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TOPIRAMATE AMNEAL 25 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

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The doctor will decide whether you need to stop taking Topiramate Amneal whilst breast-feeding, or advise you to stop
breast-feeding in order for you to continue taking the medication.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Amneal 25 mg, 50 mg, 100 mg, & 200 mg film-coated tablets
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 gets 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 Amneal is and what it is used for
2.
Before you take Topiramate Amneal
3.
How to take Topiramate Amneal
4.
Possible side effects
5.
How to store Topiramate Amneal
6.
Further information
1.

What Topiramate Amneal is and what it is used for

Topiramate Amneal belongs to a group of medicines called “antiepileptic medicines”. It is used:



2.

alone to treat certain types of seizures in adults and children over age 6.
with other medicines to treat certain types of seizures in adults and children over age 2.
to prevent migraine headaches in adults after other treatment options have been tried.
Before you take Topiramate Amneal

Do not take Topiramate Amneal

if you are allergic (hypersensitive) to Topiramate Amneal or any of the other ingredients of Topiramate Amneal
(as listed in section 6 ‘Further Information’).

to prevent migraine if you are pregnant or are able to become pregnant and are not using effective
contraception(see section 2 ‘Pregnancy and breast-feeding’ for further information).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Amneal.
Take special care with Topiramate Amneal
Check with your doctor or pharmacist before taking Topiramate Amneal if you:

or a close member of your family have or have ever had kidney problems, especially kidney stones, or kidney
disease.

have a history of blood and body fluid abnormality (metabolic acidosis). This may cause growth problems in
children.

have liver problems.

have eye problems, especially raised pressure in the eye (glaucoma).

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 Amneal.
It is important that you do not stop taking your medicine without first consulting your doctor.
You may lose weight when taking Topiramate Amneal so your weight should be checked regularly when taking 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 Amneal have had thoughts
of harming or killing themselves. If at any time you have these thoughts during your treatment with Topiramate Amneal,
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 Amneal and certain other medicines can
affect each other. Sometimes the dose of some of your other medicines or Topiramate Amneal will have to be adjusted.
In particular, 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 drugs to help you sleep (sedatives)).

birth control pills. Topiramate Amneal may make your birth control pills less effective.

Tell your doctor if your menstrual bleeding (period) changes while you are taking birth control pills and
Topiramate Amneal.
Please also discuss with your doctor or pharmacist if you are taking, or have taken, any of the following medicines:
other antiepileptic medicines, flunarizine for migraine, medicines for mental problems or depression (such as
risperidone, amitriptyline, lithium, or venlafaxine), medicines for diabetes (such as metformin, pioglitazone or glyburide),
or medicines for high blood pressure (such as hydrochlorothiazide, propranolol or diltiazem).
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start your new
medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Amneal.
Taking Topiramate Amneal with food and drink
You can take Topiramate Amneal with or without food. Drink plenty of fluids during the day to prevent kidney stones
while taking Topiramate Amneal. You should not drink alcohol when taking Topiramate Amneal.
Pregnancy and breast-feeding
Talk to your doctor before using Topiramate Amneal if you are pregnant, trying to become pregnant or breast-feeding.
Your doctor will decide if you can take Topiramate Amneal. As with other antiepilepsy medicines, there is a risk of harm
to the unborn child if Topiramate Amneal is used during pregnancy. Make sure you are very clear about the risks and
the benefits of using Topiramate Amneal for epilepsy during pregnancy.
You should not take Topiramate Amneal to prevent migraine if you are pregnant or are able to become pregnant and are
not using effective contraception.

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 Amneal . Do not drive or use any
tools or machines without talking to your doctor first. If you are concerned or want more information you should discuss
this with your doctor.
Important information about some of the ingredients of Topiramate Amneal film-coated tablets
Topiramate Amneal film-coated tablets contain lactose (a type of sugar). If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.
3.

How to take Topiramate Amneal

Always take Topiramate Amneal exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.




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

If you take more Topiramate Amneal than you should
Contact your doctor straight away or go to the casualty department of your nearest hospital. Take the medicine pack
with you even if there are no tablets left.
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.
Overdoses can be particularly serious if you have also taken other medicines together with Topiramate Amneal.
Overdose can also cause a blood and body fluid abnormality (metabolic acidosis).
If you forget to take Topiramate Amneal
If you forget to take a dose, take it as soon as you remember. If, however, 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.
If you stop taking Topiramate Amneal
Do not stop taking this medicine unless your doctor tells you to as your symptoms may return. If your doctor decides to
stop this medicine, your dose may need to be decreased gradually.
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 Amneal can cause side effects, although not everybody gets them.
If any of the following side effects occur, you should seek urgent medical attention as they can be
serious:








An allergic reaction, including symptoms such as rash, itching and swelling of the face, tissues of the eye, or
body or difficulty in breathing. This affects less than 1 person in every 10.
Severe skin reactions, 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 with raised red spots that can
blister. This affects less than 1 person in every 1000. Toxic epidermal necrolysis, which is a more severe form of
Stevens-Johnson syndrome, may also occur (the frequency of this side effect is not known).
Changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in
thinking. This affects less than 1 person in every 10.
Thoughts of harming or killing yourself, feeling paranoid or losing contact with reality or hallucinations, crying,
panic attack. This affects less than 1 person in every 100.
Blindness or glaucoma (increased pressure in the eye, associated with pain and decreased vision). This affects
less than 1 person in every 1000.
Maculopathy, a disease of the macula, the small spot in the retina of your eye where vision is sharpest (the
frequency of this side effect is not known). You should call your doctor if you notice a change or decrease in
your vision.

