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TOPIRAMATE 100 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPIRAMATE 25 MG, 50 MG, 100 MG, 200 MG FILM-COATED TABLETS
Topiramate
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if
their
symptoms are the same as yours.
• 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.
In this leaflet:
1. What Topiramate is and what it is used for
2. Before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Further information

1.

WHAT TOPIRAMATE IS AND WHAT IT IS 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 over age 2
• to prevent migraine headaches in adults

2.

BEFORE YOU TAKE TOPIRAMATE

Do not take Topiramate
• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate (listed
insection 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.
Take special care with Topiramate
Check with your doctor or pharmacist before taking Topiramate 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.

It is important that you do not stop taking your medicine without first consulting your doctor.
You should also to 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 anti-epileptic medicines such as Topiramate have had
thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact
your doctor.
Taking other medicines
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 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using
Topiramate.
Taking Topiramate 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
Talk to your doctor before using Topiramate if you are pregnant, trying to become pregnant or breastfeeding.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
becomepregnant 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.
Important information about some of the ingredients of Topiramate
The 200 mg tablet only contains sunset yellow aluminium lake (E110) and allura red aluminium lake
(E129), which may cause allergic reactions.
3.

HOW TO TAKE TOPIRAMATE

Always take Topiramate exactly as your doctor has told you. You should 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.
• 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.
• 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
• 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 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 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
Rare side effects include:
• 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).
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

Keep out of reach and sight of children.
Do not use Topiramate after the expiry date, which is stated on the blister and the carton. The expiry
date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not use topiramate if you notice discolouration of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Topiramate contains
The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg
topiramate per tablet.
The other ingredients are:
Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal anhydrous, sodium starch
glycolate (type A), magnesium stearate.
Film-coat: titanium dioxide (E171), Hypromellose (E464), macrogol 400, polysorbate 80
(E433)(25 mg only), iron oxide yellow (E172)(50/100 mg only), allura red aluminium lake (E129),
sunset yellow aluminium lake (E110) and indigo carmine aluminium lake (E132)(200 mg only).
What Topiramate looks like and contents of the pack
Your medicine comes in the form of a film-coated tablet that should look like the following:
25 mg: White, round, biconvex, film-coated tablet marked with “G” on one side and “TO” over “25”
on the other.

50 mg: Yellow, round, biconvex, film-coated tablet marked with “G” on one side and “TO” over “50”
on the other.
100 mg: Yellow, round, biconvex, film-coated tablet marked with “G” on one side and “TO” over
“100” on the other.
200 mg: Red, round, biconvex, film-coated tablet marked with “G” on one side and “TO” over “200”
on the other.
The medicinal product is available in aluminium foil blisters in pack sizes of 10, 15, 20, 28, 30, 50, 60,
90, 100, 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Generics [UK] Ltd, Station Close, Potters
Bar, Hertfordshire, EN6 1TL.
Manufacturer: Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire,
EN6 1TL .
McDermott Laboratories trading as Gerard Laboratories, 35-36
Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria
Belgium
Czech Republic
Denmark
Finland
Germany
Greece
Italy
Norway
Poland
Slovak Republic
Sweden
The Netherlands
United Kingdom

Topiramat “Arcana”
Topiramate Mylan
Topiramat Mylan
Topiramat Mylan
Topiramat Mylan
Topiramat dura 25 mg, 50 mg, 100 mg, 200 mg Filmtabletten
Topiramate / Generics
Topiramato Mylan Generics
Topiramat Mylan
Jactigen
Topiramat Mylan
Topiramat Mylan
Topiramaat Mylan
Topiramate

This leaflet was last approved in.
April 2012

Expand Transcript

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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