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Active substance(s): GABAPENTIN

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+I 70.71 lpi 45.00° 19-05-2014 10:12:42
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Package Ieaflet lnfonnation for the user

Gabapentin Morningside 100 mg Hard Capsules
Gabapentin Morningside 300 mg Hard Capsules
Gabapentln Mornlngslde 400 mg Hard Capsules
Read all or thls Ieafiet camully before you start taklng 11111 medlclne because lt contalns lmportant Information ror you.
Keep 1hls leanet. You may need to read lt agaln.
lf you have any further questions, ask your doctor, pharmacist or nurse.
- This madicina has baan prescribed for you only. Do not pass it an to others. lt may hann 1hem, even if their signs of illness are 1he same as
lf you get any slde elfects, talk to your doctor, phannaclst or nurse. Thls lncludes any posslble slde effects not llsted ln thls leanet.
What ls ln thls Ieafiet

1. What GabapenUn Momlngslde Capsules are and what 1hey are used

Gab'Pantln Momlngslde Gapsules wlth food lßd drlnk
Gabapantin Momingside Capsulas can be taken with or without food.


2. What you need to know before you take Gabspantin Mcmingside
3. How to take GabapenUn Momlngslde Capsules
4. Possible side elfects
5. How to store Gabspantin Momingsida Capsules
6. Centanis of 1he pack ancl other informalion

1. What Gabapenlin Momingside Capsules are and what thay
are uHdfor
Gabspantin belongs to a group of madicinas used to treat apilapsy and
perlpheral neuropathlc paln (long Iasting paln caused by damage to

The ac:tive ingredient in Gabapentin Momingside Capsules is gabapentin.
GabapenUn ls used to treat:
Various fonns of epilepsy (seizures 1hat are inHially limited to certain parts
of 1he brain, whether 1he seizure spreads to other parts of the brain or not).
Your doclor will prascriba Gabspantin Momingside Capsulas for you to
help treat your epllepsy when your current treatment ls not fully oontrolllng
your condilion. You should take Gabapentin Momingside Capaulea in
additicn to your rurrent treatment unless told otherwisa. Gabspantin
Momingside capsules can also be used on its own to treat adulls and
childran over 12 yaars of aga.
Paripheral neuropathic pain (long Iasting pain caused by darnage to the
nerves). A varlety of different dlaeases can cause perlpheral neuropathlc
pain (primarily ocrurring in lhe lega andlor anns), such as diabetas or
shingles. Pain sensations may ba described as hot, buming, 1hrobbing,
shootlng, stabblng, sharp, cramplng, achlng, Ungllng, numbnass, plns
and needles etc.



need to know bafore you take Gabapentln
Momlngslde Capsulea

Pregnancy and breast.feedlng
lf you are pregnant or breast-feedlng, thlnk you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice befora
taking 1his madicine.
Gabapentin Momingsida Capsul86 shculd not be taken during
pregnancy, unless you are told otherwise by your doctor. Effective
contraceptlon must ba usad by woman of chlld-bearlng potanUal.
There have been no studies specifically looking at lhe use of gabapentin
ln pregnant women, but other medlcatlons used to treat selzures have
raportad an increasad risk of hann to tha devetoping beby, perticularty
whan more than one seizure madication is Iaken at 1he same time.
Therefore, whanaver possible, you should try to taka only ona saizure
medlcaUon du ring pregnancy and only under the aclvlce of your doctor.
Contact your doctor lmmedlately lf you become pregnant, thlnk you
mlght be pregnant or are plannlng to become pregnant whlle taklng
Gabapentin Momingside Gapeules. Do not suddenly discontinue taking
1his madicine as this may Iead to breakthrough seizure, which oould
have ser1ous consequences for you and your baby.
Breat feading Gabspantin, 1he active substance of GabapeRtin
Momingside capsules, is passad on 1hrough human milk.
Because the elfect on the baby ls unknown, II ls not recommended to
breast-feed while using GabapeRtin Momingside Capsules.
Drlvtng and uelng machlnes
Gabapenun Momlngslde Capsules may produce dlzzlness, drowslness and
tirud..-s. You should not drive, oparate oomplax machinery or Iake parl in
other potanlially hazardous activities unlil you know whather this
madication affects your ability to perform 1hese activities.
Gab..,antln Momlngalda Capaules contaln lac:toae (a type of sugar).
lf you have baan told by your doctor 1hat you have an intolerance to
soma sugars, contact your doctor before taking this madicinal product.

