Atenomel 50 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Atenolol
Available from:
Clonmel Healthcare Ltd
ATC code:
C07AB; C07AB03
INN (International Name):
Atenolol
Dosage:
50 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Beta blocking agents, selective; atenolol
Authorization status:
Marketed
Authorization number:
PA0126/069/001
Authorization date:
1988-07-25

Page 1 of 6

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atenomel 25mg Tablets

Atenomel 50mg Tablets

Atenomel 100mg 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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Atenomel Tablets are and what they are used for

What you need to know before you take Atenomel Tablets

How to take Atenomel Tablets

Possible side effects

How to store Atenomel Tablets

Contents of the pack and other information

1.

What Atenomel Tablets are and what they are used for

Atenomel Tablets contain the active substance atenolol. Atenolol belongs to a group of

medicines called beta-blockers. These medicines control the heart rate and blood pressure by

making your heart beat more slowly and with less force. Atenomel is used to:

Control high blood pressure (hypertension)

Help prevent chest pain (angina)

Treat uneven heart beats (arrhythmias)

Protect the heart in early treatment after a heart attack (myocardial infarction)

Help prevent another heart attack from happening.

2.

What you need to know before you take Atenomel Tablets

Do not take Atenomel 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 disorders:

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 with a pacemaker)

very slow or irregular heart-beat, very low blood pressure or very poor circulation.

if you have phaeochromocytoma (high blood pressure caused by a tumour, usually near the

kidney) which is not treated

if you have been told that you have metabolic acidosis (abnormal levels of acid in your

blood)

Do not take Atenomel tablets if any of the above apply to you. If you are not sure, talk to your

doctor or pharmacist before taking Atenomel tablets.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Atenomel

Page 2 of 6

If you have asthma, wheezing or any other similar breathing problems, or you get

allergic reactions, for example to insect stings. If you have ever had asthma or

wheezing, do not take this medicine without first checking with your doctor.

If you suffer from a type of chest pain (angina) called Prinzmetal’s angina

If you have poor circulation or controlled heart failure

If you have first-degree heart block

If you have diabetes. Your medicine may change how you respond to having low blood

sugar. You may feel your heart beating faster

If you have thyrotoxicosis (caused by an overactive thyroid gland). Your medicine may hide

the symptoms of thyrotoxicosis

If you have a kidney disorder. You may need to have regular check-ups during your

treatment.

If you have psoriasis (a skin condition)

If you have phaeochromocytoma, an alpha-beta blocker should be given concomitantly

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before

taking Atenomel tablets.

Treatment should not be withdrawn abruptly. See Section 3 “How to take Atenomel

Tablets”

Other medicines and Atenomel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

Tell your doctor if you are taking any of the following medicines:

medicines used to lower blood pressure such as guanethidine, reserpine, diuretics (drugs

used to increase the flow of urine), vasodilators (drugs which widen the blood vessels)

Disopyramide and amiodarone (medicines for regulating the heartbeat)

Verapamil, diltiazem and nifedipine (which are used to treat high blood pressure or angina)

Clonidine (for high blood pressure or migraine). If you are taking clonidine in combination

with atenolol, you must not stop taking clonidine unless told to do so by your doctor. If you

have to stop taking clonidine you should follow your doctor’s instructions carefully on how

to do it

Digoxin (a medicine for heart failure)

Insulin and oral anti-diabetic drugs used to treat diabetes. With atenolol there is a greater

risk of hypoglycaemia (low sugar levels) and you may not get the usual warning signs of low

sugar

Lidocaine, procainamide and beta-adrenoceptor stimulants such as noradrenaline (also

known as norepinephrine) used for heart problems

Ibuprofen or indometacin (drugs used to relieve pain and reduce inflammation)

Adrenaline (epinephrine) used as a heart stimulant

Nasal decongestants or other cold remedies (including the ones you can buy in the

pharmacy)

Operations and Anaesthetics:

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are

taking Atenomel tablets. This is because you can get low blood pressure (hypotension) if you

are given certain anaesthetics while you are taking atenolol.

Pregnancy and breast-feeding:

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine

Driving and using machinery:

Page 3 of 6

This medicine is unlikely to affect your ability to drive or operate machinery, but it may cause

dizziness or fatigue. However, it is best to wait to see how your medicine affects you before

trying these activities.

