Ateni 100mg Film-coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Atenolol
Available from:
Generics (UK) Limited
ATC code:
C07AB; C07AB03
INN (International Name):
Atenolol
Dosage:
100 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Beta blocking agents, selective; atenolol
Authorization status:
Not marketed
Authorization number:
PA0405/019/002
Authorization date:
1987-04-09

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v1/May 2015

18 May 2016

13:01

Atenolol 50 mg,100 mg 28

Leaflet

897616

729993

897616

PA0405/019/

001-002

Gerard Labs

LT1730AD

281430

|reland

Black

Times New Roman

170 x 480 mm

10.5 Pt

10.5 Pt

Package leaflet: Information for the patient

Ateni 50 mg Film-coated Tablets

Ateni 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 Ateni is and what it is used for

2. What you need to know before you

take Ateni

3. How to take Ateni

4. Possible side effects

5. How to store Ateni

6. Contents of the pack and other

information.

1. What Ateni is and what it is

used for

Ateni contains atenolol which belongs to a

group of medicines called beta-blockers.

Ateni can be used to:

Treat high blood pressure (hypertension)

Help prevent chest pain (angina)

Treat irregular or abnormal rhythms of the

heart (arrhythmias)

Protect the heart following a heart attack

during early treatment (myocardial

infraction)

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 Ateni

Do not take Ateni if:

You are allergic to atenolol or any of the

other ingredients of this medicine (listed in

section 6)

You have ever had any of the following

heart problems

■ You are suffering from untreated

heart failure (this usually makes you

breathless and causes your ankle to

swell)

■ You have second or third degree heart

block,(a condition may be controlled by

a pacemaker )

■ You suffer from a slow or uneven

beating heart, very low blood pressure

or very poor circulation

You have a tumour called a

phaeochromocytoma, for which you are

not receiving treatment. This is usually

near your kidney and can cause high blood

pressure

You have higher than normal levels of acid

in your blood (metabolic acidosis)

Do not take Ateni if any of the above applies

to you. If you are not sure, talk to your doctor

or pharmacist before taking Ateni.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Ateni if:

You have ever had asthma or wheezing or

any other similar breathing problems, or

you have a history of allergic reaction e.g.

insect stings. Do not take this medicine

without first checking with your doctor,

as this may increase your risk of you

experiencing an allergic reaction

You have Prinzmetal's angina (chest pain

while resting)

You have poor blood circulation, including

Raynaud’s syndrome

You have first-degree heart block

You have diabetes. Your medicine may

change how you respond to having low

blood sugar - you may not feel your heart

beating faster

You have kidney problems. You may need

to have additional check-ups during your

treatment

You have a skin condition called psoriasis.

You have thyrotoxicosis (a condition

caused by an overactive thyroid gland).

Ateni may hide symptoms.

If you are not sure if any of the above applies

to you, talk to your doctor or pharmacist

before taking Ateni.

Other medicines and Ateni

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines including medicines

obtained without a prescription and herbal

medicines. Ateni can affect the way some

other medicines work and some medicines

can have an effect on Ateni.

In particular, tell your doctor if you are

taking any of the following medicines:

Medicines used to treat high blood

pressure such as guanethidine, reserpine

and diuretics (water tablets)

Adrenaline, also known as epinephrine (a

heart stimulant)

Medicines that are used to treat high blood

pressure, uneven heart rhythms or angina

(chest pain), such as verapamil, diltiazem

and nifedipine

Disopyramide, quinidine or amiodarone

(for irregular heartbeats)

Digoxin (for heart problems)

Clonidine (for high blood pressure or

migraine). If you are taking clonidine and

Ateni together, you must not stop taking

clonidine unless your doctor tells you to

do so. If you have to stop taking clonidine,

your doctor will give you careful

instructions on how to do it

Lidocaine, procainamide or noradrenaline,

also known as norepinephrine (for heart

problems)

