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CARAMET 50 MG / 200 MG CR TABLETS

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA / CARBIDOPA MONOHYDRATE / LEVODOPA / CARBIDOPA MONOHYDRATE / LEVODOPA

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CARAMET® 25 mg/100 mg &
50 mg/200 mg CR TABLETS
CARBIDOPA/LEVODOPA
0!#+!'% ,%!&,%4
).&/2-!4)/. &/2 4(% 53%2
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT
AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR
DOCTOR OR PHARMACIST
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU
ONLY $O NOT PASS IT ON TO OTHERS )T MAY
HARM THEM EVEN IF THEIR SIGNS OF ILLNESS ARE
THE SAME AS YOURS
s )F YOU GET ANY SIDE EFFECTS TALK TO YOUR
DOCTOR OR PHARMACIST4HIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET
7(!4 )3 ). 4()3 ,%!&,%4
1. What Caramet is and what it is used for
2. What you need to know before you
take Caramet
3. How to take Caramet
4. Possible side effects
5. How to store Caramet
6. Contents of the pack and other
information

1

WHAT CARAMET IS AND WHAT IT
IS USED FOR

s #ARAMET CONTAINS LEVODOPA WHICH IS A
DOPAMINERGIC AGENT AND CARBIDOPA WHICH
IS A DOPA DECARBOXYLASE INHIBITOR
s #ARAMET IS USED IN THE THERAPY OF
0ARKINSONS DISEASE
s 0ARKINSONS DISEASE IS CAUSED BY A LACK OF A
CHEMICAL CALLED DOPAMINE IN THE NERVOUS
SYSTEM ,EVODOPA IS CONVERTED IN THE BRAIN
TO DOPAMINE INCREASING THE AMOUNT IN THE
BRAIN TO A NORMAL LEVEL #ARBIDOPA ITSELF
DOES NOT ENTER THE BRAIN BUT IS THERE TO
PREVENT THE CONVERSION OF LEVODOPA TO
DOPAMINE OUTSIDE THE BRAIN4HIS HELPS TO
REDUCE UNWANTED EFFECTS IN OTHER PARTS OF
THE BODY4HE CONTROLLED RELEASE TABLETS ARE
GENERALLY USED IF THERAPY WITH THE NORMAL
RAPID RELEASE TABLETS OR WITH LEVODOPA ALONE
DOES NOT ADEQUATELY CONTROL YOUR
SYMPTOMS

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CARAMET

Do NOT take Caramet:
s )F YOU ARE ALLERGIC HYPERSENSITIVE TO
CARBIDOPA LEVODOPA OR ANY OF THE
INGREDIENTS OF THIS MEDICINE
s )F YOU SUFFER FROM NARROW ANGLE GLAUCOMA
INCREASED PRESSURE IN THE EYE
s )F YOU SUFFER FROM SEVERE HEART DISEASE
s )F YOU HAVE HAD AN ACUTE STROKE
s )F YOU HAVE EVER SUFFERED FROM SKIN CANCER
OR THINK THAT YOU MAY HAVE SKIN CANCER
s )F YOU ARE TAKING OR HAVE RECENTLY TAKEN
MEDICINES KNOWN AS NON SELECTIVE
MONOAMINE OXIDASE INHIBITORS -!/
INHIBITORS AND SELECTIVE -!/ ! INHIBITORS
USED TO TREAT DEPRESSION SUCH AS
PHENELZINE ISOCARBOXAZID OR MOCLOBEMIDE
4HESE MEDICINES MUST BE DISCONTINUED AT
LEAST TWO WEEKS BEFORE YOU START TAKING
#ARAMET
s )F YOU SUFFER FROM HALLUCINATIONS DELUSIONS
OR MENTAL CONFUSION
s )F YOU HAVE AN ABNORMAL HEART BEAT
s )F YOU KNOW THAT YOU ARE NOT ALLOWED TO TAKE
SYMPATHOMIMETIC AGENTS EG EPHEDRINE
MAY BE PRESENT IN MEDICINES FOR COLDS AND
NASAL STUFFINESS ADRENALINE OR
NORADRENALINE
Warnings and precautions
Talk to your doctor:
s )F YOU HAVE PREVIOUSLY TAKEN LEVODOPA FOR
YOUR ILLNESS AS THIS TREATMENT SHOULD BE
STOPPED AT LEAST  HOURS BEFORE YOU START TO
TAKE #ARAMET AND YOU MAY BE MORE PRONE
TO ABNORMAL MUSCLE MOVEMENTS AT THE
BEGINNING OF TREATMENT
s )F YOU HAVE PREVIOUSLY SUFFERED FROM SEVERE
ABNORMAL MUSCLE MOVEMENTS OR MENTAL
ILLNESS INCLUDING DEPRESSION AS YOU WILL
NEED TO BE CLOSELY MONITORED BY YOUR
DOCTOR IN CASE THESE SYMPTOMS RETURN
s )F YOU HAVE HEART OR LUNG DISEASE ASTHMA
KIDNEY OR LIVER PROBLEMS
s )F YOU HAVE BEEN TOLD BY YOUR DOCTOR THAT
YOU HAVE AN ENDOCRINE HORMONE
DISTURBANCE
s )F YOU HAVE A HISTORY OF STOMACH ULCERS
COUGHING UP BLOOD OR FITS
s )F YOU HAVE RECENTLY SUFFERED A HEART ATTACK
AS YOU WILL REQUIRE MORE CAREFUL MONITORING
s )F YOU OR YOUR FAMILYCARER NOTICES YOU ARE
DEVELOPING URGES OR CRAVINGS TO BEHAVE IN
WAYS THAT ARE UNUSUAL FOR YOU OR YOU CANNOT
RESIST THE IMPULSE DRIVE OR TEMPTATION TO
CARRY OUT CERTAIN ACTIVITIES THAT COULD HARM

