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GABAPENTIN ACCORD 400MG HARD CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Gabapentin

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

2 (Page 1 of 2)

Date

13/09/16 (Gabapentin (ACC-UK)CAP-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the user

Gabapentin Accord
100 mg hard capsules
Gabapentin Accord
300 mg hard capsules
Gabapentin Accord
400 mg hard 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.
What is in this leaflet:
1. What Gabapentin Accord is and what it is used
for
2. What you need to know before you take
Gabapentin Accord
3. How to take Gabapentin Accord
4. Possible side effects
5. How to store Gabapentin Accord
6. Contents of the pack and other information

1. What Gabapentin Accord is
and what it is used for
Gabapentin Accord belongs to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).

Approved By
Quality Assurance

Antacids for indigestion
If Gabapentin Accord and antacids containing
aluminium and magnesium are taken at the same
time, absorption of Gabapentin Accord from the
stomach may be reduced. It is therefore
recommended that Gabapentin Accord is taken
at the earliest two hours after taking an antacid.
Gabapentin Accord:
• 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.
Gabapentin Accord with food
Gabapentin Accord 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
Gabapentin Accord 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.

The active substance in Gabapentin Accord is
gabapentin.

Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning to become pregnant while taking
Gabapentin Accord. 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.

Gabapentin Accord is used to treat:

Breast-feeding

• 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 Accord for you to help treat your
epilepsy when your current treatment is not fully
controlling your condition. You should take
Gabapentin Accord in addition to your current
treatment unless told otherwise. Gabapentin
Accord 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.

Gabapentin, the active substance of Gabapentin
Accord, is passed on through human milk.
Because the effect on the baby is unknown, it is
not recommended to breast-feed while using
Gabapentin Accord.

2. What you need to know before
you take Gabapentin Accord
Do not take Gabapentin Accord
• 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
Gabapentin Accord:
• 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
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
Accord 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 Gabapentin Accord.
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 Gabapentin Accord
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 Gabapentin Accord. In addition,
combination of Gabapentin Accord with opioids
may cause symptoms like sleepiness and/or
decrease in breathing.

Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Accord 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 Accord
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 what dose is
appropriate for you.
Epilepsy, the recommended dose is
Adults and adolescents:
Take the number of capsules 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 per day. It
is usually given in 3 separate doses, by taking
the capsule(s) each day, usually once in the
morning, once in the afternoon and once in the
evening.
Gabapentin Accord 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 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 are an elderly patient (over 65 years of
age), you should take the normal dose of
Gabapentin Accord 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
Gabapentin Accord is too strong or too weak, talk
to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Accord is for oral use. Always
swallow the capsules with plenty of water.
Continue taking Gabapentin Accord until your
doctor tells you to stop.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Gabapentin

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

2 (Page 2 of 2)

Date

13/09/16 (Gabapentin (ACC-UK)CAP-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you take more Gabapentin Accord 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 Accord
than your doctor prescribed. Take along any
capsules 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 Accord
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 Accord
Do not stop taking Gabapentin Accord 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 Accord 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, such as 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)
• Gabapentin Accord 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 Accord. 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 Accord.
• 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 infection, 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)

Approved By
Quality Assurance

• 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 national
reporting system listed in the Yellow Card
Scheme Website: 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 Gabapentin Accord
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the blister, bottle and carton
after “EXP”. The expiry date refers to the last day
of that month.
Blister: Do not store above 30°C. Store in the
original package, in order to protect from
moisture.
HDPE bottle: Store in the original package, in
order to protect from moisture. Keep the bottle
tightly closed.
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 to protect the environment.

6. Contents of the pack and other
information
What Gabapentin Accord contains
The active substance is gabapentin. Each hard
gelatin capsule contains 100 mg, 300 mg or 400
mg gabapentin.
The other ingredients in Gabapentin Accord are:
Capsule contents: maize starch, copovidone
(E1201), poloxamer 407 and magnesium
stearate (E470b).
Capsule shell: gelatin and sodium laurilsulfate.
The capsules contain the colouring titanium
dioxide (E171), iron oxide red (E172) (400 mg
hard capsules) and iron oxide yellow (E172) (300
mg and 400 mg hard capsules). The printing ink
used on capsules contains shellac (E904),
propylene glycol (E1520), ammonia solution
concentrated and indigo carmine aluminium lake
(E132).
What Gabapentin Accord looks like and
contents of the pack
Gabapentin Accord 100 mg hard capsules are
opaque white/opaque white coloured size "3",
approximately 15.40 to 16.20 mm in length, hard
gelatin capsules imprinted with "G 100" on cap
with blue ink containing white to off white powder.
Gabapentin Accord 300 mg hard capsules are
opaque yellow/opaque yellow coloured size "1",
approximately 18.90 to 19.70 mm in length, hard
gelatin capsules imprinted with "G 300" on cap
with blue ink containing white to off white powder.
Gabapentin Accord 400 mg hard capsules are
opaque orange/opaque orange coloured size "0",
approximately 21.00 to 21.80 mm in length, hard
gelatin capsules imprinted with "G 400" on cap
with blue ink containing white to off white powder.
Capsules are packed in PVC/PVdC- alu blister,
alu-alu blister or HDPE bottle.
Pack sizes:
PVC/PVdC- alu blister and alu-alu blister: 20, 30,
50, 60, 84, 90, 98, 100, 200, 500 and 1000
capsules.
HDPE bottle: 100 and 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
United Kingdom
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
This leaflet was last revised in 09/2016.

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 Gabapentin Accord the
following side effects have been reported:

INP001
10 00000 0 000000

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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