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GABAPENTIN BROWN & BURK 800MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN

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150 mm

150 mm

your kidneys or are undergoing haemodialysis.

Package leaflet: Information for the user

If you are an elderly patient (over 65 years of
age), you should take the normal dose of
Gabapentin Brown & Burk 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.

GABAPENTIN BROWN & BURK 600mg film-coated tablets
GABAPENTIN BROWN & BURK 800mg film-coated tablets
Gabapentin

What is in this leaflet
1. What Gabapentin Brown & Burk is and
what it is used for
2. What you need to know before you take
Gabapentin Brown & Burk
3. How to take Gabapentin Brown & Burk
4. Possible side effects
5. How to store Gabapentin Brown & Burk
6. Contents of the pack and other
information
1. What Gabapentin Brown & Burk is and
what it is used for
Gabapentin Brown & Burk 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 Gabapentin Brown &
Burk film-coated tablets is gabapentin.

2. What you need to know before you take
Gabapentin Brown & Burk
Do not take Gabapentin Brown & Burk:
• if you are allergic to Gabapentin or any
of the other ingredients of Gabapentin
Brown & Burk film-coated tablets (listed in
section 6).

Cases of abuse and dependence have been
reported for Gabapentin Brown & Burk 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 Brown &
Burk 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
Brown & Burk 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
Brown & Burk.
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.

Method of administration
Gabapentin Brown & Burk is for oral use.
Always swallow the tablets with plenty of water.
The tablet can be divided into equal halves.

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 Brown & Burk.

Continue taking Gabapentin Brown & Burk until
your doctor tells you to stop.

Antacids for indigestion
If Gabapentin Brown & Burk and antacids
containing aluminium and magnesium are taken
at the same time, absorption of Gabapentin
Brown & Burk from the stomach may be reduced.
It is therefore recommended that Gabapentin
Brown & Burk is taken at the earliest two hours
after taking an antacid.
Gabapentin Brown & Burk:
• 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 Brown & Burk with food and drink
Gabapentin Brown & Burk can be taken with or
without food.
Pregnancy and breast-feeding
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.

If you stop taking Gabapentin Brown & Burk
Do not stop taking Gabapentin Brown & Burk
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 Brown & Burk suddenly or before
your doctor tells you, there is an increased risk
of seizures.

Pregnancy
Gabapentin Brown & Burk 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.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

There have been no studies specifically looking
at the use of Gabapentin Brown & Burk 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.

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);
• persistent stomach pain, feeling sick and
being sick as these may be symptoms of
acute pancreatitis (an inflamed pancreas).
• Gabapentin Brown & Burk 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 Brown & Burk.

Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning to become pregnant while taking
Gabapentin Brown & Burk. 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
Brown & Burk, is passed on through human milk.
Because the effect on the baby is unknown, it is
not recommended to breast-feed while using
Gabapentin Brown & Burk.
Driving and using machines
Gabapentin Brown & Burk 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.

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

3. How to take Gabapentin Brown & Burk
Always take this medicine 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.
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.

If you take more Gabapentin Brown & Burk
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 Brown & Burk 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 Brown &
Burk
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.

These symptoms may be the first signs of a
serious reaction. A doctor should examine you
to decide if you should continue taking
Gabapentin Brown & Burk.
If you are on haemodialysis, tell your doctor if
you develop muscle pain and/or weakness.

270 mm

Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin Brown & Burk
• 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).

If you have the impression that the effect of
Gabapentin Brown & Burk is too strong or too
weak, talk to your doctor or pharmacist as soon
as possible.

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.

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

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
c h a n g e s , d e p r e s s i o n , a n x i e t y,
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.

Gabapentin Brown & Burk 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 300mg and 900mg 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




Joint pain, muscle pain, back pain, twitching.
Difficulties with erection (impotence).
Swelling in the legs and arms, difficulty with
walking, weakness, pain, feeling unwell, flulike 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 (may affect up to 1 in
100 people):
• 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.
After marketing Gabapentin Brown & Burk 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 Brown & Burk
(anxiety, difficulty sleeping, feeling sick, pain,
sweating), chest pain
• Blood glucose fluctuations in patients
with diabetes.
• Breakdown of muscle fibers
(rhabdomyolysis)
• Change in blood test results (creatine
phosphokinase increased)
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 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 Brown & Burk
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 pack 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. Contents of the pack and other
information
What Gabapentin Brown & Burk film-coated
tablets contains
The active substance is Gabapentin.
Each film-coated tablet contains either 600 mg or
800 mg of gabapentin.
The other ingredients are:
Tablet core:
Hydroxypropylcellulose
Magnesium stearate
Film-coating:
Hydroxypropylcellulose
Talc
What Gabapentin Brown & Burk film-coated
tablets looks like and contents of the pack
The 600mg tablets are white to off white, oval,
biconvex film-coated tablets, engraved with ‘600’
on one side and plain on the other. Tablet
dimensions: 18.00 (length), 9.20 (width).
The 800mg tablets are white to off white, oval,
biconvex, film-coated tablets, engraved with ‘800’
on one side and plain on the other. Tablet
dimensions: 19.20 (length), 10.00 mm (width).
Supplied in blister packs of 10, 20, 30, 45, 50, 60,
84, 90, 100, 200 or 500 tablets.
Also supplied in plastic containers of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
SE: Gabapentin Brown 600mg/800mg
filmdragerade tabletter
UK: Gabapentin Brown & Burk 600mg/800mg
Film-coated Tablets
DE: Gabapentin-Micro Labs 600mg/800mg
Filmtabletten
This leaflet was last approved on March 2015

Pharmacode

6 mm

BBUK Code

Artwork Code

500 mm

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

Other medicines and Gabapentin Brown &
Burk
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines.

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225 mm

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.





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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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