Totamol Tablets 25mg

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

ATENOLOL

Dostopno od:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

Koda artikla:

C07AB03

INN (mednarodno ime):

ATENOLOL 25 mg

Farmacevtska oblika:

TABLET

Sestava:

ATENOLOL 25 mg

Tip zastaranja:

POM

Terapevtsko območje:

BETA BLOCKING AGENTS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2006-08-23

Navodilo za uporabo

Page 1 of 14
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATENOLOL 25MG TABLETS
ATENOLOL 50MG FILM-COATED TABLETS
ATENOLOL 100MG FILM-COATED TABLETS
Atenolol (Referred to as Atenolol Tablets in this leaflet)
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 Atenolol Tablets are and what they are used for
2. What you need to know before you take Atenolol Tablets
3. How to take Atenolol Tablets
4. Possible side effects
5. How to store Atenolol Tablets
6. Contents of the pack and other information
1. WHAT ATENOLOL TABLETS ARE AND WHAT THEY ARE USED FOR
Atenolol Tablets contain a medicine called atenolol. This belongs to a
group of medicines called
beta-blockers. Atenolol Tablets are used to:

Treat high blood pressure (hypertension).

Treat uneven heart beats (arrhythmias).

Help prevent chest pain (angina).

Protect the heart in the early treatment after a heart attack
(myocardial infarction).
They work by making your heart beat more slowly and with less force.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATENOLOL TABLETS
DO NOT TAKE ATENOLOL TABLETS:

If you are allergic to atenolol or any of the other ingredients of
this medicine (listed in section 6)

If you have ever had any of the following heart problems:

heart failure which is not under control (this usually makes you
breathless and causes your
ankles to swell)

second- or third-degree heart block (a condition which may be treated
by a pacemaker)

very slow or very uneven heart beats, very low blood pressure or

Lastnosti izdelka

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atenolol 25mg Tablets or Totamol 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol 25mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atenolol is indicated for:

Management of hypertension.

Management of angina pectoris.

Management of cardiac arrhythmias.

Myocardial infarction. Early intervention in the acute phase.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION Posology
The dose must always be adjusted to individual requirements of the
patients, with the
lowest possible starting dosage. The following are guidelines:
_ _
_ADULTS:_
HYPERTENSION
100 mg daily. Most patients respond to 100 mg daily given orally as a
single dose. Some
patients, however, will respond to 50 mg given as a single daily dose.
The effect will be
fully established after one to two weeks. A further reduction in blood
pressure may be
achieved by combining atenolol with other antihypertensive agents. For
example co-
administration of atenolol with a diuretic, as in Tenoretic, provides
a highly effective
and convenient antihypertensive therapy.
ANGINA Most patients with angina pectoris will respond to 100 mg given
orally once daily or 50
mg given twice daily. It is unlikely that additional benefit will be
gained by increasing
the dose.
CARDIAC ARRHYTHMIAS Having
controlled
the
arrhythmias
with
intravenous
atenolol,
a
suitable
oral
maintenance dosage is 50–100 mg daily, given as a single dose.
MYOCARDIAL INFARCTION
For patients suitable for treatment with intravenous beta-blockade and
presenting
within 12 hours of the onset of chest pain, following treatment with
intravenous
atenolol, 50 mg oral atenolol may be given about 15 minutes later,
provided no
untoward effects have occurred from the intravenous dose. This should
be followed by
a further 50 mg orally 12 hours after the intravenous dose, and then
12 hours later by
100 mg orally, once daily. If bradycar