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GABAPENTIN M&A PHARMACHEM 400MG CAPSULES

Active substance(s): GABAPENTIN

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Artwork No.

e-mail : artworkcd@gmail.com
Ph : +91-9845156610

060117/1

Colours Used

Customer

MAPharmachem

Black

Description

Gabapentin Leaflet

Keyline

Market

UK

Language

English

Size

180 x 300mm

Min. Font Size

Arial, 9 pt

Page No.

1 of 1

Version No.

3

Date

09-08-17

Software

Coreldraw 12

Packaging Development

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Quality Control (QC)

Production

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Package Leaflet: Information for the user

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.

Uncommon side effects
(which may affect more than 1 person in a 1000):
!
Allergic reactions such as hives.
GABAPENTIN
!
Decreased movement.
!
Racing heartbeat.
M&A Pharmachem 100mg, 300mg and 400mg capsules
!
Swelling that may involve the face, trunk and limbs.
!
Abnormal blood test results suggesting problems with the liver.
If you stop taking Gabapentin Capsules
the stomach may be reduced. Take Gabapentin Capsules at
Read all of this leaflet carefully before you start taking this
!
Fall.
Do not stop taking Gabapentin unless your doctor tells you to. If you
least 2 hours after taking antacids.
medicine because it contains important information for you.
!
Mental impairment.
stop taking Gabapentin Capsules suddenly there is an increased
!
If you are taking any medicines containing morphine tell your
!
Keep this leaflet. You may need to read it again.
!
Increase in blood glucose levels (most often observed in
risk of seizures, pain or discomfort. If your treatment is stopped
doctor or pharmacist, as morphine may increase the effect of
!
If you have any further questions, ask your doctor or
patients with diabetes).
and/or an alternative anticonvulsant medicine is added to the
Gabapentin.
pharmacist.
!
Agitation (a state of chronic restlessness and unintentional
therapy, this should be done gradually over a minimum of one
!
This medicine has been prescribed for you only. Do not pass it
and purposeless motions)
week.
In addition, combination of Gabapentin with opioids may cause
on to others, it may harm them, even if their symptoms are the
If you have any further questions on the use of this medicine, ask
symptoms like sleepiness and/or decrease in breathing.
same as yours.
Rare (may affect up to 1 in 1000 people)
your doctor or pharmacist.
!
If you get any side effects talk to your doctor or pharmacist.
!
Trouble breathing, shallow breaths (respiratory depression)
Gabapentin Capsules contain lactose monohydrate and
This includes any possible side effects not listed in this leaflet.
!
Loss of consciousness.
4. POSSIBLE SIDE EFFECTS
See section 4.
sunset yellow
!
Decrease in blood glucose levels (most often observed in
!
These capsules contain lactose monohydrate. If you have
patients with diabetes).
Like all medicines, Gabapentin Capsules can cause side effects,
been told by your doctor that you have intolerance to some
What is in this leaflet:
although not everybody gets them.
sugars, contact your doctor before taking this medicine.
1. What Gabapentin Capsules are and what they are used for
Since introduction to the market the following side-effects
!
Gabapentin 400mg contain sunset yellow (E110) which may
2. What you need to know before you take Gabapentin Capsules
have been reported (frequency unknown):
Tell your doctor immediately or go to the nearest hospital
cause allergic reactions.
3. How to take Gabapentin Capsules
!
Decreased platelets which may cause increased bleeding or
casualty department if you have any of the following serious
4. Possible side effects
bruising.
side
effects:
5. How to store Gabapentin Capsules
Pregnancy, breast-feeding and fertility
!
Hallucinations.
!
Swelling of the lips and face, skin rash (these may be
6. Contents of the pack and other information
Pregnancy
!
Abnormal movements such as writhing, jerking and stiffness,
symptoms of a serious allergic reaction).
Gabapentin Capsules should not be taken during pregnancy.
involuntary twitching.
!
Muscle pain and/or weakness if you are on haemodialysis.
1. WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY
Effective contraception must be used by women of child-bearing
!
Ringing in the ears.
!
Severe stomach pain (this may be a symptom of inflammation
ARE USED FOR
potential.
!
Yellowing of the skin and eyes (jaundice), liver problems.
of the pancreas).
There have been no studies specifically looking at the use of
!
Acute kidney failure, incontinence.
!
Thoughts of harming or killing yourself.
Gabapentin in pregnant women, but other medications used to
Gabapentin belongs to a group of medicines known as anti!
Increased breast tissue, breast enlargement.
!
Severe skin reaction with blistering around the mouth, eyes
treat seizures have reported an increased risk of harm to the
epileptics.
!
Side effects following sudden stopping of gabapentin (anxiety,
and genitals, possibly with fever or flu-like symptoms.
