Skip to Content

UK Edition. Click here for US version.

GABAPENTIN 600 MG TABLETS

Active substance(s): GABAPENTIN

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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 Mylan is and what it is used for
2. What you need to know before you take
Gabapentin Mylan
3. How to take Gabapentin Mylan
4. Possible side effects
5. How to store Gabapentin Mylan
6. Contents of the pack and other information

1. What Gabapentin Mylan is and what it is
used for
Gabapentin belongs to a group of medicines used to
treat epilepsy and peripheral neuropathic pain (long
lasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Mylan
is gabapentin.
Epilepsy: Gabapentin Mylan 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 this medicine for you to help
treat your epilepsy when your current treatment
is not fully controlling your condition. You should
take Gabapentin Mylan in addition to your current
treatment unless told otherwise. Gabapentin Mylan
can also be used on its own to treat adults and
children over 12 years of age.
Peripheral neuropathic pain: Gabapentin Mylan 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.

2. What you need to know before you take
Gabapentin Mylan
Do not take Gabapentin Mylan:
• 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 Mylan:
• if you suffer from kidney problems - your doctor may
prescribe a different dosing schedule
• if you are on haemodialysis (to remove waste
products because of kidney failure) - tell your doctor
if you develop muscle pain and/or weakness.
Cases of abuse and dependence have been reported
for gabapentin. Talk to your doctor if 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
antiepileptics such as gabapentin have had thoughts of
harming or killing themselves. If at any time you have
these thoughts, contact your doctor immediately.

7505xxxx

TBC

Gabapentin Mylan 600 mg Tablets
Gabapentin Mylan 800 mg Tablets

Gabapentin Mylan 600 mg Tablets
Gabapentin Mylan 800 mg Tablets

Gabapentin Mylan 600 mg Tablets
Gabapentin Mylan 800 mg Tablets

TBC

7505xxxx

Package Leaflet: Information for the patient

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 you are taking this medicine.
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.
Medicine 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. In addition, combination of gabapentin
with opioids may cause symptoms like sleepiness
and/or decrease in breathing.
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 Mylan is
taken at least two hours after taking an antacid.
This medicine:
• is not expected to interact with other antiepileptic
medicines or oral contraceptive pills containing
norethindrone or ethinyl estradiol
• may interfere with some laboratory tests - if you
require a urine test tell your doctor or hospital what
you are taking.

Adults:
Take the number of tablets 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.

Epilepsy:
Use in adults and adolescents:
Take the number of tablets 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.
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 the 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 tablets each 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.

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
(foetus), particularly when more than one seizure
medication is taken at the same time. Therefore,
whenever possible and only under advice of your
doctor, you should try to take only one seizure
medication during pregnancy.

Method and route of administration
Gabapentin Mylan is for oral use.

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
this medicine.

Driving and using machines
Gabapentin Mylan may cause dizziness, drowsiness
and tiredness. You should not drive, operate
machinery or engage in other potentially hazardous
activities until you know whether this medication
affects your ability to perform these activities.

Date: 30 Oct 2015

Affiliate Item Code 745305

SAP No. N/A

Colours

Black

Non-Print
Colours

Codes

Supplier Code N/A

Peripheral Neuropathic Pain:

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.

No. of colours

Packing Site/Printer N/A

If you have the impression that the effect of
Gabapentin Mylan is too strong or too weak, talk to
your doctor or pharmacist.

Pregnancy
Gabapentin Mylan 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.

Pharma Code TBC

MA No. 04569/1320 & 1321

Your doctor will determine what dose is appropriate
for you.

Older patients
If you are an elderly patient (over 65 years of age), you
should take this medicine normally except if you have
problems with your kidneys.

Component Type Leaflet

TrackWise PR No. 745305

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.

Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

Description Gabapentin 600 mg,800 mg ALL

Superceded Affiliate Item Code 642867

3. How to take Gabapentin Mylan

Vendor Job No. 266533
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

You should swallow the tablets whole with plenty of
water. The tablet can be divided into equal doses.
This medicine may be taken with or without food.
Continue taking this medicine until your doctor tells
you to stop.

If you take more Gabapentin Mylan than you should
If you or someone else accidentally takes too many
tablets, or if you think a child has swallowed any,
contact your doctor or go to your nearest hospital
emergency department immediately. Take along any
tablets that are left, the container and the label so
that the hospital can easily tell what medicine you
have taken. Signs of an overdose include dizziness,
double vision, slurred speech, loss of consciousness,
drowsiness and mild diarrhoea.
If you forget to take Gabapentin Mylan
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 tablet.

