OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
Active substance(s): OCTREOTIDE ACETATE
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PH - 151
08 October 2014
2
Version:
231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
PH - 151
4HE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR
HEALTHCARE PROFESSIONALS ONLY
)NSTRUCTIONS FOR USE HANDLING AND DISPOSAL
&OR SINGLE USE ONLY
/CTREOTIDE IS AN INJECTION AND A CONCENTRATE FOR SOLUTION
FOR INFUSION 4HIS MUST BE HANDLED WITH CAUTION 4HE
DILUTION MUST BE DONE UNDER ASEPTIC CONDITIONS BY
TRAINED STAFF AND IN A SPECIFIC AREA 4HE CONTACT OF
/CTREOTIDE WITH SKIN AND MEMBRANES SHOULD BE AVOIDED
)F THE SOLUTION COMES INTO CONTACT WITH THE SKIN WASH
WITH WATER AND SOAP )F THE SOLUTION COMES INTO CONTACT
WITH MEMBRANES WASH IRRIGATE THE AFFECTED AREA
WITH WATER
4O REDUCE LOCAL DISCOMFORT LET THE SOLUTION REACH
ROOM TEMPERATURE BEFORE INJECTING !VOID MULTIPLE
INJECTIONS AT SHORT INTERVALS AT THE SAME TIME
Storage:
Storage conditions:
"EFORE OPENING 3TORE IN A REFRIGERATOR #
PROTECTED FROM LIGHT $O NOT FREEZE
!FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY
PH - 151
PH - 151
'ROWTH HORMONE SECRETING PITUITARY TUMOURS MAY
SOMETIMES EXPAND AND CAUSE PROBLEMS 4ELL YOUR DOCTOR
IF YOU EXPERIENCE ANY PROBLEMS WITH YOUR EYES OR SIGHT
4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL PROBLEMS
PACKAGE LEAFLET:
GET WORSE
INFORMATION FOR THE USER
4AKING OTHER MEDICINES
Octreotide 50 micrograms/ml,
100 micrograms/ml and 500 micrograms/ml 0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
OR HAVE RECENTLY TAKEN ANY OF THE FOLLOWING MEDICINES
Solution for injection or Concentrate for INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
solution for infusion
s )NSULIN OR OTHER DRUGS FOR DIABETES
Read all of this leaflet carefully before you start
s #ICLOSPORIN A DRUG USED AFTER A TRANSPLANT
using this medicine.
s #IMETIDINE A DRUG USED TO REDUCE STOMACH ACID
s +EEP THIS LEAFLET 9OU MAY NEED TO READ IT AGAIN
s "ROMOCRIPTINE A DRUG USED IN 0ARKINSONS DISEASE
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR DOCTOR OR IN ACROMEGALY OR TO SUPPRESS BREAST MILK
OR PHARMACIST
s -EDICINES TO CONTROL BLOOD PRESSURE BETA BLOCKERS
s )F ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU
OR CALCIUM CHANNEL BLOCKERS OR AGENTS TO CONTROL
NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET
FLUID AND ELECTROLYTE BALANCE DIURETICS
PLEASE TELL YOUR DOCTOR OR PHARMACIST
s -EDICINES METABOLISED BY THE LIVER FOR EXAMPLE
CARBAMAZEPINE A DRUG USED IN PSYCHIATRIC DISORDERS
IN THIS LEAFLET:
EPILEPSY TRIGEMINAL NEURALGIA AND NEUROPATHY
1. What Octreotide is and what it is used for
DIGOXIN MEDICINE FOR CERTAIN HEART PROBLEMS AND
2. Before Octreotide is used
WARFARIN A DRUG USED TO THIN THE BLOOD AND
3. How to use Octreotide
TERFENADINE TO RELIEVE ALLERGIC SYMPTOMS
4. Possible side effects
0LEASE TELL YOUR DOCTOR OR HOSPITAL PHARMACIST IF YOU
5. How to store Octreotide
ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES
6. Further information
INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
1 WHAT OCTREOTIDE IS AND WHAT IT IS
Pregnancy and breast-feeding
USED FOR
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING ANY MEDICINES 9OU SHOULD NOT USE /CTREOTIDE
/CTREOTIDE IS A SYNTHETIC FORM OF A HORMONE CALLED
IF YOU ARE PREGNANT UNLESS YOU HAVE BEEN TOLD BY YOUR
SOMATOSTATIN WHICH OCCURS NATURALLY IN THE BODY )T
DOCTOR THAT IT IS ABSOLUTELY NECESSARY FOR YOU TO DO SO
HELPS STOP THE RELEASE OF SOME HORMONES INCLUDING 9OU SHOULD NOT BREAST FEED YOUR INFANT WHILST
GROWTH HORMONE IN THE BODY
