GABAPENTIN 300 MG CAPSULES

Active substance: GABAPENTIN

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gabapentin #300
mg caps

016695 000725

gabapentin #300
mg caps

PEEL HERE BUT DO NOT REMOVE

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Each 300 mg hard
capsule contains:
300 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.
PL 4569/0666 POM
10003793 LL0443AD
Mylan, Potters Bar,
Herts, EN6 1TL

TOP LABEL

PACKAGE LEAFLET: INFORMATION FOR THE USER

300
mg

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

Gabapentin
300 mg
Hard Capsules

(gabapentin)

Leave Blank

100 Hard
Capsules

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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 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.
Peripheral neuropathic pain: Gabapentin is
used to treat long lasting pain caused by
damage to the nerves. A variety of different

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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.
• 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.
• Decrease in white blood cells, increase in
weight.
• Accidental injury, fracture, abrasion.

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
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.

Driving and using machines
Gabapentin 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.

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.
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.

Important information about some of the
ingredients of Gabapentin
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.
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• Acute kidney failure.
• 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.
Additionally in clinical studies in children,
aggressive behaviour and jerky movements
were reported commonly.

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Gabapentin capsules are available in blister
packs of 10, 20, 30, 50, 90, 100, 200, 250 or
1000 capsules or in containers of 50, 100 or
250 capsules. Not all pack sizes 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.
Generics [UK] Limited, Potters bar, Herts, EN6
1TL, United Kingdom.
Date of revision: 03/2012

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5. HOW TO STORE GABAPENTIN
Keep out of the reach and sight of children.
Do not use Gabapentin 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.
Store the capsules below 25 °C. Keep the
bottle tightly closed. Keep the blister strip in
the outer carton.
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.

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Read all of this leaflet carefully before you
start taking this medicine.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.

BASE LABEL

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If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

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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. BEFORE YOU TAKE GABAPENTIN
Do not take Gabapentin
• if you are allergic (hypersensitive) to
gabapentin or any of the other ingredients
of Gabapentin.
Take special care with Gabapentin
• if you suffer from kidney problems

Taking Gabapentin with food and drink
Gabapentin can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
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.

• Low white blood cell counts.
• Anorexia, 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, sensitive
skin, decreased sensation, difficulty with
co-ordination, unusual eye movement,
increased, decreased or absent reflexes.
• Blurred vision, double vision.
• Vertigo.
• High blood pressure, flushing or dilation of
blood vessels.
• Difficulty breathing, bronchitis, sore throat,

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.
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.

3. HOW TO TAKE GABAPENTIN
Always take Gabapentin exactly as your
doctor has told you. You should 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 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.

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6. FURTHER INFORMATION
What Gabapentin contains:
• The active substance is gabapentin. Each
capsule, hard contains either 100 mg,
300 mg or 400 mg gabapentin.
• The other ingredients in Gabapentin
capsules are: lactose, maize starch, talc,
gelatin and titanium dioxide (E171). The
300 mg and 400 mg also contain iron
oxides (E172).
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.

• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What GABAPENTIN is and what it is used for
2. Before you take GABAPENTIN
3. How to take GABAPENTIN
4. Possible side effects
5. How to store GABAPENTIN
6. Further information
1. WHAT GABAPENTIN IS AND WHAT IT IS
USED FOR
Gabapentin belongs to a group of medicines
used to treat epilepsy and peripheral
neuropathic pain.

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

Rare side-effects: (affects 1 to 10 users in
10,000):
• Decreased platelets (blood clotting cells).
• Allergic reaction such as hives.
• Hallucinations.
• Problems with abnormal movements such
as writhing, jerking movements and stiffness.
• Ringing in the ears.
• Racing heartbeat.
• Inflammation of the pancreas.
• Inflammation of the liver, yellowing of the
skin and eyes.
• Severe skin reactions that require
immediate medical attention, swelling of
the lips and face, skin rash and redness,
hair loss.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin can cause side
effects, although not everybody gets them.
Very common side-effects: (affects more
than 1 user in 10):
• Viral infection.
• Feeling drowsy, dizziness, lack of
co-ordination.
• Feeling tired, fever.
Common side-effects: (affects 1 to 10 users
in 100):
• Pneumonia, respiratory infection, urinary
tract infection, infection, inflammation of
the ear.

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
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, the active substance of 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
using Gabapentin.

Always swallow the capsules whole with
plenty of water.
Continue taking Gabapentin until your
doctor tells you to stop.
Peripheral Neuropathic Pain:
Take the number of capsules 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 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.
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 your child’s weight. The treatment is

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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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