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GABAPENTIN GLENMARK 800 MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN

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Package leaflet: Information for the user
Gabapentin Glenmark 600 mg film-coated tablets
Gabapentin Glenmark 800 mg film-coated tablets
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 Glenmark is and what it is used
for
2. What you need to know before you take Gabapentin
Glenmark
3. How to take Gabapentin Glenmark
4. Possible side effects
5. How to store Gabapentin Glenmark
6. Contents of the pack and other information
1. What Gabapentin Glenmark is and what it is
used for
Gabapentin Glenmark 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 substance in Gabapentin Glenmark is
gabapentin.
Gabapentin Glenmark 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 Glenmark for
you to help treat your epilepsy when your current
treatment is not fully controlling your condition.
You should take Gabapentin Glenmark in addition
to your current treatment unless told otherwise.
Gabapentin Glenmark 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.
2. What you need to know before you take
Gabapentin Glenmark

Warnings and precautions
Talk to your doctor before taking Gabapentin
Glenmark
• 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 the post-marketing experience.
Talk to your doctor if you have a history of abuse or
dependence.
A small number of people being treated with antiepileptics 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
Glenmark 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 Glenmark
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.
Other medicines and Gabapentin Glenmark
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
Medicines containing opioids such as morphine
If you are taking any medicines containing opioids
(such as morphine), please tell your doctor or
pharmacist as morphine may increase the effect of
Gabapentin Glenmark. In addition, combination
of Gabapentin Glenmark with opioids may cause
symptoms like sleepiness and/or decrease in breathing.
Antacids for indigestion
If Gabapentin Glenmark and antacids containing

CODICE / ITEM:

6280610

DIMENSIONI / SIZE:

ED. / VERSION N.:

E05.0416

150x432/40 mm
COD. CLIENTE / CUSTOMER CODE:

DATA / DATE:

21/04/2016

FORM./TECH.CODE/MASTER LAYOUT:

IS 043 C V

PHARMA CODE:

N/A

455 (11001000)

VICENZA

7

STABILIMENTO / PLANT:
CHANGE DESCRIPTION:

NUOVI TESTI / NEW TEXT

PACKAGING LINE:

Gabapentin Glenmark
-- 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 Glenmark with food
Gabapentin Glenmark 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 Glenmark 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 medicines 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
Glenmark. 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
Glenmark, is passed on through human milk.
Because the effect on the baby is unknown, it is not
recommended to breast-feed while using Gabapentin
Glenmark.
Fertility
There is no effect on fertility in animal studies.

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

Property of
Zambon S.p.A
Via Lillo del Duca 10
20091 Bresso / Milano

aluminium and magnesium are taken at the same time,
absorption of Gabapentin Glenmark from the stomach
may be reduced. It is therefore recommended that
Gabapentin Glenmark are taken at the earliest two
hours after taking an antacid.

Driving and using machines
Gabapentin Glenmark 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.
Gabapentin Glenmark contains soya lecithin
If you are allergic to soya, talk to your doctor before
using this medicinal product.
3. How to take Gabapentin Glenmark
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.
Epilepsy, the recommended dose is:
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 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 Glenmark is not recommended for use
in children below 6 years of age.
Peripheral Neuropathic Pain, the recommended
dose is:
Adults:
Take the number of 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 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.

PRODOTTO / BRAND:

IS GABAPENTIN GLENMARK 600/800 - UNITED KINGDOM
REV MOCKUP APPROVATO - DATA:

N/A

LATO BIANCA / FRONT SIDE

ARTWORK REV:

REV1

CONFORME AL MASTER LAYOUT - NOTE:

IS 043 C V

LATO STAMPA BIANCA/VOLTA (SIDE PRINT FRONT/REAR):

FONT/CORPO MIN./INTERLINEA (FONT/MIN. SIZE/SPACING):

TIMES

COLORI / COLORS NO:

1

BLACK

ISTRUZIONI FORNITORE / SUPPLIER INSTRUCTION:

ISTRUZIONE PIEGATA
CON DIMENSIONI FINALI 150X40
CON CODICE LAETUS VISIVO
ALL’ESTERNO

If you are an elderly patient (over 65 years of
age), you should take the normal dose of Gabapentin
Glenmark 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.

