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TERAZOSIN 10MG TABLETS

Active substance(s): TERAZOSIN HYDROCHLORIDE DIHYDRATE / TERAZOSIN HYDROCHLORIDE DIHYDRATE / TERAZOSIN HYDROCHLORIDE DIHYDRATE

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TEVA UK Ref:

Version:

231-30-85164-W LEA TERAZOSIN A/S TAB TUK

2

11 February 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

0!#+!'% ,%!&,%4 ).&/2-!4)/.
&/2 4(% 53%2
Read all of this leaflet carefully before you start
taking this medicine.
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 $O
NOT PASS IT ON TO OTHERS )T MAY HARM THEM
EVEN IF THEIR SYMPTOMS 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 3EE SECTION 
). 4()3 ,%!&,%4
1. What Terazosin is and what it is used for
2. Before you take Terazosin
3. How to take Terazosin
4. Possible side effects
5. How to store Terazosin
6. Further information

1

WHAT TERAZOSIN IS AND WHAT IT IS
USED FOR

0HARMA CODE 

4ERAZOSIN BELONGS TO A GROUP OF MEDICINES CALLED
ALPHA BLOCKERS
4ERAZOSIN IS USED TO TREAT
s HIGH BLOOD PRESSURE
s BLOCKED URINE FLOW CAUSED BY BENIGN PROSTATIC
HYPERPLASIA "0( WHICH IS COMMON IN OLDER MEN
"0( IS CAUSED BY THE PROSTATE GLAND GROWING
TOO BIG AND OBSTRUCTING THE FLOW OF URINE FROM
THE BLADDER4HIS LEADS TO SOME UNPLEASANT
SYMPTOMS SUCH AS WEAK OR INTERRUPTED URINE
FLOW A NEED TO PASS WATER MORE FREQUENTLY
ANDOR A SUDDEN NEED TO PASS WATER4ERAZOSIN
CAN RELAX THE MUSCLE OF THE PROSTATE GLAND AND
BLADDER EXIT TO HELP RELIEVE THESE SYMPTOMS

Important information about some of the
ingredients of Terazosin
s 0ATIENTS WHO ARE INTOLERANT TO LACTOSE SHOULD
NOTE THAT4ERAZOSIN TABLETS CONTAIN A SMALL
AMOUNT OF LACTOSE )F YOUR DOCTOR HAS TOLD YOU
THAT YOU HAVE AN INTOLERANCE TO SOME SUGARS
CONTACT YOUR DOCTOR BEFORE TAKING THIS MEDICINE
Pregnancy and breast-feeding
s )F YOU ARE PREGNANT PLANNING TO BECOME
PREGNANT OR ARE BREAST FEEDING ASK YOUR
DOCTOR FOR ADVICE BEFORE TAKING THIS MEDICINE
Driving and using machines
s 4ERAZOSIN MAY CAUSE LIGHT HEADEDNESS
DIZZINESS OR DROWSINESS PARTICULARLY WITH THE
FIRST DOSE AN INCREASE IN YOUR DOSE OR AFTER
MISSING DOSES AND RESTARTING TREATMENT $/
./4 DRIVE OR OPERATE MACHINERY FOR  HOURS
AFTER YOUR FIRST DOSE WHEN YOUR DOSE IS
INCREASED OR WHEN RESTARTING TREATMENT
s )F YOU ARE AFFECTED IN ANY WAY AT ANY OTHER TIME
WHILE YOU ARE TAKING4ERAZOSIN TABLETS $/ ./4
DRIVE OR OPERATE MACHINERY

3

HOW TO TAKE TERAZOSIN

!LWAYS TAKE4ERAZOSIN EXACTLY AS YOUR DOCTOR HAS
TOLD YOU9OU SHOULD CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE
9OUR DOCTOR WILL MONITOR YOU REGULARLY DURING
YOUR TREATMENT
(A) Read this section if you are taking Terazosin
for the first time or if you have not taken
Terazosin in the last week.
If you are continuing treatment without a break,
please read section (B).