developing baby, particularly when more than one seizure
Gabapentin Capsules are used to:
difficulty
sleeping, feeling sick, pain, sweating), chest pain.
!
Gabapentin
may
cause
a
serious
or
life-threatening
allergic
medication is taken at the same time. Therefore, whenever
!
Treat epilepsy. Gabapentin can be used in addition to current
!
Breakdown of muscle fibres (rhabdomyolysis).
reaction that may affect your skin or other parts of your body
possible, you should try to take only one seizure medication during
treatment when epilepsy has not been fully controlled in
!
Change in blood test results (creatine phosphokinase
such as liver or blood. You may or may not have a rash when
pregnancy and only under the advice of your doctor. Contact your
children over 6 years and adults. It can also be used on its own
increased).
you get this type of reaction. It may cause you to be
doctor immediately if you are pregnant, become pregnant or plan to
to treat children over 12 years and adults.
!
Problems with sexual functioning including inability to achieve
hospitalized or to stop gabapentin.
become pregnant. Do not suddenly stop taking this medicine.
!
Relieve peripheral neuropathic pain (long lasting pain caused
a sexual climax, delayed ejaculation.
by damage to nerves) caused by diseases such as diabetes or
!
Low blood sodium level.
Call your doctor right away if you have any of the following
shingles.
Breast-feeding
!
Anaphylaxis (serious, potentially life threatening allergic
symptoms:
Gabapentin is passed on through breast milk. The effect on the
reaction including difficulty breathing, swelling of the lips,
- breathing problems, which if severe you may need emergency
baby is unknown; therefore you should not breast-feed your baby
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
throat, and tongue, and hypotension requiring emergency
and intensive care to continue breathing normally
unless told to by your doctor.
GABAPENTIN CAPSULES
treatment)
- skin rash
- hives
Fertility
Do NOT take Gabapentin Capsules if:
Reporting of side effects
- fever
There is no effect on fertility in animal studies.
!
you are allergic (hypersensitive) to gabapentin or any of the
If you get any side effects, talk to your doctor or pharmacist. This
- swollen glands that do not go away
other ingredients of Gabapentin Capsules (listed in section 6)
includes any possible side effects not listed in this leaflet. You can
- swelling of your lip and tongue
Driving and using machines
also report side effects directly via the Yellow Card Scheme at:
- yellowing of your skin or of the whites of the eyes
Gabapentin may cause dizziness, drowsiness and tiredness. You
Warnings and precautions
www.mhra.gov.uk/yellowcard. By reporting side effects you can
- unusual bruising or bleeding
should not drive, operate complex machinery or take part in other
Talk to your doctor or pharmacist before you take Gabapentin
help
provide more information on the safety of this medicine.
severe
fatigue
or
weakness
potentially hazardous activities until you know whether this
Capsules if:
- unexpected muscle pain
medication affects your ability to perform these activities.
- if you suffer from kidney problems your doctor may prescribe a
5. HOW TO STORE GABAPENTIN CAPSULES
- frequent infections
different dosing schedule
3. HOW TO TAKE GABAPENTIN CAPSULES
- if you have nervous system disorders, respiratory disorders, or
These symptoms may be the first signs of a serious reaction. A
Keep this medicine out of the sight and reach of children.
you are more than 65 years old, your doctor may prescribe you
doctor should examine you to decide if you should continue taking
Do not store above 25°C. Store in the original package to protect
Always take your medicine exactly as your doctor has told you.
a different dosing regimen
gabapentin.
from moisture.
Check with your doctor or pharmacist if you are not sure. Your
- you are on haemodialysis, tell your doctor if you develop
Do not use after the expiry date, which is stated on the blister strip
doctor will decide the dose that is right for you.
muscle pain and/or weakness
and
carton. The expiry date refers to the last day of that month.
If
any
of
the
following
side
effects
gets
worse
or
you
are
Gabapentin Capsules are to be swallowed with plenty of water and
- you are pregnant, trying to become pregnant or are breastMedicines should not be disposed of via wastewater or household
worried tell your doctor or pharmacist:
can be taken with or without food.
feeding
waste. Ask your pharmacist how to dispose of medicines no longer
!
Cases of abuse and dependence have been reported for
required. These measures will help to protect the environment.
Very common side-effects
Dose for neuropathic pain:
gabapentin from the post-marketing experience. Talk to your
(which may affect more than 1 person in 10):
doctor if you have a history of abuse or dependence.
!
Adults (over 18 years of age):
6. CONTENTS OF THE PACK AND OTHER INFORMATION
!
Viral infection, fever
!
A small number of people being treated with anti-epileptics
