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TOPIRAMATE SANDOZ 50 MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Topiramate 25 mg film-coated Tablets
Topiramate 50 mg film-coated Tablets
Topiramate 100 mg film-coated Tablets
Topiramate 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 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. Contents of the pack and other
information

1

without food. Drink plenty of fluids
during the day to prevent kidney
stones while taking Topiramate. You
should avoid drinking alcohol when
taking Topiramate.

What Topiramate is
and what it is used for

Pregnancy, breast-feeding and
fertility
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask
your doctor for advice before taking
this medicine.
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.

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

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.

Do not take Topiramate:
• 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 section
“Pregnancy and breast-feeding”
for further information).

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 this 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.

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

Warnings and precautions
Talk to 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 breast-feeding” for further
information).

Topiramate film-coated 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.

3

How to take
Topiramate

Always take this medicine exactly as
your doctor 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
prevent kidney stones while
taking Topiramate.

If you are not sure if any of the above
apply 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.

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.

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).

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.

Overdose can happen if you are
taking other medicines together with
Topiramate.

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.

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.

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.

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.

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

4

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, St Johnʼs 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.

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).

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Topiramate with food and drink
You can take Topiramate with or

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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.

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 by widespread
blistering and sloughing of the
outer layers of the skin (see rare
side effects).

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:

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.

Very common (may affect more
than 1 in 10 people)
• Stuffy, runny nose or sore throat
• Tingling, pain and/or numbness of
various body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss.

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:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the
safety of this medicine.

Common (may affect up to 1 in 10
people)
• Anaemia (low blood count)
• Allergic reaction (such as skin
rash, redness, itching, facial
swelling, hives)
• Loss of appetite, decrease appetite
• Aggression, agitation, anger
• 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;
rapid, uncontrollable movement of
the eyes
• Visual disturbance, such as double
vision, blurred 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.

5

How to store
Topiramate

Keep this medicine out of the sight
and reach of children.

Do not use Topiramate after the
expiry date, which is stated on the
label and the outer carton. The
expiry date refers to the last day of
the month.
HDPE containers: 1 month after first
opening.

Do not store above 25ºC. Store in
the original package 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

Uncommon (may affect up to 1 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 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.

Contents of the pack
and other information

What Topiramat Sandoz contains

The active substance is topiramate.
Topiramate 25 mg film-coated Tablets:
Each film-coated tablet contains
25 mg of topiramate.
Topiramate 50 mg film-coated Tablets:
Each film-coated tablet contains
50 mg of topiramate.
Topiramate 100 mg film-coated
Tablets:
Each film-coated tablet contains
100 mg of topiramate.
Topiramate 200 mg film-coated
Tablets:
Each film-coated tablet contains
200 mg of topiramate.

The other ingredients are: lactose
monohydrate, microcrystalline
cellulose, starch, sodium starch
glycolate, magnesium stearate,
hypromellose, titanium dioxide
(E171), macrogol, polysorbate 80.
Topiramate 50 mg and 200 mg
film-coated Tablets: yellow iron
oxide (E172).

What Topiramate film-coated
Tablets look like and contents of
the pack
Film-coated tablets
Topiramate 25 mg film-coated tablet:
White, round shaped, film-coated
tablet, plain on both sides.
Topiramate 50 mg film-coated tablet:
Yellow, round shaped, film-coated
tablet, plain on both sides.
Topiramate 100 mg film-coated tablet:
White, round shaped, film-coated
tablet, plain on both sides.
Topiramate 200 mg film-coated tablet:
Yellow, round shaped, film-coated
tablet, plain on both sides.
Blisters: 5, 6, 10, 20, 60 and 100
film-coated tablets.
HDPE container with PP cap with
silica gel canister or silica gel packet
as desiccant: 20, 28, 50, 60, 100
and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Lek Pharmaceuticals d.d,
Verovškova 57, SI 1526 Ljubljana,
Slovenia or Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179
Barleben, Germany or Salutas
Pharma GmbH, Dieselstrasse 5,
70839 Gerlingen, Germany or
LEK S.A., ul. Domaniewska 50 C,
02-674 Warsaw, Poland

Rare (may affect up to 1 in 1,000
people)
• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary
blindness, night blindness
• Lazy eye
• Swelling in and around the eyes
• Numbness, tingling and colour

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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 mouth, nose, and
eyes), a skin rash, and blistering
Abnormal skin odour
Discomfort in your arms or legs
Kidney disorder

This leaflet was last revised in
06/2014

SZ00000LT000
00000000

Artwork Proof Box
Ref: V047: Inclusion of silica gel canister 1gm as a desiccant
Proof no.
012.0

Date prepared:
26/06/2014

Colours:
Black
Black 20%
Dimensions: 110 x 540 mm

Font size:
7.5pt
Fonts:
Helvetica

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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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