Insulin and oral antidiabetic medicines (for

diabetes)

Medicines that are used to treat pain and

inflammation, such as indometacin and

ibuprofen

Medicines to treat nose or sinus congestion

or other cold remedies (including those

you can buy in a pharmacy)

Operations

If you need an anaesthetic for surgery or an

operation, tell the doctor or medical staff that

you are taking Ateni. This is because you can

get low blood pressure (hypotension) if you

are given certain anaesthetics while you are

taking Ateni

Pregnancy and breast-feeding

If you are pregnant, think you may be

pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice

before taking this medicine. Ateni is not

recommended in pregnancy or breast-

feeding.

Driving and using machines

Ateni is not likely to affect you being able to

drive or use any tools or machines. However,

it is best to wait to see how your medicine

affects you before trying these activities. Do

not drive or operate machinery if you feel

dizzy or tired whilst taking this medicine.

3. How to take Ateni Film-coated

Tablets

Always take this medicine exactly as your

doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not

sure.

Your doctor will tell you how many Ateni

tablets to take each day and when to take

them. Swallow your tablet whole with a drink

of water. Try to take your tablet at the same

time each day

Adults:

High blood pressure (Hypertension)

The recommended starting dose is 50 mg a

day. Your doctor may increase your dose up

to 100 mg daily depending on your blood

pressure.

Chest pain (angina)

The recommended dose is 50 mg to 100 mg

of Ateni once a day or 50 mg twice daily.

Irregular heart rhythms (arrhythmias)

The recommended dose is 50 mg to 100 mg

of Ateni daily.

LT1730AD / 897616

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Keyline/Drawing No.

Barcode Info

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Affiliate Item Code

Superceded Affiliate Item Code

TrackWise PR No.

MA No.

Packing Site/Printer

Supplier Code

Sign-offs

v1/May 2015

18 May 2016

13:01

Atenolol 50 mg,100 mg 28

Leaflet

897616

729993

897616

PA0405/019/

001-002

Gerard Labs

LT1730AD

281430

|reland

Black

Times New Roman

170 x 480 mm

10.5 Pt

10.5 Pt

Early treatment following a heart attack

(myocardial infarction)

The recommended dose is 50 mg of Ateni

twice daily. The dose may be changed to

100 mg once a day.

To help prevent a further heart attack

The recommended dose is 100 mg daily.

Elderly people

Your doctor may prescribe you a lower dose

than the doses given above, particularly if

you have problems with your kidney.

People with kidney problems

If you have severe problem with your

kidneys, your doctor may ask you to take

Ateni less often.

Use in children and adolescents

Ateni is not recommended for children and

adolescents.

If you take more Ateni than you should

Contact your doctor or go to the local

casualty department of your nearest hospital

immediately. Take the medicine pack with

you so that the tablets can be identified.

If you forget to take Ateni

Unless it is almost time for your next dose,

take it as soon as you remember. Otherwise,

if you miss a dose do not take a double dose

to make up for the forgotten tablet, just carry

on as before.

If you stop taking Ateni

Do not stop taking Ateni without telling

your doctor. Suddenly stopping your tablets

can cause a worsening of angina or increase

blood pressure. You doctor will tell you how

to stop gradually.

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.

If you get any of the following side effects,

talk to your doctor straight away or go to

the casualty department of your nearest

hospital immediately:

Rare

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

Liver problems, which you may notice as

yellow colouring of your skin and eyes

(jaundice), dark coloured urine, feeling

sick, being sick, loss of appetite, fever,

itching.

Heart block (which may cause an abnormal

heartbeat, dizziness, tiredness or fainting)

Worsening of breathing difficulties,

breathlessness, breathing problems e.g.

asthma

Worsening of heart failure and/or your

blood circulation, swollen ankles

Not known

(frequency cannot be estimated

from the available data):

Allergic reaction

(the signs of allergic

reaction include swelling of the face, lips,

mouth, tongue, or throat, or severe itchy

skin rash).