The dose is usually built up gradually, starting at 300 mg on the first
!
Feeling drowsy or tired, dizziness, lack of coordination.
such as gabapentin have had thoughts of harming or killing
day, followed by 600 mg on the second day and 900 mg on the third
What Gabapentin Capsules contains
themselves. If at any time you have these thoughts,
day. The dose may then be increased to a maximum of 3600 mg
!
Each capsule contains 100mg, 300mg or 400mg of the active
Common side-effects (which may affect more than 1 person in
immediately contact your doctor.
each day, given in 3 divided doses - in the morning, at midday and
substance gabapentin.
100):
!
If you require an operation or visit the doctor or dentist, tell
in the evening.
!
The other ingredients are maize starch, lactose monohydrate,
!
Pneumonia, respiratory infections, urinary tract infection,
them that you are taking gabapentin. Gabapentin may
!
The dose for the elderly and those with kidney problems
and talc.
inflammation of the ear or other infections.
interfere with some laboratory tests. If you are having a urine
may be reduced.
!
The capsules are made from gelatin and titanium oxide. The
!
Low white blood cell counts.
test, tell the clinic or hospital staff that you are taking
300mg capsule also contains yellow iron oxide (E172) and
!
Loss of (anorexia) or increased appetite.
Gabapentin.
Dose for epilepsy:
quinoline yellow (E104).The 400mg capsule also contains
!
Anger towards others, confusion, mood changes, depression,
!
Adults and children over 12 years:
sunset yellow (E110).
anxiety, nervousness, difficulty with thinking.
Tell your doctor or pharmacist if you are taking, have recently taken
The starting dose is usually between 300 mg and 900 mg each day.
!
The marking ink contains shellac glaze, black iron oxide, N!
Convulsions, jerky movements, difficulty speaking, loss of
or might take any other medicines. In particular, tell your doctor (or
The dose is then built up gradually each day in 3 divided doses - in
Butyl
alcohol, industrial methyl spirit 74 OP, soya lecithin and
memory,
tremor,
difficulty
sleeping,
headache,
sensitive
skin,
pharmacist) if you are taking or have been recently taking any
the morning, at midday and in the evening. The maximum daily
antifoam DC150.
decreased sensation (numbness), difficulty with coordination,
medicines for convulsions, sleeping disorders, depression,
dose is 3600 mg.
unusual eye movement, increased, decreased or absent
anxiety, or any other neurological or psychiatric problems.
!
Children 6-12 years of age:
What Gabapentin Capsules look like and contents of the pack
reflexes.
The dose to be given to your child will be decided by your doctor
The 100mg capsule is a hard white capsule marked with 'GABA
!
Blurred vision, double vision, vertigo.
Important information about potentially serious reactions
and is calculated using your child's weight. The treatment is started
100'. The 300mg capsule is a hard yellow capsule marked with
!
High blood pressure, flushing or dilation of blood vessels.
A small number of people taking gabapentin get an allergic reaction
using a low dose, which is gradually increased over a period of
'GABA 300'. The 400mg capsule is a hard orange capsule marked
!
Diarrhoea, stomach pain, indigestion, constipation, dry mouth
or potentially serious skin reaction, which may develop into more
approximately 3 days. It is usually given in 3 divided doses each
with 'GABA 400'.
or throat, flatulence.
serious problems if not treated. You need to know the symptoms to
day, by taking the capsules in the morning, at midday and in the
They
are available in packs of 90 or 100 capsules in blister strips of
!
Facial
swelling,
bruises,
rash,
itch,
acne.
look out for while you are taking gabapentin. Read the description
evening.
10 capsules.
!
Joint pain, muscle pain, back pain, twitching.
!
The dose for the elderly and those with kidney problems may
of these symptoms in section 4 under the heading 'Tell your
!
Difficulties with erection (impotence).
be reduced.
doctor or go to the nearest hospital casualty department if you
!
Swelling in the legs and arms, difficulty with walking,
Marketing Authorisation Holder and Manufacturer
have any of the following serious side effects'.
weakness, pain, feeling unwell, flu-like symptoms.
M&A Pharmachem Ltd, Bolton, Lancashire BL5 2AL.
Gabapentin capsules should not be given to children under 6
!
Decrease in white blood cells, increase in weight.
years of age.
Other medicines and Gabapentin Capsules
!
Accidental injury, fracture, abrasion.
This leaflet was last revised in August 2017
!
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
If you forget to take a dose
Additionally in clinical studies in children, aggressive behaviour
PP2543
obtained without a prescription.
Take it as soon as you remember unless it is nearly time for your
and
jerky movements were reported.
!
If you take antacids containing aluminium and magnesium at
next dose. Do not take two doses at the same time.
the same time as gabapentin, absorption of gabapentin from

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