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TOPIRAMATE ACCORD 25 MG FILM-COATED TABLETS

Active substance(s): 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.

13 (Page 1 of 2) (IB018)

Date

02_09_17 (Topiramate (ACC-UK) NEW-PIL-IB-07)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

Keep a list of all the medicines you take. Show
this list to your doctor and pharmacist before you
start a new medicine.
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 aged 2 years and above
• 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 if
you are a woman of childbearing potential unless
you are using effective contraception(see
“Pregnancy,breast-feeding and fertility” section
for further information). You should talk to your
doctor about the best kind of contraception to
use while you are taking topiramate tablets.
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 taking topiramate tablets to treat epilepsy
and you are pregnant or a woman of childbearing
potential (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.
Topiramate tablets may in rare cases cause high
levels of ammonia in the blood (seen in blood
tests) which can lead to a change in brain function,
especially if you are also taking a medicine called
valproic acid or sodium valproate. Since this may
be a severe condition, tell your doctor immediately
if the following symptoms occur (see also section
4 ‘Possible side effects’):
- difficulty thinking, remembering information, or
solving problems
- being less alert or aware
- feeling very sleepy with low energy
At higher doses of topiramate tablets, the risk of
developing these symptoms may increase.
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. You should talk to
your doctor about the best kind of contraception
to use while you are taking topiramate tablets.
Tell your doctor if your menstrual bleeding
changes while you are taking birth control pills
and topiramate.

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.
Pregnancy ,breast-feeding and fertility
Migraine prevention:
Topiramate tablets can harm an unborn baby.
You must not use topiramate tablets if you are
pregnant. You must not use topiramate tablets 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
topiramate tablets is suitable for you. Before the
start of treatment with topiramate tablets a
pregnancy test should be performed.
Treatment of epilepsy:
If you are a woman of childbearing potential you
should talk to your doctor about other possible
treatments instead of topiramate tablets. If the
decision is made to use topiramate tablets, you
should use effective contraception. Talk to your
doctor about the best kind of contraception to use
while you are taking topiramate tablets. Before
the start of treatment with topiramate tablets a
pregnancy test should be performed.
Talk to your doctor if you wish to become pregnant.
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.
- If you take topiramate tablets 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 tablets 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 topiramate tablets. You and
your doctor should decide if you will continue to
take topiramate tablets while you are pregnant.
Breast-feeding
The active substance in topiramate tablets
(topiramate) passes into breast milk. Effects have
been seen in breastfed babies of treated
mothers, including diarrhea, feeling sleepy,
feeling irritable, and poor weight gain. Therefore,
your doctor will discuss with you whether you
abstain from breastfeeding or whether to abstain
from treatment with topiramate tablets. Your
doctor will take into account the importance of the
medicine to the mother and the risk for the baby.
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
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 unless told to do
so by your doctor. Your symptoms may return. If
doctor decides to stop this medication, your dose
may be decreased gradually over few days.

(677964) Dt. 07:09:17, R-04_12_17, 06_02_18

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.

13 (Page 2 of 2) (IB018)

Date

02_09_17 (Topiramate (ACC-UK) NEW-PIL-IB-07)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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, 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.
• Difficulty thinking, remembering information, or
solving problems, being less alert or aware,
feeling very sleepy with low energy – these
symptoms may be a sign of a high level of
ammonia in the blood (hyperammonemia),
which can lead to a change in brain function
(hyperammonemic encephalopathy).
Other side effects include the following, if they
get serious, please tell your doctor or pharmacist:
Very common (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 (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
• 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 (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
topiramate tablets 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 (may affect upto 1 in 1,000 people)
• Abnormally elevated mood
• Loss of consciousness

Approved By
Quality Assurance

• Blindness in one eye, temporary blindness,
night blindness
• Lazy eye
• Swelling in and around the eyes
• 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
• Abnormal 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
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
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 longer use. 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
This leaflet was last revised in 02/2018.

(677964) Dt. 07:09:17, R-04_12_17, 06_02_18

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