TOPIRAMATE TEVA 300 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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Ref:

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

Version:

1

245863

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

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Pharma Code:
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Third party code:
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231-10-05971, 05981, 05991
and 06001
N/A
80 (010001)
N/A
N/A
Univers

Base Font Size:

Child:

245864

PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030.
V1: Text update: Product name change.

F. P. Code:

16 December 2013

7.5 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

323 mm
200 mm
N/A
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
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IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
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.

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

Pharma code 80

Topiramate belongs to a group of medicines called “anti epileptic
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 over
age 2
• to prevent migraine headaches in adults.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE

Do NOT take Topiramate:
• if you are allergic (hypersensitive) to topiramate, 200 mg: allura
red AC lake, 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 having
kidney dialysis
• have a history of blood and body fluid abnormality (metabolic
acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet).
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Topiramate.
It is important that you do not stop taking your medicine without first
consulting your doctor.
You should also to talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topiramate.

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 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.
Pregnancy and breast-feeding
Talk to your doctor before using Topiramate if you are pregnant,
trying to become pregnant or breast-feeding. 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.
Ask your doctor or pharmacist for advice before taking any 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 lactose
This medicinal product 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.
200 mg: This medicinal product contains allura red AC lake and may
cause allergic reactions.

3

HOW TO TAKE TOPIRAMATE

Always take Topiramate exactly as your doctor has told you. You
should 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.
• Topiramate tablets are to be swallowed whole. Avoid chewing the
tablets as they may leave a bitter taste.
• Topiramate can be taken before, during or after a meal. Drink
plenty of fluids during the day to prevent kidney stones while
taking Topiramate.
If you take more Topiramate than you should
• See a doctor right away. Take the medicine pack with you.
• Signs and symptoms of overdosage: you may feel sleepy, tired,
depressed or restless, or have abnormal body movements,
problems standing and walking, feel dizzy due to low blood
pressure, have dulling of consciousness, speech disturbances,
double vision, impaired thinking, abdominal pain or have
abnormal heart beats or fits.
Overdose can happen if you are taking other medicines together with
Topiramate.
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.
• Do not take a double dose (two doses at the same time) to make
up for a forgotten dose.
If you stop 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 medicine, ask
your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS
You may lose weight if you use Topiramate; so your weight should be
checked regularly when using this medicine. If you are losing too
Like all medicines, this medicine can cause side effects, although not
much weight or a child using this medicine is not gaining enough
everybody gets them.
weight, you should consult your doctor.
A small number of people being treated with anti epileptic 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
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, vitamins and herbal 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.

The frequency of possible side effects listed below is defined using
the following convention:
very common
(affects more than 1 user in 10)
common
(affects 1 to 10 users in 100)
uncommon
(affects 1 to 10 users in 1,000)
rare
(affects 1 to 10 users in 10,000)
very rare
(affects less than 1 user in 10,000)
not known
(frequency cannot be estimated from the
available data).

Very common side effects include:
• Weight loss
• Tingling in the arms and legs
Especially, tell your doctor or pharmacist if you are taking:
• Drowsiness or sleepiness
• other medicines that impair or decrease your thinking,
• Dizziness
concentration or muscle co-ordination (e.g. central nervous system • Diarrhoea
depressant medicines such as muscle relaxants and sedatives)
• Nausea
• birth control pills. Topiramate may make your birth control pills
• Stuffy, runny nose and sore throat
less effective.
• Tiredness
• Depression.
Tell your doctor if your menstrual bleeding changes while you are
taking birth control pills and Topiramate.
Common side effects include:
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 anti-epileptic medicines, risperidone, lithium,
hydrochlorothiazide, metformin, pioglitazone, glyburide,
amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.

• Changes in mood or behaviour including anger, nervousness,
sadness
• Weight gain
• Decrease or loss of appetite
• Reduced number of red blood cells
• Changes in thinking and alertness including confusion, problems
with concentration, memory or slowness in thinking

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
Topiramate

Ref:

231-30-87372-Y LEA TOPIRAMATE A/S TAB TUK

Version:

1

Trackwise Parent:

16 December 2013
245863

PL Number(s),
MA Holder & Packer:
Reason for revision:

EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-05971, 05981, 05991
and 06001
N/A
80 (010001)
N/A
N/A
Univers

Base Font Size:

245864

PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030.
V1: Text update: Product name change.

