Skip to Content

UK Edition. Click here for US version.

TOPAMAX SPRINKLE 15 MG HARD CAPSULES

Active substance(s): TOPIRAMATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

GB - AW_108774
© J-C 2015

Topamax® Sprinkle
15, 25 and 50 mg hard capsules
Topiramate
Topamax is registered trademark

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 Topamax is and what it is used for
2 What you need to know before you take
Topamax
3 How to take Topamax
4 Possible side effects
5 How to store Topamax
6 Contents of the pack and other information

1 What Topamax is and what it is used for
Topamax 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 Topamax
Do not take Topamax

• 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
you are able to become pregnant but you are not
using effective contraception (see section
‘pregnancy and breast-feeding’ for further
information)
If you are not sure if the above applies to you, talk
to your doctor or pharmacist before using
Topamax.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Topamax 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)
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Topamax.
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 Topamax.
You may lose weight if you use Topamax 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 Topamax have
had thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor.

Other medicines and Topamax

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Topamax and certain other medicines
can affect each other. Sometimes the dose of
some of your other medicines or Topamax 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. Topamax may make your birth
control pills less effective

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

Topamax with food and drink

You can take Topamax with or without food. Drink
plenty of fluids during the day to prevent kidney
stones while taking Topamax. You should avoid
drinking alcohol when taking Topamax.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Your doctor will discuss use of contraceptives with
you, as well as discussing whether Topamax is
suitable for you. As with other anti-epileptic
medicines, there is a risk of harm to the unborn
child if Topamax is used during pregnancy. Make
sure you are very clear about the risks and the
benefits of using Topamax for epilepsy during
pregnancy.
You should not take Topamax for migraine
prevention if you are pregnant or you are able to
become pregnant and you are not using effective
contraception.
Mothers who breast-feed while taking Topamax
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 Topamax. Do not drive
or use any tools or machines without talking to
your doctor first.

Topamax contains sucrose

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 Topamax
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 Topamax and slowly increase your dose until
the best dose is found for you
• Topamax hard capsules may be swallowed
whole or may be opened and sprinkled
on a teaspoon of soft food of any type. Examples
are applesauce, custard, ice cream, porridge,
pudding or yogurt. Drink fluids right after to make
sure all of the food and medicine mixture is
swallowed
• Hold the hard capsule upright so that you can
read the word “TOP”
• Carefully twist off the clear portion of the
capsule. You may find it best to do this over the
small portion of food onto which you will be
pouring the sprinkles
• Sprinkle all of the capsule’s contents onto
a spoonful of soft food, taking care to see that
the entire prescribed dosage is sprinkled onto
the food
• Be sure to swallow the entire spoonful of the
sprinkle/food mixture immediately.
Avoid chewing. Drink fluids immediately in order
to make sure all of the mixture is swallowed
• Never store any medicine and food mixture for
use at a later time
• Topamax can be taken before, during or after a
meal. Drink plenty of fluids during the day to
prevent kidney stones while taking Topamax

If you take more Topamax 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 Topamax.

If you forget to take Topamax

• 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 Topamax

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
product, 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 (particularly in
young children who are exposed to high
temperatures)
• 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 (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
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, 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; rapid,
uncontrollable movements 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

AW_108774..pdf - Page 1 of 3 - December 4, 2015 - 11:43:04

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
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 (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 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 lifethreatening 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
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)

© J-C 2015

GB - AW_108774

4 Possible 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.
In the UK, you can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
In Ireland, you can also report side effects directly
via: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie,
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store Topamax
• 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 bottle/carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Keep the bottle tightly
closed to protect the capsules 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 protect the environment.

6 Contents of the pack and other information
What Topamax contains

The active substance is topiramate. Each Topamax
hard capsule contains 15, 25 or 50 mg of
topiramate.
The other ingredients of Topamax are listed below:
Sugar spheres (maize starch, sucrose), povidone,
cellulose acetate
Capsule:
Gelatine, titanium dioxide (E 171)
Printing ink:
Black ink (iron oxide black (E172), shellac
and propylene glycol).

What Topamax looks like and contents
of the pack
15 mg capsules: Small white to off-white spheres in
hard gelatine capsules with white opaque body
marked '15 mg’ and clear cap marked 'TOP'.
25 mg capsules: Small white to off-white spheres in
hard gelatine capsules with white opaque body
marked '25 mg’ and clear cap marked 'TOP'.
50 mg capsules: Small white to off-white spheres in
hard gelatine capsules with white opaque body
marked '50 mg’ and clear cap marked 'TOP'.
Opaque plastic bottle of HDPE with tamperevident closure containing 20, 28, 60 or
100 capsules with granules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm
Way, High Wycombe, Bucks HP12 4EG, UK
Topamax Sprinkle hard capsules are made by:
Janssen-Cilag S.p.a., 04100 Borgo S. Michele,
Latina, Italy
OR
McGregor Cory Limited, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

AW_108774..pdf - Page 2 of 3 - December 4, 2015 - 11:43:04

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Topamax– Granulat in Kapseln
Belgium
Topamax harde capsules
Bulgaria
TOPAMAX
Cyprus
TOPAMAX Sprinkles
Czech Republic Topamax
Denmark
Topimax
Finland
Topimax kapseli, kova
France
EPITOMAX, GELULE
Germany
Topamax 25<50> Hartkapseln
Greece
TOPAMAC
Iceland
Topimax hylki, hörð
Ireland
Topamax Sprinkle Capsules
Italy
TOPAMAX capsule rigide,
60 capsule
Latvia
Topamax sprinkle capsules
Luxembourg
Topamax gélules
Malta
Topamax
Netherlands
Topamax Sprinkle, harde capsules
Norway
Topimax Kapsel, hard
Poland
Topamax kapsulki
Portugal
Topamax
Romania
TOPAMAX sprinkle caps
Slovak Republic Topamax cps
Slovenia
TOPAMAX kapsule
Spain
TOPAMAX DISPERSABLE,
cápsulas
Sweden
Topimax kapslar, hårda
United Kingdom Topamax Sprinkle capsules

For information in large
print, tape, CD or Braille,
telephone 0800 7318450
(UK) or 1800 709122 (IRE).
This leaflet was last revised in November 2015.

Expand view ⇕

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.

Hide