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TOPIRAMATE ACTAVIS 200MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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Topiramate Actavis 25mg, 50mg, 100mg
and 200mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this
medicine.
•  eep this leaflet. You may need to read it again.
K
•  f you have any further questions, ask your doctor or
I
pharmacist.
•   his medicine has been prescribed for you. Do not pass it
T
on to others. It may harm them, even if their symptoms are
the same as yours.
• f any of the side effects get serious, or if you notice any
I
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
•   he full name of this medicine is Topiramate Actavis 25mg,
T
50mg, 100mg and 200mg Film-coated Tablets but within
the leaflet it will be referred to as Topiramate tablets.

•  irth control pills as Topiramate may make these pills less
b
effective. If your menstrual bleeding changes, you have
breakthrough bleeding or spotting, tell your doctor.
• other antiepileptic medicines
•  isperidone, lithium, amitriptyline, venlafaxine
r
(for depression)
•  ydrochlorothiazide, propranolol, diltiazem (for angina and high
h
blood pressure)
•  etformin, pioglitazone, glyburide (anti diabetic medicines)
m
• flunarazine.

In this leaflet:
1 What Topiramate tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

Pregnancy and breast-feeding

1 What Topiramate tablets are and what they are
used for

Mothers who breastfeed while taking Topiramate tablets 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.

Topiramate belongs to a group of medicines called antiepileptic
medicines. It is used
• alone to treat seizures in adults and children over age 6
•  ith other medicines to treat seizures in adults and children over
w
age 2
• to prevent migraine headaches in adults.

2 Before you take

Do not take Topiramate tablets and tell your doctor

• if you are allergic (hypersensitive) to topiramate or any of the

other ingredients of Topiramate tablets (see section 6).
•  or migraine prevention do not take if you are pregnant or you
f
are able to become pregnant but you are not using effective
contraception (see ‘Pregnancy and breastfeeding’ for further
information).

Check with your doctor or pharmacist before taking
Topiramate tablets if you

•  ave kidney problems, especially kidney stones, or are having
h
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.

Other warnings

•  t is important that you do not stop taking your medicine without
I
first consulting your doctor.
•  ou should also talk to your doctor before taking any other
Y
medicine containing topiramate that is given to you as an
alternative to Topiramate tablets.
•  ou may experience significant and continuing weight loss
Y
while taking Topiramate tablets. Therefore your weight should
be checked regularly when using this medicine. If you are losing
too much weight or if a child using this medicine is not gaining
enough weight, you should consult your doctor.
•  small number of people being treated with anti-epileptic
A
medicines such as Topiramate tablets have had thoughts of
harming or killing themselves. If at any time you have these
thoughts, contact your doctor at once.

Taking other medicines

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 tablets will
have to be adjusted.
Especially, tell your doctor or pharmacist if you are taking:
•  ther medicines that impair or decrease your thinking,
o
concentration, or muscle coordination (e.g. central nervous
system depressant medicines such as muscle relaxants and
sedatives).

Taking Topiramate tablets with food and drink

You can take Topiramate tablets with or without food.
To prevent kidney stones whilst being treated with Topiramate
tablets, drink plenty of fluids during the day.
You should avoid drinking alcohol when taking Topiramate tablets.
Talk to your doctor before using Topiramate tablets if you are
pregnant, trying to become pregnant or are breast-feeding. Your
doctor will decide if you can take Topiramate tablets. As with other
antiepilepsy medicines, there is a risk of harm to the unborn child
if Topiramate tablets are used during pregnancy. Make sure you
are very clear about the risks and the benefits of using Topiramate
tablets for epilepsy during pregnancy.
You should not take Topiramate for migraine prevention if you
are pregnant or are able to become pregnant and are not using
effective contraception.

Driving and using machines

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

Important information about one of the ingredients of
Topiramate tablets

Topiramate 50mg, 100mg and 200mg tablets contain lecithin (soya
oil). If you are allergic to peanuts or soya,
do not use this medicinal product.

