Skip to Content

UK Edition. Click here for US version.

TRAMADOL 50MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Version:

TEVA UK Ref: 231-30-87831-E LEA TRAMADOL 50MG CAPS TUK

1

13 October 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

0!#+!'% ,%!&,%4 ).&/2-!4)/.
&/24(% 53%2

Read all of this leaflet carefully before you start taking 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 OF THE SIDE EFFECTS TALK TO YOUR DOCTOR OR
PHARMACIST4HIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN
THIS LEAFLET 3EE SECTION 
).4()3 ,%!&,%4

1.
2.
3.
4.
5.
6.

What Tramadol is and what it is used for
What you need to know before you take Tramadol
How to take Tramadol
Possible side effects
How to store Tramadol
Contents of the pack and other information

1

WHAT TRAMADOL IS AND WHAT IT IS USED FOR

0HARMA CODE 

s 4RAMADOL #APSULES ARE PART OF A GROUP OF DRUGS KNOWN AS
ANALGESICS WHICH ACT ON THE CENTRAL NERVOUS SYSTEM THE BRAIN
AND SPINAL CORD  !NALGESICS ARE OFTEN CALLED @PAIN KILLERS OR
@PAIN RELIEVERS
s 4RAMADOL IS USED TO RELIEVE OR TO PREVENT MODERATE TO SEVERE
PAIN

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL

DO NOT take Tramadol if you:
s ARE ALLERGIC TO4RAMADOL OR ANY OF THE OTHER INGREDIENTS OF THIS
MEDICINE
s HAVE TAKEN ENOUGH ALCOHOL TO MAKE YOU FEEL EVEN SLIGHTLY DRUNK
s HAVE TAKEN SEVERAL SLEEPING PILLS OTHER PAIN KILLERS
PSYCHOTROPIC MEDICINE MEDICINES THAT AFFECTS MOOD AND
EMOTION
s ARE ALSO TAKING -!/ INHIBITORS CERTAIN MEDICINES USED FOR
TREATMENT OF DEPRESSION OR HAVE TAKEN THEM IN THE LAST
 DAYS BEFORE TREATMENT WITH4RAMADOL CAPSULES SEE TAKING
OTHER MEDICINES
s ARE AN EPILEPTIC AND YOUR FITS ARE NOT ADEQUATELY CONTROLLED BY
TREATMENT
s AS A SUBSTITUTE IN DRUG WITHDRAWAL
Warnings and precautions
Addiction
4RAMADOL MAY CAUSE PHYSICAL AND PSYCHOLOGICAL DEPENDENCE
ADDICTION OR RELIANCE ON THE MEDICINE PARTICULARLY WITH LONG
TERM USE
s IF YOU NEED TO TAKE4RAMADOL FOR A LONG PERIOD YOUR DOCTOR
SHOULD REVIEW YOUR TREATMENT REGULARLY
s TELL YOUR DOCTOR IF YOU HAVE A HISTORY OF DRUG ABUSE OR
DEPENDENCE OR YOU ARE ADDICTED TO OTHER PAIN RELIEVERS
OPIOIDS AS YOU SHOULD ONLY USE THIS MEDICINE FOR SHORT
PERIODS AND UNDER STRICT MEDICAL SUPERVISION
Talk to your doctor before taking Tramadol if you:
s HAVE OR RECENTLY HAD A HEAD INJURY OR BRAIN DISEASE AND DUE TO
THAT YOU ARE SUFFERING FROM INCREASED PRESSURE IN THE BRAIN
s HAVE HAD ANY PROBLEMS WITH YOUR KIDNEYS OR LIVER
s SUFFER FROM EPILEPSY FITS OR SEIZURES OR HAVE HAD THEM IN THE
PAST )N SUCH CASES PLEASE CONSULT YOUR DOCTOR BEFORE TAKING
THE MEDICINE %PILEPTIC FITS HAVE BEEN REPORTED IN PATIENTS
TAKING4RAMADOL AT THE RECOMMENDED DOSE LEVEL4HE RISK MAY
BE INCREASED WHEN DOSES OF4RAMADOL EXCEED THE
RECOMMENDED UPPER DAILY DOSE LIMIT  MG 
s SUFFER FROM ASTHMA OR OTHER LUNG DISEASES OR HAVE SLOW OR
TROUBLED BREATHING
s SUFFER FROM CONSCIOUSNESS DISORDERS IF YOU FEEL THAT YOU ARE
GOING TO FAINT
s ARE IN A STATE OF SHOCK COLD SWEAT MAY BE A SIGN OF THIS 
7HEN4RAMADOL IS TAKEN FOR A LONG TIME ITS EFFECT MAY DECREASE
SO THAT HIGHER DOSES HAVE TO BE TAKEN TOLERANCE DEVELOPMENT 
Other medicines and Tramadol
0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE
RECENTLY TAKEN ANY OTHER MEDICINES INCLUDING MEDICINES
OBTAINED WITHOUT A PRESCRIPTION
DO NOT take Tramadol if you are taking:
s A MONOAMINE OXIDASE INHIBITOR -!/) WHICH IS A TYPE OF
MEDICINE THAT CAN TREAT 0ARKINSONgS $ISEASE OR DEPRESSION
SUCH AS SELEGILINE OR MOCLOBEMIDE OR IF YOU HAVE TAKEN ANY OF
THESE MEDICINES WITHIN THE PAST TWO WEEKS
4HE PAIN RELIEVING EFFECT OF 4RAMADOL MAY BE REDUCED AND THE
LENGTH OF TIME IT ACTS MAY BE SHORTENED IF YOU TAKE MEDICINES
WHICH CONTAIN
s CARBAMAZEPINE FOR EPILEPTIC FITS
s PENTAZOCINE NALBUPHINE OR BUPRENORPHINE PAIN KILLERS
s ONDANSETRON PREVENTS NAUSEA 

