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TOPAMAX SPRINKLE 15 MG HARD CAPSULES

Active substance(s): TOPIRAMATE / TOPIRAMATE / TOPIRAMATE

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Package leaflet: Information for the user

© J-C 2017

GB - AW_125915

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.
Topamax 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 Topamax, the risk of developing
these symptoms may increase.

Other medicines and Topamax

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.

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.

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)

AW_125915.pdf - Page 1 of 3 - April 12, 2017 - 13:22:24

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

© J-C 2017

GB - AW_125915

4 Possible side effects (continued)
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
• 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)
• 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
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, StevensJohnson syndrome, characterized by 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.
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 after EXP.
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 tamper-evident
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_125915.pdf - Page 2 of 3 - April 12, 2017 - 13:22:25

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 April 2017.

Expand Transcript

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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