3 How to take

Always take Topiramate tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Your doctor will usually start you on a low dose and slowly increase
your dose until the best dose is found.
Swallow whole. Do not chew. Take with or without food. To
prevent kidney stones while taking Topiramate tablets, drink
plenty of fluids during the day.
If you take Topiramate tablets only for epilepsy
• Adults – starting dose of 25mg at night. The dose will be slowly
increased to a maintenance dose, usually 100-200mg a day in 2
divided doses. Maximum dose of 500mg a day in 2 divided doses.
•  hildren over 6 years of age – starting dose of 0.5-1mg per kg of
C
body weight at night increasing slowly to a maintenance dose,
usually 100mg a day.
If you take Topiramate tablets with another epilepsy medicine
• Adults – starting dose of 25-50mg at night. The dose will be slowly
increased to a maintenance dose, usually
200-400mg a day in 2 divided doses.
•  hildren over 2 years of age – starting dose of 1-3mg per kg of
C
body weight at night increasing slowly to a maintenance dose,
usually 5-9mg per kg of body weight a day in 2 divided doses.
Prevention of migraines
• Adults – starting dose of 25mg at night. The dose will be slowly
increased to a maintenance dose of 100mg a day in 2 divided
doses.
• Children – Not recommended for use in children.

Continued top of next column
AAAG4248

Continued on next page

Topiramate Actavis 25mg, 50mg, 100mg & 200mg PIL - UK
item no: AAAG4248
print proof no: 2

pharmacode:

origination date: 08.01.14
approved for print/date

dimensions: 170 x320

min pt size:

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 16.01.14

Technical Approval

revised by: S.Anson

date sent: 08.01.14

supplier: Actavis Iceland

approved: 10.01.14

Non Printing Colours
1.
2.
3.

If you take more Topiramate tablets than you should

Uncommon (affects 1 to 10 users in 1,000):
• wind, heartburn, fullness or bloating, increased appetite
• ncreased thirst and drinking abnormally large amounts of fluid
i
•  rystals in the urine, leakage of urine and/or stools, urgent desire
c
to urinate
• 
changes in the numbers and types of blood cells. You may notice
increased bruising, nosebleeds, sore throats,
infections, breathlessness on exertion.
• ncreased acid levels in the blood, low potassium levels in the
i
blood (causing muscle twitching or weaknesses, abnormal heart
beat)
• irregular heartbeat or slowness of the heart beat
• swollen glands in the neck armpit or groin
• increase in seizures
•  roblems with or decreased verbal communication, problems
p
with learning or handwriting
• drooling, decreased or loss of sweating
•  estlessness or increased mental and physical activity,
r
hallucinations, loss of consciousness, fainting, disturbed or poor
quality sleep
• reduced or altered sense of smell
•  eeling of movement under the skin, skin discolouration, pins and
f
needles
• decreased or loss of hearing, hoarseness of the voice
• nflammation of the pancreas, causing severe abdominal pain
i
• oss of sensitivity to touch in the mouth, painful or burning
l
sensations in the mouth, breath odour, bleeding gums
•  welling of the joints, stiffness, slow or reduced movements
s
• ow blood pressure or drop in blood pressure that occurs when
l
you stand up
•  ot flushing, flu like illness, cold extremities (e.g. hands and feet)
h
•  isturbances in sexual function (erectile dysfunction, loss of
d
libido)

See a doctor right away. Take the medicine pack with you.
Signs and symptoms of overdose may include; feeling sleepy or
tired, abnormal body movements, problems standing and walking,
feeling dizzy due to low blood pressure, abnormal heart beats
or fits, double vision, changes in thinking and alertness, loss of
consciousness, speech problems, changes in mood or behaviour
(including anger or depression), stomach pain.
Overdose can happen if you are taking other medicines together
with Topiramate tablets.

