Skip to Content

UK Edition. Click here for US version.

METOPROLOL TARTRATE 50MG TABLETS

Active substance(s): METOPROLOL TARTRATE / METOPROLOL TARTRATE / METOPROLOL TARTRATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TEVA UK Ref:

Version:

231-30-85116-X LEA METOPROLOL TARTRATE A/S TAB TUK

3

05 March 2014

0!'%  &2/.4 &!#% ).3)$% /& 2%%,

PACKAGE LEAFLET: INFORMATION
FOR THE USER
2EAD 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, pharmacist or nurse.
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY
Do not pass it on to others. It 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
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
 7HAT -ETOPROLOL IS AND WHAT IT IS USED FOR
 7HAT YOU NEED TO KNOW BEFORE YOU TAKE
-ETOPROLOL
 (OW TO TAKE -ETOPROLOL
 0OSSIBLE SIDE EFFECTS
 (OW TO STORE -ETOPROLOL
 #ONTENTS OF THE PACK AND OTHER INFORMATION

(Main)

Pharma code 559



7HAT -ETOPROLOL IS AND WHAT IT IS USED
FOR

Metoprolol belongs to a group of drugs called
BETA BLOCKERS WHICH AFFECT THE HEART AND CIRCULATION
Metoprolol tablets are used to:
s MANAGE HIGH BLOOD PRESSURE
s MANAGE ANGINA PECTORIS CHEST PAIN AND
heartbeat irregularities, and may also be given
after a heart attack
s PREVENT RECURRENT MIGRAINES
s TREAT HYPERTHYROIDISM AN OVERACTIVE THYROID
gland).

2

7HAT YOU NEED TO KNOW BEFORE YOU TAKE
-ETOPROLOL

$O ./4 TAKE -ETOPROLOL IF YOU
s ARE ALLERGIC TO METOPROLOL TARTRATE OR ANY OF THE
other ingredients of this medicine (listed in
section 6)
s ARE ALLERGIC TO ANY OTHER BETA BLOCKER DRUGS
s HAVE SEVERE ASTHMA OR SEVERE ATTACKS OF
wheezing
s HAVE HEART FAILURE SEVERE SLOW HEART BEAT
irregular heart beat, narrowing of the arteries or
had a heart attack with complications
s HAVE SECOND OR THIRD DEGREE HEART BLOCK A
condition which may be treated by a
pacemaker)
s HAVE LOW BLOOD PRESSURE
s HAVE POOR CIRCULATION
s YOU BEEN TOLD THAT YOU HAVE HIGH BLOOD
pressure due to a tumour near your kidney
(phaeochromocytoma)
s ARE PREGNANT OR BREAST FEEDING
s have metabolic acidosis (a condition where there
is a change in the acid/base balance of the body).
7ARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before
taking Metoprolol. If you:
s HAVE A HISTORY OF OR SUFFER FROM ALLERGIES
s HAVE ANY OTHER HEART PROBLEMS IN PARTICULAR A
slow heartbeat
s HAVE POOR BLOOD CIRCULATION OR CONTROLLED HEART
failure
s SUFFER FROM PSORIASIS PATCHES OF THICKENED AND
sore skin)
s ARE DIABETIC9OUR TREATMENT FOR DIABETES MAY
need to be adjusted
s HAVE ANY LIVER PROBLEMS
s HAVE A HISTORY OF ASTHMA OR WHEEZING OR ANY
similar lung disorder
s HAVE RECENTLY SUFFERED A SEVERE ALLERGIC REACTION
s HAVE A TUMOUR OF THE ADRENAL GLAND
(phaeochromocytoma)
s HAVE A TYPE OF CHEST PAIN ANGINA CALLED
prinzmetal’s angina
s HAVE FIRST DEGREE HEART BLOCK
s HAVE THYROTOXICOSIS A CONDITION CAUSED BY AN
overactive thyroid gland). Your medicine may
hide the symptoms of thyrotoxicosis.
s SUFFER FROM EYE DISORDERS
If you are about to undergo surgery requiring
anaesthetic, tell your doctor or dentist that you
are taking Metoprolol.

