GABAPENTIN 100MG CAPSULES

Active substance: GABAPENTIN

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Assessed against UK PIL dated June 2011
246 LEAFLET Neurontin 201203016

PACKAGE LEAFLET: INFORMATION FOR USER

NEURONTIN 100 CAPSULES
GABAPENTIN 100mg CAPSULES
(gabapentin)
Your medicine is known by either of the above name but will be
referred to as Neurontin throughout the following leaflet.

By shafia at 5:54 pm, May 20, 2012

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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:


Information for other strength of Neurontin also may be present in
this leaflet.

is not expected to interact with other antiepileptic drugs or the
oral contraceptive pill.



Read all of this leaflet carefully, before you start taking this
medicine.

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



Keep this leaflet. You may need to read it again.

Neurontin can be taken with or without food.



If you have any 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 get serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist.
In this leaflet:
1. What Neurontin is 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 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).

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.

The active ingredient in Neurontin is gabapentin.

Driving and using machines

Neurontin is used to treat:

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.





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:

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 an 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 problemswith
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



if you suffer from kidney problems your doctor may prescribe a
different dosing schedule

Neurontin is for oral use. Always swallow the capsules or tablets
whole with plenty of water.



if you are on haemodialysis (to remove waste products because
of kidney failure), tell your doctor if you develop muscle pain
and/or weakness

Epilepsy, the usual dose is:
Adults and adolescents:

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.

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.

Important information about potentially serious reactions

Children aged 6 years and above:

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.

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.



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)

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.

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 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.

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

If you take more Neurontin than you should



Joint pain, muscle pain, back pain, twitching

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.



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

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.

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)

4. POSSIBLE SIDE EFFECTS



Hallucinations

Like all medicines, Neurontin can cause side effects, although not
everybody gets them:



Problems with abnormal movements such as writhing, jerking
movements and stiffness

Contact your doctor immediately if you experience any of the
following symptoms after taking this medicine as they can be
serious:



Ringing in the ears



servere 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)

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

persistent stomach pain, feeling sick and being sick as these
may be symptoms of acute pancreatitis (an inflamed pancreas)



Acute kidney failure, incontinence

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:



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.



skin rash



hives



fever



swollen glands that do not go away

5. HOW TO STORE NEURONTIN



swelling of your lip and tongue



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



yellowing of your skin or of the whites of the eyes





unusual bruising or bleeding

Neurontin Capsules should be stored below 30°C in the original
packaging.



severe fatigue or weakness





Do not use after the expiry date printed on the carton label or
blister strip.

unexpected muscle pain





frequent infections

If your doctor tells you to stop taking the capsules, please take
them back to the pharmacist for safe disposal. Only keep the
capsules if your doctor tells you to.



If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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

6. FURTHER INFORMATION

 Feeling tired, fever
Common side-effects (which may affect more than 1 person in
100)

What Neurontin contains



Pneumonia, respiratory infections, urinary tract infection,
inflammation of the ear or other infections



Low white blood cell counts

It also contains: lactose, maize starch, talc, gelatin and titanium
dioxide (E171).
What Neurontin looks like and contents of the pack



Anorexia, increased appetite



Neurontin Capsules are white, hard gelatin capsule marked with
‘Neurontin 100mg’ and the PD logo.

Anger towards others, confusion, mood changes, depression,
anxiety, nervousness, difficulty with thinking



Neurontin Capsules are available as blister packs of 50, 90 or 100
capsules.

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

Product Licence holder



Blurred vision, double vision



Vertigo



High blood pressure, flushing or dilation of blood vessels



Difficulty breathing, bronchitis, sore throat, cough, dry nose

Each Neurontin Capsule contains 100mg of the active ingredient,
gabapentin

Procured from within the EU and repackaged by the Product
Licence holder: ChemilinesLtd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
Manufacturer
This product is manufactured Pfizer Manufacturing Deutschland
GmbH, Mooswaldallee, 1-9, D-79090 Freiburg, Germany.
POM

PL No: 08747/0246

Leaflet revision date: 16 March 2012
Neurontin is a registered trade mark of Warner-Lambert Company
LLC, USA.
246 LEAFLET Neurontin 20120316

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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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