RECEIVING TREATMENT WITH OCTREOTIDE UNLESS YOU HAVE
BEEN TOLD TO DO SO
/CTREOTIDE IS USED
s 4O TREAT ACROMEGALY
$RIVING AND USING MACHINES
!CROMEGALY IS A CONDITION WHERE THE BODY PRODUCES /CTREOTIDE MAY MAKE YOU FEEL DIZZY )F THIS HAPPENS
TOO MUCH GROWTH HORMONE 4HE LEVEL OF GROWTH
DO NOT DRIVE OR OPERATE MACHINERY 2EMEMBER THAT IF
HORMONE CONTROLS THE GROWTH OF TISSUES ORGANS AND YOU ARE UNWELL YOUR ABILITY TO OPERATE MACHINERY
BONES 4OO MUCH HORMONE MEANS THE SIZE OF BONES MAY BE AFFECTED
AND TISSUES ESPECIALLY IN THE HANDS AND FEET IS
LARGER THAN NORMAL 4HE SYMPTOMS OF ACROMEGALY )MPORTANT INFORMATION ABOUT SOME OF THE
INCLUDE HEADACHE EXCESSIVE PERSPIRATION NUMB
ingredients of Octreotide
HANDS AND FEET TIREDNESS AND JOINT PAIN )N MOST
/CTREOTIDE MICROGRAMSML MICROGRAMSML
CASES THE OVERPRODUCTION OF GROWTH HORMONE IS
AND MICROGRAMSML 3OLUTION FOR INJECTION OR
CAUSED BY AN ENLARGEMENT IN THE PITUITARY GLAND A #ONCENTRATE FOR SOLUTION FOR INFUSION CONTAINS LESS
PITUITARY ADENOMA
THAN MMOL SODIUM PER DOSE IE ESSENTIALLY
/CTREOTIDE IS USED TO TREAT PEOPLE WITH ACROMEGALY hSODIUM FREEv
s WHEN OTHER TYPES OF TREATMENT FOR ACROMEGALY
/THER 3PECIAL 7ARNINGS
SURGERY OR RADIOTHERAPY ARE NOT SUITABLE OR
s 4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL
HAVE NOT WORKED
s AFTER RADIOTHERAPY TO COVER THE INTERIM PERIOD SYMPTOMS GET WORSE
UNTIL THE RADIOTHERAPY BECOMES FULLY EFFECTIVE s /CTREOTIDE SHOULD ONLY BE USED IN PREGNANCY IF
CLEARLY NEEDED 4ELL YOUR DOCTOR IF YOU ARE PREGNANT
s BEFORE SURGERY ON THE PITUITARY GLAND
OR WANT TO BECOME PREGNANT
s 4O RELIEVE STOMACH OR BOWEL SYMPTOMS ASSOCIATED s 7OMEN OF CHILD BEARING POTENTIAL MUST USE AN
with certain tumours known as
EFFECTIVE CONTRACEPTIVE METHOD DURING TREATMENT
@GASTROENTEROPANCREATIC TUMOURS RARE TUMOURS OF WITH /CTREOTIDE
THE STOMACH BOWELS OR PANCREAS
/VERPRODUCTION OF SPECIFIC HORMONES AND OTHER
3 HOW TO USE OCTREOTIDE
RELATED NATURAL SUBSTANCES CAN BE CAUSED BY SOME
RARE CONDITIONS OF THE STOMACH BOWELS OR
!LWAYS USE /CTREOTIDE EXACTLY AS YOUR DOCTOR HAS
PANCREAS 4HIS UPSETS THE NATURAL HORMONAL
TOLD YOU 9OU SHOULD CHECK WITH YOUR DOCTOR OR
BALANCE OF THE BODY AND RESULTS IN A VARIETY OF
PHARMACIST IF YOU ARE UNSURE OF ANYTHING
SYMPTOMS SUCH AS FLUSHING DIARRHOEA LOW BLOOD
9OUR MEDICINE MUST BE INJECTED SUBCUTANEOUSLY IE
PRESSURE RASH AND WEIGHT LOSS 4REATMENT WITH
INTO THE TISSUE UNDER THE SKIN 9OUR DOCTOR OR NURSE
/CTREOTIDE HELPS TO CONTROL THESE SYMPTOMS
WILL SHOW YOU HOW TO DO THIS )F YOU ARE UNSURE GO
s 4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC
BACK AND ASK FOR ADVICE 9OU MUST USE A CLEAN STERILE
surgery
SYRINGE AND NEEDLE EVERY TIME
/CTREOTIDE CAN BE USED IN SOME PATIENTS WHEN
4HE UPPER ARMS THIGHS AND STOMACH ARE GOOD AREAS
THEY HAVE AN OPERATION ON THE PANCREAS )T MAY
HELP REDUCE SOME OF THE PROBLEMS WHICH CAN OCCUR FOR SUBCUTANEOUS INJECTION #HOOSE A DIFFERENT PLACE
EACH TIME SO THAT YOU DONT IRRITATE A PARTICULAR AREA
IN THE ABDOMEN AFTER THE OPERATION SUCH AS
+EEP CHANGING THE INJECTION SITE $ONT INJECT INTO THE
INFLAMMATION SWELLING AND INFECTION
SAME PLACE TOO FREQUENTLY
2 BEFORE OCTREOTIDE IS USED
4O AVOID SIDE EFFECTS LIKE STOMACH ACHE WIND
DIARRHOEA AND CONSTIPATION DO NOT INJECT AT MEALTIMES
9OU SHOULD ./4 BE GIVEN /CTREOTIDE
)NJECT BETWEEN MEALS OR BEFORE GOING TO BED
s IF YOU ARE ALLERGIC HYPERSENSITIVE TO OCTREOTIDE
ACETATE OR ANY OF THE OTHER INGREDIENTS OF
)N RARE CASES /CTREOTIDE WILL HAVE TO BE INJECTED
/CTREOTIDE SEE SECTION
INTRAVENOUSLY INTO A VEIN )F THIS IS NECESSARY THE
s IF YOU ARE BREAST FEEDING
DOCTOR OR NURSE WILL DO IT AND MONITOR YOU CLOSELY 9OU
