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TOPIRAMATE 200 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate 25, 50, 100 and
200 mg Tablets
Topiramate
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.
What is in this leaflet:
1. What Topiramate Tablets are and what they are used for
2. What you need to know before you take Topiramate Tablets
3. How to take Topiramate Tablets
4. Possible side effects
5. How to store Topiramate Tablets
6. Contents of the pack and other information
1. WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED
FOR:
Topiramate Tablets belong to a group of medicines called “antiepileptic
medicines.” They are used:
• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children over
age 2
• to prevent migraine headaches in adults
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE
TABLETS
Do not take Topiramate Tablets
• if you are allergic (hypersensitive) to topiramate or any of the other
ingredients of Topiramate Tablets (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 breastfeeding’ for further information).
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Topiramate Tablets.
Warnings and precautions
Check with your doctor or pharmacist before taking Topiramate
Tablets 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)
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before using Topiramate Tablets.
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
Topiramate Tablets.
You may lose weight if you use Topiramate Tablets 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 anti-epileptic medicines
such as Topiramate Tablets have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
Other medicines and Topiramate Tablets
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription, vitamins and herbal medicines. Topiramate Tablets and
certain other medicines can affect each other. Sometimes the dose
of some of your other medicines or Topiramate Tablets 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. Topiramate Tablets may make your birth control
pills less effective.
Tell your doctor if your menstrual bleeding changes while you are
taking birth control pills and Topiramate Tablets.
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.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before using Topiramate Tablets.
Taking Topiramate Tablets with food and drink
You can take Topiramate Tablets with or without food. Drink plenty of
fluids during the day to prevent kidney stones while taking Topiramate
Tablets. You should avoid drinking alcohol when taking Topiramate
Tablets.
Pregnancy and breast-feeding
Talk to your doctor before using Topiramate Tablets if you are
pregnant, trying to become pregnant or breast-feeding. Your
doctor will decide if you can take Topiramate Tablets. As with other
antiepilepsy medicines, there is a risk of harm to the unborn child if
Topiramate Tablets are used during pregnancy. Make sure you are
very clear about the risks and the benefits of using Topiramate Tablets
for epilepsy during pregnancy.
You should not take Topiramate Tablets for migraine prevention if
you are pregnant or you are able to become pregnant and you are
not using effective contraception.
Mothers who breastfeed while taking Topiramate Tablets must tell the
doctor as soon as possible if the baby experiences anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Topiramate has minor or moderate influence on the ability to drive
and use machines. Dizziness, tiredness, and vision problems may
occur during treatment with Topiramate Tablets. Do not drive or use
any tools or machines without talking to your doctor first.
Topiramate Tablets contains lactose
Topiramate Tablets contain lactose. If you have been told by your
doctor that you have intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. HOW TO TAKE TOPIRAMATE TABLETS
Always take Topiramate Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
• Take Topiramate Tablets exactly as prescribed. Your doctor will
usually start you on a low dose of Topiramate Tablets and slowly
increase your dose until the best dose is found for you.
• Topiramate Tablets are to be swallowed whole. Avoid chewing the
tablets as they may leave a bitter taste.
• Topiramate Tablets can be taken before, during, or after a meal.
Drink plenty of fluids during the day to prevent kidney stones while
taking Topiramate Tablets.
If you take more Topiramate Tablets than you should
• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy or tired, or have abnormal body movements,
problems standing and walking, feel dizzy due to low blood
pressure, or have abnormal heart beats or fits.
Overdose can happen if you are taking other medicines together
with Topiramate Tablets. Signs and symptoms of over dosage may
include convulsions, drowsiness, speech disturbances, double vision,
impaired thinking, abnormal coordination, dulling of consciousness,
low blood pressure, abdominal pain, agitation, dizziness and
depression.
If you forget to take Topiramate Tablets
• 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 Topiramate Tablets
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, Topiramate Tablets can cause side effects,
although not everybody gets them.
The frequency of possible side effects listed below is defined using
the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Very common side effects include:
• Weight loss
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy, runny nose and sore throat
• Tiredness
• Depression

