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GABAPENTIN 300MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / 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

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).

The active substance in Gabapentin Capsules is
gabapentin.

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.

• 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

What you need to know before
you take Gabapentin Capsules

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

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).
• if you have nervous system disorders, respiratory
disorders, or you are more than 65 years old,
your doctor may prescribe you a different
dosing regimen.
Cases of abuse and dependence have been
reported for gabapentin from the post-marketing
experience. Talk to your doctor if you have a
history of abuse or dependence.
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
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 the 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’.
Muscle weakness, tenderness or pain and
particularly, if at the same time, you feel unwell or
have a high temperature it may be caused by an
abnormal muscle breakdown which can be
life-threatening and lead to kidney problems. You
may also experience discoloration of your urine, and
a change in blood test results (notably blood
creatine phosphokinase increased). If you
experience any of these signs or symptoms,
please contact your doctor immediately.

Other medicines and Gabapentin Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular, tell your doctor (or pharmacist) if you
are taking or have been recently taking any
medicines for convulsions, sleeping disorders,
depression, anxiety, or any other neurological or
psychiatric problems.

Medicines containing opioids such as morphine
If you are taking any medicines containing opioids
(such as morphine), please tell your doctor or
pharmacist as morphine may increase the effect
of Gabapentin Capsules.
In addition, combination of Gabapentin Capsules
with opioids may cause symptoms like sleepiness
and/or decrease in breathing.
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.

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

Pregnancy, breast-feeding and fertility
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.

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.

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.
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.
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.
Fertility
There is no effect on fertility in animal studies.

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.

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.

3

How to take Gabapentin Capsules

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Your doctor will determine what dose is
appropriate for you.

Epilepsy, the recommended 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.

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 recommended
for use in children below 6 years of age.

Peripheral Neuropathic Pain, the
recommended 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.

Continued on the next page >>

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.

• 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.

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.

Uncommon (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
• Mental impairment
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in
patients with diabetes)
• agitation (a state of chronic restlessness and
unintentional and purposeless motions)

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.

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

Rare side-effects (may affect up to 1 in 1,000
people):
• Low blood sugar (most often observed in
patients with diabetes)
• Loss of consciousness
• Trouble breathing, shallow breaths (respiratory
depression)

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

If you take more Gabapentin Capsules than
you should
If you or someone else accidentally takes too many
capsules, or if you think a child has swallowed any,
contact your doctor or go to your nearest hospital
casualty department immediately. As Gabapentin
capsules may make you drowsy, it is recommended
that you ask someone else to drive you to the doctor
or hospital, or that you call an ambulance.
Symptoms of an overdose are dizziness, double
vision, slurred speech, loss of consciousness,
drowsiness and mild diarrhoea. 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.

Not known: frequency cannot be estimated
from the available data:
• anaphylaxis (serious, potentially life threatening
allergic reaction including difficulty breathing,
swelling of the lips, throat, and tongue, and
hypotension requiring emergency treatment)

After marketing Gabapentin Capsules 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
• Breakdown of muscle fibres (rhabdomyolysis)
• Change in blood test results (creatine
phosphokinase increased)
• Problems with sexual functioning including
inability to achieve a sexual climax, delayed
ejaculation
• Hyponatraemia (low blood sodium level)

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

4

Possible side effects

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.

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:
• 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)
• breathing problems, which if severe you may
need emergency and intensive care to
continue breathing normally
• 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.

5

How to store Gabapentin
Capsules

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 label after ‘EXP’. The
expiry date refers to the last day of that month.
Do not store above 25ºC.
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.

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.

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

If you are on haemodialysis, tell your doctor if you
develop muscle pain and/or weakness.

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

Other side effects include:

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

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

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.

Common (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)

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.
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 08/2017.

SZ00000LT000

Artwork Proof Box
Ref: V062: Safety update of SPC and PL
Proof no.
013.0

Date prepared:
18/08/2017

Colours:
Black
Dimensions: 148 x 500 mm

Font size:
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Fonts:
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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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