Skip to Content

UK Edition. Click here for US version.

GABAPENTIN MYLAN 400 MG HARD CAPSULES

Active substance(s): GABAPENTIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Gabapentin Mylan
#400 mg

Gabapentin Mylan
#400 mg

GLUE AREA

REVERSE

Gabapentin Mylan
400 mg hard capsules

PEEL HERE BUT DO NOT REMOVE

PEEL HERE BUT DO NOT REMOVE

FRONT FACE
400
mg

100 hard capsules
Each 400 mg hard capsule contains: 400 mg
of gabapentin. This product contains: lactose
monohydrate. Read the package leaflet before use.
For oral use. Take as directed by the doctor. Keep
out of the reach and sight of children. Do not
store above 25°C. Keep the container tightly closed.

LEAVE BLANK

PL 04569/0667  POM
770494 LL0444AI
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

01

28

09

26

11

Stop taking this medicine and contact your
doctor immediately or go to the nearest
hospital casualty department straight away
if you experience any of the following signs
after taking this medicine as they can be
serious:
Common (may affect up to 1 in 10 people)
• serious chest infection which may cause fever,
chills, shortness of breath, cough, phlegm
and occasionally blood (pneumonia) • fits
(convulsions) • decreased white blood cell
count (leucopenia) which may cause you to
suffer from more frequent infections e.g. sore
throat, fever, severe chills and mouth ulcers etc.
22

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.
As this medicine 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. Signs of an overdose
include dizziness, double vision, slurred
speech, loss of consciousness, drowsiness and
mild diarrhoea.
If you forget to take Gabapentin
If you forget to take a dose, take it as soon as
you remember unless it is time for your next

this medication affects your ability to perform
these activities.
Gabapentin contains 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
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

15

17

Description Gabapentin 400 mg 100
Component Type Label Leaflet
Affiliate Item Code 770494
Superceded Affiliate Item Code 636990
TrackWise PR No. 770494
MA No. 04569/0667
Packing Site/Printer N/A
Supplier Code LL0444AI

of coordination. • feeling tired.
Common (may affect up to 1 in 10 people)
• urinary tract infection, general infections,
inflammation of the ear • loss of appetite or
an increased appetite. • anger towards others,
confusion, fluctuation in mood, depression,
anxiety, nervousness, difficulty with thinking.
• jerky movements, difficulty with speaking,
loss of memory, shaking, difficulty sleeping,
headache, numbness, tingling or pins and
needles, decreased sensation, difficulty with
coordination • rapid unusual eye movement,
increased, decreased or absent reflexes.
• blurred vision, double vision. • spinning

Gabapentin.
Antacids for indigestion
If gabapentin and antacids containing
aluminium and magnesium are taken at the
same time, absorption of gabapentin from
the stomach may be reduced. It is therefore
recommended that Gabapentin is taken at
least two hours after taking an antacid.
Pregnancy and breast-feeding
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

than usual, feeling or being sick, or confused
(acute kidney failure). • destruction of muscle
fibres associated with muscle cramps, muscle
pain, fever and red-brown discoloration of the
urine (rhabdomyolysis)
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 hospitalized or to stop
Gabapentin.
Call your doctor right away if you have any of
the following symptoms:

27

25

12

Rare (may affect up to 1 in 1,000 people)
• loss of consciousness
Not known (frequency cannot be estimated
from the available data)
• severe skin reactions that require immediate
attention such as swelling of the lips and face,
skin rash and redness (these may be signs
of a serious allergic reaction). • potentially
life-threatening skin rashes (Stevens-Johnson
syndrome) appearing initially as reddish targetlike spots or circular patches often with central
blisters on the trunk. Additional signs to look
for include ulcers in the mouth, throat, nose,
genitals and conjunctivitis (red and swollen

14

16

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.
Use in 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 recommended dose to control epilepsy
is 25-35 mg/kg/day. It is usually given in
3 divided doses, by taking the capsule(s) each

20

you are taking gabapentin.
Read the description of these signs in
section 4 of this leaflet under ‘Stop taking this
medicine and contact your doctor immediately
or go to the nearest hospital casualty
department straight away if you experience
any of the following signs after taking this
medicine as they can be serious’
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Medicines containing opioids such as
morphine