/THER MEDICINES AND -ETOPROLOL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines of the following:
s CLONIDINE FOR HIGH BLOOD PRESSURE OR MIGRAINE 
If you are taking clonidine and metoprolol
together, do not stop taking clonidine unless
your doctor has told you to do so. If you have
to stop taking clonidine or metoprolol, your
doctor will give you careful instructions about
how to do it.
s OTHER DRUGS FOR YOUR HEART OR TO REDUCE BLOOD
pressure, e.g. prazosin
s OTHER BETA BLOCKERS EG TIMOLOL FOR GLAUCOMA
s MONOAMINE OXIDASE INHIBITORS FOR DEPRESSION
e.g. phenelzine
s VERAPAMIL DILTIAZEM HYDRALAZINE NIFEDIPINE
(used to treat heart problems)
s QUINIDINE AMIODARONE FOR HEART PROBLEMS
s CIMETIDINE USED TO TREAT HEARTBURN
s CARDIAC GLYCOSIDES EG DIGOXIN USED TO TREAT
heart failure)
s RIFAMPICIN USED TO TREAT TUBERCULOSIS
s LIDOCAINE USED AS A LOCAL ANAESTHETIC TO RELIEVE
pain)
s ERGOTAMINE USED TO TREAT MIGRAINE
s MEDICINES TO TREAT OTHER MENTAL ILLNESSES SUCH
as phenothiazines)
s ANTIRETROVIRAL DRUGS EG RITONAVIR USED TO TREAT
AIDS and some other conditions
s DRUGS TO PREVENT MALARIA
s MEDICINES TO TREAT FUNGAL INFECTIONS
s ADRENALINE USED IN EMERGENCY TREATMENT EG
allergic reactions)
s INDOMETACIN AND CELECOXIB USED TO TREAT
inflammation of the joints, gout and period
pain) medicines for the treatment of diabetes
(including insulin). Your doctor may need to
adjust your dose of these medicines.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take other
medicines, including medicines obtained without
a prescription.
4AKING -ETOPROLOL WITH FOOD DRINK AND ALCOHOL
You should keep your alcohol intake to a
minimum while you are taking Metoprolol, as
alcohol may increase the effect of this drug.
0REGNANCY BREAST FEEDING AND FERTILITY
)F YOU ARE PREGNANT OR BREAST FEEDING THINK YOU
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
$RIVING AND USING MACHINES
Metoprolol may cause dizziness and tiredness, if
affected do not drive or operate machinery.
-ETOPROLOL CONTAINS ,ACTOSE MONOHYDRATE
Patients who are intolerant to LACTOSE should note
that Metoprolol Tablets contain a small amount of
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3

(OW TO TAKE -ETOPROLOL

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor, pharmacist or nurse if you are not sure.
The tablets should be swallowed preferably with
a glass of water. Metoprolol can be taken with or
without food.
The recommended dose is:
Adults:
s (IGH BLOOD PRESSURE
Initially 100 mg/day in the morning, which may
be increased to a maximum of 400 mg daily.
Your doctor may combine this dose with a
diuretic ('water tablet') or another blood
PRESSURE LOWERING DRUG
s !NGINA
50 to 100 mg two or three times daily.
s )RREGULAR HEARTBEAT
50 mg two or three times daily. If necessary this
may be increased to 300 mg/day in divided
doses.
s (YPERTHYROIDISM
50 mg four times daily. Your doctor may reduce
the dosage as your condition improves.
s (EART ATTACK
The usual maintenance dose following a heart
attack is 200 mg daily.
s -IGRAINE PREVENTION
100 to 200 mg/day in divided doses.

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

-%4/02/,/, 4!242!4%
 MG !.$  MG 4!",%43

TEVA UK Ref:

Version:

231-30-85116-X LEA METOPROLOL TARTRATE A/S TAB TUK

3

0!'%  2%!2 &!#% /543)$% /& 2%%,

s BRUISING OR INCREASED SENSITIVITY OF THE SKIN TO
sunlight, worsening of patches of thickened and
sore skin (psoriasis)
Older people:
s INCREASED SWEATING LOSS OF HAIR ALOPECIA
A reduced dose may be necessary.
s IMPOTENCE OR LOSS OF LIBIDO
Use in children and adolescents:
s PAINFUL JOINTS
Metoprolol tablets are not recommended for use s CHEST PAIN
in children.
Frequency not known (cannot be estimated from
)F YOU TAKE MORE -ETOPROLOL THAN YOU SHOULD
the available data):
If you (or someone else) swallow a lot of the
s CONFUSION
tablets all together, or if you think a child has
s ABNORMAL LEVELS OF CERTAIN TYPES OF FATS SUCH AS
swallowed any of the tablets, contact your nearest
cholesterol or triglycerides in the blood
hospital casualty department or your doctor
s ABNORMAL CURVATURE OF THE PENIS WITH PAINFUL
immediately. An overdose is likely to cause low
erections (known as Peyronie’s disease)
blood pressure (feeling dizzy or faint), a slow
s RETROPERITONEAL FIBROSIS WHERE ABNORMAL SCAR
heartbeat, your heart may suddenly stop,
tissue occurs behind the membrane that lines
difficulty breathing, reduced consciousness,
the cavity of the abdomen. This may present
feeling sick, being sick, blue discolouration of skin
with pain in the back, groin or the lower
and coma. Please take this leaflet, any remaining
abdomen
tablets and the container with you to the hospital s HEPATITIS
or doctor so that they know which tablets were
s POSITIVE ANTI NUCLEAR ANTIBODIES AN INDICATOR OF
consumed.
autoimmune disease where the body attacks its
own tissues)
)F YOU FORGET TO TAKE -ETOPROLOL
s MEMORY LOSS NERVOUSNESS ANXIETY TASTE
If you forget to take a tablet, take one as soon as
disturbance
you remember, unless it is nearly time to take the
s CONJUNCTIVITIS
next one. Do not take a double dose to make up
s AN INCREASE IN INTERMITTENT CLAUDICATION A
for a forgotten tablet dose. Take the remaining
CRAMP LIKE PAIN BROUGHT ON BY EXERCISE 
doses at the correct time.
If any of the side effects get serious, or if you
)F YOU STOP TAKING -ETOPROLOL
notice any side effects not listed in this leaflet,
You should continue to take these tablets for as
please tell your doctor or pharmacist.
long as your doctor tells you to.
2EPORTING OF SIDE EFFECTS
DO NOT stop taking your medicine without
talking to your doctor first, even if you feel better. If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
Your treatment with Metoprolol must not be
side effects not listed in this leaflet. You can also
stopped suddenly. If it is necessary to stop
report side effects directly via the Yellow Card
treatment, your doctor should reduce your dose
Scheme at: www.mhra.gov.uk/yellowcard
gradually.
By reporting side effects you can help provide
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or nurse. more information on the safety of this medicine.
s 0ATIENTS WITH LIVER PROBLEMS
A reduced dose may be necessary.

