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NEURONTIN 100MG CAPSULES

Active substance(s): GABAPENTIN

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Package leaflet:
Information for the user

®

Neurontin 100mg
Capsules
(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 symptoms
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.
The name of your medicine is NEURONTIN
100MG CAPSULES but will be referred to as
Neurontin throughout of this leaflet.
Please note that this leaflet also contains
information about other strengths such as
Neurontin 300mg, 400mg Capsules and
Neurontin 600mg, 800mg Film-coated tablets.

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

1. What Neurontin is and what
it is used for
Neurontin 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 Neurontin is
gabapentin.
Neurontin 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 Neurontin for you to
help treat your epilepsy when your
current treatment is not fully controlling
your condition. You should take Neurontin
in addition to your current treatment
unless told otherwise. Neurontin 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 Neurontin
Do not take Neurontin
if you are allergic (hypersensitive) 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 Neurontin:
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)
Cases of abuse and dependence have been
reported for gabapentin from the postmarketing 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 Neurontin
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 Neurontin.
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 Neurontin
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

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

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

Neurontin:
is 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.

Neurontin with food
Neurontin 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
Neurontin 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.

Because the effect on the baby is unknown, it
is not recommended to breast-feed while
using Neurontin.

Fertility
There is no effect on fertility in animal studies.

Driving and using machines
Neurontin 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.

Neurontin contains lactose
Neurontin hard capsules contain lactose (a
type of sugar). 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 Neurontin
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:

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.

Take the number of capsules or tablets as
instructed. Your doctor will usually build up
your dose gradually. The starting dose will
generally be between 300mg and 900mg
each day. Thereafter, the dose may be
increased as instructed by your doctor, up to
a maximum of 3600mg 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.

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

Children aged 6 years and above:

Breast-feeding
Gabapentin, the active substance of
Neurontin, is passed on through human milk.

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 25-35mg per kg of body
weight per day. It is usually given in 3
separate doses, by taking the capsule(s) or
tablet(s) each day, usually once in the
morning, once in the afternoon and once in
the evening.

Neurontin is not recommended for use in
children below 6 years of age.

Peripheral Neuropathic Pain, the
recommended dose is
Adults:
Take the number of capsules or tablets as
instructed by your doctor. Your doctor will
usually build up your dose gradually. The
starting dose will generally be between
300mg and 900mg each day. Thereafter, the
dose may be increased as instructed by your
doctor up to a maximum of 3600mg 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.

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.
If you are an elderly patient (over 65 years
of age), you should take the normal dose of
Neurontin 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
Neurontin is too strong or too weak, talk to
your doctor or pharmacist as soon as
possible.
Method of administration
Neurontin is for oral use. Always swallow the
capsules or tablets with plenty of water.
The tablet can be divided into equal halves.
Continue taking Neurontin until your doctor
tells you to stop.

If you take more Neurontin 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
Neurontin than your doctor prescribed.

Take along any capsules or tablets 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 Neurontin
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 Neurontin
Do not stop taking Neurontin 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
Neurontin 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.

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

4. Possible side effects
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)
Neurontin may cause a serious or lifethreatening 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
Neurontin. 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

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)
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 (may affect up to 1 in 100
people):
Allergic reactions such as hives
Decreased movement
Racing heart beat
Swelling that may involve the face, trunk
and limbs
Abnormal blood test results suggesting
problems with the liver
Mental impairment
Fall
Increase in blood glucose levels (most
often observed in patients with diabetes)
Rare (may affect up to 1 in 1,000 people):
Loss of consciousness
Decrease in blood glucose levels (most
often observed in patients with diabetes)
After marketing Neurontin 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 fibers
(rhabdomyolysis)
Change in blood test results (creatine
phosphokinase increased)
Problems with sexual functioning
including inability to achieve a sexual
climax, delayed ejaculation
Low blood sodium level
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help
provide more information on the safety of this
medicine.

5. How to store Neurontin
Do not store above 30°C.Store in the original
Packing.
Do not use after the expiry date which is
stated on the carton after ‘Exp’. The expiry
date refers to the last day of that month.
Keep out of the sight and reach of children.
Remember if your doctor tells you to stop
taking this medicine, return any unused
capsules to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells
you to.
If your capsules become discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
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 Neurontin contains
The active ingredient in Neurontin is
gabapentin.
Each capsule contains 100mg gabapentin.
The other ingredients in Neurontin are:
Capsule contents: Lactose monohydrate,
corn starch and talc.
Capsule shell: gelatin, purified water and
sodium lauryl sulphate.
The 100mg capsules contain the colouring
titanium dioxide (E171).

The printing ink used on all capsules contains
shellac, titanium dioxide (E171) and
indigocarmine (E132).

What Neurontin looks like and
contents of the pack
Neurontin 100mg capsules are white,hard
gelatin capsules imprinted with ‘Neurontin
100mg’ and PD logo.
Neurontin capsules are available as blister
packs of 100 capsules.
Manufactured by: Pfizer Manufacturing
Deutschland GmbH, D-79090 Freiburg,
Germany.
Procured from within the EU and
repackaged by the Product Licence
Holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, HA4 0NU, UK.
Neurontin 100mg Capsules
PL No: 18799/2594
Leaflet date: 05.08.2015

POM

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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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