TOPIRAMATE ARROW 100MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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Topiramate Tablets – UK Leaflet

UK/H/0951/001-004/IB/016

Package leaflet: Information for the user
Topiramate Arrow 25mg, 50mg, 100mg and 200mg Film-coated Tablets
(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 notpass it on to others. It may
harm them, even if their signs of illnessare 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.
What is in this leaflet:
1.
What Topiramate Tablets are and what they are used for
2.
What you need to know before you take Topiramate
Tablets
3.
How to take Topiramate Tablets
4.
Possible side effects
5.
How to store Topiramate Tablets
6
Contents of the pack and further information
1. WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR
Topiramate Tablets 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
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE
TABLETS
Do not take Topiramate Tablets:



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 Tablets.
Warnings and precautionsTalk to your doctor or pharmacist before taking Topiramate
Tablets if you:


have kidney problems, especially kidney stones, or are getting kidney dialysis

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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 Tablets.
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 Tablets.
You may lose weight if you use Topiramate 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
Tablets have had thoughts of harming or killing themselves. If at any time you have these
thoughts, immediately contact your doctor.
Other medicines and Topiramate tablets
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 Tablets and certain other medicines can affect each other.
Sometimes the dose of some of your other medicines or Topiramate 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 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 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 and flunarazine,
St. John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression).

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If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before using Topiramate Tablets.
Topiramate Tablets with food and drink and alcohol
You can take Topiramate Tablets with or without food. Drink plenty of fluids during the
day to prevent kidney stones while taking Topiramate Tablets. 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 for advice before taking this medicine.
As with other antiepilepsy medicines, there is a risk of harm to the unborn child if
Topiramate Tablets are used during pregnancy. Make sure you are very clear about the
risks and the benefits of using Topiramate Tablets for epilepsy during pregnancy.
You should not take Topiramate 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 Tablets 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
Tablets. Do not drive or use any tools or machines without talking to your doctor first.
Topiramate Tablets Film-coated Tablets contain lactose
This medicinal product contains lactose anhydrous. 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 TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.




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

If you take more Topiramate Tablets than you should
 See a doctor right away. Take the medicine pack with you.

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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 Tablets.
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 Tablets
Do not take a double dose 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 Tablets
Do not stop taking Topiramate Tabletsunless 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.
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

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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

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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 affect up to 1 in 1000 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)

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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 or pharmacist. 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 TABLETS
Keep this medicine out of the sight and reach of children.
Blisters: Store in the original package in order to protect from moisture.
HDPE Bottles: 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, bottle and
blister 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.

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6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topiramate Tablets contain:


The active substance is topiramate (each film-coated tablet contains 25mg, 50mg,
100mg or 200mg of topiramate).



The other ingredients in the tablet core are microcrystalline cellulose, sodium starch
glycolate (type A), maize starch, pregelatinised, lactose anhydrous, aniseed flavour,
sacharrin sodium and magnesium stearate.

The tablet coat for the 25mg tablets is Opadry AMB OY-B-28920 White which contains
polyvinyl alcohol, titanium dioxide (E171), talc, lecithin and xanthan gum.
The tablet coat for the 50mg tablets is Opadry AMB 80W62680 Yellow which contains
polyvinyl alcohol, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide
black (E172), lecithin and xanthan gum.
The tablet coat for the 100mg tablets is Opadry AMB 80W62681 Yellow which contains
polyvinyl alcohol, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide
black (E172), lecithin and xanthan gum.
The tablet coat for the 200mg tablets is Opadry AMB 80W64830 Pink which contains
polyvinyl alcohol, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide
black (E172), iron oxide red (E172), lecithin and xanthan gum.
What Topiramate Tablets look like and contents of the pack:
Your medicine is in the form of film-coated tablets.
The 25mg tablets are white, round, film-coated tablets with ‘TI’ on one side and ‘>’ on
the other.
The 50mg tablets are yellow, round, film-coated tablets with ‘TI’ over ‘50’ on one side
and ‘>’ on the other.
The 100mg tablets are yellow, round, film-coated tablets with ‘TI’ over ‘100’ on one side
and ‘>’ on the other.
The 200mg tablets are pink, round, film-coated tablets with ‘TI’ over ’200’ on one side
and ‘>’ on the other.
Topiramate Tablets are available in blisters and HDPE bottles containing 20, 28, 50, 56,
60, 84, 90, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow Generics Limited, Whiddon Valley, Barnstaple, Devon, EX32 8NS,
United Kingdom

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Manufacturer:
Arrow Pharm (Malta) Limited 62 Hal Far Industrial Estate, Birzebbugia, BBG06, Malta
or
Selamine Limited T/A Arrow Generics Limited, Unit 4, Willsborough Cluster,
Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Ireland
or
Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany
or
Akmon Pharmaceutical Industries LLC, Industrijska cesta 1J, 1290 Grosuplje, Slovenia
or
Bluepharma Indústria Farmacêutica SA, S. Martinho do Bispo, 3045-016, Coimbra,
Portugal
This leaflet was last revised in 05/2014

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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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