TOPIRAMATE MYLAN 200 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user

TOPIRAMATE MYLAN 25 mg, 50 mg,
100 mg, 200 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
•  eep this leaflet. You may need to read it again.
K
If
•  you have any further questions, ask your doctor or pharmacist.
T
• his 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 possible side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. See section 4.
What is in this leaflet:
W
1.  hat Topiramate is and what it is used for
W
2.  hat you need to know before you take Topiramate
3.  ow to take Topiramate
H
P
4.  ossible side effects
5.  ow to store Topiramate
H
C
6.  ontents of the pack and other information
1.  hat Topiramate is and what it is used for
W
Topiramate belongs to a group of medicines called “antiepileptic medicines.” It is used:
• lone to treat seizures in adults and children over age 6
a
w
•  ith other medicines to treat seizures in adults and children over age 2
t
• o prevent migraine headaches in adults
W
2.  hat you need to know before you take Topiramate
Do not take Topiramate
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 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 Topiramate.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate if you:
h
•  ave kidney problems, especially kidney stones, or are getting kidney dialysis
h
•  ave a history of blood and body fluid abnormality (metabolic acidosis)
h
•  ave liver problems
h
•  ave eye problems, especially glaucoma
h
•  ave a growth problem
a
• re on a high fat diet (ketogenic diet)
a
• re pregnant or could become pregnant (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 Topiramate.
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.
You may lose weight if you use Topiramate 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
Topiramate have had thoughts of harming or killing themselves. If at any time you
have these thoughts, immediately contact your doctor.
Other medicines and Topiramate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
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:
•  ther medicines that impair or decrease your thinking, concentration, or muscle
o
coordination (e.g. central nervous system depressant medicines such as muscle
relaxants and sedatives).
•  irth control pills. Topiramate may make your birth control pills less effective.
b
Tell your doctor if your menstrual bleeding changes while you are taking birth control
pills and Topiramate.
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 and 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 Topiramate.
Topiramate 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. You should avoid drinking alcohol
when taking Topiramate.

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 Topiramate. As with other antiepilepsy medicines, there is a risk of
harm to the unborn child if Topiramate is used during pregnancy. Make sure you are very
clear about the risks and the benefits of using Topiramate for epilepsy during pregnancy.
You should not take Topiramate 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 Topiramate must tell the doctor as soon as
possible if the baby experiences anything unusual.
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.
Do not drive or use any tools or machines without talking to your doctor first.
Important information about some of the ingredients of Topiramate
Topiramate (200 mg) contains sunset yellow aluminium lake (E110) and allura red
aluminium lake (E129) which may cause allergic reactions.
3.  ow to take Topiramate
H
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Y
• our doctor will usually start you on a low dose of Topiramate and slowly increase
your dose until the best dose is found for you.
T
• opiramate tablets are to be swallowed whole. Avoid chewing the tablets as they
may leave a bitter taste.
• opiramate can be taken before, during, or after a meal. Drink plenty of fluids
T
during the day to prevent kidney stones while taking Topiramate.
If you take more Topiramate than you should
S
• ee a doctor right away. Take the medicine pack with you.
• ou may feel sleepy, tired, less alert; lack coordination; have difficulty speaking or
Y
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 Topiramate.
• 
If you forget to take Topiramate
•  you forget to take a dose, take it as soon as you remember it. However, if it is
If
almost time for your next dose, skip the missed dose and continue as usual. If you
miss two or more doses, contact your doctor.
•  o not take a double dose (two doses at the same time) to make up for a forgotten dose.
D
If you stop taking Topiramate
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 medicine, ask your doctor or
pharmacist.
P
4.  ossible 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)
•  epression (new or worse)
D
Common (may affect up to 1 in 10 people)
• eizures (fits)
S
•  nxiety, irritability, confusion, disorientation, changes in mood or behaviour,
A
including anger, nervousness, sadness,
• roblems with concentration, slowness of thinking, loss of memory, problems with
P
memory (new onset, sudden change or increased severity)
K
•  idney stone, frequent or painful urination
A
•  llergic reaction (such as skin rash, redness, itching, facial swelling, hives) and
erythma multiforme, a condition of raised red spots that can blister.
Uncommon (may affect up to1 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)
D
•  ecreased or loss of sweating
•  aving thoughts of serious self-harm, trying to cause serious self-harm
H
Rare (may affect up to 1 in 1000 people)
• 
Glaucoma which is a blockage of fluid in the eye causing increased pressure in
the eye, pain and decreased vision
• evere skin reaction, including Stevens-Johnson syndrome, a life threatening skin
S
condition in which the upper layer of the skin separates from the lower, that may
present with sores in multiple mucosal sites (such as the mouth, nose, and eyes) and
erythma multiforme, a condition of raised red spots that can blister.
Not known (frequency cannot be estimated from the available data)
• 
Inflammation of the liver, liver failure
• oxic epidermal necrolysis, a life-threatening condition related to, yet more severe
T
than Stevens-Johnson syndrome, characterised by widespread blistering and
sloughing of the outer layers of the skin (see rare side effects)

Other side effects include:
Very common (may affect more than 1 in 10 people)
•  eight loss
W
• ingling, pain and/or numbness of various body parts
T
•  rowsiness, sleepiness or tiredness
D
•  izziness
D
•  iarrhoea
D
•  ausea
N
• tuffy, runny nose and sore throat
S

