Skip to Content

UK Edition. Click here for US version.

METOPROLOL TARTRATE 100MG TABLETS

Active substance(s): METOPROLOL TARTRATE

View full screen / Print PDF » Download 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
2EADALLOFTHISLEAFLETCAREFULLYBEFOREYOUSTART
TAKINGTHISMEDICINEBECAUSEITCONTAINS
IMPORTANTINFORMATIONFORYOU
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
doctor, pharmacist or nurse.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
7HAT-ETOPROLOLISANDWHATITISUSEDFOR
7HATYOUNEEDTOKNOWBEFOREYOUTAKE
-ETOPROLOL
(OWTOTAKE-ETOPROLOL
0OSSIBLESIDEEFFECTS
(OWTOSTORE-ETOPROLOL
#ONTENTSOFTHEPACKANDOTHERINFORMATION

(Main)

Pharma code 559



7HAT-ETOPROLOLISANDWHATITISUSED
FOR

Metoprolol belongs to a group of drugs called
BETA BLOCKERS WHICHAFFECTTHEHEARTANDCIRCULATION
Metoprolol tablets are used to:
s MANAGEHIGHBLOODPRESSURE
s MANAGEANGINAPECTORISCHESTPAIN AND
heartbeat irregularities, and may also be given
after a heart attack
s PREVENTRECURRENTMIGRAINES
s TREATHYPERTHYROIDISMANOVERACTIVETHYROID
gland).

2

7HATYOUNEEDTOKNOWBEFOREYOUTAKE
-ETOPROLOL

$O./4TAKE-ETOPROLOLIFYOU
s AREALLERGICTOMETOPROLOLTARTRATEORANYOFTHE
other ingredients of this medicine (listed in
section 6)
s AREALLERGICTOANYOTHERBETA BLOCKERDRUGS
s HAVESEVEREASTHMAORSEVEREATTACKSOF
wheezing
s HAVEHEARTFAILURE SEVERESLOWHEARTBEAT
irregular heart beat, narrowing of the arteries or
had a heart attack with complications
s HAVESECONDORTHIRDDEGREEHEARTBLOCKA
condition which may be treated by a
pacemaker)
s HAVELOWBLOODPRESSURE
s HAVEPOORCIRCULATION
s YOUBEENTOLDTHATYOUHAVEHIGHBLOOD
pressure due to a tumour near your kidney
(phaeochromocytoma)
s AREPREGNANTORBREAST FEEDING
s have metabolic acidosis (a condition where there
is a change in the acid/base balance of the body).
7ARNINGSANDPRECAUTIONS
Talk to your doctor or pharmacist or nurse before
taking Metoprolol. If you:
s HAVEAHISTORYOFORSUFFERFROMALLERGIES
s HAVEANYOTHERHEARTPROBLEMS INPARTICULAR A
slow heartbeat
s HAVEPOORBLOODCIRCULATIONORCONTROLLEDHEART
failure
s SUFFERFROMPSORIASISPATCHESOFTHICKENEDAND
sore skin)
s AREDIABETIC9OURTREATMENTFORDIABETESMAY
need to be adjusted
s HAVEANYLIVERPROBLEMS
s HAVEAHISTORYOFASTHMAORWHEEZINGORANY
similar lung disorder
s HAVERECENTLYSUFFEREDASEVEREALLERGICREACTION
s HAVEATUMOUROFTHEADRENALGLAND
(phaeochromocytoma)
s HAVEATYPEOFCHESTPAINANGINA CALLED
prinzmetal’s angina
s HAVEFIRSTDEGREEHEARTBLOCK
s HAVETHYROTOXICOSISACONDITIONCAUSEDBYAN
overactive thyroid gland). Your medicine may
hide the symptoms of thyrotoxicosis.
s SUFFERFROMEYEDISORDERS
If you are about to undergo surgery requiring
anaesthetic, tell your doctor or dentist that you
are taking Metoprolol.

/THERMEDICINESAND-ETOPROLOL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines of the following:
s CLONIDINEFORHIGHBLOODPRESSUREORMIGRAINE 
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 OTHERDRUGSFORYOURHEARTORTOREDUCEBLOOD
pressure, e.g. prazosin
s OTHERBETABLOCKERS EGTIMOLOL FORGLAUCOMA
s MONOAMINE OXIDASEINHIBITORS FORDEPRESSION
e.g. phenelzine
s VERAPAMIL DILTIAZEM HYDRALAZINE NIFEDIPINE
(used to treat heart problems)
s QUINIDINE AMIODARONEFORHEARTPROBLEMS
s CIMETIDINEUSEDTOTREATHEARTBURN
s CARDIACGLYCOSIDESEGDIGOXINUSEDTOTREAT
heart failure)
s RIFAMPICINUSEDTOTREATTUBERCULOSIS
s LIDOCAINEUSEDASALOCALANAESTHETICTORELIEVE
pain)
s ERGOTAMINEUSEDTOTREATMIGRAINE
s MEDICINESTOTREATOTHERMENTALILLNESSESSUCH
as phenothiazines)
s ANTIRETROVIRALDRUGSEGRITONAVIR USEDTOTREAT
AIDS and some other conditions
s DRUGSTOPREVENTMALARIA
s MEDICINESTOTREATFUNGALINFECTIONS
s ADRENALINEUSEDINEMERGENCYTREATMENTEG
allergic reactions)
s INDOMETACINANDCELECOXIBUSEDTOTREAT
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-ETOPROLOLWITHFOOD DRINKANDALCOHOL
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 FEEDINGANDFERTILITY
)FYOUAREPREGNANT ORBREAST FEEDING THINKYOU
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
$RIVINGANDUSINGMACHINES
Metoprolol may cause dizziness and tiredness, if
affected do not drive or operate machinery.
-ETOPROLOLCONTAINS,ACTOSEMONOHYDRATE
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

