Metoprolol 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metoprolol tartrate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

C07AB02

INN (International Name):

Metoprolol tartrate

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5025903005889

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METOPROLOL TARTRATE 50 MG TABLETS
METOPROLOL TARTRATE 100 MG TABLETS
Metoprolol Tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This 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.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Metoprolol is and what it is used for
2.
What you need to know before you take Metoprolol
3.
How to take Metoprolol
4.
Possible side effects
5.
How to store Metoprolol
6.
Contents of the pack and other information
1.
WHAT METOPROLOL IS AND WHAT IT IS USED FOR
Metoprolol belongs to a family of medicines known as beta-blockers.
Metoprolol is used:
-
to treat high blood pressure (hypertension)
-
to prevent and control angina
-
to treat cardiac arrhythmias (irregular heart beats)
-
to prevent migraines
-
as part of the treatment of an overactive thyroid gland
(hyperthyroidism)
-
to prevent another heart attack when you are recovering from a heart
attack (myocardial
infarction)
or during early stages of heart attack (myocardial infarction) to
reduce further
damage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOPROLOL
DO NOT TAKE METOPROLOL:
-
if you are allergic to metoprolol
tartrate or to any of the other ingredients of this medicine
(listed in section 6)
-
if you have suffered an allergic reaction to a beta-blocker medicine
in the past
-
if you suffer from a slow heart beat (bradycardia) or low blood
pressure (hypotension)
-
if you suffer from untreated heart failure (when your heart does not
pump enough blood around
the body) or missed heart beats (heart block)
-
if you suffer from sick sinus syndrome (a t

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Metoprolol Tartrate 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg metoprolol tartrate.
Excipient with known effect:
Each tablet contains 39 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, biconvex tablets marked “ML” score line “50”one side
and “G” on reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metoprolol is a beta-adrenoreceptor blocking drug indicated for:
hypertension, angina pectoris,
cardiac arrhythmias especially supraventricular tachyarrhythmias,
migraine prophylaxis, adjunct to
treatment of hyperthyroidism, long-term prophylaxis after recovery
from acute myocardial infarction.
Early intervention with metoprolol in myocardial infarction reduces
infarct size and the incidence of
ventricular fibrillation. Pain relief may also decrease the need for
opiate analgesics. Metoprolol has
been shown to reduce mortality when administered to patients with
acute myocardial infarction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose must always be adjusted to the individual requirements of the
patient but should not exceed
400 mg/day. The following are guidelines:
_Adults_:
_Hypertension_: Initially, 100 mg daily, increased by 100 mg daily at
weekly intervals to 200 mg daily
if needed, in single or divided (twice daily) doses. Over the dosage
range most patients may be
expected to respond rapidly and satisfactorily. A further reduction in
blood pressure may be achieved
if Metoprolol tablets are used in conjunction with an antihypertensive
diuretic or other hypotensive
agent.
Metoprolol tablets may be administered with benefit both to previously
untreated patients with
hypertension and to those in whom the response to previous therapy is
inadequate. In the latter type of
patient the previous therapy may be continued and Metoprolol tablets
added into the regime with
adjustment of the previous therapy if necessary.
_Angina Pectoris:_ 50-100 mg two or