Atenomel tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3.

How to take Atenomel Tablets

Always take Atenomel Tablets exactly as your doctor or pharmacist has told you. Check with

your doctor or pharmacist if you are not sure.

You should swallow your tablets whole with water.

Adults:

The recommended dose for adults is:

Hypertension (high blood pressure): The recommended dose is 50 mg once daily. If required

your doctor may increase the dose to 100 mg once daily.

Angina (chest pain): The recommended dose is 100 mg once daily or 50 mg twice daily.

Irregular heartbeats: The recommended dose is 50 mg to 100 mg once daily.

The early treatment of a heart attack (myocardial infarction): The recommended dose is 50 mg

twice a day. Your doctor may then change this to 100 mg once a day.

To help prevent another heart attack: The recommended dose is 100 mg a day.

You should try to take your tablets at the same time every day.

Use in children:

Atenolol is not recommended for use in children due to lack of data on safety and efficacy.

Older people:

If you are an older person your doctor may decide to give you a lower dose, particularly if you

have problems with your kidneys.

People with kidney problems:

If you have severe problems with your kidneys, your doctor may ask you to take atenolol less

often.

If you take more Atenomel Tablets than you should:

If you have taken too many tablets you should contact your nearest hospital casualty department

or your doctor immediately.

If you forget to take Atenomel Tablets:

If you forget to take a dose, do so as soon as you remember and then go on as before. Do not

take a double dose to make up for a forgotten dose.

If you stop taking Atenomel Tablets:

Do not stop taking Atenomel Tablets even if you are feeling well, unless your doctor tells you to

do so.

Treatment should not be withdrawn abruptly. The dosage should be withdrawn gradually

over a period of 7 – 14 days, to facilitate a reduction in beta-blocker dosage. Patients should be

followed during withdrawal especially those with ischaemic heart disease.

Page 4 of 6

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine:

Allergic reactions:

If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps

on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.

Common (may affect up to 1 in 10 people):

You may notice that your pulse rate becomes slower while you are taking the tablets. This is

normal, but if you are concerned please tell your doctor about it

Cold hands and feet

Diarrhoea

Feeling sick (nausea)

Feeling tired

Problems with your heart or worsening problems with your heart

Fatigue

Sweating

Feeling drowsy

Increased dream activity

Depression

A sudden, unexpected rash or burning, red or peeling skin

Conjunctivitis.

Uncommon (may affect up to 1 in 100 people):

Disturbed sleep

Muscle weakness or muscle cramps

Diabetes or worsening diabetes

Rare (may affect up to 1 in 1,000 people):

Heart block (which can cause an abnormal heart beat, dizziness, tiredness or fainting)

Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s

disease)

Mood changes

Nightmares

Feeling confused

Changes in personality (psychoses) or hallucinations

Headache

Dizziness (particularly when standing up)

Tingling of your hands

Being unable to get an erection (impotence)

Dry mouth

Dry eyes

Disturbances of vision

Thinning of your hair

Skin rash

Reduced numbers of platelets in your blood (this may make you bruise more easily)

Purplish marks on your skin

Jaundice (causing yellowing of your skin or the whites of your eyes).

Very rare (may affect up to 1 in 10,000 people):

Page 5 of 6

Worsening angina attacks if you have experienced chest pains (angina pectoris)

Reduced libido, impotence

Changes to some of the cells or other parts of your blood. Your doctor may take blood

samples every so often to check whether Atenomel has had any effect on your blood.

Not known (frequency cannot be estimated from the available data):

Lupus-like syndrome (a disease where the immune system produces antibodies that attacks

mainly skin and joints).

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your

medicine. This happens rarely, affecting less than 1 in 1,000 people.

Psoriasis (a skin condition)

Being short of breath or having swollen ankles (if you have heart failure)

Asthma or breathing problems

Poor circulation.

You may experience symptoms of an over active thyroid such as increased heart rate and

tremor, may be hidden during treatment with Atenomel.

You may experience symptoms of low blood sugar (hypoglycaemia), such as increased heart

rate or tremor, may be hidden by Atenomel, particularly if you are dieting for prolonged periods

or subject to great physical exertion.

