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TOPIRAMATE ACCORD 50 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Topiramate Accord 25 mg
film-coated tablets
Topiramate Accord 50 mg
film-coated tablets
Topiramate Accord 100
mg film-coated tablets
Topiramate Accord 200
mg film-coated tablets
Topiramate
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Topiramate is and what it is used for
2. Before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Further 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 over age 2
• to prevent migraine headaches in adults

2. Before you take Topiramate
Do NOT take Topiramate
• if you are allergic (hypersensitive) to topiramate
or any of the other ingredients of Topiramate
(see section 6, Further information).
• to prevent a migraine headache if you are
pregnant, think you may be pregnant or are of
child-bearing age and not using an effective
method of contraception.
If you are not sure if the above applies to you, talk
to your doctor or pharmacist before using
topiramate.
Take special care with Topiramate
Check with your doctor or pharmacist before
taking topiramate if you:
• have kidney problems, especially kidney stones,
or are getting kidney dialysis
• have a history of blood and body fluid
abnormality (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet)
• are pregnant or could become pregnant (see
section “pregnancy and breastfeeding� for
further information)
If you 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 to talk to your doctor before taking
any medicine containing topiramate that is given
to you as an alternative to topiramate.
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
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.
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 will have to be
adjusted.

It is important to drink plenty of water whilst you
are taking topiramate especially if you are taking
exercise or the weather is hot.
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 antiepilepsy
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.
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 breastfeed 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.
Important information about some of the
ingredients of Topiramate
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.
Warning! Each tablet bottle contains a desiccant
capsule. This a small canister on which “Do not
eat” is written. Do not eat this.

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.
• You may feel sleepy or tired, or have abnormal
body movements, problems standing and
walking, feel dizzy due to low blood pressure, or
have abnormal heart beats or fits.
Overdose can happen if you are taking other
medicines together with topiramate.
Signs and symptoms of over dosage may include
convulsions, drowsiness, speech disturbances,
double vision, impaired thinking, abnormal
coordination, dulling of consciousness, low blood
pressure, abdominal pain, agitation, dizziness and
depression.
If you forget to take Topiramate
Take the missed dose as soon as you remember.
If it is almost time for your next dose, do not take
the missed dose but simply take your next dose at
the normal time. If you miss two or more doses,
contact your doctor.
Do not take a double dose to make up for the one
you missed.
If you stop taking Topiramate
You may have more fits or sudden worsening of
the headaches. It is important that you keep taking
your tablets until your doctor tells you to stop. If
the doctor decides to stop your treatment with
topiramate they will usually do so gradually over a
period of a few weeks. It is important that you
follow what the doctor tells you to do.
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 can cause side
effects, although not everybody gets them.
If you notice a rash, itching, blistering or other
effects on the skin, eyes, mouth or genitals or
you get a high temperature, you should stop
taking the tablets and contact your doctor
immediately.
Patients taking topiramate can have thoughts of
harming themselves or taking their own lives. If
you get these thoughts at any time, contact your
doctor or go to a hospital immediately.

Especially, tell your doctor or pharmacist if you are
taking:
• other medicines that impair or decrease your
thinking, concentration, or muscle coordination
(e.g. central nervous system depressant
medicines such as muscle relaxants and
sedatives).
• birth control pills. Topiramate may make your
birth control pills less effective.

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).

Tell your doctor if your menstrual bleeding
changes while you are taking birth control pills and
topiramate.

The following side effects have been reported:
Very common side effects (probably affecting
more than 1 in 10 people):
• weight loss
• tingling in the arms and legs
• drowsiness or sleepiness
• dizziness
• diarrhoea
• nausea (feeling sick)
• stuffy, runny nose and sore throat
• tiredness
• depression

Keep a list of all the medicines you take. Show this
list to your doctor and pharmacist before you start
a new medicine.
Other medicines you should discuss with your
doctor or pharmacist include other antiepileptic
medicines,
risperidone,
lithium,
hydrochlorothiazide, metformin, pioglitazone,
glyburide, amitriptyline, propranolol, diltiazem,
venlafaxine, flunarazine
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
topiramate.
Taking Topiramate with food and drink
You can take topiramate with or without food.
It is recommended not to drink alcohol whilst you
are taking topiramate as this can increase the risk
of side effects.