YOURSELF OR OTHERS4HESE BEHAVIOURS ARE
CALLED IMPULSE CONTROL DISORDERS AND CAN
INCLUDE ADDICTIVE GAMBLING EXCESSIVE
EATING OR SPENDING AN ABNORMALLY HIGH
SEX DRIVE OR AN INCREASE IN SEXUAL
THOUGHTS OR FEELINGS9OUR DOCTOR MAY
NEED TO REVIEW YOUR TREATMENTS
Children and adolescents
This medicine is not recommended for
children and adolescents under 18 years
of age.
Other medicines and Caramet:
s -EDICINES TO LOWER BLOOD PRESSURE SUCH AS
AN !#% INHIBITOR EG CAPTOPRIL ENALAPRIL A
THIAZIDE EG BENDROFLUMETHIAZIDE A
BETA BLOCKER EG SOTALOL PROPRANOLOL A
CALCIUM CHANNEL BLOCKER EG VERAPAMIL
MOXONIDINE OR RESERPINE
s 4RICYCLIC ANTIDEPRESSANTS EG AMITRIPTYLINE
s -EDICINES THAT HELP RELAX MUSCLES AND STOP
SHAKING SUCH AS ATROPINE SULPHATE
HYOSCINE BUTYLBROMIDE OR PAPAVARINE
s 3ELEGILINE OR ENTACAPONE USED TO TREAT
0ARKINSONS DISEASE
s !MANTADINE USED TO TREAT 0ARKINSONS
DISEASE AND VIRAL INFECTIONS
s -ETOCLOPRAMIDE USED TO TREAT NAUSEA AND
SICKNESS
s 3YMPATHOMIMETIC ACTIVE SUBSTANCES EG
ADRENALINE NORADRENALINE OR EPHEDRINE
%PHEDRINE MAY BE PRESENT IN MEDICINES FOR
COLDS AND NASAL STUFFINESS
s )RON TABLETS FOR ANAEMIA
s 0HENYTOIN USED IN THE TREATMENT OF
EPILEPSY
s -ONOAMINE OXIDASE INHIBITORS -!/)S
USED TO TREAT DEPRESSION EG PHENELZINE
s !N ANTICHOLINERGIC AGENT USED TO TREAT
NERVE IMPULSES EG TRIHEXYPHENIDYL
s )F YOU ARE ALSO TAKING A
NEUROLEPTICANTIPSYCHOTIC MEDICINAL
PRODUCT USED TO TREAT MENTAL ILLNESS EG
CHLORPROMAZINE
s )SONIAZID
0LEASE ALSO TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY
OTHER MEDICINES INCLUDING MEDICINES
OBTAINED WITHOUT A PRESCRIPTION
Caramet with food and drink
4ELL YOUR DOCTOR IF YOU ARE ON A HIGH PROTEIN
DIET AS IT MAY AFFECT THE EFFECTIVENESS OF
#ARAMET
#ARAMET SHOULD BE TAKEN  MINUTES BEFORE
A MEAL
Pregnancy, breast-feeding and fertility
$O NOT TAKE #ARAMET IF YOU ARE PREGNANT
PLANNING TO BECOME PREGNANT OR
BREAST FEEDING
7OMEN OF CHILD BEARING AGE MUST USE A
RELIABLE FORM OF CONTRACEPTION WHILST TAKING
#ARAMET
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE
BEFORE TAKING ANY MEDICINE
Driving and using machines
3OME PEOPLE TREATED WITH #ARAMET MAY
SUFFER FROM LIGHT HEADEDNESS OR DROWSINESS
AND SUDDEN ONSET OF SLEEP WITHOUT ANY PRIOR
WARNING )F THIS SIDE EFFECT HAPPENS TO YOU
YOU MUST NOT DRIVE OR OPERATE MACHINERY
4HIS APPLIES UNTIL YOU ARE SURE THAT THESE
RECURRENT EPISODES OR THE DROWSINESS HAVE
SUBSIDED

