GABAPENTIN 800 MG FILM-COATED TABLETS

Active substance: GABAPENTIN

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Gabapentin UK

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gabapentin 100 mg capsules, hard
Gabapentin 300 mg capsules, hard
Gabapentin 400 mg capsules, hard
Gabapentin 600 mg film-coated tablets
Gabapentin 800 mg film-coated 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 (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 [MAH] 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.

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2.

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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 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 Pfizer 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 Pfizer.
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.
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 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.
Taking Gabapentin with food and drink
Gabapentin can be taken with or without food.
Pregnancy and breast feeding
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.
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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 a breakthrough seizure, which could have serious consequences for you and your baby.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Gabapentin
Gabapentin capsules, hard contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
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.
Epilepsy, the usual dose is:
Adults and adolescents:
Take the number of capsules or 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.
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 per day. It is usually given
in 3 separate doses, by taking the capsule(s) or 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 capsules or 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

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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 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 and route of administration
Oral use.
Always swallow the capsules or tablets with plenty of water. The tablet can be divided into equal
halves.
Continue taking Gabapentin until your doctor tells you to stop.
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 capsules or 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 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)
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:

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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
(affects more than 1 user in 10):




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

Common side-effects
(affects 1 to 10 users in 100):

















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.

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Uncommon side-effects
(affects 1 to 10 users in 1,000):
 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
 Breakdown of muscle fibers (rhabdomyolysis)
 Change in blood test results (creatine phosphokinase increased)
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 label and blister foil after
EXP. The expiry date refers to the last day of that month.
Gabapentin capsules, hard: do not store above 30°C
Gabapentin film-coated tablets: 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
Gabapentin capsules, hard
The active substance is gabapentin.
Each hard capsule contains either 100 mg, 300 mg or 400 mg gabapentin.
The other ingredients in Gabapentin capsules are:
Capsule contents:
lactose monohydrate
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maize starch
talc
Capsule shell 100 mg:
gelatin
sodium laurilsulfate
titanium dioxide (E171)
Capsule shell 300 mg:
gelatin
sodium laurilsulfate
titanium dioxide (E171)
yellow iron oxide (E172)
Capsule shell 400 mg:
gelatin
sodium laurilsulfate
titanium dioxide (E171)
yellow iron oxide (E172)
red iron oxide (E172)
Printing ink:
shellac
titanium dioxide (E171)
Indigocarmine aluminium salt (E132)
Gabapentin film-coated tablets
The active substance is gabapentin. Each film-coated tablet contains either 600 mg or 800 mg
gabapentin
The other ingredients in Gabapentin film-coated tablets are:
Poloxamer 407 (ethylene oxide and propylene oxide)
copovidone
maize starch
magnesium stearate
Fim-coating:
Opadry white YS-1-18111
Hydroxypropylcellulose
Talc
What Gabapentin looks like and contents of the pack
Capsules, hard
The 100 mg capsules are white hard capsules marked with "G" and “5026”.
The 300 mg capsules are yellow hard capsules marked with "G" and “5027”.
The 400 mg capsules are orange hard capsules marked with "G" and “5028”.
Supplied in PVC/PVDC/aluminium foil blisters of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000
capsules.
Not all pack sizes may be marketed.
Film-coated tablets
The tablets 600 mg tablets are white, elliptical film-coated tablets with a bisecting score on both sides
and debossed with “NT” and “16” on one side.
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The 800 mg tablets are white, elliptical film-coated tablets with a bisecting score on both sides and
debossed with “NT” and “26” on one side.
The tablet can be divided into equal halves.
Supplied in PVC/PE/PVDC/aluminium foil blisters or PVC/PVDC/aluminium foil blisters of 20, 30,
45, 50, 60, 84, 90, 100, 200, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, UK
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
D-79090 Freiburg
Germany
Company contact address: Medical Information Department, Pfizer Limited, Walton Oaks, Dorking
Road, Tadworth, Surrey KT20 7NS. Telephone: 01304 616 161.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Gabapentin Pfizer 300/400 mg Hartkapseln; Gabapentin Pfizer 600/800 mg
Filmtabletten
Belgium
Gabapentine Pfizer 100/300/400 mg gélules/ harde capsules/ Hartkapseln;
Gabapentine Pfizer 600/800 mg comprimés pelliculés/ filmomhulde tabletten/
Filmtabletten
Denmark
Gabapentin Pfizer
Finland
Gabapentin Pfizer
France
Gabapentine Pfizer
Germany
Gabapentin Pfizer 100/300/400 mg Hartkapseln; Gabapentin Pfizer
600/800 mg Filmtabletten
Ireland
Gabapentin Pfizer 100/300/400 mg Hard Capsules; Gabapentin Pfizer
600/800 mg Film-Coated Tablets
Italy
Gabapentin Pfizer 100/300/400 mg capsule rigide; Gabapentin Pfizer
600/800 mg compresse rivestite con film
Luxembourg
Gabapentine Pfizer 100/300/400 mg gélules; Gabapentine Pfizer 600/800 mg
comprimés pelliculés
Portugal
Gabapentina Parke-Davis
Romania
Gabapentin Pfizer
Sweden
Gabapentin Pfizer
UK
Gabapentin 100/300/400 mg Hard Capsules; Gabapentin 600/800 mg Film
Coated Tablets
This leaflet was last revised in 04/2013
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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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