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GABAPENTIN SANDOZ 100 MG CAPSULES

Active substance(s): GABAPENTIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00311LT07A

Gabapentin Sandoz 100 mg Capsules
Gabapentin Sandoz 300 mg Capsules
Gabapentin Sandoz 400 mg Capsules

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. Content of the pack and other information

1

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.

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.

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.

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.

Breast-feeding
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.

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

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.

3

What you need to know before you
take Gabapentin

Do not take Gabapentin
• if you are allergic (hypersensitive) to gabapentin or
any of the other ingredients of this medicine (listed in
section 6).

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.

Your doctor will determine what dose is appropriate for
you.

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 (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 this may be symptoms of acute
pancreatitis (an inflamed pancreas).

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.

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.

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

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 these symptoms to
look out for while you are taking Gabapentin.

Epilepsy, the usual dose is:

Adults and adolescents:
Take the number of capsules 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.

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'.
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

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 capsule(s) each day,
usually once in the morning, once in the afternoon and
once in the evening.

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 recommended for use in children
below 6 years of age.
Peripheral Neuropathic Pain, the usual dose is:

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.

Adults:
Take the number of capsules 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 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.

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

Pregnancy and breast-feeding
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.

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.

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.

draft: 44028751, 44028752, 44030809
laetus code: 15290
mat.no.: 46143812

How to take Gabapentin

Continued on the next page >>

46143812

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Ref: V049 - Product name change in the UK
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Date prepared:
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Colours:
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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 that you have not taken, together with the
container and the label so that the hospital can easily
tell what medicine you have taken.

• Blood glucose fluctuations in patients with diabetes.
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase
increased)

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 the Yellow
Card Scheme: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

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.

5

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.

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 label after ‘EXP’. The expiry date refers to
the last day of that month.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

How to store Gabapentin

Store below 25ºC.
Blisters: Store in the original package in order to protect
from moisture.
Tablet containers: Keep the tablet container tightly
closed in order to protect from moisture.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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.

Contact your doctor immediately if you experience
any of the following symptoms after taking this
medicine as they can be serious:

6

• severe skin reactions that require immediate
attention, such as 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 a 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.

Content of the pack and other
information

What Gabapentin contains
• The active substance is: gabapentin.

Each capsule, hard contains either 100 mg, 300 mg or
400 mg of gabapentin.

• the other ingredients in the capsules are:
capsule content: pregelatinised maize starch, maize
starch, talc and colloidal anhydrous silica.
capsule shell: consists of gelatin, sodium lauril
sulphate, coloured with titanium dioxide (E171) and
iron oxide yellow (E172) (300 mg and 400 mg
capsules) and iron oxide red (E172) (400 mg
capsules).

What Gabapentin looks like and contents of the
pack

Capsule, hard
Gabapentin 100 mg Capsules are gelatin capsules, hard
with a white, opaque body and cap.
Gabapentin 300 mg Capsules are gelatin capsules, hard
with a yellow, opaque body and cap.
Gabapentin 400 mg Capsules are gelatin capsules, hard
with a brown, opaque body and cap.

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.

Gabapentin 100 mg Capsules: PVC/PE/PVDC//Alu
blister: 7, 15, 20, 30, 50, 60, 90, 100 and 200 capsules,
hard.
HDPE tablet container with child resistant closure: 50,
100 capsules, hard.

Other side effects include:
Very common side-effects (may affect more than 1
in 10 people):

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

Gabapentin 300 mg Capsules: PVC/PE/PVDC//Alu
blister: 20, 30, 50, 60, 90, 100, 200 and 500 capsules,
hard.
HDPE tablet container with child resistant closure: 50,
100 capsules, hard.

Common side-effects (may affect up to 1 in 10
people):
• Pneumonia, respiratory infection, urinary tract infection,
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.

Gabapentin 400 mg Capsules: PVC/PE/PVDC//Alu
blister: 20, 30, 50, 60, 90, 100, 200 and 500 capsules,
hard.
HDPE tablet container with child resistant closure: 50,
100 capsules, hard.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing authorization holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
or

Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljubljana,
Slovenia
or

LEK S.A.,
ul. Domaniewska 50 C, 02-672 Warszawa,
Poland

Additionally in clinical studies in children, aggressive
behaviour and jerky movements were reported
commonly.

or

Uncommon side-effects (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 problems with
the liver.

Sandoz GmbH,
Biochemiestrasse 10, 6250 Kundl,
Austria.

This leaflet was last revised in July 2014.

draft: 44028751, 44028752, 44030809
laetus code: 15290
mat.no.: 46143812

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)

46143812
SZ00311LT07A

Artwork Proof Box
Ref: V049 - Product name change in the UK
Proof no.
011.0

Date prepared:
24/07/2014

Colours:
Black
Black 20%
Dimensions: 165 x 500 mm

Font size:
8pt
Fonts:
Helvetica

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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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