Skip to Content

UK Edition. Click here for US version.

GABAPENTIN WOCKHARDT 100MG HARD CAPSULES

Active substance(s): GABAPENTIN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Wockhardt 100mg, 300mg and 400mg Capsules
Gabapentin
(Referred to as Gabapentin Capsules in the remainder of the leaflet)

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
Gabapentin Capsules belong to a group of
medicines used to treat epilepsy and peripheral
neuropathic pain.
Epilepsy: Gabapentin Capsules are 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 Capsules for you to help treat your
epilepsy when your current treatment is not
fully controlling your condition. You should
take Gabapentin Capsules in addition to your
current treatment unless told otherwise.
Gabapentin Capsules can also be used on its own
to treat adults and children over 12 years of age.
Peripheral neuropathic pain: Gabapentin
Capsules are used to treat long-lasting pain
caused by damage to the nerves. A variety of
different diseases can cause peripheral (primarily
occurring in the legs and/or arms) neuropathic
pain, 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.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE GABAPENTIN CAPSULES
Do not take Gabapentin Capsules
• if you are allergic (hypersensitive) to
gabapentin or any of the other ingredients of
this medicine (listed in section 6).
Important information about potentially
serious reactions
A small number of people taking Gabapentin
Capsules 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 Capsules.
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’.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin Capsules
• if you suffer from kidney problems
• if you develop signs such as persistent
stomach pain, feeling sick and being sick
contact your doctor immediately
• 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.
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.
Other medicines and Gabapentin Capsules
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
If you are taking any medicines containing
morphine, please tell your doctor or pharmacist
as morphine may increase the effect of
Gabapentin Capsules. In addition, combination
of Gabapentin with opioids may cause symptoms
like sleepiness and/or decrease in breathing.
Gabapentin Capsules are not expected to
interact with other antiepileptic drugs or the
oral contraceptive pill.
Gabapentin Capsules may interfere with some
laboratory tests, if you require a urine test tell
your doctor or hospital that you are taking
Gabapentin Capsules.
Excretion of Gabapentin Capsules are not
affected by probenecid.
If Gabapentin Capsules and antacids containing

aluminium and magnesium are taken at the
same time, absorption of Gabapentin Capsules
from the stomach may be reduced. It is
therefore recommended that Gabapentin
Capsules are taken at the earliest two hours
after taking an antacid.
Gabapentin Capsules with food and drink
Gabapentin Capsules can be taken with or
without food.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before
taking any medicine. Gabapentin Capsules
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
foetus, particularly when more than one seizure
medication is taken at the same time.
Therefore, whenever possible and only under
the advice of your doctor, you should try to
take only one seizure medication during
pregnancy.
Do not suddenly discontinue taking this
medicine as this may lead to breakthrough
seizure, which could have serious
consequences for you and your baby.
Contact your doctor immediately if you
become pregnant, think you might be
pregnant or are planning to become pregnant
while taking Gabapentin Capsules.
Gabapentin, the active substance of Gabapentin
Capsules, is excreted in human milk.
Because the effect on the nursing infant is
unknown, it is not recommended to breast-feed
your baby while using Gabapentin Capsules.
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 engage 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 has told you. Check with your doctor or
pharmacist if you are not sure. Your doctor will
determine what dose is appropriate for you.
If you have the impression that the effect of
Gabapentin Capsules is too strong or too weak,
talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of
age), you should take Gabapentin Capsules
normally except if you have problems with your
kidneys.
Your doctor may prescribe a different dosing
schedule and/or dose if you have problems
with your kidneys.
Always swallow the capsules whole with plenty
of water.
Continue taking Gabapentin Capsules until
your doctor tells you to stop.
• Peripheral Neuropathic Pain:
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
stepwise up to a maximum of 3600 mg each
day and your doctor will tell you to take this in
3 divided doses, i.e. once in the morning, once
in the afternoon and once in the evening.
• Epilepsy
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 stepwise
up to a maximum of 3600 mg each day and
your doctor will tell you to take this in 3 divided
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/kg/day. It is usually given
in 3 divided doses, by taking the capsule(s)
each day, usually once in the morning, once in
the afternoon and once in the evening.
Gabapentin Capsules are not recommended for
use in children below 6 years of age.

ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Keyline
(non-printing)

Text
free area

Process
Black

Gabapentin 100mg, 300mg and 400mg Capsules
Wockhardt UK

UK
(w)150 x (h)400mm
Dummy
9pt.
Gabapentin_Leaflet_107104-3.ai
Adobe Illustrator CS5
Myriad Pro Regular / Bold
8th February, 2016
R 1st PDF sent on - 11TH FEB. 2016
R 2nd PDF sent on - 19TH FEB. 2016
R 3rd PDF sent on - 31ST MARCH 2016

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • New regulatory text

Non-Regulatory

If you take more Gabapentin Capsules than
you should
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
the nearest hospital casualty department
immediately. Take along any capsules that are
left, the container and the label so that the
hospital can easily tell what medicine you have
taken. 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.
Symptoms of an overdose are dizziness, double
vision, slurred speech, loss of consciousness,
drowsiness and mild diarrhoea.
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 product, 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.
Gabapentin Capsules 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 a rash when you get this type of reaction.
It may cause you to be hospitalized or to stop
Gabapentin Capsules.
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
- unusual bruising or Bleeding
- yellowing of your skin or of the whites of the
eyes
- 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 Capsules.
If you are on haemodialysis, tell your doctor if
you develop muscle pain and/or weakness.
Very common: may affect more than 1 in 10
people
• Feeling drowsy, dizziness, lack of coordination
• Viral infection
• Feeling tired, fever.
Common: may affect up to 1 in 10 people
• Pneumonia, respiratory infection, urinary tract
infection, infection, inflammation of the ear
• Low white blood cell counts
• Anorexia, increased appetite
• Anger towards others, confusion, fluctuation
in mood, depression, anxiety, nervousness
• Convulsions, jerky movements, difficulty with
speaking, loss of memory, tremor, difficulty
sleeping, headache, sensitive skin, decreased
sensation, 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
• Incontinence
• Difficulties with erection
• Swelling in the legs and arms or swelling that
may involve the face, trunk and limbs,
difficulty with walking, weakness, pain,
feeling unwell, flu-like symptoms
• Decrease in white blood cells, increase in weight
• Accidental injury, fracture, abrasion.
Uncommon: may affect up to 1 in 100 people
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in
patients with diabetes)
• Hypokinesia
• Mental impairment
Rare: may affect up to 1 in 1,000 people
• Decreased platelets (blood clotting cells)
• Allergic reaction such as hives

• Hallucinations
• Loss of consciousness
• Problems with abnormal movements such as
writhing, jerking movements and stiffness
• Ringing in the ears
• Racing heartbeat
• Inflammation of the pancreas
• Inflammation of the liver, yellowing of the
skin and eyes
• Acute kidney failure
• Severe skin reactions that require immediate
medical attention, swelling of the lips and
face, skin rash and redness, hair loss
• Adverse events following the abrupt
discontinuation of gabapentin (anxiety,
difficulty sleeping, feeling sick, pain,
sweating), chest pain
• Low blood sugar (most often observed in
patients with diabetes), abnormal blood test
results suggesting problems with the liver.
Side effects for which the frequency cannot
be estimated based on the available data
are listed below:
• Low blood sodium
• 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
• Breakdown of muscle fibers (Rhabdomyolysis)
• Problems with abnormal movements such as
writhing, jerking movements and stiffness
• Increased breast tissue, breast enlargement
• Problems with sexual functioning including
inability to achieve a sexual climax, delayed
ejaculation
• Change in blood test results (creatine
phosphokinase increased)
Additionally in clinical studies in children,
aggressive behaviour and jerky movements
were reported commonly.
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 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.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Store below 25°C. Store in the original package.
Do not throw away 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, hard contains either 100mg,
300mg or 400mg gabapentin.
• The other ingredients are lactose
monohydrate, talc, maize starch, gelatin,
titanium dioxide (E171), sodium lauryl
sulfate, yellow iron oxide (E172) [300mg
capsules only] and red iron oxide (E172)
[400mg capsules only].
• The capsule printing ink contains shellac,
dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol, black iron oxide
(E172) and purified water.
What Gabapentin Capsules look like and the
contents of the pack
100mg: white, gelatin capsules marked with
GA100.
300mg: yellow, gelatin capsules marked with
GA300.
400mg: orange, gelatin capsules marked with
GA400.
Gabapentin Capsules are available in
transparent blister packs of 20, 50, 100 and
200 capsules, although not all pack sizes may
be marketed.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other sources of information:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Reference number
Gabapentin Wockhardt
100mg Hard Capsules
PL 29831/0616
Gabapentin Wockhardt
300mg Hard Capsules
PL 29831/0618
Gabapentin Wockhardt
400mg Hard Capsules
PL 29831/0617
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in 04/2016
107104/3

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