Skip to Content

UK Edition. Click here for US version.

GABAPENTIN BROWN & BURK 300 MG CAPSULES HARD

Active substance(s): GABAPENTIN

View full screen / Print PDF » Download PDF ⇩
Transcript
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 : 20-03-2015
Packaging
Development

Production
Head (Site)

Head
QC (Site)

Head
QA (Site)

Sign/
Date

150 mm

150 mm

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.

Package leaflet: Information for the user

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

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.

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 with food and
drink
Gabapentin Brown & Burk can be taken with or
without food.

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.

A small number of people being treated with antiepileptics 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.
Other medicines and Gabapentin Brown &
Burk Capsules
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines.

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.

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

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.
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.

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.

Your doctor will determine what dose is
appropriate for you.
Epilepsy, the usual dose is:

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 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.

270 mm

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.

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.

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.

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, flu-

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 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.
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 people (over 65 years of
age), you should take the normal dose of

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.

Pharmacode

6 mm



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 (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 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:
SE: Gabapentin Brown
100 mg/300 mg/400 mg kapsel, hård
UK: Gabapentin Brown & Burk
100mg/300mg/400mg Capsules, Hard
DE: Gabapentin-Micro Labs
100mg/300mg/400mg Hartkapseln
This leaflet was last approved on March 2015

BBUK Code

Artworkcode

500 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 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.

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 and breast-feeding

The active substance in Gabapentin Brown &
Burk Capsules is gabapentin.

Do not take Gabapentin Brown & Burk:
• if you are allergic to gabapentin or any of
the other ingredients of Gabapentin Brown &
Burk Capsules (listed in section 6).

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

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;

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.

2. What you need to know before you take
Gabapentin Brown & Burk

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

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 belongs to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting pain caused by
damage to the nerves).

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
Pharmacode
treatment unless
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.

Method of administration

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.

230 mm

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



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.

Hide