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TOPIRAMATE ACTAVIS 15MG CAPSULES HARD

Active substance(s): TOPIRAMATE / TOPIRAMATE / TOPIRAMATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramate Actavis 15mg and 25mg Capsules, hard
(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 get 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 Capsules are and what they are used for
2. Before you take Topiramate Capsules
3. How to take Topiramate Capsules
4. Possible side effects
5. How to store Topiramate Capsules
6. Further information

Taking Topiramate Capsules 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 Capsules. You
should avoid drinking alcohol when taking topiramate.
Pregnancy and breast-feeding
Talk to your doctor before using Topiramate Capsules if you are pregnant,
trying to become pregnant or breast-feeding. Your doctor will decide if you
can take Topiramate Capsules.

1.  HAT TOPIRAMATE CAPSULES ARE AND WHAT THEY ARE
W
USED FOR

As with other antiepilepsy medicines, there is a risk of harm to the unborn
child if Topiramate Capsules are used during pregnancy. Make sure you are
very clear about the risks and the benefits of using topiramate for epilepsy
during pregnancy.

Topiramate Capsules belong to a group of medicines called “antiepileptic
medicines.”
They are 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.

You should not take Topiramate Capsules 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.

2. BEFORE YOU TAKE TOPIRAMATE CAPSULES
Do not take Topiramate Capsules:
• if you are allergic (hypersensitive) to topiramate or any of the other
ingredients of Topiramate Capsules (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 Capsules.

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.

Take special care with Topiramate Capsules:
Check with your doctor or pharmacist before taking Topiramate Capsules 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 Capsules.
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 Capsules.
You may lose weight if you use Topiramate Capsules 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 Capsules 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 Capsules 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 Capsules.
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 and flunarazine.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Topiramate Capsules.

Important information about some of the ingredients of
Topiramate Capsules:
This medicinal product contains sucrose. If you have been told by your doctor
that you have intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. HOW TO TAKE TOPIRAMATE CAPSULES
Always take Topiramate Capsules exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
• Take Topiramate Capsules 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 Capsules may be swallowed whole or may be opened and
sprinkled on a teaspoon of soft food of any type. Examples are apple
sauce, custard, ice cream, porridge, pudding or yogurt. Drink fluids right
after to make sure all of the food and medicine mixture is swallowed.
• Hold the hard capsule upright so that the wording is the correct way up
• Carefully twist off the top part (cap) of the capsule. You may find it best
to do this over the small portion of food onto which you will be pouring
the sprinkles.
• Sprinkle all of the capsule’s contents onto a spoonful of soft food, taking
care to see that the entire prescribed dosage is sprinkled onto the food.
• Be sure to swallow the entire spoonful of the sprinkle/food mixture
immediately. Avoid chewing.
• Drink fluids immediately in order to make sure all of the mixture is
swallowed.
• Never store any medicine and food mixture for use at a later time.
• Topiramate Capsules 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 Capsules 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 Capsules.
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 Capsules
• 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.

Topiramate 15mg & 25mg PIL - UK (Arrow)

colours/plates:
1. Black

item no: AAAG2105

dimensions: 180 x 300

print proof no: 4

pharmacode:

origination date: 13.11.13

min pt size: 9pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 03.12.13

Technical Approval

revised by: S.Anson

date sent: 13.11.13

supplier: Actavis Malta Hal-Far

technically app. date: 18.11.13

Non Printing Colours
1.
2.
3.

If you stop taking Topiramate Capsules
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 Capsules 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
• Dizziness
and legs
• Stuffy, runny nose • Diarrhoea
and sore throat
• Tiredness

• Drowsiness or
sleepiness
• Nausea
• Depression.

