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NEURONTIN 400 MG HARD CAPSULES

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Neurontin® 100 mg Hard Capsules
Neurontin® 300 mg Hard Capsules
Neurontin® 400 mg Hard Capsules
Neurontin® 600 mg film-coated tablets
Neurontin® 800 mg film-coated tablets

1924/1925/1926
1927/1928
20.01.12[9]

(gabapentin)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
This medicine is available using any of the above names but will be
referred to as Neurontin throughout this leaflet.
In this leaflet:
1. What is Neurontin and what it is used for
2. Before you take Neurontin
3. How to take Neurontin
4. Possible side effects
5. How to store Neurontin
6. Further information
1. WHAT IS NEURONTIN 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 ingredient 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. BEFORE YOU TAKE NEURONTIN
Do not take Neurontin

if you are allergic (hypersensitive) to gabapentin or any of the other
ingredients of Neurontin
Take special care with 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)
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.
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 these 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’
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken 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 Neurontin.
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.
Taking Neurontin with food and drink
Neurontin can be taken with or without food.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Neurontin
Neurontin hard capsules contain lactose (a type of sugar). If you have been
told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE NEURONTIN
Always take Neurontin exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
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.
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. Continue taking Neurontin until your
doctor tells you to stop.
Method and route of administration
Neurontin is for oral use. Always swallow the capsules or tablets whole with
plenty of water.
Epilepsy, the usual 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 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) 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 usual 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.
If you have kidneys 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 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, Neurontin 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 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
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 side-effects (which may affect more than 1 person in
10):

Viral infection

Feeling drowsy, dizziness, lack of coordination

Feeling tired, fever
Common side-effects (which may affect less than 1 person in 10)

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 side effects (which may affect more than 1 person in a
1000):

Allergic reactions 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
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.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NEURONTIN
Keep out of the reach and sight of children.
Do not use Neurontin after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
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.
If your capsules or tablets become discoloured or shown any other signs of
deterioration please contact your doctor or pharmacist before taking your
medicine.
6. FURTHER INFORMATION
What Neurontin contains
Neurontin Hard Capsules
The active substance is gabapentin. Each hard capsule, contains either
100 mg, 300 mg or 400 mg gabapentin.
The other ingredients in Neurontin capsules are:
lactose monohydrate, maize starch, talc, gelatin, sodium lauryl sulphate,
shellac, indigo carmine aluminium lake (E132) and titanium dioxide (E171).
Neurontin 300mg Capsules and Neurontin 400mg Capsules also contain
iron oxide (E172).
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 tablets are:
poloxamer 407 (ethylene oxide and propylene oxide), copolyvidone, maize
starch, magnesium stearate, Opadry white YS-1-18111
(hydroxypropylcellulose, talc), candelilla wax.
What Neurontin looks like and contents of the pack
Hard Capsule
100mg two-piece, white opaque hard capsule, imprinted with 'Neurontin
100 mg' and 'PD' in blue ink and containing a white to off-white
powder
300mg two-piece, yellow opaque hard capsule, imprinted with 'Neurontin
300 mg' and 'PD' in blue ink and containing a white to off-white
powder
400mg two-piece, orange opaque hard capsule, imprinted with
'Neurontin 400 mg' and 'PD' in blue ink and containing a white to
off-white powder
Neurontin 100mg capsules come in blister packs of 100 capsules.
Neurontin 300mg and 400mg capsules come in blister packs of 50 and 100
capsules.
Film-coated tablet:
600mg white, elliptical film-coated tablets with a bisecting score on both
sides and debossed with “NT” and “16” on one side
800mg white, elliptical film-coated tablets with a bisecting score on both
sides and debossed with “NT” and “26” on one side
Neurontin tablets come in blister packs of 100 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Neurontin is manufactured by Goedecke GmbH, Mooswaldallee 1, D-79090
Freiburg, Germany. Procured from within the EU by Product Licence holder
Tenolol Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.

POM

Neurontin 100 mg Hard Capsules PL No: 30900/1924
Neurontin 300 mg Hard Capsules PL No: 30900/1925
Neurontin 400 mg Hard Capsules PL No: 30900/1926
Neurontin 600mg film-coated tablets PL No: 30900/1927
Neurontin 800mg film-coated tablets PL No: 30900/1928

Leaflet revision and issue date (Ref) 20.01.12[9]
Neurontin is a registered trademark of Warner-Lambert Company LLC.

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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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