Atenolol 25mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-12-2019
Summary of Product characteristics
(SPC)
02-01-2020
Public Assessment Report
(PAR)
07-05-2010
Active ingredient:
Atenolol
Available from:
Viatris UK Healthcare Ltd
ATC code:
C07AB03
INN (International Name):
Atenolol
Dosage:
25mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02040000
Patient Information leaflet
The name of your medicine is Atenolol 25mg/50mg/100mg Tablets.
They contain the active ingredient called Atenolol.
Atenolol belongs to a group of medicines called beta blockers. It
works by slowing the heart rate and relaxing the blood vessels so the
heart does not have to pump as hard.
Atenolol Tablets may be used for:
• high blood pressure
• relief of chest pain (angina)
• controlling heart beats which are irregular or too fast
• early treatment of myocardial infarction (heart attack)
DO NOT TAKE ATENOLOL TABLETS IF YOU:
• are allergic (hypersensitive) to Atenolol or any of the other
ingredients of Atenolol Tablets. See section 6. An allergic reaction
may include a rash, itching, difficulty breathing or swelling of the
face, lips, throat or tongue
• have slow heart beat or low blood pressure
• have or ever had cardiogenic shock (heart problem)
• have heart or blood vessel disease including untreated heart
failure (due to recent heart attack),
• have peripheral artery disease (poor circulation in the legs or
feet
due to narrow or blocked arteries)
• have disturbances in heart rhythm including sick sinus syndrome
(irregular heart beat) or heart block
• have high blood pressure due to a tumour near the kidney
(phaeochromocytoma)
• have ‘metabolic acidosis’ abnormal chemical levels in the
blood
such as potassium, sodium, calcium and urea
• have untreated phaeochromocytoma (rare tumour that usually
starts in the cells of one of your adrenal glands).
TAKE SPECIAL CARE WITH ATENOLOL TABLETS IF YOU HAVE:
• heart failure or disease that is being controlled
• chest pain (Prinzmetal’s angina)
• Raynaud’s disease (poor circulation causing cold hands)
• any kind of heart problems
• suffer from lung disorders
• are a diabetic
• have myasthenia gravis is a chronic disease characterised by
fluctuating levels of muscle weakness.
• have history of hypersensitivity
• a family history of heart disease or stroke
• hypoglycaemia (low blood sugar). Atenolol may hide the
symptoms o
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atenolol 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol 25mg
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
White, circular, biconvex, uncoated tablets with ‘FIL’ engraved
above the
score line, ‘25’ below the score line, on one side and plain on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atenolol 25mg tablets are indicated for the management of:
Hypertension
Angina pectoris
Cardiac arrhythmias
Acute myocardial infarction, as early intervention.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
_ _
_Hypertension: _
_ _
The majority of patients respond to a single oral dose of 100mg daily
though
some patients respond to 50mg, the effect being established fully
after one or
two weeks. A further reduction in blood pressure may be obtained by
combining atenolol tablets with other antihypertensive therapy such as
diuretics.
_Angina: _
The majority of patients respond to a single oral dose of 100mg daily
or to
50mg given twice daily. Increasing the dose above l00mg daily is
unlikely to
confer additional benefit.
_Cardiac arrhythmias. _
_ _
The initial dose for control of arrhythmias by intravenous application
of
atenolol is 2.5mg. This dose may be administered in intervals of 5
minutes
until the recommended effect is observed or until the maximum dose of
0.15mg per kg of body weight has been reached, respectively. When the
arrhythmia has been controlled with intravenous atenolol, the
recommended
oral maintenance dose of Atenolol tablets is a single daily dose of 50
- 100mg.
_ _
_Myocardial infarction: _
_ _
In those patients who are considered suitable for beta-blocker therapy
(presenting for treatment within 12 hours of the onset of chest pain),
appropriate intravenous beta-blocker therapy should be supplemented 15
minutes later by a single oral dose of 50mg atenolol
tablet providing intravenous therapy has been well tolerated. A
further oral
dose of
50mg Atenolol tablet should be given 12 hours later fo
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