It is important that you take the correct tablet at
the correct time.
s 4HE TABLETS SHOULD BE SWALLOWED PREFERABLY
WITH A DRINK OF WATER
s 4HE FIRST TIME YOU TAKE A NEW STRENGTH OF
4ERAZOSIN4ABLET YOU SHOULD TAKE IT IN THE
BEFORE YOU TAKE TERAZOSIN
EVENING AT BEDTIME
s &OLLOWING DOSES OF THE SAME STRENGTH MAY BE
DO NOT take Terazosin if you:
TAKEN IN THE MORNING
s ARE ALLERGIC HYPERSENSITIVE TO TERAZOSIN OR ANY
s )F YOU ARE AT ALL UNSURE ABOUT WHEN TO TAKE
OF THE OTHER INGREDIENTS OF THIS MEDICINE
YOUR TABLETS YOU SHOULD CONSULT YOUR DOCTOR
s ARE ALLERGIC HYPERSENSITIVE TO OTHER SIMILAR
FOR ADVICE
MEDICINES SUCH AS PRAZOSIN OR DOXAZOSIN
s HAVE EVER FAINTED WHEN URINATING
Adults (including the elderly)
s HAVE THE RARE HEREDITARY PROBLEM OF GALACTOSE s High Blood Pressure
INTOLERANCE ,APP LACTASE DEFICIENCY OR
/N DAYS  TO  TAKE ONE  MG TABLET EACH DAY
GLUCOSE GALACTOSE MALABSORPTION
4HE FIRST TABLET SHOULD BE TAKEN AT BEDTIME
&ROM DAY  ONWARDS TAKE ONE  MG TABLET
Take special care with Terazosin
YELLOW TABLET EACH DAY FOR A WEEK UNTIL YOU
Talk to your doctor before you start to take this
REACH DAY  2EMEMBER YOU SHOULD TAKE YOUR
medicine if you:
FIRST  MG TABLET AT BEDTIME
s HAVE ANY LIVER PROBLEMS
7HEN YOU HAVE FINISHED THIS TWO WEEK
s HAVE ANY HEART PROBLEMS
TREATMENT YOUR DOCTOR WILL DECIDE HOW TO
CONTINUE YOUR TREATMENT AND MAY GIVE YOU A
Taking other medicines
PRESCRIPTION FOR MORE TABLETS .OW READ
Talk to your doctor if you are taking any of the
SECTION " 
following:
s !#% INHIBITORS USED TO TREAT HIGH BLOOD
s "ENIGN PROSTATIC HYPERPLASIA
PRESSURE EG CAPTOPRIL OR LISINOPRIL
/N DAYS  TO  TAKE ONE  MG TABLET EACH DAY
s DIURETICS hWATER TABLETSv USED TO TREAT HEART
4HE FIRST TABLET SHOULD BE TAKEN AT BEDTIME
FAILURE OR HIGH BLOOD PRESSURE EG FUROSEMIDE
&ROM DAY  ONWARDS START TAKING ONE  MG
OR SPIRONOLACTONE
TABLET YELLOW TABLET EACH DAY FOR  DAYS
s ANY OTHER MEDICINE USED TO TREAT HIGH BLOOD
2EMEMBER YOU SHOULD TAKE YOUR FIRST  MG
PRESSURE EG ATENOLOL VERAPAMIL OR AMLODIPINE
TABLET AT BEDTIME
&ROM DAY  ONWARDS START TAKING ONE  MG
3OME PATIENTS WHO TAKE ALPHA BLOCKER THERAPY FOR
TABLET TAN TABLETS EACH DAY FOR  DAYS
THE TREATMENT OF HIGH BLOOD PRESSURE OR PROSTATE
2EMEMBER YOU SHOULD TAKE YOUR FIRST  MG
ENLARGEMENT MAY EXPERIENCE DIZZINESS OR LIGHT
TABLET AT BEDTIME
HEADEDNESS WHICH MAY BE CAUSED BY LOW BLOOD
7HEN YOU HAVE FINISHED THIS FOUR WEEK
PRESSURE UPON SITTING OR STANDING UP QUICKLY #ERTAIN
TREATMENT YOUR DOCTOR WILL DECIDE HOW TO
PATIENTS HAVE EXPERIENCED THESE SYMPTOMS WHEN
CONTINUE YOUR TREATMENT AND MAY GIVE YOU A
TAKING DRUGS FOR ERECTILE DYSFUNCTION IMPOTENCE
PRESCRIPTION FOR MORE TABLETS .OW READ
WITH ALPHA BLOCKERS )N ORDER TO REDUCE THE
SECTION " 
LIKELIHOOD THAT THESE SYMPTOMS OCCUR YOU SHOULD
BE ON A REGULAR DAILY DOSE OF YOUR ALPHA BLOCKER
(B) Read this section if you have taken Terazosin
BEFORE YOU START DRUGS FOR ERECTILE DYSFUNCTION
before and are continuing with your next pack.
s 7HEN YOU HAVE FINISHED YOUR LAST PACK YOUR
0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE
DOCTOR MAY PRESCRIBE MORE TABLETS TO CONTINUE
TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES
YOUR TREATMENT9OUR MAINTENANCE DOSE WILL BE
INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
ADJUSTED ACCORDING TO HOW YOU HAVE
)F YOU ARE UNDERGOING EYE SURGERY BECAUSE OF
RESPONDED TO TREATMENT AND IS USUALLY
CATARACT CLOUDINESS OF THE LENS PLEASE INFORM
BETWEEN  n  MG DAILY9OUR DOCTOR WILL
YOUR EYE SPECIALIST BEFORE THE OPERATION THAT YOU
DECIDE WHICH STRENGTH OF TABLET YOU NEED9OU
ARE USING OR HAVE PREVIOUSLY USED4ERAZOSIN4HIS
MAY BE GIVEN A NEW PACK OF TABLETS CONTAINING
IS BECAUSE TERAZOSIN MAY CAUSE COMPLICATIONS
EITHER  MG YELLOW TABLETS  MG TAN TABLETS
DURING THE SURGERY WHICH CAN BE MANAGED IF YOUR
OR  MG BLUE TABLETS OF4ERAZOSIN
SPECIALIST IS PREPARED IN ADVANCE
Take one tablet each day.

