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GABAPENTIN ACCORD 600 MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN

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Package leaflet: Information for the user

Gabapentin Accord 600 mg
Film-coated tablets
Gabapentin Accord 800 mg
Film-coated tablets
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 or nurse.
• 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 or nurse.This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1. What Gabapentin Film-coated tablets are and
what they are used for
2. What you need to know before you take
Gabapentin Film-coated tablets
3. How to take Gabapentin Film-coated tablets
4. Possible side effects
5. How to store Gabapentin Film-coated tablets
6. Content of the pack and other information

1. What Gabapentin Film-coated
tablets are and what they are
used for
Gabapentin Film-coated tablets belong 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 Gabapentin Film-coated
tablets is gabapentin.
Gabapentin Film-coated tablets are 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
Gabapentin Film-coated tablets for you to help
treat your epilepsy when your current treatment
is not fully controlling your condition. You should
take Gabapentin Film-coated tablets in addition
to your current treatment unless told otherwise.
Gabapentin Film-coated tablets 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 Gabapentin
Film-coated tablets
Do not take Gabapentin Film-coated tablets
if you are allergic (hypersensitive) to gabapentin
or any of the other ingredients of this medicine
(listed in section 6).
Warning and precautions
• 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 Gabapentin 600
mg /800 mg film-coated tablets 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
Gabapentin 600 mg /800 mg film-coated tablets.
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 Gabapentin
Film-coated tablets.
Antacids for indigestion
If Gabapentin Film-coated tablets and antacids
containing aluminium and magnesium are taken
at the same time, absorption of Gabapentin
Film-coated tablets from the stomach may be
reduced. It is therefore recommended that
Gabapentin Film-coated tablets is taken at the
earliest two hours after taking an antacid.
Gabapentin Film-coated tablets:
• 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 Gabapentin Film-coated tablets with
food and drink
Gabapentin Film-coated tablets can be taken with
or without food.
Pregnancy
Gabapentin Film-coated tablets 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
Gabapentin Film-coated tablets. 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 Gabapentin
Film-coated tablets, is passed on through human
milk. Because the effect on the baby is unknown,
it is not recommended to breast-feed while using
Gabapentin Film-coated tablets.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Gabapentin Film-coated tablets 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.

3. How to take Gabapentin
Film-coated tablets
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
appropriate for you.

what

dose

is

If you have the impression that the effect of
Gabapentin Film-coated tablets 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
Gabapentin Film-coated tablets 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 Gabapentin Film-coated tablets
until your doctor tells you to stop.
Method and route of administration
Gabapentin Film-coated tablets is for oral use.
Always swallow the tablets whole with plenty of
water.
Epilepsy, the usual dose is:
Adults and adolescents:
Take the number of 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 2535 mg/kg/day.
It is usually given in 3 separate doses, by taking
the tablet(s) each day, usually once in the
morning, once in the afternoon and once in the
evening.
Gabapentin Film-coated tablets is not
recommended for use in children below 6
years of age.
Peripheral Neuropathic Pain, the usual dose is:
Adults:
Take the number of 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.
If you take more Gabapentin Film-coated
tablets 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
Gabapentin Film-coated tablets than your doctor
prescribed.

Take along any 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 Gabapentin Film-coated
tablets
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 Gabapentin Film-coated
tablets
Do not stop taking Gabapentin Film-coated
tablets 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 Gabapentin Film-coated tablets
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
product, 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)
• persistant stomach pain, feeling sick and being
sick as these may be symptoms of acute
pancreatitis (an inflamed pancreas)
• Gabapentin 600 mg /800 mg film-coated tablets
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 Gabapentin 600 mg /800
mg film-coated tablets. 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 Gabapentin
600 mg /800 mg film-coated tablets.
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):
• dizziness
• lack of coordination
• viral infection
• feeling drowsy
• feeling tired
• fever
Common side-effects (which may affect more
than 1 person in 100):
• 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
• 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
• blurred vision, double vision
• vertigo
• high blood pressure
• flushing or dilation of blood vessels
• difficulty breathing, bronchitis, cough
• sore throat
• 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.

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:
• acute kidney failure, incontinence
• inflammation of the liver, yellowing of the skin
and eyes (jaundice),
• hallucinations
• problems with abnormal movements such as
writhing, jerking movements and stiffness
• adverse
events
following
the
abrupt
discontinuation of gabapentin (anxiety, difficulty
sleeping, feeling sick, pain, sweating), chest pain
• increased breast tissue, breast enlargement
• decreased platelets (blood clotting cells)
• 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
• blood glucose fluctuations in patients with
diabetes
If you get any side effects , talk to your doctor
or pharmacist or nurse. This includes any side
effects not listed in this leaflet.

5. How to store Gabapentin
Film-coated tablets
• Keep this medicine out of the sight and reach of
children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date
which is stated on the carton after ‘EXP’. The
expiry date refers to the last day of that month.
• 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.

6. Content of the pack and other
information
What Gabapentin Film-coated tablets contain:
The active ingredient is Gabapentin. Each
film-coated tablet has either 600 mg or 800 mg
Gabapentin.
The other ingredients are:
Core tablet:
Maize starch, Copovidone, Poloxamer 407,
Hydroxypropyl cellulose (E463), Magnesium
Stearate(E572)
Coating:
Hydroxypropyl cellulose (E463), talc
Printing ink composition
Propylene glycol, Shellac glaze, Iron oxide black
(E172), Ammonium hydroxide
What Gabapentin Film-coated tablets look like
and contents of the pack:
600 mg Tablets are available as Approximately
17.25 mm X 10.15 mm white to off-white, Oval
shaped, film coated tablets imprinted G1 on one
side with black ink and plain on other side.
800 mg Tablets are available as Approximately
19.5 mm x 10 mm white to off-white, Capsule
shaped, film coated tablets imprinted G2 on one
side with black ink and plain on other side.
Gabapentin Film-coated tablets are packed in
PVC/PVdC - aluminum blister packs of 20, 30, 50,
60, 90, 100, 200 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex
HA1 4HF, UK
Manufacturer
Accord Healthcare Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex
HA1 4HF, UK
The leaflet was last revised in 02/2014.

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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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