Atenolol 2care4 100 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

24-04-2019

Produktens egenskaper Produktens egenskaper (SPC)

23-02-2016

Aktiva substanser:
atenolol
Tillgänglig från:
2care4 ApS,
ATC-kod:
C07AB03
INN (International namn):
atenolol
Dos:
100 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
atenolol 100 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; propylenglykol Hjälpämne
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 100 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
58714
Tillstånd datum:
2019-04-24

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

11-09-2020

Produktens egenskaper Produktens egenskaper - engelska

11-09-2020

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Package leaflet: Information for the user

Atenolol Actavis 25 mg film-coated tablets

Atenolol Actavis 50 mg film-coated tablets

Atenolol Actavis 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.

What is in this leaflet

What /…/ is and what it is used for

What you need to know before you take /…/

How to take /…/

Possible side effects

How to store /…/

Contents of the pack and other information

1.

What /…/ is and what it is used for

/…/ contains a medicine called atenolol. This belongs to a group of medicines called

beta-blockers. It works by making your heart beat more slowly and with less force.

/…/ is used to:

Treat high blood pressure (hypertension).

Treat certain types of uneven heart beats (arrhythmias).

Help prevent chest pain (angina).

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

2.

What you need to know before you use /…/

Do not take /…/

if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section

if you have ever had or currently have 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).

– collapse caused by severe heart problems (a condition called cardiogenic shock where the

heart is unable to pump enough blood to the body).

– certain disorder in your heart rhythm, called sick sinus syndrome.

– very slow heart beats (less than 45-50 beats per minute) or very uneven heart beats.

– very low blood pressure.

– very poor blood circulation in your arms and legs (which may cause your fingers and toes to

tingle or turn pale or blue).

if you have a tumour called phaeochromocytoma that is not being treated. This is usually near

your kidney and can cause high blood pressure.

if you have been told that you have higher than normal levels of acid in your blood (metabolic

acidosis).

if you use certain medicines containing floctafenine as active substance.

- if you are receiving intravenous injections of certain medicines containing verapamil or

diltiazem as active substances (used to treat heart conditions).

if you have severe asthma or other serious lung disorder (such as severe chronic obstructive

pulmonary disease).

Do not take /…/ if any of the above apply to you. If you are not sure, talk to your doctor

or pharmacist before taking /…/.

Warnings and precautions

Talk to your doctor or pharmacist before taking /…/ if:

you have asthma, wheezing or any other similar breathing problems. If you have ever had

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

you get allergic reactions, for example to insect stings, foods and other substances. Allergic

reactions can occur more quickly and be more intense. Atenolol can reduce the efficacy of

adrenaline (used to treat severe allergic reaction).

you have a type of chest pain (angina) called Prinzmetal's angina.

you have poor blood circulation in your arms and legs.

you have a mild heart rhythm disorder (first-degree heart block).

you have a heart problem such as narrowing of the arteries (ischaemic heart disease).

- you have a tendency to a slow pulse. Atenolol can make the pulse even slower. If your pulse

falls below 55 beats per minute your doctor will probably reduce the dose of atenolol.

you have diabetes. Your medicine may mask signs of low blood sugar level, such as fast

heartbeat and trembling.

you have psoriasis or if you have ever suffered from this skin disease.

you have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine

may hide the symptoms of thyrotoxicosis.

you have a tumour near the kidneys called pheochromocytoma that is being treated

you have problems with your kidneys. You may need to have some check-ups during your

treatment.

you are receiving a complete anaesthesia. Tell the anaesthetist that you are taking atenolol.

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

/…/.

Other medicines and /…/

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. This is because

/…/ can affect the way some other medicines work and some medicines can have an effect on /…/.

In particular, tell your doctor if you are taking any of the following medicines:

Floctafenine (used to treat pain and swelling) (see ‘Do not take /…/’ in this section).

Verapamil or diltiazem (used to treat heart conditions) (see ‘Do not take /…/’ in this section)

Clonidine (for high blood pressure or migraine). If you are taking clonidine and /…/ together,

do 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 about how to do it.

Nifedipine (for high blood pressure or chest pain).

Disopyramide, quinidine or amiodarone (for an uneven heart beat).

Digoxin (for heart problems).

