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GABAPENTIN TEVA 800MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN

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Transcript
TEVA UK Ref:

Version:

231-30-63706-ZA LEA GABAPENTIN A/S TAB TUK

1

7 October 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Gabapentin
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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.
2.
3.
4.
5.
6.

What Gabapentin is and what it is used for
What you need to know before you take Gabapentin
How to take Gabapentin
Possible side effects
How to store Gabapentin
Contents of the pack and other information

1

What Gabapentin is and what it is used for

Pharma code 494

Gabapentin belongs to a group of medicines used to
treat epilepsy and peripheral neuropathic pain (longlasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Tablets is
gabapentin.
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 otherwise.
• Gabapentin can also be used on its own to treat adults
and children over 12 years of age.
Peripheral neuropathic pain
• peripheral neuropathic pain (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

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 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
• 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 post- marketing 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.

REG0065202

Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicines containing morphine
If you are taking any medicines containing morphine,
please tell your doctor or pharmacist as morphine may
increase the effect of 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 the
earliest two hours after taking an antacid.
• Gabapentin is not expected to interact with other
anti-epileptic drugs or the oral contraceptive pill.
• Gabapentin may interfere with some laboratory tests;
if you require a urine test tell your doctor or hospital
that you are taking Gabapentin.
Gabapentin with food and drink
• Gabapentin can be taken with or without food.
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
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.
Contact your doctor immediately if you become
pregnant, think you might be pregnant or are planning to
become pregnant while taking Gabapentin.
Do not suddenly discontinue taking this medicine as this
may lead to breakthrough seizure, which could have
serious consequences for you and your baby.
Breast-feeding
Gabapentin, the active substance of Gabapentin Tablets,
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.
Driving and using machines
Gabapentin 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.

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.
For lower dosages, which cannot be applied with these
strengths, other strengths and dosage forms are
available.
If you have the impression that the effect of Gabapentin
is too strong or too weak, talk to your doctor or
pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you
should take the normal dose of Gabapentin unless you
have problems with your kidneys. Your doctor may
prescribe a different dosing schedule and/or dose if you
have problems with your kidneys.
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.
Continue taking Gabapentin until your doctor tells you to
stop.
The recommended dose for treating epilepsy

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’

Adults and adolescents:
Take the number of tablets 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.

Muscle weakness, tenderness or pain and particularly, if
at the same time, you feel unwell or have a high
temperature it may be caused by an abnormal muscle
breakdown which can be life-threatening and lead to
kidney problems. You may also experience discoloration
of your urine, and a change in blood test results (notably
blood creatine phosphokinase increased). If you
experience any of these signs or symptoms, please
contact your doctor immediately.

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
tablet(s) each day, usually once in the morning, once
in the afternoon and once in the evening.

Version 4.7

Top of page cut-off to middle of registration mark: 44 mm.

GABAPENTIN Teva 600 mg
and 800 mg
Film-coated TABLETS

Approved

Page 1 of 3

TEVA UK Ref:

Version:

231-30-63706-ZA LEA GABAPENTIN A/S TAB TUK

1

7 October 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Gabapentin is not recommended for use in children
below 6 years of age.
The recommended dose for treating Peripheral
Neuropathic Pain:
Adults:
Take the number of tablets 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
as instructed by your doctor up to a maximum of
3600 mg each day and your doctor will tell you to take
this in 3 separate doses, i.e. once in the morning, once in
the afternoon and once in the evening.
Method and route of administration
Gabapentin is for oral use. Always swallow the tablets
whole with plenty of water.
If you take more Gabapentin 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 casualty
department immediately. As Gabapentin tablets 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, loss of
consciousness, drowsiness and mild diarrhea. Take along
any tablets that are left that you have not taken, together
with the container and the label so that the hospital can
easily tell what medicine you have taken.
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 dose. DO NOT
take a double dose to make up for a forgotten dose.
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 will get them.
Contact your doctor immediately if you experience any
of the following symptoms after taking this medicine as
they can be serious:
• severe skin reactions such as swelling of the lips and
face, skin rash and redness, and/or hair loss.
• persistent stomach pain, feeling sick and being sick as
these may be symptoms of acute pancreatitis (an
inflamed pancreas)
• 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 hospitalized or to
stop Gabapentin. 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.
If you are on haemodialysis, tell your doctor if you
develop muscle pain and/or weakness.
Other side effects include:
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 infection, urinary tract
infection, other infections, 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
(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, dry
nose
• Vomiting (being sick), nausea (feeling sick), problems
with teeth, inflamed gums, diarrhoea, stomach pain,
indigestion, constipation, dry mouth or throat,
flatulence

