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TOPIRAMATE ACTAVIS 50MG CAPSULES HARD

Active substance(s): TOPIRAMATE

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

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE TOPIRAMATE CAPSULES
Keep this medicine out of the sight and reach of children.
Store in the original container. Keep the container tightly
closed in order to protect from moisture.

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

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.

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

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

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

What Topiramate Capsules contain
The active substance is topiramate (each capsule contains
50mg of topiramate).

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

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-II85F18378 White (which contains polyvinyl alcohol-part
hydrolysed, macrogol, talc and titanium dioxide).

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 if you are
a woman of childbearing potential unless you are using
effective contraception (see section ‘pregnancy and
breastfeeding’ for further information). You should talk to
your doctor about the best kind of contraception to use
while you are taking Topiramate Capsules.

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

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 50mg capsules are white with ‘50’ printed in black on
the body and ‘>’ over ‘Ti’ on the cap.

If you are not sure if the above applies to you, talk to your
doctor or pharmacist before using Topiramate Capsules.

Topiramate Capsules are available in HDPE bottles
containing 14, 20, 28, 56 and 60 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.

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)
• a re taking Topiramate Capsules to treat epilepsy and

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 December 2017

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPIRAMATE CAPSULES

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

you are pregnant or a woman of childbearing potential
(see section ‘Pregnancy and breastfeeding’ for further
information)

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.
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. You should talk to your
doctor about the best kind of contraception to use while
you are taking Topiramate Capsules.
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,

50944034 BBBA1624

page 4

page 1

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

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

approved for print/date

Originator:
Origination Date:
Revision Date:
Revised By:

50944034

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle
Pharmacode: 5289

Proof Round

Date Sent:
21/12/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Item number:

2

BBBA1624
Dimensions:
260 x 210
Min Body Text Size: 9pt
Supplier:
Actavis UK

S.Anson
11.01.18
12.01.18
S.Anson

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
n/a
Date received: n/a

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

risperidone, lithium, hydrochlorothiazide, metformin,
pioglitazone, glyburide, amitriptyline, propranolol, diltiazem,
venlafaxine and flunarizine, 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
Migraine prevention
Topiramate Capsules can harm an unborn baby. You must
not use Topiramate Capsules if you are pregnant. You must
not use Topiramate Capsules 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
Capsules are suitable for you. Before the start of treatment
with Topiramate Capsules a pregnancy test should be
performed.
Treatment of epilepsy
If you are a woman of childbearing potential you should
talk to your doctor about other possible treatments
instead of Topiramate Capsules. If the decision is made
to use Topiramate Capsules, you should use effective
contraception.
Talk to your doctor about the best kind of contraception to
use while you are taking Topiramate Capsules. Before the
start of treatment with Topiramate Capsules a pregnancy
test should be performed.
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 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.
- If you take Topiramate Capsules 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 Capsules 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 Capsules. You and your doctor
should decide if you will continue to take Topiramate
Capsules while you are pregnant.
Breast-feeding
The active substance in Topiramate Capsules (topiramate)
passes into breast milk. Effects have been seen in breast-

fed babies of treated mothers, including diarrhoea, feeling
sleepy, feeling irritable, and poor weight gain. Therefore,
your doctor will discuss with you whether you abstain from
breast-feeding or whether to abstain from treatment with
Topiramate Capsules. Your doctor will take into account
the importance of the medicine to the mother and the risk
for the baby.

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.

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.

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.

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.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

3. HOW TO TAKE TOPIRAMATE CAPSULES

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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.

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)

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

Other side effects include the following, if they get serious,
please tell your doctor or pharmacist:

page 2

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
• 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)

page3

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

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

approved for print/date

Originator:
Origination Date:
Revision Date:
Revised By:

50944034

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle
Pharmacode: 5289

Proof Round

Date Sent:
21/12/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Item number:

2

BBBA1624
Dimensions:
260 x 210
Min Body Text Size: 9pt
Supplier:
Actavis UK

S.Anson
11.01.18
12.01.18
S.Anson

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
n/a
Date received: n/a

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

+ 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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