Monoamine oxidase (MAO) inhibitors (used to treat depression)

Sultopride (used to treat mental problems)

Adrenaline, also known as epinephrine (a medicine that stimulates the heart).

Medicines to relieve pain and inflammation (e.g. ibuprofen, indometacin, aspirin or diclofenac).

Insulin or medicines that you take by mouth for diabetes.

Baclofen (a muscle relaxant).

Tricyclic antidepressants, barbiturates or phenothiazines (for depression and sleep disturbance).

Ampicillin (antibiotic to treat bacterial infections).

Lidocaine and procainamide (for heart problems)

Contrast liquids which are used for radiological examination.

Operations

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

/…/. This is because you can get low blood pressure (hypotension) if you are given certain

anaesthetics while you are taking /…/.

/…/ with food and drink

The intake of alcohol while using /…/ may lower your blood pressure.

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.

/…/ is not recommended during pregnancy or breast-feeding.

Driving and using machines

Your medicine 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.

If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines.

/…/ contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say

essentially ‘sodium-free’.

3.

How to take /…/

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 tablets to take each day and when to take them.

Read the label on the carton to remind you what the doctor said.

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 usual starting dose is 25 mg daily. The usual maintenance dose is 50 mg to 100 mg once daily.

Chest pain (angina)

The usual dose is 50 mg to 100 mg daily. The dose of 100 mg daily can be divided in two dosages.

Uneven heart beats (arrhythmias)

The usual dose is 50 mg to 100 mg once daily.

The early treatment of a heart attack (myocardial infarction)

The usual dose is 50 mg to 100 mg daily.

Elderly people

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

problems with your kidneys.

People with severe kidney problems

If you have severe kidney problems your doctor may decide to give you a lower dose.

Use in children and adolescents under 18 years of age

/…/ is not recommended for children or adolescents under 18 years of age

If you take more /.../ than you should

If you take more /.../ than prescribed by your doctor, talk to a doctor or go to a hospital straight away.

Take the medicine pack with you so that the tablets can be identified.

Symptoms of an overdose of /…/ may include:

a very slow heartbeat, very low blood pressure and shortness of breath.

If you forget to take /.../

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next

dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking /.../

Do not stop taking /.../ without talking to your doctor. In some cases, you may need to stop taking it

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.

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.

Other possible side effects:

Common (may affect up to 1 in 10 people)

Slow pulse rate

Cold hands and feet.

Symptoms of an upset stomach such as diarrhoea, feeling sick (nausea), throwing up (vomiting)

or constipation.

Feeling tired.

Uncommon (may affect up to 1 in 100 people)

Disturbed sleep.

Liver function problems seen as raised transaminase levels in blood tests.

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

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

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

disease).

Mood changes.

Nightmares.

Depression.

Feeling confused.

Changes in personality (psychoses) or hallucinations.

Headache.

Dizziness (particularly when standing up).

Feeling of tingling, pricking or numbness in skin (like ‘pins and needles’)

Being unable to get an erection (impotence).

Dry mouth.

Dry eyes.

Disturbances of vision.

Various skin reactions such as allergic skin rash, itching, hair loss and inflammation.

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 less than 1 in 10,000 people)

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

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

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

Atenolol may mask the symptoms of a condition called “thyrotoxicosis” (problems with your

thyroid gland).

Atenolol may mask the symptoms of low blood sugar levels (diabetes)

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.

Pain and cramps in legs causing limping when walking (intermittent claudication).

Poor circulation.

Reporting of side effects

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

any possible side effects not listed in this leaflet.

You can also report side effects directly via the

national reporting system listed in Appendix V. By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store /…/

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, bottle and blister after

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

This medicinal product does not require any special storage conditions.

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 /…/ contains

The active substance is atenolol. Each /…/ 25 mg film-coated tablet contains 25 mg atenolol.

Each /…/ 50 mg film-coated tablet contains 50 mg atenolol. Each /…/ 100 mg film-coated

tablet contains 100 mg atenolol.

The other ingredients are

Tablet core:

microcrystalline cellulose (E460), maize starch,

crospovidone Type A (E1202), calcium hydrogen phosphate dihydrate (E341), colloidal

anhydrous silica, magnesium stearate (E572), hydrogenated vegetable oil , sodium laurilsulfate;

Film-coat:

titanium dioxide (E171), hypromellose, propylene glycol (E1520), talc (E553b).

