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GABAPENTIN ACTAVIS100MG CAPSULES

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• swelling of the legs and arms,
difficulty with walking, weakness, pain,
accidental injury, fracture, abrasion.
Uncommon (occurs in less than 1 in
100 users)
• slowed movements.
• fall.
• difficulty with thinking.
• high blood sugar (most often observed
in patients with diabetes).
Rare (occurs in less than 1 in 1000
users)
• blood glucose changes in diabetics.
• hair loss, hallucinations (seeing things
that are not there), problems with
abnormal movements such as writhing,
jerking movements and stiffness,
ringing in the ears.
• acute kidney failure, chest pain, racing
heartbeat.
• abnormal blood test results suggesting
problems with the liver.
• low blood sugar (most often observed
in patients with diabetes).
• loss of consciousness.

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

5 How to store gabapentin
Keep out of the reach and sight 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 Further information

What gabapentin capsules
contain

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).

Not known (frequency cannot be
estimated from the data)
• breast enlargement in both men and
women.
• worsening of myoclonus (muscle
spasms), fainting.
• low blood sodium level.
Children
• The following effects were only
reported in children: respiratory
infection, inflammation of the ear,
convulsions and bronchitis.
• Common (occurs in more than 1 in
100 users) – aggressive behaviour,
restlessness and hyperactivity.

What gabapentin capsules looks
like and contents of the pack

Gabapentin 100mg Capsules are white,
the 300mg capsules are yellow and the
400mg capsules are orange.

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

The packs contain: 100 capsules.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK


Gabapentin Capsules
100, 300 & 400mg x 100’s (UK)

Revision date May 2015
Actavis, Barnstaple, EX32 8NS, UK

50854514 AAAH9056

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Gabapentin Actavis 100mg,
300mg and 400mg capsules

capsules

Read all of this leaflet carefully
before you start taking this
medicine.
•  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 any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

2 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
(see section 6).

Tell your doctor before taking
Gabapentin capsules if you

• suffer with different types of seizures
including absences.
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.

In this leaflet:
1 What Gabapentin capsules are
and what they are used for
2 Before you take Gabapentin
capsules
3 How to take Gabapentin
capsules
4 Possible side effects
5 How to store Gabapentin
capsules
6 Further information

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’

1 What Gabapentin capsules are

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.

Taking other medicines

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 morphine (strong
pain killer), as morphine may increase
the effect of Gabapentin capsules.

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Gabapentin 100mg, 300mg & 400mg 100 Capsules PIL - UK

1. Black
item no: AAAH9056

dimensions: 210 x 296

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

print proof no: 3

pharmacode:

origination date: 01.05.15

min pt size: 9

Pharmacode: 2141

originated by: S.Anson

JDE No.:

50854514

Date Sent:
29/04/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

colours/plates:

approved for print/date

2.
3.
4.
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revision date: 18.05.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

• 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.

you that you have an intolerance to
some sugars, contact your doctor before
taking this medicine.

3 How to take Gabapentin

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 and breastfeeding

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.
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.

Driving and using machines

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.

Sugar intolerance

The capsules contain lactose
monohydrate. If your doctor has told
Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Gabapentin Capsules
100, 300 & 400mg x 100’s (UK)

capsules

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.

Dosage
Epilepsy:
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.
Peripheral 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.

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
Continued over page

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.

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, drowsiness and mild diarrhoea.

If you forget to take 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.

If you stop taking Gabapentin
capsules

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.

Tell your doctor or pharmacist if the
following side effects occur or get worse:
Very common (occurs in more than 1
in 10 users)
• feeling drowsy, dizziness, lack of
coordination, fever.

4 Possible side effects
Like all medicines, Gabapentin capsules
can cause side effects, although not
everybody gets them.

Common (occurs in more than 1 in 100
users)
• feeling unwell, flu-like symptoms, sore
throat, cough, dry mouth or throat,
runny nose.
• loss of appetite, increased appetite,
being or feeling sick, problems with
teeth, inflamed gums, diarrhoea,
stomach pain, indigestion,
constipation, flatulence, increase in
weight.
• anger towards others, confusion,
mood changes, depression, anxiety,
nervousness, difficulty with thinking,
jerky movements, twitching, difficulty
with speaking or coordination,
increased, decreased or absent
reflexes, loss of memory, tremor,
difficulty sleeping, headache, spinning
sensation.
• ‘pins and needles’, decreased sensation,
facial swelling, bruises, rash, itch, acne,
unusual eye movement, blurred vision,
double vision, joint, muscle or back
pain.
• high blood pressure, flushing or
dilation of blood vessels.
• incontinence, difficulties with erection.

Contact your doctor at once if the
following effects happen:
• allergic reactions such as difficulty
breathing, swelling of the face, lips,
trunk and limbs, hives, skin rash and
redness or severe skin reactions such as
flushing, blisters and ulcers.
• low white blood cell counts or
decreased platelets (causing
increased bruising, nosebleeds, sore
throats), pneumonia, urinary tract
or viral infections, other infections,
inflammation of the pancreas (causing
pain and tenderness in the stomach
and back) or liver (causing yellowing of
the skin and eyes, tiredness or fever).
• Gabapentin may cause a serious or lifethreatening 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 hospitalised or to stop
gabapentin.

Continued top of next column

page 2

Continued over page

page 3

Gabapentin 100mg, 300mg & 400mg 100 Capsules PIL - UK

1. Black
item no: AAAH9056

dimensions: 210 x 296

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

print proof no: 3

pharmacode:

origination date: 01.05.15

min pt size: 9

Pharmacode: 2141

originated by: S.Anson

JDE No.:

50854514

Date Sent:
29/04/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

colours/plates:

approved for print/date

2.
3.
4.
5.
6.

revision date: 18.05.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

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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