TOPIRAMATE GLENMARK 25MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Glenmark 25mg film-coated tablets
Topiramate Glenmark 50mg film-coated tablets
Topiramate Glenmark 100mg film-coated tablets
Topiramate Glenmark 200mg film-coated 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. See
section 4.
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 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
TOPIRAMATE TABLETS
Do not take Topiramate tablets
• 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 breastfeeding’
for further information).
If you are not sure if the above applies to you, talk to your
doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine
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 this medicine.
It is important that you do not stop taking your medicine
without first consulting your doctor.
You may lose weight if you use topiramate 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-epileptics
such as topiramate have had thoughts of harming or killing
themselves. If at any time you have thoughts like this,
immediately contact your doctor.
Topiramate might decrease perspiration, especially in children,
causing body temperature to rise during exercise and exposure
to warm environments. Therefore, it is important to drink plenty
of water during the treatment with topiramate, especially if you
are taking exercise or the weather is hot to reduce the risk of
heat-related adverse events, like headache and nausea.
Other medicines and Topiramate tablets
Tell your doctor or your pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription, vitamins and herbal
medicines.
Topiramate and certain other medicines can affect each other.
Sometimes the dose of some of your other medicines or
topiramate 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 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.
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 this medicine.
Topiramate tablets with food and drink
You can take the tablets with or without food. Drink plenty of
fluids during the day to prevent kidney stones while taking
topiramate.You should avoid drinking when taking topiramate.
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 topiramate.
As with other anti-epilepsy medicines, there is a risk of harm to
the unborn child if topiramate is used during pregnancy. Make

sure you are very clear about the risks and the benefits of using
topiramate for epilepsy during pregnancy.
You should not take topiramate 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 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
Dizziness, tiredness, and vision problems may occur during
treatment with topiramate. Do not drive or use any tools or
machines without talking to your doctor first.
Topiramate tablets contains lactose
If you have been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking this
medicinal product.
Topiramate tablets 50mg film-coated tablets contain sunset
yellow which may cause allergic reactions.
The bottles of Topiramate tablets contain a canister of silica
gel desiccant. The desiccant canister must not be swallowed.
3. HOW TO TAKE TOPIRAMATE TABLETS
Always take Topiramate tablets exactly as your doctor has told
you. 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 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 these 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, 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, have abdominal pain or seizures
(fits).
Overdose can happen if you are taking other medicines
together with Topiramate tablets
If you forget to take Topiramate tablets
• If you forget to take a dose, take it as soon as you remember.
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.
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 apetite,
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.
• Swelling of the conjunctiva of the eye.
• Toxic epidermal necrolysis which is a more severe form of
Stevens-Johnson syndrome, characterized by widespread
blistering and sloughing of the outer layers of the skin (see
rare side effects)
• Cough.
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.

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 www.mhra.gov.
uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE TOPIRAMATE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Topiramate tablets after the expiry date which is
stated on the blister/bottle and the outer carton. The expiry
date refers to the last day of that month.
Plastic bottles
• Do not store above 25°C.
• Keep the container tightly closed in order to protect from
moisture.
Blisters
• Do not store above 25°C.
• Store in the original blister package in order to protect 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 to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topiramate Tablets contain
- The active substance is topiramate. Each film-coated tablet
contains 25 mg, 50 mg, 100 mg, 200 mg of topiramate.
- The other ingredients are:
• tablet core Lactose monohydrate, microcrystalline
cellulose (E460), pregelatinised maize starch, sodium
starch glycollate (Type A), magnesium stearate.
• tablet coating
- for Topiramate Tablets 25mg film-coated tablets,
hypromellose, macrogol 400, polysorbate 80, titanium
dioxide (E171).
- for Topiramate Tablets 50mg film- coated tablets,
hypromellose, macrogol 400, polysorbate 80, sunset yellow
lake (E110) , titanium dioxide (E171) and yellow iron oxide
(E172).
- for Topiramate Tablets 100mg and 200mg fim-coated
tablets, hypromellose, macrogol 400, polysorbate 80,
titanium dioxide (E171), red iron oxide (E172) and yellow
iron oxide (E172).
What Topiramate Tablets look like and contents of the pack
Film-coated tablet
Topiramate Tablets 25mg film-coated tablets: round, white,
film-coated tablets with ‘G’ engraved on one side and ‘25’ on
the other.
Topiramate Tablets 50mg film-coated tablets : round, yellow,
film-coated tablets with ‘G’ engraved on one side and ‘50’ on
the other.
Topiramate Tablets 100mg film-coated tablets : round, yellow,
film-coated tablets with ‘G’ engraved on one side and ‘100’ on
the other.
Topiramate Tablets 200mg film-coated tablets : round, pink,
film-coated tablets with ‘G’ engraved on one side and ‘200’ on
the other.
Topiramate Tablets 25mg, 50mg, 100mg and 200mg filmcoated tablets are available in plastic bottles with tamperproof, flip-open caps containing 20, 28, 30, 50, 56, 60, 100
and 200* tablets and a dessicant cannister. The desiccant
must not be swallowed.
Topiramate Tablets 25mg, 50mg, 100mg and 200mg filmcoated tablets are also available in aluminium foil blisters of
4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 120 and 200*
tablets.
*Not all packs sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glenmark Generics (Europe) Ltd,
Laxmi House, 2-B Draycott Avenue, Kenton, Harrow,
Middlesex, HA3 OBU, United Kingdom
Manufacturer:
Glenmark Pharmaceuticals s.r.o.,Hvězdova 1716/2b, 140 78
Prague 4, Czech Republic
Tillomed Laboratories Limited, 3 Howard Road,Eaton Socon,
St. Neots, Cambridgeshire, PE19 8ET, United Kingdom
Glenmark Generics (Europe) Ltd., Building 2, Croxley Green
Business Park, Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
This medicinal product is authorised in the Member States
of the EEA under the following names:
DE Topiramat Glenmark 25 /50 /100 /200 mg Filmtabletten
CZ Topimark 25 /50 /100 mg
NL Topiramaat Glenmark 25 /50 /100 /200 mg Filmomhulde
tabletten
PL Toramat
RO Torlepta 25 /50 /100 mg
SK Topimark 25 /50 /100 /200 mg
UK Topiramate 25 /50 /100 /200 mg Film-coated tablets
This leaflet was last revised in: 01/2014

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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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