What /…/ looks like and contents of the pack

/…/ 25 mg: White, round, biconvex film-coated tablet scored and with AI engraved on one side.

/…/ 50 mg: White, round, biconvex film-coated tablet scored and with AH engraved on one side.

/…/ 100 mg: White, round, biconvex film-coated tablet scored and with AJ engraved on one side.

The tablet can be divided into equal halves.

Pack sizes:

Blisters (PVC/Al):

/…/ 25 mg film-coated tablets: 20, 30, 90 and 100 film-coated tablets

/…/ 50 mg film-coated tablets: 20, 30, 50, 90 and 100 film-coated tablets

/…/ 100 mg film-coated tablets: 20, 30, 42, 90 and 100 film-coated tablets

Tablet container (HDPE) with plastic screw cap (PP):

/…/ 25 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

/…/ 50 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Tablet container (HDPE) with plastic cap (HDPE):

/…/ 100 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Marketing Authorisation Holder

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

Manufacturer

Actavis UK Limited

Whiddon Valley, Barnstaple

EX32 8NS North Devon

United Kingdom

Balkanpharma – Dupnitsa AD

3, Samokovsko Shose Str.

2600 Dupnitsa

Bulgaria

PharmaPack International

B.V. Bleiswijkseweg 51

2712 PB Zoetermeer

The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following

names:

Iceland

Atenolol Actavis

Sweden

Atenolol Actavis

This leaflet was last revised in

{MM/YYYY}.

<[To be completed nationally]>

2020-09-10

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Atenolol Actavis 25 mg film-coated tablets

Atenolol Actavis 50 mg film-coated tablets

Atenolol Actavis 100 mg film-coated tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each /…/ 25 mg film-coated tablet contains 25 mg atenolol

Each /…/ 50 mg film-coated tablet contains 50 mg atenolol

Each /…/ 100 mg film-coated tablet contains 100 mg atenolol

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Film-coated tablet

/…/ 25 mg: White, round, biconvex film-coated tablet scored and with AI engraved on one side.

/…/ 50 mg: White, round, biconvex film-coated tablet scored and with AH engraved on one side.

/…/ 100 mg: White, round, biconvex film-coated tablet scored and with AJ engraved on one side.

The tablet can be divided into equal doses.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of:

Hypertension

Chronic stable angina pectoris

Supraventricular arrhythmias:

- paroxysmal supraventricular tachycardia (in therapeutic or prophylactic treatment)

- atrial fibrillation and atrial flutter: in case of inadequate response to maximum dosages of

cardiac glycosides; in cases where cardiac glycosides may be contraindicated or may be

associated with an unfavorable risk/benefit ratio

Ventricular arrhythmias:

- ventricular extrasystoles (prophylactic or therapeutic treatment), if the extrasystoles are the

result of increased sympathetic activity

- ventricular tachycardias and ventricular fibrillation (prophylactic treatment), especially when

the ventricular abnormality is the result of elevated sympathetic activity

Secondary prevention after acute myocardial infarction

4.2

Posology and method of administration

For oral administration.

Posology

The dosage should be determined on an individual basis. It is recommended to start with the lowest

possible dosage so that heart failure, bradycardia and bronchial symptoms are noticed timely. This is

especially important in elderly. Further adaptation should be done gradually (e.g., once a week) under

controlled conditions or based on the clinical effect.

Adults

Hypertension

A starting dose of 25 mg is recommended. The usual maintenance dosage in

hypertension is one tablet (50-100 mg) daily. The maximum effect will be reached after 1-2 weeks. If

further improvement of the bloodpressure is desired, atenolol may be combined with another anti-

hypertensive e.g., a diuretic.

Angina pectoris

: 50-100 mg daily, depending on the clinical effect, in order to obtain a heartbeat in

rest of 55-60 beats per minute. Increasing the dose above 100 mg daily does not generally lead to an

increased antianginous effect. If desired the dosage of 100 mg daily can be divided in two dosages.

