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TOPIRAMATE APTIL 200MG FILM-COATED TABLETS

Active substance(s): TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Aptil 25, 50, 100 and 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 Film-coated Tablets are and what they are used for
2.
Before you take Topiramate Film-coated Tablets
3.
How to take Topiramate Film-coated Tablets
4.
Possible side effects
5.
How to store Topiramate Film-coated Tablets
6.
Further information

1.

WHAT TOPIRAMATE FILM-COATED 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 over age 2
to prevent migraine headaches in adults

2.

BEFORE YOU TAKE TOPIRAMATE FILM-COATED TABLETS

Do not take Topiramate Film-coated Tablets
-

if you are allergic (hypersensitive) to topiramate or any of the other ingredients of
Topiramate Film-coated 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 Film-coated Tablets.
Take special care with Topiramate Film-coated Tablets
Check with your doctor or pharmacist before taking Topiramate Film-coated 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 Film-coated Tablets.
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 Film-coated Tablets.
You may lose weight if you use Topiramate Film-coated 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
Film-coated Tablets 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 Film-coated Tablets and certain other medicines can affect each
other. Sometimes the dose of some of your other medicines or Topiramate Film-coated
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 Film-coated 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 Film-coated 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 Film-coated Tablets.
Taking Topiramate Film-coated Tablets with food and drink
You can take Topiramate Film-coated Tablets with or without food. Drink plenty of fluids
during the day to prevent kidney stones while taking Topiramate Film-coated Tablets. You
should avoid drinking alcohol when taking Topiramate Film-coated Tablets.

Pregnancy and breast-feeding
Talk to your doctor before using Topiramate Film-coated Tablets if you are pregnant,
trying to become pregnant or breast-feeding. Your doctor will decide if you can take
Topiramate Film-coated Tablets. As with other antiepilepsy medicines, there is a risk of
harm to the unborn child if Topiramate Film-coated Tablets are used during pregnancy.
Make sure you are very clear about the risks and the benefits of using Topiramate Filmcoated Tablets for epilepsy during pregnancy.
You should not take Topiramate Film-coated 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 Film-coated 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
Dizziness, tiredness, and vision problems may occur during treatment with Topiramate
Film-coated Tablets. Do not drive or use any tools or machines without talking to your
doctor first.
Important information about some of the ingredients of Topiramate Film-coated
Tablets
Topiramate 50 mg, 100 mg and 200 mg Film-coated Tablets contain lecithin (soya oil). If
you are allergic to peanuts or soya, do not use this medicinal product.

3.

HOW TO TAKE TOPIRAMATE FILM-COATED TABLETS

Always take Topiramate Film-coated Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
-

-

Take Topiramate Film-coated Tablets exactly as prescribed. Your doctor will
usually start you on a low dose of Topiramate Film-coated Tablets and slowly
increase your dose until the best dose is found for you.
Topiramate Film-coated Tablets are to be swallowed whole. Avoid chewing the
tablets as they may leave a bitter taste.
Topiramate Film-coated Tablets can be taken before, during, or after a meal. Drink
plenty of fluids during the day to prevent kidney stones while taking Topiramate
Film-coated Tablets.

If you take more Topiramate Film-coated Tablets than you should
-

See a doctor right away. Take the medicine pack with you.
Signs and symptoms of over dosage may include convulsions (fits), drowsiness (sleepy or
tired), speech disturbances, double vision, impaired thinking, abnormal coordination
(abnormal body movements or problems standing and walking), dulling of consciousness,
low blood pressure, abdominal pain, agitation, dizziness, depression and abnormal heart
beats.

Overdose can happen if you are taking other medicines together with Topiramate Filmcoated Tablets.

If you forget to take Topiramate Film-coated Tablets
-

dose.

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

If you stop taking Topiramate Film-coated 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 Film-coated 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

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 tablets

Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original packaging (blisters, bottles) in order to protect from
moisture. Keep the bottle tightly closed in order to protect from moisture.

Do not use Topiramate Film-coated Tablets after the expiry date which is stated on the
label. The expiry date refers to the last day of that month. Topiramate tablets supplied in
bottles must be used within 60 days of opening. There is a space provided on the bottle for
you to write the date that you opened them.
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 tablets contain
The active substance is topiramate.
Each tablet contains either 25mg, 50mg, 100mg or 200mg of the active substance.
The other ingredients are mannitol, starch (pregelatinised), cellulose (microcrystalline),
croscarmellose sodium, silica (colloidal anhydrous), magnesium stearate, polyvinyl
alcohol, titanium dioxide, macrogols (macrogol 3350), talc.
The following ingredients are also in the
 50mg and 100mg tablets - lecithin (Soya) (E322) and iron oxide yellow (E172).
 200mg tablets - lecithin (Soya) (E322) and iron oxide red (E172).
What Topiramate tablets looks like and contents of the pack
Topiramate 25mg Film-coated Tablets are round, biconvex, white tablets
Topiramate 50mg Film-coated Tablets are round, biconvex, light yellow tablets
Topiramate 100mg Film-coated Tablets are round, biconvex, yellow tablets
Topiramate 200mg Film-coated Tablets are oval, biconvex, salmon-coloured tablets
Topiramate Film-coated Tablets are available in packs of 60 tablets.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer
Actavis hf
Reykjavikurvegur 78 IS-220
Hafnarfjordur
Iceland
This leaflet was last updated 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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