Rare (may affect up to 1 in 1,000 people)
• xcessive skin sensitivity
E
• 
Impaired sense of smell
•  enal tubular acidosis
R
•  dour
O
S
• welling in the tissues around the eye
•  aynaud’s syndrome. A disorder affecting the blood vessels, in the fingers, toes,
R
ears and causing pain and cold sensitivity
• issue calcification (calcinosis).
T
•  lood bicarbonate decreased
B

Common (may affect up to 1 in 10 people)
•  eight gain
W
•  ecrease or loss of appetite
D
R
•  educed number of red blood cells
•  ifficulty falling or staying asleep
D
P
• roblems with speech or speech disorder, slurred speech
•  lumsiness, or lack of coordination, feeling of unsteadiness when walking
C
•  ecreased ability to complete routine tasks
D
Involuntary trembling or shaking in the arms, hands or legs
• 
•  educed sense of touch or sensation
R
U
•  ncontrollable movement of the eyes
•  istorted sense of taste
D
•  isual disturbance, such as blurred vision, double vision, decreased vision, difficulty
V
focussing
• ensation of spinning, ringing sound in the ears, ear pain
S
S
• hortness of breath
•  ose bleeds
N
• omiting
V
•  onstipation
C
• tomach pain or discomfort
S
• 
Indigestion
•  ry mouth
D
• ingling or numbness of the mouth
T
•  air loss
H
• oint pain or swelling
J
•  uscle spasms, muscle twitching, muscle weakness or muscle pain
M
•  hest pain
C
• ever
F
• oss of strength
L
•  eneral feeling of feeling unwell
G

Not Known (frequency cannot be estimated from the available data)
•  aculopathy is a disease of the macula, the small spot in the retina where vision is
M
keenest. You should call your doctor if you notice a change or decrease in your vision.
• welling of the conjunctiva of the eye.
S
•  ough
C

Uncommon (may affect up to 1 in 100 people)
•  rystals in the urine
C
•  bnormal blood counts, including reduced white blood cell count or platelet
A
count, or increased eosinophils
• 
Increase in liver enzymes
• levated mood
E
•  earing, seeing or feeling things that are not there, severe mental disorder (psychosis)
H
• howing and feeling no emotion, unusual suspiciousness, panic attack
S
• 
Irregular heartbeat or slowness of the heart beat
• wollen glands in the neck, armpit or groin
S
• roblems with verbal communication
P
•  rooling
D
•  estlessness or increased mental and physical activity
R
• lowed thinking, decreased wakefulness or alertness
S
•  nusual feeling or sensation that may precede a migraine or a certain type of seizure
U
• oss of consciousness
L
• ainting
F
• xcessive sleepiness
E
• low or diminished movements
S
D
•  isturbed or poor quality sleep
• 
Impaired or distorted sense of smell
• roblems with handwriting or speech
P
• eeling of movement under the skin
F
• ye problems including dry eyes, light sensitivity, involuntary twitching, tearing
E
and decreased vision
D
•  ecreased or loss of hearing.
•  oarseness of the voice
H
• 
Inflammation of the pancreas
G
•  as
H
•  eartburn
L
• oss of sensitivity to touch
•  leeding gums
B
• ullness or bloating
F
• ainful or burning sensations in the mouth
P
B
•  reath odour
• eakage of urine and/or stools, blood in urine
L
•  rgent desire to urinate
U
• ain in the kidney area and/or bladder caused by kidney stones
P
• kin discolouration
S
L
• ocalized swelling in the skin
• welling of the face.
S
• welling of the joints.
S
•  usculoskeletal stiffness or muscle fatigue
M
• ow potassium levels in the blood
L
• 
Increased appetite
• 
Increased thirst and drinking abnormally large amounts of fluid
• ow blood pressure or decrease in blood pressure that occurs when you stand up
L
•  ot flushing
H
• lu like illness
F
•  old extremities (e.g. hands and face)
C
• eeling drunk
F
• roblems with learning
P
•  isturbances in sexual function (erectile dysfunction, loss of libido)
D
•  allucinations
H
•  ecreased verbal communication
D

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.

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 side
effects not listed in this leaflet.
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.  ow to store Topiramate
H
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 blister and the
carton. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not use this medicine if you notice discolouration of the tablets.

6.  ontents of the pack and other information
C
What Topiramate contains
The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg,
100 mg or 200 mg topiramate per tablet.
The other ingredients are:
Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal anhydrous,
sodium starch glycolate (type A), magnesium stearate.
Film-coat: titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate
80 (E433) (25 mg only), iron oxide yellow (E172) (50 mg, 100 mg only), allura red
aluminium lake (E129), sunset yellow aluminium lake (E110) and indigo carmine
aluminium lake (E132) (200 mg only).
What Topiramate looks like and contents of the pack
Your medicine comes in the form of a film-coated tablet that should look like the
following:
25 mg: White, round, biconvex, film-coated tablet marked with “G” on one side and
“TO” over “25” on the other.
50 mg: Yellow, round, biconvex, film-coated tablet marked with “G” on one side and
“TO” over “50” on the other.
100 mg: Yellow, round, biconvex, film-coated tablet marked with “G” on one side and
“TO” over “100” on the other.
200 mg: Red, round, biconvex, film-coated tablet marked with “G” on one side and
“TO” over “200” on the other.
The medicinal product is available in aluminium foil blisters in pack sizes of 10, 15, 20,
28, 30, 50, 60, 90, 100, 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers:
Generics [UK] Ltd, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in
August 2014

484362

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
(web3)