Arrhythmias

: Initially controlled intravenously. A suitable oral maintenance dosage is 50-100 mg

daily, given as a single dose.

Secondary prevention after myocardial infarction

: Initially controlled intravenously, followed by

50 mg orally about 10 minutes after the intravenous dose provided no adverse effects occur. This

should be followed by a further 50 mg orally 12 hours later. Maintenance dose 100 mg daily in 1-2

dosages for 6 days or until discharge from hospital.

The Elderly

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

function. Dosage should be titrated according to clinical effect.

Children and adolescents under 18 years of age

: The use of atenolol is not recommended in children

or adolescents under 18 years of age.

Impaired renal function

: Atenolol is excreted via the kidneys, therefore the dosage will need to be

adjusted in severe renal conditions.

GFR (mL/min/1,73 m

2

BSA)

Recommended daily dose atenolol (mg/day)

>35

No dose adjustment necessary

15-35

25-50 (or 50-100 every second day)

<15

25-50 every second day

In haemodialysis a 50 mg tablet is administered after each dialysis. The administration should be done

in hospital since sudden decrease of the arterial pressure may occur.

Decreased hepatic function:

No dose adjustment is necessary.

4.3

Contraindications

Second or third degree heart block

Cardiogenic shock

Uncontrolled heart failure

Sick sinus syndrome (including sino-atrial block)

Untreated phaeochromocytoma

Metabolic acidosis

Bradycardia (less than 45-50 beats per minute)

Hypotension

Hypersensitivity to the active substance(s) or any of the excipients listed in section 6.1

Severe peripheral circulatory disturbances

Concomitant use of floctafenine

Concomitant intravenous use of verapamil or diltiazem

Severe asthma and severe chronic obstructive pulmonary disease such as airway obstructions

4.4

Special warnings and precautions for use

Ischaemic heart disease:

Especially in patients with ischaemic heart disease, treatment should not be

discontinued suddenly. The dosage should be gradually reduced, i.e. over 1-2 weeks, if necessary at

the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition,

hypertension and arrhythmias may develop. Furthermore, there is a risk of myocardial infarction and

sudden death.

Untreated congestive heart disease:

Atenolol should not be used in patients with untreated congestive

heart failure. The condition should be stabilised first.

Surgery:

When a patient is scheduled for surgery, and it has been decided to interrupt beta-blockade,

therapy should be discontinued for at least 24 hours. Continuation of beta-blockade reduces the risk of

arrhythmias during induction and intubation, however the risk of hypotension may be increased as

well.

If treatment is continued, caution should be observed with the use of certain anaesthetic drugs. The

patient may be protected against vagal reactions by intravenous administration of atropine.

Peripheral Circulatory Disease:

In patients with peripheral circulatory disorders (Raynaud’s disease

or syndrome, intermittent claudication), atenolol should be used with great caution as aggravation of

these disorders may occur. Severe peripheral circulatory disorders are a contra-indication (see section

4.3).

Heart rate disorders:

Atenolol may induce bradycardia. If the pulse rate decreases to less than 50-55

beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage

should be reduced.

Respiratory disorders:

In patients with chronic obstructive pulmonary disorders, airway obstructions

may be aggravated. Therefore, atenolol should only be used for these patients with the utmost care.

Heart block:

Due to its negative effect on conduction time, atenolol should only be given with caution

to patients with first degree heart block.

Renal impairment:

In patients with impaired renal function, the dose should be adjusted to reduced

glomerular filtration rate (see section 4.2).

Elderly:

The elderly should be treated with caution, starting with a lower dosage (see section 4.2).

Prinzmetal’s anginal:

Atenolol may increase the number and duration of anginal attacks in patients

with Prinzmetal’s angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction.

For these patients atenolol should only be used with the utmost care.

Psoriasis:

Patients with anamnestically known psoriasis should take atenolol only after careful

consideration.

Allergies:

Atenolol may increase both the sensitivity towards allergens and the seriousness of

anaphylactic reactions. Atenolol may reduce the efficacy of the usual dose of adrenaline (epinephrine)

used to treat allergic reactions.

Hypersensitivity:

Atenolol may cause a hypersensitivity reaction including angio-oedema and

urticaria (see section 4.8).