If you forget to take Topiramate tablets

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 tablets

Do not stop taking this medicine even if you feel better unless
your doctor tells you to as 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, Topiramate tablets can cause side effects,
although not everybody gets them.
Contact your doctor at once if you have the following side
effects:
•  igns of an allergic reaction such as difficulty breathing, swelling
s
of the face, lips, trunk and limbs, hives, skin rash and redness or
severe skin reactions such as flushing, blisters and ulcers.
• severe skin reactions, including Stevens-Johnson syndrome, a

life threatening skin condition in which the upper layer of the skin
separates from the lower, and erythma multiforme, a condition of
raised red spots that can blister.
•  oxic epidermal necrolysis which is a more severe form of StevensT
Johnson syndrome.
•  aculopathy is a disease of the macula, the small spot in the
M
retina where vision is keenest. You should call your doctor if you
notice a change or decrease in your vision.
•  roblems with the eyes including signs of raised pressure in the
p
eye (glaucoma) such as blurred or decreased vision, eye pain and
redness of the eyes.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
Very common (affects more than 1 user in 10):
• weight loss, diarrhoea, feeling sick
• tingling in the arms and legs
• drowsiness or sleepiness, tiredness, dizziness
• stuffy, runny nose and sore throat
• depression
Common (affects 1 to 10 users in 100):
•  hanges in mood or behaviour including anger, nervousness,
c
sadness
•  hanges in thinking and alertness including confusion, problems
c
with concentration, memory or slowness in thinking
• weight gain, decrease or loss of appetite
• being sick, constipation, stomach pain, indigestion
•  ry mouth, altered sense of taste, tingling or numbness of the
d
mouth
•  idney stones causing sudden pain in the abdomen,
k
frequent or painful urination
•  educed number of red blood cells. You may notice excessive
r
tiredness, paleness of the skin.
•  lurred speech,  lumsiness or problems with walking,
s
c
involuntary shaking in the arms, hands or legs
• reduced sense of touch or sensation
• ringing sound in the ears, ear pain
• shortness of breath, nose bleeds
• skin rash and/or itchy skin, hair loss
• oint pain, muscle spasms, muscle twitching or muscle weakness,
j
loss of strength
• chest pain
• fever, general feeling of being unwell

Rare (affects 1 to 10 users in 10,000):
• excessive skin sensitivity, odour
• renal tubular acidosis
•  aynaud’s syndrome. A disorder affecting the blood vessels, in the
r
fingers, toes, ears and causing pain and cold sensitivity
• abdominal build up of calcium salts in the tissues
• increase in liver enzymes seen in tests
•  ellowing of the skin or eyes, or tiredness, pain in the abdomen,
y
joints or muscles (hepatitis, hepatic failure)
Unknown (cannot be estimated from the available data):
• cough
Tell your doctor if you notice any of the above side effects or
notice any other effects not listed.


5 How to store

Keep out of the reach and sight of children.
Do not store above 25ºC.
Do not use after the expiry date which is stated on the label. The
expiry date refers to the last day of that month.
Topiramate tablets which are supplied in bottles must be used
within 60 days of opening. There is a space provided on the bottle
for you to write the date that you opened them.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6 Further information

What Topiramate tablets contain

The active substance (the ingredient that makes the tablet work)
is topiramate. Each tablet contains either 25mg, 50mg, 100mg or
200mg of the active substance.
The other ingredients are mannitol, starch (pregelatinised),
cellulose (microcrystalline), croscarmellose sodium, silica (colloidal
anhydrous), magnesium stearate, polyvinyl alcohol, titanium
dioxide, macrogols (macrogol 3350), talc.
The following ingredients are also in the:
•  0mg and 100mg tablets - lecithin (Soya) (E322) and iron oxide
5
yellow (E172).
•  00mg tablets - lecithin (Soya) (E322) and iron oxide red (E172).
2

What Topiramate tablets look like and contents of the
pack
25mg tablets are round, biconvex, white tablets.
50mg tablets are round, biconvex, light yellow tablets.
100mg tablets are round, biconvex, yellow tablets.
200mg tablets are oval, biconvex, salmon-coloured tablets.
Pack size of 60 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis hf
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland
This leaflet was last revised in January 2014.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Continued top of next column
AAAG4248

Actavis, Barnstaple, EX32 8NS, UK

Topiramate Actavis 25mg, 50mg, 100mg & 200mg PIL - UK
item no: AAAG4248
print proof no: 2

pharmacode:

origination date: 08.01.14
approved for print/date

dimensions: 170 x320

min pt size:

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 16.01.14

Technical Approval

revised by: S.Anson

date sent: 08.01.14

supplier: Actavis Iceland

approved: 10.01.14

Non Printing Colours
1.
2.
3.