Common side effects (probably affecting fewer
than 1 in 10 people):
• 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
• 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 (probably affecting fewer
than 1 in 100 people):
• 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
• Gas
• 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
• Localized 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
• 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
• Increase in liver enzymes
Rare side effects (probably affecting fewer than 1
in 1,000 people):
• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma which is a blockage of fluid in the eye
causing increased pressure in the eye, pain and
decreased vision
• Renal tubular acidosis
• 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, and erythma
multiforme, a condition of raised red spots that
can blister
• 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
• 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.
• Toxic epidermal necrolysis which is a more
severe form of Stevens-Johnson syndrome (see
uncommon side effects).
Paediatric population (ADRs reported more
frequently (≥2-fold) in children than in adults):
• Decreased appetite
• Increased appetite
• Hyperchloraemic acidosis
• Hypokalaemia
• Abnormal behaviour
• Aggression
• Apathy
• Initial insomnia
• Suicidal ideation
• Disturbance in attention
• Lethargy
• Circadian rhythm sleep disorder
• Poor quality sleep
• Lacrimation increased
• Sinus bradycardia
• Feeling abnormal
• Gait disturbance
ADRs that were reported in children but not in
adults:
• Eosinophilia
• Psychomotor hyperactivity
• Vertigo
• Vomiting
• Hyperthermia
• Pyrexia
• Learning disability
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Topiramate
tablets
Keep out of the reach and sight of children.
Do not use Topiramate tablets 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 25ºC. Keep the container
tightly closed in order to protect from moisture.
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 contains
The active substance is topiramate.
Topiramate Accord 25mg Film-coated tablet: Each
film coated tablet contains 25 mg topiramate.
Topiramate Accord 50mg Film-coated tablet: Each
film coated tablet contains 50 mg topiramate.
Topiramate Accord 100mg Film-coated tablet: Each
film coated tablet contains 100 mg topiramate.
Topiramate Accord 200mg Film-coated tablet: Each
film coated tablet contains 200 mg topiramate.
The other ingredients are lactose monohydrate
(see section 2: important information about some
of the ingredients of Topiramate tablets), Cellulose
microcrystalline, Starch, Pregelatinised (i.e.
potato
starch),
croscarmellose
sodium,
magnesium stearate.
• The 25 mg tablets are coated with
hypromellose, titanium dioxide (E171) and
macrogol 6000.
• The 50 mg and 100 mg tablets are coated with
hypromellose,
titanium
dioxide
(E171),
macrogol 6000 and iron oxide yellow (E172)
• The 200 mg tablets are coated with
hypromellose,
titanium
dioxide
(E171),
macrogol 6000 and iron oxide red (E172).
What Topiramate tablets looks like and
content of the pack
Film-coated tablet.
The 25 mg film-coated tablets are white round and
biconvex, with bevelled edges and embossed TP
on one side and 25 on the other.
The 50 mg film-coated tablets are light yellow
round and biconvex with bevelled edges and
embossed TP on one side and 50 on the other.
The 100 mg film-coated tablets are dark yellow
round and biconvex, with bevelled edges and
embossed TP on one side and 100 on the other.
The 200 mg film-coated tablets are red, round and
biconvex, with bevelled edges and embossed TP
on one side and 200 on the other.
Topiramate film-coated tablets are available in
aluminium/aluminium blisters in packs sizes of 10,
14, 20, 28, 30, 50, 56, 60, 100, 120 and 200
film-coated tablets or in high density polyethylene
(HDPE) bottles fitted with a white opaque
polypropylene child resistant closure with wad
having induction sealing liner supplied in
cardboard cartons in pack sizes of 14,30,60,100
and 200 film-coated tablets. In each container
there is a desiccant canister, which should not be
swallowed.
Not all pack sizes may be marketed.
Topiramate is available in four strengths
containing either 25 mg, 50 mg, 100 mg and 200
mg topiramate.
Marketing authorization holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex,
HA1 4HF, United Kingdom
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex,
HA1 4HF, United Kingdom
or
Cemelog BRS Limited,
2040 Budaörs, Vasút u. 13., Hungary.
This leaflet was last approved in 01/2014

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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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