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GABAPENTIN 100MG CAPSULES

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Gabapentin 100 mg and 300 mg Capsules

SZ00000LT000

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 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 (see section 4).

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

1

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

What Gabapentin Capsules are
and what they are used for

Gabapentin Capsules belongs to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).

Pregnancy
Gabapentin Capsules 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.

The active ingredient in Gabapentin Capsules is
gabapentin.

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, 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.

Gabapentin Capsules 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
Gabapentin Capsules for you to help treat your
epilepsy when your current treatment is not
fully controlling your condition. You should take
Gabapentin Capsules in addition to your
current treatment unless told otherwise.
Gabapentin Capsules can also be used on its
own to treat adults and children over 12 years
of age.

Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning to become pregnant while taking
Gabapentin Capsules. Do not suddenly
discontinue taking this medicine as this may lead
to breakthrough seizure, which could have
serious consequences for you and your baby.

• 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. Pain sensations may be described as
hot, burning, throbbing, shooting, stabbing,
sharp, cramping, aching, tingling, numbness,
pins and needles etc.

2

Breast feeding
Gabapentin, the active substance of Gabapentin
Capsules, is passed on through human milk.
Because the effect on the baby is unknown, it is
not recommended to breast-feed while using
Gabapentin Capsules.

What you need to know before
you take Gabapentin Capsules

Driving and using machines
Gabapentin Capsules may produce dizziness,
drowsiness and tiredness.
You should not drive, operate complex machinery
or take part in other potentially hazardous
activities until you know whether this medication
affects your ability to perform these activities.

Do not take Gabapentin Capsules
• if you are allergic to gabapentin or any of the
other ingredients of this medicine (listed in
section 6).

Gabapentin Capsules contains 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin Capsules
• if you suffer from kidney problems your doctor
may prescribe a different dosing schedule.
• if you are on haemodialysis (to remove waste
products because of kidney failure), tell your
doctor if you develop muscle pain and/or
weakness.
• if you develop signs such as persistent
stomach pain, feeling sick and being sick
contact your doctor immediately as these may
be symptoms of acute pancreatitis (an
inflamed pancreas).

3

How to take Gabapentin Capsules

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.

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.

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

If you are an elderly patient (over 65 years of
age), you should take the normal dose of
Gabapentin Capsules unless you have problems
with your kidneys. Your doctor may prescribe a
different dosing schedule and/or dose if you have
problems with your kidneys.

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

Continue taking Gabapentin Capsules until your
doctor tells you to stop.

Method and route of administration
Gabapentin Capsules is for oral use. Always
swallow the capsules whole with plenty of water.

Epilepsy, the usual dose is:
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 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.

Other medicines and Gabapentin Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.

Medicines containing morphine
If you are taking any medicines containing
morphine, please tell your doctor or pharmacist
as morphine may increase the effect of
Gabapentin Capsules.

Antacids for indigestion
If Gabapentin Capsules and antacids containing
aluminium and magnesium are taken at the same
time, absorption of Gabapentin Capsules from
the stomach may be reduced. It is therefore
recommended that Gabapentin Capsules is taken
at the earliest two hours after taking an antacid.

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 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
per kg of body weight per day.
It is usually given in 3 separate doses, by taking
the capsule(s) each day, usually once in the
morning, once in the afternoon and once in the
evening.

Gabapentin Capsules
• are not expected to interact with other
antiepileptic drugs or the oral contraceptive pill.
• may interfere with some laboratory tests, if you
require a urine test tell your doctor or hospital
what you are taking.

Gabapentin Capsules are not recommended
for use in children below 6 years of age.

Gabapentin Capsules with food and drink
Gabapentin Capsules can be taken with or
without food.

Continued on the next page >>

Artwork Proof Box
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Peripheral Neuropathic Pain, the usual dose
is:
Adults
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 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.

• 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 (may affect up to 1 in
100 people):
• 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.

If you have kidney problems or are receiving
heamodialysis
Your doctor may prescribe a different dosing
schedule and/or dose if you have problems with
your kidneys or are undergoing haemodialysis.

