GABAPENTIN 800MG TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Gabapentin 600 mg Tablets
Gabapentin 800 mg Tablets

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.

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 (long lasting pain caused by damage to the
nerves).
The active ingredient in Gabapentin 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 (long lasting pain
caused by damage to the nerves): A variety of
different diseases can cause peripheral
neuropathic pain (primarily occurring in the
legs and/or arms), 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).
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 ʻContact your
doctor immediately if you experience any of the
following symptoms after taking this medicine as
they can be seriousʼ.
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.
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
antiepileptic drugs or the oral contraceptive pill.
• may interfere with some laboratory tests, if
you require a urine test tell your doctor or
hospital what you are taking.
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
developing baby, particularly when more than
one seizure medication is taken at the same time.
Therefore, whenever possible, you should try to
take only one seizure medication during pregnancy
and only under the advice of your doctor.
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,
is passed on through human milk. Because the
effect on the baby is unknown, it is not
recommended to breast-feed while using
Gabapentin.
Driving and using machines
Gabapentin may produce dizziness, drowsiness
and tiredness. You should not drive, operate
complex machinery or take part in other
potentially hazardous activities until you know
whether this medication affects your ability to
perform these activities.
Gabapentin contains castor oil.
This may cause stomach upset and diarrhoea.

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
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.

Continue taking Gabapentin until your doctor tells
you to stop.
Method and route of administration
Gabapentin is for oral use. Always swallow the
tablets whole with plenty of water. The tablets
can be divided into equal doses.

Epilepsy, the usual dose is:
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 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.

Continued on the next page >>

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
childʼs 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
per kg of body weight per day.
It is usually given in 3 separate doses, by taking
the tablet(s) 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.

Peripheral Neuropathic Pain, the usual dose is:
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
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.

If you take more Gabapentin than you should
Higher than recommended doses may result in
an increase in side effects including loss of
consciousness, dizziness, double vision, slurred
speech, drowsiness and diarrhoea.
Call your doctor or go to the nearest hospital
emergency unit immediately if you take more
Gabapentin than your doctor prescribed. Take
along any tablets 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 gets 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 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)
• 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 side effects (may affect more
than 1 in 10 people):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever

Common side effects (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, 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 side effects (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
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
• 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
• Blood glucose fluctuations in patients with diabetes.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

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 label after ʻEXPʼ. The
expiry date refers to the last day of that month.
Do not store above 25ºC

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 contains
• The active substance is gabapentin.
Each film-coated tablet contains either 600 mg
or 800 mg of gabapentin.
• the other ingredients on the tablet core:
cellulose microcrystalline;
hydroxypropylcellulose; castor oil;
hydrogenated, sodium laurilsulphate and
magnesium stearate;
Film-coating: lustre clear (containing:
microcrystalline cellulose, carrageenan,
macrogol) and titanium dioxide (E171).

What Gabapentin looks like and contents of
the pack
Gabapentin 600 mg Film-coated Tablet: White,
film-coated tablet, oblong, biconvex, scored on
both sides.
Gabapentin 800 mg Film-coated Tablet: White,
film-coated tablet, oblong, biconvex, scored on
both sides.
Gabapentin PVC/PVdC/aluminium: 20, 30, 50,
60, 90, 100, 200 or 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Combino Pharm S.L., c/Fructuos Gelabert 6-8,
08970-Sant Joan Despi, Barcelona, Spain or
Salutas Pharma GmbH, Dieselstrasse 5, 70839
Gerlingen, Germany or Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany.
This leaflet was last revised in 04/2014.

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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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