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GABAPENTIN 300MG HARD CAPSULES

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PATIENT INFORMATION LEAFLET
Gabapentin Arrow 100mg, 300mg and 400mg Capsules
(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. Do not pass it on to others. It may harm
them, even if their symptoms 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.
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 Gabapentin Capsules.
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.
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.
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.
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 and breastfeeding
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.
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 Gabapentin Capsules exactly as your doctor has told you.
You should 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.
If you take more Gabapentin Capsules than you should
Call your doctor or go to the nearest hospital emergency unit 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.
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 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.
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

- 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.
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, difficulty
with thinking
• 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.
Rare: may affect up to 1 in 1,000 people
• Decreased platelets (blood
clotting cells)
• Allergic reaction such as hives
• Hallucinations
• 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
• Blood glucose fluctuations in
patients with diabetes, abnormal
blood test results suggesting
problems with the liver.
Additionally in clinical studies in children, aggressive behaviour and jerky
movements were reported commonly.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE GABAPENTIN CAPSULES
Keep out of the reach and sight of children.
Do not use Gabapentin Capsules after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
You should store your medicine below 25ºC. Store in the original package.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to 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 in Gabapentin Capsules are lactose monohydrate,
talc, maize starch, gelatin, titanium dioxide (E171), yellow iron oxide
(E172) [300mg capsules only] and red iron oxide (E172) [400mg capsules
only].
• The capsule printing ink contains shellac, titanium dioxide (E171) and
FD&C Blue 1 / Brilliant Blue FCF Lake (E133).
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 Nort, Wrexham Industrial Estate, Wrexham, LL13 9UF, United Kingdom
Manufacturer:
Arrow Pharm (Malta) Limited
HF 62, Hal Far Industrial Estate, Birzebbugia BBG06, Malta
This leaflet was last revised in

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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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