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TOPIRAMATE CIPLA 200 MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

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Package leaflet: Information for the user
TOPIRAMATE CIPLA 25 mg film-coated tablets
TOPIRAMATE CIPLA 50 mg film-coated tablets
TOPIRAMATE CIPLA 100 mg film-coated tablets
TOPIRAMATE CIPLA 200 mg film-coated tablets
topiramate

prevent kidney stones while taking Topiramate Cipla. You should avoid drinking alcohol while
taking Topiramate Cipla.
Pregnancy and breast-feeding

2. What you need to know before you take Topiramate Cipla
Do not take Topiramate Cipla:
• 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 if you are a woman of childbearing
potential unless you are using effective contraception (see section Pregnancy and
breast-feeding for further information). You should talk to your doctor about the best kind of
contraception to use while you are taking Topiramate Cipla.
If you are not sure if the above apply to you, talk to your doctor or pharmacist before using
Topiramate Cipla
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate Cipla 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 taking Topiramate Cipla to treat epilepsy and you are pregnant or a woman of
childbearing potential (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 Topiramate Cipla.
It is important that you do not stop taking this 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 Cipla.
You may lose weight while taking Topiramate Cipla so your weight should be checked
regularly. 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
Cipla have had thoughts of harming or killing themselves. If at any time you have these
thoughts, immediately contact your doctor.
Other medicines and Topiramate Cipla
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Topiramate Cipla and certain other medicines can affect each other.
Sometimes the dose of some of your other medicines or Topiramate Cipla will have to be
adjusted.
Especially tell you doctor if you are taking:
• other medicines that impair or decrease your thinking, concentration or muscle
co-ordination (e.g. central nervous system depressant medicines such as muscle relaxants
and sedatives) birth control pills. Topiramate Cipla may make your birth control pills less
effective You should talk to your doctor about the best kind of contraception to use while
you are taking Topiramae Cipla.
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and
Topiramate Cipla.
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 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 apply to you, talk to your doctor or pharmacist before
using Topiramate Cipla.
Topiramate Cipla with food, drink and alcohol
This medicine can be taken with or without food. Drink plenty of fluids during the day to

Page 1

Breast-feeding
The active substance in Topiramate Cipla (topiramate) passes into breast milk. Effects have
been seen in breastfed babies of treated mothers, including diarrhea, feeling sleepy, feeling
irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you
abstain from breastfeeding or whether to abstain from treatment with Topiramate Cipla. Your
doctor will take into account the importance of the medicine to the mother and the risk for the
baby.
Mothers who breast-feed while taking this medicine must tell their 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 Topiramate Cipla.
Do not drive or use any tools or machines without talking to your doctor first.
Topiramate Cipla 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 Topiramate Cipla
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 topiramate and slowly increase your
dose until the best dose is found for you.
• Topiramate Cipla are to be swallowed whole. Avoid chewing the tablets as they may leave
a bitter taste.
• Topiramate Cipla can be taken before, during, or after a meal. Drink plenty of fluids during
the day to prevent kidney stones while taking this medicine.
If you take more Topiramate Cipla than you should
• If you have accidentally taken more than your prescribed dose, contact your nearest
hospital casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining tablets 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 Cipla.
If you forget to take Topiramate Cipla
• If you miss a dose do not worry, take it as soon as you remember, then keep taking the
medicine as your doctor has told you. If it is almost time for the next dose, do not take the
missed dose. Take your next dose at the usual time and then carry on as prescribed. If you
miss two or more doses, contact your doctor. Do not take a double dose to make up for a
forgotten dose.

TOPIRAMATE CIPLA
25 mg, 50 mg, 100 mg and 200 mg
FILM-COATED TABLETS

2D code
Pharmacode Area

21068438

If you stop taking Topiramate Cipla
Do not stop taking this medicine unless told to do so by your doctor. If you stop too suddenly
your seizures or migraines might come back. 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.
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

21068438

Topiramate is the active substance of Topiramate Cipla. Topiramate Cipla belong to a group
of medicines called “antiepileptic medicines”. They can be 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

TOPIRAMATE CIPLA
25 mg, 50 mg, 100 mg and 200 mg
FILM-COATED TABLETS

1. What Topiramate Cipla is and what it is used for

Talk to your doctor if you wish to become pregnant.
As with other antiepilepsy medicines, there is a risk of harm to the unborn child if this
medicine are used during pregnancy. Make sure you are very clear about the risks and
benefits of this medicine for epilepsy during pregnancy.
• If you take Topiramate Cipla during pregnancy, your baby has a higher risk for birth
defects, particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the
mouth). Newborn boys may also have a malformation of the penis (hypospadia). These
defects can develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramate Cipla during pregnancy, your baby may be smaller than expected at
birth. Talk to your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition that have a lower risk of birth defects.
• Tell your doctor straight away if you become pregnant while taking Topiramate Cipla. You
and your doctor should decide if you will continue to take Topiramate Cipla while you are
pregnant.

2D code
Pharmacode Area

What is in this leaflet
1. What Topiramate Cipla is and what it is used for
2. What you need to know before you take Topiramate Cipla
3. How to take Topiramate Cipla
4. Possible side effects
5. How to store Topiramate Cipla
6. Contents of the pack and other information

Treatment of epilepsy:
If you are a woman of childbearing potential you should talk to your doctor about other
possible
treatments instead of Topiramate Cipla. If the decision is made to use Topiramate Cipla, you
should use effective contraception. Talk to your doctor about the best kind of contraception to
use while you are taking Topiramate Cipla. Before the start of treatment with Topiramate
Cipla a pregnancy test should be performed.

