METOPROLOL TARTRATE TABLETS BP 50MG

Active substance: METOPROLOL TARTRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PE1456-Quark

29-06-05

9:58

Page 1

SAP CODE: PE1456

Ivax Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.

SUPPLIER
INSTRUCTIONS
Artwork text and content
must not be reset,remade,
amended or altered. The
only exceptions to this are:

Bleeds, chokes, spreads or
other adjustments required
for print reproduction
purposes only.

Product Name: METOPROLOL TAB BP 50 & 100MG 56 IUK
Date: 29/06/05

Draft: 05

Designer: CMC

Component: LEAFLET

Template: LF20

Barcode: N/A

Pharmacode: 750

Dimensions: 310 X 165mm

Signature: ......................................... Date:

Signature: ......................................... Date:

Artworkers Signature: CMC
REVISION DATE: n/a
COLOURS USED

Cutter guide (not for print)

FONTS USED

BLACK

If you have any difficulties
please contact:

PMS 2768

TINTS USED

PMS 137 10%

Other information: N/A

50%

/

/

/

/

/

/

/

/

Packaging Technologist:

Software Used: Adobe illustrator version 8.0

PMS 137

M.Y. Healthcare, Waterford.
Tel. 051-376484
Fax 051-378407

Artwork Co-ordinator:

Job No: 6175

FONT SIZES

REVISER: n/a
BLISS LIGHT
BLISS BOLD
BLISS MEDIUM
BLISS REGULAR
BLISS CAPS LIGHT
ZAPF DINGBATS

BLISS LIGHT 8.5PT
BLISS BOLD 10.25PT
BLISS MEDIUM 7PT / 9.4PT / 20.7PT / 10.4PT
BLISS REGULAR 6PT
BLISS CAPS LIGHT 16PT
ZAPF DINGBATS 6PT

Regulatory:
Subject to MCA / IMB approval
Approved by Reg. Dept. for print
Signature: ......................................... Date:

Design Review Board:
Signature: ......................................... Date:

9:58

Page 2

It gives you
important
information about
your medicine.
If you want to
know more, or
you are not sure
about anything,
ask your
pharmacist or
doctor.
Keep the leaflet
until you have
finished the
medicine.

What’s in your medicine
Metoprolol Tartrate Tablets are
circular, white to off-white,
uncoated tablets that come in two
strengths. Each tablet contains
either 50mg or 100mg of the active
ingredient Metoprolol tartrate.
They also contain: colloidal silica,
lactose, magnesium stearate, maize
starch, polyvidone, E460.
Metoprolol Tartrate Tablets are
available in pack sizes of 28s, 30s,
50s, 56s, 60s, 84s, 90s, 100s, 112s,
250s, 500s, 1000s.

About your medicine
The name of your medicine is
Metoprolol Tartrate Tablets which is
the generic (common) name. Your
doctor may have given you this
medicine before from another
company and it may have looked

IVAPL000

slightly different.
Either brand will have the same
effect.
Metoprolol Tartrate Tablets may be
used to:
● reduce high blood pressure.
● relieve chest pain (angina).
● control irregular heartbeats.
● prevent symptoms caused by an
overactive thyroid gland.
● prevent migraine attacks.
● decrease heart damage and death
due to heart attacks.

Before taking your
medicine

Metoprolol is one of a group of
medicines called beta-blockers.
MA holder/Manufacturer: Alpharma,
Barnstaple, EX32 8NS, UK.

750

Patient information leaflet

Metoprolol Tartrate 50mg Tablets BP
Metoprolol Tartrate 100mg Tablets BP

Please read this
leaflet carefully
before you start
to take your
medicine.

