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GABAPENTIN WOCKHARDT 100MG HARD CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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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 (long lasting pain caused by
damage to the nerves).
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 (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.
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).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin Capsules
• 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 nervous system disorders,
respiratory disorders, or you are more than
65 years old, your doctor may prescribe you a
different dosing regimen.
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
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.
Other medicines and Gabapentin Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular, tell your doctor (or pharmacist) if you
are taking or have been recently taking any
medicines for convulsions, sleeping disorders,
depression, anxiety, or any other neurological or
psychiatric problems.
Medicines containing opioids such as morphine
If you are taking any medicines containing opioids
(such as morphine), please tell your doctor or
pharmacist as opioids may increase the effect of
Gabapentin Capsules. In addition, combination of
Gabapentin with opioids may cause symptoms
like sleepiness and/or decrease in breathing.
Antacids for indigestion
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
• 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 Capsules with food
Gabapentin 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 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
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 Capsules. 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
Capsules, is passed on through human milk.
Because the effect on the baby is unknown, it is
not recommended to breast-feed your baby while
using Gabapentin Capsules.
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.
Gabapentin Capsules contain lactose (a type of
sugar). 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.
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.
Gapapentin Capsules is not recommended for use
in children below 6 years of age.
Peripheral Neuropathic Pain, the
recommended 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 300 mg and 900 mg each day.
Thereafter, the dose may be increased as directed
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 patient (over 65 years of age)
You should take the normal dose of Gabapentin
Capsules 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 Capsules is too strong or too weak, talk
to your doctor or pharmacist as soon as possible
Method of administration
Gabapentin Capsules is for oral use. Always
swallow the capsules with plenty of water.
Continue taking Gabapentin Capsules until your
doctor tells you to stop.
If you take more Gabapentin Capsules than
you should
Higher than recommended doses may result in an
increase in side effects including loss of

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

UK
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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
Capsules 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 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.
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:
• Breathing problems, which if severe you may
need emergency and intensive care to
continue breathing normally
• 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)
• Yellowing of the skin and eyes (jaundice),
inflammation of the liver
• Anaphylaxis (serious, potentially life
threatening allergic reaction including
difficulty breathing, swelling of the lips,
throat, and tongue, and hypotension
requiring emergency treatment)
• 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).
• Low white blood cell counts e.g. infections
• Decreased platelets (blood clotting cells)
e.g. bruising easily
• 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 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
• yellowing of your skin or of the whites of
the eyes
• unusual bruising or bleeding
• 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.
Other side effects include:
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 or
other infections
• 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
• Increase in weight

• Accidental injury, fracture, abrasion.
Additionally in clinical studies in children,
aggressive behaviour and jerky movements were
reported commonly.
Uncommon: (may affect up to 1 in 100 people)
• agitation (a state of chronic restlessness and
unintentional and purposeless motions)
• 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)
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)
• Allergic reaction such as hives
• Acute kidney failure, incontinence
• Trouble breathing, shallow breaths (respiratory
depression)
After marketing Gabapentin Capsules the
following side effects have been reported:
• Hallucinations
• Problems with abnormal movements such as
writhing, jerking movements and stiffness
• Ringing in the ears
• 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
Additionally, suicidal ideation and behaviour have
been reported in patients treated with
anti-epileptic agents; seek medical advice should
signs of suicidal ideation or behaviour emerge.
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 25ºC. 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 08/2017.
107104/5

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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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