F. P. Code:

Child:

7.5 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

323 mm
200 mm
N/A
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)































Slurred speech
Clumsiness or problems with walking
Involuntary shaking in the arms, hands or legs
Reduced sense of touch or sensation
Involuntary movement of the eyes
Distorted sense of taste
Visual disturbance, blurred vision, double vision
Ringing sound in the ears
Ear pain
Shortness of breath
Nose bleeds
Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent urination
Painful urination
Hair loss
Skin rash and/or itchy skin
Joint pain
Muscle spasms, muscle twitching or muscle weakness
Chest pain
Fever
Loss of strength
General feeling of feeling unwell
Allergic reaction.

Uncommon side effects include:
• Crystals in the urine
• Abnormal blood counts including reduced white blood cell count
or platelet count or increased eosinophils
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck, armpit or groin
• Increase in seizures
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary
twitching, tearing and decreased vision
• Decreased or loss of hearing
• Hoarseness of the voice
• Inflammation of the pancreas
• Wind
• Heartburn
• Loss of sensitivity to touch in the mouth
• Bleeding gums
• Fullness or bloating
• Painful or burning sensations in the mouth
• Breath odour
• Leakage of urine and/or stools
• Urgent desire to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decrease or loss of sweating
• Skin discolouration
• Localised swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increased acid levels in the blood
• Low potassium levels in the blood
• Increase in liver enzymes in the blood
• Increased appetite
• Increased thirst and drinking abnormally large amounts of fluid
• Low blood pressure or decrease in blood pressure that occurs
when you stand up
• Hot flushing
• Flu like illness
• Cold extremities (e.g. hands and face)
• Problems with learning
• Disturbances in sexual function (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication.
Rare side effects include:
• Excessive skin sensitivity
• Impaired sense of smell
• Renal tubular acidosis
• Odour
• Swelling in the tissues around the eye
• Raynaud’s syndrome. A disorder affecting the blood vessels in the
fingers, toes, ears and causing pain and cold sensitivity.
• Inflammation of the liver (hepatitis), liver failure
• Tissue calcification (calcinosis).

• increased acid levels with increased level of chlorine in the blood
(acidosis hyperchloraemic)
• low potassium levels in the blood (hypokalaemia)
• abnormal behaviour
• aggression
• apathy
• lying awake before you go asleep (initial insomnia)
• thoughts about suicide (suicidal ideation)
• disturbance in attention
• lethargy
• problems with normal sleep pattern (circadian rhythm sleep
disorder)
• poor quality sleep
• increased tears secretion (lacrimation increased)
• slow heart beat (sinus bradycardia)
• feeling abnormal
• gait disturbance.
Additional side effects that were reported in children but not in
adults in clinical studies include
• increased count of eosinophils in the blood (eosinophilia)
• restlessness accompanied by an increase in motor activity
including muscle spasms, tremors and twitching (psychomotor
hyperactivity)
• dizziness
• vomiting
• increased body temperature
• fever
• problems with learning.
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 TOPIRAMATE

Keep 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.
Do not store above 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