MUST ./4 INJECT /CTREOTIDE INTO YOUR VEINS YOURSELF
4AKE SPECIAL CARE WITH /CTREOTIDE
s IF YOU ARE PREGNANT
4HE USUAL DOSAGES ARE GIVEN BELOW HOWEVER YOUR
s AS OCTREOTIDE MAY AFFECT YOUR BLOOD SUGAR LEVELS
DOCTOR WILL DECIDE WHAT DOSAGE TO GIVE TO YOU AS THIS
9OU OR YOUR DOCTOR SHOULD CLOSELY MONITOR YOUR
DEPENDS ON THE NATURE OF YOUR TREATMENT YOUR AGE
BLOOD SUGAR LEVELS
AND YOUR MEDICAL CONDITION
s IF YOU HAVE ANY THYROID PROBLEMS OR HAVE HAD A
For the treatment of acromegaly
DISEASE WHICH MAY HAVE AFFECTED YOUR THYROID
s IF YOU HAVE ANY PROBLEMS WITH YOUR LIVER OR HAVE YOU s 4HE USUAL DOSE IS TO MG THREE TIMES A DAY
BY SUBCUTANEOUS INJECTION $EPENDING ON HOW
HAD A DISEASE WHICH MAY HAVE AFFECTED YOUR LIVER
s IF YOU HAVE EVER SUFFERED FROM GALLSTONES OR OTHER YOU RESPOND YOUR DOCTOR WILL ADJUST THE DOSE UNTIL
THEY FIND THE RIGHT DOSE
STOMACH PROBLEMS
s IF YOU HAVE A HISTORY OF 6ITAMIN " DEFICIENCY
4O RELIEVE SYMPTOMS CAUSED BY OVER PRODUCTION OF
9OUR DOCTOR MAY NEED TO MONITOR YOUR VITAMIN " some hormones
LEVELS DURING THERAPY WITH OCTREOTIDE
s 9OUR DOCTOR WILL USUALLY START YOUR TREATMENT WITH
9OUR DOCTOR MAY WANT TO GIVE YOU A CHECK UP FROM TIME MG ONCE OR TWICE DAILY BY SUBCUTANEOUS
TO TIME WHILE YOU ARE BEING TREATED WITH /CTREOTIDE INJECTION $EPENDING ON HOW YOU RESPOND YOUR
DOCTOR MAY GRADUALLY INCREASE THE DOSE UNTIL THEY
FIND YOUR IDEAL DOSE
PH - 151
4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC SURGERY Uncommon:
s MG THREE TIMES A DAY FOR SEVEN DAYS STARTING ON s $EHYDRATION
s &AST HEART BEAT
THE DAY OF THE OPERATION
08 October 2014
2
Version:
231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
PH - 151
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
/CTREOTIDE SOLUTION DILUTED IN MGML
SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
DEMONSTRATED FOR HOURS WHEN STORED BELOW #
&ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
AND VALIDATED ASEPTIC CONDITIONS
$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
VISIBLE PARTICLES
$ISPOSAL
!NY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE
DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS
"
PH - 151
"
PH - 151
0EOPLE WITH LIVER OR KIDNEY PROBLEMS MAY BE GIVEN A Frequency not known:
s !NAPHYLAXIS A TYPE OF ALLERGIC REACTION WHICH
SMALLER DOSE
CAUSES DIFFICULTY IN BREATHING OR DIZZINESS
4HERE IS VERY LITTLE EXPERIENCE OF USING OCTREOTIDE IN
ALLERGYHYPERSENSITIVITY REACTIONS
CHILDREN
s )TCHY RASH
s )NFLAMMATION OF THE PANCREAS
)F YOU RECEIVE MORE /CTREOTIDE THAN YOU SHOULD
)F YOU ARE CONCERNED THAT YOU MAY HAVE BEEN GIVEN TOO s ,IVER INFLAMMATION HEPATITIS SYMPTOMS MAY
MUCH /CTREOTIDE TELL YOUR DOCTOR OR NURSE IMMEDIATELY INCLUDE YELLOWING OF THE SKIN AND EYES JAUNDICE
NAUSEA VOMITING LOSS OF APPETITE GENERALLY
FEELING UNWELL ITCHING LIGHT COLOURED URINE
If you miss a dose of Octreotide
s )RREGULAR HEART BEAT
!S YOU WILL BE GIVEN THIS MEDICINE UNDER CLOSE
s ,IVER DYSFUNCTION
SUPERVISION IT IS VERY UNLIKELY THAT YOU WILL MISS A
DOSE )F YOU THINK THAT YOU HAVE MISSED A DOSE OF
)F ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU NOTICE
TREATMENT TELL A DOCTOR OR NURSE AT ONCE
ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET PLEASE TELL
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS YOUR DOCTOR OR PHARMACIST
PRODUCT ASK YOUR DOCTOR OR PHARMACIST
5 HOW TO STORE OCTREOTIDE
4 POSSIBLE SIDE EFFECTS
+EEP OUT OF THE REACH AND SIGHT OF CHILDREN
,IKE ALL MEDICINES /CTREOTIDE CAN CAUSE SIDE EFFECTS
$O NOT USE /CTREOTIDE AFTER THE EXPIRY DATE WHICH IS
ALTHOUGH NOT EVERYBODY GETS THEM
STATED ON THE LABEL AFTER %80 4HE EXPIRY DATE REFERS
-OST PEOPLE WHO ARE PRESCRIBED /CTREOTIDE BENEFIT FROM TO THE LAST DAY OF THAT MONTH