3

HOW TO TAKE CARAMET

!LWAYS TAKE #ARAMET EXACTLY AS YOUR DOCTOR
HAS TOLD YOU9OU SHOULD CHECK WITH YOUR
DOCTOR OR PHARMACIST IF YOU ARE NOT SURE
4HE TABLETS SHOULD BE SWALLOWED WHOLE
WITH A DRINK OF WATER AND BE TAKEN 
MINUTES BEFORE A MEAL
4HE USUAL DOSAGE INSTRUCTIONS ARE GIVEN
BELOW
4HE NUMBER OF TABLETS YOU SHOULD TAKE EACH
DAY WILL DEPEND UPON YOUR PERSONAL NEEDS
9OUR DOCTOR WILL TELL YOU HOW MANY TABLETS TO
TAKE EACH DAY $URING THE FIRST FEW WEEKS
YOUR DOCTOR MAY CHANGE YOUR DOSE OF
#ARAMET UNTIL IT IS EXACTLY RIGHT )T IS
IMPORTANT TO FOLLOW YOUR DOCTORS
INSTRUCTIONS CAREFULLY )F YOU ARE NOT SURE OF
ANYTHING ALWAYS ASK YOUR DOCTOR
$EPENDING ON YOUR NEEDS THE DOSAGE MAY
BE AS LOW AS ONE PROLONGED RELEASE TABLET
TAKEN TWICE DAILY (IGHER DOSAGES SHOULD NOT
NORMALLY EXCEED  TABLETS PER DAY TAKEN IN
THREE OR MORE DIVIDED DOSES AT INTERVALS OF
BETWEEN  AND  HOURS
)F YOU ARE TAKING LEVODOPA WITH ANOTHER
MEDICINE THIS TREATMENT WILL BE
DISCONTINUED AT LEAST  HOURS BEFORE
STARTING TREATMENT WITH #ARAMET
Use in children and adolescents
4HIS MEDICINE IS NOT RECOMMENDED FOR
CHILDREN AND ADOLESCENTS UNDER  YEARS OF
AGE

