Skip to Content

UK Edition. Click here for US version.

TOPIRAMATE RANBAXY 100MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Topiramate Ranbaxy 25 mg Film-coated Tablets
Topiramate Ranbaxy 50 mg Film-coated Tablets
Topiramate Ranbaxy 100 mg Film-coated Tablets
Topiramate Ranbaxy 200 mg 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 further questions, please 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 is and what it is used for
2. What you need to know before you take
Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Contents of the pack and other information
1. WHAT TOPIRAMATE IS AND WHAT IT IS USED
FOR
Topiramate belongs to a group of drugs called
“antiepileptic medicines”.
Topiramate is 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 after careful
evaluation of possible alternative treatment options.
Topiramate is not intended to treat an individual
migraine attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE
Do not take Topiramate
• 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 Topiramate.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Topiramate
• 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)
There have been reports of impairment of cognitive
function (problem in thought processes) in adults on
topiramate therapy. In this case your doctor may
discontinue or decrease the dose of this medicine.
While taking this medicine if you develop:
• deep and labored breathing, difficulty in breathing, loss
of appetite, nausea, vomiting, excessive tiredness,
changes in the rhythm or rate of the heart beat. These
symptoms may be due to metabolic acidosis. Your
doctor would monitor your serum bicarbonate level.
• decreased sweating and rise in body temperature.
These may occur especially in young children exposed
to high ambient temperature. Inform your doctor as
soon as possible.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before using Topiramate.
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.
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 antiepileptic medicines such as Topiramate have had
thoughts of harming or killing themselves. If at any time
you have these thoughts, immediately contact your
doctor.

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, flunarizine.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before using Topiramate.
Topiramate tablets with food and drink
You can take Topiramate with or without food. Drink
plenty of fluids during the day to prevent kidney stones
while taking Topiramate. You should avoid drinking
alcohol when taking Topiramate.
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
or pharmacist for advise before taking this medicine.
Your doctor will decide if you can take Topiramate. As
with other antiepilepsy 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 contains lactose monohydrate
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 TOPIRAMATE
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
• Take Topiramate 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 can be taken before, during, or after a
meal. Drink plenty of fluids during the day to prevent
kidney stones while taking Topiramate.
If you take more Topiramate than you should
• See a doctor right away. Take the medicine pack with
you.
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. Overdose can
happen if you are taking other medicines together with
Topiramate.
If you forget to take Topiramate
• 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
Do not stop taking this medicine unless told to do 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
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Other medicines and Topiramate:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other 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.

Very common side effects (may affect more than 1 in
10 people)
• 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 (may affect up to 1 in 10
people)
• 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
• Feeling abnormal
Uncommon side effects (may affect up to 1 in 100
people)
• Crystals in the urine
• Abnormal blood counts, including reduced white blood
cell count or platelet count, or increased eosinophils,
increase in liver enzymes
• 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
• Suicidal thoughts
Rare side effects (may affect up to 1 in 1,000 people)
• 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
erythema 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
• Inflammation of the liver, liver failure
• Tissue calcification (calcinosis).

• Decreased appetite
• Increased appetite
• Hyperchloraemic acidosis (increased acid levels in the
blood)
• Hypokalaemia (low potassium levels in the blood)
• Abnormal behaviour
• Aggression
• Apathy (sadness)
• Initial insomnia (trouble sleeping)
• Suicidal ideation
• Disturbance in attention
• Lethargy (feeling of tiredness)
• Circadian rhythm sleep disorder (a group of sleep
disorder affecting the timing of sleeps)
• Poor quality sleep
• Lacrimation increased (eye problems like increased
tearing)
• Sinus bradycardia (slowness of the heart beat)
• Feeling abnormal
• Gait disturbance (problems with walking)
Side effects that were reported in children but not in
adults in double-blind controlled studies include:
• Eosinophilia (abnormal blood counts, increased
eosinophils)
• Psychomotor hyperactivity (restlessness or increased
mental and physical activity)
• Vertigo (dizziness)
• Vomiting (being sick)
• Hyperthermia (extremely high body temperature)
• Pyrexia (fever or high temperature)
• Learning disability
If you get any side effects, talk to your doctor of
pharmacist. This includes any possible side effects not
listed in this leaflet.
5. HOW TO STORE TOPIRAMATE
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day
of that month.
This medicinal product does not require any special
storage conditions.
Do not use if the tablets do not have the appearance
described below.
Keep the bottle tightly sealed.
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 Film-coated Tablets contains:
The active substance is topiramate
Each film-coated tablet contains 25 mg topiramate
Each film-coated tablet contains 50 mg topiramate
Each film-coated tablet contains 100 mg topiramate
Each film-coated tablet contains 200 mg topiramate
The other ingredients are:
Tablet core
Lactose monohydrate, starch pregelatinised,
microcrystalline cellulose, sodium starch glycolate (Type
A), magnesium Stearate.
Tablet coating
Hypromellose, titanium dioxide (E171), macrogol 400,
polysorbate 80 and iron oxide yellow (E172) (50 mg, 100
mg), iron oxide red E 172 (200 mg)
What Topiramate film-coated tablets looks like and
contents of the pack
Topiramate Ranbaxy 25 mg Film-coated Tablet is
White, film-coated, circular tablets debossed with 'TP1'
on one side and plain on the other side.
Topiramate Ranbaxy 50 mg Film-coated Tablet is
Yellow-coloured, film-coated, circular
tablets debossed with 'TP2' on one side and plain on the
other side.
Topiramate Ranbaxy 100 mg Film-coated Tablet is
Yellow-coloured, film-coated,
circular tablets debossed with 'TP3' on one side and plain
on the other side.
Topiramate Ranbaxy 200 mg Film-coated Tablet is
Peach-coloured, film-coated,
circular tablets debossed with 'TP4' on one side and plain
on the other side.
Topiramate is available in HDPE bottle pack containing
20, 28, 30, 50, 60, 100, 120, 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom
Manufacturer
Ranbaxy Ireland Limited
Spafield, Cork Road
Cashel, Co.Tipperary,
Ireland
This leaflet was last revised in January 2014.

Unknown frequency (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 (see uncommon
side effects).
• Cough
Children and adolescents
Side effects reported more frequently (³
2-fold) in
children than in adults in double-blind controlled studies
include:

5107258

PACKAGE LEAFLET: INFORMATION FOR THE USER

[ 5107258] - LIT. TOPIRAMATE TAB, Dewas- UK, Size : 140 x 440 mm RLL-DWS : 21.01.14vs, (101238)

Expand view ⇕

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.

Hide