TAKING IT BUT A FEW PEOPLE CAN BE UPSET BY IT )F YOU
ARE RECEIVING THIS MEDICINE ON A LONG TERM BASIS THEN Storage conditions:
"EFORE OPENING 3TORE IN A REFRIGERATOR #
YOU WILL GO TO HOSPITAL FROM TIME TO TIME TO HAVE
PROTECTED FROM LIGHT $O NOT FREEZE
REGULAR CHECK UPS
4HERE IS NO NEED TO WORRY IF YOU SUFFER FROM ANY OF THE !FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
FOLLOWING COMMON REACTIONS AT THE SITE OF INJECTION
s 0AIN STINGING TINGLING BURNING REDNESS AND SWELLING After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
4HESE RARELY LAST FOR MORE THAN MINUTES AND WILL BE /CTREOTIDE SOLUTION DILUTED IN MGML
LESS IF YOU LET YOUR MEDICINE REACH ROOM TEMPERATURE SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
BEFORE INJECTING
DEMONSTRATED FOR HOURS WHEN STORED BELOW #
3OME SIDE EFFECTS CAN BE SERIOUS 3TOP TAKING /CTREOTIDE &ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
and tell your doctor straight away if you notice that: SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
s 9OUR FACE BECOMES FLUSHED OR SWOLLEN OR YOU
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
DEVELOP SPOTS OR A RASH
s 9OUR CHEST FEELS TIGHT YOU BECOME SHORT OF BREATH AND VALIDATED ASEPTIC CONDITIONS
OR WHEEZY
$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
s 9OU FEEL FAINT POSSIBLY AS A RESULT OF A FALL IN BLOOD VISIBLE PARTICLES
PRESSURE
&OR SINGLE USE ONLY
4HESE MIGHT BE A RESULT OF AN ALLERGIC REACTION
)F YOU DEVELOP ANY OF THE FOLLOWING SEE YOUR DOCTOR -EDICINES SHOULD NOT BE DISPOSED OF VIA WASTEWATER
OR HOUSEHOLD WASTE !SK YOUR PHARMACIST HOW TO
immediately:
DISPOSE OF MEDICINES NO LONGER REQUIRED 4HESE
s 0ROLONGEDTROUBLESOME BLOATING OF THE STOMACH
MEASURES WILL HELP TO PROTECT THE ENVIRONMENT
WITH PAIN
s .AUSEAVOMITING ASSOCIATED WITH DROWSINESS
s &EELING RESTLESS OR GIDDY
6 FURTHER INFORMATION
s 9ELLOWING OF THE SKIN OR WHITES OF YOUR EYES
s !CUTE PANCREATITIS SUDDEN SEVERE BURNING PAINS What Octreotide contains
IN THE STOMACH 4HIS MAY HAPPEN WITHIN THE FIRST
FEW HOURS OR DAYS OF TREATMENT AND RESOLVES ITSELF s 4HE ACTIVE SUBSTANCE IS OCTREOTIDE AS THE ACETATE
%ACH ML OF SOLUTION FOR INJECTION OR CONCENTRATE FOR
UPON DRUG WITHDRAWAL
SOLUTION FOR INFUSION CONTAINS MICROGRAMS
MICROGRAMS AND MICROGRAMS OCREOTIDE
4HE FOLLOWING SIDE EFFECTS HAVE ALSO BEEN REPORTED
s 4HE OTHER INGREDIENTS ARE GLACIAL ACETIC ACID
AND THE APPROXIMATE FREQUENCIES SHOWN
SODIUM ACETATE TRIHYDRATE % MANNITOL %
6ERY COMMON
AND WATER FOR INJECTIONS
#OMMON TO
7HAT /CTREOTIDE LOOKS LIKE AND CONTENTS OF THE PACK
5NCOMMON TO
/CTREOTIDE MICROGRAMSML MICROGRAMSML
2ARE TO
AND MICROGRAMSML 3OLUTION FOR INJECTION OR
6ERY RARE
.OT KNOWN CANNOT BE ESTIMATED FROM THE AVAILABLE DATA #ONCENTRATE FOR SOLUTION FOR INFUSION IS A CLEAR AND
COLOURLESS SOLUTION 4HE SOLUTION IS SUPPLIED IN
Very common:
COLOURLESS GLASS VIALS CLOSED WITH SERUM RUBBER
s 3TOMACH ACHE NAUSEA WIND DIARRHOEA OR
STOPPERS AND SEALED WITH ALUMINIUM FLIP OFF CAPS
CONSTIPATION 4HESE WILL BE LESS IF YOU INJECT
FITTED WITH PLASTIC FLIP OFF DISCS 4HE PRODUCT IS PACKED
BETWEEN MEALS OR BEFORE GOING TO BED
IN CARDBOARD BOXES
s #HANGES IN BLOOD SUGAR LEVELS HYPERGLYCAEMIA
/CTREOTIDE MICROGRAMSML MICROGRAMSML
s (EADACHE
AND MICROGRAMSML SOLUTION FOR INJECTION OR
s 'ALLSTONES
CONCENTRATE FOR SOLUTION FOR INFUSION IS AVAILABLE IN
s ,OCAL PAIN AT THE SITE OF INJECTION
PACK SIZES OF AND VIALS
Common:
.OT ALL PACK SIZES MAY BE MARKETED
s 3LOW HEART BEAT
s (AIR LOSS
Marketing Authorisation Holder and Manufacturer
s )TCHING
Marketing Authorisation Holder
s 2ASH
4EVA 5+ ,IMITED %ASTBOURNE ". !'