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

If you have the impression that the effect of
Gabapentin Glenmark is too strong or too weak, talk to
your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Glenmark is for oral use. Always swallow
the tablets with plenty of water.
Continue taking Gabapentin until your doctor tells you
to stop.







If you take more Gabapentin Glenmark than you
should
If you or someone else accidentally takes too many
tablets or if you think a child has swallowed any,
contact your doctor or go to your nearest hospital
casualty department immediately. As Gabapentin
tablets 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 tablets 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 Glenmark
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 Glenmark
Do not stop taking Gabapentin Glenmark 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 Glenmark 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

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.
• Difficulty with thinking
• Fall
• 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 Gabapentin Glenmark 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 fibers (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 (hyponatremia)
Other possible side effects

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

Deoiled phospholipids from soybean may very rarely
cause allergic reactions.

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 Glenmark may cause a serious or lifethreatening 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 Glenmark.
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

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

These symptoms may be the first signs of a serious
reaction. A doctor should examine you to decide if
you should continue taking Gabapentin Glenmark.
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 coordination
• Feeling tired, fever

Common (may affect up to 1 in 10people):
• Pneumonia, respiratory infection, 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

5. How to store Gabapentin Glenmark
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 carton and label after “Exp”. The expiry
date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
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 Glenmark contains
The active substance is gabapentin.
Each film-coated tablet contains 600 mg or 800 mg
gabapentin.
The other ingredients in Gabapentin Glenmark
tablets are:
Tablet core: macrogol 4000; pregelatinised starch
(maize); silica, colloidal anhydrous; magnesium
stearate;
Film-coating: poly(vinyl alcohol); titanium dioxide
(E171); talc; lecithin of soya; xanthan gum.
What Gabapentin Glenmark looks like and
contents of the pack
The 600 mg film-coated tablets are white, capsuleshaped film-coated tablets (17,5 x 7 mm) with a logo
(600) embossed on one side.
The 800 mg film-coated tablets are white, capsuleshaped film-coated tablets (18,9 x 9,7 mm).
Supplied in PVC/aluminium blister in packs of
20, 50, 100, 200 and 200 (2x100) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2-B Draycott Avenue
Kenton, Middlesex
HA3 OBU
United Kingdom
Manufacturer
Zambon S.p.A.
Vicenza
Italy
This leaflet was last revised in April 2016

6280610 E05.0416 IS 043 C V (cp. 9/9)

Property of
Zambon S.p.A
Via Lillo del Duca 10
20091 Bresso / Milano
CODICE / ITEM:

6280610

DIMENSIONI / SIZE:

ED. / VERSION N.:

E05.0416

150x432/40 mm
COD. CLIENTE / CUSTOMER CODE:

DATA / DATE:

21/04/2016

FORM./TECH.CODE/MASTER LAYOUT:

IS 043 C V

PHARMA CODE:

N/A

455 (11001000)

VICENZA

7

STABILIMENTO / PLANT:
CHANGE DESCRIPTION:

NUOVI TESTI / NEW TEXT

PACKAGING LINE:

PRODOTTO / BRAND:

IS GABAPENTIN GLENMARK 600/800 - UNITED KINGDOM
REV MOCKUP APPROVATO - DATA:

N/A

LATO VOLTA / BACK SIDE

ARTWORK REV:

REV1

CONFORME AL MASTER LAYOUT - NOTE:

IS 043 C V

LATO STAMPA BIANCA/VOLTA (SIDE PRINT FRONT/REAR):

FONT/CORPO MIN./INTERLINEA (FONT/MIN. SIZE/SPACING):

TIMES

COLORI / COLORS NO:

1

BLACK

ISTRUZIONI FORNITORE / SUPPLIER INSTRUCTION:

ISTRUZIONE PIEGATA
CON DIMENSIONI FINALI 150X40
CON CODICE LAETUS VISIVO
ALL’ESTERNO

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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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