Topiramate Actavis 25mg, 50mg, 100mg
and 200mg Film-coated Tablets
Read all of this leaflet carefully before you
start taking this medicine.
•  eep this leaflet. You may need to read it
K
again.
•  f you have any further questions, ask your
I
doctor or pharmacist.
•   his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• f any of the side effects get serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
•   he full name of this medicine is
T
Topiramate Actavis 25mg, 50mg, 100mg
and 200mg Film-coated Tablets but
within the leaflet it will be referred to as
Topiramate tablets.

•  irth control pills as Topiramate may make
b
these pills less effective. If your menstrual
bleeding changes, you have breakthrough
bleeding or spotting, tell your doctor.
• other antiepileptic medicines
•  isperidone, lithium, amitriptyline, venlafaxine
r
(for depression)
•  ydrochlorothiazide, propranolol, diltiazem
h
(for angina and high blood pressure)
•  etformin, pioglitazone, glyburide (anti
m
diabetic medicines)
• flunarazine.

In this leaflet:
W
1  hat Topiramate tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

Pregnancy and breast-feeding

W
1  hat Topiramate tablets are and
what they are used for

Topiramate belongs to a group of medicines
called antiepileptic medicines. It is used
•  lone to treat seizures in adults and children
a
over age 6
•  ith other medicines to treat seizures in adults
w
and children over age 2
• to prevent migraine headaches in adults.

2 Before you take
Do not take Topiramate tablets and tell
your doctor
• if you are allergic (hypersensitive) to

topiramate or any of the other ingredients of
Topiramate tablets (see section 6).
•  or migraine prevention do not take if you
f
are pregnant or you are able to become
pregnant but you are not using effective
contraception (see ‘Pregnancy and
breastfeeding’ for further information).

Check with your doctor or pharmacist
before taking Topiramate tablets 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.

Other warnings

•  t is important that you do not stop taking
I
your medicine without first consulting your
doctor.
•  ou should also talk to your doctor before
Y
taking any other medicine containing
topiramate that is given to you as an
alternative to Topiramate tablets.
•  ou may experience significant and continuing
Y
weight loss while taking Topiramate tablets.
Therefore your weight should be checked
regularly when using this medicine. If you are
losing too much weight or if a child using this
medicine is not gaining enough weight, you
should consult your doctor.
•  small number of people being treated with
A
anti-epileptic medicines such as Topiramate
tablets have had thoughts of harming or
killing themselves. If at any time you have
these thoughts, contact your doctor at once.

Taking other medicines

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 tablets will have to be adjusted.
Especially, tell your doctor or pharmacist if you
are taking:
•  ther medicines that impair or decrease
o
your thinking, concentration, or muscle
coordination (e.g. central nervous system
depressant medicines such as muscle
relaxants and sedatives).

Taking Topiramate tablets with food
and drink

You can take Topiramate tablets with or without
food.
To prevent kidney stones whilst being treated
with Topiramate tablets, drink plenty of fluids
during the day.
You should avoid drinking alcohol when taking
Topiramate tablets.
Talk to your doctor before using Topiramate
tablets if you are pregnant, trying to become
pregnant or are breast-feeding. Your doctor
will decide if you can take Topiramate tablets.
As with other antiepilepsy medicines, there is a
risk of harm to the unborn child if Topiramate
tablets are used during pregnancy. Make sure
you are very clear about the risks and the
benefits of using Topiramate tablets for epilepsy
during pregnancy.
You should not take Topiramate for migraine
prevention if you are pregnant or are able to
become pregnant and are not using effective
contraception.
Mothers who breastfeed while taking
Topiramate tablets 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 whilst taking Topiramate tablets. Do not
drive or use any tools or machines without
talking to your doctor first.

Important information about one of the
ingredients of Topiramate tablets

Topiramate 50mg, 100mg and 200mg tablets
contain lecithin (soya oil). If you are allergic to
peanuts or soya,
do not use this medicinal product.

3 How to take

Always take Topiramate tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Your doctor will usually start you on a low dose
and slowly increase your dose until the best
dose is found.
Swallow whole. Do not chew. Take with or
without food. To prevent kidney stones while
taking Topiramate tablets, drink plenty of
fluids during the day.