Hypoglycaemia:

The symptoms of hypoglycaemia may be masked by atenolol, in particular

tachycardia. Diabetic patients should be warned that this ‘warning sign’ may not occur. Insulin

sensitivity may be reduced in patients treated with atenolol.

Diabetic patients:

Treatment should be initiated with a glycaemia monitoring.

Thyrotoxicosis:

Beta-blockade may mask cardiovascular signs of thyrotoxicosis.

Treated phaeochromocytoma:

Atenolol should be used with blood pressure monitoring in patients

with treated pheochromocytoma.

Excipient(s):

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say

essentially ‘sodium-free’.

4.5

Interaction with other medicinal products and other forms of interaction

Combinations contra-indicated:

Floctafenine:

Beta-adrenergic blocking agents may impede the compensatory cardiovascular reactions associated

with hypotension or shock that may be induced by floctafenine.

Calcium antagonists of the verapamil or diltiazem type:

Negative influence on the contractility and AV-conduction.

Concomitant use not recommended:

Digitalis glycosides:

Association with atenolol may increase the atrioventricular conduction time and decrease heart rate.

Concomitant use can increase the risk of bradycardia.

Monoamineoxidase inhibitors

(except MAO-B inhibitors)

Clonidine:

Beta-blockers increase the risk of rebound hypertension. 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.

Sultopride:

Atenolol should not be concomitantly administered with sultopride since there is an increased risk of

ventricular arrhythmias, e.g. torsades de pointes.

Use with caution:

Class I anti-arrhythmic drugs (e.g. disopyramide, quinidine) and amiodaron

May have potentiating effect on atrial-conduction time and induce a negative inotropic effect.

Insulin and oral antidiabetic drugs:

May intensify the blood sugar lowering effects of these drugs (especially non-selective beta-blockers).

Beta-adrenergic blockade may prevent the appearance of signs of hypoglycaemia (tachycardia).

Anaesthetic drugs:

Attenuation of the reflex tachycardia and increase the risk of hypotension.

Continuation of beta-blockades reduces the risk of arrhythmia during induction and intubation. The

anaesthesiologist should be informed when the patient is receiving a beta-blocking agent.

Anaesthetic agents causing myocardial depression, such as cyclopropane and trichlorethylene,

lidocaine, procainamide and beta-adrenoceptor stimulants such as noradrenaline (norepinephrine) are

best avoided.

Baclofen:

Causes an increased antihypertensive activity.

Contrast media, iodinated:

Atenolol may impede the compensatory cardiovascular reactions associated with hypotension or

shock induced by iodated contrast products.

Amiodaron:

Combination with atenolol may result in additive depressant effects on conduction and negative

inotropic effects, especially in patients with underlying sinus node dysfunction or atrioventricular

node dysfunction.

Take into account:

Calcium antagonists; dihydropyridine derivates such as nifedipine:

The risk of hypotension may be increased. In patients with latent cardiac insufficiency, treatment with

atenolol may lead to cardiac failure.

Prostaglandin synthetase inhibiting drugs (like NSAID’s):

May decrease the hypotensive effects of atenolol.

Sympathicomimetic agents (e.g. adrenaline (epinephrine)):

May counteract the effect of atenolol.

Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines as well as

other antihypertensive agents

May increase the bloodpressure lowering effect and/or risk of bradycardia.

Ampicillin:

May reduce the bioavailability of atenolol. Therefore the physician should watch for evidence of

altered atenolol response especially when large doses of ampicillin are administered concomitantly

4.6

Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of atenolol in pregnant women to determine its potential

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

Animal studies showed no teratogenicity or foetotoxic effects after systemic administration in the

therapeutic dose range.

Administration of atenolol in pregnancy has been associated with reduced foetal growth.

On the basis of its pharmacological properties, adverse effects may occur in the foetus and newborn

infant, if used in the second and third trimesters (especially hypoglycaemia, hypotension and

bradycardia). Beta-blockers reduce placental perfusion. Because of lack of experience, administration

of atenolol during pregnancy is not recommended.

Breastfeeding

Atenolol is secreted into breast milk reaching higher concentration than in plasma. A

risk on the suckling child cannot be excluded (beta-blockade). Therefore, breastfeeding should be

discontinued during treatment with atenolol.