s 3HORTNESS OF BREATH
5NITED +INGDOM
s $IZZINESS
s ,OSS OF APPETITE
Manufacturer
s #HANGES IN BLOOD SUGAR LEVELS HYPOGLYCAEMIA
4EVA 0HARMACEUTICAL 7ORKS 0RIVATE ,IMITED #OMPANY
s )MPAIRED GLUCOSE TOLERANCE
( 'ÚDÚLLÚ
s 3TOMACH DISCOMFORT AFTER A MEAL
4ÈNCSICS -IHÈLY ÞT
s 6OMITING
(UNGARY
s "LOATED STOMACH
4HIS LEAFLET WAS LAST REVISED IN /CTOBER
s ,OOSE FAECES STOOLS
s $ISCOLOURATION OF FAECES
0,
s &AT IN YOUR FAECES PALE AND FATTY LOOSE STOOLS
0,
s )NFLAMMATION OF THE GALLBLADDER
s "ILIARY SLUDGE
s 9ELLOW SKIN AND EYES
s !BNORMAL LIVER FUNCTION TEST RESULTS
s #HANGES IN ACTIVITY OF THE THYROID GLAND
HYPOTHYROIDISM CAUSING CHANGES IN HEART RATE
APPETITE OR WEIGHT TIREDNESS FEELING COLD OR
"
SWEATING TOO MUCH ANXIETY OR SWELLING AT THE
FRONT OF THE NECK
"
08 October 2014
2
Version:
231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
PH - 151
4HE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR
HEALTHCARE PROFESSIONALS ONLY
)NSTRUCTIONS FOR USE HANDLING AND DISPOSAL
&OR SINGLE USE ONLY
/CTREOTIDE IS AN INJECTION AND A CONCENTRATE FOR SOLUTION
FOR INFUSION 4HIS MUST BE HANDLED WITH CAUTION 4HE
DILUTION MUST BE DONE UNDER ASEPTIC CONDITIONS BY
TRAINED STAFF AND IN A SPECIFIC AREA 4HE CONTACT OF
/CTREOTIDE WITH SKIN AND MEMBRANES SHOULD BE AVOIDED
)F THE SOLUTION COMES INTO CONTACT WITH THE SKIN WASH
WITH WATER AND SOAP )F THE SOLUTION COMES INTO CONTACT
WITH MEMBRANES WASH IRRIGATE THE AFFECTED AREA
WITH WATER
4O REDUCE LOCAL DISCOMFORT LET THE SOLUTION REACH
ROOM TEMPERATURE BEFORE INJECTING !VOID MULTIPLE
INJECTIONS AT SHORT INTERVALS AT THE SAME TIME
Storage:
Storage conditions:
"EFORE OPENING 3TORE IN A REFRIGERATOR #
PROTECTED FROM LIGHT $O NOT FREEZE
!FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY
PH - 151
PH - 151
'ROWTH HORMONE SECRETING PITUITARY TUMOURS MAY
SOMETIMES EXPAND AND CAUSE PROBLEMS 4ELL YOUR DOCTOR
IF YOU EXPERIENCE ANY PROBLEMS WITH YOUR EYES OR SIGHT
4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL PROBLEMS
PACKAGE LEAFLET:
GET WORSE
INFORMATION FOR THE USER
4AKING OTHER MEDICINES
Octreotide 50 micrograms/ml,
100 micrograms/ml and 500 micrograms/ml 0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
OR HAVE RECENTLY TAKEN ANY OF THE FOLLOWING MEDICINES
Solution for injection or Concentrate for INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
solution for infusion
s )NSULIN OR OTHER DRUGS FOR DIABETES
Read all of this leaflet carefully before you start
s #ICLOSPORIN A DRUG USED AFTER A TRANSPLANT
using this medicine.
s #IMETIDINE A DRUG USED TO REDUCE STOMACH ACID
s +EEP THIS LEAFLET 9OU MAY NEED TO READ IT AGAIN
s "ROMOCRIPTINE A DRUG USED IN 0ARKINSONS DISEASE
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR DOCTOR OR IN ACROMEGALY OR TO SUPPRESS BREAST MILK
OR PHARMACIST
s -EDICINES TO CONTROL BLOOD PRESSURE BETA BLOCKERS
s )F ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU
OR CALCIUM CHANNEL BLOCKERS OR AGENTS TO CONTROL
NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET
FLUID AND ELECTROLYTE BALANCE DIURETICS
PLEASE TELL YOUR DOCTOR OR PHARMACIST
s -EDICINES METABOLISED BY THE LIVER FOR EXAMPLE
CARBAMAZEPINE A DRUG USED IN PSYCHIATRIC DISORDERS
IN THIS LEAFLET:
EPILEPSY TRIGEMINAL NEURALGIA AND NEUROPATHY
1. What Octreotide is and what it is used for
DIGOXIN MEDICINE FOR CERTAIN HEART PROBLEMS AND
2. Before Octreotide is used
WARFARIN A DRUG USED TO THIN THE BLOOD AND
3. How to use Octreotide
TERFENADINE TO RELIEVE ALLERGIC SYMPTOMS
4. Possible side effects
0LEASE TELL YOUR DOCTOR OR HOSPITAL PHARMACIST IF YOU
5. How to store Octreotide
ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES
6. Further information
INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
1 WHAT OCTREOTIDE IS AND WHAT IT IS
Pregnancy and breast-feeding
USED FOR
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING ANY MEDICINES 9OU SHOULD NOT USE /CTREOTIDE
/CTREOTIDE IS A SYNTHETIC FORM OF A HORMONE CALLED
IF YOU ARE PREGNANT UNLESS YOU HAVE BEEN TOLD BY YOUR
