Topamax 100 mg Film-coated Tablets

Main information

  • Trade name:
  • Topamax 100 mg Film-coated Tablets
  • Dosage:
  • 100 milligram(s)
  • Pharmaceutical form:
  • Film-coated tablet
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Topamax 100 mg Film-coated Tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Other antiepileptics; topiramate

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PPA1097/002/005
  • Authorization date:
  • 14-07-2017
  • Last update:
  • 13-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Aggression, abnormal behaviour

Difficulty falling or staying asleep

Feeling of unsteadiness when walking

Not feeling well

Decrease in potassium level in the blood

Showing and/or feeling no emotion

Watery eyes

Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

Sensation of spinning (vertigo)

Vomiting

Fever

Uncommon (may affect up to 1 in 100 people)

Increase in eosinophils (a type of white blood

cell) in the blood

Hyperactivity

Feeling warm

Learning disability

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: HPRA Pharmacovigilance,

Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1

6764971; Fax: +353 1 6762517. Website:

www.hpra.ie; e-mail: medsafety@hpra.ie. By

reporting side effects you can help provide more

information on the safety of this medicine.

5. HOW TO STORE TOPAMAX

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date

which is stated on the bottle/carton. The expiry

date refers to the last day of that month.

Do not store above 25°C. Store the tablets in

the original package (blister) to protect

from moisture. Keep the bottle tightly closed to

protect the tablets from moisture.

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.

6. CONTENTS OF THE PACK AND OTHER

INFORMATION

What Topamax contains

The active substance is topiramate.

The other ingredients of Topamax are listed below.

Core tablet:

Lactose monohydrate, pregelatinized maize

starch, microcrystalline cellulose, sodium starch

glycolate (Type A), magnesium stearate

Film-coating:

Opadry white, Opadry yellow, Pink 1, Carnauba

wax.

What Topamax looks like and contents of the

pack

Description of the product

Yellow round tablets, 9 mm in diameter, “TOP” on

one side, “100” on the other.

Blister pack of an aluminium/aluminium foil in

strips. Pack sizes of 60 tablets.

Product procured from within the EU, repackaged

and distributed by the Parallel Product

Authorisation Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch,

Worcestershire, B98 0RE, UK.

Manufactured by:

Cilag AG, Schaffhausen, Switzerland

Janssen Pharmaceuticals N.V., Beerse, Belgium.

This medicinal product is authorised in the

Member States of the EEA under the following

names:

Austria Topamax – Filmtabletten

Belgium Topamax tabletten

Bulgaria TOPAMAX

Cyprus TOPAMAX tabs

Czech Republic Topamax

Denmark Topimax

Estonia TOPAMAX

Finland Topimax tabletti,

kalvopäällysteinen

France EPITOMAX, COMPRIME

PELLICULE

Germany

Topamax 25<50><100><200>

mg Filmtabletten

Greece TOPAMAC

Hungary

Topamax film-coated tablet

Iceland

Topimax filmuhúðaðar töflur

Ireland TOPAMAX Tablets

Italy TOPAMAX compresse rivestite

con film, 60 compresse

Latvia Topamax coated tablets

Lithuania

Topamax

Luxembourg Topamax comprimés

Malta Topamax

Netherlands Topamax, filmomhulde tabletten

Norway Topimax Tabletter filmdrasjert

Poland Topamax tabletki powlekane

Portugal Topamax

Romania TOPAMAX tablets

Slovak Republic

Topamax

Slovenia

TOPAMAX filmsko oblozene

tablete

Spain

TOPAMAX Comprimidos

recubiertos

Sweden Topimax tabletter, filmdragerade

United Kingdom

TOPAMAX Tablets

Topamax is a

registered trademark of

Johnson &

Johnson.

PPA1097/002/005

Revision date: 21/06/2018

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: +44 (0)1527 505414

for help.

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 Topamax.

You may lose weight if you use Topamax 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 Topamax have

had thoughts of harming or killing themselves. If at

any time you have these thoughts, immediately

contact your doctor.

Topamax may in rare cases cause high levels of

ammonia in the blood (seen in blood tests) which

can lead to a change in brain function, especially if

you are also taking a medicine called valproic acid

or sodium valproate. Since this may be a severe

condition, tell your doctor immediately if the

following symptoms occur (see also section 4

‘Possible side effects’):

- difficulty thinking, remembering information, or

solving problems

- being less alert or aware

- feeling very sleepy with low energy

At higher doses of Topamax, the risk of developing

these symptoms may increase.

Other medicines and Topamax

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines.

Topamax and certain other medicines can affect

each other. Sometimes the dose of some of your

other medicines or Topamax 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. Topamax 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

Topamax.

