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TOPIRAMATE ACTAVIS 50MG CAPSULES HARD

Active substance(s): TOPIRAMATE

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• Increased saliva
• Skin discolouration, localised swelling in the skin
•S
 welling of the joints, musculoskeletal stiffness, pain

PACKAGE LEAFLET: INFORMATION FOR THE USER

5. HOW TO STORE TOPIRAMATE CAPSULES
Keep this medicine out of the sight and reach of children.

in side
•C
 rystals in the urine, blood in urine, leakage of urine
and/or stools, urgent desire to urinate, pain in the
kidney area and/or bladder caused by kidney stones
•D
 isturbances in sexual function (erectile dysfunction,
loss of libido)
• Increase in body temperature, flu like illness
• Cold extremities (e.g. hands and face)
• Feeling drunk
• Increase in liver enzymes
• Problems with learning

Store in the original container. Keep the container tightly
closed in order to protect from moisture.
Do not use this medicine 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.
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.

Rare side effects include: (may affect up to 1 in 1,000
people)
• Abnormally elevated mood
• Excessive skin sensitivity
•N
 ight blindness, swelling in the tissues around the eye,
lazy eye
•R
 aynaud’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
• Skin odour
• Discomfort in your arms or legs
• Renal tubular acidosis
• Tissue calcification (calcinosis)

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Topiramate Capsules contain
The active substance is topiramate (each capsule
contains 50mg of topiramate).

Not known: (frequency cannot be estimated from the
available data)
• Swelling of the conjunctiva of the eye
•M
 aculopathy 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
• Cough

The black printing ink contains shellac, ethanol,
isopropanol, butanol, propylene glycol, purified water,
strong ammonia solution, potassium hydroxide and black
iron oxide (E-172).

The other ingredients of Topiramate Capsules 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).

What Topiramate Capsules look like and contents of
the pack:
Your medicine is in the form of hard gelatin capsules

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.

The 50mg capsules are white with ‘50’ 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:
Actavis UK Limited, Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK
This leaflet was revised in August 2015

By reporting side effects you can help provide more
information on the safety of this medicine.

Topiramate Actavis 50mg Capsules, hard

(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 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.
In this leaflet:
1. What Topiramate Capsules are and what they are
used for
2. What you need to know before you take
Topiramate Capsules
3. How to take Topiramate Capsules
4. Possible side effects
5. How to store Topiramate Capsules
6. Contents of the pack and other information
1. WHAT TOPIRAMATE CAPSULES ARE AND WHAT
THEY ARE USED FOR
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
•w
 ith other medicines to treat seizures in adults and
children over age 2
• to prevent migraine headaches in adults
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE CAPSULES

If you are not sure if the above applies to you, talk to your
doctor or pharmacist before using Topiramate Capsules.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Topiramate Capsules if you:
• h ave kidney problems, especially kidney stones, or are
getting kidney dialysis
• h ave 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)

page 4

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
Topiramate Capsules. If you are losing too much weight
or a child using Topiramate Capsules is not gaining
enough weight, you should consult your doctor.
A small number of people being treated with antiepileptic 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.
Other medicines and Topiramate Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take 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.

Do not take Topiramate Capsules:
• if you are allergic (hypersensitive) to topiramate or
any of the other ingredients of this medicine (listed in
section 6).
• f or 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).

AAAH3845 50818118

If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Topiramate
Capsules.

Especially, tell your doctor or pharmacist if you are
taking:
•O
 ther medicines that impair or decrease your thinking,
concentration, or muscle coordination (e.g. central
nervous system depressant medicines such as muscle
relaxants and sedatives).
•B
 irth 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.

page 1

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Topiramate Capsules
50mg x 60’s (UK)
JDE No.:

50818118

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle
Pharmacode: 4763
Date Sent:
05/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

colours/plates:

Topiramate 50mg 60 Capsules PIL - UK

1. Black

item no: AAAH3845

dimensions: 260 x 210 Reel fed

print proof no: 7

pharmacode:

origination date: 29.10.14

min pt size: 9

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 29.07.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

