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GABAPENTIN TEVA 100 MG CAPSULES HARD

Active substance(s): GABAPENTIN

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PAGE 1: FRONT FACE (INSIDE OF REEL)

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 613

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).
• if you have nervous system disorders, respiratory disorders, or you
are more than 65 years old, your doctor may prescribe you a
different dosing regimen.
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. In particular, tell
your doctor (or pharmacist) if you are taking or have been recently
taking any medicines for convulsions, sleeping disorders, depression,
anxiety, or any other neurological or psychiatric problems.
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

Gabapentin Teva 100/300/400 mg capsules

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.

• 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)
• Trouble breathing, shallow breaths (respiratory depression)
After marketing the following side effects have been reported:
Uncommon: (may affect up to 1 in 100 people)
• Agitation (a state of chronic restlessness and unintentional and
purposeless motions)
Not known: (frequency cannot be estimated from the available data)
• 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
4. Possible side effects
(anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
• Breakdown of muscle fibres (rhabdomyolysis)
Like all medicines, this medicine can cause side effects, although not
• Change in blood test results (creatine phosphokinase increased)
everybody gets them.
• Problems with sexual functioning including inability to achieve a
Contact your doctor immediately if you experience any of the
sexual climax, delayed ejaculation
following symptoms after taking this medicine as they can be serious:
• Low blood sodium level
• Anaphylaxis (serious, potentially life threatening allergic reaction
Reporting of side effects
including difficulty breathing, swelling of the lips, throat, and
If you get any side effects, talk to your doctor, pharmacist or nurse.
tongue, and hypotension requiring emergency treatment)
This includes any possible side effects not listed in this leaflet. You can
• Severe skin reactions that require immediate attention, swelling of
also report side effects directly via the Yellow Card Scheme at:
the lips and face, skin rash and redness, and/or hair loss (these may www.mhra.gov.uk/yellowcard.
be symptoms of a serious allergic reaction)
By reporting side effects you can help provide more information on the
• Persistent stomach pain, feeling sick and being sick as these may be safety of this medicine.
symptoms of acute pancreatitis (an inflamed pancreas)
5. How to store Gabapentin Teva capsules
• Gabapentin Teva capsules may cause a serious or life-threatening
allergic reaction that may affect your skin or other parts of your
Keep this medicine out of the sight and reach of children.
body such as your liver or blood cells. You may or may not have
Do not use this medicine after the expiry date which is stated on the
rash when you get this type of reaction. It may cause you to be
blister and the carton after EXP. The expiry date refers to the last day
hospitalised or to stop Gabapentin Teva capsules.
of that month.
Call your doctor right away if you have any of the following symptoms:
Do not store above 25ºC.
• skin rash
Store in the original package.
• hives
• fever
Do not throw away any medicines via wastewater or household waste.
• swollen glands that do not go away
Ask your pharmacist how to throw away medicines you no longer use.
• swelling of your lips and tongue
These measures will help protect the environment.
• yellowing of your skin or of the whites of the eyes
6. Contents of the pack and other information
• unusual bruising or bleeding
• severe fatigue or weakness
What Gabapentin Teva capsules contain
• unexpected muscle pain
- The active substance is gabapentin.
• frequent infections
- Each capsule contains 100 mg, 300 mg or 400 mg gabapentin.
• Breathing problems, which if severe you may need emergency and
- The other ingredients are
intensive care to continue breathing normally.
Capsule content: Lactose anhydrous, Maize starch, Talc.
These symptoms may be the first signs of a serious reaction. A doctor
Capsule shell: gelatin and the following colours:
should examine you to decide if you should continue taking
100 mg capsules: titanium dioxide (E 171).
Gabapentin Teva capsules.
300 mg capsules: titanium dioxide (E 171), yellow iron oxide (E 172).
• If you are on haemodialysis, tell your doctor if you develop muscle
400 mg capsules: titanium dioxide (E 171), red and yellow iron oxides
pain and/or weakness.
(E 172).
Other side effects include:
Printing Ink: Shellac, Propylene Glycol, Ammonia solution, Potassium
Very common (may affect more than 1 in 10 people)
Hydroxide, Black iron oxide.
• Viral infection
What Gabapentin Teva capsules look like and contents of the pack
• Feeling drowsy, dizziness, lack of co-ordination
The 100 mg capsules are white with the imprinting “100” on one side
• Feeling tired, fever
and “G” on the other.
Common (may affect up to 1 in 10 people)
The 300 mg capsules are yellow with the imprinting “300” on one side
• Pneumonia, respiratory infections, urinary tract infection,
and “G” on the other.
inflammation of the ear or other infections
The 400 mg capsules are orange with the imprinting “400” on one side
• Low white blood cell counts
and “G” on the other.
• Anorexia, increased appetite
Pack sizes:
• Anger towards others, confusion, mood changes, depression,
Blisters: 10, 20, 50, 90, 100, 200 (2x100), 250 capsules.
anxiety, nervousness, difficulty with thinking
Hospital pack: 500 (5x100), 1000 (10x100) capsules.
• Convulsions, jerky movements, difficulty with speaking, loss of
Unit dose: 20x1, 60x1, 100x1 capsule.
memory, tremors, difficulty sleeping, headache, sensitive skin,
decreased sensation (numbness), difficulty with coordination,
Not all pack sizes may be marketed.
unusual eye movement, increased, decreased or absent reflexes
Marketing Authorisation Holder and Manufacturer
• Blurred vision, double vision
MA holder: ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm,
• Vertigo
Germany.
• High blood pressure, flushing or dilation of blood vessels
Manufacturer:
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
Teva UK Limited, Eastbourne, BN22 9AG.
• Vomiting (being sick), nausea (feeling sick), problems with teeth,
inflamed gums, diarrhoea, stomach pain, indigestion, constipation, This leaflet was last revised in August 2017.
dry mouth or throat, flatulence
• Facial swelling, bruises, rash, itching, acne
• Joint pain, muscle pain, back pain, twitching
• Difficulties with erection

EAS1415a
88267-L
200 x 323

+ Expand Transcript

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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