4

0OSSIBLE SIDE EFFECTS

5

(OW TO STORE -ETOPROLOL

+EEP OUT OF THE SIGHT AND REACH OF CHILDREN
Like all medicines, this medicine can cause side
Do not store above 25°C.
effects, although not everybody gets them.
Do not use this medicine after the expiry date
If the following happens, stop taking the tablets
which is stated on the outer packaging. The expiry
and tell your doctor immediately or go to the
date refers to the last day of that month.
casualty department at your nearest hospital:
s AN ALLERGIC REACTION SWELLING OF THE LIPS FACE OR Do not throw away any medicines via wastewater
neck leading to severe difficulty in breathing;
or household waste. Ask your pharmacist how to
skin rash or hives).
throw away medicines you no longer use. These
This is a very serious but rare side effect. You may measures will help to protect the environment.
need urgent medical attention or hospitalisation.
#ONTENTS OF THE PACK AND OTHER
4HE SIDE EFFECTS LISTED BELOW HAVE BEEN REPORTED
INFORMATION
#OMMON MAY AFFECT UP TO  IN  PEOPLE 
s HEADACHE DIZZINESS OR UNUSUAL TIREDNESS
7HAT -ETOPROLOL 4ABLETS CONTAIN
s SLOW HEART BEAT
s 4HE ACTIVE INGREDIENT IS METOPROLOL TARTRATE
s LOW BLOOD PRESSURE WHICH MIGHT MAKE YOU FAINT s 4HE OTHER INGREDIENTS ARE MICROCRYSTALLINE
or dizzy
cellulose (E460), lactose monohydrate, sodium
s FEELING SHORT OF BREATH WHEN EXERCISING
starch glycolate, colloidal anhydrous silica and
s FEELING OR BEING SICK STOMACH ACHE
magnesium stearate.
2ARE MAY AFFECT UP TO  IN   PEOPLE 
7HAT -ETOPROLOL 4ABLETS LOOK LIKE AND CONTENTS OF
s DEPRESSION
THE PACK
s SLEEP DISORDERS SUCH AS SLEEPINESS DIFFICULTY IN s 4HE  MG TABLETS ARE ROUND BICONVEX WHITE
sleeping or nightmares
tablets, engraved ‘4A5’ with a breakline on the
s FEELING LESS ALERT
reverse.
s COLDNESS NUMBNESS OR TINGLING IN YOUR HANDS
s 4HE  MG TABLETS ARE ROUND BICONVEX WHITE
and feet
tablets, engraved ‘4A6’ with a breakline on the
s MUSCLE CRAMPS
reverse.
s HEART PROBLEMS WHICH CAN CAUSE SHORTNESS OF
s 4HE PRODUCT IS AVAILABLE IN PACK SIZES OF  
breath or ankle swelling (heart failure) or
56, 60, 100, 500 tablets.
irregular heart beat or a very fast, uneven or
Not all pack sizes may be marketed
forceful heartbeat
-ARKETING !UTHORISATION (OLDER AND -ANUFACTURER
s WATER RETENTION OEDEMA
Marketing Authorisation holder and company
s POOR BLOOD CIRCULATION WHICH MAKES THE TOES
responsible for manufacture: TEVA UK Limited,
and fingers numb and pale (Raynaud's
Eastbourne, BN22 9AG
phenomenon)
4HIS LEAFLET WAS LAST REVISED January 2015
s BREATHLESSNESS OR WHEEZINESS BRONCHOSPASM
s DIARRHOEA OR CONSTIPATION
0,  
s SKIN RASH INCLUDING NETTLE RASH PATCHES OF
thickened and sore skin) and/or itching.
6ERY RARE MAY AFFECT UP TO  IN   PEOPLE 
s REDUCTION IN BLOOD PLATELETS WHICH INCREASES
risk of bleeding or bruising
s WEIGHT GAIN
s HALLUCINATIONS OR PERSONALITY DISORDERS
s DRY OR SORE EYES OR PROBLEMS WITH VISION
s RINGING IN THE EARS TINNITUS OR PARTIAL LOSS OF
hearing or deafness (hearing problems)
s GANGRENE
s RUNNY AND ITCHY NOSE RHINITIS DRY MOUTH
s CHANGES IN THE RESULTS OF LIVER FUNCTION TESTS
 8

6

160 x 323

05 March 2014

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