REG0031298

1

13 October 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

4HE RISK OF SIDE EFFECTS INCREASES
s IF YOU ARE TAKING MEDICINES WHICH MAY CAUSE CONVULSIONS
FITS SUCH AS CERTAIN ANTIDEPRESSANTS OR ANTIPSYCHOTICS4HE
RISK OF HAVING A FIT MAY INCREASE IF YOU TAKE4RAMADOL AT THE
SAME TIME9OUR DOCTOR WILL TELL YOU WHETHER4RAMADOL IS
SUITABLE FOR YOU
s IF YOU ARE TAKING CERTAIN ANTIDEPRESSANTS4RAMADOL MAY INTERACT
WITH THESE MEDICINES AND YOU MAY EXPERIENCE SYMPTOMS SUCH
AS INVOLUNTARY RHYTHMIC CONTRACTIONS OF MUSCLES INCLUDING
THE MUSCLES THAT CONTROL MOVEMENT OF THE EYE AGITATION
EXCESSIVE SWEATING TREMOR EXAGGERATION OF REFLEXES
INCREASED MUSCLE TENSION BODY TEMPERATURE ABOVE  ยช#
Talk to your doctor or pharmacist if you are taking, have recently
taken or might take any of the following:
s OTHER MEDICINES THAT SLOW THE NERVOUS SYSTEM INCLUDING
TRANQUILLISERS SLEEPING PILLS ANTIDEPRESSANTS AND OTHER PAIN
RELIEVERS SUCH AS MORPHINE AND CODEINE
s LITHIUM A MEDICINE USED TO TREAT CERTAIN TYPES OF MENTAL
ILLNESS
s CIMETIDINE A MEDICINE USED TO TREAT CERTAIN CONDITIONS CAUSED
BY TOO MUCH ACID BEING PRODUCED IN THE STOMACH
s MEDICINES WHICH MAY CAUSE CONVULSIONS FITS SUCH AS CERTAIN
ANTIDEPRESSANTS4HE RISK OF HAVING A FIT MAY INCREASE IF YOU
TAKE4RAMADOL AT THE SAME TIME
s SELECTIVE SEROTONIN REUPTAKE INHIBITORS OFTEN REFERRED TO AS
332)S USED TO TREAT DEPRESSION 4RAMADOL MAY INTERACT WITH
THESE MEDICINES AND YOU MAY EXPERIENCE SYMPTOMS SUCH AS
CONFUSION RESTLESSNESS FEVER SWEATING UNCOORDINATED
MOVEMENT OF LIMBS OR EYES UNCONTROLLABLE JERKING OF
MUSCLES OR DIARRHOEA
s IF YOU TAKE COUMARIN ANTICOAGULANTS MEDICINES FOR BLOOD
THINNING EG WARFARIN TOGETHER WITH4RAMADOL4HE EFFECT OF
THESE MEDICINES ON BLOOD CLOTTING MAY BE AFFECTED AND
BLEEDING MAY OCCUR
"EFORE YOU HAVE GENERAL ANAESTHETICS MEDICINES USED FOR
TEMPORARY LOSS OF BODILY SENSATION DURING AN OPERATION MAKE
SURE YOU TELL YOUR DOCTOR OR DENTIST THAT YOU ARE TAKING4RAMADOL
#APSULES
Taking Tramadol with food and drink
s $/ ./4 TAKE ALCOHOL WHILST TAKING4RAMADOL #APSULES &OOD
DOES NOT INFLUENCE THE EFFECT OF4RAMADOL
Pregnancy, breast-feeding and fertility
s 4RAMADOL IS NOT RECOMMENDED IF YOU ARE PREGNANT THINK YOU
