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GABAPENTIN TEVA 300 MG CAPSULES HARD

Active substance(s): GABAPENTIN

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TEVA UK Ref:

231-30-88267-J LEA GABAPENTIN TEVA A/S CAP TUK (RAT)

Version:

2

01 February 2016

PAGE 1: FRONT FACE (INSIDE OF REEL)

Gabapentin Teva 100/300/400 mg capsules
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 Teva capsules are and what they are used for
2. What you need to know before you take Gabapentin Teva capsules
3. How to take Gabapentin Teva capsules
4. Possible side effects
5. How to store Gabapentin Teva capsules
6. Contents of the pack and other information

1. What Gabapentin Teva capsules are and what they are
used for

Pharma code 600

Gabapentin belongs to a group of medicines used to treat epilepsy
and neuropathic pain (long lasting pain caused by damage to the
nerves). The active substance in Gabapentin Teva capsules is
gabapentin.
Gabapentin Teva capsules are 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 Teva capsules for
you to help treat your epilepsy when your current treatment is not
fully controlling your condition. You should take Gabapentin Teva
capsules in addition to your current treatment unless told otherwise.
Gabapentin Teva capsules 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, pins and needles etc. Another symptom may be numbness.

2. What you need to know before you take Gabapentin
Teva capsules
Do not take Gabapentin Teva capsules:
• if you are allergic to gabapentin 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 Teva
capsules,
• 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).
Cases of abuse and dependence have been reported for gabapentin
from 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 Teva capsules 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 Teva capsules.
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, 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 Teva capsules
Tell your doctor or pharmacist if you are taking/using, have recently
taken/used or might take/use any other medicines, including
medicines obtained with or without a prescription.
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 Teva capsules. In addition, combination of
Gabapentin Teva capsules with opioids may cause symptoms like
sleepiness and/or decrease in breathing.
Antacids for indigestion
If Gabapentin Teva capsules and antacids containing aluminium and
magnesium are taken at the same time, absorption of Gabapentin
Teva capsules from the stomach may be reduced. It is therefore
recommended that Gabapentin Teva capsules are taken at the earliest
two hours after taking an antacid.

Gabapentin Teva capsules
• are 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 Gabapentin Teva
capsules.
Gabapentin Teva capsules with food
Gabapentin Teva capsules can be taken with or without food.
Pregnancy, breast-feeding and fertility
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.
Pregnancy
Gabapentin Teva capsules 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 Teva capsules. 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 Teva capsules, is
passed on through human milk. Because the effect on the baby is
unknown, it is not recommended to breast-feed while using
Gabapentin Teva capsules.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Teva capsules may cause dizziness, problems with
coordination, 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 Teva capsules contains lactose
The capsules contain lactose (a type of sugar). 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 Teva capsules
Gabapentin Teva capsules are not recommended for use in children
below 6 years of age.
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. For
higher dosages, which cannot be applied with these strengths, other
strengths and dosages forms are available.
Epilepsy, the recommended 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 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/kg/day. It is usually given in 3 divided doses, by taking the
capsule(s) each day, usually once in the morning, once in the
afternoon and once in the evening.
Gabapentin Teva capsules are not recommended for use in children
below 6 years of age.
Peripheral Neuropathic Pain, the recommended dose is
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
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.

Top of page cut-off to middle of registration mark: 44 mm.

Package leaflet: Information for the user

TEVA UK Ref:

231-30-88267-J LEA GABAPENTIN TEVA A/S CAP TUK (RAT)

Version:

2

01 February 2016

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you are an elderly patient (over 65 years of age), you should take the
normal dose of Gabapentin Teva capsules 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 Teva capsules
is too strong or too weak, talk to your doctor or pharmacist as soon as
possible.
Method of administration
Gabapentin Teva capsules are for oral use. Always swallow the
capsules whole with plenty of water.
Continue taking Gabapentin Teva capsules until your doctor tells you
to stop.
If you take more Gabapentin Teva capsules than you should
If you or someone else accidentally takes too many capsules, or if you
think a child has swallowed any, contact your doctor or go to your
nearest hospital casualty department immediately. As Gabapentin
Teva capsules 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, drowsiness and mild diarrhoea.
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.
If you forget to take Gabapentin Teva capsules
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 Teva capsules
Do not stop taking Gabapentin Teva capsules 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 Teva capsules
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. 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 Teva capsules 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
hospitalised or to stop Gabapentin Teva capsules.
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 lips 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 Teva capsules.
• 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 co-ordination
• Feeling tired, fever
Common (may affect up to 1 in 10 people)
• 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, tremors, 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, itching, 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 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 problems with the liver
• Mental impairment
• Falls
• High blood sugar (most often observed in patients with diabetes)
Rare (may affect up to 1 in 1,000 people):
• Loss of consciousness
• Low blood sugar (most often observed in patients with diabetes)
After marketing 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 fibres (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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Gabapentin Teva capsules
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
blister and the carton after EXP. The expiry date refers to the last day
of that month.
Do not store above 25ºC.
Store in the original package.
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 Teva capsules contain
- The active substance is gabapentin.
- Each capsule contains 100 mg, 300 mg or 400 mg gabapentin.
- The other ingredients are
Capsule content: Lactose anhydrous, Maize starch, Talc.
Capsule shell: gelatin and the following colours:
100 mg capsules: titanium dioxide (E 171).
300 mg capsules: titanium dioxide (E 171), yellow iron oxide (E 172).
400 mg capsules: titanium dioxide (E 171), red and yellow iron oxides
(E 172).
Printing Ink: Shellac, Propylene Glycol, Ammonia solution, Potassium
Hydroxide, Black iron oxide.
What Gabapentin Teva capsules look like and contents of the pack
The 100 mg capsules are white with the imprinting “100” on one side
and “G” on the other.
The 300 mg capsules are yellow with the imprinting “300” on one side
and “G” on the other.
The 400 mg capsules are orange with the imprinting “400” on one side
and “G” on the other.
Pack sizes:
Blisters: 10, 20, 50, 90, 100, 200 (2x100), 250 capsules.
Hospital pack: 500 (5x100), 1000 (10x100) capsules.
Unit dose: 20x1, 60x1, 100x1 capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA holder: ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany.
Manufacturer:
Teva UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in February 2016.

88267-J
200 x 323

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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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