These side effects are serious. You may need

medical attention.

Other side effects include:

Common

(may affect up to 1 in 10 people):

the heart beating more slowly

cold fingers and toes

stomach disturbances such as feeling sick

(nausea) and diarrhoea

tiredness

Uncommon

(may affect up to 1 in

100 people):

disturbed sleep

increases in liver enzyme levels (which

will affect blood test results)

Rare

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

numbness and spasm in the fingers

which is followed by warmth and pain

(Raynaud’s syndrome)

thinning, or hair loss

skin rash, including worsening of psoriasis

thrombocytopenia (bruising or bleeding

more easily)

mood changes

nightmares

feeling confused

psychoses or hallucinations (disturbances

of the mind)

headache

dizziness, particularly when standing up

tingling of the hands and feet

impotence (unable to get an erection)

dry mouth

dry eyes

disturbance of vision

purpura (purple spots on the skin)

Very rare

(may affect up to 1 in

10,000 people):

changes to some of the cells or other

parts of your blood. It is possible that

your doctor may occasionally take blood

samples to check whether Ateni has had

any effect on your blood.

Not know

(frequency cannot be estimated

from the available data)

Lupus-like syndrome (a disease where the

immune system produce antibodies that

attack mainly skin and joints)

Do not be concerned by this list of side

effects. You may not get any of them. If any

of the side effects get serious, or if you notice

any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your

doctor or pharmacist. 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 Ateni

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 label, blister and carton

after "Exp". The expiry date refers to the last

day of that month.

Do not store above 25°C. Store in the

original package.

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 Ateni contains:

The active substance is atenolol. Each film-

coated tablet contains either 50 mg or 100 mg

of atenolol.

The other ingredients are: calcium hydrogen

phosphate (anhydrous), heavy magnesium

carbonate, sodium starch glycolate (type A),

maize starch, colloidal anhydrous silica

and magnesium stearate. The film-coating

contains Opadry white Y-1-7000 (consisting

of hypromellose, titanium dioxide (E171) and

macrogol 400).

What Ateni Film-coated Tablets look like

and contents of the pack:

Ateni 50 mg Film-coated Tablets are white,

film coated bi convex tablets marked "AT 50"

on one side and "G" on the other side.

Ateni 100 mg Film-coated Tablets are white,

film coated bi convex tablets, marked "AT

100" on one side and "G" on the other side.

Ateni Film-coated Tablets are available in

child- resistant plastic bottles with tamper

evident seal of 28, 100, 250, 500 and 1000*

tablets and blister packs of 7, 10, 14, 15 and

28* tablets.

(*not all pack sizes may be marketed)

Marketing Authorisation Holder:

Generics [UK] Limited, Station Close,

Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom

Manufacturer:

McDermott Laboratories Ltd. t/a

Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

The leaflet was last revised in May 2016.

LT1730AD / 897616

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Ateni 100mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 100 mg atenolol.

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated tablet.

White film-coated, biconvex tablet, approximately 10 mm in diameter, marked 'AT100'

on one side and 'G'

on the

reverse.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Atenolol is a beta-adrenoceptor blocking drug indicated for:

hypertension

angina pectoris

cardiac arrhythmias

myocardial infarction: early intervention in the acute phase and late intervention for long term prophylaxis after

recovery from myocardial infarction

4.2 Posology and method of administration

Posology

Adults

Hypertension: Initially 50 mg daily. The full effect of this dose will usually be seen within 1-2 weeks. If an optimal

response is not achieved the dosage may be increased to 100 mg daily. A further reduction in blood pressure may be

achieved by combining Ateni with other antihypertensive agents.

Angina pectoris: 100 mg once daily or 50 mg twice daily. It is unlikely that additional benefit will be gained by

increasing the dose.

Cardiac arrhythmias: 50 mg-100 mg daily after having controlled the arrhythmias with intravenous atenolol.