Tell your doctor if your menstrual bleeding

Changes while you are taking birth control pills

and Topamax.

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 anti-epileptic

medicines, risperidone, lithium,

hydrochlorothiazide, metformin, pioglitazone,

glyburide, amitriptyline, propranolol, diltiazem,

venlafaxine, flunarazine, St. John's wort

(Hypericum perforatum) (a herbal preparation

used to treat depression).

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.

What is in this leaflet

1. What Topamax is and what it is used for

2. What you need to know before you take

Topamax

3. How to take Topamax

4. Possible side effects

5. How to store Topamax

6. Contents of the pack and other information

1. WHAT TOPAMAX IS AND WHAT IT IS USED

FOR

Topamax belongs to a group of medicines called

“anti-epileptic medicines”.

It is used:

alone to treat seizures in adults and children

over age 6

with other medicines to treat seizures in adults

and children aged 2 years and above

to prevent migraine headaches in adults

2. WHAT YOU NEED TO KNOW BEFORE YOU

TAKE TOPAMAX

Do not take Topamax

if you are allergic to topiramate or any of the

other ingredients of this medicine (listed in

section 6).

for 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 Topamax.

If you are not sure if the above applies to you, talk

to your doctor or pharmacist before using

Topamax.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Topamax 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)

*

are taking Topamax to treat epilepsy and you are

pregnant or a woman of childbearing potential

(see section ‘pregnancy and breastfeeding’ for

further information)

If you are not sure if any of the above applies to

you, talk to your doctor or pharmacist before using

Topamax.

Topamax 100mg Film-coated Tablets

(topiramate)

POM

®

Ref:1097/002/005/210618/1/F

Package leaflet: Information for the user

3. HOW TO TAKE TOPAMAX

Always take this medicine exactly as your doctor

has told you. Check with your doctor or pharmacist

if you are not sure.

Your doctor will usually start you on a low dose

of Topamax and slowly increase your dose until

the best dose is found for you.

Topamax tablets are to be swallowed whole.

Avoid chewing the tablets as they may leave a

bitter taste.

Topamax can be taken before, during, or after a

meal. Drink plenty of fluids during the day to

prevent kidney stones while taking Topamax.

If you take more Topamax than you should

See a doctor right away. Take the medicine

pack with you.

You may feel sleepy, tired, or less alert; lack

coordination; have difficulty speaking or

concentrating; have double or blurred vision;

feel dizzy due to low blood pressure; feel

depressed or agitated; or have abdominal pain,

or seizures (fits).

Overdose can happen if you are taking other

medicines together with Topamax.

If you forget to take Topamax

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.

*

Do not take a double dose (two doses at the

same time) to make up for a forgotten dose.

If you stop taking Topamax

Do not stop taking this medicine 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 product, 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)

Anxiety, irritability, changes in mood, confusion,

disorientation

Problems 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)

Increased 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 (particularly in

young children who are exposed to high

temperatures)

Having thoughts of serious self-harm, trying to

cause serious self-harm

Loss of part of the field of vision

Reduced or slow body movements, involuntary

abnormal or repetitive muscle movements

Fainting

Abnormal sense of touch; impaired sense of

touch

Impaired, distorted, or no sense of smell

Unusual feeling or sensation that may precede

a migraine or a certain type of seizure

Dry eye, sensitivity of the eyes to light, eyelid

twitching, watery eyes

Decreased or loss of hearing, loss of hearing in

one ear

Slow or irregular heartbeat, feeling your heart

beating in your chest

Low blood pressure, low blood pressure upon

standing (consequently, some people taking

Topamax may feel faint, dizzy, or may pass out

when they stand up or sit up suddenly)

Flushing, feeling warm

Pancreatitis (inflammation of the pancreas)

Excessive passing of gas or wind, heartburn,

abdominal fullness or bloating

Bleeding gums, increased saliva, drooling,

breath odour

Excessive intake of fluids, thirst

Skin discolouration

Muscle stiffness, pain in side

Blood in urine, incontinence (lack of control) of

urine, urgent desire to urinate, flank or kidney

pain

Difficulty getting or keeping an erection, sexual

dysfunction

Flu-like symptoms

Cold fingers and toes

Feeling drunk

Learning disability

Rare (may affect up to 1 in 1,000 people)

Abnormally elevated mood

Loss of consciousness

Blindness in one eye, temporary blindness,

night blindness

Lazy eye

Swelling in and around the eyes

Numbness, tingling and colour change (white,

blue then red) in fingers and toes when

exposed to the cold

Inflammation of the liver, liver failure

Stevens Johnson syndrome, a potentially

life-threatening condition that may present with

sores in multiple mucosal sites (such as the

mouth, nose, and eyes), a skin rash, and

blistering

Abnormal skin odour

Discomfort in your arms or legs

Kidney disorder

Not known (frequency cannot be estimated

from the available data)

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.

