Skip to Content

UK Edition. Click here for US version.

TOPIRAMATE MYLAN 100 MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet:
Information for the patient

Keep a list of all the medicines you take. Show this list to your doctor and
pharmacist before you start a new medicine.

Topiramate Mylan 25 mg
Film-coated Tablets
Topiramate Mylan 50 mg
Film-coated Tablets
Topiramate Mylan 100 mg
Film-coated Tablets
Topiramate Mylan 200 mg
Film-coated Tablets

Other medicines you should discuss with your doctor or pharmacist
include other antiepileptic medicines, risperidone, lithium,
hydrochlorothiazide, haloperidol (used to treat mental health problems),
metformin, pioglitazone, glyburide, (used to treat diabetes), amitriptyline,
moclobemide, imipramine (used to treat depression), propranolol,
diltiazem, digoxin, (used to treat heart conditions), flunarizine, (used to
treat migraine), proguanil (used to prevent malaria), omeprazole (used
to treat indigestion) and St. John’s wort (Hypericum perforatum) (a herbal
preparation used to treat depression).

topiramate

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

Topiramate with alcohol

You should avoid drinking alcohol when taking Topiramate.

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 side effects not listed in
this leaflet. See section 4.

What is in this leaflet

1. W
 hat 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. C
 ontents of the pack and other information

1. What Topiramate is and what it is used for
Topiramate belongs to a group of medicines called “antiepileptic
medicines.” It is used:
• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children aged 2 years
and above
• to prevent migraine headaches in adults

Pregnancy, breast-feeding and fertility

Migraine prevention:
Topiramate can harm an unborn baby. You must not use this medicine if
you are pregnant. You must not use Topiramate for migraine prevention if
you are a woman of childbearing potential unless you are using effective
contraception. Talk to your doctor about the best kind of contraception
and whether this medicine is suitable for you. Before the start of treatment
with Topiramate a pregnancy test should be performed. Talk to your doctor
if you wish to become pregnant.
Treatment of epilepsy:
If you are a woman of childbearing potential you should talk to your doctor
about other possible treatments instead of Topiramate. If the decision is
made to use this medicine, you should use effective contraception. Talk
to your doctor about the best kind of contraception to use while you
are taking Topiramate. Before the start of treatment with Topiramate a
pregnancy test should be performed.
Talk to your doctor if you wish to become pregnant.
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 the benefits of using Topiramate for epilepsy during
pregnancy.
• If you take Topiramate during pregnancy, your baby has a higher risk
for birth defects, particularly, cleft lip (split in the top lip) and cleft
palate (split in the roof of the mouth). Newborn boys may also have a
malformation of the penis (hypospadia). These defects can develop early
in pregnancy, even before you know you are pregnant.
• If you take Topiramate during pregnancy, your baby may be smaller than
expected at birth. Talk to your doctor if you have questions about this
risk during pregnancy.
• There may be other medicines to treat your condition that have a lower
risk of birth defects.
• Tell your doctor straight away if you become pregnant while taking this
medicine. You and your doctor should decide if you will continue to take
Topiramate while you are pregnant.

2. What you need to know before you take Topiramate
Do not take Topiramate:

Breast-feeding
The active substance in this medicine (topiramate) passes into breast milk.
Effects have been seen in breastfed babies of treated mothers, including
diarrhoea, feeling sleepy, feeling irritable, and poor weight gain. Therefore,
your doctor will discuss with you whether you abstain from breast-feeding
or whether to abstain from treatment with Topiramate. Your doctor will
take into account the importance of the medicine to the mother and the
risk for the baby.
Mothers who breast-feed while taking topiramate must tell the doctor as
soon as possible if the baby experiences anything unusual.