2

REG0068768

Version 1.3

Approved

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

TERAZOSIN 2 mg, 5 mg
AND 10 mg TABLETS

TEVA UK Ref:

Version:

231-30-85164-W LEA TERAZOSIN A/S TAB TUK

2

11 February 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children
s 4ERAZOSIN IS NOT RECOMMENDED FOR USE IN
CHILDREN
If you take more Terazosin than you should
s )F YOU ACCIDENTALLY TAKE MORE THAN  TABLET IN A
DAY YOU SHOULD CONTACT YOUR DOCTOR
IMMEDIATELY
s )F YOU OR SOMEONE ELSE SWALLOW A LOT OF THE
TABLETS ALL TOGETHER OR IF YOU THINK A CHILD HAS
SWALLOWED ANY OF THE TABLETS CONTACT YOUR
NEAREST HOSPITAL CASUALTY DEPARTMENT OR YOUR
DOCTOR IMMEDIATELY
!N OVERDOSE IS LIKELY TO CAUSE VERY LOW BLOOD
PRESSURE RESULTING IN FAINTING DIZZINESS AND
DROWSINESS
0LEASE TAKE THIS LEAFLET ANY REMAINING TABLETS
AND THE CONTAINER WITH YOU TO THE HOSPITAL OR
DOCTOR SO THAT THEY KNOW WHICH TABLETS WERE
CONSUMED
If you forget to take Terazosin
s )F YOU HAVE FORGOTTEN TO TAKE A TABLET OF A NEW
STRENGTH AT BEDTIME ASK YOUR DOCTOR OR
PHARMACIST FOR ADVICE BEFORE CONTINUING
s )F YOU FORGET TO TAKE A TABLET AT THE NORMAL TIME
TAKE ONE AS SOON AS YOU REMEMBER $/ ./4
TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN
DOSE4AKE THE REMAINING DOSES AT THE CORRECT
TIME
s )F YOU HAVE FORGOTTEN TO TAKE A TABLET FOR
SEVERAL DAYS $/ ./4 CONTINUE USING THE SAME
TABLETS You must contact your doctor for
advice before you start taking Terazosin tablets
again as your treatment may have to be
restarted as if you are taking it for the first time.
If you stop taking Terazosin
s 9OU SHOULD CONTINUE TO TAKE YOUR TABLETS
UNLESS YOUR DOCTOR TELLS YOU NOT TO $/ ./4
STOP JUST BECAUSE YOU FEEL BETTER
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF
THIS PRODUCT ASK YOUR DOCTOR OR PHARMACIST