Common side effects include:
• Changes in mood or behaviour, including anger, nervousness,
sadness
• Weight gain
• Decrease or loss of appetite
• Reduced number of red blood cells
• Changes in thinking and alertness, including confusion, problems
with concentration, memory or slowness in thinking
• Slurred speech
• Clumsiness, or problems with walking
• Involuntary shaking in the arms, hands or legs
• Reduced sense of touch or sensation
• Involuntary movement of the eyes
• Distorted sense of taste
• Visual disturbance, blurred vision, double vision
• Ringing sound in the ears
• Ear pain
• Shortness of breath
• Nose bleeds
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Skin rash and/or itchy skin
• Joint pain
• Muscle spasms, muscle twitching or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of feeling unwell
• Allergic reaction
Uncommon side effects include:
• Crystals in the urine
• Abnormal blood counts, including reduced white blood cell count
or platelet count, or increased eosinophils
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck armpit or groin
• Increase in seizures
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary
twitching, tearing and decreased vision
• Decreased or loss of hearing
• Hoarseness of the voice
• Inflammation of the pancreas
• Gas
• Heartburn
• Loss of sensitivity to touch in the mouth

Bleeding gums
Fullness or bloating
Painful or burning sensations in the mouth
Breath odour
Leakage of urine and/or stools
Urgent desire to urinate
Pain in the kidney area and/or bladder caused by kidney stones
Decrease or loss of sweating
Skin discolouration
Localized swelling in the skin
Swelling of the face
Swelling of the joints
Musculoskeletal stiffness
Increased acid levels in the blood
Low potassium levels in the blood
Increased appetite
Increased thirst and drinking abnormally large amounts of fluid
Low blood pressure or decrease in blood pressure that occurs
when you stand up
• Hot flushing
• Flu like illness
• Cold extremities (e.g. hands and face)
• Problems with learning
• Disturbances in sexual function (erectile dysfunction, loss of
libido)
• Hallucinations
• Decreased verbal communication
• Increase in liver enzymes
Rare side effects include:
• Liver failure
• Hepatitis
• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma which is a blockage of fluid in the eye causing increased
pressure in the eye, pain and decreased vision
• Renal tubular acidosis
• Severe skin reaction, including Stevens-Johnson syndrome, a life
threatening skin condition in which the upper layer of the skin
separates from the lower, and erythma multiforme, a condition
of raised red spots that can blister
• Odour
• Swelling in the tissues around the eye
• Raynaud’s syndrome. A disorder affecting the blood vessels, in
the fingers, toes, ears and causing pain and cold sensitivity
• Tissue calcification (calcinosis).
Side effects of unknown frequency
• 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.
• Swelling of the conjunctiva of the eye.
• Toxic epidermal necrolysis which is a more severe form of
Stevens-Johnson syndrome (see uncommon side effects).
• Cough
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TOPIRAMATE TABLETS
Keep out of the reach and sight of children.
Do not use Topiramate Tablets after the expiry date which is on the
label. The expiry date refers to the last day of that month.
Store below 25°C.
HDPE tablet containers: Keep container tightly closed.



















Blisters: Store in the original package.
Medicines should not be disposed of via waste water or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topiramate Tablets contain
The active substance is topiramate.
• Each Topiramate Tablet contains 25, 50, 100, 200 mg of
topiramate.
The other ingredients are listed below:
Lactose monohydrate, microcrystalline cellulose (E460) (Avicel PH
101), pregelatinised starch, sodium starch glycolate, colloidal silicon
dioxide, magnesium stearate, Opadry White, Yellow, Pink, (depending
on the colour, contains Hypromellose (E 464), Titanium dioxide (E
171), Macrogol, Iron Oxide ( E 172) and polysorbate 80 (E 433) and
Opacode Black.
OPACODE contains, Shellac Glaze in ethanol, Iron Oxide Black (E
172), Isopropyl Alcohol, N-butyl alcohol, Propylene glycol (E 1520)
and Ammonium hydroxide (E 527).
What Topiramate Tablets look like and contents of the pack
Topiramate 25 mg Tablets: White to off white, circular, biconvex film
coated tablets, imprinted “25” (in black ink) on one side and plain
on the other side.
Topiramate 50 mg Tablets: Light yellow, circular, biconvex film
coated tablets, imprinted “50” (in black ink) on one side and plain
on the other side.
Topiramate 100 mg Tablets: Dark yellow, circular, biconvex film
coated tablets, imprinted “100” (in black ink) on one side and plain
on the other side.
Topiramate 200 mg Tablets: Reddish pink, oval shaped, biconvex film
coated tablets, imprinted “200” on one side and plain on other side.
Topiramate Tablets are packed in:
• Blisters
Pack Sizes: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 120, 200
tablets
• Bottle with child-resistant closure
Pack Sizes: 60 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire WA16 0PF
United Kingdom.
This leaflet was last revised in February 2013
CODE NO. GO/DRUGS/654

ID#: 231917

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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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