Print Free Area

Make sure it is safe for you to take
Metoprolol Tablets. You should not
take these tablets if you:
● are sensitive to metoprolol, a
related medicine, any of the
ingredients in the product or to
other beta-blockers.
● have disturbances in heart rhythm
(including sick sinus syndrome or
heart block).
● suffer from a slow heart beat or
have suffered a heart attack
which has been complicated by
significantly slow heart beats.
● suffer from a form of angina
known as Prinzmetal’s angina.

have heart disease (including
severe or uncontrolled heart
failure).
● have severe blood vessel disease.
● have untreated
phaeochromocytoma (high blood
pressure due to a tumour near the
kidney).
● have metabolic acidosis abnormal chemical levels in the
blood (eg of potassium, sodium,
calcium, urea).
● suffer from low blood pressure.
● have or have had breathing
difficulties, wheezing, asthma or
chronic bronchitis.
● have diabetes associated with
frequent episodes of low blood
sugar (hypoglycaemia).
● have impaired liver or kidney
function, or liver or kidney
disease/failure.
● have difficulties in passing urine,
(your water).
Patients with rare hereditary
problems of galactose intolerance,
the Lapp lactase deficiency or
glucose-galactose malabsorption
should not take this medicine. If you
have or think you have problems in
absorbing sugars (for example
glucose, lactose, galactose) you
must not take these tablets and
must talk to your doctor.
If you answer yes to any of the


Print Free
Area

following questions, talk to your
pharmacist or doctor before you
take the tablets:
● are pregnant, plan to become
pregnant or breast feeding?
● do you have or have you had the
skin condition psoriasis?
● do you suffer from diabetes?
● do you suffer from myasthenia
gravis (muscle weakness)?
● do you have a history of allergies?
● are you going to have an
operation or anaesthetic?
● are you using or addicted to
cocaine?
● are you taking or being treated
with other medicines such as:
● anxiolytics or hypnotics
(eg temazepam, nitrazepam,
diazepam),
● medicines to treat heart
conditions (eg amiodarone,
digoxin, disopyramide, hydralazine,
lidocaine, propafenone, quinidine),
● adrenaline (epinephrine),
● prazosin (used to treat high blood
pressure, heart failure or
enlargement of the prostate gland)
● medicines for high blood pressure
(eg clonidine, nifedipine,
verapamil, diltiazem, hydralazine
and other beta-blockers),

eye drops for treating glaucoma
(eg timolol),
● medicines to treat depression
(eg amitriptyline, MAOI’s such as
phenelzine, tranylcypromine),
● medicines to treat diabetes
(eg insulin),
● medicines to treat epilepsy
(eg phenobarbital),
● medicines to treat migraine
(eg ergotamine),
● moxisylyte (used in Raynaud’s
syndrome),
● rifampicin (used to treat severe
infections),
● cimetidine (used to treat
indigestion and stomach ulcers),
● xanthine derivatives,
eg aminophylline and theophylline
(used in the treatment of asthma),
● alprostadil (used to treat erectile
dysfunction),
● aldesleukin (used to treat some
cancers, particularly cancer of the
kidney),
● mefloquine (used to treat
malaria),
● tropisetron (used to prevent
nausea and vomiting),
● trimetaphan (used during surgery),
● medicines to treat mental illness
(eg chlorpromazine),


Print Free Area

29-06-05

PE 1456

PE1456-Quark

29-06-05

9:58

Page 3

Taking your medicine
Your doctor has decided the dose
which is best for you.
Always follow your doctor’s
instructions with regard to how
many tablets and when to take the

Print Free Area

tablets, exactly.
If you do not understand how you
should take the tablets ask your
doctor or pharmacist. The pharmacy
label will also tell you how the
tablets should be taken.
If you are taking other medicines
your doctor may need to reduce the
dosages listed below depending
upon the type of medication. The
dosage may also need to be reduced
if you suffer from impaired kidney or
liver function.
The usual dosages are described below:
Indication
High blood pressure

Angina
Irregular heart beats
Heart attacks
Overactive thyroid gland
Prevention of migraine
Elderly
Children

doctor decides to stop your tablets
he/she may prescribe a gradual
reduction in the dose.
If you forget to take a dose, take
another as soon as you remember
and then your next dose at the usual
time. NEVER take two doses at the
same time.
If you are elderly, it is particularly
important to take this medicine
exactly as directed by the doctor.
If you accidentally take more than
your prescribed dose, contact your
nearest hospital casualty

Dosage
100mg initially. This dose can be increased up to
200mg in either a single dose once a day or in
divided doses throughout the day (twice a day or
four times a day whichever is more appropriate).
50-100mg 2-3 times daily.
50mg 2-3 times daily. This dose may be increased
up to 300mg in divided doses throughout the day.
200mg daily taken in divided doses (50mg every
six hours).
50mg 4 times daily.
100-200mg taken in divided doses (morning and
evening).
The above dosages may need to be reduced.
Not recommended.

