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GABAPENTIN MILPHARM 300 MG CAPSULES HARD

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Gabapentin Milpharm 100 mg capsules, hard
Gabapentin Milpharm 300 mg capsules, hard
Gabapentin Milpharm 400 mg capsules, hard
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
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 is and what it is used for
2. What you need to know before you take Gabapentin Milpharm
3. How to take Gabapentin Milpharm
4. Possible side effects
5. How to store Gabapentin Milpharm capsules
6. Contents of the pack and other information
1. What Gabapentin Milpharm is and what it is used for
Gabapentin Milpharm 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 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 for you to help treat
your epilepsy when your current treatment is not fully controlling
your condition. You should take Gabapentin Milpharm in addition to
your current treatment unless told otherwise. Gabapentin Milpharm
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
Do not take Gabapentin Milpharm
- 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
- 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 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.
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 lifethreatening 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.
Notice: The HDPE bottle contains desiccant. Do not swallow.
Other medicines and Gabapentin Milpharm
Tell to your doctor or pharmacist if you are taking or have recently
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. In addition,
combination of Gabapentin with opioids may cause symptoms like
sleepiness and/or decrease in breathing.
Antacids for indigestion
If Gabapentin Milpharm and antacids containing aluminium and
magnesium are taken at the same time, absorption of Gabapentin
Milpharm from the stomach may be reduced. It is therefore
recommended that Gabapentin Milpharm is taken at the earliest
two hours after taking an antacid.
Gabapentin:
- 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 that you are taking.

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Gabapentin Milpharm
capsules, hard

Package leaflet: Information for the user

Gabapentin Milpharm
capsules, hard

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Gabapentin Milpharm with food, drink and alcohol
Gabapentin Milpharm 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 any medicine.
Pregnancy:
Gabapentin Milpharm 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 medicine is taken at
the same time. Therefore, whenever possible you should try to take
only one seizure medicine 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. 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, 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.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Milpharm 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 medicine affects your ability to perform these activities.
3. How to take Gabapentin Milpharm
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 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
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 capsule(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 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 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 Gabapentin 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 is too
strong or too weak, talk to your doctor or pharmacist as soon as
possible.
Method of Administration
Gabapentin is for oral use. Always swallow the capsules whole with
plenty of water.
Continue taking Gabapentin until your doctor tells you to stop
If you take more Gabapentin 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
Gabapentin 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.
If you forget to take Gabapentin Milpharm
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
Do not stop taking Gabapentin Milpharm 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
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:
• Anaphylaxis [(serious, potentially life threatening allergic
reaction including difficulty breathing, swelling of the lips, throat,
and tongue, and hypotension requiring emergency treatment)
Frequency not known]
• persistent stomach pain, feeling sick and being sick as these
may be symptoms of acute pancreatitis (an inflamed pancreas)
• Gabapentin Milpharm 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.
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.
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 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
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 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)
Rare (may affect up to 1 in 1,000 people):
• Decrease in blood glucose levels (most often observed in
patients with diabetes)
• Loss of consciousness
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 occuring 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

5. How to store Gabapentin Milpharm 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 carton/label/bottle after EXP. The expiry date refers to the last
date of that month.
Store below 250C.
Blister pack: Store in the original package.
HDPE bottle pack: Store in the original container.
Use within 12 months after first opening the HDPE bottle.
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 to protect the environment.
6. Contents of the pack and other information
What Gabapentin Milpharm contains
- The active substance is gabapentin.
Each 100 mg hard capsule contains 100 mg gabapentin.
Each 300 mg hard capsule contains 300 mg gabapentin.
Each 400 mg hard capsule contains 400 mg gabapentin.
- The other ingredients are:
Capsule contents: Maize starch and talc.
Capsule shell:
100 mg: Titanium dioxide (E171), sodium lauril sulfate, gelatin.
300 mg: Yellow iron oxide (E172), titanium dioxide (E171), sodium
lauril sulfate, gelatin.
400 mg: Red iron oxide (E172), yellow iron oxide (E172), titanium
dioxide (E171), sodium lauril sulfate, gelatin.
Printing ink: Shellac, propylene glycol, black iron oxide, potassium
hydroxide
What Gabapentin Milpharm looks like and contents of the pack
Capsule, hard.
Gabapentin Milpharm 100 mg capsules imprinted with 'D' on white
cap and '02' on white body, containing white to off-white crystalline
powder.
Gabapentin Milpharm 300 mg capsules imprinted with 'D' on yellow
cap and '03' on yellow body, containing white to off-white crystalline
powder.
Gabapentin Milpharm 400 mg capsules imprinted with 'D' on
orange cap and '04' on orange body, containing white to off-white
crystalline powder.
Gabapentin Milpharm 100 mg capsules are available in:
- Clear PVC/PVdC – Aluminium foil blister packs of 10, 20, 30,
50, 60, 90, 100 and 200 capsules, hard.
- HDPE bottle with polypropylene closure containing silica gel
desiccant: 100, 200 and 1000 capsules, hard.
Gabapentin Milpharm 300 mg capsules are available in:
- Clear PVC/PVdC – Aluminium foil blister packs of 10, 20, 30,
50, 60, 90, 100 and 200 capsules, hard.
- HDPE bottle with polypropylene closure containing silica gel
desiccant: 100, 200 and 1000 capsules, hard.
Gabapentin Milpharm 400 mg capsules are available in:
- Clear PVC/PVdC – Aluminium foil blister packs of 10, 20, 30,
50, 60, 90, 100, 200 and 300 capsules, hard.
- HDPE bottle with polypropylene closure containing silica gel
desiccant: 100, 200, 300 and 500 capsules, hard.
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:
Czech Republic Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
tvrdé tobolky
Denmark
Gabapentin Aurobindo
France
Gabapentine Arrow Génériques 100 mg/
300 mg/ 400mg, gélules
Germany
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
Hartkapseln
Ireland
Gabin 100 mg/ 300 mg/ 400mg capsules, hard
Italy
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
capsule rigide
Latvia
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
cietās kapsulas
Lithuania
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
kietos kapsulės
Netherlands
Gabapentine Aurobindo 100 mg/ 300 mg/ 400mg,
capsules, hard
Portugal
Gabapentina Aurobindo
Romania
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
capsule
Slovak Republic Gabapentin Vipharm 100 mg/ 300 mg/ 400mg
tvrdé kapsuly
Spain
Gabapentina Aurobindo 100 mg/ 300 mg/ 400mg
cápsulas duras
Sweden
Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg
kapslar, hårda
United Kingdom Gabapentin Milpharm 100 mg/ 300 mg/ 400mg
capsules, hard
This leaflet was last revised in 03/2017.

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.

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Reporting of side effects

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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