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GABAPENTIN M&A PHARMACHEM 400MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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Artwork No.

060117/1

Colours Used

Customer

MAPharmachem

Black

Description

Gabapentin Leaflet

Keyline

Market

UK

Language

English

Size

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Ph : +91-9845156610

180 x 300mm

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Arial, 9 pt

Page No.

1 of 1

Version No.

1

Date

06-01-17

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Packaging Development

Coreldraw 12
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Package Leaflet: Information for the user

GABAPENTIN
M&A Pharmachem 100mg, 300mg and 400mg capsules
Gabapentin Capsules contain lactose monohydrate and
sunset yellow
!
These capsules contain lactose monohydrate. If you have
been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicine.
!
Gabapentin 400mg contain sunset yellow (E110) which may
cause allergic reactions.

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.

Pregnancy, breast-feeding and fertility
Pregnancy
Gabapentin Capsules should not be taken during pregnancy.
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 are pregnant, become pregnant or plan to
become pregnant. Do not suddenly stop taking this medicine.

What is in this leaflet:
1. What Gabapentin Capsules are and what they are used for
2. What you need to know before you take Gabapentin Capsules
3. How to take Gabapentin Capsules
4. Possible side effects
5. How to store Gabapentin Capsules
6. Contents of the pack and other information
1. WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY
ARE USED FOR
Gabapentin belongs to a group of medicines known as antiepileptics.
Gabapentin Capsules are used to:
!
Treat epilepsy. Gabapentin can be used in addition to current
treatment when epilepsy has not been fully controlled in
children over 6 years and adults. It can also be used on its own
to treat children over 12 years and adults.
!
Relieve peripheral neuropathic pain (long lasting pain caused
by damage to nerves) caused by diseases such as diabetes or
shingles.

Breast-feeding
Gabapentin is passed on through breast milk. The effect on the
baby is unknown; therefore you should not breast-feed your baby
unless told to by your doctor.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin may cause 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GABAPENTIN CAPSULES
!

3. HOW TO TAKE GABAPENTIN CAPSULES

Do NOT take Gabapentin Capsules if:
you are allergic (hypersensitive) to gabapentin or any of the
other ingredients of Gabapentin Capsules (listed in section 6)

Warnings and precautions
Talk to your doctor before you take Gabapentin Capsules if:
- you suffer from kidney problems
- you are on haemodialysis, tell your doctor if you develop
muscle pain and/or weakness
- you are pregnant, trying to become pregnant or are breastfeeding
!
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.
!
If you require an operation or visit the doctor or dentist, tell
them that you are taking gabapentin. Gabapentin may
interfere with some laboratory tests. If you are having a urine
test, tell the clinic or hospital staff that you are taking
Gabapentin.
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 not treated. You need to know the symptoms to
look out for while you are taking gabapentin. Read the description
of these symptoms in section 4 under the heading 'Tell your
doctor or go to the nearest hospital casualty department if you
have any of the following serious side effects'.
Other medicines and Gabapentin Capsules
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
If you take antacids containing aluminium and magnesium at
the same time as gabapentin, absorption of gabapentin from
the stomach may be reduced. Take Gabapentin Capsules at
least 2 hours after taking antacids.
!
If you are taking any medicines containing morphine tell your
doctor or pharmacist, as morphine may increase the effect of
Gabapentin.

Always take your medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. Your
doctor will decide the dose that is right for you.
Gabapentin Capsules are to be swallowed with plenty of water and
can be taken with or without food.
Dose for neuropathic pain:
!
Adults (over 18 years of age):
The dose is usually built up gradually, starting at 300 mg on the first
day, followed by 600 mg on the second day and 900 mg on the third
day. The dose may then be increased to a maximum of 3600 mg
each day, given in 3 divided doses - in the morning, at midday and
in the evening.
!
The dose for the elderly and those with kidney problems
may be reduced.
Dose for epilepsy:
Adults and children over 12 years:
The starting dose is usually between 300 mg and 900 mg each day.
The dose is then built up gradually each day in 3 divided doses - in
the morning, at midday and in the evening. The maximum daily
dose is 3600 mg.
!
Children 6-12 years of age:
The dose to be given to your child will be decided by your doctor
and is calculated using your child's weight. The treatment is started
using a low dose, which is gradually increased over a period of
approximately 3 days. It is usually given in 3 divided doses each
day, by taking the capsules in the morning, at midday and in the
evening.
!
The dose for the elderly and those with kidney problems may
be reduced.
!