3. How to Iake Gabapentin Momingsida Capsulaa
Do not taka Gabepentin Momlngslda Capsuln
- if you are allergic to gabapentin or any of the other ingrudianta of
1his madicine Qistad in section 6).

Always take this madicine exactly as your doctor or phannacist has told
you. Check with your doctor or phannacist if you are not sure.

Wamlngs lßd praea.utlona Talk to your doctor, pharmacist or nuree

Your doctor will datarmina what dosa is appropriata for you.

befora taking Gabapantin Momingside Capsules

lf you have 1ha impressicn !hat the elfect of Gabspantin Momingsida
Capsulas is too strong or too waak, talk to your doctor or pharmacist as
soon as posslble.


if you sulfer from kidney problems your doctor may prescribe a


if you are on haamodialysis (to remove wasta products bacausa of
kldney fallure), teil your doctor lf you develop muscle paln andlor

different dosing schadule


if you develop signs such as persistant starnach pain, faaling sick
and being sick contact your doctor immadiataly as 1hese may be
symptoms of acute pancreaUUs (an lnftamad pancreas).

A small number of peopla balng treatad wlth anU-eplleptlcs such as
gabapenUn have had 1houghts of hannlng or kllllng themselves. lf at any
time you have thesa 1houghts, immadiately contect your doctor.
lmportant lnformaUon about potanllally aerlous reacUons
A small number of people taklng Gabapentln Momlngslde capsules get
an allergic reaction or potantially sariaus skin reaction, which may
develop into mors sariaus problams if thay are not treatad. You naad to
know the symptoms to Iook out for whlla you are taklng Gabapandn
Momlngslde Capsules.
Read tha descrlpCion alth- symptoms ln sacUon 4 of thiiiNIIet under
'Contllct your dod.or lrnrnBdltlt8ly lf you exparlence arry of the fo/lowlng
s~ sffertaldng th/s medlclne as lhey can be settous'
other medlclnes and Gab..,entln Momlngslda Capsules
Teil your doctor or phannaclst lf you are taklng, have recentiy taken or
might Iake any other medicines.
Medlclnes contalnlng morphlne lf you are taklng any medlclnes
contalnlng morphlne, please tell your doctor or phannaclst as morphlne
may increase the elfect of gabapentin.
Antacida for Indigestion
lf Gabapentin Momlngslde Capsules and antaclds contalnlng alumlnlum
and magnesium are Iaken at lhe same time, absorption of Gabapentin
Momingside Capsulas from 1he stomach may be ruducad. lt is 1herafore
recommended that Gabapentin Momingside capsulas are taken at the
earllest two hours after taldng an antacld.
GabapenUn Momlngslde capsules:
are not expected to lnteract wlth other antiepllepUc drugs er 1he oral
contraceptive pill.
may interfera with some Iaboretory tasts, if you require a urine tast
lall your doctor or hospltal what you are taldng.


lf you are an aldarly patiant (over 65 years or qa), you should Iake
1he nonnal dose of Gabapentin Momlngslde Capsules unless you have
problems with your kidneys.
Your doctor may prescribe a different dosing schedule andlor dose if you
have problems with your kidneya.
Continue taking GabapeRtin Momingside Capsules until your doctor teils
you to &top.
Mathod and route or admlnlstratlon
Gabapentin Momingside Capsules ara for oral use. Always swallow the
capsules whole with planty of watar.
Epllapsy, tha uaual doll8 Ia:
Adults and adol-ntll:
Taka tha numbsr of capsulas as instructed. Your doctor will usually build up
your dose gradually. The starling dose will generally be between 300 mg
and 900 mg each dey. Thereatter, 1he doaa may bs incraased as instructad
by your doctor up to a maximum of 3600 rng aach day and your doctor will
1811 you to take this in 3 separate doses, i.a. once in 1ha moming, once in
the aftemoon and once ln the evenlng.
Childran aged 6 years and above:
Tha dosa to ba given to your child will be dacided by your doctor as it is
calculated against your child's weight. The treatment is started with a low
initial dOBB which is gradually incraased over a period of approximately 3
days. The usual dose to control epilepsy is 25-35 mg par kg of body
waight per day. lt is usually given in 3 separate doses, by taking tha
capsule(s) each day, usually once ln the momlng, once ln 1he aftemoon
and cnce in the evening.
Gab..,antln Momlngslda c..,auln ara not recommanded for usa ln
chlldran below • years or .....
Paripharal Neuropathie Pain, tha usual dose is:
Take 1he number of capsulas as instructad by your doctor. Your dcctor
will usually build up your dose gredually. The starling dose will generelly
be belween 300 mg and 900 mg each day. Thereafter, the dose may be

