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TOPIRAMATE ACCORD 25 MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE / TOPIRAMATE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Topiramate 25mg / 50mg / 100mg / 200mg

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

12 (Page 1 of 2) UK-H-1438-001-004-IB-07

Date

14_04_16 (Topiramate (ACC-UK) NEW-PIL-IB-07)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the patient

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 because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist.This includes any possible side
effects not listed in this leaflet. See section 4
What is in this leaflet
1. What topiramate tablets are and what they are
used for
2. What you need to know before you take
topiramate tablets
3. How to take topiramate tablets
4. Possible side effects
5. How to store topiramate tablets
6. Contents of the pack and other information

1. What topiramate tablets are and
what they are 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. What you need to know before
you take topiramate tablets
Do not take topiramate tablets:
 if you are allergic (hypersensitive) to topiramate
or any of the other ingredients of this medicine
(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
“Pregnancy,breast-feeding and fertility” section
for further information).
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before taking
topiramate tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking
topiramate tablets 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
“pregnancy ,breastfeeding and fertility”-section
for further information)
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking topiramate tablets.
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 this medicine.
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.
Other medicines and topiramate tablets
Tell your doctor or pharmacist if you are taking
,have recently taken or might take any other
medicines, Topiramate tablets and certain other
medicines can affect each other. Sometimes the
dose of some of your other medicines or this
medicine 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).
• birth control pills. This medicine may make your
birth control pills less effective.
Tell your doctor if your menstrual bleeding
changes while you are taking birth control pills
and topiramate.
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 and
St. John’s Wort (Hypericum perforatum; a herbal
preparation used to treat depression).
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
using topiramate.
Topiramate tablets 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 tablets.
You should avoid drinking alcohol when taking
Topiramate tablets.

Approved By
Quality Assurance

Pregnancy ,breast-feeding and fertility
If you are pregnant or breast feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. Your doctor will discuss use
of contraceptives with you, as well as discussing
whether Topiramate is suitable for you. As with
other anti-epileptic medicines, there is a risk of
harm to the unborn child if Topiramate is used
during pregnancy. Make sure you are very velar
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.
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 tablets contain 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 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 tablets
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• Take topiramate exactly as prescribed. Your
doctor will usually start you on a low dose of
topiramate and slowly increase your dose until
the best dose is found for you.
• 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 tablets 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 tablets
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
forgotten dose.
If you stop taking topiramate tablets
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
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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking this medicine and tell your doctor, or
go to a hospital straight away if you have any of
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, changes in mood, confusion,
disorientation
• 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
Uncommon (may affect up to 1 in 100 people)
• 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
• Having thoughts of serious self-harm, trying to
cause serious self-harm
• Loss of part of the field of vision
Rare (may affect up to 1 in 1,000 people)
Glaucoma – blockage of fluid in eye causing
increased pressure in the eye, pain, or decreased
vision.
Other side effects include the following, if they
get serious, please tell your doctor or pharmacist:
Very common side effects ( may affect more
than 1 in 10 people):
• weight loss
• tingling, pain and/or numbness of various body
parts
• dizziness
• diarrhoea
• nausea (feeling sick)
• stuffy, runny nose and sore throat
• sleepiness,tiredness
Common side effects ( may affect upto 1 in
10 people):
• Anaemia (low number of red blood cells)
• Allergic reaction (such as skin rash, redness,
itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal
behaviour

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Topiramate 25mg / 50mg / 100mg / 200mg

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

12 (Page 2 of 2) UK-H-1438-001-004-IB-07

Date

14_04_16 (Topiramate (ACC-UK) NEW-PIL-IB-07)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