Do not suddenly stop taking this medicine as
this may lead to breakthrough seizure, which
could have serious consequences for you and
your baby.
Breast-feeding
Gabapentin, passes into human milk. Because
the effect on the nursing newborn is unknown,
it is not recommended to breast-feed your
baby while taking Gabapentin.
Driving and using machines
Gabapentin may cause dizziness, drowsiness
and tiredness. You should not drive, operate
machinery or engage in other potentially
hazardous activities until you know whether
13

24

29

10

Gabapentin 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.

eyes). The rash may progress to widespread
blistering or peeling of the skin. • a severe
condition of the skin (Erythema multiforme)
that may affect the mouth and other parts of
the body signs include red, often itchy spots,
similar to the rash of measles, which starts on
the limbs and sometimes on the face and the
rest of the body. The spots may blister or may
progress to form raised, red, pale-centered
marks. Those affected may have fever, sore
throat, headache and/or diarrhoea. • an
inflamed pancreas which may cause stomach
pain (spreading to the back) and being sick.
• kidney disease leading to passing less urine

injuries, such as broken bones, scratches or
bruises.
Uncommon (may affect up to 1 in 100 people)
• racing heartbeat • unusually reduced or slow
body movement • swelling that may involve
the trunk • increase in liver enzymes and
bilirubin seen in a blood test • fall • difficulty
with thinking • high blood sugar (most often
seen in patients with diabetes) • nettle rash or
itchy rash
Rare (may affect up to 1 in 1,000 people)
• low blood sugar (most often seen in patients
with diabetes) • loss of consciousness

08

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. In addition,
combination of gabapentin with opioids
may cause symptoms like sleepiness and/or
decrease in breathing.
Gabapentin is not expected to interact
with other antiepileptic medicines or oral
contraceptive pills containing norethindrone or
ethinyl estradiol.
Gabapentin may interfere with some
laboratory tests, if you require a urine test tell
your doctor or hospital that you are taking

Pharma Code 668
SAP No. N/A
Vendor Job No. 269153
Trackwise Proof No. 3
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info 5016695000732

33

31

you have a history of abuse or dependence.
During treatment
If you develop signs such as persistent stomach
pain, feeling sick and being sick contact your
doctor immediately as these may be signs of
acute pancreatitis (an inflamed pancreas).
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, contact
your doctor immediately.
Increase in seizures or new types of seizure
have been seen in some people taking
gabapentin. Talk to your doctor or pharmacist if

you notice a change to your condition.
If you experience any signs such as feeling
dizzy and drowsy (which could increase
accidental injury), confusion, loss of
consciousness and reduced mental state
while taking gabapentin, talk to you doctor or
pharmacist for advice.
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 the signs to look out for while

35

phosphokinase seen in a blood test • low levels
of sodium in the blood
Additional side effects in children
Aggressive behaviour was commonly reported.
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.

06

2. What you need to know before you take
Gabapentin
Do not take Gabapentin
• if you are allergic 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:
• if you suffer from kidney problems
• if you are on haemodialysis (to remove waste
products because of kidney failure).
Cases of abuse and dependence have been
reported for gabapentin. Talk to your doctor if
07

• 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 signs may be the first signs of a
serious reaction. A doctor should examine
you to decide if you should continue taking
Gabapentin.
Other possible side effects:
Very common (may affect more than 1 in
10 people)
• viral infection. • feeling drowsy, dizziness, lack

04

otherwise. Gabapentin can also be used on its
own to treat adults and children over 12 years
of age.
Peripheral neuropathic pain
Gabapentin is 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.
05

30

the environment.
6. Contents of the pack and other
information
What Gabapentin contains
The active substance is gabapentin.
Each hard capsule contains either 100 mg,
300 mg or 400 mg gabapentin.
The other ingredients are:
Capsule contents: lactose anhydrous (see
section 2, ‘Gabapentin contains lactose’), maize
starch and talc.
Capsule shell: gelatin.
The 100mg capsules contain the colouring
titanium dioxide (E171); the 300mg capsules

What is in this leaflet
1. What Gabapentin is and what it is used for
2. What you need to know before you take
Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Contents of the pack and other information

1. What Gabapentin is and what it is used for
Gabapentin belongs to a group of medicines
used to treat epilepsy and peripheral
neuropathic pain.
Epilepsy
Gabapentin is 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 for
you to help treat your epilepsy when your
current treatment is not fully controlling your
condition. You should take Gabapentin in
addition to your current treatment unless told