!

Gabapentin capsules should not be given to children under 6
years of age.

!

If you forget to take a dose
Take it as soon as you remember unless it is nearly time for your
next dose. Do not take two doses at the same time.

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

If you take more Gabapentin Capsules than you should
If you accidentally take too many capsules, tell your doctor
immediately or go to the nearest hospital casualty department.
Take with you the container and any capsules that are left, so that
the hospital can easily tell what medicine you have taken.

If you stop taking Gabapentin Capsules
Do not stop taking Gabapentin unless your doctor tells you to. If you
stop taking Gabapentin Capsules suddenly there is an increased
risk of seizures, pain or discomfort. If your treatment is stopped
and/or an alternative anticonvulsant medicine is added to the
therapy, this should be done gradually over a minimum of one
week.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin Capsules can cause side effects,
although not everybody gets them.
Tell your doctor immediately or go to the nearest hospital
casualty department if you have any of the following serious
side effects:
!
Swelling of the lips and face, skin rash (these may be
symptoms of a serious allergic reaction).
!
Muscle pain and/or weakness if you are on haemodialysis.
!
Severe stomach pain (this may be a symptom of inflammation
of the pancreas).
!
Thoughts of harming or killing yourself.
!
Severe skin reaction with blistering around the mouth, eyes
and genitals, possibly with fever or flu-like symptoms.
!
Gabapentin may cause a serious or life-threatening allergic
reaction that may affect your skin or other parts of your body
such as liver or blood. You may or may not have a rash when
you get this type of reaction. It may cause you to be
hospitalized or to stop gabapentin.
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.
If any of the following side effects gets worse or you are
worried tell your doctor or pharmacist:
Very common side-effects
(which may affect more than 1 person in 10):
!
Viral infection, fever
!
Feeling drowsy or tired, dizziness, lack of coordination.
Common side-effects (which may affect more than 1 person in
100):
!
Pneumonia, respiratory infections, urinary tract infection,
inflammation of the ear or other infections.
!
Low white blood cell counts.
!
Loss of (anorexia) or increased appetite.
!
Anger towards others, confusion, mood changes, depression,
anxiety, nervousness, difficulty with thinking.
!
Convulsions, jerky movements, difficulty 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.
!
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 side effects
(which may affect more than 1 person in a 1000):
!
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).
Agitation (a state of chronic restlessness and unintentional
and purposeless motions)

Rare (may affect up to 1 in 1000 people)
Loss of consciousness.
Decrease in blood glucose levels (most often observed in
patients with diabetes).

Since introduction to the market the following side-effects
have been reported (frequency unknown):
Decreased platelets which may cause increased bleeding or
bruising.
!
Hallucinations.
!
Abnormal movements such as writhing, jerking and stiffness,
involuntary twitching.
!
Ringing in the ears.
!
Yellowing of the skin and eyes (jaundice), liver problems.
!
Acute kidney failure, incontinence.
!
Increased breast tissue, breast enlargement.
!
Side effects following sudden stopping of gabapentin (anxiety,
difficulty sleeping, feeling sick, pain, sweating), chest pain.
!
Breakdown of muscle fibres (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 the Yellow Card Scheme at:
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 CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect
from moisture.
Do not use after the expiry date, which is stated on the blister strip
and carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Gabapentin Capsules contains
!
Each capsule contains 100mg, 300mg or 400mg of the active
substance gabapentin.
!
The other ingredients are maize starch, lactose monohydrate,
and talc.
!
The capsules are made from gelatin and titanium oxide. The
300mg capsule also contains yellow iron oxide (E172) and
quinoline yellow (E104).The 400mg capsule also contains
sunset yellow (E110).
!
The marking ink contains shellac glaze, black iron oxide, NButyl alcohol, industrial methyl spirit 74 OP, soya lecithin and
antifoam DC150.
What Gabapentin Capsules look like and contents of the pack
The 100mg capsule is a hard white capsule marked with 'GABA
100'. The 300mg capsule is a hard yellow capsule marked with
'GABA 300'. The 400mg capsule is a hard orange capsule marked
with 'GABA 400'.
They are available in packs of 90 or 100 capsules in blister strips of
10 capsules.
Marketing Authorisation Holder and Manufacturer
M&A Pharmachem Ltd, Bolton, Lancashire BL5 2AL.
This leaflet was last revised in January 2017
PP2517

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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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