+I 70.71 lpi 45.00° 19-05-2014 10:13:10
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incraasad as instructsd by your dociDr up to a maximum of 3600 mg
aach day and your doctDr will tall you to take this in 3 saparata dosas,
l.e. once ln the momlng, onoe ln the aftamoon and onoe ln the evenlng.

lf you hava lddnay problams or are recelvlng humodlalysls
Your doclor may prascribe a different dosing schedula andlor dosa if you
have problams wlth your kldneys or ara undergolng haemodlalysls.
lfyou taka more ~n Momlngalde Capsut.. than you should
Higher than recommandad d0686 may result in an incraasa in side
elfects lncludlng loss of consclousness, dlzzlness, double vlslon, slumsd
speach, drowainess and diarrhoaa. Call your doctor or go to the neeraal
hospital emergancy unit immedistaly if you heve Iaken more Gabepentin
Momingsicle Capsulas than your doctor prescribed. Take along any
capsules thal you have not Iaken, Iogether wHh the contalner and the
Iabei so that the hospltal can easlly tell what medlclne you have Iaken.
lf you forget ta Iake Gm.pentln Momlngalde Capsulu
lf you forget to take a dose, take lt as soon as you remernbar unless lt ls
Urne for your next dose. Do not take a double dose to make up for a
forgotlen doae.
lf you atop taldng Gm.,.ntln Momlngslde Capsut. .
Do not stop taking Gabepentin Morningside Capsules unless your doclor
teils you to. lf your treatment is stopped it should be done gradually over
a minimum of 1 week. lf you stop laking Gabapentin Momingside
Capsules suddenly or before your doctor teils you, thene ls an lncreased
rlsk of selzures.
lf you have any further quastions on tha usa of this medicine, ask your
doclor, phannaclst or nurse.

4. Posslbla slda 8ll'8cts
Like all medicines, this madicine can cause side effacts, although not
everybody gets them.
Contact your doctar immediately if you experience any of the
followlng symptoma alter taklng thla rnedlclna u thay can ba
severe skin raaclions that require immediat& attenlion, swelling of
the lips and faca, skin rash and radness andlor hair loss (thesa may
ba symptoms of a sariaus allergic reacöon)
persistent stomach paln, feellng slck and belng slck as these may be
symptoms of acuta pancreatilis (an intlamed pancreas)
Gabepentin Momingside Capsules may causa a serious or lif&.
thraatening allargic raacöon lhat may affecl your skin or other parts
of your body such as your llver or blood cells. You may or may not
have resh when you get this type of reaclion. II may csuse you to be
hospitelised or to stop Gabepentin MomingBide Capsules. Call your
doclor right away if you have any of tha following symptoms:
skln resh
swollen glands that do not go away
swelllng of your llp and tongue
yellowing of your skin or of the whites of lhe eyes
unusual bruising or bleeding
severe fatigue or waakness
unexpected muscle pain
frequent infecöona
These symptoms may be the ftrst slgns of a ser1ous reacllon. A doctor
should examine you to dacide if you should continua taking Gabe.penUn
Momingsicle Capsules.

lf you are on haamodialysis, teil your doctor if you develop muscle pain
andlor weakness.
Othar side effacls include:
Very c:ommon siele~ (whlch may .tract- t1wm 1 person ln 10):
Viral infaction
Feeling drowsy, dizziness, Iack of coordination
Feeling tired, faver
Common aide-affacta (which may affact more than 1 panon in 100):
Pneumonie, raspiratory inrection, urinary tract infaclion, inftammation
of the ear or other infactions
Lew white blood cell COUnts
Anoraxia, increased appetite
Anger towards others, confusion, mood changes, deprassion,
anxiety, nervousness, difliculty wilh thinking
Conwlsions, jerky movements, difficulty with spaaking, loss of
memory, tremor, difliculty sleeping, headache, sensitive skin,
decraasad sensation (numbness), difficully with coordination,
unusual eye movement, lncraased, decreased or absent raftexas
Blurred vlslon, double vlslon
High blood pressura, ftushing or dilation of blood vessels
Dlfllculty breathlng, bronchltls, sora throat, cough, dry nose
VomHing (belng slck), nausea (feellng slck), problems wlth teeth,
intlamed gums, diarrhoea, stomach pain, indigestion, constipation,
dry mouth or throat, flatulenca
Facial swelling, bruises, rash, itch, acna
Joint paln, muscle paln, back paln, twltchlng
Difliculöes with erection (impotanca)
Swelling in tha tags and anns, difliculty wilh welking, waakness,
pain, faeling unwell, ftu·like symptoms
Decraase ln whlta blood calls, lncreasa ln walght
Aceidental injury, fracture, abresion