s )NFLAMMATION OF A VEIN SOMETIMES
ACCOMPANIED BY A CLOT
If you take more Caramet than you should
)F YOU OR SOMEONE ELSE SWALLOW A LOT OF THE s 3HORTNESS OF BREATH AND OTHER BREATHING
PROBLEMS
TABLETS ALL TOGETHER OR IF YOU THINK A CHILD HAS
s )NCREASED SEXUAL DESIRE
SWALLOWED ANY OF THE TABLETS CONTACT YOUR
NEAREST HOSPITAL CASUALTY DEPARTMENT OR YOUR s (EARTBURNINDIGESTION STOMACH PAIN A
DARK DISCOLOURATION OF THE SALIVA
DOCTOR IMMEDIATELY
s 4EETH CLENCHING HICCUPS STOMACH ULCERS
If you forget to take Caramet
DARK TARRY STOOLS BURNING SENSATION IN THE
)F YOU FORGET TO TAKE A DOSE TAKE IT AS SOON AS
MOUTH
YOU REMEMBER UNLESS IT IS NEARLY TIME TO
s .ETTLE RASH ITCHING FLUSHING HAIR LOSS
TAKE THE NEXT ONE .EVER TAKE TWO DOSES
REDNESS
AND SWELLING
TOGETHER4AKE THE REMAINING DOSES AT THE
s )NCREASED SWEATING A DARK DISCOLOURATION
CORRECT TIME
OF THE SWEAT
If you stop taking Caramet
s !CTIVATION OF SKIN CANCER A RASH CAUSED BY
9OU SHOULD CONTINUE TO TAKE THESE TABLETS FOR
INFLAMMATION AND LEAKING OF BLOOD VESSELS
AS LONG AS YOUR DOCTOR TELLS YOU TO $O NOT
s $IFFICULTY IN PASSING URINE OR INCONTINENCE
STOP TAKING YOUR MEDICINE UNLESS YOUR DOCTOR s 3ERIOUS PAINFUL PERSISTENT ERECTION
TELLS YOU TO )F THIS IS THE FIRST TIME YOU ARE
s 0ATHOLOGICAL GAMBLING FAILURE TO RESIST
TAKING THIS TYPE OF MEDICINE FOR YOUR
GAMBLING IMPULSES DESPITE SERIOUS
SYMPTOMS IT MAY BE UP TO  MONTHS BEFORE
PERSONAL OR FAMILY CONSEQUENCES
YOU CAN SEE THE FULL BENEFIT OF YOUR TREATMENT s )NCREASED SEX DRIVE
)F YOUR TREATMENT IS DISCONTINUED OR REDUCED s (YPERSEXUALITY ALTERED SEXUAL INTEREST AND
ABRUPTLY YOU WILL REQUIRE CAREFUL MONITORING
BEHAVIOUR OF SIGNIFICANT CONCERN TO THE
BY YOUR DOCTOR
PATIENT OR OTHERS
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE s 5NCONTROLLABLE EXCESSIVE SHOPPING OR
SPENDING
OF THIS PRODUCT ASK YOUR DOCTOR OR
s "INGE EATING EATING LARGE AMOUNTS OF FOOD
PHARMACIST
IN A SHORT TIME PERIOD OR COMPULSIVE
EATING EATING MORE FOOD THAN NORMAL AND
POSSIBLE
SIDE
EFFECTS
4
MORE THAN IS NEEDED TO SATISFY YOUR
HUNGER 
,IKE ALL MEDICINES #ARAMET CAN CAUSE SIDE
EFFECTS ALTHOUGH NOT EVERYBODY GETS THEM
Very rare (affecting fewer than one person
)F THE FOLLOWING HAPPENS STOP TAKING #ARAMET in 10,000):
AND TELL YOUR DOCTOR IMMEDIATELY OR GO TO THE s 3EVERE REDUCTION IN THE NUMBER OF WHITE
BLOOD CELLS WHICH MAKES INFECTIONS MORE
CASUALTY DEPARTMENT AT YOUR NEAREST HOSPITAL
LIKELY
s &EVER AND SERIOUS DETERIORATION OF YOUR
s %XTREME DAYTIME DROWSINESS AND SUDDEN
GENERAL CONDITION
ON SET OF SLEEP
s !N ALLERGIC REACTION SWELLING OF THE FACE
HANDS FEET LIPS TONGUE OR THROAT OR
)F ANY OF THE SIDE EFFECTS GET SERIOUS IF YOU
DIFFICULTY IN BREATHING OR SWALLOWING This
NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET
is a very serious but rare side effect. You
OR IF YOU EXPERIENCE ANY OF THESE UNUSUAL
may need urgent medical attention or
BEHAVIOURS MENTIONED BEFORE PLEASE TELL
hospitalisation.
YOUR DOCTOR OR PHARMACIST THEY WILL DISCUSS
4HE FOLLOWING SIDE EFFECTS HAVE BEEN REPORTED WAYS OF MANAGING OR REDUCING THE
SYMPTOMS
AT THE APPROXIMATE FREQUENCIES SHOWN
Common (affecting fewer than one person
in 10 but more than one person in 100):
s ,OSS OF APPETITE
s (ALLUCINATIONS CONFUSION
LIGHT HEADEDNESS
s .IGHTMARES DROWSINESS EXHAUSTION
s 0ROBLEMS SLEEPING DEPRESSION
s !BNORMAL FEELING OF WELL BEING
s -EMORY LOSS PERIODS OF MENTAL ILLNESS
s !BNORMAL MUSCLE MOVEMENTS INCLUDING
UNCONTROLLED MOVEMENTS THAT SEEM TO
MOVE AROUND THE BODY ABNORMAL MUSCLE
RIGIDITY
s )MPAIRMENT OF VOLUNTARY MOVEMENT IE
TREMORS TICS CHANGES IN MUSCLE TONE
SLOWNESS OF MOVEMENT PROBLEMS WITH
SPEECH
s 0ALPITATIONS IRREGULAR HEART BEAT
s 0ROBLEMS WITH BALANCE FEELING FAINT AND
FAINTING
s .AUSEA VOMITING DRY MOUTH AND BITTER
TASTE IN THE MOUTH

