GABAPENTIN 800 MG TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GABAPENTIN 600 mg TABLETS
GABAPENTIN 800 mg TABLETS
(gabapentin)

Read all of this leaflet carefully before you start taking this
medicine because it contains important information
for you.
K
•  eep this leaflet. You may need to read it again.
•  f you have any further questions, ask your doctor
I
or pharmacist.
•  his medicine has been prescribed for you only. Do not
T
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
•  f you get any side effects, talk to your doctor or
I
pharmacist. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet:
What Gabapentin Tablets are and what they are used for
1. 
What you need to know before you take
2. 
Gabapentin Tablets
How to take Gabapentin Tablets
3. 
4. 
Possible side effects
How to store Gabapentin Tablets
5. 
6. 
Contents of the pack and other information
1. WHAT Gabapentin TABLETS ARE AND WHAT
THEY ARE USED FOR
Gabapentin belongs to a group of medicines used to treat
epilepsy and peripheral neuropathic pain (long lasting pain
caused by damage to the nerves).
The active ingredient in Gabapentin Tablets is gabapentin.
Epilepsy: Gabapentin Tablets are used to treat various forms
of epilepsy (seizures that are initially limited to certain parts
of the brain, whether the seizure spreads to other parts of the
brain or not). Your doctor will prescribe this medicine for you
to help treat your epilepsy when your current treatment is not
fully controlling your condition. You should take Gabapentin
Tablets in addition to your current treatment unless told
otherwise. Gabapentin Tablets can also be used on their own
to treat adults and children over 12 years of age.
Peripheral neuropathic pain: Gabapentin Tablets are used
to treat long lasting pain caused by damage to the nerves. A
variety of different diseases can cause peripheral (primarily
occurring in the legs and/or arms) neuropathic pain, such
as diabetes or shingles. Pain sensations may be described as
hot, burning, throbbing, shooting, stabbing, sharp, cramping,
aching, tingling, numbness, pins and needles etc.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Gabapentin TABLETS
Do not take Gabapentin Tablets
• f you are allergic (hypersensitive) to gabapentin or any of the
i
other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin Tablets:
• f you suffer from kidney problems - your doctor may
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prescribe a different dosing schedule;
• f you are on haemodialysis (to remove waste products
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because of kidney failure) - tell your doctor if you develop
muscle pain and/or weakness
• f you develop signs such as persistent stomach pain, feeling
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sick and being sick - contact your doctor immediately as
these may be symptoms of acute pancreatitis (an
inflamed pancreas).

A small number of people being treated with anti-epileptics
such as gabapentin have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Important information about potentially serious reactions
A small number of people taking Gabapentin Tablets get an
allergic reaction or potentially serious skin reaction, which may
develop into more serious problems if they are not treated.
You need to know these symptoms to look out for while you
are taking this medicine.
Read the description of these symptoms in section 4 of
this leaflet under 'Contact your doctor immediately if you
experience any of the following symptoms after taking this
medicine as they can be serious'.
Other medicines and Gabapentin Tablets
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicine containing morphine
If you are taking any medicines containing morphine, please
tell your doctor or pharmacist as morphine may increase the
effect of gabapentin.
Antacids for indigestion
If gabapentin and antacids containing aluminium and
magnesium are taken at the same time, absorption of
gabapentin from the stomach may be reduced. It is therefore
recommended that Gabapentin Tablets are taken at least two
hours after taking an antacid.
Gabapentin Tablets:
•  re not expected to interact with other anti-epileptics or the
a
oral contraceptive pill
•  ay interfere with some laboratory tests - if you require a
m
urine test tell your doctor or hospital what you are taking
Gabapentin Tablets with food and drink
This medicine can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Gabapentin Tablets should not be taken during pregnancy,
unless you are told otherwise by your doctor.
Effective contraception must be used by women of
child-bearing potential.
There have been no studies specifically looking at the use of
gabapentin in pregnant women, but other medications used
to treat seizures have reported an increased risk of harm to
the developing baby (foetus), particularly when more than
one seizure medication is taken at the same time. Therefore,
whenever possible and only under advice of your doctor, you
should try to take only one seizure medication
during pregnancy.
Do not suddenly discontinue taking this medicine as this
may lead to breakthrough seizure, which could have serious
consequences for you and your baby.
Contact your doctor immediately if you become pregnant,
think you might be pregnant or are planning to become
pregnant while taking this medicine.
Gabapentin, the active substance of Gabapentin Tablets, is
excreted in human milk. Because the effect on the baby is
unknown, it is not recommended to breastfeed your baby
while taking this medicine.