4

POSSIBLE SIDE EFFECTS

,IKE ALL MEDICINES 4ERAZOSIN CAN CAUSE SIDE
EFFECTS ALTHOUGH NOT EVERYBODY GETS THEM

)N ADDITION THE FOLLOWING EFFECTS HAVE BEEN
REPORTED HOWEVER THESE MAY NOT NECESSARILY
HAVE BEEN CAUSED BY TAKING4ERAZOSIN
s SWELLING OF THE FACE SWOLLEN OR SORE THROAT
s CHEST PAIN STOMACH PAIN NECK AND SHOULDER
PAIN
s SWEATING FEVER COLD AND FLU SYMPTOMS
s BRONCHITIS AND INCREASED COUGH
s NOSE BLEED RUNNY NOSE
s DRY MOUTH
s INDIGESTION CONSTIPATION DIARRHOEA WIND
BEING SICK
s JOINT PAINDISORDERS GOUT MUSCLE PAIN ARTHRITIS
s TINNITUS RINGING IN THE EARS
s CONJUNCTIVITIS EYE INFECTION CHANGES IN VISION
s CHANGE IN HEART RATEBEAT
s ITCHY SKIN RED SKIN RASHES
s ANXIETY UNABLE TO SLEEP INSOMNIA
s CHANGE IN THE FREQUENCY OF PASSING WATER
s URINARY TRACT INFECTION AND INCONTINENCE HAVE
BEEN REPORTED MAINLY BY WOMEN WHO HAVE
GONE THROUGH THE MENOPAUSE
s UNEXPLAINED BRUISING SKIN CUTS TAKING LONGER
TO HEAL
s PAINFUL PROLONGED ERECTION
s CHANGES IN THE CHEMISTRY OF THE BLOOD IE
BLOOD CELL NUMBERS MAY REDUCE
Reporting of side effects
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR
PHARMACIST4HIS INCLUDES ANY POSSIBLE SIDE EFFECTS
NOT LISTED IN THIS LEAFLET9OU CAN ALSO REPORT SIDE
EFFECTS DIRECTLY VIA THE9ELLOW #ARD 3CHEME AT
WWWMHRAGOVUKYELLOWCARD
"Y REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE
MORE INFORMATION ON THE SAFETY OF THIS MEDICINE

5

HOW TO STORE TERAZOSIN

Keep out of the reach and sight of children.
$O NOT STORE ABOVE ยช# 3TORE IN THE ORIGINAL
PACKAGE $O NOT USE4ERAZOSIN AFTER THE EXPIRY
DATE THAT IS STATED ON THE OUTER PACKAGING4HE
EXPIRY DATE REFERS TO THE LAST DAY OF THAT MONTH
-EDICINES SHOULD NOT BE DISPOSED OF VIA
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
PHARMACIST HOW TO DISPOSE OF MEDICINES NO
LONGER REQUIRED4HESE MEASURES WILL HELP TO
PROTECT THE ENVIRONMENT