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

Driving and using machines

• if you are allergic to topiramate or any of the other ingredients of this
medicine (listed in section 6).
• for migraine prevention: if you are pregnant or if you are a woman of
childbearing potential unless you are using effective contraception
(see section ‘pregnancy and breastfeeding’ for further information). You
should talk to your doctor about the best kind of contraception to use
while you are taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate if you:
• have kidney problems, especially:
* kidney stones
* high levels of calcium in your urine
* if a member of your family has or ever had kidney stones
* or you are getting kidney dialysis
• have a history of blood and body fluid abnormality (metabolic acidosis)
which may be associated with:
* severe breathing problems
* severe or prolonged diarrhoea
* surgery
* or a high fat, low carbohydrate (ketogenic) diet
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are taking Topiramate to treat epilepsy and you are pregnant or
a woman of childbearing potential (see section ‘pregnancy and
breast-feeding’ for further information)
If you are not sure if any of the above applies 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 talk to your doctor before taking any medicine containing
topiramate that is given to you as an alternative to Topiramate.

During treatment

You may lose weight if you use topiramate so your weight should be
checked regularly when using this medicine. If you are losing too much
weight or a child using this medicine is not gaining enough weight, you
should consult your doctor.
A small number of people being treated with antiepileptic medicines such
as topiramate have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.
You may experience an increase in fits (seizures) or have a different type of
seizure; if this happens, talk to your doctor.
If you develop any problems with your vision and/or your eyes, you should
contact your doctor immediately.

Other medicines and Topiramate

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Topiramate and certain other medicines
can affect each other. Sometimes the dose of some of your other medicines
or Topiramate will have to be adjusted.
Especially, tell your doctor or pharmacist if you are taking:
• other medicines that impair or decrease your thinking, concentration, or
muscle coordination (e.g. central nervous system depressant medicines
such as muscle relaxants and sedatives e.g. diazepam).
• birth control pills. Topiramate may make your birth control pills
less effective. You should talk to your doctor about the best kind of
contraception to use while you are taking Topiramate.
Tell your doctor if your menstrual bleeding changes while you are taking
birth control pills and Topiramate.

Description

Topiramate 200 mg_25 mg_50 mg_100 mg 200_90_60_28_
30_50_20_15_100_10

Component Type Leaflet
Affiliate Item Code 1343259
Superceded Affiliate Item Code 1145065
TrackWise PR No. 1343259
MA No. PL 04569/0782-85
Packing Site/Printer

European Packaging
Centre (Oudehaske - NL)

Supplier Code TBA

No. of colours

SAP No. N/A

Colours

Trackwise Proof No. 2
Client Market United Kingdom

Topiramate (200 mg) contains sunset yellow aluminum lake
(E110) and allura red aluminium lake (E129)

The 200 mg tablet only contains sunset yellow aluminium lake (E110) and
allura red aluminium lake (E129), which 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.
• 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 especially if exercising or during warm weather
or activities where you will become hot prevent kidney stones while
taking topiramate. Other forms of this medicine may be available which
may be more suitable for patients who cannot swallow tablets, ask your
doctor or pharmacist.

If you take more Topiramate than you should

• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy, tired or less alert; lack coordination; have difficulty
speaking or concentrating; have double or blurred vision; feel dizzy due
to low blood pressure; feel depressed or agitated; or have abdominal
pain or seizures (fits).
• 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
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor, or seek medical attention immediately if you have the
following side effects:
Very common (may affect more than 1 in 10 people):
• Depression (new or worse)
Common (may affect up to 1 in 10 people):
• Seizures (fits)
• Anxiety, irritability, confusion, disorientation, changes in mood or
behaviour, including anger, nervousness, sadness

Date: 09 Jan 18

Pharma Code N/A

Vendor Job No. 523236

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.