MAY BE PREGNANT OR ARE PLANNING TO HAVE A BABY ASK YOUR
DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING THIS MEDICINE
Driving and using machines
s 4RAMADOL MAY CAUSE DROWSINESS DIZZINESS AND BLURRED
VISION4HIS MAY BE MADE WORSE IF ALCOHOL ANDOR OTHER
MEDICINES THAT SLOW THE NERVOUS SYSTEM SUCH AS PHENOBARBITAL
DIAZEPAM AMITRIPTYLINE CHLORPROMAZINE ARE TAKEN AT THE SAME
TIME )F YOU ARE AFFECTED $/ ./4 DRIVE OR OPERATE MACHINERY
4HE MEDICINE CAN AFFECT YOUR ABILITY TO DRIVE AS IT MAY MAKE YOU
SLEEPY OR DIZZY
s $O NOT DRIVE WHILE TAKING THIS MEDICINE UNTIL YOU KNOW HOW IT
AFFECTS YOU
s )T IS AN OFFENCE TO DRIVE IF THIS MEDICINE AFFECTS YOUR ABILITY TO
DRIVE
(OWEVER YOU WOULD NOT BE COMMITTING AN OFFENCE IF
s 4HE MEDICINE HAS BEEN PRESCRIBED TO TREAT A MEDICAL OR DENTAL
PROBLEM AND
s 9OU HAVE TAKEN IT ACCORDING TO THE INSTRUCTIONS GIVEN BY THE
PRESCRIBER OR IN THE INFORMATION PROVIDED WITH THE MEDICINE
AND
s )T WAS NOT AFFECTING YOUR ABILITY TO DRIVE SAFELY
4ALK TO YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE WHETHER IT IS
SAFE FOR YOU TO DRIVE WHILE TAKING THIS MEDICINE

3

HOW TO TAKE TRAMADOL

4RAMADOL #APSULES ARE FOR ORAL USE !LWAYS SWALLOW Tramadol
WHOLE NOT DIVIDED OR CHEWED WITH SUFFICIENT LIQUID
!LWAYS TAKE THIS MEDICINE EXACTLY AS YOUR DOCTOR HAS TOLD YOU
#HECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE
4HE DOSAGE SHOULD BE ADJUSTED TO THE INTENSITY OF YOUR PAIN AND
YOUR INDIVIDUAL PAIN SENSITIVITY )N GENERAL THE LOWEST
PAIN RELIEVING DOSE SHOULD BE TAKEN
4HE CAPSULES SHOULD BE SWALLOWED PREFERABLY WITH A DRINK OF
WATER4HE USUAL DOSE IS
s Adults, Elderly and Children aged 12 years and over
 OR  CAPSULES EVERY FOUR HOURS
$O NOT TAKE MORE THAN  CAPSULES IN  HOURS
Elderly patients
)N ELDERLY PATIENTS ABOVE  YEARS THE EXCRETION OF TRAMADOL
MAY BE DELAYED )F THIS APPLIES TO YOU YOUR DOCTOR MAY
RECOMMEND PROLONGING THE DOSAGE INTERVAL
s Severe liver or kidney disease (insufficiency)/dialysis patients
0ATIENTS WITH SEVERE LIVER ANDOR KIDNEY INSUFFICIENCY SHOULD
NOT TAKE4RAMADOL )F IN YOUR CASE THE INSUFFICIENCY IS MILD OR
MODERATE YOUR DOCTOR MAY RECOMMEND PROLONGING THE
DOSAGE INTERVAL

Version 5.2

Approved

Top of page cut-off to middle of registration mark: 44 mm.