Problems with your cholesterol levels may occur during treatment with Atenomel.

Your doctor may monitor you for signs of bruising or bleeding under the skin while you are

taking Atenomel.

Your doctor may monitor your liver function while you are taking Atenomel.

Your doctor may monitor your kidney function if you have severe kidney disease.

Do not be concerned by this list of side effects. You may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1

6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can

help provide more information on the safety of this medicine.

5.

How to store Atenomel Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after

EXP. The expiry date refers to the last day of that month.

Do not store above 25

Store in the original package.

Keep blister in the outer carton.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Atenomel Tablets contain:

Page 6 of 6

- The active substance is atenolol 25 mg, 50 mg or 100 mg.

- The other ingredients are maize starch, pregelatinised maize starch, lactose monohydrate,

povidone, sodium laurilsulfate, silica colloidal anhydrous and magnesium stearate.

What Atenomel Tablets look like and contents of pack:

Atenomel 25 mg Tablets: White, round, biplanar tablet marked ‘C23’.

Atenomel 50 mg Tablets: White, round, biconvex tablet with a breakline and marked ‘C24’.

Atenomel 100 mg Tablets: White, round, biconvex tablet with a breakline marked ‘C25’.

Atenomel 25 mg, 50 mg and 100 mg tablets are available in packs containing 14, 15, 28, 30, 56,

60 and 100 tablets

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary

Manufacturer:

STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany

This leaflet was last revised in June 2017.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Atenomel 50 mg Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains atenolol 50 mg.

Excipients with known effect:

Each tablet contains lactose monohydrate 30.9mg

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablets

White, round biconvex tablet with a breakline and marked “C24”

The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

A beta-adrenoceptor blocker for the treatment of essential hypertension.

Management of angina pectoris.

Control of cardiac arrhythmias.

In early intervention in the acute phase of myocardial indarction and for long-term prophylaxis after recovery from

myocardial infarction.

4.2 Posology and method of administration

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 Atenomel 25 mg with other antihypertensive agents.

Mangement 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. It is unlikely that additional benefit will be gained by increasing the dose.

Control of cardiac arrhythmias:

An oral maintenance dose of atenolol is 50 mg to 100 mg, given once daily.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

1

Early and late intervention after myocardial infarction:

Oral treatment with atenolol can be initiated in haemodynamically stable patients with 50 mg twice daily, and then 100

mg once daily.

During the early phase of acute myocardial infarction, treatment with atenolol should be initiated in

hospital under close monitoring.

If bradycardia and/or hypotension requiring treatment, or any other untoward effects

occur, atenolol should be discontinued.

Atenolol 100 mg daily is recommended for long-term prophylaxis of myocardial infarction.

Children:

There is no paediatric experience with atenolol and for this reason it is not recommended for use in children.

Older people:

Dosage requirements may be reduced, especially in patients with impaired renal function.

Renal failure:

Since atenolol is excreted via the kidneys dosage should be adjusted in cased of severe impairment of renal function.

No significant accumulation of atenolol occurs in patients who have a creatinine clearance greater that 35 ml/min/1.73

m² (normal range is 100-150 ml/min/1.73m²).

For patients with a creatinine clearance of 15-35 ml/min/1.73m² (equivalent to serum creatinine of 300-600

micromol/litre), the dose should be 50 mg daily.

For patients with a creatinine clearance of less than 15 ml/min/1.73 m² (equivalent to serum creatinine of greater than

600 micromol/litre), the dose should be 25 mg daily or 50 mg on alternative days.

Patients on haemodialysis should be given 50 mg after each dialysis: this should be done under hospital supervision as

marked falls in blood pressure can occur.

Administration

Route of administration: Oral

4.3 Contraindications

Atenolol as well as other beta-blockers should not be used in patients with any of the following: known hypersensitivity

to the active substance or any of the excipients listed in section 6.1; bradycardia, cardiogenic shock, hypotension,

metabolic acidosis, severe peripheral arterial circulatory disturbances, 2

and 3

degree heart block, sick sinus

syndrome, untreated phaeochromocytoma, uncontrolled heart failure.