Slnca lntroductlon to 1111 markat 11M followlng slde..tfecta hava

baan ntported:

Dacreasad platelets (blood clolling calls)
Problems wHh abnonnal movements such as wrtthlng, )erklng
movementa and sliffness
Ringing in the ears
A group of side effects that could include swollan lymph nodes
(lsolated small ralsed lumps under the skln), fever, rash, and
lnftammaUon of llver occurrlng Iogether
Yellowing ofthe skin and eyes Uaundica)
lnflammation of tha liver
Acute kldney fallure, lncontlnence
lncreased breast Ussue, bneast enlargement
Adverae events follawing the abrupt disconlinuation d gabapentin
(anxiely, diflicully sleeping, faeling siele, pain, sweating), ehest pain
Blood glucosa ftuctuations in paUents wilh diabates.

lf you gat any side effacls, talk to your doctDr, phannacist or nurse. This
includes any sida effacls not listed in this leaftat.

5. How ta stara Gabepantin Morningaida C.psules
Keep this medicina out of the Bight and rasch of childran.
Do not use lhis medicina alter the axpiry data which ls stated on lhe
csrton aflar "Exp.". The axpiry data refars to the last day ofthat month.
Do not stora abova 300C. ln order
stora in the original package.

to protacl from light and moistura,

Do not lhrow away any medicines via wasteweter or hausehold waste.
Ask your phannacist how to throw away medicines you no Ionger use.
These measures will help protect the environmenl

8. Contants of lhe pack and othar Information
What Gabepentin Momlngslda Capsulas contaln
The aclive substance is gabapentin. Each hard capsule conteins
either1 00 mg, 300 mg or 400 mg gabapentin.
Tha othar ingredients in Gabspantin Momingside Capsules ara:
Capsule contants:
LaciDse monohydrate
Capsule shell:
Tha 100 mg capsule shell (n"3, light gnaen and ivory} contains:
Qulnolelne yellow (E104)
Indigo cannine (E132)
Titanium dioxide (E171)
Yellow iron OJcide (E172)

Tha 300 mg capsula shell (n"O, dark. gnaen and whita) contains:
Yellow iron oxide (E172)
Indigo cannine (E132)
Titanium dioxide (E171)

Tha 400 mg capsule shell (n"O, gnaen and white) contains:
Yellow Iren OJdde (E172)
Indigo cannine (E132)
Titanium dioxide (E171)
What Gabapentln Momlngslda Capsulu Iook llke and contants of
tha pack
Hard Capsule
Gabepantin Momingsida Capsules ara packad in PVC+P\10/AI blistars.
The available pack sizes ara:
100 mg; 20, 50, 60, 90,100 or500capaules, hard
300 mg and 400 mg: 30, 50, 60, 90, 100 or 500 capsules, hard
Not all pack slzes may ba markated.
Marketing Authoriaation Holdar
Momingside Healthcara Ltd
115 Narberough Road
West Pharma- Produ~es da Especialidades FarmacAuticas, S.A.
Rua Joilo de Deus, n"11, 2700-486 Amadora
AUantlc Pharma • Produ~as Fannaciutlcas S.A.,
Rua da Tapada Grande, n.• 2, Abrunhelra, 271 o-o&9 Slntra
Tacnimede • Sociedede T6cnico-Medicinal, S.A.
Quinte da Cerca, Caixaria, 2565-187 Dois Portos

AddiUonally ln cllnlcal studles ln chlldren, aggressive behavlour and jerky
movemants wera raported commonly.

Fanmalaber- Produtos FannacAuticos, SA.
Zona lndustrlal de Condalxa-e-Nova
3150·194 Condetxa-a-Nova

Uncommon slda..rracts {whlch may atl'act lau lhan 1 person ln

Thla Ieafiet wu last ravlload ln May 2014

Allergie reaction such as hives


Decraasad movemant
Raclng haartbeat
Swelling lhat may involve the face, trunk and Iimba
Abnonnal blood last results suggasting problems with the livar


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