If you take Topiramate tablets only for
epilepsy
• Adults – starting dose of 25mg at night. The
dose will be slowly increased to a maintenance
dose, usually 100-200mg a day in 2 divided
doses. Maximum dose of 500mg a day in 2
divided doses.
•  hildren over 6 years of age – starting dose
C
of 0.5-1mg per kg of body weight at night
increasing slowly to a maintenance dose,
usually 100mg a day.
If you take Topiramate tablets with another
epilepsy medicine
• Adults – starting dose of 25-50mg at night. The
dose will be slowly increased to a maintenance
dose, usually
200-400mg a day in 2 divided doses.
•  hildren over 2 years of age – starting dose
C
of 1-3mg per kg of body weight at night
increasing slowly to a maintenance dose,
usually 5-9mg per kg of body weight a day in 2
divided doses.
Prevention of migraines
• Adults – starting dose of 25mg at night. The

dose will be slowly increased to a maintenance
dose of 100mg a day in 2 divided doses.
•  hildren – Not recommended for use in
C
children.

Continued top of next column
AAAH2942

Continued on next page

Topiramate Actavis 25mg, 50mg, 100mg & 200mg Bottle PIL - UK
item no: AAAH2942
print proof no: 1

pharmacode:

origination date: 06.10.14
approved for print/date

dimensions: 145 x 400

min pt size: 8

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date:

Technical Approval

revised by:

date sent: 06.10.14

supplier: Actavis Dupnitsa Bulgaria

approved: 06.10.14

Non Printing Colours
1.
2.
3.

If you take more Topiramate tablets
than you should

Uncommon (affects 1 to 10 users in 1,000):
•  ind, heartburn, fullness or bloating,
w
increased appetite
• ncreased thirst and drinking abnormally large
i
amounts of fluid
•  rystals in the urine, leakage of urine and/or
c
stools, urgent desire to urinate
• 
changes in the numbers and types of blood
cells. You may notice increased bruising,
nosebleeds, sore throats,
infections, breathlessness on exertion.
• ncreased acid levels in the blood, low
i
potassium levels in the blood (causing muscle
twitching or weaknesses, abnormal heart
beat)
• rregular heartbeat or slowness of the heart
i
beat
• swollen glands in the neck armpit or groin
• increase in seizures
•  roblems with or decreased verbal
p
communication, problems with learning or
handwriting
• drooling, decreased or loss of sweating
•  estlessness or increased mental and physical
r
activity, hallucinations, loss of consciousness,
fainting, disturbed or poor quality sleep
• reduced or altered sense of smell
•  eeling of movement under the skin, skin
f
discolouration, pins and needles
•  ecreased or loss of hearing, hoarseness of
d
the voice
• nflammation of the pancreas, causing severe
i
abdominal pain
• oss of sensitivity to touch in the mouth,
l
painful or burning sensations in the mouth,
breath odour, bleeding gums
•  welling of the joints, stiffness, slow or reduced
s
movements
• ow blood pressure or drop in blood pressure
l
that occurs when you stand up
•  ot flushing, flu like illness, cold extremities
h
(e.g. hands and feet)
•  isturbances in sexual function (erectile
d
dysfunction, loss of libido)

See a doctor right away. Take the medicine pack
with you.
Signs and symptoms of overdose may include;
feeling sleepy or tired, abnormal body
movements, problems standing and walking,
feeling dizzy due to low blood pressure,
abnormal heart beats or fits, double vision,
changes in thinking and alertness, loss of
consciousness, speech problems, changes
in mood or behaviour (including anger or
depression), stomach pain.
Overdose can happen if you are taking other
medicines together with Topiramate tablets.