32

sensation (vertigo). • high blood pressure,
flushing or dilation of blood vessels. • shortness
of breath, chest infection (bronchitis), sore
throat and discomfort when swallowing,
cough, runny or blocked nose. • vomiting
(being sick), nausea (feeling sick), problems
with teeth, inflamed gums, diarrhoea, stomach
pain, indigestion, constipation, dry mouth or
throat, wind. • facial swelling, bruises, acne. •
joint pain, muscle pain, back pain, twitching.
• difficulty getting or maintaining an erection.
• swelling in the legs and arms difficulty with
walking, pain, generally feeling unwell, flu-like
symptoms. • increase in weight. • accidental

100 hard capsules
Each 400 mg hard capsule contains: 400 mg
of gabapentin. This product contains: lactose
monohydrate. Read the package leaflet before use.
For oral use. Take as directed by the doctor. Keep
out of the reach and sight of children. Do not
store above 25°C. Keep the container tightly closed.

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.

03

Not known (frequency cannot be estimated
from the available data)
• sensing things that are not real
(hallucinations) • ringing in the ears • problems
with abnormal movements such as writhing,
jerking movements and stiffness affecting
the eyes, head, neck and body • hair loss •
uncontrolled passing of urine • increased breast
tissue, breast enlargement in males •problems
with sexual functioning including changes
in sex drive, inability to reach a sexual climax,
delayed ejaculation • signs of withdrawal (such
as anxiety, difficulty sleeping, feeling sick, pain,
sweating), chest pain • increase in creatine

1000 capsules or in containers of 50, 100,
200 or 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road,, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters
Bar, Hertfordshire, EN6 1TL
United Kingdom.
Date of revision February 2016

Gabapentin Mylan
400 mg hard capsules

02

Package Leaflet: Information for the Patient
Gabapentin 100 mg Hard Capsules
Gabapentin 300 mg Hard Capsules
Gabapentin 400 mg Hard 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
only. Do not pass it on to others. It may harm

34

5. How to store Gabapentin
Keep this medicine out of sight and reach of
children.
Do not use this medicine after the expiry date,
which is stated on the label, carton or bottle
after ‘EXP’. The expiry date refers to the last day
of that month.
Do not store above 25 °C.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: Store in the original package.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect

400
mg

PL 04569/0667  POM
770494 LL0444AI
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

36

contain the colourings: titanium dioxide (E171)
and iron oxide yellow (E172) and the 400mg
capsules contain the colourings titanium
dioxide (E171), iron oxide yellow (E172) and
iron oxide red (E172).
What Gabapentin looks like and contents of
the pack
Each hard gelatin capsule contains a white
powder.
Capsule, hard body and cap: the 100 mg
capsules are white, the 300 mg capsules are
yellow and the 400 mg capsules are orange.
Gabapentin is available in blister packs of
10, 20, 30, 50, 60, 90, 100, 200, 250, 500 or

5 016695 000732

BASE LABEL

TOP LABEL

23

Gabapentin is too strong or too weak, talk to
your doctor or pharmacist.
Always swallow the capsules whole with plenty
of water. This medicine may be taken with or
without food.
Continue taking Gabapentin until your doctor
tells you to stop.
Epilepsy:
Use in 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

dose. Do not take a double dose to make up for
a forgotten capsule.
If you stop taking Gabapentin
Do not stop taking Gabapentin 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 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.

day, usually once in the morning, once in the
afternoon and once in the evening.
Gabapentin is not recommended for use in
children below 6 years of age.
Peripheral Neuropathic Pain:
Take the number of capsules as instructed by
your doctor. Your doctor will usually build up
your dose gradually.
The recommended 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.
Older patients
If you are an elderly patient (over 65 years of
age), you should take Gabapentin normally
except you have problems with your kidneys.
Patients with 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 take more Gabapentin 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

18

21

19

Date: 12 Feb 2016

Time: 17:51
Page Count

No. of colours 4
Colours
Non-Print
Colours

Black

PMS 306

PMS
Rhodamine Red

Keyline

Braille

Glue
Free Area

1/1

PMS
2905

Equate CMYK
with
Main Font Myriad Pro

Body Text Size 8 pt

Dimensions 47 x 101mm

Min Text Size used 4 pt

Sign-offs

v1/May 2015

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