CONTENTS OF THE PACK AND OTHER INFORMATION

What Topiramate Teva contains
The active substance is topiramate.
25 mg: Each film-coated tablet contains 25 mg topiramate.
50 mg: Each film-coated tablet contains 50 mg topiramate.
100 mg: Each film-coated tablet contains 100 mg topiramate.
200 mg: Each film-coated tablet contains 200 mg topiramate.
300 mg: Each film-coated tablet contains 300 mg topiramate.
400 mg: 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).
25, 300 and 400 mg: macrogol 4000, polydextrose and hypromellose.
50 mg: macrogol 3350, polyvinyl alcohol, talc and yellow iron oxide
(E172).
100 mg: macrogol 4000, polydextrose, hypromellose, yellow iron
oxide (E172), black iron oxide (E172).
200 mg: 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
25 mg: White to off-white, film-coated, capsule-shaped tablet debossed
“T25” on one side and plain on the other.
50 mg: 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.
100 mg: 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.
200 mg: 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.
300 mg: 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.
400 mg: 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.
Side effects of unknown frequency:
Topiramate Teva 300 mg/400 mg Film-coated tablets
• Maculopathy is a disease of the macula, the small spot in the retina
Blisters: 10, 28, 30, 50, 60, 100, 120 and 200 film-coated tablets.
where vision is keenest. You should call your doctor if you notice a
Bottles: 60 film-coated tablets.
change or decrease in your vision.
Not all pack sizes may be marketed.
• Swelling of the conjunctiva of the eye
• Cough
Marketing Authorisation Holder and Manufacturer
• Toxic epidermal necrolysis which is a more severe form of
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East
Stevens-Johnson syndrome (see uncommon side effects).
Sussex, BN22 9AG, United Kingdom.
Side effects reported more frequently (≥2 fold) in children than in
adults in clinical studies include:
• decreased appetite
• increased appetite

This leaflet was last revised in December 2013.
PL 00289/1053-8
87372-Y
200 x 323

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 USER
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.
WHAT IS IN THIS LEAFLET:

322K114200513

Univers
8 Pt

Third party code:

Fonts:
Base Font Size:

(3rd party code - could change)

(3rd party code - could change)

F. P. Code:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

BLACK

EAN Code:
Pharma Code:

434 mm
160 mm
L:
W:

231-10-05971, 05981, 05991
and 06001
N/A
1465 (0110111010)

Dimensions:

PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Teva Israel.
V1: Text update: Product name change.

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

1
Version:

245863

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

Child:

245864

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN

18 December 2013

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 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.
Pregnancy and breast-feeding
Talk to your doctor before using Topiramate if you
are pregnant, trying to become pregnant or
breast-feeding. 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.
Ask your doctor or pharmacist for advice before
taking any 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 lactose
This medicinal product 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.

Topiramate belongs to a group of medicines called
200 mg: This medicinal product contains allura red
“anti epileptic medicines. It is used:

AC lake and may cause allergic reactions.
• alone to treat seizures in adults and children over
age 6
HOW TO TAKE TOPIRAMATE
• with other medicines to treat seizures in adults
and children over age 2
Always take Topiramate exactly as your doctor has
• to prevent migraine headaches in adults.
told you. You should check with your doctor or
WHAT YOU NEED TO KNOW BEFORE YOU pharmacist if you are not sure.

3

2

TAKE TOPIRAMATE

• Take Topiramate exactly as prescribed. Your
doctor will usually start you on a low dose of
Do NOT take Topiramate:
Topiramate and slowly increase your dose until
• if you are allergic (hypersensitive) to topiramate,
the best dose is found for you.
200 mg: allura red AC lake, or any of the other
• Topiramate tablets are to be swallowed whole.
ingredients of Topiramate (listed in section 6 )
Avoid chewing the tablets as they may leave a
• for migraine prevention if you are pregnant or
bitter taste.
you are able to become pregnant but you are not • Topiramate can be taken before, during or after a
using effective contraception (see section
meal. Drink plenty of fluids during the day to
‘pregnancy and breast-feeding’ for further
prevent kidney stones while taking Topiramate.
information).
If you take more Topiramate than you should
If you are not sure if the above applies to you, talk
• See a doctor right away. Take the medicine pack
to your doctor or pharmacist before using
with you.
Topiramate.
• Signs and symptoms of overdosage: you may
feel sleepy, tired, depressed or restless, or have
Warnings and precautions
abnormal body movements, problems standing
Talk to your doctor or pharmacist before taking
and walking, feel dizzy due to low blood
Topiramate if you:
pressure, have dulling of consciousness, speech
• have kidney problems, especially kidney stones
disturbances, double vision, impaired thinking,
or are having kidney dialysis
abdominal pain or have abnormal heart beats or
• have a history of blood and body fluid
fits.
abnormality (metabolic acidosis)
• have liver problems
Overdose can happen if you are taking other
• have eye problems, especially glaucoma
medicines together with Topiramate.
• have a growth problem
If you forget to take Topiramate
• are on a high fat diet (ketogenic diet).
• If you forget to take a dose, take it as soon as you
If you are not sure if any of the above apply to you,
remember it. However, if it is almost time for
talk to your doctor or pharmacist before using
your next dose, skip the missed dose and
Topiramate.
continue as usual. If you miss two or more
doses, contact your doctor.
It is important that you do not stop taking your
• Do not take a double dose (two doses at the
medicine without first consulting your doctor.
same time) to make up for a forgotten dose.
You should also to talk to your doctor before taking
If you stop taking Topiramate
any medicine containing topiramate that is given to
Do not stop taking this medicine unless told to do
you as an alternative to Topiramate.
so by your doctor. Your symptoms may return. If
You may lose weight if you use Topiramate; so your your doctor decides to stop this medication, your
weight should be checked regularly when using
dose may be decreased gradually over a few days.
this medicine. If you are losing too much weight or
If you have any further questions on the use of this
a child using this medicine is not gaining enough
medicine, ask your doctor or pharmacist.
weight, you should consult your doctor.