If you forget to take Topiramate tablets
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 tablets

Do not stop taking this medicine even if you
feel better unless your doctor tells you to as
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, Topiramate tablets can cause
side effects, although not everybody gets them.
Contact your doctor at once if you have the
following side effects:
•  igns of an allergic reaction such as difficulty
s
breathing, swelling of the face, lips, trunk and
limbs, hives, skin rash and redness or severe
skin reactions such as flushing, blisters and
ulcers.
• severe skin reactions, including Stevens
Johnson syndrome, a life threatening skin
condition in which the upper layer of the
skin separates from the lower, and erythma
multiforme, a condition of raised red spots
that can blister.
•  oxic epidermal necrolysis which is a more
T
severe form of Stevens-Johnson syndrome.
•  aculopathy is a disease of the macula, the
M
small spot in the retina where vision is keenest.
You should call your doctor if you notice a
change or decrease in your vision.
•  roblems with the eyes including signs of
p
raised pressure in the eye (glaucoma) such
as blurred or decreased vision, eye pain and
redness of the eyes.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
Very common (affects more than 1 user in 10):
• weight loss, diarrhoea, feeling sick
• tingling in the arms and legs
• drowsiness or sleepiness, tiredness, dizziness
• stuffy, runny nose and sore throat
• depression
Common (affects 1 to 10 users in 100):
•  hanges in mood or behaviour including
c
anger, nervousness, sadness
•  hanges in thinking and alertness including
c
confusion, problems with concentration,
memory or slowness in thinking
• weight gain, decrease or loss of appetite
•  eing sick, constipation, stomach pain,
b
indigestion
•  ry mouth, altered sense of taste, tingling or
d
numbness of the mouth
•  idney stones causing sudden pain in the
k
abdomen,
frequent or painful urination
•  educed number of red blood cells. You may
r
notice excessive tiredness, paleness of the
skin.
• 
slurred speech,  lumsiness or problems with
c
walking,
involuntary shaking in the arms, hands or legs
• reduced sense of touch or sensation
• ringing sound in the ears, ear pain
• shortness of breath, nose bleeds
• skin rash and/or itchy skin, hair loss
• oint pain, muscle spasms, muscle twitching or
j
muscle weakness, loss of strength
• chest pain
• fever, general feeling of being unwell

Rare (affects 1 to 10 users in 10,000):
• excessive skin sensitivity, odour
• renal tubular acidosis
•  aynaud’s syndrome. A disorder affecting the
r
blood vessels, in the fingers, toes, ears and
causing pain and cold sensitivity
•  bdominal build up of calcium salts in the
a
tissues
• increase in liver enzymes seen in tests
•  ellowing of the skin or eyes, or tiredness, pain
y
in the abdomen, joints or muscles (hepatitis,
hepatic failure)
Unknown (cannot be estimated from the
available data):
• cough



Tell your doctor if you notice any of the
above side effects or notice any other effects
not listed.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25ºC.
Do not use after the expiry date which is stated
on the label. The expiry date refers to the last
day of that month.
Topiramate tablets which are supplied in
bottles must be used within 60 days of opening.
There is a space provided on the bottle for you
to write the date that you opened them.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 Further information
What Topiramate tablets contain

The active substance (the ingredient that makes
the tablet work) is topiramate. Each tablet
contains either 25mg, 50mg, 100mg or 200mg
of the active substance.
The other ingredients are mannitol, starch
(pregelatinised), cellulose (microcrystalline),
croscarmellose sodium, silica (colloidal
anhydrous), magnesium stearate, polyvinyl
alcohol, titanium dioxide, macrogols (macrogol
3350), talc.
The following ingredients are also in the:
•  0mg and 100mg tablets - lecithin (Soya)
5
(E322) and iron oxide yellow (E172).
•  00mg tablets - lecithin (Soya) (E322) and iron
2
oxide red (E172).

What Topiramate tablets look like and
contents of the pack

25mg tablets are round, biconvex, white tablets.
50mg tablets are round, biconvex, light yellow
tablets.
100mg tablets are round, biconvex, yellow
tablets.
200mg tablets are oval, biconvex, salmoncoloured tablets.
Pack size of 60 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in September 2014.

If you would like a
leaflet with larger
text, please contact
01271 311257.
Continued top of next column
AAAH2942

Actavis, Barnstaple, EX32 8NS, UK

Topiramate Actavis 25mg, 50mg, 100mg & 200mg Bottle PIL - UK
item no: AAAH2942
print proof no: 1

pharmacode:

origination date: 06.10.14
approved for print/date

dimensions: 145 x 400

min pt size: 8

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date:

Technical Approval

revised by:

date sent: 06.10.14

supplier: Actavis Dupnitsa Bulgaria

approved: 06.10.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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