GABAPENTIN 100 MG CAPSULES

Active substance: GABAPENTIN

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Gabapentin

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Pharma code 487

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.
• 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
(long lasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Hard Capsules
is gabapentin.
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 (long lasting pain
caused by damage to the nerves): A variety of
different diseases can cause peripheral neuropathic
pain (primarily occurring in the legs and/or arms),
such as diabetes or shingles. These pain sensations
may be described as hot, burning, throbbing,
shooting, stabbing, sharp, cramping, aching,
tingling, numbness, pins and needles.

• 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.
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. Therefore,
whenever possible you should try to take only one
seizure medication during pregnancy and only
under the advice of your doctor.
• 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
Capsules, is excreted in human milk. Because the
effect on the baby is unknown, it is not
recommended to breast-feed while using
Gabapentin.
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.
Important information about some of the
ingredients of Gabapentin
The 300 mg capsules contain sunset yellow (E110)
which may cause rarely allergic reactions.

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.
DO NOT take Gabapentin:
• if you are allergic (hypersensitive) to gabapentin Your doctor will determine what dose is
or any of the other ingredients of Gabapentin
appropriate for you. If you have the impression that
(see section 6, Further information).
the effect of Gabapentin is too strong or too weak,
talk to your doctor or pharmacist.
Take special care with Gabapentin
If you are an elderly patient (over 65 years of age),
• If you suffer from kidney problems
you should take the normal dose of Gabapentin,
• If you are receiving haemodialysis, tell your
unless you have problems with your kidneys.
doctor if you develop muscle pain and/or
Your doctor may prescribe a different dosing
weakness
schedule and/or dose, if you have problems with
• if you develop signs such as persistent stomach
your kidneys.
pain, feeling sick and being sick contact your
doctor immediately.
Continue taking Gabapentin until your doctor tells
you to stop.
A small number of people being treated with
The usual dose for treating epilepsy:
anti-epileptics such as gabapentin have had
thoughts of harming or killing themselves. If at any Gabapentin is not recommended for use in children
time you have these thoughts, immediately contact below 6 years of age.
your doctor.
Epilepsy
Adults and adolescents:
Important information about potentially serious
Take the number of capsules as instructed. Your
reactions
A small number of people taking Gabapentin get an doctor will usually build up your dose gradually.
allergic reaction or potentially serious skin reaction, • The starting dose will generally be between
300 mg and 900 mg each day.
which may develop into more serious problems if
• Thereafter, the dose may be increased stepwise
they are not treated. You need to know these
up to a maximum of 3600 mg, each day and your
symptoms to look out for while you are taking
doctor will tell you to take this in 3 separate
Gabapentin.
doses, i.e. once in the morning, once in the
Read the description of these symptoms in section
afternoon and once in the evening.
4 of this leaflet under ‘Contact your doctor
immediately if you experience any of the following Children aged 6 years and above:
symptoms after taking this medicine as they can be The dose to be given to your child will be decided
serious’.
by your doctor as it is calculated against your
child’s weight. The treatment is started with a low
Taking other medicines
initial dose which is gradually increased over a
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines, period of approximately 3 days.
• The usual dose to control epilepsy is 25-35 mg
including medicines obtained without a
per kg per day. It is usually given in 3 separate
prescription.
doses, by taking the capsule(s) each day, usually
• If you are taking any medicines containing
once in the morning, once in the afternoon and
morphine, please tell your doctor or pharmacist
once in the evening.
as morphine may increase the effect of
Gabapentin.
The usual dose for treating Peripheral Neuropathic
Pain:
Gabapentin
Take the number of capsules as instructed by your
• is not expected to interact with other antidoctor. Your doctor will usually build up your dose
epileptic drugs or the oral contraceptive pill.
gradually.

2

BEFORE YOU TAKE GABAPENTIN

Top of page cut-off to middle of registration mark: 44 mm.

