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SEGOSANA 400 MG CAPSULES

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Package leaflet: Information for the user

SEGOSANA 100MG CAPSULES
SEGOSANA 300MG CAPSULES
SEGOSANA 400MG CAPSULES
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 of the 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 Segosana is and what it is used for
2. What you need to know before you take
Segosana
3. How to take Segosana
4. Possible side effects
5. How to store Segosana
6. Contents of the pack and other
information
1. What Segosana is and what it is
used for
Segosana 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 Segosana Capsules
is gabapentin.
Segosana 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 Segosana for you
to help treat your epilepsy when your
current treatment is not fully controlling
your condition. You
should take Segosana
in addition to your
current treatment
unless told otherwise.
CODE
Segosana 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 Segosana
Do not take Segosana:
• if you are allergic to gabapentin or any of
the other ingredients of Segosana
Capsules (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Segosana
• 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 Segosana 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 Segosana 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 Segosana
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
Segosana.
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 Segosana Capsules
Tell your doctor or pharmacist if you are
taking or have recently taken or might take
any other medicines.

Medicines containing morphine
If you are taking any medicines containing
morphine, please tell your doctor or
pharmacist as morphine may increase the
effect of Segosana.
Antacids for indigestion
If Segosana and antacids containing
aluminium and magnesium are taken at the
same time, absorption of Segosana from the
stomach may be reduced. It is therefore
recommended that Segosana is taken at the
earliest two hours after taking an antacid.
Segosana:
• 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;
Segosana with food and drink
Segosana can be taken with or without food.
Pregnancy and breast-feeding
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.

Zentiva
GABAPENTIN 100MG/300MG/400MG CAPSULES, HARD

LEAFLET
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416117 (iss 6)
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Pregnancy
Segosana 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.

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There have been no studies specifically
looking at the use of Segosana 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 Segosana. 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
Segosana, is passed on through human
milk. Because the effect on the baby is
unknown, it is not recommended to
breast-feed while using Segosana.
Driving and using machines
Segosana 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.

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3. How to take Segosana
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 usual 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 of body
weight 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.
Segosana is not recommended for use in
children below 6 years of age.
Peripheral Neuropathic Pain, the usual
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 300mg and 900mg
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.

Zentiva Regulatory
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Date:
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THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
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Date:
Signature:

00000000
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If you are an elderly patient (over 65 years
of age), you should take the normal dose of
Segosana 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 Segosana is too strong or too weak,
talk to your doctor or pharmacist as soon
as possible.
Method of administration
Segosana is for oral use. Always swallow
the capsules with plenty of water.
Continue taking Segosana until your doctor
tells you to stop.
If you take more Segosana 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 Segosana
than your doctor prescribed. Take along any
capsules 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 Segosana
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 Segosana
Do not stop taking Segosana 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
Segosana 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).
• Segosana 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
Segosana.
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 Segosana.
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.

CODE

• 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 (may affect up
to 1 in 100 people):
• 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.
After marketing Segosana 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 Segosana (anxiety,
difficulty sleeping, feeling sick, pain,
sweating), chest pain
• Blood glucose fluctuations in patients
with diabetes.
• Breakdown of muscle fibers
(rhabdomyolysis)
• Change in blood test results (creatine
phosphokinase increased)
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.

Zentiva
GABAPENTIN 100MG/300MG/400MG CAPSULES, HARD

LEAFLET
000
00000
416117 (iss 6)
00000
435561
5-NOV-14
5
AS
2 of 2
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150 x 500mm
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N/A
N/A
Helvetica
Minimum Point Size of Text: 9pt
1

5. How to store Segosana
Keep this medicine out of the sight and reach
of children.

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Do not use this medicine after the expiry
date which is stated on the pack after
EXP. The expiry date refers to the last day
of that month.
Do not store above 30°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
What Segosana Capsules contains
The active substance is gabapentin.
Each hard-capsule contains either 100 mg,
300 mg or 400 mg of gabapentin.
The other ingredients are:
Capsule contents:
Maize starch
Talc
Capsule shell:
Gelatin
Sodium laurilsulfate
100 mg capsules: Titanium dioxide (E171)
300 mg capsules: Titanium dioxide (E171),
yellow iron oxide (E172)
400 mg capsules: Titanium dioxide (E171),
red and yellow iron oxide (E172)
What Segosana Capsules looks like
and contents of the pack
The 100 mg capsules are white hard
capsules containing a white crystalline
powder. The capsule length is 15.70 mm.
The 300 mg capsules are yellow hard
capsules containing a white crystalline
powder. The capsule length is 19.00 mm.
The 400 mg capsules are orange hard
capsules containing a white crystalline powder.
The capsule length is 21.20 mm.
Supplied in blister packs of 10, 20, 30, 50,
60, 84, 90, 98, 100, 200, 500, 1000
capsules.
Also supplied in plastic containers of 300,
400 or 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.
Distributed by: Zentiva, One Onslow
Street, Guildford, Surrey, GU1 4YS, UK
This leaflet was last revised in
November 2014

00000

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

00000000
00000000

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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