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Active substance(s): TOPIRAMATE

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To amend the post
By symonsp at 1:49 pm, Apr 25, 2017 ® code for Italian
Topamax Sprinkle
15mg Capsules
‘04010’ to
Read all of this leaflet carefully before you start taking this medicine
with food and drink
because it contains important information for you.
take Topamax with or without food. Drink plenty of fluids during
changes assessed.

 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
 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.
 The name of your medicine is Topamax Sprinkle 15mg Capsules but
will be referred to as Topamax throughout the remainder of this leaflet.
 Please note that this medicine is also available in other strengths,
Topamax Sprinkle 25mg and 50mg Capsules.

the day to prevent kidney stones while taking Topamax.
You should avoid drinking alcohol when taking Topamax.

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

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

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
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
 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
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.

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
Your doctor will discuss use of contraceptives with you, as well as
discussing whether Topamax is suitable for you. As with other antiepileptic 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.

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.
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
 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
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
 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.
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
 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,
 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
 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
 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
 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 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
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).
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
 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:
By reporting side effects you can help provide more information on the
safety of this medicine.

Keep out of the sight and reach of children
Keep the container tightly closed
Do not store above 25°C
Protect from moisture
Do not use Topamax Sprinkle after the expiry date which is stated on
the label. The expiry date refers to the last day of that month
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist
 Medicines should not be disposed of via wastewater or household
waste. These measures will help protect the environment. Return any
leftover Topamax to your pharmacist
The active ingredient in Topamax Sprinkle is topiramate.
Each hard capsule contains 15mg of topiramate.
The other ingredients are Sugar spheres (sucrose and maize starch),
Povidone, Cellulose Acetate, Gelatin and Titanium dioxide (E171).
Printing ink: Black iron oxide (E172), Pharmaceutical glaze and
Propylene glycol.
What Topamax Sprinkle looks like and contents of the pack
Hard gelatin capsule with white body and clear cap. The capsules
contain white to off-white spheres. The capsule is marked ‘TOP’ on the
cap and ’15 mg’ on the capsule body.
Topamax Sprinkle is available in bottles containing 60 capsules.
Manufactured by
Janssen-Cilag S.p.A., 04100 Borgo S. Michele, Latina, Italy.
Procured from within the EU by the product licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by: XXXXXXXXXXXXX
PL: 33532/0116
Leaflet dated 25th April 2017
Topamax® is a registered trademark of Janssen-Cilag Ltd.

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