Time: 10:03
Page Count

1/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 272 x 400 mm

Body Text Size 10.5 pt
Min Text Size used 7.5 pt

Sign-offs

v1/May 2015

If you stop taking Gabapentin Mylan
Do not stop taking this medicine 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.

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).
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)
• persistent stomach pain that spreads to the back,
feeling sick and being sick as these may be signs of
acute pancreatitis (an inflamed pancreas)
• potentially life-threatening skin rashes (StevensJohnson syndrome) appearing initially as reddish
target-like 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 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-centred marks. Those affected may have fever,
sore throat, headache and/or diarrhoea.
• kidney disease leading to passing less urine 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 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 hospitalised
or to stop this medicine.
Call your doctor right away if you have any of the
following signs:
• skin rash
• itchy, lumpy, 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 this medicine.

Other possible side effects:
Very common (may affect more than 1 in 10 people)
• viral infection
• feeling drowsy, dizziness, lack of coordination
• feeling tired.

Common (may affect up to 1 in 10 people)
• urinary tract infection, inflammation of the ear or
other infections
• loss of appetite, increased appetite
• anger towards others, confusion, mood swings,
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 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
pains, 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 injuries, such as broken bones, scratches
or bruises.
Uncommon (may affect up to 1 in 100 people)
• unusually reduced or slow body movement
• racing heartbeat
• swelling that may involve the trunk
• abnormal blood test results suggesting problems
with the liver
• fall
• difficulty with thinking
• high blood sugar (most often observed in patients
with diabetes).
Rare (may affect up to 1 in 1,000 people)
• low blood sugar (most often observed in patients
with diabetes
• loss of consciousness.
Not known (frequency cannot be estimated from the
available data)
• sensing things that are not real (hallucinations)
• problems with abnormal movements such as
writhing, jerking movements and stiffness affecting
the eyes, head, neck and body
• ringing in the ears
• hair loss
• problems with sexual functioning including changes
in sex drive, inability to reach a sexual climax,
delayed ejaculation
• uncontrolled passing of urine
• increased breast tissue, breast enlargement in males
• signs of withdrawal (anxiety, difficulty sleeping,
feeling sick, pain, sweating), chest pain
• blood glucose changes in patients with diabetes
• change in blood test results (increase in creatine
phosphokinase)
• low levels of sodium in the blood.

Do not store above 25°C.
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 the environment.

6. C
 ontents of the pack and other information
What Gabapentin Mylan contains
• The active substance is gabapentin.
• Each tablet contains 600 mg gabapentin.
• Each tablet contains 800 mg gabapentin.
• The other ingredients are hydroxypropylcellulose,
mannitol, poloxamer, crospovidone, talc,
magnesium stearate
What Gabapentin Mylan look like and contents of
the pack
Gabapentin Mylan 600 mg Tablets: White to off-white,
oval, biconvex, uncoated, beveled edged tablets
debossed with “MYLAN” on one side and “G” to the left
of the score and “24” to the right of the score on the
other side.


Gabapentin Mylan 800 mg Tablets: White to off-white,
oval, biconvex, uncoated, beveled edged tablets
debossed with “MYLAN” on one side and “G” to the left
of the score and “25” to the right of the score on the
other side.
Packs of 20, 30, 45, 50, 90 and 100 tablets are packed
in white opaque HDPE bottle with white opaque
polypropylene (PP) cap containing desiccant
(silica gel).
Packs of 20, 30, 45, 50, 60, 90, 100, 200, 250 and
500 are packed in OPA/Al/PVC blister.
Packs of 90 x 1 and 500 x 1 tablets are supplied as
OPA/Al/PVC perforated unit dose blister.
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
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1,
Hungary
This leaflet was last revised in May 2015

Additional side effects in children
Aggressive behaviour was commonly reported.
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
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Gabapentin Mylan
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 after EXP. The expiry date refers
to the last day of that month.
CODE No.: MH/DRUGS/25/NKD/89

Description Gabapentin 600 mg,800 mg ALL

Date: 30 Oct 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 745305

SAP No. N/A

Colours

Black

Non-Print
Colours

Codes

Superceded Affiliate Item Code 642867
TrackWise PR No. 745305
MA No. 04569/1320 & 1321
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 266533
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 10:03
Page Count

2/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 272 x 400 mm

Body Text Size 10.5 pt
Min Text Size used 7.5 pt

Sign-offs

v1/May 2015

745305

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