Since introduction to the market the following
side-effects have been reported:
• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as
writhing, jerking movements and stiffness
• Ringing in the ears
• 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
• Yellowing of the skin and eyes (jaundice),
inflammation of the liver
• 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.
• Breakdown of muscle fibres (rhabdomyolysis)
• Change in blood test results (creatine
phosphokinase increased)

If you take more Gabapentin Capsules than
you should
Higher than recommended doses may result in
an increase in side 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 Capsules than your doctor prescribed.
Take along any capsules that you have not 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 Capsules
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 Capsules
Do not stop taking Gabapentin Capsules 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 Capsules suddenly or before your
doctor tells you, there is an increased risk of
seizures.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via Yellow
Card Scheme: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

5

Possible side effects

How to store Gabapentin
Capsules

Keep this medicine out of the sight and reach of
children.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Do not use this medicine after the expiry date
which is stated on the label after ‘EXP’. The
expiry date refers to the last day of that month.
Do not store above 25ºC.

Contact your doctor immediately if you
experience any of the following symptoms
after taking this medicine as they can be
serious:
• severe skin reactions that require immediate
attention, swelling of the lips and face, skin
rash and redness and/or hair loss (these may
be symptoms of a serious allergic reaction)
• persistent stomach pain, feeling sick and being
sick as these may be symptoms of acute
pancreatitis (an inflamed pancreas)
• Gabapentin Capsules 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 Capsules.
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.

In-use shelf-life:
HDPE bottle: 12 weeks.

HDPE bottle: Keep the container tightly closed.
PVC/Alu blister: Store in the original package.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Gabapentin Capsules contain
• The active substance is: gabapentin.

Each capsule, hard contains either 100 mg or
300 mg of gabapentin.

• The other ingredients in the capsules are:
capsule content: Lactose anhydrous, maize
starch and talc.

capsule shell: consists of gelatin, titanium
dioxide (E171) (100 mg and 300 mg capsules)
and iron oxide yellow (E172) (300 mg
capsules).

These symptoms may be the first signs of a
serious reaction. A doctor should examine you
to decide if you should continue taking
Gabapentin Capsules.

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):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever.

What Gabapentin Capsules look like and
content of the pack
Gabapentin 100mg Capsules are gelatin
capsules (size 3), hard with a white, opaque body
and cap.
Gabapentin 300mg Capsules are hard gelatin
capsules (size 1), hard with a yellow, opaque
body and cap.
PVC/Alu blister: 10, 20, 30, 50, 60, 90, 100 and
200 (2x100), 250 capsules, hard.
hospital pack: 500 (5x100), 1,000 (10x100)
capsules, hard.
unit dose: 20x1, 60x1, 100x1 capsule, hard.
HDPE bottle: 50, 100, 200, 250 capsules, hard.

Common side effects (may affect up to 1 in 10
people):
• Pneumonia, respiratory infections, urinary tract
infection, inflammation of the ear or other
infections
• Low white blood cell counts
• Anorexia, increased appetite
• Anger towards others, confusion, mood
changes, depression, anxiety, nervousness,
difficulty with thinking
• Convulsions, jerky movements, difficulty with
speaking, loss of memory, tremor, difficulty
sleeping, headache, sensitive skin, decreased
sensation (numbness), 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 (impotence)
• Swelling in the legs and arms, difficulty with
walking, weakness, pain, feeling unwell, flu-like
symptoms

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing authorization holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guerricke-Allee 1, 39179 Barleben,
Germany or
Salutas Pharma GmbH,
Dieselstrasse 5, D-70839 Gerlingen,
Germany or
LEK Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubjana,
Slovenia.
This leaflet was last revised in 03/2014.

SZ00000LT000

Artwork Proof Box
Ref: V056: Update texts in line with reference product - nat. phase
Proof no.
009.1

Date prepared:
12/03/2014

Colours:
Black
Dimensions: 148 x 500 mm

Font size:
8pt
Fonts:
Helvetica

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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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