GABAPENTIN 800 MG TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Gabapentin 600mg Tablets
Gabapentin 800mg 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 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 (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, soya, peanut or any of the other
ingredients of Gabapentin.

Take special care with Gabapentin
• if you suffer from kidney problems (your doctor
may prescribe a different dosing schedule);
• if you are on haemodialysis (a procedure to
remove waste materials from blood 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 or 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.

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.

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 medicines 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.

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

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 medicines used to treat seizures have
reported an increased risk of harm to the foetus,
particularly when more than one seizure medicine
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
Tablets, is passed on through human milk.
Because the effect on the baby 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 medicine
affects your ability to perform these activities.

Ask your doctor or pharmacist for advice before
taking any medicine.
Important information about some of the
ingredients of Gabapentin
Gabapentin contains lecithin of soya. If you are
allergic to peanut or soya, do not take this
medicine.

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.

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.
Epilepsy, the usual dose is:

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.

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 per 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.

Continued on the next page >>

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 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.
Method and route of administration
Gabapentin is for oral use. Always swallow the
tablets with plenty of water.

If you have kidneys 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 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 if you take more Gabapentin than
your doctor prescribed. Take along any tablets
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 period of time (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 product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Gabapentin 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).
If you are on haemodialysis, tell your doctor if you
develop muscle pain and/or weakness.

Other side effects include:

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 (inflammation of the lung),
respiratory infection, urinary tract infection,
inflammation of the ear or other infections
• Low white blood cell counts
• Anorexia (loss of appetite), 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
(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
• A group of side effects that 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

Other possible side effects

Lecithin of soya may very rarely cause allergic
reactions.

If any of the side effects become 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 carton and blisters. The expiry
date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.

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

Possible side effects

What Gabapentin contains
The active substance is gabapentin. Each
film-coated tablet contains 600 mg or 800 mg
gabapentin.

The other ingredients in Gabapentin tablets are:
Tablet core: macrogol 4000, pregelatinised starch
from maize, silica, colloidal anhydrous,
magnesium stearate.
Film-coating: poly (vinyl alcohol), titanium dioxide
(E171), talc, lecithin of soya, xanthan gum.

What Gabapentin looks like and contents of
the pack
The 600 mg film-coated tablets are white,
capsule-shaped film-coated tablets with a logo
(600) embossed on one side.

The 800 mg film-coated tablets are white,
capsule-shaped film-coated tablets.

The film coated tablets are supplied in
PVC/aluminium blister packs of 50, 60, 90, 100,
200, 200 (2x100) and samples with 20 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Zambon S.p.A,
Via della Chimica 9, 36100 - Vicenza, Italy.
or

Klocke Verpackungs-Service GmbH,
Max-Becker-Str. 6, 76356 Weingarten, Germany.
or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany.
or

Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany.

This leaflet was last approved in 08/2011 (to be
amended after approval).
SZ00000LT000

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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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