These tablets should be taken as
instructed by your doctor, with a
glass of water. Continue to take
them for as long as your doctor tells
you to, it may be dangerous to stop
without his/her advice. The tablets
must not be stopped until you have
sought your doctor’s advice. If your

department, or tell your doctor
immediately. Take any remaining
tablets and the container with you
to show to the doctor.

After taking your medicine

Like many medicines, Metoprolol
Tartrate Tablets may occasionally
cause side-effects in some patients,
particularly when you first start
taking it. These may include:
Effects on the nervous system:
occasional tiredness; dizziness;
headache; numbness; muscle cramps;
depression; inability to think clearly;
sleepiness or difficulty in sleeping;
nightmares; changes in personality;
hallucinations.
Effects on the heart: occasionally
slowing of the heart rate; lowering of
blood pressure on standing; heart
disease; irregular heart rhythm; water
retention; heart flutter; cold, blue or
numb fingers or toes (Raynaud’s
phenomenon); chest pain; gangrene
in patients with severe poor
circulation, occasional fainting.
Effects on the gut: occasionally
feeling or being sick; rarely diarrhoea
or constipation; dry mouth;
abdominal pain; hepatitis and liver
problems.
Effects on the skin: skin rash;
sensitivity to light; increased
sweating; hair loss.
Effects on the lungs: shortness of
breath or painful breathing especially
after exercise; bronchospasm; runny
nose.
Effects on hormones and
metabolism: weight gain;
disturbances of sexual desire and
performance.

Print Free
Area

Effects on the ears: ringing in the
ears; loss of hearing with high doses.
Effects on the blood: effects on
blood clotting, easy or unexplained
bruising.
Other effects: visual disturbances;
dry/irritated eyes; joint swelling or
pain, changes in the results of blood
tests. If you need to have a blood
test tell your doctor you are taking
Metoprolol Tablets.
You should consult your doctor if
these occur.
If you get a skin rash or dry eyes or
any other unusual effects, tell your
doctor immediately and seek advice.
Your doctor may want you to
gradually stop the tablets.

Date of last revision:
January 2005
H01331012 A

Storing your medicine
Do not use the tablets after the
expiry date shown on the product
packaging.
Keep the tablets below 25°C in a dry
place, protected from light,
and in the original packaging.
KEEP THEM IN A SECURE PLACE
WHERE CHILDREN CANNOT GET
AT THEM.
REMEMBER, this medicine is for YOU
only. NEVER give it to anyone else.
It may harm them, even if their
symptoms are the same as yours.
Unless your doctor tells you to, do
not keep medicines that you no
longer need - give them back to your
pharmacist for safe disposal.

IVAPL000

Metoprolol Tartrate 50mg Tablets BP
Metoprolol Tartrate 100mg Tablets BP

corticosteroids (eg hydrocortisone,
prednisolone),
● non-steroidal anti-inflammatory
drugs (eg ibuprofen, diclofenac)?
● are you taking a contraceptive pill
which contains oestrogen or
having hormone replacement
therapy (HRT)?
● are you taking any other tablets or
medicines that you may have
bought without a prescription?
Before you take Metoprolol Tablets
please make sure that you inform
your doctor of all medicines or
tablets that you may be taking.
You are advised NOT to drink
alcohol with this medicine.
If you see another doctor or go into
hospital, especially if you need an
operation or are having an
anaesthetic, let them know what
medicines you are taking and take
the tablets with you.
These tablets may affect your
ability to drive or operate
machinery. Occasionally dizziness
or fatigue may occur and if so you
should not drive or operate
machinery. You should discuss this
with your doctor.


Patient information leaflet

Print Free Area

PE 1456

PE1456-Quark

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
(web5)