Tenormin 100mg Film-coated Tablets.

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Malta Medicines Authority

Ակտիվ բաղադրիչ:

ATENOLOL

Հասանելի է:

AstraZeneca UK Limited

ATC կոդը:

C07AB03

INN (Միջազգային անվանումը):

ATENOLOL

Դեղագործական ձեւ:

FILM-COATED TABLET

Կազմը:

ATENOLOL 100 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

BETA BLOCKING AGENTS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2005-11-22

Տեղեկատվական թերթիկ

IM PIL Tenormin 25mg, 50mg, 100mg CV 16 0118a (Based on CV 15 0107)
11/04/2017 RS
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENORMIN 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS
atenolol
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.
IN THIS LEAFLET:
1. What Tenormin is and what it is used for
2. What you need to know before you take Tenormin
3. How to take Tenormin
4. Possible side effects
5. How to store Tenormin
6. Contents of the pack and other information
1.
WHAT TENORMIN IS AND WHAT IT IS USED FOR
Tenormin contains a medicine called atenolol. This belongs to a group
of medicines called
beta-blockers. Tenormin is used to:

Treat high blood pressure (hypertension).

Help prevent chest pain (angina).

Treat uneven heart beats (arrhythmias).

Protect the heart in the early treatment after a heart attack
(myocardial infarction).

Help prevent another heart attack from happening.
It works by making your heart beat more slowly and with less force.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TENORMIN
DO NOT TAKE TENORMIN:

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)
IM PIL Tenormin 25mg, 50mg, 100mg CV 16 0118a (Based on CV 15 0107)
11/04/2017 RS
Page 2 of 7
- very slow or ver

Ապրանքի հատկությունները

Summary of Product Characteristics
MT cSmPC Tenormin Tablets 25mg 50mg 100mg CV 17 0040 (based on CV 15
0155) 249/05/2017 RS
Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Tenormin 25 mg Film-coated Tablets.
Tenormin 50 mg Film-coated Tablets.
Tenormin 100 mg Film-coated Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg Tablets:
Each tablet contains 25 mg Atenolol.
50 mg Tablets:
Each tablet contains 50 mg Atenolol.
100 mg Tablets:
Each tablet contains 100 mg Atenolol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Tenormin 25 mg Film-coated Tablets _
Film-coated tablet.
White, round, biconvex, film-coated tablets, which are intagliated
with 25 on one
face and plain on the reverse face.
_Tenormin 50 mg Film-coated Tablets _
Film-coated tablet.
White, round, biconvex, film-coated tablets, which are intagliated
with 50 on one
face and bisected on the reverse face.
_Tenormin 100 mg Film-coated Tablets _
Film-coated tablet.
Summary of Product Characteristics
MT cSmPC Tenormin Tablets 25mg 50mg 100mg CV 17 0040 (based on CV 15
0155) 249/05/2017 RS
Page 2 of 12
White, round, biconvex, film-coated tablets, which are intagliated
with 100 on one
face and bisected on the reverse face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Control of hypertension.
Management of angina pectoris.
Control of cardiac arrhythmias.
In early intervention in the acute phase of myocardial infarction and
for long-term
prophylaxis after recovery from myocardial infarction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
CONTROL OF HYPERTENSION:
Most patients respond to 50 mg daily given orally as a single dose. If
necessary, the
dose may be increased to 100 mg daily. The effect will be fully
established after one
to two weeks. A further reduction in blood pressure may be achieved by
combining
Tenormin 25 with other antihypertensive agents.
MANAGEMENT OF ANGINA PECTORIS:
Most patients with angina pectoris will respond to 100 mg daily given
orally as a
single dose or as 50 mg given twice a day.