TRAMADOL 50 mg CAPSULES

Version:

TEVA UK Ref: 231-30-87831-E LEA TRAMADOL 50MG CAPS TUK

Psychiatric disorders
rare: HALLUCINATIONS CONFUSION SLEEP DISORDERS ANXIETY AND
NIGHTMARES
0SYCHOLOGICAL COMPLAINTS MAY APPEAR AFTER TREATMENT WITH
4RAMADOL CAPSULES4HEIR INTENSITY AND NATURE MAY VARY
ACCORDING TO THE PATIENTS PERSONALITY AND LENGTH OF THERAPY 
4HESE MAY APPEAR AS A CHANGE IN MOOD MOSTLY HIGH SPIRITS
OCCASIONALLY IRRITATED MOOD CHANGES IN ACTIVITY SLOWING DOWN
BUT SOMETIMES AN INCREASE IN ACTIVITY AND BEING LESS AWARE AND
LESS ABLE TO MAKE DECISIONS WHICH MAY LEAD TO ERRORS IN
JUDGEMENT $EPENDENCE MAY OCCUR
Metabolism and nutrition disorders
not known DECREASE IN BLOOD SUGAR LEVEL
Eye disorders
rare: BLURRED VISION
not known: DILATION OF THE PUPIL
Respiratory disorders
rare: SHORTNESS OF BREATH DYSPNOEA 
7ORSENING OF ASTHMA HAS BEEN REPORTED HOWEVER IT HAS NOT
BEEN ESTABLISHED WHETHER IT WAS CAUSED BY TRAMADOL
Stomach and bowel disorders
very common: FEELING SICK
common: BEING SICK CONSTIPATION DRY MOUTH
uncommon: URGE TO BE SICK RETCHING STOMACH TROUBLE EG
FEELING OF PRESSURE IN THE STOMACH BLOATING DIARRHOEA
Skin disorders
common: SWEATING
uncommon: SKIN REACTIONS EG ITCHING RASH 
Muscle disorders
rare: WEAK MUSCLES
Liver and biliary disorders
very rare: INCREASE IN LIVER ENZYME VALUES
Urinary disorders
rare: PASSING WATER DIFFICULT OR PAINFUL LESS URINE THAN NORMAL
General disorders
common: TIREDNESS WEAKNESS LOW ENERGY
%XCESSIVE SWEATING HAS BEEN REPORTED DURING THE TREATMENT WITH
4RAMADOL ALTHOUGH THE FREQUENCY IS NOT KNOWN
&EELING FLUSHED FEELING HOT AND RED SKIN HAS RARELY BEEN SEEN
DURING THE TREATMENT "LOOD DISORDERS HAVE BEEN REPORTED "LOOD
DISORDERS MAY BE CHARACTERISED BY FEVER OR CHILLS SORE THROAT
ULCERS IN YOUR MOUTH OR THROAT UNUSUAL TIREDNESS OR WEAKNESS
UNUSUAL BLEEDING OR UNEXPLAINED BRUISING
POSSIBLE
SIDE
EFFECTS
)F 4RAMADOL IS TAKEN OVER A LONG PERIOD OF TIME DEPENDENCE MAY
4
OCCUR ALTHOUGH THE RISK IS VERY LOW 7HEN TREATMENT IS STOPPED
,IKE ALL MEDICINES THIS MEDICINE CAN CAUSE SIDE EFFECTS ALTHOUGH ABRUPTLY SIGNS OF WITHDRAWAL MAY APPEAR SEE @)F YOU STOP TAKING
NOT EVERYBODY GETS THEM
4RAMADOL #APSULES 
Stop taking the capsules and tell your doctor immediately OR GO
Reporting of side effects:
TO THE CASUALTY DEPARTMENT AT YOUR NEAREST HOSPITAL IF THE
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR PHARMACIST 
FOLLOWING HAPPENS
4HIS INCLUDES ANY POSSIBLE SIDE EFFECTS
s AN ALLERGIC REACTION CAUSING SWELLING OF THE LIPS FACE OR NECK
NOT LISTED IN THIS LEAFLET9OU CAN ALSO REPORT SIDE EFFECTS DIRECTLY
LEADING TO SEVERE DIFFICULTY IN BREATHING OR SEVERE SKIN RASH OR VIA THE9ELLOW #ARD 3CHEME AT
HIVES
WWWMHRAGOVUKYELLOWCARD
s SHOCKSUDDEN CIRCULATION FAILURE
"Y REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE MORE INFORMATION
s DIFFICULTY BREATHING
ON THE SAFETY OF THIS MEDICINE
s A FIT
s A CONSTANT SORE THROAT OR HIGH TEMPERATURE
5 HOW TO STORE TRAMADOL
4HESE ARE VERY SERIOUS BUT RARE SIDE EFFECTS9OU MAY NEED
Keep this medicine out of the sight and reach of children.
URGENT MEDICAL ATTENTION OR HOSPITALISATION
+EEP
THIS MEDICINE IN A DRY PLACE BELOW ยช#
5SUALLY THE FREQUENCY OF SIDE EFFECTS IS CLASSIFIED AS FOLLOWS
$O NOT USE THIS MEDICINE AFTER THE EXPIRY DATE THAT IS STATED ON
s VERY COMMON MORE THAN  OUT OF  PERSONS
THE OUTER PACKAGING4HE EXPIRY DATE REFERS TO THE LAST DAY OF THAT
s COMMON MORE THAN  OUT OF  PERSONS
MONTH
s UNCOMMON MORE THAN  OUT OF   PERSONS
$O NOT THROW AWAY ANY MEDICINE VIA WASTEWATER OR HOUSEHOLD
s RARE MORE THAN  OUT OF   PERSONS
WASTE !SK YOUR PHARMACIST HOW TO THROW AWAY MEDICINES YOU
s VERY RARE LESS THAN  OUT OF   PERSONS
NO LONGER USE4HESE MEASURES WILL HELP TO PROTECT THE
s NOT KNOWN CAN NOT BE ESTIMATED FROM THE AVAILABLE DATA 
ENVIRONMENT
Heart and blood circulation disorders
s

