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GABAPENTIN BRISTOL LABS 300MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Gabapentin Bristol Labs 100 mg Capsules
Gabapentin Bristol Labs 300 mg Capsules
Gabapentin Bristol Labs 400 mg Capsules
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 Capsules are and what they
are used for
2. What you need to know before you take
Gabapentin Capsules
3. How to take Gabapentin Capsules
4. Possible side effects
5. How to store Gabapentin Capsules
6. Contents of the pack and other information

1. What Gabapentin Capsules are and what
they are used for
The name of your medicine is Gabapentin Capsules
and it contains the active ingredient gabapentin
Gabapentin 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 for you to help
treat your epilepsy when your current treatment is
not fully controlling your condition. You should take
Gabapentin in addition to your current treatment
unless told otherwise. Gabapentin 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.

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2. What you need to know before you take
Gabapentin Capsules

Do not take Gabapentin Capsules:
• If you are allergic 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 capsules:
• 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 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.
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 Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicines containing opiods such as morphine
If you are taking any medicines containing opioids (such
as morphine), please tell your doctor or pharmacist as
opiods may cause symptoms like sleepiness and/or
decrease in breathing.
Antacids for indigestion

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If Gabapentin and antacids containing aluminium and
magnesium are taken at the same time, absorption of
Gabapentin from the stomach may be reduced. It is
therefore recommended that Gabapentin is taken at
the earliest two hours after taking an antacid.
Gabapentin:
- is not expected to interact with other anti-epileptic
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 Capsules with food and drink and
alcohol
The capsules 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 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. 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 is passed on through human milk. Because
the effect on the baby is unknown, it is not recommended
to breast-feed while using Gabapentin.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Capsules 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.

Gabapentin capsules contain Lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Gabapentin Capsules
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.
Method and route of administration
For oral use only. Always swallow the capsules or tablets
whole with plenty of water.
Continue taking Gabapentin until your doctor tells you
to stop.
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 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.
Gabapentin 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 or 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
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are undergoing haemodialysis.

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Package leaflet: Information for the user

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4. Possible Side Effects
Like all medicines, Gabapentin Capsules 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)
• anaphylaxis (serious, potentially life threatening
allergic reaction including difficulty breathing,
swelling of the lips, throat, and tongue, and
hypotension requiring emergency treatment)
(frequency not known, cannot be estimated from the
available data)
• persistent stomach pain, feeling sick and being sick
as these may be symptoms of acute pancreatitis (an
inflamed pancreas)
• Gabapentin Capsules may cause a serious or life

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Uncommon: may affect up to 1 in 100 people:
• Mental impairment
• Decreased movement
• Racing heartbeat
• Swelling that may involve the face, trunk and limbs
• Abnormal blood test results suggesting problems
with the liver
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in patients
with diabetes)
• Agitation (a state of chronic restlessness and
unintentional and purposeless motions)
Rare: may affect up to 1 in 1,000 people
• Loss of consciousness
• Low blood sugar (most often observed in patients
with diabetes)
Not known: frequency cannot be estimated from
the available data
• 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,
• Blood glucose fluctuations in patients with diabetes.
• 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
• Hyponatraemia
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
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 Capsules
• Keep this medicine out of the sight and reach of
children.

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• Do not use this medicine after the expiry date (EXP)
which is stated on the carton. The expiry date refers
to the last day of that month.
• Do not store above 250C. Store in the original
package.
• 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 Capsules contain
• The active substance is Gabapentin. Each capsule
contains 100mg, 300mg or 400mg Gabapentin. The
other ingredients are:
• Capsule fill: Lactose Monohydrate, Maize Starch,
Talc.
• Capsule shell: Gelatin, Titanium dioxide (E171) The
300mg Capsules contain Yellow Iron Oxide (E172);
the 400mg Capsules contain: Yellow Iron Oxide
(E172), Red Iron Oxide (E172)
• Printing ink: Shellac Glaze, Vegetable Carbon
(E153), Antifoam , Industrial Methylated Spirit.
What Gabapentin Capsules look like and contents
of the pack
100mg: Hard gelatin capsule with white cap/white body
and printed with “BL 100”.
300mg: Hard gelatin capsule with yellow cap/yellow
body and printed with “BL 300’’.
400mg: Hard gelatin capsule with orange cap/orange
body and printed with “BL 400’’.
All strengths are available in blister pack of 10 x 10
capsules
Marketing Authorisation Holder and
Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
info@bristol-labs.co.uk
Email:
Gabapentin Bristol Labs 100 mg Capsules;
PL 17907/0371
Gabapentin Bristol Labs 300 mg Capsules;
PL 17907/0372
Gabapentin Bristol Labs 400 mg Capsules;
PL 17907/0373
This leaflet was last revised in January 2017
To request a copy of this leaflet in Braille, large print or
audio format then please contact the licence holder at
the address (or telephone, fax, email) above.
V11 13-01-17 D1

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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. 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
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 to1 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-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.

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If you are an elderly patient (over 65 years of age),
you should take the normal dose of Gabapentin 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
is too strong or too weak, talk to your doctor or pharmacist
as soon as possible.
If you take more Gabapentin Capsules 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.
If you or someone else accidentally takes too many
capsules, or if you think a child has swallowed any,
contact your doctor or go to your nearest hospital
casualty department immediately. As Gabapentin
capsules may make you drowsy, it is recommended that
you ask someone else to drive you to the doctor or
hospital, or that you call an ambulance.
If you forget to take Gabapentin Capsules
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 Capsules
Do not stop taking Gabapentin Capsules 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 Capsules 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.

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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