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GABAPENTIN SANDOZ 600 MG TABLETS

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Gabapentin 600mg Tablets
Gabapentin 800mg 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 (see section 4).

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 substance 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

What you need to know before you
take Gabapentin

Do not take Gabapentin
• if you are allergic to gabapentin, soya, peanut 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 (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 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 the symptoms to
look out for while you are taking Gabapentin.
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’.
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.
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.
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Medicines 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 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
Gabapentin can be taken with or without food.
Pregnancy, breast-feeding and fertility
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
Tablets, is passed on through human milk. Because the
effect on the baby is unknown, it is not recommended
to breast-feed while using Gabapentin.
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.
Fertility
There is no effect on fertility in animal studies.
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 lecithin of soya.
If you are allergic to peanut or soya, do not take this
medicine.

3

How to take Gabapentin

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will determine what dose is
appropriate for you.
Epilepsy, the recommended 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 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 per kg
of body weight 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.
Gabapentin is not recommended for use in
children below 6 years of age.
Peripheral Neuropathic Pain, the
recommended 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
Continued on the next page >>

tell you to take this in 3 divided 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 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 the impression that the effect of
Gabapentin is too strong or too weak, talk to your
doctor or pharmacist as soon as possible.
Method of administration
Gabapentin is for oral use. Always swallow the tablets
with plenty of water.
Continue taking Gabapentin until your doctor tells you
to stop.
If you take more Gabapentin than you should
If you or someone else accidentally takes too many
film-coated tablets, or if you think a child has swallowed
any, contact your doctor or go to your nearest
hospital casualty department immediately. As
gabapentin film-coated 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
and mild diarrhoea.
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
medicine, ask your doctor or pharmacist.

4

problems with the liver
Mental impairment
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)
• Hyponatraemia
After marketing Gabapentin 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
• 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
• Low blood sodium level
Other possible side effects
Lecithin of soya may very rarely cause allergic
reactions.
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 Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.

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 (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 (inflammation of the lung),
respiratory infections, 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

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 and blisters. The expiry date
refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
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 600 mg or 800 mg
gabapentin.
The other ingredients 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 and Manufacturer
Marketing authorisation holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
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-Geuricke-Alee 1,
39179 Barleben, Germany
or
Salutas Pharma GmbH, Dieselstrasse 5, 70839
Gerlingen, Germany
This leaflet was last revised in 10/2015.

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

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Expand Transcript

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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