REG0065202

Version 4.7






Facial swelling, bruises, rash, itch, 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, flu-like 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.
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.
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in patients
with diabetes)
Rare (may affect up to 1 in 1,000 people):
• Loss of consciousness
• Low blood sugar (most often observed in patients with
diabetes)
Since introduction to the market the following
side-effects have been reported:
• 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
• Inflammation of the liver, yellowing of the skin and
eyes (jaundice)
• 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)
• Change in blood test results (creatine phosphokinase
increased)
• Problems with sexual functioning including inability to
achieve a sexual climax, delayed ejaculation
• Hyponatraemia
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.

5

How to store Gabapentin

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.
Do not store above 25°C. 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 the environment.

6

Contents of the pack and other information

What Gabapentin Teva contains
• The active substance is gabapentin. Each film-coated
tablet contains either 600 mg or 800 mg gabapentin.
• The other ingredients are:
Core: povidone, cellulose, microcrystalline,
crospovidone, talc, hydrogenated vegetable
(soyabean) oil Type I
Coating: hypromellose, titanium dioxide (E171),
macrogol 400.
What Gabapentin Teva looks like and contents of the
pack
• Gabapentin 600 mg Tablets are white to off-white, oval
shaped, bevelled edged, film-coated tablets, engraved
“7173” on one side, and “93” on the other side.
• Gabapentin 800 mg Tablets are white to off-white, oval
shaped, bevelled edged, film-coated tablets, engraved
“7174” on one side, and “93” on the other side.
• Gabapentin Tablets are available in blister packs of 10,
28, 50, 84, 90, 100 or 200 tablets, or in bottles (HDPE)
of 28, 50, 90, 100, 200 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG, England.
This leaflet was last revised: September 2015
PL 00289/0593-0594

Approved

63706-ZA

Page 2 of 3

TEVA UK Ref:

Version:

231-30-26541-E LEA GABAPENTIN A/S TAB TUK
1

7 October 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Gabapentin
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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.
2.
3.
4.
5.
6.

What Gabapentin is and what it is used for
What you need to know before you take Gabapentin
How to take Gabapentin
Possible side effects
How to store Gabapentin
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 (longlasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Tablets is
gabapentin.
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 otherwise.
• Gabapentin can also be used on its own to treat adults
and children over 12 years of age.
Peripheral neuropathic pain
• peripheral neuropathic pain (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

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 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
• 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 post- marketing 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.

Pharma code
TBC

REG0076652

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.

Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicines containing morphine
If you are taking any medicines containing morphine,
please tell your doctor or pharmacist as morphine may
increase the effect of 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 the
earliest two hours after taking an antacid.
• Gabapentin is not expected to interact with other
anti-epileptic drugs or the oral contraceptive pill.
• Gabapentin may interfere with some laboratory tests;
if you require a urine test tell your doctor or hospital
that you are taking Gabapentin.
Gabapentin with food and drink
• Gabapentin can be taken with or without food.
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
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.
Contact your doctor immediately if you become
pregnant, think you might be pregnant or are planning to
become pregnant while taking Gabapentin.
Do not suddenly discontinue taking this medicine as this
may lead to breakthrough seizure, which could have
serious consequences for you and your baby.
Breast-feeding
Gabapentin, the active substance of Gabapentin Tablets,
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.
Driving and using machines
Gabapentin 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.

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.
For lower dosages, which cannot be applied with these
strengths, other strengths and dosage forms are
available.
If you have the impression that the effect of Gabapentin
is too strong or too weak, talk to your doctor or
pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you
should take the normal dose of Gabapentin unless you
have problems with your kidneys. Your doctor may
prescribe a different dosing schedule and/or dose if you
have problems with your kidneys.
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.
Continue taking Gabapentin until your doctor tells you to
stop.
The recommended dose for treating epilepsy

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’

Adults and adolescents:
Take the number of tablets 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.