(OWTOTAKE-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 (IGHBLOODPRESSURE
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 LOWERINGDRUG
s !NGINA
50 to 100 mg two or three times daily.
s )RREGULARHEARTBEAT
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 (EARTATTACK
The usual maintenance dose following a heart
attack is 200 mg daily.
s -IGRAINEPREVENTION
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!.$MG4!",%43

TEVA UK Ref:

Version:

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

3

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

s BRUISINGORINCREASEDSENSITIVITYOFTHESKINTO
sunlight, worsening of patches of thickened and
sore skin (psoriasis)
Older people:
s INCREASEDSWEATING LOSSOFHAIRALOPECIA
A reduced dose may be necessary.
s IMPOTENCEORLOSSOFLIBIDO
Use in children and adolescents:
s PAINFULJOINTS
Metoprolol tablets are not recommended for use s CHESTPAIN
in children.
Frequency not known (cannot be estimated from
)FYOUTAKEMORE-ETOPROLOLTHANYOUSHOULD
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 ABNORMALLEVELSOFCERTAINTYPESOFFATSSUCHAS
swallowed any of the tablets, contact your nearest
cholesterol or triglycerides in the blood
hospital casualty department or your doctor
s ABNORMALCURVATUREOFTHEPENISWITHPAINFUL
immediately. An overdose is likely to cause low
erections (known as Peyronie’s disease)
blood pressure (feeling dizzy or faint), a slow
s RETROPERITONEALFIBROSISWHEREABNORMALSCAR
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 POSITIVEANTI NUCLEARANTIBODIESANINDICATOROF
consumed.
autoimmune disease where the body attacks its
own tissues)
)FYOUFORGETTOTAKE-ETOPROLOL
s MEMORYLOSS 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 ANINCREASEININTERMITTENTCLAUDICATIONA
for a forgotten tablet dose. Take the remaining
CRAMP LIKEPAINBROUGHTONBYEXERCISE 
doses at the correct time.
If any of the side effects get serious, or if you
)FYOUSTOPTAKING-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.
2EPORTINGOFSIDEEFFECTS
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 0ATIENTSWITHLIVERPROBLEMS
A reduced dose may be necessary.

4

0OSSIBLESIDEEFFECTS

5

(OWTOSTORE-ETOPROLOL

+EEPOUTOFTHESIGHTANDREACHOFCHILDREN
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 ANALLERGICREACTIONSWELLINGOFTHELIPS FACEOR 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.
#ONTENTSOFTHEPACKANDOTHER
4HESIDEEFFECTSLISTEDBELOWHAVEBEENREPORTED
INFORMATION
#OMMONMAYAFFECTUPTOINPEOPLE 
s HEADACHE DIZZINESS ORUNUSUALTIREDNESS
7HAT-ETOPROLOL4ABLETSCONTAIN
s SLOWHEARTBEAT
s 4HEACTIVEINGREDIENTISMETOPROLOLTARTRATE
s LOWBLOODPRESSUREWHICHMIGHTMAKEYOUFAINT s 4HEOTHERINGREDIENTSAREMICROCRYSTALLINE
or dizzy
cellulose (E460), lactose monohydrate, sodium
s FEELINGSHORTOFBREATHWHENEXERCISING
starch glycolate, colloidal anhydrous silica and
s FEELINGORBEINGSICK STOMACHACHE
magnesium stearate.
2AREMAYAFFECTUPTOIN PEOPLE 
7HAT-ETOPROLOL4ABLETSLOOKLIKEANDCONTENTSOF
s DEPRESSION
THEPACK
s SLEEPDISORDERSSUCHASSLEEPINESS DIFFICULTYIN s 4HEMGTABLETSAREROUND BICONVEXWHITE
sleeping or nightmares
tablets, engraved ‘4A5’ with a breakline on the
s FEELINGLESSALERT
reverse.
s COLDNESS NUMBNESSORTINGLINGINYOURHANDS
s 4HEMGTABLETSAREROUND BICONVEXWHITE
and feet
tablets, engraved ‘4A6’ with a breakline on the
s MUSCLECRAMPS
reverse.
s HEARTPROBLEMSWHICHCANCAUSESHORTNESSOF
s 4HEPRODUCTISAVAILABLEINPACKSIZESOF 
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(OLDERAND-ANUFACTURER
s WATERRETENTIONOEDEMA
Marketing Authorisation holder and company
s POORBLOODCIRCULATIONWHICHMAKESTHETOES
responsible for manufacture: TEVA UK Limited,
and fingers numb and pale (Raynaud's
Eastbourne, BN22 9AG
phenomenon)
s BREATHLESSNESSORWHEEZINESSBRONCHOSPASM 4HISLEAFLETWASLASTREVISEDJanuary 2015
s DIARRHOEAORCONSTIPATION
0, 
s SKINRASHINCLUDINGNETTLERASH PATCHESOF
thickened and sore skin) and/or itching.
6ERYRAREMAYAFFECTUPTOIN PEOPLE 
s REDUCTIONINBLOODPLATELETS WHICHINCREASES
risk of bleeding or bruising
s WEIGHTGAIN
s HALLUCINATIONSORPERSONALITYDISORDERS
s DRYORSOREEYESORPROBLEMSWITHVISION
s RINGINGINTHEEARSTINNITUS ORPARTIALLOSSOF
hearing or deafness (hearing problems)
s GANGRENE
s RUNNYANDITCHYNOSERHINITIS DRYMOUTH
s CHANGESINTHERESULTSOFLIVERFUNCTIONTESTS
 8

6

160 x 323

05 March 2014

Expand view ⇕

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