GABAPENTIN 800MG TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Gabapentin 600 mg Tablets
Gabapentin 800 mg Tablets

Gabapentin

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Gabapentin is and what it is used for
2. Before you take Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Further 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
• 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

Before you take Gabapentin

Do not take Gabapentin
• if you are allergic (hypersensitive) to
gabapentin or any of the other ingredients of
Gabapentin.

Take special care with Gabapentin
• if you suffer from kidney problems
• if you are on haemodialysis, 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
(these may be symptoms of acute
pancreatitis).
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.
Contact your doctor immediately if you
experience these symptoms.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Some medicines can affect the way Gabapentin
works, or Gabapentin itself can reduce the
effectiveness of other medicines taken at the
same time. These include:

• any medicines containing morphine, please tell
your doctor or pharmacist as morphine may
increase the effect of Gabapentin.
• antacids, as 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 may interfere with some laboratory
tests, if you require a urine test tell your doctor or
hospital that you are taking Gabapentin.
You should not take Gabapentin in addition to
your current treatment unless told otherwise.

Taking Gabapentin with food and drink
Gabapentin can be taken with or without food.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

Pregnancy
Gabapentin should not be taken during
pregnancy, unless you are told otherwise by your
doctor. If you discover you are pregnant, do not
suddenly discontinue taking this medicine as this
may lead to serious consequences for you and
your baby.

Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning to become pregnant while taking
Gabapentin.

Effective contraception must be used by women
of child-bearing age.

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 unless told to do so by your doctor.

Driving and using machines
Gabapentin may produce dizziness, drowsiness
and tiredness. If you experience these
symptoms, do not drive or use any tools and
machinery until you know whether this
medication affects your ability to perform these
activities.
Important information about some of the
ingredients of Gabapentin:
The tablets contain castor oil. This may cause
stomach upset and diarrhoea.

3

How to take Gabapentin

Always take Gabapentin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.

Your doctor will determine what dose is
appropriate for you.

Always swallow the tablets with plenty of water.
The tablets can be divided into equal halves.

Continue taking Gabapentin until your doctor tells
you to stop.

Epilepsy:
Adults and adolescents:
Take the number of tablets as instructed. Your
doctor will usually build up your dose gradually.
The usual 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.

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 initially with a low initial
dose which is gradually increased over a period
of approximately 3 days.
The usual starting 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:
Adults:
Take the number of tablets as instructed by your
doctor. Your doctor will usually build up your dose
gradually.
The usual 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

Elderly
If you are an elderly patient (over 65 years of
age), you should take the normal dose of
Gabapentin except if you have problems with
your kidneys.

Continued on the next page >>

If you have kidneys problems or are receiving
heamodialysis
Your doctor may prescribe a different dosing
schedule and/or dose if you have problems with
your kidneys or are undergoing haemodialysis.
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 take more Gabapentin than you should
Higher than recommended doses may result in
an increase in undesirable 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. 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, pain or discomfort.
Adverse events following the abrupt
discontinuation of gabapentin include the
following: anxiety, difficulty sleeping, feeling sick,
pain, sweating and chest pain.
Please tell your doctor if you have any of the
following symptoms.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

Possible side effects

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

Tell your doctor immediately if you experience
any of the following symptoms after taking this
medicine. Although they are very rare, these
symptoms can be serious.
• Swelling of the lips and face, skin rash and
redness and/or hair loss (these may be
symptoms of a serious allergic reaction),
• If you are on haemodialysis, tell your doctor if
you develop muscle pain and/or weakness,
• Persistent stomach pain, feeling sick and being
sick (these may be symptoms of acute
pancreatitis)
Other possible side effects during treatment:

Very common side-effects (which may affect
more than 1 person in 10):

• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever
Common side-effects (which may affect more
than 1 person in 100):

• Pneumonia, respiratory infection, urinary tract
infection, infection, 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, 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 or runny 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
• 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.
Uncommon side-effects (which may affect more
than 1 person in 1000):
• 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
• Inflammation of the pancreas
• 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
• Blood glucose fluctuations in patients with
diabetes.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

How to store Gabapentin

Keep out of the reach and sight of children.

Do not use Gabapentin 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 25°C

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

Further information

What Gabapentin 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 Tablet: White, film-coated
tablet, oblong, biconvex, scored on both sides.

Gabapentin 800 mg 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 approved in 06/2011 (to
be amended after approval).

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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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