4

A small number of people being treated with antiPOSSIBLE SIDE EFFECTS
epileptic medicines such as Topiramate have had
thoughts of harming or killing themselves. If at any
Like all medicines, this medicine can cause side
time you have these thoughts, immediately contact
effects, although not everybody gets them.
your doctor.
The frequency of possible side effects listed below
Other medicines and Topiramate
is defined using the following convention:
Please tell your doctor or pharmacist if you are
very common (affects more than 1 user in 10)
taking or have recently taken any other medicines,
common
(affects 1 to 10 users in 100)
including medicines obtained without a
uncommon
(affects 1 to 10 users in 1,000)
prescription, vitamins and herbal medicines.
rare
(affects 1 to 10 users in 10,000)
Topiramate and certain other medicines can affect
very rare
(affects less than 1 user in 10,000)
each other. Sometimes the dose of some of your
not known
(frequency cannot be estimated
other medicines or Topiramate will have to be
from the available data).
adjusted.
Very common side effects include:
Especially, tell your doctor or pharmacist if you are
• Weight loss
taking:
• Tingling in the arms and legs
• other medicines that impair or decrease your
• Drowsiness or sleepiness
thinking, concentration or muscle co-ordination
• Dizziness
(e.g. central nervous system depressant
• Diarrhoea
medicines such as muscle relaxants and
• Nausea
sedatives)
• Stuffy, runny nose and sore throat
• birth control pills. Topiramate may make your
• Tiredness
birth control pills less effective.
• Depression.
Tell your doctor if your menstrual bleeding changes
Common side effects include:
while you are taking birth control pills and
• Changes in mood or behaviour including anger,
Topiramate.
nervousness, sadness
Keep a list of all the medicines you take. Show this • Weight gain
list to your doctor and pharmacist before you start • Decrease or loss of appetite
• Reduced number of red blood cells
a new medicine.
• Changes in thinking and alertness including
Other medicines you should discuss with your
confusion, problems with concentration,
doctor or pharmacist include other anti-epileptic
memory or slowness in thinking
medicines, risperidone, lithium,
• Slurred speech
hydrochlorothiazide, metformin, pioglitazone,
• Clumsiness or problems with walking
glyburide, amitriptyline, propranolol, diltiazem,
• Involuntary shaking in the arms, hands or legs
venlafaxine, flunarizine.
• Reduced sense of touch or sensation
If you are not sure if any of the above apply to you, • Involuntary movement of the eyes
• Distorted sense of taste
talk to your doctor or pharmacist before using
• Visual disturbance, blurred vision, double vision
Topiramate.
• Ringing sound in the ears
• Ear pain
• Shortness of breath
• Nose bleeds
322K114200513

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322K114200513

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BLACK

434 mm
160 mm
EAN Code:
Pharma Code:

L:
W:

231-10-05971, 05981, 05991
and 06001
N/A
1465 (0110111010)

Dimensions:

PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Teva Israel.
V1: Text update: Product name change.

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

1
Version:

245863

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

Child:

245864

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN

18 December 2013







Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent urination
Painful urination
Hair loss
Skin rash and/or itchy skin
Joint pain
Muscle spasms, muscle twitching or muscle
weakness
Chest pain
Fever
Loss of strength
General feeling of feeling unwell
Allergic reaction.