Driving and using machines
Gabapentin Tablets may produce dizziness, drowsiness and
tiredness. You should not drive, operate complex machinery
or engage in other potentially hazardous activities until you
know whether this medication affects your ability to perform
these activities.
3. HOW TO TAKE Gabapentin TABLETS
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 determine what dose is appropriate for you.
If you have the impression that the effect of Gabapentin
Tablets is too strong or too weak, talk to your doctor
or pharmacist.
If you are an elderly patient (over 65 years of age), you should
take this medicine normally except if you have problems with
your kidneys.
Peripheral Neuropathic Pain:
Adults
Take the number of tablets as instructed by your doctor. Your
doctor will usually build up your dose gradually. The starting
dose will generally be between 300 mg and 900 mg each
day. Thereafter, the dose may be increased stepwise up to a
maximum of 3600 mg each day and your doctor will tell you
to take this in 3 divided doses, i.e. once in the morning, once in
the afternoon and once in the evening.
Epilepsy:
Adults and adolescents:
Take the number of tablets as instructed. Your doctor will
usually build up your dose gradually. The starting dose
will generally be between 300 mg and 900 mg each day.
Thereafter, the dose may be increased stepwise up to a
maximum of 3600 mg each day and your doctor will tell you
to take this in 3 divided doses, i.e. once in the morning, once in
the afternoon and once in the evening.
Children aged 6 years and above:
The dose to be given to your child will be decided by your
doctor as it is calculated against the child's weight. The
treatment is started with a low initial dose, which is gradually
increased over a period of approximately 3 days. The usual
dose to control epilepsy is 25-35 mg/kg/day. It is usually given
in 3 divided doses, by taking the tablets each day, usually once
in the morning, once in the afternoon and once in the evening.
If you have kidney problems or are receiving haemodialysis
Your doctor may prescribe a different dosing schedule
and/or dose if you have problems with your kidneys or are
undergoing haemodialysis.
Gabapentin Tablets are not recommended for use in children
below 6 years of age.
Method and route of administration
Gabapentin Tablets are for oral use. You should swallow the
tablets whole with plenty of water or they may be halved
depending on dose required.
Continue taking this medicine until your doctor tells you to
stop.
If you take more Gabapentin Tablets than you should
Higher than recommended doses may result in an increase in
undesirable effects including loss of consciousness, dizziness,
double vision, slurred speech, drowsiness and diarrhoea.
Call your doctor or go to the nearest hospital emergency unit
immediately. Take along any tablets that are left, the container
and the label so that the hospital can easily tell what medicine
you have taken.

If you forget to take Gabapentin Tablets
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose. Do not take a double dose
to make up a forgotten dose.
If you stop taking Gabapentin Tablets
Do not stop taking this medicine unless your doctor tells you
to. If your treatment is stopped it should be done gradually
over a minimum of 1 week. If you stop taking Gabapentin
Tablets suddenly or before your doctor tells you, there is an
increased risk of seizures.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin Tablets can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you experience any of the
following symptoms after taking this medicine as they can
be serious:
s
•  evere skin reactions that require immediate attention such
as swelling of the lips and face, skin rash and redness, and/or
hair loss (these may be symptoms of a serious
allergic reaction).
p
•  ersistent stomach pain, feeling sick and being sick as
these may be symptoms of acute pancreatitis (an inflamed
pancreas).
t
•  his medicine may cause a serious or life-threatening allergic
reaction that may affect your skin or other parts of your body
such as your liver or blood cells. You may or may not have
rash when you get this type of reaction. It may cause you to
be hospitalized or to stop this medicine.
Call your doctor right away if you have any of the following
symptoms:
• skin rash
i
• tchy, lumpy, skin rash (hives)
• fever
s
•  wollen glands that do not go away
s
•  welling of your lip and tongue
•  ellowing of your skin or of the whites of the eyes
y
•  nusual bruising or bleeding
u
•  evere fatigue or weakness
s
•  nexpected muscle pain
u
• frequent infections
These symptoms may be the first signs of a serious reaction. A
doctor should examine you to decide if you should continue
taking Gabapentin Tablets.
If you are on haemodialysis, tell your doctor if you develop
muscle pain and/or weakness.

