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GABAPENTIN BROWN & BURK 400 MG CAPSULES HARD

Active substance(s): GABAPENTIN

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MICRO LABS LIMITED
Bangalore, INDIA

1) Product

:

Gabapentin Brown & Burk Capsules, hard - BBUK

2) Strength

:

100/300/400 mg

3) Component

:

Leaflet

4) No of Colours

:

1

5) Dimension

:

150 x 500 mm

6) Artwork Code

:

NA

7) Pharma Code

:

NA

8) Font Type and Size

:

Arial, 9pt

9) Technical Specification:

Code No. :

WOA
WA

Reason for Change
Approved
by

Contract Giver/
PL holder

Regulatory
Affairs

Colours used
Black

Colours not for Printing
Keylines

NA

NA

Revision: 00

NA

Date : 03-08-2016

Packaging
Development

Head Production/
Packing (Site)

Head QC
(Site)

Head QA
(Site)

Sign/
Date

150 mm

150 mm

Package leaflet: Information for the user

GABAPENTIN BROWN & BURK 100MG CAPSULES, HARD
GABAPENTIN BROWN & BURK 300MG CAPSULES, HARD
GABAPENTIN BROWN & BURK 400MG CAPSULES, HARD

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 Capsules 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 this medicines (listed
in section 6).
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).

A small number of people being treated with antiepileptics 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
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'

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 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.

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, 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.

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.

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

Fertility
There is no effect on fertility in animal studies.
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.

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.

3. How to take Gabapentin Brown & Burk
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

If you are on haemodialysis, tell your doctor if
you develop muscle pain and/or weakness.

Your doctor will determine what dose is
appropriate for you.

Other side effects include:

Epilepsy, the recommended dose is:

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 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, flulike symptoms.
• Decrease in white blood cells, increase in
weight.
• Accidental injury, fracture, abrasion.

Gabapentin Brown & Burk is not recommended
for use in children below 6 years of age.
Peripheral Neuropathic Pain, the
recommended dose is:

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.

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 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.

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

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.

Medicines containing 'opioids' (strong
painkillers) such as morphine
If you are taking any medicines containing
opioids (such as morphine), please tell your

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

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.

4. Possible side effects

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.

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

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.

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

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.

270 mm

Cases of abuse and dependence have been
reported for Gabapentin from the postmarketing experience. Talk to your doctor if you
have a history of abuse or dependence.

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.
• Mental impairment
• Fall
• Increase in blood glucose levels (most often
observed in patients with diabetes)

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.

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.

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.

Additionally in clinical studies in children,
aggressive behaviour and jerky movements

Pharmacode

6 mm

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 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
• 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 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 store above 30°C.
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 Capsules
contains
The active substance is gabapentin.
Each hard capsule, contains either 100 mg,
300 mg or 400 mg of gabapentin.
The other ingredients are:
Capsule contents:
Maize starch
Talc
Capsule shell:
Gelatin
Sodium laurilsulfate
100 mg capsules: Titanium dioxide (E171)
300 mg capsules: Titanium dioxide (E171),
yellow iron oxide (E172)
400 mg capsules: Titanium dioxide (E171), red
and yellow iron oxide (E172)
What Gabapentin Brown & Burk Capsules
looks like and contents of the pack
The 100 mg capsules are white hard capsules
containing a white crystalline powder. The
capsule length is 15.70 mm.
The 300 mg capsules are yellow hard capsules
containing a white crystalline powder. The
capsule length is 19.00 mm.
The 400 mg capsules are orange hard capsules
containing a white crystalline powder. The
capsule length is 21.20 mm.
Supplied in blister packs of 10, 20, 30, 50, 60, 84,
90, 98, 100, 200, 500, 1000 capsules.
Also supplied in plastic containers of 300, 400 or
500 capsules.
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:
UK: Gabapentin Brown & Burk
100mg/300mg/400mg Capsules, Hard
DE: Gabapentin-Micro Labs
100mg/300mg/400mg Hartkapseln
This leaflet was last approved on
August 2016

BBUK Code

Artworkcode

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
y o u r c o n d i t i o n . Yo u s h o u l d t a k e
Gabapentin Brown & Burk in addition to
your current
treatment unless
told otherwise.
Gabapentin Brown
& Burk can also be
Pharmacode
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.

doctor or pharmacist as opioids may increase
the effect of Gabapentin Brown & Burk. In
addition, combination of Gabapentin Brown
and Burk with opioids may cause symptoms like
sleepiness and/or decrease in breathing.

230 mm

225 mm

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

were reported.

Method of administration
Gabapentin Brown & Burk is for oral use. Always
swallow the capsules with plenty of water.

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 of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

dose if you have problems with your kidneys.

Expand view ⇕

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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