GABAPENTIN 400 MG CAPSULES

Active substance: GABAPENTIN

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gabapentin #400
mg caps

REVERSE

400 Gabapentin 400 mg
mg Hard Capsules
100 Hard Capsules
Each 400 mg hard capsule contains:
400 mg of gabapentin. This product contains:
lactose monohydrate. Read the package leaflet
before use. For oral use. Take as directed by the
doctor. Keep out of the reach and sight of
children. Do not store above 25°C. Keep the
container tightly closed.

LEAVE BLANK

PL 4569/0667 POM
10004358 00000000
Mylan, Potters Bar,
Herts, EN6 1TL

100 or 250 capsules*.
* Not all pack sizes 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.
Generics [UK] Limited, Potters bar, Herts, EN6
1TL, United Kingdom.

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(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.
• 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

• Racing heartbeat.
• Hair loss.
• Adverse events following the abrupt
discontinuation of gabapentin (anxiety,
difficulty sleeping, feeling sick, pain,
sweating), chest pain.
• Blood glucose fluctuations in patients with
diabetes, abnormal blood test results
suggesting problems with the liver.

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Epilepsy
Gabapentin 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 Gabapentin for you
to help treat your epilepsy when your current
treatment is not fully controlling your
condition. You should take Gabapentin in

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GABAPENTIN
Do not take Gabapentin
• if you are allergic (hypersensitive) to
gabapentin or any of the other ingredients
of Gabapentin.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Gabapentin:
• if you suffer from kidney problems
• if you develop signs such as persistent
stomach pain, feeling sick and being sick
contact your doctor immediately.
A small number of people being treated with
anti-epileptics such as Gabapentin have had

Additional side effects in children and
adolescents:
Additionally in clinical studies in children,
aggressive behaviour and jerky movements
were reported commonly.
If any of the side effects gets serious, or if you

before taking any medicine.
Gabapentin 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 foetus, particularly when more
than one seizure medication is taken at the
same time. Therefore, whenever possible and
only under the advice of your doctor, you
should try to take only one seizure
medication during pregnancy.
Do not suddenly discontinue taking this

These symptoms may be the first signs of a
serious reaction. A doctor should examine
you to decide if you should continue taking
Gabapentin.
Other side effects include:

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Very common (may affect more than 1 in 10
people):
• Viral infection.
• Feeling drowsy, dizziness, lack of
coordination.
• Feeling tired, fever.

pale stools, yellowing of the skin or whites
of the eyes.
• An inflamed pancreas which may cause
abdominal pain and being sick.
• Kidney problems leading to passing less
urine than usual, and feeling sick, tired or
confused.
These side effects are serious. You may need
medical attention.
Tell your doctor if you suffer from a sore
throat, fever, severe chills and mouth ulcers.
This can be due to a lack of white blood cells.

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Gabapentin may cause a serious or
life-threatening allergic reaction that may

If you forget to take Gabapentin
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
for a forgotten dose.

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If you stop taking Gabapentin
Do not stop taking Gabapentin 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 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.

Other medicines and Gabapentin
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
If you are taking any medicines containing
morphine, please tell your doctor or
pharmacist as morphine may increase the
effect of Gabapentin.
Gabapentin is not expected to interact with
other antiepileptic drugs or the oral
contraceptive pill.
Gabapentin may interfere with some

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The 100 mg capsules contain the colouring
E171 (Titanium dioxide); the 300 mg capsules
contain the colourings: E171 (Titanium
dioxide) and E172 (Iron oxide yellow): and the
400 mg capsules contain the colourings: E171
(Titanium dioxide), E172 (Iron oxide yellow)
and E172 (Iron oxide red).
What Gabapentin looks like and contents of
the pack
The 100 mg capsules are white, the 300 mg
capsules are yellow and the 400 mg capsules
are orange.
Gabapentin capsules are available in blister
packs of 10, 20, 30, 50, 90, 100, 200, 250, 500
or 1000 capsules or in containers of 50, 200,

Important information about potentially
serious reactions
A small number of people taking Gabapentin
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 Gabapentin.

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Read the description of these symptoms in
Section 4 of this leaflet under 'Contact your
doctor immediately if you experience any of

laboratory tests, if you require a urine test tell
your doctor or hospital that you are taking
Gabapentin.
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 is taken at
the earliest two hours after taking an antacid.
Gabapentin with food and drink
Gabapentin can be taken with or without
food (see section 3 'How to take Gabapentin').

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Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice

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 Gabapentin.
Gabapentin, is excreted in human milk.
Because the effect on the nursing infant is
unknown, it is not recommended to
breast-feed your baby while taking
Gabapentin.

5. HOW TO STORE GABAPENTIN

Store the capsules below 25°C.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: Store in the original package.
Do not throw away any medicines via
wastewater or household waste. Ask your

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3. HOW TO TAKE GABAPENTIN

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Epilepsy:
Adults and adolescents:
Take the number of capsules 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.

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• Swelling 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.
• Increase in weight.
• Accidental injury, fracture, abrasion.
Rare (may affect up to 1 in 100 people):
• Decreased platelets (blood clotting cells)
which may lead to unusual bruising or
bleeding of the skin.
• Sensing things that are not real
(hallucinations).
• Problems with abnormal movements such as
writhing, jerking movements and stiffness.
• Ringing in the ears.

