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GABAPENTIN ACTAVIS 100MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Uncommon (may affect up to 1 in 100
people):
• allergic reaction 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
• mental impairment
• fall
• increase in blood glucose levels (most often
observed in patients with diabetes)
• agitation (a state of chronic restlessness and
unintentional and purposeless motions)

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

Gabapentin Actavis 100mg,
300mg and 400mg capsules

By reporting side effects you can help provide
more information on the safety of this
medicine.
5

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)
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
• breakdown of muscle fibers
(rhabdomyolysis)
• muscle spasms
• 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
• anaphylaxis (serious, potentially life
threatening allergic reaction including
difficulty breathing, swelling of the lips,
throat, and tongue, and hypotension
requiring emergency treatment)

Package Leaflet: Information for the patient

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep this leaflet. You may need to read
it again.
•  I f you have any further questions, ask
your doctor, pharmacist or nurse.
•  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.
•  I f you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any side effects not listed in this
leaflet. See section 4.

How to store Gabapentin capsules
Keep out of the sight and reach of children.
Do not store the capsules above 25°C
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.

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

2

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

The active substance (the ingredient that
makes the medicine work) is gabapentin.
Each capsule contains either 100mg, 300mg
or 400mg gabapentin.
The other ingredients in the capsules are
lactose monohydrate, maize starch, talc.
The capsule shell contains titanium dioxide
(E171) and gelatin, yellow iron oxide (E172)
(300mg and 400mg capsules) and red iron
oxide (E172) (400mg capsules only).
The printing ink contains Shellac (E904),
propylene glycol (E1520), black iron oxide
(E172) and potassium hydroxide (E525).

1

What Gabapentin capsules looks like
and contents of the pack

 hat Gabapentin capsules are
W
and what they are used for

Gabapentin capsules belong to a group of
medicines used to treat:
•v
 arious forms of epilepsy – Gabapentin
capsules can be used on their own in adults
and children aged 12 years and over or in
combination with other medicines to treat
epilepsy in adults and children aged 6 years
and over.
•p
 eripheral neuropathic pain - This is
long lasting pain caused by damage to the
nerves.

Gabapentin 100mg Capsules are white, the
300mg capsules are yellow and the 400mg
capsules are orange.
The packs contain: 100 capsules.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Revision date January 2017

Continued top of next column
50918493 BBBA0466

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Gabapentin all strengths x all sizes
(UK)
JDE No.:

page 4

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

• if you are allergic (hypersensitive) to
gabapentin or any of the other ingredients
of Gabapentin capsules (see section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse
before taking Gabapentin capsules
• if you suffer from kidney problems your
doctor may prescribe a different dosing
schedule
• if you suffer with different types of seizures
including absences.
• 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 postmarketing experience. Talk to your doctor if
you have a history of abuse or dependence.
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.

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’

Continued over page

page 1

Gabapentin 100mg, 300mg & 400mg 100 Capsules PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
19/01/17
Technologist: R.Wrey

Do not take Gabapentin capsules

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50918493

Pharmacode: 3919

 hat you need to know before
W
you take Gabapentin capsules

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0466

Originator:
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Origination Date: 23.01.17
Revision Date:
Revised By:

Technical
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Date sent:
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Date received: n/a

Dimensions:
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Min Body Text Size: 8pts
Supplier:
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Colours

Non Printing Colours

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1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Other medicines and Gabapentin
capsules

Driving and using machines

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription. In particular:
• 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 capsules with
opioids may cause symptoms like sleepiness
and/or decrease in breathing.
• antacids containing aluminium and
magnesium (used to reduce stomach acid)if 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 least
two hours after taking an antacid.

When taking Gabapentin capsules you may
become drowsy, dizzy or feel tired, especially
at the start of treatment or after a dose
increase. Make sure you are not affected
before driving or operating machinery.

Gabapentin capsules contain lactose
The capsules contain lactose monohydrate.
If your doctor has told you that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
3

Urine Tests

Gabapentin capsules may interfere with
urine tests. If you require a urine test, tell
your doctor or hospital that you are taking
Gabapentin capsules

Pregnancy, breastfeeding and fertility

Pregnancy
Gabapentin capsules should not be taken
during pregnancy, unless advised by 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.
Other medicines used to treat seizures
may increase the 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 stop taking this medicine as
this may lead to breakthrough seizures, which
could have serious consequences for you and
your baby.
Breast-feeding
If you are taking Gabapentin capsules, do not
breastfeed, unless advised to by your doctor,
as this medicine will pass into breast milk and
may harm the baby.
Fertility
There is no effect on fertility in animal studies.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Gabapentin all strengths x all sizes
(UK)
JDE No.:

Always take Gabapentin capsules exactly as
your doctor has told you. If you are not sure,
check with your doctor or pharmacist.
Gabapentin capsules are usually taken
three times a day (morning, afternoon and
evening). Always swallow the capsules whole
with plenty of water, with or without food.
Your doctor will determine what dose is
appropriate for you. If you are an elderly
patient (over 65 years old), have kidney
disease or are having haemodialysis
you should take Gabapentin capsules as
prescribed by your doctor.
Continue taking Gabapentin capsules until
your doctor tells you to stop.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Other side effects include:

Do not stop taking this medicine suddenly, as
your symptoms may get worse. Your doctor
will reduce the dose gradually, you may
experience anxiety, difficulty sleeping, feeling
sick, pain, sweating.
4

•E
 pilepsy:
Adults and children aged 12 years or over:
The usual starting dose is between 300mg
and 900mg each day. The dose may then be
increased gradually to a maximum of 3600mg
each day.
Children aged 6 years and above:
The dose depends on the body weight of
your child. The treatment is started with a low
initial dose which is gradually increased over
a period of about 3 days. The usual dose to
control epilepsy is 25-35mg per kg per day.
Gabapentin capsules are not recommended
for use in children below 6 years of age.
•P
 eripheral neuropathic pain:
The usual starting dose is between 300mg
and 900mg each day. The dose may then be
increased gradually to a maximum of 3600mg
each day.

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:
• s evere 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)
•p
 ersistent stomach pain, feeling sick and
being sick as these may be symptoms of
acute pancreatitis (an inflamed pancreas)
•G
 abapentin 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
•y
 ellowing 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 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
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

Continued over page

• 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):
• viral infection
• feeling drowsy, dizziness, lack of
coordination
• feeling tired, fever
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, sensations
such as pins and needles, 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, runny 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, itchy skin, 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, flulike 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. Respiratory tract
infections, inflammation of the middle ear
and ear drum, convulsions and bronchitis
were also reported.

Continued top of next column

page 2

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page 3

Gabapentin 100mg, 300mg & 400mg 100 Capsules PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
19/01/17
Technologist: R.Wrey

If you forget to take Gabapentin
capsules

If you stop taking Gabapentin
capsules

Dosage

50918493

Pharmacode: 3919

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 miss 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.

How to take Gabapentin capsules

Continued top of next column

the doctor or hospital, or that you call an
ambulance. Symptoms of an overdose are
dizziness, double vision, slurred speech,
drowsiness or tiredness, loss of consciousness
and mild diarrhoea. Overdose of gabapentin,
particularly in combination with other CNS
depressant medications, may result in coma.

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0466

Originator:
S.Anson
Origination Date: 23.01.17
Revision Date:
Revised By:

Technical
Approval

Date sent:
n/a
Date received: n/a

Dimensions:
296 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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