21068438

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.

Migraine prevention:
Topiramate Cipla can harm an unborn baby. You must not use Topiramate Cipla if you are
pregnant. You must not use Topiramate Cipla for migraine prevention if you are a woman of
childbearing potential unless you are using effective contraception. Talk to your doctor about
the best kind of contraception and whether Topiramate Cipla is suitable for you. Before the
start of treatment with Topiramate Cipla a pregnancy test should be performed.

Page 2

PRAC variation
Date: 20/02/2018

Uncommon (may affect up to 1 in 100 people)
• inflammation of the pancreas causing pain in the upper abdomen. This could become
severe and cause nausea and vomiting, fever and rapid heart rate. This could require
hospitalization and may be life threatening.
• 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.
• 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
multiforma, a condition of raised red spots that can blister.
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.
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):
• weight loss
• tingling in the arms and legs
• drowsiness or sleepiness; tiredness;dizziness
• diarrhoea; nausea (feeling sick)
• stuffy, runny nose and sore throat
Common (may affect up to 1 in 10 people):
• weight gain; decrease or loss of appetiteanaemia (low blood count)
• 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, visual disturbances, blurred vision, double vision
• distorted sense of taste
• ringing sound in the ears; ear pain
• shortness of breath
• nose bleeds
• vomiting (being sick); constipation; stomach pain; indigestion
• dry mouth; tingling or numbness of the mouth
• kidney stones; frequent urination; painful urination
• hair loss
• skin rash or itchy skin
• joint pain; muscle spasms, muscle twitching or muscle weakness
• chest pain
• fever
• loss of strength
• general feeling of feeling unwell
• cough
• nasal congestion (blocked nose)
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Decreased ability to complete routine tasks
• Sensation of spinning (vertigo)
Uncommon (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
ncreased 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 increase in mental and physical activity
• 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
• Excessive passing of gas or wind, heartburn
• loss of sensitivity to touch in the mouth; bleeding gums; painful or burning sensations in the
mouth; breath odour
• fullness or bloating
• leakage of urine and/or stools; urgent desire to urinate; pain in the kidney area and/or
bladder caused by kidney stones
• Blood in urine
• 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
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Increased appetitie
Increase in liver enzymes
Elevated mood
Severe mental disorder (psychosis)
Showing and/or felling no emotion, unusual suspiciousness, panic attack
Slowed thinking, decreased wakefulness or alertness
Abnormal sense of touch; impaired sense of touch
Unusual felling or sensation that may precede a migraine or a certain type of seizure
Felling drunk
Excessive passing of gas or wind, heartburn
Problems with reading

Rare (may affect up to 1 in 1,000 people):
• excessive skin sensitivity
• loss of consciousness
• impaired sense of smell
• renal tubular acidosis
• odour
• swelling in the tissues around the eye
• swelling in the tissues around the eye
• Raynaud’s Syndrome. A disorder affecting the blood vessels, causing numbness, tingling
and color change (white, blue then red) in fingers and toes when exposed to cold
• tissue calcification (calcinosis)
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Inflammation of the liver, liver failure
• Discomfort in your arms and legs
Not known (frequency cannot be estimated from the available data):
• swelling of the conjunctiva of the eye.
Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see
serious 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: 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 Cipla
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 bottle and carton after
'EXP'. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Store in the original package.
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 protect the
environment.

6. Contents of the pack and other information
What Topiramate Cipla contain:
The active ingredient is topiramate. Each Topiramate Cipla film-coated tablets contains
25, 50, 100, or 200 mg of topiramate.
Tablet core:
The ingredients are lactose monohydrate, pregelatinized starch, microcrystalline cellulose,
sodium starch glycolate and magnesium stearate.
Film-coating:
Topiramate 25 mg Tablets are coated with OPADRY® White YS-1-7079, the ingredients of
which are titanium dioxide, hypromellose, polysorbate 80 and indigo carmine aluminium lake
(E132).
Topiramate 50 & 100 mg Tablets are coated with OPADRY® Beige YS-1-17174-A, the
ingredients of which are titanium dioxide, hypromellose, polysorbate 80, iron oxide yellow
(E172) and iron oxide red (E172).
Topiramate 200 mg Tablets are coated with OPADRY® Pink YS-1-14779-A, the ingredients of
which are titanium dioxide, hypromellose, polysorbate 80 and iron oxide red (E172).
What Topiramate Cipla look like and the contents of the pack:
Topiramate Cipla 25 mg: white coloured, circular, biconvex film-coated tablets.
Topiramate Cipla 50 mg: light-orange coloured, circular, biconvex film-coated tablets.
Topiramate Cipla 100 mg: orange coloured, circular, biconvex film-coated tablets.
Topiramate Cipla 200 mg: pink coloured, biconvex, caplet-shaped film-coated tablets.
Topiramate Cipla are available in containers of 60, 100 & 200 film-coated tablets and
blister packs of 28, 56, 60 & 84 film-coated tablets. Not all pack sizes will be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park,
Addlestone, Surrey, KT15 2LE, United Kingdom.
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium.

21068438

• Allergic reaction (Such as skin rash, redness, itching, facial swelling, hives)

This leaflet was last revised in 02/2018.
Page 4

PRAC variation
Date: 20/02/2018

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