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NEURONTIN 300MG HARD CAPSULES

Active substance(s): GABAPENTIN

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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).

UNITED KINGDOM

Warnings and Precautions

®

Neurontin

100 mg, 300 mg & 400 mg hard capsules
600 mg & 800 mg film-coated tablets
Gabapentin
1. What Neurontin is and what it is used for
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.

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

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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.

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 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 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.

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.

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 Neurontin

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:
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) or tablet(s) each day,
usually once in the morning, once in the afternoon and once in the
evening.

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.
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

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.

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

Fertility
There is no effect on fertility in animal studies.

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 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.

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.

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.

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.

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.

Your doctor will determine what dose is appropriate for you.

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 300 mg and 900 mg each day. Thereafter,
the dose may be increased as instructed by your doctor, up to a

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Package leaflet:
Information for the user

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.
You will find more about NEURONTIN on
the back of this leaflet

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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
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)

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• 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 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 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

• 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

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

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)

• 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
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

Additionally in clinical studies in children, aggressive behaviour and
jerky movements were reported commonly.

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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the relevant national reporting
system detailed below:
UK
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on
the safety of this medicine.

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.

What Neurontin contains

The 800 mg tablets are white, elliptical film-coated tablets with a
bisecting score on both sides and debossed with “NT” and “26” on
one side.

Neurontin hard capsules
The active substance is gabapentin. Each hard gelatin capsule
contains either 100 mg, 300 mg or 400 mg gabapentin.

Supplied in PVC/PE/PVDC/aluminium foil blister packs or PVC/
PVDC/aluminium foil blister packs of 20, 30, 45, 50, 60, 84, 90,
100, 200, 500 tablets.

The other ingredients in Neurontin capsules are:
Capsule contents: lactose monohydrate, maize starch and talc.
Capsule shell: gelatin, purified water and sodium lauryl sulphate.

Not all pack sizes may be marketed.

The 100 mg capsules contain the colouring E171 (titanium dioxide),
the 300 mg capsules contain the colourings E171 (titanium dioxide)
and E172 (yellow iron oxide) and the 400 mg capsules contain the
colourings E171 (titanium dioxide) and E172 (red and yellow iron
oxide). The printing ink used on all capsules contains shellac, E171
(titanium dioxide) and E132 (indigo carmine).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, UK
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
D-79090 Freiburg
Germany

Neurontin film-coated tablets
The active substance is gabapentin. Each film-coated tablet
contains either 600 mg or 800 mg gabapentin.
The other ingredients in Neurontin film-coated tablets are:
Poloxamer 407 (ethylene oxide and propylene oxide), copovidone,
maize starch and magnesium stearate.
Film-coating: Opadry white YS-1-18111 (hydroxypropylcellulose, talc)
Polishing agent: candelilla wax

Company contact address: Medical Information Department,
Pfizer Limited, Walton Oaks, Dorking Road, Tadworth,
Surrey KT20 7NS. Telephone: 01304 616 161.
Neurontin hard capsules and film-coated tablets are authorised
in the following Member States of the EEA under the tradename
Neurontin:

What Neurontin looks like and contents of the pack

Do not use this medicine after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Do not store Neurontin hard capsules above 30°C.
Do not store Neurontin film coated tablets above 25°C.

Supplied in PVC/PVDC/aluminium foil blister packs of 20, 30, 50,
60, 84, 90, 98, 100, 200, 500, 1000 capsules.

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

Film-coated tablet
The 600 mg tablets are white, elliptical film-coated tablets with a
bisecting score on both sides and debossed with “NT” and “16” on
one side.

6. Contents of the pack and other information

Capsule, hard
The 100 mg capsules are white hard capsules marked with
“Neurontin 100mg” and “PD”.
The 300 mg capsules are yellow hard capsules marked with
“Neurontin 300mg” and “PD”.
The 400 mg capsules are orange hard capsules marked with
“Neurontin 400mg” and “PD”.

5. How to store Neurontin

Not all pack sizes may be marketed.

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Method of administration

Austria, Belgium/Luxembourg, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway,
Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United
Kingdom
This leaflet was last revised in 05/2015.
Ref: NN 24_3 UK

19.05.15 14:56

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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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