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, 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
Capsules.
Topiramate Capsules with food, drink and alcohol
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
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 advice before taking this medicine.
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.
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.
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 Capsules contain sucrose
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 this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
• T ake 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.
• T opiramate 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.
•H
 old the hard capsule upright so that the wording is the
correct way up
•C
 arefully 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.
•S
 prinkle 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.
•B
 e sure to swallow the entire spoonful of the sprinkle/
food mixture immediately. Avoid chewing.
•D
 rink fluids immediately in order to make sure all of the
mixture is swallowed.
•N
 ever store any medicine and food mixture for use at
a later time.
• T opiramate 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
•S
 ee a doctor right away. Take the medicine pack with
you.
• Y ou 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
Do not take a double dose (two doses at the same time)
to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you
remember it. However if it’s almost time for your next
dose, skip the missed dose and continue as usual. If you
miss two or more doses, contact your doctor.
If you stop taking Topiramate Capsules
Do not stop taking Topiramate Capsules 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
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)
•A
 nxiety, irritability, changes in mood, confusion,
disorientation
•P
 roblems with concentration, slowness of thinking, loss
of memory, problems with memory (new onset, sudden
change or increased severity)
• Kidney stone, frequent or painful urination
Uncommon (may affect up to 1 in 100 people)
• I ncreased acid level in the blood (may cause troubled
breathing including shortness of breath, loss of
appetite, nausea, vomiting, excessive tiredness, and
fast or uneven heart beats)
• Decreased or loss of sweating
•H
 aving thoughts of serious self-harm, trying to cause
serious self-harm
Rare (may affect up to 1 in 1,000 people)
•G
 laucoma – blockage of fluid in eye causing increased
pressure in the eye, pain, or decreased vision
•S
 evere 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
Not known (frequency cannot be estimated from the
available data)
• T oxic epidermal necrolysis which is a more severe form
of Stevens-Johnson syndrome (see rare side effects)
Other side effects include the following, if they get
serious, please tell your doctor or pharmacist:
Very common side effects include: (may affect more
than 1 in 10 people)
• Stuffy, runny nose and sore throat
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Nausea, diarrhoea
• Tiredness
• Weight loss
Common side effects include: (may affect up to 1 in 10
people)
• Reduced number of red blood cells
•A
 llergic reaction (such as skin rash, redness, itching,
facial swelling, hives)
• Decrease or loss of appetite
• Aggression, agitation, anger
• Difficulty in sleeping
• Slurred speech
• Involuntary shaking in the arms, hands or legs

page 2

• Reduced sense of touch or sensation
• Involuntary movements of the eyes
• Distorted sense of taste
• Visual disturbance, blurred vision, double vision
•S
 ensation of spinning (vertigo), 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
• Hair loss
• Skin rash and/or itchy skin
• J oint pain, muscle spasms, muscle pain, muscle

twitching or muscle weakness, chest pain

• F ever, loss of strength, irritability, clumsiness, or

problems with walking, general feeling of feeling
unwell, weight gain

Uncommon side effects include: (may affect up to 1 in
100 people)
•A
 bnormal blood counts, including reduced white blood
cell count or platelet count, or increased eosinophils
• Swollen glands in the neck, armpit or groin
• Low potassium levels in the blood
• I ncreased appetite, increased thirst and drinking
abnormally large amounts of fluid
• Hallucinations, severe mental disorder (psychosis)
•D
 ecreased verbal communication, disturbed or poor
quality sleep
• Restlessness or increased mental and physical activity
•S
 howing and/or feeling no emotion, unusual
suspiciousness, panic attack
• Problems with reading, speech disorder
• Loss of consciousness
• Problems with verbal communication
• Fainting
• Abnormal sense of touch
• Impaired or distorted sense of smell
• Drooling
• Excessive sleepiness
•S
 low or diminished movements, involuntary, abnormal
or repetitive muscle movements
•U
 nusual feeling or sensation that may precede a
migraine or a certain type of seizure (aura)
• Problems with handwriting
• Feeling of movement under the skin
• E ye problems including dry eyes, light sensitivity,
involuntary twitching, tearing and decreased vision
• Decreased or loss of hearing
• I rregular heartbeat or slowness of the heartbeat,
feeling your heart beating in your chest
• L ow blood pressure or decrease in blood pressure that
occurs when you stand up
• Hot flushing
• Hoarseness of the voice
• Inflammation of the pancreas
• Gas, heartburn, fullness or bloating
• L oss of sensitivity to touch in the mouth, painful or
burning sensations in the mouth, bleeding gums, breath
odour

page3

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Topiramate Capsules
50mg x 60’s (UK)
JDE No.:

50818118

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle
Pharmacode: 4763
Date Sent:
05/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

colours/plates:

Topiramate 50mg 60 Capsules PIL - UK

1. Black

item no: AAAH3845

dimensions: 260 x 210 Reel fed

print proof no: 7

pharmacode:

origination date: 29.10.14

min pt size: 9

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 29.07.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

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.

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