5

HOW TO STORE CARAMET

+EEP OUT OF THE REACH AND SIGHT OF CHILDREN
$O NOT TAKE AFTER THE EXPIRY DATE THAT IS STATED
ON THE OUTER PACKAGING4HIS MEDICINAL
PRODUCT DOES NOT REQUIRE ANY SPECIAL STORAGE
INSTRUCTIONS
$O NOT THROW AWAY ANY MEDICINES VIA
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
PHARMACIST HOW TO THROW AWAY MEDICINES
YOU NO LONGER USE4HESE MEASURES WILL HELP
PROTECT THE ENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Caramet contains:
s 4HE ACTIVE INGREDIENTS ARE LEVODOPA AND
CARBIDOPA
s %ACH  MG MG PROLONGED RELEASE
TABLET CONTAINS  MG OF LEVODOPA AND
 MG OF CARBIDOPA AS CARBIDOPA
Uncommon (affecting fewer than one
MONOHYDRATE
person in 100 but more than one person in s %ACH  MG MG PROLONGED RELEASE
1,000):
TABLET CONTAINS  MG OF LEVODOPA AND
s 7EIGHT LOSS OR WEIGHT GAIN
 MG OF CARBIDOPA AS CARBIDOPA
s ,ETHARGY INCREASED TREMOR AND SHAKING
MONOHYDRATE
IN THE HANDS
s 4HE OTHER INGREDIENTS ARE
s (IGH BLOOD PRESSURE
)N THE CORE FUMARIC ACID HYPROMELLOSE
s (OARSENESS CHEST PAIN
SODIUM STEARYL FUMARATE COLLOIDAL SILICA
s #ONSTIPATION DIARRHOEA EXCESS
ANHYDROUS AND QUINOLINE YELLOW %
PRODUCTION OF SALIVA
)N THE COATING HYPROMELLOSE MACROGOL
s $IFFICULTY IN SWALLOWING WIND
IRON OXIDES % AND TITANIUM DIOXIDE
s 'ENERALISED SWELLING
% 
s -USCLE SPASMS
What Caramet looks like and contents of
s $ARK DISCOLOURATION OF THE URINE
the pack:
s &EELING OF WEAKNESS A GENERAL FEELING
s #ARAMET  MG  MG #2 TABLETS ARE
OF BEING UNWELL
ORANGE BROWN ROUND BICONCAVE
s !N APPARENT WORSENING OF 0ARKINSON
PROLONGED RELEASE TABLETS
SYMPTOMS hFLARE UPSv 
s #ARAMET  MG  MG #2 TABLETS ARE
Rare (affecting fewer than one person in
ORANGE BROWN ROUND BICONVEX
1,000 but more than one person in 10,000):
PROLONGED RELEASE TABLETS
s !GITATION FEAR DIFFICULTY THINKING
s 4HE  MG MG PRODUCT IS AVAILABLE IN
s "LOOD DISORDERS WHICH MAY BE
PACK SIZES OF       TABLETS
CHARACTERISED BY FEVER OR CHILLS SORE THROAT s 4HE  MG MG PRODUCT IS AVAILABLE IN
ULCERS IN YOUR MOUTH OR THROAT UNUSUAL
PACK SIZES OF       TABLETS
TIREDNESS OR UNUSUAL BLEEDING OR
Marketing Authorisation Holder and
UNEXPLAINED BRUISING
Manufacturer
s $ISORIENTATION HEADACHE SLUGGISHNESS FITS
4HE -ARKETING !UTHORISATION HOLDER IS4%6!
s ! REACTION TO AN ACTIVE SUBSTANCE
5+ ,IMITED %ASTBOURNE ". !' AND THE
CHARACTERISED BY FEVER MUSCLE RIGIDITY
COMPANY RESPONSIBLE FOR MANUFACTURE IS
FEELING DIZZY OR FAINT TREMOR DROWSINESS
0HARMACHEMIE "6 (AARLEM 4HE
AND CONFUSION /THER SYMPTOMS CAN
.ETHERLANDS
INCLUDE FITS AND CHANGES IN HEART RATE
s 0INS AND NEEDLES AND NUMBNESS FALLING
This leaflet was last revised: October 2012
OVER PROBLEMS WALKING
0, 
s 2ESTRICTION IN THE OPENING OF THE MOUTH
BLURRED VISION A DYSFUNCTION OF THE NERVES
IN THE FACE AND AROUND THE EYE WHICH
CAUSES UNCONTROLLABLE PROLONGED BLINKING
s (ORNERS SYNDROME WHICH CAUSES A
CONSTRICTED PUPIL DROOPING EYELIDS AND
FACIAL DRYNESS
s %YE PROBLEMS INCLUDING DOUBLE VISION AND
DILATION OF THE PUPILS IN THE EYE
 8
4%6! 5+ ,IMITED

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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