Non-Print
Colours

Keyline/Drawing No N/A

Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Time: 08:55

1

Page Count

1/2

Black
Technical
Info

Code
Area

Myriad Pro
210 x 420 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

• Problems with concentration, slowness of thinking, loss of memory,
problems with memory (new onset, sudden change or increased
severity)
• Kidney stone, frequent or painful urination
• Allergic reaction (such as skin rash, redness, itching and facial swelling,
including swelling of the nose, lips, eyelids and tongue, hives)
• Decreased vision
Uncommon (may affect up to1 in 100 people):
• Increased number of infections, with sore throat, fever, chills or mouth
ulcers, which may be due to a decrease in white blood cells which may
be seen in blood tests
• Increased acid level in the blood (may cause troubled breathing
including shortness of breath, loss of appetite, nausea, vomiting,
excessive tiredness, and fast or uneven heart beats)
• Decreased or loss of sweating, which can cause a serious rise in
temperature with hot dry skin, feeling and being sick, headache,
dizziness and fainting
• Having thoughts of serious self-harm, trying to cause serious self-harm
• Hearing, seeing or feeling things that are not there, severe mental
disorder (psychosis)
• Loss of control of muscle movements which affect walking in a straight
line, which will show up in medical tests
• Decreased or loss of hearing
• Severe pain in the centre of the abdomen (tummy) which may be
swollen, with fever, feeling or being sick (pancreatitis, inflammation of
the pancreas)
• Pain in the kidney area and/or bladder caused by a ‘kidney’ stone or
crystals which can move into the bladder or other parts of the urinary
system. You may experience severe pain in the back and lower stomach
and pass little or no urine.
Rare (may affect up to 1 in 1000 people):
• Decrease in the amount of water that you pass, confusion, muscle
cramps, uneven heartbeat (renal tubular acidosis)
• Feeling irritable and excitable with mood changes and behaving out of
character
• Glaucoma which is a blockage of fluid in the eye causing increased
pressure in the eye, pain and decreased vision, blindness in one eye,
temporary blindness
• Yellowing of the skin and eyes (Inflammation of the liver, liver failure)
• Severe skin reaction, including Stevens-Johnson syndrome, a life
threatening skin condition in which the upper layer of the skin separates
from the lower, that may present with sores in multiple mucosal sites
(such as the mouth, nose, and eyes) and erythema multiforme, a
condition of raised red spots that can blister
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 may notice a change or decrease in your
vision.
• Toxic epidermal necrolysis, a life-threatening condition related to,
yet more severe than Stevens-Johnson syndrome, characterised by
widespread blistering and sloughing of the outer layers of the skin
(see rare side effects)

Other possible side effects
Very common (may affect more than 1 in 10 people):
• Weight loss
• Tingling, pain and/or numbness of various body parts
• Drowsiness, sleepiness or tiredness
• Dizziness
• Diarrhoea
• Feeling sick (nausea)
• Stuffy, runny nose and sore throat

Uncommon (may affect up to 1 in 100 people):
• Abnormal blood counts, including reduced platelet count (you may
bruise or bleed more easily), or increased eosinophils
• Increase in liver enzymes
• Elevated mood
• Showing and feeling no emotion, unusual suspiciousness, panic attack
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck, armpit or groin
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Decreased wakefulness or alertness
• Unusual feeling or sensation that may precede a migraine or a certain
type of seizure
• Loss of consciousness
• Fainting and feeling faint
• Excessive sleepiness
• Slow or diminished movements, uncontrolled repetitive twitching of
muscles
• Disturbed or poor quality sleep (e.g. waking early in the morning)
• Impaired or distorted sense of smell
• Problems with handwriting or speech, such as stuttering or constantly
repeating words
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary twitching,
tearing, enlarged pupil, seeing flashes of light, abnormal sensations in
the eye

Topiramate 200 mg_25 mg_50 mg_100 mg 200_90_60_28_
30_50_20_15_100_10

Component Type Leaflet
Affiliate Item Code 1343259
Superceded Affiliate Item Code 1145065
TrackWise PR No. 1343259
MA No. PL 04569/0782-85
Packing Site/Printer

European Packaging
Centre (Oudehaske - NL)

Supplier Code TBA

No. of colours

SAP No. N/A

Colours

Trackwise Proof No. 2
Client Market United Kingdom












Rare (may affect up to 1 in 1,000 people):
• Feeling hopeless
• Uncontrolled shaking which may affect the tongue, hands or head when
performing tasks
• Decreased bodily movement, being unreactive
• Excessive skin sensitivity
• Impaired sense of smell
• Odour
• Swelling in the tissues around the eye, problems with vision in dim light,
lazy eye
• Raynaud’s syndrome. A disorder affecting the blood vessels, in the
fingers, toes, ears and causing pain and cold sensitivity
• Small white lumps under the skin or in other parts of the body, which
may leak a chalky white liquid which may be caused by a substance
called calcium collecting (calcinosis)
• Blood bicarbonate decreased which will show up in blood tests
Not Known (frequency cannot be estimated from the available data):
• Swelling of the clear covering of the eye surface (conjunctiva)