Other side effects
If you are concerned about any side effects please talk to your doctor. If any of the following side effects gets serious, or
if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Some side effects may occur more often in children.
Very common side effects (affecting more than 1 person in every 10):

Weight loss

Tingling in the arms and legs

Drowsiness or sleepiness, dizziness, tiredness

Diarrhoea, nausea

Stuffy, runny nose and sore throat

Depression
Common side effects (affecting less than 1 person in every 10):

Changes in mood or behaviour, including anger, nervousness, sadness, irritability, sleeplessness, anxiety

Weight gain, decrease or loss of appetite

Reduced number of red blood cells

Slurred speech

Clumsiness, or difficulties with walking or balance

Involuntary shaking in the arms, hands or legs

Convulsions

Reduced sense of touch or sensation

Altered sense of taste

Disturbances in vision, blurred vision, double vision, involuntary movement of the eyes

Ringing sound in the ears, ear pain, feeling of spinning

Shortness of breath and difficulty in breathing

Nose bleeds













Vomiting, constipation, stomach pain, indigestion
Dry mouth, tingling or numbness of the mouth
Kidney stones
Frequent or painful urination
Hair loss
Skin rash and/or itchy skin
Joint pain
Muscle spasms, muscle twitching or muscle weakness
Chest pain
Fever
Loss of strength, feeling unwell in general.

Uncommon side effects (affecting less than 1 person in every 100):

Abnormal blood counts, including changes in white blood cell count or platelet count

Irregular heart beat or slow heart beat

Swollen glands in the neck, armpit or groin

Increase in certain types of seizures

Difficulties with speaking and communicating, with handwriting or learning

Restlessness or increased mental and physical activity

Changes or loss in sensation, a feeling of burning

Loss of consciousness

Fainting or feeling lightheaded

Slow or diminished movements

Numbness or pain in the hands or feet, cold extremities (e.g. hands and face)

Disturbed or poor quality sleep

Distorted sense of smell

Loss or reduction of taste

Feeling of movement under the skin

Eye problems and changes including dry eyes, short sight, light sensitivity, involuntary twitching, watery eyes,
and decreased vision

Decreased or loss of hearing, ear discomfort

Hoarseness of the voice

Inflammation of the pancreas

Loss of sensitivity to touch in the mouth, bleeding gums, bad breath

Painful or burning sensations in the mouth, making more saliva than usual, drooling

Heartburn, fullness, bloating in the stomach or flatulence (gas)

Leakage of urine and/or stools, urgent desire to urinate, blood in your urine, crystals in the urine

Pain in the kidney area and/or bladder caused by kidney stones

Decreased or no sweating

Skin discolouration

Swelling of the face

Swelling of the joints

Muscle and bone stiffness, muscle pain or tiredness

Increased acid levels in the blood

Low potassium levels in the blood

Increased appetite, increased thirst and drinking abnormally large amounts of fluid

Low blood pressure or decrease in blood pressure that occurs when you stand up, causing dizziness

Hot flushes

Flu-like illness

Disturbances in sexual function (erectile dysfunction, loss of libido).
Rare side effects (affecting less than 1 person in every 1000):

Movement disorders

Extra-sensitive skin

Impaired sense of smell

Eye problems including swelling in the tissues around the eye, lazy eye, flickering in the eye, changes in your
eyesight

Too much acid in the blood due to kidney problems

Skin odour

Raynaud’s syndrome, a disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold
sensitivity

Deposits of calcium in the tissues (calcinosis).
If any of the side effects above 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 Amneal

Keep out of the reach and sight of children.
Do not use Topiramate Amneal after the expiry date which is stated on the label and the carton after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C.
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 Amneal contains


The active substance is Topiramate Amneal. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200
mg Topiramate Amneal.


The other ingredients are:
Tablet core: cellulose microcrystalline, lactose monohydrate, starch pregelatinised (maize), sodium starch glycolate (type
A), magnesium stearate.
Film coat: hypromellose, Titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide yellow (E172) (only in
Topiramate Amneal 50 mg & /100 mg), iron oxide red (E172) (only in Topiramate Amneal 200 mg).
What Topiramate Amneal looks like and contents of the pack
Film-coated tablet.
Topiramate Amneal 25 mg film-coated tablets:
White, circular, biconvex film-coated tablets debossed with ‘E’ on one side and ‘22’ on the other side.
Topiramate Amneal 50 mg film-coated tablets:
Light yellow coloured, circular, biconvex film-coated tablets debossed with ‘E’ on one side and ‘33’ on the other side.
Topiramate Amneal 100 mg film-coated tablets:
Dark yellow coloured, circular, biconvex bevelled edged film-coated tablets debossed with ‘E’ on one side and ‘23’ on
the other side.
Topiramate Amneal 200 mg film-coated tablets:
Pink coloured, circular, biconvex, bevelled edged film-coated tablets debossed with ‘E’ on one side and ‘24’ on the
other side.
Topiramate Amneal film-coated tablets are available in HDPE bottles and Alu-Alu blisters.
Presentations:
Bottles:
25mg: 20 & 60 tablets
50mg, 100mg & 200mg: 60 tablets
Blisters:
25mg, 50mg, 100mg & 200mg: 20, 28, 50, 60 & 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
This leaflet was last revised in 04/2014

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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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