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GABAPENTIN MILPHARM 800 MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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5 mm 8 mm 5 mm

Package leaflet: Information for the user

Gabapentin Milpharm 600 mg
film-coated tablets
Gabapentin Milpharm 800 mg
film-coated tablets
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 Milpharm Tablets is and what it is used for
2. What you need to know before you take Gabapentin
Milpharm Tablets
3. How to take Gabapentin Milpharm Tablets
4. Possible side effects
5. How to store Gabapentin Milpharm Tablets
6. Contents of the pack and other information
1. What Gabapentin Milpharm Tablets is and what it is
used for
Gabapentin Milpharm Tablets 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 Milpharm Tablets is
gabapentin.
Gabapentin Milpharm 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 Milpharm Tablets for you to help treat your
epilepsy when your current treatment is not fully controlling
your condition. You should take Gabapentin Milpharm
Tablets in addition to your current treatment unless told
otherwise. Gabapentin Milpharm Tablets 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
Milpharm Tablets
Do not take Gabapentin Milpharm Tablets:
• 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
Milpharm
• 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 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.
Important information about potentially serious reactions
A small number of people taking Gabapentin Milpharm 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 these symptoms to look out for while
you are taking Gabapentin Milpharm Tablets.

absorption of Gabapentin Milpharm Tablets from the stomach
may be reduced. It is therefore recommended that Gabapentin
Milpharm Tablets is taken at the earliest two hours after taking
an antacid.
Gabapentin Milpharm Tablets:
• 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;
Gabapentin Milpharm Tablets with food and drink and
alcohol
Gabapentin Milpharm Tablets can be taken with or without food.
Pregnancy and breast-feeding and fertility
Pregnancy
Gabapentin Milpharm Tablets 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 Milpharm Tablets. 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, the active substance of Gabapentin Milpharm
Tablets, is passed on through human milk. Because the effect
on the baby is unknown, it is not recommended to breast-feed
while using Gabapentin Milpharm Tablets.
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.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Milpharm 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 Gabapentin Milpharm Tablets
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.
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 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.
Gabapentin Milpharm 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.

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’

If you have kidneys 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.

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.

If you are an elderly patient (over 65 years of age), you
should take the normal dose of Gabapentin Milpharm 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.
Continue taking Gabapentin Milpharm Tablets until your doctor
tells you to stop.

Antacids for indigestion
If Gabapentin Milpharm Tablets and antacids containing
aluminium and magnesium are taken at the same time,
Black

If you have the impression that the effect of Gabapentin
Milpharm is too strong or too weak, talk to your doctor or
pharmacist as soon as possible.
Method of administration
Gabapentin Milpharm Tablets is for oral use. Always swallow
the tablets with plenty of water.
Continue taking Gabapentin Milpharm until your doctor tells you
to stop.
If you take more Gabapentin Milpharm Tablets than you
should
Higher than recommended doses may result in an increase
in side effects including loss of consciousness, dizziness,

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Other medicines and Gabapentin Milpharm Tablets
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 Gabapentin Milpharm Tablets. In addition,
combination of Gabapentin Milpharm with opioids may cause
symptoms like sleepiness and/or decrease in breathing.

5 mm 8 mm 5 mm

If you forget to take Gabapentin Milpharm Tablets
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 Milpharm Tablets
Do not stop taking Gabapentin Milpharm Tablets 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 Milpharm 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.
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 Milpharm Tablets 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 Gabapentin Milpharm Tablets.
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 Gabapentin Milpharm Tablets.
If you are on haemodialysis, tell your doctor is 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 side-effects (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.
Uncommon (may affect up to 1 in 100 people):
• Agitation (a state of chronic restlessness and unintentional
and purposeless motions)
• Allergic reactions 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.
• Fall
• Mental impairment
• Increase in blood glucose levels (most often observed in
patients with diabetes)
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)
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
Anaphylaxis (serious, potentially life threatening allergic
reaction including difficulty breathing, swelling of the lips,
throat, and tongue, and hypotension requiring emergency
treatment)

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 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.
5. How to store Gabapentin Milpharm Tablets
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 after EXP. The expiry date refers to the last day of
the month.
Store below 25°C.
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
• The active substance is gabapentin.
Each film-coated tablet contains 600 mg gabapentin.
Each film-coated tablet contains 800 mg gabapentin.


The other ingredients in are: Maize starch, crospovidone
(Type A), copovidone (VA 64), microcrystalline cellulose
(KG-1000), microcrystalline cellulose (PH-102), magnesium
stearate
coating material: Hydroxypropyl cellulose, talc
What Gabapentin Milpharm Tablets looks like and contents
of the pack
Film-coated tablet
Gabapentin Milpharm 600 mg tablets are white, biconvex,
elliptical, film-coated tablets, with deep break line on both sides
and debossed with ‘D’ and ‘24’ on either side of the break line
on one side and plain on other side.
The tablet can be divided into equal doses.
Gabapentin Milpharm 800 mg tablets are white, biconvex,
elliptical, film-coated tablets, with deep break line on both sides
and debossed with ‘D’ and ‘25’ on either side of the break line
on one side and plain on other side.
The tablet can be divided into equal doses.
Gabapentin Milpharm film-coated tablets are available in
Polyamide/Aluminium/PVC – Aluminium foil blister pack: 10, 20,
30, 50, 60, 90, 100, 200 and 500 tablets
HDPE container: 20 and 500 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States
of the EEA under the following names:
France:
GABAPENTINE ARROW GENERIQUES 600
mg/ 800 mg, comprimé pelliculé
Germany:
Gabapentin Aurobindo 600 mg/ 800 mg
Filmtabletten
Netherlands:
Gabapentine Aurobindo 600 mg/ 800 mg,
filmomhulde tabletten
Portugal :
Gabapentina Aurobindo 600 mg/ 800 mg
comprimidos revestidos por película
Spain:
Gabapentina Aurobindo 600 mg/ 800 mg
comprimidos recubiertos con película
United Kingdom: Gabapentin Milpharm 600mg/ 800mg filmcoated tablets
This leaflet was last revised in 01/2017.

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double vision, slurred speech, drowsiness and
diarrhoea. Call your doctor or go to the nearest
hospital emergency unit immediately if you take more
Gabapentin Milpharm than your doctor prescribed.
Take along any capsules or tablets that you have not
taken, together with the container and the label so that
the hospital can easily tell what medicine you have
taken.

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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