TOPIRAMATE 25MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX® 25mg FILM-COATED TABLETS
(Topiramate)
The name of your medicine is Topamax 25mg film-coated
Tablets, but will be referred to as Topamax throughout the
remainder of this leaflet.
This product is available in multiple strengths and all strengths
will be referred to throughout this leaflet.
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 you get side effects and they become serious, or if you
notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist
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 “antiepileptic
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 (hypersensitive) to topiramate or any of the
other ingredients of Topamax (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 breast-feeding’
for further information).
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 pregnant or could become pregnant (see section
‘pregnancy and breast-feeding’ 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.
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 antiepileptic
medicines such as Topamax have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Other medicines 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 antiepileptic 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).
If you are not sure if any of the above applies 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, breast-feeding and fertility
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.
Your doctor will decide if you can take Topamax. As with other
antiepilepsy 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.
You should not take Topamax for migraine prevention if you are
pregnant or you are able to become pregnant and you are not
using effective contraception.
Mothers who breast-feed while taking Topamax must tell the
doctor as soon as possible if the baby experiences anything
unusual.
Ask your doctor or pharmacist for advice before taking this
medicine.
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.
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

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.

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.

Especially, tell your doctor or pharmacist if you are taking:

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

 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.
Tell your doctor if your menstrual bleeding changes while you
are taking birth control pills and Topamax.

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
 Having thoughts of serious self-harm, trying to cause serious
self-harm
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
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
 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
 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
 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
 Increased acid level in the blood
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 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.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
5. How to store Topamax





Keep out of the sight and reach of children
Keep the container tightly closed
Do not store above 25°C
Do not use Topamax tablets after the expiry date which is
stated on the label. The expiry date refers to the last day of
that month
 Medicines should not be disposed of via wastewater or
household waste. These measures will help protect the
environment. Return any leftover Topamax tablets to your
pharmacist
6. Contents of the pack and other information
What Topamax contains
 The active substance is topiramate.
 Each tablet contains 25mg of topiramate.
 Each tablet also contains the following ingredients: lactose,
pregelatinised starch, carnauba wax, microcrystalline
cellulose (E460), sodium starch glycolate, magnesium
stearate, hypromellose, macrogol, polysorbate 80, titanium
dioxide (E171) and iron oxide (E172).
What Topamax looks like and contents of the pack
Your tablets are small white film coated tablets marked ‘TOP’ on
one side and ‘25’ on the other side.
Topamax Tablets are available in plastic bottles of 60 tablets or
blister packs of 60 tablets.
Manufacturer
Manufactured by: Janssen Pharmaceutica N.V.,Beerse,
Belgium.
Or

POM

Cilag AG, Schaffhausen, Switzerland.
It is procured from within the EU. Parallel Import Product
Licence holder: G Pharma Ltd, Salford M50 2PU.
PL 16369/0250

Topamax® 25mg film-coated Tablets

Leaflet revision and issue date:

08/10/2013

‘Topamax’ is a registered trademark of Janssen-Cilag.

Expand view ⇕

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.

Hide
(web2)