Additional side effects in children and adolescents

The side effects in children are generally similar to those seen in adults.
However, some side effects are either seen more frequently in children
and/or can be more severe in children than in adults. Side effects which
may be more severe include decreased or loss of sweating and increase of
the acid level in the blood. Side effects which may occur more frequently in
children include upper respiratory tract illnesses.
If you get any side effects, talk to your doctor or pharmacist. This includes
any 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 blister
and the carton after EXP. The expiry date refers to the last day of that
month.
Store in the original package in order to protect from light and moisture.
Do not use this medicine if you notice discolouration of the tablets.
Do not throw away any medicines 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 contains

The active substance is topiramate. Each film-coated tablet contains 25 mg,
50 mg, 100 mg or 200 mg topiramate per tablet.
The other ingredients are:
• Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal
anhydrous, sodium starch glycolate (type A), magnesium stearate.
• Film-coat: titanium dioxide (E171), hypromellose (E464), macrogol 400,
polysorbate 80 (E433) (25 mg only), iron oxide yellow (E172) (50 mg,
100 mg only), allura red (E129), sunset yellow (E110) and indigo carmine
(E132) (200 mg only) (see section 2 “Topiramate 200 mg contains sunset
yellow aluminium lake (E110) and allura red aluminium lake (E129)”).

What Topiramate looks like and contents of the pack

Your medicine comes in the form of a film-coated tablet that should look
like the following:
25 mg: White, round, film-coated tablet with sides that curve outwards,
marked with “G” on one side and “TO” over “25” on the other.
50 mg: Yellow, round, film-coated tablet with sides that curve outwards,
marked with “G” on one side and “TO” over “50” on the other.
100 mg: Yellow, round, film-coated tablet with sides that curve outwards,
marked with “G” on one side and “TO” over “100” on the other.
200 mg: Red, round, film-coated tablet with sides that curve outwards,
marked with “G” on one side and “TO” over “200” on the other.
The medicinal product is available in aluminium foil blisters in pack sizes of
10, 15, 20, 28, 30, 50, 60, 90, 100, 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers:

Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands
This leaflet was last revised in November 2017.

Date: 09 Jan 18

Pharma Code N/A

Vendor Job No. 523236


















Hoarseness of the voice
Gas or wind
Heartburn
Loss of sensitivity to touch or altered sense of touch that may feel
unpleasant, which can affect the mouth of face
Bleeding gums
Fullness or bloating
Painful or burning sensations in the mouth
Breath odour
Loss of taste
Leakage of urine and/or stools, blood in urine
Urgent desire to urinate
Skin discolouration
Localised swelling in the skin
Swelling of the face
Swelling of the joints
Musculoskeletal stiffness or muscle fatigue
Low potassium levels 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, which may make you feel dizzy or faint
Breathlessness, especially after exercise
Hot flushing, feeling warm
Flu like illness
Cold extremities (e.g. hands and face)
Feeling drunk
Problems with learning
Disturbances in sexual function (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication
Feeling tearful or crying

Reporting of side effects

Common (may affect up to 1 in 10 people):
• Weight gain
• Decrease or loss of appetite
• Feeling tired, breathless with pale skin- this may be caused by reduced
number of red blood cells
• 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
• Uncontrolled trembling or shaking in the arms, hands or legs
• Reduced sense of touch or sensation
• Uncontrollable movement of the eyes
• Distorted sense of taste
• Visual disturbance, such as blurred vision, double vision,
difficulty focussing
• Sensation of spinning, ringing sound in the ears, ear pain
• Shortness of breath
• Nose bleeds
• Being sick (vomiting)
• Constipation
• Gastritis, stomach pain or discomfort
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Hair loss
• Joint pain or swelling
• Muscle spasms, muscle twitching, muscle weakness or muscle pain
• Chest pain (which is caused by the muscles and bones in the chest)
• Fever
• Loss of strength
• General feeling of feeling unwell
• Cough

Description






1

Time: 08:55
Page Count

2/2

Black

Non-Print
Colours

Keyline/Drawing No N/A

Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Myriad Pro
210 x 420 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

1343259

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide