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TOPIRAMATE 200 MG FILM-COATED TABLETS

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2467
09.02.13[3]

Topamax® 200 mg film-coated tablets
Topiramate 200 mg film-coated tablets
(topiramate)
PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Topamax throughout the leaflet.
Topamax tablets are also available in other strengths.
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 (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
- 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
breastfeeding’ 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, 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.
Mothers who breast-feed while taking Topamax 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
Topamax. Do not drive or use any tools or machines without talking to your
doctor first.
Topamax contains 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 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 tablets are to be swallowed whole. Avoid chewing the tablets
as they may leave a bitter taste
- 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
- 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:
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
- 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
- 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 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
- Increased acid level in the blood
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)
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.
5. HOW TO STORE TOPAMAX
- Keep out of the sight and reach of children
o
- Do not store above 25 C. Store in the original package.
Keep container tightly closed in order to protect from moisture.
- Do not use Topamax tablets after the expiry date which is stated on the
label. The expiry date refers to the last day of that month.
- If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste.
These measures will help protect the environment. Return any leftover
Topamax tablets to your pharmacist
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topamax contains
The active ingredient in Topamax is topiramate.
Each film-coated tablet contains 200 mg topiramate.
Also contains the following inactive ingredients:
Core-tablet: lactose monohydrate, pregelatinised maize starch,
microcrystalline cellulose (E460), sodium starch glycollate, magnesium
stearate
Film-coating: Opadry pink (which contains titanium dioxide (E171),
hypromellose 2910 (E464) (3 cp), hypromellose 2910 (E464) (6 cp),
macrogol 400, red iron oxide (E172), polysorbate 80) and carnauba wax.
What Topamax look like and contents of the pack
Topamax are salmon round film-coated tablets embossed ‘TOP’ on one
side and ‘200’ on the other.
Topamax comes in a plastic bottle with a tamper evident seal and child
resistant closure. Available in packsize of 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by
Cilag AG., Hochstrasse 201, Schaffhausen, CH-8205, Switzerland.
Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-2340, Beerse, Belgium.
Procured from within the EU by the Product Licence holder Tenolol Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL No: 30900/2467

Leaflet revision and issue date (Ref) 09.02.13[3]
Topamax is a trademark of Janssen-Cilag.

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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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