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GABAPENTIN 800 MG TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Mylan 600 mg Tablets
Gabapentin Mylan 800 mg Tablets
(gabapentin)
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.
-  you have any further questions, ask your doctor or
If
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.
-  you get any side effects, talk to your doctor or pharmacist.
If
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Gabapentin Mylan is and what it is used for
2. What you need to know before you take Gabapentin Mylan
3. How to take Gabapentin Mylan
4. Possible side effects
5. How to store Gabapentin Mylan
6. Contents of the pack and other information
1. WHAT Gabapentin MYLAN IS AND WHAT IT IS 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 Mylan is gabapentin.
Epilepsy: Gabapentin Mylan is 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
Mylan in addition to your current treatment unless told
otherwise. Gabapentin Mylan can also be used on its own to
treat adults and children over 12 years of age.
Peripheral neuropathic pain: Gabapentin Mylan is 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 MYLAN
Do not take Gabapentin Mylan
-  you are allergic to gabapentin or any of the other
if
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin
Mylan:
-  you suffer from kidney problems - your doctor may
if
prescribe a different dosing schedule;
-  you are on haemodialysis (to remove waste products
if
because of kidney failure) - tell your doctor if you develop
muscle pain and/or weakness
-  you develop signs such as persistent stomach pain, feeling
if
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 antiepileptics
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 Mylan 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.

3. HOW TO TAKE Gabapentin MYLAN
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

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’.

Your doctor will determine what dose is appropriate for you.

Other medicines and Gabapentin Mylan
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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.

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.

Peripheral Neuropathic Pain:

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 Mylan is taken at least two
hours after taking an antacid.
Gabapentin Mylan:
• s not expected to interact with other antiepileptics or the
i
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 Mylan 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 Mylan 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 Mylan, 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.

Date: 03 Jun 2014
Description Gabapentin 600/800mg 100
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 431982

SAP No. N/A

Superceded Affiliate Item Code 374923
TrackWise PR No. 431982
MA No. 04569/1320 & 1321

Vendor Job No. 230613
Proof No. 1
Client Market UK

No. of colours
Colours

1

If you have the impression that the effect of Gabapentin Mylan
is too strong or too weak, talk to your doctor or pharmacist.

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 Mylan is not recommended for use in children
below 6 years of age.
Method and route of administration
Gabapentin Mylan is 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 Mylan 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.

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Driving and using machines
Gabapentin Mylan 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.

Myriad Pro
272 x 312mm

Body Text Size 9 pt

If you forget to take Gabapentin Mylan
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 Mylan
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
Mylan 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 medicine,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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:
•  evere skin reactions that require immediate attention such
s
as swelling of the lips and face, skin rash and redness, and/
or hair loss (these may be symptoms of a serious allergic
reaction).
•  ersistent stomach pain, feeling sick and being sick as
p
these may be symptoms of acute pancreatitis (an inflamed
pancreas).
•  his medicine may cause a serious or life-threatening allergic
t
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:
•  kin rash
s
• tchy, lumpy, skin rash (hives)
i
•  ever
f
•  wollen glands that do not go away
s
•  welling of your lip and tongue
s
•  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
•  requent infections
f
These symptoms may be the first signs of a serious reaction. A
doctor should examine you to decide if you should continue
taking Gabapentin Mylan.
If you are on haemodialysis, tell your doctor if you develop
muscle pain and/or weakness.
Other side effects include:
Very common side-effects (may affect more than 1 in
10 people):
•  iral infection
V
•  eeling drowsy, dizziness, lack of coordination
F
•  eeling tired, fever
F
Common side-effects (may affect 1 to 10 people):
•  neumonia, respiratory infection, urinary tract infection,
P
inflammation of the ear or other infections
•  ow white blood cell counts
L
•  oss of appetite, increased appetite
L
•  nger towards others, confusion, mood swings, depression,
A
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
•  lurred vision, double vision
B
•  feeling of dizziness or ‘spinning’ (vertigo)
A
•  igh blood pressure, flushing or dilation of blood vessels
H

•  ifficulty breathing, bronchitis, sore throat, cough, dry nose
D
•  omiting (being sick), nausea (feeling sick), problems with
V
teeth, inflamed gums, diarrhoea, stomach pains, indigestion,
constipation, dry mouth or throat, wind (flatulence)
•  acial swelling, bruises, rash, itch, acne
F
•  oint pain, muscle pain, back pain, twitching
J
•  ifficulties with erection
D
•  welling in the legs and arms or swelling that may involve
S
the face, trunk and limbs, difficulty with walking, weakness,
pain, feeling unwell, flu-like symptoms
•  ecrease in white blood cells, increase in weight
D
•  ccidental injury, fracture, minor injury to the surface of the
A
skin (abrasion)
Uncommon side-effects (may affect 1 to 100 people):
•  llergic reaction such as itchy, lumpy, skin rash (hives)
A
•  ecreased movement
D
•  acing heartbeat
R
•  welling that may involve the face, trunk and limbs
S
•  bnormal blood test results suggesting problems with the
A
liver
Since introduction to the market the following side-effects
have been reported (Frequency not known: cannot be
estimated from the available data):
•  ecreased platelets (blood clotting cells)
D
•  allucinations
H
•  roblems with abnormal movements such as writhing,
P
jerking movements and stiffness
•  inging in the ears
R
•  group of side effects that could include swollen lymph
A
nodes (isolated small raised lumps under the skin), fever,
rash and inflammation of liver occurring together
•  nflammation of the liver, yellowing of the skin and eyes
I
•  cute kidney failure, incontinence
A
•  ncreased breast tissue, breast enlargement
I
•  dverse events following the abrupt discontinuation of
A
this medicine (anxiety, difficulty sleeping, feeling sick, pain,
sweating), chest pain
•  lood glucose changes in patients with diabetes
B
•  reakdown of muscle fibres (rhabdomyolysis)
B
•  hange in blood test results (creatine phosphokinase
C
increased).

Gabapentin Mylan 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
Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

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 Mylan
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 after EXP. The expiry date refers to the last day of
that month.
Do not store above 25°C.
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.
6. Contents of the pack and other INFORMATION
What Gabapentin Mylan contains
- The active substance is gabapentin.
- Each tablet contains 600 mg gabapentin.
- Each tablet contains 800 mg gabapentin.
- 
The other ingredients are hydroxypropylcellulose, mannitol,
poloxamer 407, crospovidone (Type A), talc, magnesium
stearate

Date: 03 Jun 2014
Description Gabapentin 600/800mg 100
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 431982

SAP No. N/A

Superceded Affiliate Item Code 374923
TrackWise PR No. 431982
MA No. 04569/1320 & 1321

Vendor Job No. 230613
Proof No. 1
Client Market UK

No. of colours
Colours

1

This leaflet was last revised in May 2014

Time: 12:15
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Main Font

Supplier Code TBC

Barcode Info N/A

Dimensions

Sign-offs

What Gabapentin Mylan look like and contents of the pack
Gabapentin Mylan 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.

Myriad Pro
272 x 312mm

Body Text Size 9 pt

431982

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.

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