Children aged under 12 years
4RAMADOL IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER
 YEARS OF AGE
How long should you take Tramadol
9OU SHOULD NOT TAKE4RAMADOL FOR LONGER THAN NECESSARY )F
YOU NEED TO BE TREATED FOR A LONGER PERIOD YOUR DOCTOR WILL
CHECK AT REGULAR SHORT INTERVALS IF NECESSARY WITH BREAKS IN
TREATMENT WHETHER YOU SHOULD CONTINUE TO TAKE 4RAMADOL AND
AT WHAT DOSE )F YOU HAVE THE IMPRESSION THAT THE EFFECT OF
4RAMADOL IS TOO STRONG OR TOO WEAK TALK TO YOUR DOCTOR OR
PHARMACIST
If you take more Tramadol than you should
)F YOU OR SOMEONE ELSE SWALLOW TOO MANY CAPSULES ALL TOGETHER
OR IF YOU THINK A CHILD HAS SWALLOWED ANY OF THE CAPSULES CONTACT
YOUR NEAREST HOSPITAL CASUALTY DEPARTMENT OR YOUR DOCTOR
IMMEDIATELY
!N OVERDOSE IS LIKELY TO CAUSE CONTRACTION OF THE PUPILS OF THE
EYES VOMITING LOSS OF EFFECTIVE BLOOD FLOW SEDATION AND COMA
FITS AND DIFFICULTIES IN BREATHING
0LEASE TAKE THIS LEAFLET ANY REMAINING CAPSULES AND THE
CONTAINER WITH YOU TO THE HOSPITAL OR DOCTOR SO THAT THEY KNOW
WHICH CAPSULES WERE CONSUMED
If you forget to take Tramadol
)F YOU FORGET TO TAKE THIS MEDICINE TAKE ONE AS SOON AS YOU
REMEMBER UNLESS IT IS NEARLY TIME TO TAKE THE NEXT ONE $/ ./4
TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE
If you stop taking Tramadol
)F YOU INTERRUPT OR FINISH TREATMENT WITH4RAMADOL TOO SOON PAIN
IS LIKELY TO RETURN )F YOU WISH TO STOP TREATMENT ON ACCOUNT OF
UNPLEASANT EFFECTS PLEASE TELL YOUR DOCTOR 'ENERALLY THERE WILL
BE NO AFTER EFFECTS WHEN TREATMENT WITH4RAMADOL IS STOPPED
(OWEVER ON RARE OCCASIONS PEOPLE WHO HAVE BEEN TAKING
4RAMADOL FOR SOME TIME MAY FEEL UNWELL IF THEY ABRUPTLY STOP
TAKING THEM4HEY MAY FEEL AGITATED ANXIOUS NERVOUS OR SHAKY
4HEY MAY BE CONFUSED HYPERACTIVE HAVE DIFFICULTY SLEEPING
SPASM OR UNCONTROLLED MUSCULAR ACTION TREMOR AND HAVE
STOMACH OR BOWEL DISORDERS 6ERY FEW PEOPLE MAY GET PANIC
ATTACKS DELUSIONS PARANOIA HALLUCINATIONS OR FEELING A LOSS OF
IDENTITY4HEY MAY EXPERIENCE UNUSUAL PERCEPTIONS SUCH AS
ITCHING TINGLING AND NUMBNESS AND hRINGINGv IN THE EARS
TINNITUS  )F YOU EXPERIENCE ANY OF THESE COMPLAINTS AFTER
STOPPING4RAMADOL PLEASE CONSULT YOUR DOCTOR
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS PRODUCT ASK
YOUR DOCTOR OR PHARMACIST