SOMATOSTATIN WHICH OCCURS NATURALLY IN THE BODY )T
DOCTOR THAT IT IS ABSOLUTELY NECESSARY FOR YOU TO DO SO
HELPS STOP THE RELEASE OF SOME HORMONES INCLUDING 9OU SHOULD NOT BREAST FEED YOUR INFANT WHILST
GROWTH HORMONE IN THE BODY
RECEIVING TREATMENT WITH OCTREOTIDE UNLESS YOU HAVE
BEEN TOLD TO DO SO
/CTREOTIDE IS USED
s 4O TREAT ACROMEGALY
$RIVING AND USING MACHINES
!CROMEGALY IS A CONDITION WHERE THE BODY PRODUCES /CTREOTIDE MAY MAKE YOU FEEL DIZZY )F THIS HAPPENS
TOO MUCH GROWTH HORMONE 4HE LEVEL OF GROWTH
DO NOT DRIVE OR OPERATE MACHINERY 2EMEMBER THAT IF
HORMONE CONTROLS THE GROWTH OF TISSUES ORGANS AND YOU ARE UNWELL YOUR ABILITY TO OPERATE MACHINERY
BONES 4OO MUCH HORMONE MEANS THE SIZE OF BONES MAY BE AFFECTED
AND TISSUES ESPECIALLY IN THE HANDS AND FEET IS
LARGER THAN NORMAL 4HE SYMPTOMS OF ACROMEGALY )MPORTANT INFORMATION ABOUT SOME OF THE
INCLUDE HEADACHE EXCESSIVE PERSPIRATION NUMB
ingredients of Octreotide
HANDS AND FEET TIREDNESS AND JOINT PAIN )N MOST
/CTREOTIDE MICROGRAMSML MICROGRAMSML
CASES THE OVERPRODUCTION OF GROWTH HORMONE IS
AND MICROGRAMSML 3OLUTION FOR INJECTION OR
CAUSED BY AN ENLARGEMENT IN THE PITUITARY GLAND A #ONCENTRATE FOR SOLUTION FOR INFUSION CONTAINS LESS
PITUITARY ADENOMA
THAN MMOL SODIUM PER DOSE IE ESSENTIALLY
/CTREOTIDE IS USED TO TREAT PEOPLE WITH ACROMEGALY hSODIUM FREEv
s WHEN OTHER TYPES OF TREATMENT FOR ACROMEGALY
/THER 3PECIAL 7ARNINGS
SURGERY OR RADIOTHERAPY ARE NOT SUITABLE OR
s 4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL
HAVE NOT WORKED
s AFTER RADIOTHERAPY TO COVER THE INTERIM PERIOD SYMPTOMS GET WORSE
UNTIL THE RADIOTHERAPY BECOMES FULLY EFFECTIVE s /CTREOTIDE SHOULD ONLY BE USED IN PREGNANCY IF
CLEARLY NEEDED 4ELL YOUR DOCTOR IF YOU ARE PREGNANT
s BEFORE SURGERY ON THE PITUITARY GLAND
OR WANT TO BECOME PREGNANT
s 4O RELIEVE STOMACH OR BOWEL SYMPTOMS ASSOCIATED s 7OMEN OF CHILD BEARING POTENTIAL MUST USE AN
with certain tumours known as
EFFECTIVE CONTRACEPTIVE METHOD DURING TREATMENT
@GASTROENTEROPANCREATIC TUMOURS RARE TUMOURS OF WITH /CTREOTIDE
THE STOMACH BOWELS OR PANCREAS
/VERPRODUCTION OF SPECIFIC HORMONES AND OTHER
3 HOW TO USE OCTREOTIDE
RELATED NATURAL SUBSTANCES CAN BE CAUSED BY SOME
RARE CONDITIONS OF THE STOMACH BOWELS OR
!LWAYS USE /CTREOTIDE EXACTLY AS YOUR DOCTOR HAS
PANCREAS 4HIS UPSETS THE NATURAL HORMONAL
TOLD YOU 9OU SHOULD CHECK WITH YOUR DOCTOR OR
BALANCE OF THE BODY AND RESULTS IN A VARIETY OF
PHARMACIST IF YOU ARE UNSURE OF ANYTHING
SYMPTOMS SUCH AS FLUSHING DIARRHOEA LOW BLOOD
9OUR MEDICINE MUST BE INJECTED SUBCUTANEOUSLY IE
PRESSURE RASH AND WEIGHT LOSS 4REATMENT WITH
INTO THE TISSUE UNDER THE SKIN 9OUR DOCTOR OR NURSE
/CTREOTIDE HELPS TO CONTROL THESE SYMPTOMS
WILL SHOW YOU HOW TO DO THIS )F YOU ARE UNSURE GO
s 4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC
BACK AND ASK FOR ADVICE 9OU MUST USE A CLEAN STERILE
surgery
SYRINGE AND NEEDLE EVERY TIME
/CTREOTIDE CAN BE USED IN SOME PATIENTS WHEN
4HE UPPER ARMS THIGHS AND STOMACH ARE GOOD AREAS
THEY HAVE AN OPERATION ON THE PANCREAS )T MAY
HELP REDUCE SOME OF THE PROBLEMS WHICH CAN OCCUR FOR SUBCUTANEOUS INJECTION #HOOSE A DIFFERENT PLACE
EACH TIME SO THAT YOU DONT IRRITATE A PARTICULAR AREA
IN THE ABDOMEN AFTER THE OPERATION SUCH AS
+EEP CHANGING THE INJECTION SITE $ONT INJECT INTO THE
INFLAMMATION SWELLING AND INFECTION
SAME PLACE TOO FREQUENTLY
2 BEFORE OCTREOTIDE IS USED
4O AVOID SIDE EFFECTS LIKE STOMACH ACHE WIND
DIARRHOEA AND CONSTIPATION DO NOT INJECT AT MEALTIMES
9OU SHOULD ./4 BE GIVEN /CTREOTIDE
)NJECT BETWEEN MEALS OR BEFORE GOING TO BED
s IF YOU ARE ALLERGIC HYPERSENSITIVE TO OCTREOTIDE
ACETATE OR ANY OF THE OTHER INGREDIENTS OF
)N RARE CASES /CTREOTIDE WILL HAVE TO BE INJECTED
/CTREOTIDE SEE SECTION
INTRAVENOUSLY INTO A VEIN )F THIS IS NECESSARY THE
s IF YOU ARE BREAST FEEDING
DOCTOR OR NURSE WILL DO IT AND MONITOR YOU CLOSELY 9OU
MUST ./4 INJECT /CTREOTIDE INTO YOUR VEINS YOURSELF
4AKE SPECIAL CARE WITH /CTREOTIDE
s IF YOU ARE PREGNANT