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Common (may affect up to 1 in 10 people):
• Pneumonia, respiratory infection, urinary
tract infection, infection, inflammation of
the ear.
• Loss of appetite or an increased appetite.
• Anger towards others, confusion,
fluctuation in mood, depression, anxiety,
nervousness, difficulty with thinking.
• Convulsions, jerky movements, difficulty
with speaking, loss of memory, tremor,
difficulty sleeping, headache, numbness,
tingling or pins and needles, difficulty with
coordination, unusual eye movement,
increased, decreased or absent reflexes.
• Blurred vision, double vision.
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Driving and using machines
Gabapentin may produce dizziness,
drowsiness and tiredness. You should not

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 Gabapentin.
Call your doctor right away if you have any
of the following symptoms:
• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling of your lip and tongue
• yellowing of your skin or of the whites of
the eyes
• unusual bruising or bleeding
• severe fatigue or weakness

Your doctor will determine what dose is
appropriate for you.
If you have the impression that the effect of
Gabapentin 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 Gabapentin normally
except if you have problems with your
kidneys.
Your doctor may prescribe a different dosing
schedule and/or dose if you have problems
with your kidneys.
Always swallow the capsules whole with
plenty of water.
Continue taking Gabapentin until your
doctor tells you to stop.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking
Gabapentin and tell your doctor
immediately or go to your nearest hospital
emergency department:
Rare (may affect up to 1 in 1,000 people):
• Allergic reactions such as skin rashes or
swelling of the face, lips, tongue and/or
throat which may cause difficulty breathing
or swallowing.
• Severe skin reactions which can cause
blisters, sores and ulceration.
• Liver problems which may cause dark urine,

decided by your doctor as it is calculated
against your 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 capsule(s) each day, usually once in the
morning, once in the afternoon and once in
the evening.
Gabapentin is not recommended for use in
children below 6 years of age.

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Keep out of the sight and reach of children.
Do not use this medicine after the expiry
date, which is shown on the label, carton or
bottle after 'EXP'. The expiry date refers to the
last day of that month.

thoughts of harming or killing themselves.
If at any time you have these thoughts,
immediately contact your doctor.

07

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notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

06

Gabapentin contains lactose
The capsules contain 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.

Children aged 6 years and above:
The dose to be given to your child will be

Date of revision: February 2013

Peripheral neuropathic pain
Gabapentin 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.

drive, operate complex machinery or engage
in other potentially hazardous activities until
you know whether this medication affects
your ability to perform these activities.

Always take Gabapentin exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

PL 4569/0667 POM
10004358 00000000
Mylan, Potters Bar,
Herts, EN6 1TL

addition to your current treatment unless
told otherwise. Gabapentin can also be used
on its own to treat adults and children over
12 years of age.

the following symptoms after taking this
medicine as they can be serious'.

• unexpected muscle pain
• frequent infections.

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• Vertigo.
• High blood pressure, flushing or dilation of
blood vessels.
• Difficulty breathing, bronchitis, sore throat,
cough, dry nose.
• Vomiting (being sick), nausea (feeling sick),
problems with teeth, inflamed gums,
diarrhoea, stomach pain, indigestion,
constipation, dry mouth or throat,
flatulence.
• Facial swelling, bruises, rash, itch, acne.
• Joint pain, muscle pain, back pain,
twitching.
• Incontinence.
• Difficulties with erection.
• Failure to reach orgasm (female).

Each 400 mg hard capsule contains:
400 mg of gabapentin. This product contains:
lactose monohydrate. Read the package leaflet
before use. For oral use. Take as directed by the
doctor. Keep out of the reach and sight of
children. Do not store above 25°C. Keep the
container tightly closed.

04

Gabapentin belongs to a group of medicines
used to treat epilepsy and peripheral
neuropathic pain.

What Gabapentin contains
The active substance is gabapentin.
Each hard capsule contains either 100 mg,
300 mg or 400 mg gabapentin.
The other ingredients in Gabapentin capsules
are:
Capsule contents: Lactose anhydrous, maize
starch and talc.
Capsule shell: gelatin.

100 Hard Capsules

What is in this leaflet:
1. What Gabapentin is and what it is used for.
2. What you need to know before you take
Gabapentin.
3. How to take Gabapentin.
4. Possible side effects.
5. How to store Gabapentin.
6. Contents of the pack and other
information.

1. WHAT GABAPENTIN IS AND WHAT IT IS
USED FOR

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

400 Gabapentin 400 mg
mg Hard Capsules

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.

GABAPENTIN 100 mg HARD CAPSULES
GABAPENTIN 300 mg HARD CAPSULES
GABAPENTIN 400 mg HARD CAPSULES

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pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

02

PACKAGE LEAFLET: INFORMATION FOR THE USER

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PEEL HERE BUT DO NOT REMOVE

PEEL HERE BUT DO NOT REMOVE

FRONT FACE

GLUE AREA

47 mm

gabapentin #400
mg caps

32

60 mm

BASE LABEL

TOP LABEL

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.

Peripheral Neuropathic Pain:
Take the number of capsules as instructed by
your doctor. Your doctor will usually build up

If you take more Gabapentin than you
should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take along any
capsules that are left, the container and the
label so that the hospital can easily tell what
medicine you have taken.

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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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