Early and late intervention after myocardial infarction: Oral treatment with Ateni 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 infraction, treatment with Ateni should be initiated in hospital under close monitoring.

Discontinue atenolol if bradycardia and/or hypotension requiring treatment or any other untoward effects occur.

Ateni 100 mg daily is recommended for long-term prophylaxis of myocardial infraction.

Paediatric population

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

adolescents under 18 years of age.

Older people

The elderly may require reduced dosage, particularly when renal function is impaired.

Renal impairment

Atenolol is excreted via the kidneys and dosage should be adjusted as follows:

Glomerular Filtration Rate

> 35ml/min/1.73 m²

Normal dosage.

15 – 35 ml/min/1.73 m²

Oral dose should be 50mg daily.

< 15ml/min/1.73 m²

Oral dose should be 25mg daily or 50mg on alternate days.

Patients on haemodialysis should be given 50mg orally after each dialysis with close monitoring as marked falls in

blood pressure may occur.

Method of administration

For oral use.

4.3 Contraindications

As with other beta-blockers, Atenolol is contra-indicated in patients with the following:

hypersensitivity to the active substance or to any of the excipients listed in section 6.1

second or third degree heart block

cardiogenic shock

uncontrolled heart failure

sick sinus syndrome

hypotension

untreated phaeochromocytoma

severe peripheral circulatory disturbances

bradycardia (< 45 bpm)

metabolic acidosis

4.4 Special warnings and precautions for use

Special care should be taken with patients whose cardiac reserve is poor. Beta-adrenoceptor blockers should be avoided

in patients with uncontrolled heart failure (see section 4.3).

However, they may be used in patients whose signs of

failure have been controlled.

One of the pharmacological actions of atenolol is to reduce heart rate. In the rare instances when symptoms may be

attributable to the slow heart rate, and the pulse rate drops to less than 50-55 bpm at rest, the dose may be reduced.

Due to its negative effect on conduction time, caution must be exercised if given to patients with first degree heart

block.

Atenolol may mask the symptoms of hypoglycaemia, in particular tachycardia

In patients with phaeochromocytoma, a beta-blocker should only be given with an alpha-blocker.

Ateni 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.

Although contraindicated in severe peripheral circulatory disturbances (see section 4.3), beta-blockers should be used

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with great caution in patients with less severe peripheral circulatory disorders (e.g. Raynaud’s disease/syndrome,

intermittent claudication) as they may aggravate these disorders.

Atenolol 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.

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

For patients with a creatinine clearance of 35 ml/min/1.73m

and below, dosage should be reduced (see section 4.2).

Atenolol may cause a more serious 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.

Patients with known psoriasis should take beta-blockers only after careful consideration, as psoriasis may be

aggravated.

Atenolol may cause an increase in airways resistance in asthmatic patients, therefore utmost caution must be exercised.

If increase airways resistance dose occur, Ateni should be discontinued and bronchodilator therapy (e.g. salbutamol)

administered if necessary.

If a beta-blocker is withdrawn before surgery therapy, it should be discontinued for 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.

Atenolol may mask the signs of thyrotoxicosis.

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 antihypertensive 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 I)

Caution must be exercised when prescribing a beta-blocker with Class I antiarrhythmic agents such as disopyramide, or

with amiodarone, which may have a potentiating effect on atrial-conduction time and induce a negative inotropic effect

Calcium channel blockers

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

diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or

sinoatrial or atrioventricular 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.

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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. If

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

clonidine administration has stopped.

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.

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 (epinephrine), may counteract the effect of beta-blockers.

4.6 Fertility, pregnancy and lactation

Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeing.

Pregnancy

Atenolol crosses the placental barrier and appears in 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.

Breast-feeding

Atenolol is excreted in breast milk with accumulation occurring at concentrations significantly greater than

corresponding plasma levels. Nursing infants must be closely monitored for bradycardia and hypoglycaemia and other

signs and symptoms of beta-blockade if the mother is receiving atenolol, although breast feeding is not recommended.