Toxic epidermal necrosis, a life-threatening

condition related to, yet more severe than,

Stevens-Johnson syndrome, characterized by

widespread blistering and sloughing of the outer

layers of the skin (see rare side effects)

Children

The side effects in children are generally similar to

those seen in adults, but the following side effects

may be more common in children than adults:

Problems with concentration

Increased acid level in the blood

Having thoughts of serious self-harm

Tiredness

Decreased or increased appetite

Rare (may affect up to 1 in 1,000 people)

Glaucoma – blockage of fluid in eye causing

increased pressure in the eye, pain, or

decreased vision

Difficulty thinking, remembering information, or

solving problems, being less alert or aware,

feeling very sleepy with low energy – these

symptoms may be a sign of a high level of

ammonia in the blood (hyperammonemia),

which can lead to a change in brain function

(hyperammonemic encephalopathy).

Other side effects include the following, if they

get serious, please tell your doctor or

pharmacist:

Very common (may affect more than 1 in 10

people)

Stuffy, runny nose or sore throat

Tingling, pain and/or numbness of various body

parts

Sleepiness, tiredness

Dizziness

Nausea, diarrhoea

Weight loss

Common (may affect up to 1 in 10 people)

Anaemia (low blood count)

Allergic reaction (such as skin rash, redness,

itching, facial swelling, hives)

Loss of appetite, decreased appetite

Aggression, agitation, anger, abnormal behavior

Difficulty falling or staying asleep

Problems with speech or speech disorder,

slurred speech

Clumsiness or lack of coordination, feeling of

unsteadiness when walking

Decreased ability to complete routine tasks

Decreased, loss of, or no sense of taste

Involuntary trembling or shaking; rapid,

uncontrollable movements of the eyes

Visual disturbance, such as double vision,

blurred vision, decreased vision, difficulty

focusing

Sensation of spinning (vertigo), ringing in the

ears, ear pain

Shortness of breath

Cough

Nose bleeds

Fever, not feeling well, weakness

Vomiting, constipation, abdominal pain or

discomfort, indigestion, stomach or intestinal

infection

Dry mouth

Hair loss

Itching

Joint pain or swelling, muscle spasms or

twitching, muscle aches or weakness, chest

pain

Weight gain

Uncommon (may affect up to 1 in 100 people)

Decrease in platelets (blood cells that help stop

bleeding), decrease in white blood cells that

help to protect you against infection, decrease

in potassium level in the blood

Increase in liver enzymes, increase in

eosinophils (a type of white blood cell) in the

blood

Swollen glands in the neck, armpit, or groin

Increased appetite

Elevated mood

Hearing, seeing, or feeling things that are not

there, severe mental disorder (psychosis)

Showing and/or feeling no emotion, unusual

suspiciousness, panic attack

Problems with reading, speech disorder,

problems with handwriting

Restlessness, hyperactivity

Slowed thinking, decreased wakefulness or

alertness

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before using

Topamax.

Topamax with food and drink

You can take Topamax with or without food. Drink

plenty of fluids during the day to prevent kidney

stones while taking Topamax. You should avoid

drinking alcohol when taking Topamax.

Pregnancy and breast-feeding

Migraine prevention:

Topamax can harm an unborn baby. You must not

use Topamax if you are pregnant. You must not

use Topamax 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

Topamax is suitable for you. Before the start of

treatment with Topamax 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 Topamax. If the decision is

made to use Topamax, you should use effective

contraception. Talk to your doctor about the best

kind of contraception to use while you are taking

Topamax. Before the start of treatment with

Topamax a pregnancy test should be performed.

Talk to your doctor if you wish to become

pregnant.

As with other anti-epileptic medicines, there is a

risk of harm to the unborn child if Topamax is used

during pregnancy. Make sure you are very clear

about the risks and the benefits of using Topamax

for epilepsy during pregnancy.

If you take Topamax 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 Topamax 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 Topamax. You and your

doctor should decide if you will continue to take

Topamax while you are pregnant.

Breast-feeding

The active substance in Topamax (topiramate)

passes into breast milk. Effects have been seen in

breastfed babies of treated mothers, including

diarrhea, 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

Topamax. Your doctor will take into account the

importance of the medicine to the mother and the

risk for the baby.

Mothers who breast-feed while taking Topamax

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 Topamax. Do not drive

or use any tools or machines without talking to

your doctor first.

Topamax contains lactose

If you have been told by your doctor that you have

an intolerance to some sugars, contact your doctor

before taking this medicinal product.

Ref:1097/002/005/210618/1/B