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LECOMIG 600 MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN / GABAPENTIN

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Package leaflet: Information for the user
Lecomig 600 mg film-coated tablets
Lecomig 800 mg film-coated tablets
Gabapentin

1. What Lecomig is and what it is used for
Lecomig 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 Lecomig is gabapentin.
Lecomig 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 Lecomig for you to help treat your
epilepsy when your current treatment is not fully
controlling your condition. You should take Lecomig
Film-coated Tablets in addition to your current
treatment unless told otherwise. Lecomig Film-coated
Tablets can also be used on its own to treat adults and
adolescents 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 Lecomig
Do not take Lecomig:
- if you are allergic (hypersensitive) 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 Lecomig:
● 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 Lecomig Film-coated
Tablets 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 Lecomig Film-coated
Tablets.
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 Lecomig
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 opioids may increase the effect of Lecomig.
In addition, combination of Lecomig with opioids may
cause symptoms like sleepiness and/or decrease in
breathing.
Antacids for indigestion
If Lecomig and antacids containing aluminium and
magnesium are taken at the same time, absorption of
Lecomig from the stomach may be reduced. It is therefore
recommended that Lecomig is taken at the earliest two
hours after taking an antacid.
Lecomig:
● 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.
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
Lecomig 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 Lecomig. Do not suddenly
discontinue taking this medicine as this may lead to a
breakthrough seizure, which could have serious
consequences for you and your baby.
Breast-feeding
Gabapentin is passed on through human milk. Because
the effect on the baby is unknown, it is not recommended
to breast-feed while using Lecomig.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Lecomig film-coated tablets 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. How to take Lecomig
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 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.
Lecomig Film-coated Tablets 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.
If you are an elderly patient (over 65 years of age),
you should take the normal dose of Lecomig Film-coated
Tablets 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 Lecomig
Film-coated Tablets is too strong or too weak, talk to your
doctor or pharmacist as soon as possible.
Method of administration
Lecomig are for oral use. Always swallow the tablets with
plenty of water (e.g. a glass of water).
The tablet can be divided into equal halves.
Lecomig Tablets can be taken with or without food.
Continue taking Lecomig until your doctor tells you
to stop.
If you take more Lecomig 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 Lecomig
than your doctor prescribed. Take along any tablets that
you have not taken, together with the container and the

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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
symptoms 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 Lecomig is and what it is used for
2. What you need to know before you take Lecomig
3. How to take Lecomig
4. Possible side effects
5. How to store Lecomig
6. Contents of the pack and other information

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)
● Lecomig 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 hospitalized or to stop Lecomig.
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
These symptoms may be the first signs of a serious
reaction. A doctor should examine you to decide if you
should continue taking Lecomig.
● 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 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, 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
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
● Fall
● Increase in blood glucose levels (most often observed
in patients with diabetes)
● Agitation (a state of chronic restlessness and
unintentional and purposeless motions)
Rare (may affect up to 1 in 1,000 people):
● Loss of consciousness
● Decrease in blood glucose levels (most often observed
in patients with diabetes)
Not Known
● Anaphylaxis (serious, potentially life threatening
allergic reaction including difficulty breathing,
swelling of the lips, throat, and tongue, and
hypotension requiring emergency treatment)

After marketing Gabapentin 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
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
at www.mhra.gov.co.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.
5. How to store Lecomig
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 / bottle and carton after “EXP”.
The expiry date refers to the last day of that month.
PVC/PVDC - Aluminum Blister Pack: Do not store
above 25°C.
Aluminum - Aluminum Blister Pack and Bottle Pack:
Do not store above 30°C.
Store in the original package in order to protect from
moisture.

Shelf life after first opening of the bottle: 120 days.
Do not throw away any medicines via wastewater 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 Lecomig contains
The active substance is gabapentin.
Each film-coated tablet contains 600 mg gabapentin.
Each film-coated tablet contains either 800 mg
gabapentin.
The other ingredients are:
Tablet core: Poloxamer 407, copovidone, maize starch
and magnesium stearate.
Film-coating: Opadry 12B58900 White [Hypromellose
(E464), Titanium Dioxide (E171), Macrogol
400 (E1521), Polysorbate 80 (E433)], Macrogol
8000 and Talc
What Lecomig looks like and contents of the pack
Film-coated tablet
White to off white, oval shaped, biconvex scored film
coated tablets debossed with “G” and “31” on one side,
approximately 17.40 ± 0.2 mm in length
The tablet can be divided into equal doses.
White to off white, oval shaped, biconvex scored film
coated tablets debossed with “G” and “13” on one side,
approximately 19.10 ± 0.2 mm in length
The tablet can be divided into equal doses.
Lecomig comes in blisters containing 1, 10, 30, 45, 50, 60,
84, 90, 100, 120, 180, 200 film-coated tablets and in
bottles with 100, 500 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex, HA3 0BU
United Kingdom.
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom.
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
56617 Vysoke Myto
Czech Republic.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany
- Gabapentin Glenmark 600 mg /
800 mg Filmtabletten
Denmark
- Gabapentin Glenmark
United Kingdom - LECOMIG 600 mg /
800 mg Film-coated Tablets
Austria
- Gabapentin Glenmark 600 mg /
800 mg Filmtabletten
Spain
- Gabapentin Viso Farmacéutica
600 mg / 800 mg comprimidos
recubiertos con película EFG
Finland
- Gabapentin Glenmark 600 mg /
800 mg kalvopäällysteiset tabletit
Norway
- Gabapentin Glenmark
Poland
- EPIGAPENT
This leaflet was last revised in 06/2017.

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420 mm

label so that the hospital can easily tell what medicine you
have taken.
If you forget to take Lecomig
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 Lecomig
Do not stop taking Lecomig 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
Lecomig Tablets 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.

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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