4.7 Effects on ability to drive and use machines

Although symptoms such as dizziness and fatigue have occasionally been reported in association with the use of beta-

blockers, the ability to drive and use machines is usually unaffected by atenolol therapy.

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4.8 Undesirable effects

Atenolol tablets are well tolerated. In clinical studies, the undesired effects 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 (

1/10), common (

1/100 < 1/10), uncommon (

1/1,000,< 1/100), rare (

1/10,000, < 1/1,000), very rare

(<1/10,000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Rare:

Purpura, thrombocytopenia

Psychiatric disorders:

Uncommon:

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

Rare:

Mood changes, nightmares, confusion, psychoses and hallucinations

Nervous system disorders:

Rare:

Dizziness, headache, paraesthesia.

Eye disorders:

Rare:

Dry eyes, visual disturbances.

Cardiac disorders:

Common:

Bradycardia.

Rare:

Heart failure deterioration, precipitation of heart block.

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.

Respiratory, thoracic and mediastinal disorders:

Rare:

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

Gastrointestinal disorders:

Common:

Gastrointestinal disturbances.

Rare:

Dry mouth.

Hepatobiliary disorders:

Rare:

Hepatic toxicity including intrahepatic cholestasis.

Skin and subcutaneous tissue disorders:

Rare:

Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.

Not known:

Hypersensitivity reactions, including angioedema and urticaria

Musculoskeletal and connective tissue disorders

Not known:

Lupus-like syndrome

Reproductive system and breast disorders:

Rare:

Impotence.

General disorders and administration site conditions:

Common:

Fatigue.

Investigations:

Uncommon:

Elevations of transaminase levels.

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Very rare:

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

is not clear.

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

Symptoms

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

Treatment

Close supervision is required. Gastric emptying, activated charcoal and a laxative to prevent absorption of any drug still

present in the gastrointestinal tract. The use of plasma and plasma substitutes to treat hypotension and shock, and the

possible uses of haemoialysis 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/hour 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.

Symptomatic therapy

Haemodialysis could be used with severe poisoning, especially in patients with impaired renal function.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: beta-blocking agents, plain, selective; ATC Code: C07AB03.

Mechanism of action

Atenolol is a beta-blocker which has preferential effect on the beta

-receptors chiefly located in the heart

(cardioselective). This selectivity diminishes with increased dosage. Atenolol does not possess intrinsic

sympathomimetic activity or membrane stabilising activity. It has negative inotropic effects (and is therefore

contraindicated 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 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.

Clinical efficacy and safety

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

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Atenolol is effective for at least 24 hours after a single oral dose. The drug facilitates compliance by its acceptability to

patients and simplicity of dosing

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

5.2 Pharmacokinetic properties

Absorption

Atenolol is incompletely absorbed (40-50%) after oral administration with peak plasma concentrations occurring within

2-4 hours. 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 reaches the systemic circulation unaltered

Distribution

Atenolol penetrates tissues poorly due to its low lipid solubility. It exhibits low (approximately 3 %) plasma protein

binding.

Elimination

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.

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

Core

Calcium hydrogen phosphate (anhydrous)

Magnesium carbonate, heavy

Sodium starch glycolate (type A)

Maize starch

Colloidal anhydrous silica

Magnesium stearate

Film Coat

Opadry White Y-1-7000, consisting of the following:

Hypromellose

Titanium dioxide (E171)

Macrogol 400

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

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Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

Polypropylene pots with polyethylene child resistant cap with tamper evident seal - Pack sizes 28, 100, 250, 500 and

1000

PVdC/Aluminium foil blister packs - Pack sizes 7, 10, 14, 15 and 28

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA0405/019/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

April 1987

Date of last renewal:

April 2007

10 DATE OF REVISION OF THE TEXT

June 2016

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