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TOPIRAMATE ACTAVIS 25 MG 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 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.
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.

What is 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

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.

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.  HAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE
W
CAPSULES
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).
• 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.
Warnings and precautions
Talk to 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 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.
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:
• 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, 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.

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.
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
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 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.
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.

Topiramate 15mg & 25mg Capsules hard PIL - UK (Arrow)
item no: AAAG8657

dimensions: 180 x 300

print proof no: 2

pharmacode:

origination date: 116.05.14

min pt size: 8.5pts

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 03.06.14

Technical Approval

revised by: DR

date sent: 19.05.14

supplier: Actavis Malta Hal-Far

technically app. date: 20.05.14

Non Printing Colours
1.
2.
3.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Replace with:
Very common side effects include: (may affect more than 1 in 10 people)
• Stuffy, runny nose and sore throat
• Depression
• 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
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Decrease or loss of appetite
• Changes in mood or behaviour, including anger, nervousness, sadness
• Changes in thinking and alertness, including confusion, problems with
concentrating, memory or slowness in thinking
• 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
• Seizures (fits)
• Visual disturbance, blurred vision, double vision
• Sensation 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
• Joint pain, muscle spasms, muscle pain, muscle twitching or muscle
weakness, chest pain
• Kidney stones, frequent urination, painful urination
• Fever, 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)
• Abnormal blood counts, including reduced white blood cell count or platelet
count, or increased eosinophils
• Swollen glands in the neck, armpit or groin
• Increased acid levels in the blood, low potassium levels in the blood
• Increased appetite, increased thirst and drinking abnormally large amounts of
fluid
• Suicidal thoughts or suicide attempt
• Hallucinations, severe mental disorder (psychosis)
• Decreased verbal communication, disturbed or poor quality sleep
• Restlessness or increased mental and physical activity
• Showing 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
• Slow or diminished movements, involuntary, abnormal or repetitive muscle
movements
• Unusual feeling or sensation that may precede a migraine or a certain type of
seizure (aura)
• 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
• Irregular heartbeat or slowness of the heartbeat, feeling your heart beating in
your chest
• Low 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
• Loss of sensitivity to touch in the mouth, painful or burning sensations in the
mouth, bleeding gums, breath odour
• Increased saliva
• Decrease or loss of sweating
• Skin discolouration, localised swelling in the skin
• Swelling of the joints, musculoskeletal stiffness, pain in side
• Crystals 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
• Disturbances 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 affects up to 1 in 1,000 people)
• Abnormally elevated mood
• Excessive skin sensitivity
• Glaucoma which is a blockage of fluid in the eye causing increased pressure in
the eye, pain and decreased vision
• Night blindness, swelling in the tissues around the eye, lazy eye
• Raynaud’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
• 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 erythema multiforme, a condition of raised red spots that can blister
• Skin odour
• Discomfort in your arms or legs
• Renal tubular acidosis
• Tissue calcification (calcinosis)
Not known: (frequency cannot be estimated from the available data)
• Swelling of the conjunctiva of the eye
• 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
• Cough
• Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson
syndrome (see uncommon side effects)
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
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.
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.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away any medicines you no longer use. These
measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER 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).
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 May 2014
AAAG8657

Topiramate 15mg & 25mg Capsules hard PIL - UK (Arrow)
item no: AAAG8657

dimensions: 180 x 300

print proof no: 2

pharmacode:

origination date: 116.05.14

min pt size: 8.5pts

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 03.06.14

Technical Approval

revised by: DR

date sent: 19.05.14

supplier: Actavis Malta Hal-Far

technically app. date: 20.05.14

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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