Atenolol Crescent 50mg Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
24-05-2020
Shusha Tabia za bidhaa (SPC)
24-05-2020

Viambatanisho vya kazi:

ATENOLOL

Inapatikana kutoka:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC kanuni:

C07AB03

INN (Jina la Kimataifa):

ATENOLOL 50 mg

Dawa fomu:

TABLET

Tungo:

ATENOLOL 50 mg

Dawa ya aina:

POM

Eneo la matibabu:

BETA BLOCKING AGENTS

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2020-01-10

Taarifa za kipeperushi

                                PACKAGE INFORMATION LEAFLET
ATENOLOL CRESCENT 25MG, 50MG, 100MG TABLETS
Please read all of this leaflet carefully before you start taking this
medicine.
•
Keep the leaflet, you may need to read it again.
•
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Atenolol Tablets are and what they are used for
2.
Before you take Atenolol Tablets
3.
How to take Atenolol Tablets
4.
Possible side effects
5.
How to store Atenolol Tablets
6.
Further information
1.
WHAT ATENOLOL TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine is called a beta-blocker. It acts on the heart and
decreases blood pressure. The medicine can
help to reduce your blood pressure or treat your chest pain (angina).
It may also help to keep your heart
beating regularly if you have palpitations or to protect it after a
heart attack.
2.
BEFORE YOU TAKE ATENOLOL TABLETS
_ _
DO NOT TAKE THESE TABLETS IF:
-
you are allergic to atenolol or to any of the other ingredients of
this medicine (see section 6)
-
you have low blood pressure
-
you have very poor circulation
-
you have phaeochromocytoma (high blood pressure caused by a tumour,
usually near the kidney)
which is not being treated
-
you suffer from metabolic acidosis (abnormal levels of acid in your
blood)
-
you have another heart problem such as second or third degree heart
block or uncontrolled heart
failure
-
you have a condition called Prinzmetal
'
s
angina
-
you have a slow or uneven heartbeat
-
you have or have had breathing problems such as asthma, wheezing or
reversible obstructive airways
disease.
Do not take this medicine if you have wheezing or asthma. Talk to your
doctor first.
CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS
IF:
-
                                
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Tabia za bidhaa

                                Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Atenolol Crescent 25 mg Tablets
Atenolol Crescent 50mg Tablets
Atenolol Crescent 100mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol Crescent 25 mg Tablets
Atenolol 25 mg per tablet
Atenolol Crescent 50 mg Tablets
Atenolol 50mg per tablet
Atenolol Crescent 100 mg Tablets
Atenolol 100mg per tablet
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Atenolol Tablets 25mg
Atenolol Crescent 25 mg Tablets are presented as orange, biconvex,
film coated tablets engraved with
company logo on one side and A511 on the other side.
Atenolol Tablets 50mg
Atenolol Crescent 50 mg Tablets are presented as orange film coated,
biconvex tablets engraved with
company logo on one face and A431 on the other face.
Atenolol Tablets 100mg
Atenolol Crescent 100 mg Tablets are presented as orange film coated,
biconvex tablets engraved with
company logo on one face and A432 on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. Management of hypertension
2. Management of angina pectoris
3. Management of cardiac arrhythmias
4. Myocardial infarction - early intervention in the acute phase.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Page 2 of 12
Hypertension
Usual Dose: 100 mg daily as a single dose.
Some patients may respond to 50 mg as a single daily dose.
The therapeutic effect is fully established after administration for
one to two weeks.
Further reduction in blood pressure, if desired, can be achieved by
combining atenolol with other
antihypertensive agents.
Angina
100 mg once daily or 50 mg twice daily
Additional benefit is unlikely to be gained by increasing the dose.
Arrhythmias
Having controlled the arrhythmia with intravenous “atenolol”
maintenance oral dose: 50 - 100 mg daily
as a single dose.
Myocardial infarction
Patients presenting within 12 hours of the onset of chest pains and
suitable for beta-adrenoceptor
blockade therapy.
_Injection _
Atenolol 5-10 mg administered by slow intravenous injection (1
mg/mi
                                
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