Muscle weakness, tenderness or pain and particularly, if
at the same time, you feel unwell or have a high
temperature it may be caused by an abnormal muscle
breakdown which can be life-threatening and lead to
kidney problems. You may also experience discoloration
of your urine, and a change in blood test results (notably
blood creatine phosphokinase increased). If you
experience any of these signs or symptoms, please
contact your doctor immediately.

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
tablet(s) each day, usually once in the morning, once
in the afternoon and once in the evening.

Version 3.7

Pharma code
TBC

GABAPENTIN Teva 600 mg
and 800 mg
Film-coated TABLETS

Approved

Page 1 of 3

TEVA UK Ref:

Version:

231-30-26541-E LEA GABAPENTIN A/S TAB TUK
1

7 October 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The recommended dose for treating Peripheral
Neuropathic Pain:
Adults:
Take the number of tablets 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
as instructed by your doctor up to a maximum of
3600 mg each day and your doctor will tell you to take
this in 3 separate doses, i.e. once in the morning, once in
the afternoon and once in the evening.
Method and route of administration
Gabapentin is for oral use. Always swallow the tablets
whole with plenty of water.
If you take more Gabapentin 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 casualty
department immediately. As Gabapentin tablets 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, loss of
consciousness, drowsiness and mild diarrhea. Take along
any tablets that are left that you have not taken, together
with the container and the label so that the hospital can
easily tell what medicine you have taken.
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 dose. DO NOT
take a double dose to make up for a forgotten dose.
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 will get them.
Contact your doctor immediately if you experience any
of the following symptoms after taking this medicine as
they can be serious:
• severe skin reactions such as swelling of the lips and
face, skin rash and redness, and/or hair loss.
• persistent stomach pain, feeling sick and being sick as
these may be symptoms of acute pancreatitis (an
inflamed pancreas)
• 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 hospitalized or to
stop Gabapentin. 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.
If you are on haemodialysis, tell your doctor if you
develop muscle pain and/or weakness.
Other side effects include:
Very common (may affect more than 1 in 10 people):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever.

Pharma code
TBC

Common (may affect up to 1 in 10 people):
• Pneumonia, respiratory infection, urinary tract
infection, other infections, 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
(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, 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
• Difficulties with erection (impotence)
• Swelling in the legs and arms, difficulty with walking,
weakness, pain, feeling unwell, flu-like 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.
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.
• Fall
• Difficulty with thinking
• High blood sugar (most often observed in patients
with diabetes)

Pharma code
TBC

Gabapentin is not recommended for use in children
below 6 years of age.

Rare (may affect up to 1 in 1,000 people):
• Loss of consciousness
• Low blood sugar (most often observed in patients with
diabetes)
Since introduction to the market the following
side-effects have been reported:
• 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
• Inflammation of the liver, yellowing of the skin and
eyes (jaundice)
• 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)
• Change in blood test results (creatine phosphokinase
increased)
• Problems with sexual functioning including inability to
achieve a sexual climax, delayed ejaculation
• Hyponatraemia
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.

5

How to store Gabapentin

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.
Do not store above 25°C. 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 the environment.

6

Contents of the pack and other information

What Gabapentin Teva contains
• The active substance is gabapentin. Each film-coated
tablet contains either 600 mg or 800 mg gabapentin.
• The other ingredients are:
Core: povidone, cellulose, microcrystalline,
crospovidone, talc, hydrogenated vegetable
(soyabean) oil Type I
Coating: hypromellose, titanium dioxide (E171),
macrogol 400.
What Gabapentin Teva looks like and contents of the
pack
• Gabapentin 600 mg Tablets are white to off-white, oval
shaped, bevelled edged, film-coated tablets, engraved
“7173” on one side, and “93” on the other side.
• Gabapentin 800 mg Tablets are white to off-white, oval
shaped, bevelled edged, film-coated tablets, engraved
“7174” on one side, and “93” on the other side.
• Gabapentin Tablets are available in blister packs of 10,
28, 50, 84, 90, 100 or 200 tablets, or in bottles (HDPE)
of 28, 50, 90, 100, 200 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder- TEVA UK Limited,
Eastbourne, BN22 9AG, England
Company responsible for manufacture: Teva
pharmaceutical works private limited company,
Pallagi ut 13, 4042 Debrecen, Hungary
This leaflet was last revised: September 2015
PL 00289/0593-0594

26541-E

REG0076652

Version 3.7

Approved

Page 2 of 3

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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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