s

uncommon: EFFECTS ON THE HEART AND BLOOD CIRCULATION POUNDING
OF THE HEART FAST HEART BEAT A FALL IN BLOOD PRESSURE ON STANDING
UP WHICH CAUSES DIZZINESS LIGHT HEADEDNESS FEELING FAINT OR
COLLAPSE 4HESE ADVERSE EFFECTS MAY PARTICULARLY OCCUR IN PATIENTS
IN AN UPRIGHT POSITION OR UNDER PHYSICAL STRAIN
rare: SLOW HEART BEAT INCREASE IN BLOOD PRESSURE
Nervous system disorders
very common: DIZZINESS
common: HEADACHES DROWSINESS
rare: CHANGES IN APPETITE ABNORMAL SENSATIONS EG ITCHING
TINGLING NUMBNESS TREMBLING SLOW BREATHING EPILEPTIC FITS
MUSCLE TWITCHES UNCOORDINATED MOVEMENT TRANSIENT LOSS OF
CONSCIOUSNESS SYNCOPE 
Not known: DIFFICULTY IN SPEAKING
)F THE RECOMMENDED DOSES ARE EXCEEDED OR IF OTHER MEDICINES
THAT DEPRESS BRAIN FUNCTION ARE TAKEN AT THE SAME TIME BREATHING
MAY SLOW DOWN
%PILEPTIC FITS HAVE OCCURRED MAINLY AT HIGH DOSES OF4RAMADOL OR
WHEN4RAMADOL WAS TAKEN AT THE SAME TIME AS OTHER MEDICINES
WHICH MAY INDUCE FITS

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Tramadol Capsules contain:
s 4HE ACTIVE INGREDIENT IS4RAMADOL (YDROCHLORIDE  MG
s 4HE OTHER INGREDIENTS ARE MICROCRYSTALLINE CELLULOSE SODIUM
STARCH GLYCOLATE MAGNESIUM STEARATE COLLOIDAL ANHYDROUS
SILICA
s 4HE CAPSULE SHELL CONTAINS GELATIN INDIGO CARMINE % IRON
OXIDE YELLOW % TITANIUM DIOXIDE % SHELLAC IRON OXIDE
BLACK % AND PROPYLENE GLYCOL %
What Tramadol Capsules look like and contents of the pack:
s 4RAMADOL  MG #APSULES ARE GREEN AND PALE YELLOW CAPSULES
MARKED WITH 4 
s 4RAMADOL  MG #APSULES ARE AVAILABLE IN PACK SIZES OF  
 AND  CAPSULES
.OT ALL PACK SIZES MAY BE MARKETED
Marketing Authorisation Holder and Manufacturer
-ARKETING !UTHORISATION HOLDER AND #OMPANY RESPONSIBLE FOR
MANUFACTURE4%6! 5+ ,IMITED %ASTBOURNE ". !'
This leaflet was last revised: 09/2014.
 %
0, 
 X 

Page 1 of 2

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.

Hide