D
•  ifficulty breathing, bronchitis, sore throat, cough, dry nose
•  omiting (being sick), nausea (feeling sick), problems with
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teeth, inflamed gums, diarrhoea, stomach pains, indigestion,
constipation, dry mouth or throat, wind (flatulence)
•  acial swelling, bruises, rash, itch, acne
F
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•  oint pain, muscle pain, back pain, twitching
D
•  ifficulties with erection
S
•  welling in the legs and arms or swelling that may involve
the face, trunk and limbs, difficulty with walking, weakness,
pain, feeling unwell, flu-like symptoms
D
•  ecrease in white blood cells, increase in weight
A
•  ccidental injury, fracture, minor injury to the surface of the
skin (abrasion)
Uncommon side-effects (may affect 1 to 100 people):
A
•  llergic reaction such as itchy, lumpy, skin rash (hives)
• Decreased movement
• Racing heartbeat
S
•  welling that may involve the face, trunk and limbs
A
•  bnormal blood test results suggesting problems with
the liver
Since introduction to the market the following side-effects
have been reported:
D
•  ecreased platelets (blood clotting cells)
• Hallucinations
•  roblems with abnormal movements such as writhing,
P
jerking movements and stiffness
•  inging in the ears
R
A
•  group of side effects that could include swollen lymph
nodes (isolated small raised lumps under the skin), fever, rash
and inflammation of liver occurring together
I
•  nflammation of the liver, yellowing of the skin and eyes
•  evere skin reactions that require immediate medical
S
attention, swelling of the lips and face, skin rash and redness,
hair loss
•  cute kidney failure, incontinence
A
I
•  ncreased breast tissue, breast enlargement
A
•  dverse events following the abrupt discontinuation of
this medicine (anxiety, difficulty sleeping, feeling sick, pain,
sweating), chest pain
•  lood glucose changes in patients with diabetes.
B

What Gabapentin Tablets look like and contents of the pack
Gabapentin 600 mg Tablets: White to off-white, oval, biconvex,
uncoated, beveled edged tablets debossed with 'MYLAN' on
one side and 'G' to the left of the score and '24' to the right of
the score on the other side.
The tablet can be divided into equal halves.
Gabapentin 800 mg Tablets: White to off-white, oval, biconvex,
uncoated, beveled edged tablets debossed with 'MYLAN' on
one side and 'G' to the left of the score and '25' to the right of
the score on the other side.
The tablet can be divided into equal halves.
Packs of 20, 30, 45, 50, 90 and 100 tablets are packed in white
opaque HDPE bottle with white opaque polypropylene (PP)
cap containing desiccant (silica gel).
Packs of 20, 30, 45, 50, 60, 90, 100, 200, 250 and 500 are packed
in OPA/Al/PVC blister.
Packs of 90 x 1 and 500 x 1 tablets are supplied as OPA/Al/PVC
perforated unit dose blister.
Not all pack sizes and types may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland

Additionally in clinical studies in children, aggressive
behaviour and jerky movements were reported commonly.
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 Gabapentin TABLETS

Other side effects include:

Keep out of the reach and sight of children.

Very common side-effects (may affect more than 1 in
10 people):
• Viral infection
F
•  eeling drowsy, dizziness, lack of coordination
F
•  eeling tired, fever

Do not use this medicine after the expiry date which is stated
on the carton after 'EXP'. The expiry date refers to the last day
of that month.

Common side-effects (may affect 1 to 10 people):
P
•  neumonia, respiratory infection, urinary tract infection,
inflammation of the ear or other infections
•  ow white blood cell counts
L
L
•  oss of appetite, increased appetite
A
•  nger towards others, confusion, mood swings, depression,
anxiety, nervousness, difficulty with thinking
•  eizures, jerky movements, difficulty with speaking, loss of
S
memory, tremor, difficulty sleeping, headache, sensitive skin,
decreased sensation, difficulty with coordination, unusual
eye movement, increased, decreased or absent reflexes
B
•  lurred vision, double vision
•  feeling of dizziness or 'spinning' (vertigo)
A
H
•  igh blood pressure, flushing or dilation of blood vessels

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.

Do not store above 25°C.

6. Contents of the pack and other INFORMATION
What Gabapentin Tablets contain
T
•  he active substance is gabapentin.
E
•  ach tablet contains 600 mg gabapentin.
E
•  ach tablet contains 800 mg gabapentin.
•  he other ingredients are hydroxypropylcellulose,
T
mannitol, poloxamer 407, crospovidone (Type A), talc,
magnesium stearate

This leaflet was last revised in October 2013

10005044

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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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