GABAPENTIN 800MG FILM-COATED TABLETS

Active substance: GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
600 MG FILM-COATED TABLETS
800 MG FILM-COATED TABLETS
[To be completed nationally]
(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 side effect 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 is and what it is used for
2.
Before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Further information.
1.

WHAT IS AND WHAT IT IS USED FOR

belongs to a group of medicines used to treat epilepsy and peripheral neuropathic
pain.
Epilepsy: 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 for you to help treat your epilepsy when your current
treatment is not fully controlling your condition. You should take in addition to
your current treatment unless told otherwise. can also be used on its own to treat
adults and children over 12 years of age.
Peripheral neuropathic pain: is used to treat 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.

BEFORE YOU TAKE

Do not take
if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of
.
Take special care with
- if you suffer from kidney problems
- if you develop signs such as persistent stomach pain, feeling sick and being sick contact your
doctor immediately.
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.

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Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
If you are taking any medicines containing morphine, please tell your doctor or pharmacist as
morphine may increase the effect of .
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 that you are taking .
If and antacids containing aluminium and magnesium are taken at the same time,
absorption of from the stomach may be reduced. It is therefore recommended that
is taken at the earliest two hours after taking an antacid.
Taking with food and drink
can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 foetus, particularly when
more than one seizure medication is taken at the same time. Therefore, whenever possible and only
under advice of your doctor, you should try to take only one seizure medication during pregnancy.
Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which
could have 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, the active substance of , 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
.
Driving and using machines
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

Always take 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.

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If you have the impression that the effect of is too strong or too weak, talk to your
doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take normally
except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your
kidneys.
Always swallow the tablets whole with plenty of water.
Continue taking until your doctor tells you to stop.
Peripheral Neuropathic Pain:
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.
Epilepsy:
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 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 the 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 tablets each day, usually once in the morning, once in the afternoon and
once in the evening.
is not recommended for use in children below 6 years of age.
The 600mg and 800mg tablets may be halved. Gabapentin is also available in 100mg and 300mg
strengths.
If you take more than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take along any tablets that
are left, the container and the label so that the hospital can easily tell what medicine you have taken.
If you forget to take
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 a forgotten dose.
If you stop taking

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Do not stop taking 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 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, can cause side effects, although not everybody gets them.
Very common side-effects which may affect more than 1 person in 10 are listed below:




Viral infection
Feeling drowsy, dizziness, lack of coordination
Feeling tired, fever

Common side-effects which may affect more than 1 person in 100 are listed below:


















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 nose
Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhea,
stomach pains, indigestion, constipation, dry mouth or throat, flatulence
Facial swelling, bruises, rash, itch, acne
Joint pain, muscle pain, back pain, twitching
Incontinence
Difficulties with erection
Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, difficulty
with walking, weakness, pain, feeling unwell, flu-like symptoms
Decrease in white blood cells, increase in weight
Accidental injury, fracture, abrasion

Rare side-effects which may affect less than 1 person in 1000 are listed below:











Decreased platelets (blood clotting cells)
Allergic reaction such as hives
Hallucinations
Problems with abnormal movements such as writhing, jerking movements and stiffness
Ringing in the ears
Racing heartbeat
Inflammation of the pancreas
Inflammation of the liver, yellowing of the skin and eyes
Severs skin reactions that require immediate medical attention, swelling of the lips and face, skin
rash and redness, hair loss
Acute kidney failure
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Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping,
feeling sick, pain, sweating), chest pain
Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting
problems with the liver.

Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported
commonly.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5.

HOW TO STORE

Keep out of the reach and sight of children.
Do not store above 25oC. Store in the original package in order to protect from moisture.
Do not use after the expiry date which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
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 contains
-

The active substance is gabapentin.
The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, hydrogenated
castor oil, sodium lauril sulphate, and magnesium stearate. The tablet film-coating consists of
cellulose microcrystalline, carrageenan, macrogol, hydroxyethylcellulose, maltodextrin and
titanium dioxide (E171).

What looks like and contents of the pack
Gabapentin 600mg Film-coated Tablets: White, film-coated tablets, oblong biconvex, grooved on both
sides.
Gabapentin 800mg Film-coated Tablets: White, film-coated tablets, oblong, biconvex, grooved on one
side.
is available in blisters of 10 tablets in packs of 20, 30, 50, 60, 90, 100, 120, 180,
200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
[To be completed nationally]
Manufacturer:
[To be completed nationally]

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This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria
Belgium
Cyprus
Greece
Poland
Portugal
The Netherlands
United Kingdom

‘Gabapentin Arcana 600 mg & 800 mg – Filmtabletten’
‘Gabapentine Mylan 600 mg & 800 mg Filmomhulde Tabletten’’
‘Gabapentin/Generics 600 mg & 800 mg Tablets’
‘Gabapentin/Generics 600 mg & 800 mg Tablets’
‘Izumyl’
‘Gabapentin Anova’
‘Gabapentine Mylan 600 mg & 800 mg Filmomhulde Tabletten’
‘Gabapentin 600 mg & 800 mg Film-coated Tablets’

This leaflet was last approved in {08/2010}.
[To be completed nationally]

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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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