4HE USUAL DOSAGES ARE GIVEN BELOW HOWEVER YOUR
s AS OCTREOTIDE MAY AFFECT YOUR BLOOD SUGAR LEVELS
DOCTOR WILL DECIDE WHAT DOSAGE TO GIVE TO YOU AS THIS
9OU OR YOUR DOCTOR SHOULD CLOSELY MONITOR YOUR
DEPENDS ON THE NATURE OF YOUR TREATMENT YOUR AGE
BLOOD SUGAR LEVELS
AND YOUR MEDICAL CONDITION
s IF YOU HAVE ANY THYROID PROBLEMS OR HAVE HAD A
For the treatment of acromegaly
DISEASE WHICH MAY HAVE AFFECTED YOUR THYROID
s IF YOU HAVE ANY PROBLEMS WITH YOUR LIVER OR HAVE YOU s 4HE USUAL DOSE IS TO MG THREE TIMES A DAY
BY SUBCUTANEOUS INJECTION $EPENDING ON HOW
HAD A DISEASE WHICH MAY HAVE AFFECTED YOUR LIVER
s IF YOU HAVE EVER SUFFERED FROM GALLSTONES OR OTHER YOU RESPOND YOUR DOCTOR WILL ADJUST THE DOSE UNTIL
THEY FIND THE RIGHT DOSE
STOMACH PROBLEMS
s IF YOU HAVE A HISTORY OF 6ITAMIN " DEFICIENCY
4O RELIEVE SYMPTOMS CAUSED BY OVER PRODUCTION OF
9OUR DOCTOR MAY NEED TO MONITOR YOUR VITAMIN " some hormones
LEVELS DURING THERAPY WITH OCTREOTIDE
s 9OUR DOCTOR WILL USUALLY START YOUR TREATMENT WITH
9OUR DOCTOR MAY WANT TO GIVE YOU A CHECK UP FROM TIME MG ONCE OR TWICE DAILY BY SUBCUTANEOUS
TO TIME WHILE YOU ARE BEING TREATED WITH /CTREOTIDE INJECTION $EPENDING ON HOW YOU RESPOND YOUR
DOCTOR MAY GRADUALLY INCREASE THE DOSE UNTIL THEY
FIND YOUR IDEAL DOSE
PH - 151
4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC SURGERY Uncommon:
s MG THREE TIMES A DAY FOR SEVEN DAYS STARTING ON s $EHYDRATION
s &AST HEART BEAT
THE DAY OF THE OPERATION
08 October 2014
2
Version:
231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
PH - 151
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
/CTREOTIDE SOLUTION DILUTED IN MGML
SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
DEMONSTRATED FOR HOURS WHEN STORED BELOW #
&ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
AND VALIDATED ASEPTIC CONDITIONS
$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
VISIBLE PARTICLES
$ISPOSAL
!NY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE
DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS
"
PH - 151
"
PH - 151
0EOPLE WITH LIVER OR KIDNEY PROBLEMS MAY BE GIVEN A Frequency not known:
s !NAPHYLAXIS A TYPE OF ALLERGIC REACTION WHICH
SMALLER DOSE
CAUSES DIFFICULTY IN BREATHING OR DIZZINESS
4HERE IS VERY LITTLE EXPERIENCE OF USING OCTREOTIDE IN
ALLERGYHYPERSENSITIVITY REACTIONS
CHILDREN
s )TCHY RASH
s )NFLAMMATION OF THE PANCREAS
)F YOU RECEIVE MORE /CTREOTIDE THAN YOU SHOULD
)F YOU ARE CONCERNED THAT YOU MAY HAVE BEEN GIVEN TOO s ,IVER INFLAMMATION HEPATITIS SYMPTOMS MAY
MUCH /CTREOTIDE TELL YOUR DOCTOR OR NURSE IMMEDIATELY INCLUDE YELLOWING OF THE SKIN AND EYES JAUNDICE
NAUSEA VOMITING LOSS OF APPETITE GENERALLY
FEELING UNWELL ITCHING LIGHT COLOURED URINE
If you miss a dose of Octreotide
s )RREGULAR HEART BEAT
!S YOU WILL BE GIVEN THIS MEDICINE UNDER CLOSE
s ,IVER DYSFUNCTION
SUPERVISION IT IS VERY UNLIKELY THAT YOU WILL MISS A
DOSE )F YOU THINK THAT YOU HAVE MISSED A DOSE OF
)F ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU NOTICE
TREATMENT TELL A DOCTOR OR NURSE AT ONCE
ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET PLEASE TELL
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS YOUR DOCTOR OR PHARMACIST
PRODUCT ASK YOUR DOCTOR OR PHARMACIST
5 HOW TO STORE OCTREOTIDE
4 POSSIBLE SIDE EFFECTS
+EEP OUT OF THE REACH AND SIGHT OF CHILDREN
,IKE ALL MEDICINES /CTREOTIDE CAN CAUSE SIDE EFFECTS
$O NOT USE /CTREOTIDE AFTER THE EXPIRY DATE WHICH IS
ALTHOUGH NOT EVERYBODY GETS THEM
STATED ON THE LABEL AFTER %80 4HE EXPIRY DATE REFERS
-OST PEOPLE WHO ARE PRESCRIBED /CTREOTIDE BENEFIT FROM TO THE LAST DAY OF THAT MONTH
TAKING IT BUT A FEW PEOPLE CAN BE UPSET BY IT )F YOU
ARE RECEIVING THIS MEDICINE ON A LONG TERM BASIS THEN Storage conditions:
"EFORE OPENING 3TORE IN A REFRIGERATOR #
YOU WILL GO TO HOSPITAL FROM TIME TO TIME TO HAVE
PROTECTED FROM LIGHT $O NOT FREEZE
REGULAR CHECK UPS
4HERE IS NO NEED TO WORRY IF YOU SUFFER FROM ANY OF THE !FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
FOLLOWING COMMON REACTIONS AT THE SITE OF INJECTION