)F THE FOLLOWING HAPPENS STOP TAKING THE TABLETS
FURTHER INFORMATION
AND TELL YOUR DOCTOR IMMEDIATELY OR GO TO THE
CASUALTY DEPARTMENT AT YOUR NEAREST HOSPITAL
s AN ALLERGIC REACTION SWELLING OF THE LIPS FACE OR What Terazosin tablets contain:
s 4HE ACTIVE INGREDIENT IS  MG  MG OR  MG
NECK LEADING TO SEVERE DIFFICULTY IN BREATHING
TERAZOSIN AS HYDROCHLORIDE DIHYDRATE 
SKIN RASH OR HIVES 
4HIS IS A VERY SERIOUS BUT RARE SIDE EFFECT9OU MAY s 4HE OTHER INGREDIENTS ARE LACTOSE MONOHYDRATE
MAIZE STARCH POVIDONE CROSPOVIDONE TALC AND
NEED URGENT MEDICAL ATTENTION OR HOSPITALISATION
MAGNESIUM STEARATE % 
The most common side effects are:
s 4HE  MG TABLETS ALSO CONTAIN QUINOLINE YELLOW
s DIZZINESS LIGHT HEADEDNESS OR FAINTING
% 
4HESE EFFECTS MAY OCCUR WHEN YOU FIRST START
s 4HE  MG TABLETS ALSO CONTAIN YELLOW IRON
TAKING THE TABLETS OR WHEN YOU START TO TAKE A
OXIDE % AND RED IRON OXIDE % 
HIGHER DOSE ESPECIALLY WHEN STANDING UP
s 4HE  MG TABLETS ALSO CONTAIN INDIGO CARMINE
QUICKLY FROM A LYING OR SITTING POSITION )F THIS
% 
HAPPENS YOU SHOULD LIE DOWN UNTIL YOU FEEL
What Terazosin tablets look like and contents of
BETTER THEN YOU SHOULD SIT FOR A FEW MINUTES
BEFORE STANDING AGAIN TO PREVENT THESE EFFECTS the pack:
s 4HE  MG TABLETS ARE MOTTLED YELLOW ROUND
FROM RETURNING
FLAT TABLET WITH BEVELLED EDGES %MBOSSED WITH
4HESE EFFECTS USUALLY GO AWAY AND SHOULD NOT RETURN
hv ON ONE SIDE AND hv ON THE OTHER SIDE
ONCE YOU HAVE BECOME USED TO TAKING YOUR TABLETS
s 4HE  MG TABLETS ARE MOTTLED TAN ROUND FLAT
Other common side effects are:
TABLET WITH BEVELLED EDGES %MBOSSED WITH
s WEAKNESS
hv ON ONE SIDE AND hv ON THE OTHER SIDE
s SLEEPINESS
s 4HE  MG TABLETS ARE MOTTLED BLUE ROUND FLAT
s PALPITATIONS
TABLET WITH BEVELLED EDGES %MBOSSED WITH
s FEELING SICK
hv ON ONE SIDE AND hv ON THE OTHER SIDE
s SWELLING OF THE LEGS AND FEET
s 4HE  MG ARE AVAILABLE IN PACKS OF   
s BLOCKED OR ITCHY NOSE
  AND  TABLETS
s BLURRED VISION
s 4HE  MG ARE AVAILABLE IN PACKS OF   
   AND  TABLETS
Other less frequent side effects are:
s 4HE  MG ARE AVAILABLE IN PACKS OF   
s BACK PAIN
 AND  TABLETS
s PAIN IN EXTREMITIES IE FINGERS AND TOES
s 4HE  MG AND  MG TABLETS ALSO COME IN STARTER
s HEADACHE
PACKS
s WATER RETENTION
.OT ALL PACK SIZES MAY BE MARKETED
s WEIGHT GAIN
s DECREASED SEX DRIVE INABILITY TO GET OR KEEP AN Marketing Authorisation Holder and Manufacturer
ERECTION
-ARKETING !UTHORISATION HOLDER AND COMPANY
s DEPRESSION NERVOUSNESS
RESPONSIBLE FOR MANUFACTURE4%6! 5+ ,IMITED
s PINS AND NEEDLES
%ASTBOURNE ". !'
s VERTIGO
This leaflet was last revised: *ANUARY 
s SINUSITIS INFLAMMATION OF THE SINUSES
0,  
s FAST HEART BEAT
s SHORTNESS OF BREATH

6

 7
 X 

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0364-0365-0366-terazosin-2mg-5mg-10mg-tablets

APPROVALS
Signed by
Darryl Hill

REG0068768

Meaning of Signature
Regulatory Affairs Approval

Version 1.3

Approved

Server Date
16-Apr-2015 09:58:53 AM

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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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