Common side effects include:
• Changes in mood or • Weight gain
behaviour, including • Changes in thinking
anger, nervousness, and alertness,
sadness
including confusion,
• Reduced number of problems with
red blood cells
concentrating,
• Clumsiness, or
memory or slowness
problems with
in thinking
walking
• Involuntary shaking in
• Involuntary
the arms, hands or
movements of the
legs
eyes
• Distorted sense of
• Ringing sound in the taste
ears
• Ear pain
• Nose bleeds
• Vomiting
• Stomach pain
• Indigestion
• Tingling or numbness • Kidney stones
of the mouth
• Hair loss
• Painful urination
• Muscle spasms,
• Joint pain
muscle twitching or
• Fever
muscle weakness
• Allergic reaction
• Loss of strength
Uncommon side effects include:
• Crystals in the urine • Abnormal blood
• Swollen glands in the counts, including
neck, armpit or groin reduced white blood
• Drooling
cell count or platelet
• Fainting
count, or increased
• Impaired or distorted eosinophils
sense of smell
• Increases in seizures
• Eye problems
• Restlessness or
including dry eyes,
increased mental and
light sensitivity,
physical activity
involuntary twitching, • Slow or diminished
tearing and
movements
decreased vision • Problems with
• Inflammation of the handwriting
pancreas
• Decreased or loss of
• Loss of sensitivity to hearing
touch in the mouth • Gas
• Painful or burning • Bleeding gums
sensations in the • Breath odour
mouth
• Pain in the kidney
• Urgent desire to
area and/or bladder
urinate
caused by kidney
• Skin discolouration stones
• Swelling of the joints • Localised swelling in
• Low potassium levels the skin
in the blood
• Musculoskeletal
• Low blood pressure stiffness
or decrease in blood • Increased appetite
pressure that occurs • Hot flushing
when you stand up • Problems with
• Cold extremities (e.g. learning
hands and face)
• Decreased verbal
• Hallucinations
communication

• Decrease or loss of
appetite
• Slurred speech
• Reduced sense of
touch or sensation
• Visual disturbance,
blurred vision, double
vision
• Shortness of breath
• Constipation
• Dry mouth
• Frequent urination
• Skin rash and/or itchy
skin
• Chest pain
• General feeling of
feeling unwell.

Rare side effects include:
• Excessive skin sensitivity
• Raynaud’s syndrome. A disorder
• Renal tubular acidosis
affecting the blood vessels, in the
• Swelling in the tissues around the fingers, toes, ears and causing
eye
pain and cold sensitivity
• Impaired sense of smell
• Glaucoma which is a blockage of
• Severe skin reaction, including
fluid in the eye causing increased
Stevens-Johnson syndrome, a life pressure in the eye, pain and
threatening skin condition in
decreased vision
which the upper layer of the skin • Odour
separates from the lower, and
• Tissue calcification (calcinosis)
erythma multiforme, a condition of • Inflammation of the liver, liver
raised red spots that can blister
failure.
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 StevensJohnson 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 CAPSULES
Keep out of the reach and sight of children.
Store in the original container. Keep the container tightly closed in order to
protect from moisture.
Do not use Topiramate Capsules after the expiry date which is stated on
the carton and bottle after EXP: The expiry date refers to the last day of
that month.
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 Capsules contain:
The active substance is topiramate (each capsule contains 15mg or 25mg of
topiramate).
The other ingredients are sugar spheres (which contain sucrose, maize
starch), povidone, aniseed flavour, saccharin sodium (E 954), magnesium
stearate, gelatin, titanium dioxide (E-171) and Opadry-II-85F18378 White
(which contains polyvinyl alcohol-part hydrolysed, macrogol, talc and
titanium dioxide).
The black printing ink contains shellac, ethanol, isopropanol, butanol,
propylene glycol, purified water, strong ammonia solution, potassium
hydroxide and black iron oxide (E-172).

• Irregular heartbeat or
slowness of the heart
beat
• Problems with verbal
communication
• Loss of consciousness
• Disturbed or poor
quality sleep
• Feeling of movement
under the skin
• Hoarseness of the
voice
• Heartburn
• Fullness or bloating
• Leakage of urine
and/or stools
• Decrease or loss of
sweating
• Swelling of the face
• Increased acid levels
in the blood
• Increased thirst and
drinking abnormally
large amounts of fluid
• Flu like illness
• Disturbances in
sexual function
(erectile dysfunction,
loss of libido)
• Increase in liver
enzymes.

What Topiramate Capsules look like and contents of the pack:
Your medicine is in the form of hard gelatin capsules
The 15mg capsules are white with ‘15’ printed in black on the body
and ‘>’ over ‘Ti’ on the cap.
The 25mg capsules are white with ‘25’ printed in black on the body
and ‘>’ over ‘Ti’ on the cap.
Topiramate Capsules are available in HDPE bottles containing 14, 20, 28, 56
and 60 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður,
Iceland
Manufacturer:
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia,
BBG3000, Malta
This leaflet was revised in November 2013

AAAG2105

Topiramate 15mg & 25mg PIL - UK (Arrow)

colours/plates:
1. Black

item no: AAAG2105

dimensions: 180 x 300

print proof no: 4

pharmacode:

origination date: 13.11.13

min pt size: 9pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 03.12.13

Technical Approval

revised by: S.Anson

date sent: 13.11.13

supplier: Actavis Malta Hal-Far

technically app. date: 18.11.13

Non Printing Colours
1.
2.
3.

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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