s 0AIN STINGING TINGLING BURNING REDNESS AND SWELLING After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
4HESE RARELY LAST FOR MORE THAN MINUTES AND WILL BE /CTREOTIDE SOLUTION DILUTED IN MGML
LESS IF YOU LET YOUR MEDICINE REACH ROOM TEMPERATURE SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
BEFORE INJECTING
DEMONSTRATED FOR HOURS WHEN STORED BELOW #
3OME SIDE EFFECTS CAN BE SERIOUS 3TOP TAKING /CTREOTIDE &ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
and tell your doctor straight away if you notice that: SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
s 9OUR FACE BECOMES FLUSHED OR SWOLLEN OR YOU
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
DEVELOP SPOTS OR A RASH
s 9OUR CHEST FEELS TIGHT YOU BECOME SHORT OF BREATH AND VALIDATED ASEPTIC CONDITIONS
OR WHEEZY
$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
s 9OU FEEL FAINT POSSIBLY AS A RESULT OF A FALL IN BLOOD VISIBLE PARTICLES
PRESSURE
&OR SINGLE USE ONLY
4HESE MIGHT BE A RESULT OF AN ALLERGIC REACTION
)F YOU DEVELOP ANY OF THE FOLLOWING SEE YOUR DOCTOR -EDICINES SHOULD NOT BE DISPOSED OF VIA WASTEWATER
OR HOUSEHOLD WASTE !SK YOUR PHARMACIST HOW TO
immediately:
DISPOSE OF MEDICINES NO LONGER REQUIRED 4HESE
s 0ROLONGEDTROUBLESOME BLOATING OF THE STOMACH
MEASURES WILL HELP TO PROTECT THE ENVIRONMENT
WITH PAIN
s .AUSEAVOMITING ASSOCIATED WITH DROWSINESS
s &EELING RESTLESS OR GIDDY
6 FURTHER INFORMATION
s 9ELLOWING OF THE SKIN OR WHITES OF YOUR EYES
s !CUTE PANCREATITIS SUDDEN SEVERE BURNING PAINS What Octreotide contains
IN THE STOMACH 4HIS MAY HAPPEN WITHIN THE FIRST
FEW HOURS OR DAYS OF TREATMENT AND RESOLVES ITSELF s 4HE ACTIVE SUBSTANCE IS OCTREOTIDE AS THE ACETATE
%ACH ML OF SOLUTION FOR INJECTION OR CONCENTRATE FOR
UPON DRUG WITHDRAWAL
SOLUTION FOR INFUSION CONTAINS MICROGRAMS
MICROGRAMS AND MICROGRAMS OCREOTIDE
4HE FOLLOWING SIDE EFFECTS HAVE ALSO BEEN REPORTED
s 4HE OTHER INGREDIENTS ARE GLACIAL ACETIC ACID
AND THE APPROXIMATE FREQUENCIES SHOWN
SODIUM ACETATE TRIHYDRATE % MANNITOL %
6ERY COMMON
AND WATER FOR INJECTIONS
#OMMON TO
7HAT /CTREOTIDE LOOKS LIKE AND CONTENTS OF THE PACK
5NCOMMON TO
/CTREOTIDE MICROGRAMSML MICROGRAMSML
2ARE TO
AND MICROGRAMSML 3OLUTION FOR INJECTION OR
6ERY RARE
.OT KNOWN CANNOT BE ESTIMATED FROM THE AVAILABLE DATA #ONCENTRATE FOR SOLUTION FOR INFUSION IS A CLEAR AND
COLOURLESS SOLUTION 4HE SOLUTION IS SUPPLIED IN
Very common:
COLOURLESS GLASS VIALS CLOSED WITH SERUM RUBBER
s 3TOMACH ACHE NAUSEA WIND DIARRHOEA OR
STOPPERS AND SEALED WITH ALUMINIUM FLIP OFF CAPS
CONSTIPATION 4HESE WILL BE LESS IF YOU INJECT
FITTED WITH PLASTIC FLIP OFF DISCS 4HE PRODUCT IS PACKED
BETWEEN MEALS OR BEFORE GOING TO BED
IN CARDBOARD BOXES
s #HANGES IN BLOOD SUGAR LEVELS HYPERGLYCAEMIA
/CTREOTIDE MICROGRAMSML MICROGRAMSML
s (EADACHE
AND MICROGRAMSML SOLUTION FOR INJECTION OR
s 'ALLSTONES
CONCENTRATE FOR SOLUTION FOR INFUSION IS AVAILABLE IN
s ,OCAL PAIN AT THE SITE OF INJECTION
PACK SIZES OF AND VIALS
Common:
.OT ALL PACK SIZES MAY BE MARKETED
s 3LOW HEART BEAT
s (AIR LOSS
Marketing Authorisation Holder and Manufacturer
s )TCHING
Marketing Authorisation Holder
s 2ASH
4EVA 5+ ,IMITED %ASTBOURNE ". !'
s 3HORTNESS OF BREATH
5NITED +INGDOM
s $IZZINESS
s ,OSS OF APPETITE
Manufacturer
s #HANGES IN BLOOD SUGAR LEVELS HYPOGLYCAEMIA
4EVA 0HARMACEUTICAL 7ORKS 0RIVATE ,IMITED #OMPANY
s )MPAIRED GLUCOSE TOLERANCE
( 'ÚDÚLLÚ
s 3TOMACH DISCOMFORT AFTER A MEAL
4ÈNCSICS -IHÈLY ÞT
s 6OMITING
(UNGARY
s "LOATED STOMACH
4HIS LEAFLET WAS LAST REVISED IN /CTOBER
s ,OOSE FAECES STOOLS
s $ISCOLOURATION OF FAECES
0,
s &AT IN YOUR FAECES PALE AND FATTY LOOSE STOOLS
0,
s )NFLAMMATION OF THE GALLBLADDER
s "ILIARY SLUDGE
s 9ELLOW SKIN AND EYES
s !BNORMAL LIVER FUNCTION TEST RESULTS
s #HANGES IN ACTIVITY OF THE THYROID GLAND
HYPOTHYROIDISM CAUSING CHANGES IN HEART RATE
APPETITE OR WEIGHT TIREDNESS FEELING COLD OR
"
SWEATING TOO MUCH ANXIETY OR SWELLING AT THE
FRONT OF THE NECK
"
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