4.4 Special warnings and precautions for use

Atenolol as with other beta-blockers:

Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days, to

facilitate a reduction in beta-blocker dosage.. patients should be followed during withdrawal, especially those

with ischaemic heart disease.

When a patient is scheduled for surgery, and a decision is made to discontinue beta-blocker therapy, this should

be done at least 24 hours prior to the procedure. The risk-benefit assessment of stopping beta-blockade should

be made for each patient. If treatment is continued, an anaesthetic with little negative inotropic activity should

be selected to minimise the risk of myocardial depression. The patient may be protected against vagal reactions

by intravenous administration of atropine.

Although contraindicted in uncontrolled heart failure (see Section 4.3), may be used in patients whose signs of

heart failure have been controlled. Caution must be excerised in patients whose cardiac reserve is poor.

May increase the number and duration of angina attacks in patients with Prinzmetal’s angina due to unopposed

alpha-receptor mediated coronary artery vasoconstriction. Atenolol is a beta

-selective beta-blocker;

consequently, its use may be considered although utmost caution must be exercised.

Although contraindicated in severe peripheral arterial circulatory disturbances (see section 4.3), may also

aggravate less severe peripheral arterial circulatory disturbances.

Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-

degree heart block.

May mask the symptoms of hypoglycaemia, in particular, tachycardia.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

2

May mask the signs of thyrotoxicosis.

Will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient

develops symptoms which may be attributable to a slow heart rate and the pulse rate drops to less than 50-55

bpm at rest, the dose may be reduced.

May cause a more severe reaction to a variety of allergens when given to patients with a history of anaphylactic

reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline (epinephrine)

used to treat the allergic reactions.

May cause a hypersensitivity reaction including angioedema and urticaria.

May cause an increase in airways resistance in asthmatic patients. Atenolol is a beta

-selective beta-blocker;

consequently its use may be considered although utmost caution must be exercised. If increased airways

resistance does occur, atenolol should be discontinued and bronchodilator therapy (e.g. salbutamol)

administered if necessary.

Should only be given to patients with psoriasis after careful consideration, as psoriasis may be aggravated.

Since Atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatine clearance of

below 35 ml/min/1.73 m².

As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given

concomitantly.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose

malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Adrenergic neurone-blocking agents

Adrenergic-neurone blocking agents such as guanethidine, reserpine, diuretics and anti-hypertensive agents, including

the vasodilator group, will have an additive effect on the hypotensive action of the drug.

Anaesthetic agents

Caution must be exercised when using anaesthetic agents with atenolol.

The anaesthetist should be informed and the

choice of anaesthetic should be an agent with as little negative inotropic activity as possible.

Use of beta-blockers with

anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension.

Anaesthetic

agents causing myocardial depression are best avoided.

Antiarrhythmic agents (Class 1)

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction

time and induce negative inotropic effect.

Calcium channel blockers

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects e.g. verapamil, diltiazem

can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or sino-atrial

or atrio-ventricular conduction abnormalities.

This may result in severe hypotension, bradycardia and cardiac failure.

Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of

discontinuing the other.

Clonidine

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.

If the two

drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine.

replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after

clonidine administration has stopped. (See also prescribing information for clonidine).

Digitalis glycosides

Digitalis glycosides, in association with beta-blockers, may increase atrioventricular conduction time.

Dihydropyridines

Concomitant therapy with dihydropyridines e.g. nifedipine, may increase the risk of hypotension, and cardiac failure

may occur in patients with latent cardiac insufficiency.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

3

Insulin and oral antidiabetic drugs

Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering

effects of these drugs. Symptoms of hypoglycaemia, particularly tachycardia, may be masked (See Section 4.4).

Myocardial depressants

The beta-blocker should only be used with caution in patients who are receiving concomitant myocardial depressants

such as halogenated anaesthetics,

lidocaine,

procainamide and beta-adrenoceptor

stimulants such as noradrenaline

(norepinephrine).

Prostaglandin synthetase-inhibiting drugs

Concomitant use of prostaglandin synthetase inhibiting drugs,e.g. ibuprofen, indometacin, may decrease the

hypotensive effects of beta-blockers.

Sympathomimetic agents

Concomitant use of sympathomimetic agents, e.g. adrenaline, may counteract the effect of beta blockers.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Atenolol crosses the placental barrier and appears in the cord blood.

