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NEURONTIN 100MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Package leaflet:
Information for the user

Neurontin is used to treat


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 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.

The name of your medicine is Neurontin
100mg Capsules but will be referred to as
Neurontin throughout this leaflet.
Please note that this leaflet also contains
information about other strengths such as
Neurontin 300mg, 400mg Capsules and
Neurontin 600mg and 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.



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.

3. How to take Neurontin

Pregnancy, breast-feeding and
fertility

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

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.

Your doctor will determine what dose is
appropriate for you.

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

Epilepsy, the recommended dose is
Adults and adolescents
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.
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 25-35mg 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.

4. Possible side effects

Common: (may affect up to 1 in 10
people)

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
 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
















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 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
 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
 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
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original
packaging
Do not take the capsules after the expiry date
which is stated on the carton and blister label
after ‘Exp’. The expiry date refers to the last
day of that month.

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 the 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. Contents of the pack and
other 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 is white, hard gelatin capsule
imprinted with ‘Neurontin 100mg’ and PD
logo.
Neurontin are available as blister packs of
100 capsules.
Manufactured by: Pfizer Manufacturing
Deutschalnd 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, Middlesex, HA4 0NU, UK.
®

Neurontin 100mg Capsules;
PL 18799/2594
POM
Leaflet date: 23.02.2017

Neurontin is a registered trademark of
Pfizer group of companies.

Blind or partially
sighted?
Is this leaflet hard to
see or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

Expand Transcript

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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