GABAPENTIN 100 mg, 300 mg
AND 400 mg HARD CAPSULES

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• The starting dose will generally be between 300
mg and 900 mg each day. Thereafter, the dose
may be increased as instructed by your doctor up
to a maximum of 3600 mg each day and your
doctor will tell you to take this in 3 separate
doses, i.e. once in the morning, once in the
afternoon and once in the evening.
Method and route of administration
Gabapentin is for oral use. Always swallow the
capsules whole with plenty of water.
If you take more Gabapentin 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 if you take more
Gabapentin than your doctor prescribed. Take along
any capsules that you have not yet taken, together
with the container and the label so that the hospital
can easily tell what medicine you have taken.
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.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Gabapentin can cause side
effects, although not everybody gets them.
Contact your doctor immediately if you
• experience severe skin reactions such as swelling
of the lips and face, skin rash and redness and/or
hair loss.
• are receiving haemodialysis. Tell your doctor if
you develop muscle pain and/or weakness.
Gabapentin 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 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
• Unexpected muscle pain
• 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.
Other side effects include:
Very common side-effects (which may affect more
than 1 person in 10):
• viral infection
• feeling drowsy, dizziness, lack of coordination
• feeling tired, fever.
Common side-effects (which may affect more than
1 person in 100):
• pneumonia, respiratory infection, urinary tract
infection, infection, inflammation of the ear
• 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 coordination, 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,
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
• difficulties with erection
• swelling in the legs and arms, difficulty with
walking, weakness, pain, feeling unwell, flu-like
symptoms
• decrease in white blood cells, increase in weight
• accidental injury, fracture, abrasion.
Additionally in clinical studies in children,
aggressive behaviour and jerky movements were
reported commonly.
Uncommon side-effects (which may affect more
than 1 person in 1000):
• allergic reaction such as hives
• decreased movement
• racing heartbeat
• swelling that may involve the face, trunk and limbs
• abnormal blood test results suggesting problems
with the liver.
Since introduction to the market the following
side-effects have also been reported. The frequency
of these effects is not known:
• decreased platelets (blood clotting cells)
• hallucinations
• problems with abnormal movements such as
writhing, jerking movements and stiffness
• ringing in the ears
• 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
• acute kidney failure, incontinence
• increased breast tissue, breast enlargement
• adverse events following the abrupt
discontinuation of Gabapentin (anxiety, difficulty
sleeping, feeling sick, pain, sweating), chest pain
• blood glucose fluctuations in patients with
diabetes.
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.

5

HOW TO STORE GABAPENTIN

Keep out of the reach and sight of children.
Do not use Gabapentin after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original
container. Keep blister 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.

6

FURTHER INFORMATION

What Gabapentin capsules contain:
• The active substance is gabapentin. Each hard
capsule contains either 100 mg, 300 mg or
400 mg gabapentin.
• The other ingredients are:
Capsules: talc, pregelatinised (maize) starch.
Capsule cap/body: gelatin, black iron oxide (E172)
[100 mg & 400 mg], titanium dioxide (E171),
erythrosin (E127) [300 mg], sunset yellow (E110)
[300 mg], red iron oxide (E172) [400 mg], yellow
iron oxide (E172) [400 mg].
Printing ink: shellac, black iron oxide (E172),
propylene glycol.
What Gabapentin Capsules look like and contents
of the pack:
• Gabapentin 100 mg Capsules are hard gelatin
capsules with a grey cap and body, filled with a
white to off-white powder with small
agglomerates. The capsule cap and body are
each imprinted with the numbers ’93’ and ’38’.
• Gabapentin 300 mg Capsules are hard gelatin
capsules with an orange cap and body, filled with
a white to off-white powder with small
agglomerates. The capsule cap and body are
each imprinted with the numbers ’93‘ and ’39‘.
• Gabapentin 400 mg Capsules are hard gelatin
capsules with a brown cap and body, filled with a
white to off-white powder with small
agglomerates. The capsule cap and body are
each imprinted with the numbers ’93‘ and ’40‘.
• Gabapentin Capsules are available in pack sizes
of: 20, 28, 30, 50, 90, 100, 500 (10 x 50) or 1000
(20 x 50). The 300 and 400 mg capsules are also
available in packs of 200 (2x100).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG, England.
This leaflet was last revised: October 2012
PL 00289/0590-0592

63616-Y
160 x 323

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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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