GABAPENTIN 800MG FILM-COATED TABLETS

Active substance: GABAPENTIN

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PATIENT INFORMATION LEAFLET
Gabapentin 600 mg & 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 Tablets are and what they are used for
2. Before you take Gabapentin Tablets
3. How to take Gabapentin Tablets
4. Possible side effects
5. How to store Gabapentin Tablets
6. Further information

Taking Gabapentin Tablets with food and drink
Gabapentin Tablets can be taken with or without food.
Pregnancy
Gabapentin Tablets 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 Tablets.
Effective contraception must be used by women of child-bearing age.
Breastfeeding
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 Tablets unless told to do so by
your doctor.
Ask your doctor or pharmacist for advice before taking any medicine

1. WHAT GABAPENTIN TABLETS ARE AND WHAT THEY ARE
USED FOR
Gabapentin Tablets belong to a group of medicines used to treat
epilepsy and peripheral neuropathic pain (long lasting pain caused by
damage to the nerves).

Driving and using machines
Gabapentin Tablets may produce dizziness, drowsiness and tiredness.
If you experience these symptoms, do not drive, or use any tools or
machinery until you know whether this medication affects your ability
to perform these activities.

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.

3. HOW TO TAKE GABAPENTIN TABLETS
Always take Gabapentin Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

2. BEFORE YOU TAKE GABAPENTIN TABLETS
Do not take Gabapentin Tablets
− if you are allergic (hypersensitive) to gabapentin or any of the other
ingredients of Gabapentin Tablets
Take special care with Gabapentin Tablets
− 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
Some medicines can affect the way Gabapentin Tablets work, or
Gabapentin Tablets themselves 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
Tablets.
Antacids, as absorption of Gabapentin Tablets from the stomach
may be reduced. It is therefore recommended that Gabapentin
Tablets are taken at the earliest two hours after taking an
antacid.

Gabapentin Tablets may interfere with some laboratory tests, if you
require a urine test tell your doctor or hospital what you are taking.
You should not take Gabapentin Tablets in addition to your current
treatment unless told otherwise.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

Your doctor will determine what dose is appropriate for you.
Always swallow the tablets whole with plenty of water.
Continue taking Gabapentin Tablets 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 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 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 Tablets are 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 Tablets unless you have problems with
your kidneys.
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 kidney or are undergoing
haemodialysis.

If you have the impression that the effect of Gabapentin Tablets is
too strong or too weak, talk to your doctor or pharmacist, as soon
as possible
If you take more Gabapentin Tablets 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 Tablets
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 Tablets
Do not stop taking Gabapentin Tablets 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 Tablets 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 medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin Tablets 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 side effects include:
Very common side effects (which may affect more than
1 person in 10)
Dizziness, lack of coordination, viral infection, feeling drowsy, feeling
tired, fever.
Common side effects (which may affect 1 to 10 persons in 100)
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.
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.
Also 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 (wind).
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 1-10 persons 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:
• Acute kidney failure, incontinence
• Inflammation of the pancreas
• Inflammation of the liver, yellowing of the skin and eyes (jaundice)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking
movements and stiffness
• Adverse events following the abrupt discontinuation of
gabapentin (anxiety, difficulty sleeping, feeling sick, pain,
sweating, chest pain)
• Increased breast tissue, breast enlargement
• Decreased platelets (blood clotting cells)
• Ringing in the ears
• Blood glucose fluctuations in patients with diabetes
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 TABLETS
Keep out of the reach and sight of children.
Do not use Gabapentin Tablets after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Do not store Gabapentin Tablets above 25°C. Store in the original
package in order to protect from moisture
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 Tablets contain
The active substance is gabapentin . Each film-coated tablet contains
either 600 mg or 800 mg gabapentin.
The other ingredients in Gabapentin Tablets are:
Tablet core: Poloxamer type 407, Copovidone, Sodium Starch
Glycolate type A, Hydrogenated vegetable oil, Talc, Colloidal silica
anhydrous. Coating: Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol, Talc.
What Gabapentin Tablets look like and contents of the pack
Gabapentin 600 mg film-coated tablets are white oval film-coated
tablets embossed with '600', supplied in PVC/PE/PVDC/aluminium foil
blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets.
Not all pack sizes may be marketed.
Gabapentin 800 mg film-coated tablets are white oval film-coated
tablets embossed with '800', supplied in PVC/PE/PVDC/aluminium foil
blister packs of 20, 30, 45, 50, 84, 90, 100, 200, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Rivopharm UK, 6th floor, 28 Kingsway, London WC2B 6JR, UK
Manufacturer
SynerLAB - Laboratoires BTT
Zone Industrielle de Krafft 67150 Erstein, FRANCE
Distributed by:
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex, CM6 3LY
This leaflet was last approved in {MM/YYYY}

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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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