• Difficulty falling or staying asleep
• Problems with speech or speech disorder,
slurred speech
• Clumsiness, or lack of coordination, feeling of
unsteadiness when walking
• Decreased ability to complete routine tasks
• Decreased, loss of, or no sense of taste
• Involuntary trembling or shaking in the arms,
hands or legs; rapid, uncontrollable movements
of the eyes
• Visual disturbance, such as blurred vision,
double vision, decreased vision, difficulty
focusing
• Sensation of spinning (vertigo), ringing in the
ears, ear pain
• Shortness of breath
• Cough
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or
discomfort, indigestion, stomach or intestinal
infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or
twitching, muscle aches or weakness, chest
pain
• Weight gain
Uncommon side effects ( may affect upto1 in
100 people):
• Decrease in platelets (blood cells that help stop
bleeding), decrease in white blood cells that
help to protect you against infection, decrease
in potassium level in the blood
• Increase in liver enzymes, increase in
eosinophils (a type of white blood cell) in the
blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not
there, severe mental disorder (psychosis)
• Showing and/or feeling no emotion, unusual
suspiciousness, panic attack
• Problems with reading, speech disorder,
problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or
alertness
• Reduced or slow body movements, involuntary
abnormal or repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of
touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede
a migraine or a certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid
twitching, watery eyes
• Decreased or loss of hearing, loss of hearing in
one ear
• Slow or irregular heartbeat, feeling your heart
beating in your chest
• Low blood pressure, low blood pressure upon
standing (consequently, some people taking
Topamax may feel faint, dizzy, or may pass out
when they stand up or sit up suddenly)
• Flushing, feeling warm
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or wind, heartburn,
abdominal fullness or bloating
• Bleeding gums, increased saliva, drooling,
breath odour
• Excessive intake of fluids, thirst
• Skin discolouration
• Muscle stiffness, pain in side
• Blood in urine, incontinence (lack of control) of
urine, urgent desire to urinate, flank or kidney
pain
• Difficulty getting or keeping an erection, sexual
dysfunction
• Flu-like symptoms
• Cold fingers and toes
• Feeling drunk
• Learning disability
Rare side effects (may affect upto 1 in 1,000
people):
• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness,
night blindness
• Lazy eye
• Numbness, tingling and colour change (white,
blue then red) in fingers and toes when
exposed to the cold
• Inflammation of the liver, liver failure
• Stevens-Johnson syndrome, a potentially life
threatening condition that may present with
sores in multiple mucosal sites (such as the
month, nose, and eyes), a skin rash, and
blistering
• Anbormal skin odour
• Discomfort in your arms or legs
• Kidney disorder
Not known (frequency cannot be estimated
from the available data)
• Maculopathy is a disease of the macula, the
small spot in the retina where vision is keenest.
You should call your doctor if you notice a
change or decrease in your vision.
• Toxic epidermal necrosis, a life-threatening
condition related to, yet more severe than,
Stevens-Johnson syndrome, characterized ny
widespread blistering and sloughing of the outer
layers of the skin (see rare side effects).
Children
The side effects in children are generally similar
to those seen in adults, but the following side
effects may be more common in children than
adults:
- Problems with concentration
- Increased acid level in the blood
- Having thoughts of serious self-harm
- Tiredness
- Decreased or increased appetite
- Aggression, abnormal behaviour
- Difficulty falling or staying asleep
- Feeling of unsteadiness when walking
- Not feeling well
- Decrease in potassium level in the blood
- Showing and/or feeling no emotion
- Watery eyes
- Slow or irregular heartbeat
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)
- Sensation of spinning (vertigo)
- Vomiting
- Fever

Approved By
Quality Assurance

Uncommon (may affect up to 1 in 100 people)
- Increase in eosinophils (a type of white blood
cell) in the blood
- Hyperactivity
- Feeling warm
- Learning disability
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store topiramate tablets
Keep this medicine out of 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 25ºC. Keep the container
tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longeruse. These
measures will help to protect the environment.

6. Contents of the pack and other
information
What topiramate tablets contain
The active substance is topiramate.
Each film-coated tablet contains 25 mg topiramate.
Each film-coated tablet contains 50 mg topiramate.
Each film-coated tablet contains 100 mg topiramate.
Each film-coated tablet contains 200 mg topiramate.
The other ingredients are lactose monohydrate
(see section 2: topiramate tablets contain
lactose), cellulose microcrystalline, starch,
pregelatinised (i.e. potato starch), croscarmellose
sodium and 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 look like and
contents of the pack
Film-coated tablet.
Topiramate Accord is available in four strengths
containing either 25 mg, 50 mg, 100 mg and 200
mg topiramate.
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.
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
Wessling Hungray Limited
1047 Budapest, Fóti út 56
Hungary
This leaflet was last revised in 04/2016

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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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