Uncommon side effects include:
• Crystals in the urine
• Abnormal blood counts including reduced white
blood cell count or platelet count or increased
eosinophils
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck, armpit or groin
• Increase in seizures
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical
activity
• Loss of consciousness
• Fainting
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Feeling of movement under the skin
• Eye problems including dry eyes, light
sensitivity, involuntary twitching, tearing and
decreased vision
• Decreased or loss of hearing
• Hoarseness of the voice
• Inflammation of the pancreas
• Wind
• Heartburn
• Loss of sensitivity to touch in the mouth
• Bleeding gums
• Fullness or bloating
• Painful or burning sensations in the mouth
• Breath odour
• Leakage of urine and/or stools
• Urgent desire to urinate
• Pain in the kidney area and/or bladder caused by
kidney stones
• Decrease or loss of sweating
• Skin discolouration
• Localised swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increased acid levels in the blood
• Low potassium levels in the blood
• Increase in liver enzymes in the blood
• Increased appetite
• Increased thirst and drinking abnormally large
amounts of fluid
• Low blood pressure or decrease in blood
pressure that occurs when you stand up
• Hot flushing
• Flu like illness
• Cold extremities (e.g. hands and face)
• Problems with learning
• Disturbances in sexual function (erectile
dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication.
Rare side effects include:
• Excessive skin sensitivity
• Impaired sense of smell
• Renal tubular acidosis
• Odour
• Swelling in the tissues around the eye
• Raynaud’s syndrome. A disorder affecting the
blood vessels in the fingers, toes, ears and
causing pain and cold sensitivity.
• Inflammation of the liver (hepatitis), liver failure
• Tissue calcification (calcinosis).
Side effects of unknown frequency:
• 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.
• Swelling of the conjunctiva of the eye
• Cough
• Toxic epidermal necrolysis which is a more
severe form of Stevens-Johnson syndrome (see
uncommon side effects).
Side effects reported more frequently (≥2 fold) in
children than in adults in clinical studies include:
• decreased appetite
• increased appetite
• increased acid levels with increased level of
chlorine in the blood (acidosis hyperchloraemic)
• low potassium levels in the blood (hypokalaemia)
• abnormal behaviour
• aggression
• apathy
• lying awake before you go asleep (initial
insomnia)
• thoughts about suicide (suicidal ideation)
• disturbance in attention
• lethargy
• problems with normal sleep pattern (circadian
rhythm sleep disorder)
• poor quality sleep
• increased tears secretion (lacrimation increased)
• slow heart beat (sinus bradycardia)
• feeling abnormal
• gait disturbance.
Additional side effects that were reported in
children but not in adults in clinical studies include
• increased count of eosinophils in the blood
(eosinophilia)
• restlessness accompanied by an increase in
motor activity including muscle spasms, tremors
and twitching (psychomotor hyperactivity)
• dizziness






vomiting
increased body temperature
fever
problems with learning.

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 TOPIRAMATE

Keep 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.
Do not store above 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

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Topiramate Teva contains
The active substance is topiramate.
25 mg: Each film-coated tablet contains 25 mg
topiramate.
50 mg: Each film-coated tablet contains 50 mg
topiramate.
100 mg: Each film-coated tablet contains 100 mg
topiramate.
200 mg: Each film-coated tablet contains 200 mg
topiramate.
300 mg: Each film-coated tablet contains 300 mg
topiramate.
400 mg: 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),
25, 300 and 400 mg: macrogol 4000, polydextrose
and hypromellose.
50 mg: macrogol 3350, polyvinyl alcohol, talc and
yellow iron oxide (E172).
100 mg: macrogol 4000, polydextrose,
hypromellose, yellow iron oxide (E172), black iron
oxide (E172).
200 mg: 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
25 mg: White to off-white, film-coated,
capsule-shaped tablet debossed “T25” on one side
and plain on the other.
50 mg: 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.
100 mg: 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.
200 mg: 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.
300 mg: 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.
400 mg: 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 December 2013.
PL 00289/1053-8

87218-Z
160 x 434

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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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