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TOPAMAX SPRINKLE 50MG CAPSULES

Active substance(s): TOPIRAMATE

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S166 LEAFLET Topamax 20140226

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

TOPAMAX SPRINKLE 50mg CAPSULES
(topiramate)
Your medicine is known as Topamax Sprinkle 50mg Capsules but
will be referred to as Topamax throughout the following leaflet.
Information for other strengths of Topamax i.e. 15mg and 25mg
also may be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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 for advice before
taking this medicine. Your doctor will decide if you can take
Topamax. As with other antiepilepsy 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.



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

Ask your doctor or pharmacist for advice before taking this
medicine.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

Driving and using machines

Mothers who breast-feed while taking Topamax must tell the doctor
as soon as possible if the baby experiences anything unusual.

What is in this leaflet

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.

1

What Topamax is and what it is used for

Topamax contains sucrose

2

What you need to know before you take Topamax

3

How to take Topamax

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

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:

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



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



Hold the hard capsule upright so that you can read the word
“TOP”

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPAMAX



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

Do not take Topamax


if you are allergic (hypersensitive) to topiramate or any of the
other ingredients of Topamax (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

If you take more Topamax than you should



have a history of blood and body fluid abnormality (metabolic
acidosis)



See a doctor right away. Take the medicine pack with you





have liver problems



have eye problems, especially glaucoma

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).



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)

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

It is important that you do not stop taking your medicine without first
consulting your doctor.



Do not take a double dose (two doses at the same time) to
make up for a forgotten dose

You should also talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topamax.

If you stop taking Topamax

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

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)

Especially, tell your doctor or pharmacist if you are taking:





Common (may affect up to 1 in 10 people)



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.

Depression (new or worse)



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

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:



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

Very common (may affect more than 1 in 10 people)


Stuffy, runny nose or sore throat



Abnormal skin odour



Tingling, pain and/or numbness of various body parts



Discomfort in your arms or legs



Sleepiness, tiredness



Kidney disorder



Dizziness



Nausea, diarrhoea

Not known (frequency cannot be estimated from the available
data)



Weight loss



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)

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



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

5

HOW TO STORE TOPAMAX



Vomiting, constipation, abdominal pain or discomfort,
indigestion, stomach or intestinal infection



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





Do not store your capsules above 25°C.

Dry mouth





Keep the bottle tightly closed.

Hair loss





Itching



Joint pain or swelling, muscle spasms or twitching, muscle
aches or weakness, chest pain

Do not use Topamax after the expiry date which is stated on the
carton and bottle label. The expiry date refers to the last day of
that month.





Weight gain

Capsules should not be thrown in your bin or put down the
drain. If they are out of date, or no longer suitable for you, return
them to your pharmacist.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
CONTENTS OF THE PACK AND OTHER INFORMATION

Uncommon (may affect up to 1 in 100 people)

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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.



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

6



Swollen glands in the neck, armpit, or groin

What Topamax contains



Increased appetite





Elevated mood

Each Capsule contains 50mg of the active ingredient,
topiramate.



Hearing, seeing, or feeling things that are not there, severe
mental disorder (psychosis)





Showing and/or feeling no emotion, unusual suspiciousness,
panic attack

Topamax also contains the following: sugar spheres, povidone,
cellulose acetate, gelatin, titanium dioxide (E171) and black
printing ink (black iron oxide (E172), shellac and propylene
glycol).



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



Product Licence holder

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

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



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

POM



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)

Leaflet revision date: 26 February 2014



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

What Topamax looks like and contents of the pack


Topamax is a white capsule with a clear cap marked ‘TOP
50mg’ containing white spheres.



Topamax is available in white plastic bottles with a tamper
evident screw cap containing 60 capsules.

Manufacturer
This product is manufactured by Janssen-Cilag Sp.a., 04010 Borgo
S. Michele, Latina, Italy.
PL No. 19488/0166

Topamax is a registered trade mark of Johnson & Johnson, USA.
S166 LEAFLET Topamax 20140226

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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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