No studies have been performed on

the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded.

Atenolol has been used

under close supervision for the treatment of hypertension in the third trimester.

Administration of atenolol to pregnant

women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation.

The use of atenolol in women who are, or may become, pregnant requires that the anticipated benefit be weighed

against the possible risks, particularly in the first and second trimesters.

Breastfeeding:

There is significant accumulation of atenolol in breast milk.

Neonates born to mothers who are receiving atenolol at parturition or breat-feeding may be at risk for hypoglycaemia

and bradcardia. Caution should be exercised when Atenolol is administered during pregnancy or to a woman who is

breast feeding.

4.7 Effects on ability to drive and use machines

Use is unlikely to result in any impairment of the ability of patients to drive or operate machinery.

However it should

be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable effects

Atenolol is well tolerated. In clinical studies, the undesired events reported are usually attributable to the

pharmacological actions of atenolol.

The following undesired events, listed by body system, have been reported with the following frequencies: very

common (

10%), common (1-9.9%), uncommon (0.1-0.9%), rare (0.01-0.09%), very rare ( <0.01%) including isolated

reports, not known (cannot be estimated from the available data).

Cardiac disorders

Common:

Bradycardia, atrioventricular conduction disturbances or exacerbation of cardiac insufficiency

Rare:

Heart failure deterioration, precipitation of heart block.

In patients with angina pectoris, worsening of angina attacks cannot be ruled out to occur in isolated instances.

There

have been reports of worsening complaints in patients with peripheral arterial occlusive disease (including those with

Raynaud’s syndrome).

Vascular disorders:

Common:

Cold extremities.

Rare:

Postural hypotension which may be associated with syncope, intermittent claudication may be increased

if already present, in susceptible patients Raynaud’s phenomenon.

Nervous system disorders:

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

4

Common:

disturbances of the central nervous system such as fatigue, sweating, drowsiness, or increased dream

activity (especially at the start of therapy)

Rare:

Dizziness, headache, paraesthesia.

Psychiatric disorders:

Uncommon:

Sleep disturbances of the type noted with other beta-blockers.

Rare:

Mood changes, nightmares, confusion, psychoses and hallucinations.

Very rare (incl. isolated reports): Reduced libido, impotence.

Gastrointestinal disorders:

Common:

Gastrointestinal disturbances.

Rare:

Dry mouth.

Investigations:

Uncommon:

Elevations of transaminase levels.

Very rare:

An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this

is not clear.

Hepato-biliary disorders:

Rare:

Hepatic toxicity including intrahepatic cholestasis.

Blood and lymphatic system disorders:

Rare:

Purpura, thrombocytopenia.

Skin and subcutaneous tissue disorders:

Common:

Allergic skin reactions (erythema, pruritis, exanthema).

Rare:

Alopecia, psoriasiform skin reactions, exacerbation of psoriasis,

skin rashes.

Not known:

Hypersensitivity reactions, including angioedema and urticaria.

Eye disorders:

Common:

Conjunctivitis

Rare:

Dry eyes, visual disturbances.

Reproductive system and breast disorders:

Rare:

Impotence.

Respiratory, thoracic and mediastinal disorders:

Rare:

Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

General disorders and administration site conditions:

Common:

Fatigue.

Musculoskeletal and connective tissue disorder

Uncommon:

Muscle weakness, muscle cramps.

Not known:

Lupus-like syndrome

Endocrine disorders

In patients with hyperthyroidism, the clinical signs of thyrotoxicosis (e.g., tachycardia, tremor) may be masked during

atenolol therapy.

Metabolism and nutrition disorders:

Uncommon:

Latent diabetes mellitus becoming manifest or manifest diabetes mellitus becoming worse.

Patients following an absolute diet for prolonged periods of time and those subject to great physical exertion may

experience hypoglycaemic episodes when using atenolol at the same time.

The warning signs of hypoglycaemia

(tachycardia and tremor in particular) may be masked.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

5

Atenolol therapy may be associated with lipid metabolism disruptions.

While total cholesterol was usually normal,

HDL cholesterol was reduced and plasma triglycerides were elevated.

