TOPIRAMATE MILPHARM 100 MG FILM-COATED TABLETS

Active substance: TOPIRAMATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramate Milpharm 25 mg film-coated tablets
Topiramate Milpharm 50 mg film-coated tablets
Topiramate Milpharm 100 mg film-coated tablets
Topiramate Milpharm 200 mg film-coated tablets
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 Topiramate Milpharm is and what it is used for
2. What you need to know before you take Topiramate Milpharm
3. How to take Topiramate Milpharm
4. Possible side effects
5. How to store Topiramate Milpharm
6. Contents of the pack and other information

P150

P150

Topiramate Milpharm

Topiramate Milpharm

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Topiramate Milpharm. You should avoid drinking alcohol when
taking Topiramate Milpharm.
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 Milpharm. As
with other antiepilepsy medicines, there is a risk of harm to the
unborn child if Topiramate Milpharm is used during pregnancy.
Make sure you are very clear about the risks and the benefits of
using Topiramate Milpharm for epilepsy during pregnancy.
You should not take Topiramate Milpharm 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 Milpharm 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 Topiramate Milpharm. Do not drive or use any tools
or machines without talking to your doctor first.

1. What Topiramate Milpharm is and what it is used for
Topiramate 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 Topiramate
Milpharm
Do not take Topiramate Milpharm

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, breast-feeding and fertility” for further
information).

Topiramate Milpharm film-coated tablets contain lactose.
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 Milpharm
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 Topiramate
Milpharm and slowly increase your dose until the best dose is
found for you.
Topiramate Milpharm tablets are to be swallowed whole. Avoid
chewing the tablets as they may leave a bitter taste.
Topiramate Milpharm can be taken before, during, or after a
meal. Drink plenty of fluids during the day to prevent kidney
stones while taking Topiramate Milpharm.

If you take more Topiramate Milpharm than you should
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Topiramate Milpharm.




Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate
Milpharm 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, breast-feeding and fertility” for further information)

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Topiramate Milpharm
It is important that you do not stop taking your medicine without first
consulting your doctor.

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).
Signs and symptoms of over dosage may include convulsions,
drowsiness, speech disturbances, double vision, impaired
thinking, and abnormal coordination, dulling of consciousness,
low blood pressure, abdominal pain, agitation, dizziness, and
depression.

Overdose can happen if you are taking other medicines together
with Topiramate Milpharm.
If you forget to take Topiramate Milpharm

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 Topiramate Milpharm

You should also talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topiramate Milpharm.
You may lose weight if you use Topiramate Milpharm 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.

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

A small number of people being treated with anti-epileptic
medicines such as Topiramate Milpharm have had thoughts of
harming or killing themselves. If at any time you have these
thoughts, immediately contact your doctor.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Other medicines and Topiramate Milpharm

Tell your doctor, or seek medical attention immediately if you
have the following side effects:

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Topiramate Milpharm and
certain other medicines can affect each other. Sometimes the dose
of some of your other medicines or Topiramate Milpharm 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 Milpharm 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 Milpharm.
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 apply to you, talk to your
doctor or pharmacist before using Topiramate Milpharm.
Topiramate Milpharm with food, drink and alcohol
You can take Topiramate Milpharm with or without food. Drink
plenty of fluids during day to prevent kidney stones while taking

Black

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

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 topiramate 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 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, 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. How to store Topiramate Milpharm
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 carton and bottle or blister after EXP. The expiry date refers to
the last day of that month.
Store below 25°C.
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 Topiramate Milpharm contains


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



The other ingredients are:
Tablet core: cellulose microcrystalline, lactose monohydrate,
starch pregelatinised (maize), sodium starch glycolate (type A),
magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171),
macrogol 400, polysorbate 80, iron oxide yellow (E172) (only in
Topiramate Milpharm 50 mg & /100 mg), iron oxide red (E172)
(only in Topiramate Milpharm 200 mg).

What Topiramate Milpharm looks like and contents of the pack
Film-coated tablet.
Topiramate Milpharm 25 mg film-coated tablets:
White, circular, biconvex film-coated tablets debossed with ‘E’ on
one side and ‘22’ on the other side.
Topiramate Milpharm 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 Milpharm 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 Milpharm 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 Milpharm film-coated tablets are available in polyamide
/ aluminium / PVC blister packs and HDPE tablet container with
polypropylene cap with dessicant (silica gel).
Presentations:
Blister pack:
60 film-coated tablets
Bottle pack:
60 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Cyprus:
Topiramate Aurobindo 25 mg/50 mg/100 mg/
200 mg επικαλυμμένα με λεπτό υμένιο δισκία
France:
TOPIRAMATE AUROBINDO 50 mg/
100 mg/200 mg, comprimé pelliculé
Italy:
Topiramat Aurobindo 25 mg/50 mg/
100 mg/200 mg compresse rivestite con film
Malta:
Topiramate 25 mg/50 mg/100 mg/200 mg
film-coated tablets
Netherlands:
Topiramaat Aurobindo 25 mg/50 mg/
100 mg/200 mg filmomhulde tabletten
Romania:
Topiramat Aurobindo 25 mg/50 mg/100 mg/
200 mg comprimate filmate
Spain:
TOPIRAMATO AUROBINDO 25 mg/50 mg/
100 mg/200 mg comprimidos recubiertos con
película EFG
The United Kingdom: Topiramate Milpharm 25 mg/50 mg/100 mg/
200 mg film-coated tablets
This leaflet was last revised 06/2014.

P150

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

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

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
(web1)