mg film-coated tablets: Salmon,
film-coated, capsule-shaped tablet scored and
debossed “T” and “200” on either side of the score
on one side, and plain on the other side. The tablet
can be divided into equal halves.
Topiramate 300mg film-coated tablets: White to
off-white, film-coated, capsule-shaped tablet scored
and debossed “T” and “300” on either side of the
score on one side, and plain on the other side. The
tablet can be divided into equal halves.
Topiramate 400mg film-coated tablets: White to
off-white, film-coated, capsule-shaped tablet scored
and debossed “T” and “400” on either side of the
score on one side and plain on the other side. The
tablet can be divided into equal halves.
Pack sizes:
Topiramate Teva 25 mg film-coated tablets
Blisters: 10, 20, 28, 30, 50, 56, 60, 100 and 120
film-coated tablets.
Bottles: 60 film-coated tablets.
Topiramate Teva 50 mg/100 mg/ 200 mg film-coated
tablets
Blisters: 10, 20, 28, 30, 50, 56, 60, 100, 120 and 200
film-coated tablets.
Bottles: 60 film-coated tablets.
Topiramate Teva 300 mg/400 mg film-coated tablets
Blisters: 10, 28, 30, 50, 60, 100, 120 and 200
film-coated tablets.
Bottles: 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG,
United Kingdom.
This leaflet was last revised in March 2015
PL 00289/1053-8

87218-ZA
434 x 160

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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