Precautionary notes:

As patients with pre-existing severe renal insufficiency have, in isolated instances, experienced deterioration of kidney

function during treatment with other beta-receptor blocking drugs, atenolol therapy should be accompanied by

appropriate kidney function monitoring.

Reports of elevated liver enzymes have been noted with the use of atenolol but they are rare.

Other beta-blocking

drugs have been associated with severe liver damage.

As other beta-receptor blocking drugs have been associated with thrombocytopenic or non-thrombocytopenic purpura,

patients on atenolol therapy should be watched for signs of purpura.

Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is

adversely affected by any of the above reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include: close supervision, treatment in an intensive care ward, the use of gastric lavage,

activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of

plasma or plasma substitutes to treat hypotension and shock.

The possible uses of haemodialysis or haemoperfusion

may be considered.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously and/or a cardiac pacemaker.

If necessary

this may be followed by a bolus dose of glucagon 10 mg intravenously.

If required this may be repeated or followed by

an intravenous infusion of glucagon 1-10 mg/hr depending on response.

If no response to glucagon occurs, or if

glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by

intravenous infusion may be given.

Dobutamine, because of its positive inotropic effect could also be used to treat

hypotension and acute cardiac insufficiency.

It is likely that these doses would be inadequate to reverse the cardiac

effects of beta-blockade if a large overdose has been taken.

The dose of dobutamine should therefore be increased if

necessary to achieve the required response according to the clinical condition of the patient.

Bronchospasm can usually be reversed by bronchodilators.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Beta-blocking agents, selective.

CO7A BO3

Atenolol is a beta-blocker which is beta

-selective (i.e. acts preferentially on beta

-adrenergic receptors in the heart).

Selectivity decreases with increasing dose.

Atenolol is without intrinsic sympathomimetric and membrane-stabilising activities and as with other beta-blockers,

has negative inotropic effects (and is therefore contraindicted in uncontrolled heart failure).

As with other beta-blockers, the mode of action of atenolol in the treatment of hypertension is unclear.

It is probably the action of atenolol in reducing cardiac rate and contractility which makes it effective in eliminating or

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

6

reducing the symptoms of patients with angina.

It is unlikely that any additional ancillary properties possessed by S(-) atenolol, in comparison with the racemic

mixture, will give rise to different therapeutic effects.

Atenolol is effective and well tolerated in most ethnic populations although the response may be less in black patients.

Atenolol is compatible with diuretics, other antihypertensive agents and antianginal agents (see section 4.5).

5.2 Pharmacokinetic properties

Absorption of atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma

concentrations occurring 2-4 hours after dosing. The atenolol blood levels are consistent and subject to little variability.

There is no significant hepatic metabolism of atenolol and more than 90% of that absorbed reached the systemic

circulation unaltered. The plasma half-life is about 6 hours but this may rise in severe renal impairment since the

kidney is the major route of elimination. Atenolol penetrates tissues poorly due to its low lipid solubility and its

concentration in brain tissue is low. Plasma protein binding is low (approximately 3%).

Atenolol is effective for at least 24 hours after a single oral daily dose. This simplicity of dosing facilitates compliance

by it acceptability to patients.

5.3 Preclinical safety data

Atenolol is a drug on which extensive clinical experience has been obtained.

Relevant information for the prescriber is

provided elsewhere in the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Pregelatinised maize starch

Lactose monohydrate

Povidone

Sodium laurilsulfate

Colloidal silicon dioxide

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

Keep blister in the outer carton.

6.5 Nature and contents of container

Blister packs consisting of aluminium foil and PVC/PvDC film. The blisters are packed in a folded cardboard box.

Pack sizes: 14, 15, 28, 30, 56, 60 and 100 tablets.

Not all pack sizes may be marketed.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

7

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Clonmel Healthcare Limited,

Waterford Road,

Clonmel,

Co. Tipperary,

Ireland.

8 MARKETING AUTHORISATION NUMBER

PA0126/069/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 25 July 1988

Date of last renewal: 25 July 2008

10 DATE OF REVISION OF THE TEXT

September 2015

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

2

/

0

6

/

2

0

1

7

C

R

N

2

1

9

4

0

9

0

p

a

g

e

n

u

m

b

e

r

:

8

Similar products

Search alerts related to this product

View documents history

Share this information