4.7

Effects on ability to drive and use machines

There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or

operating machines it should be taken into account that occasionally dizziness or fatigue may occur.

4.8

Undesirable effects

The following undesirable effects have been observed during treatment with atenolol with the

following frequencies:

Very common (

1/10)

Common (

1/100 to <1/10)

Uncommon (

1/1,000 to <1/100)

Rare (

1/10,000 to <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.

Endocrine disorders:

Not known: Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia

.

Psychiatric disorders

Uncommon: Sleep disturbances.

Rare: Mood changes, nightmares, depression, 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, Raynaud's phenomenon (in susceptible patients).

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.

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. In all cases cessation of therapy should

be gradual.

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 the national reporting system

listed in Appendix V.

4.9

Overdose

Symptoms

The most important effects are on the heart. Bradycardia, hypotension, pulmonary oedema, syncope

and cardiogenic shock may develop. First or second degree AV block may occur and rarely

arrhythmias.

Treatment

After ingestion of an overdose or in the case of hypersensitivity, the patient should be kept under

close supervision and treated in an intensive care ward.

Activated charcoal and a laxative should be used to prevent absorption of any drug still present in the

gastrointestinal tract (within one hour). Plasma or plasma substitutes can be used to treat hypotension

or shock. The use of haemodialysis or haemoperfusion may be considered.

Excessive bradycardia can be treated 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 and 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-blocker 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

Pharmacotherapeutic group: Beta blocking agents, selective

ATC code: CO7A B03

Atenolol is a beta-adrenoceptor blocking agent which is cardioselective, its principal action being on

beta-adrenergic receptors in the heart. It is without intrinsic sympathomimetic and membrane

stabilising activities and as with other beta-blockers, has negative inotropic effects (and is therefore

contraindicated in uncontrolled heart failure). Its mode of action 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.

Atenolol is effective and well-tolerated in most ethnic populations. However the response may be

less in black patients.

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. The narrow dose range and early patient

response ensure that the effect of the drug in individual patients is quickly demonstrated. Atenolol is

compatible with diuretics, other hypotensive agents and antianginals (see section 4.5). Since it acts

preferentially on beta-receptors in the heart, atenolol may, with care, be used successfully in the

treatment of patients with respiratory disease, who cannot tolerate non-selective beta-blockers.

Human studies have shown that a negligible amount of atenolol crosses the blood brain barrier. Early

intervention in acute myocardial infarction reduces infarct size and may decrease morbidity and

mortality. Fewer patients with a threatened infarction progress to frank infarction; the incidence of

ventricular arrhythmias is decreased and marked pain relief may result in reduced need of opiate

analgesics. Early mortality is decreased. Atenolol is an additional treatment to standard coronary care.

5.2

Pharmacokinetic properties

Absorption:

The oral bioavailability is about 50 to 60%. The bioavailability is decreased by 20%

when taken with food. Peak plasma concentrations are found 2-4 hours after repeated oral

administration. There is a linear relationship between dosage and plasma concentration. The inter-

subject variability in AUC and C

is about 30-40%.

Distribution:

The volume of distribution is 50 to 75 L. Only small amounts are reported to cross the

blood-brain barrier and plasma-protein binding is minimal (less than 5%).

(Women: it crosses the placenta and is distributed into breast milk where concentrations higher than

those in maternal plasma have been achieved).

Metabolism:

Atenolol undergoes little or no hepatic metabolism.

Elimination:

Most of an absorbed dose (85-100%) is excreted unchanged via the urine. The clearance

is about 6 L/h and the half-life is about 6 to 9 hours. In elderly patients, clearance is decreased and

elimination half-life increased. The clearance is correlated to renal function and the elimination is

prolonged in patients with renal impairment. Impaired liver function does not influence the

pharmacokinetics of atenolol.

5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already

included in other sections.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core

Cellulose, microcrystalline Type 101 (E460)

Maize starch

Crospovidone Type A (E1202)

Calcium hydrogen phosphate dehydrate (E341)

Colloidal anhydrous silica

Magnesium stearate (E572)

Hydrogenated vegetable oil

Sodium laurilsulfate

Film-coat

Titanium dioxide (E171)

Hypromellose 5cP

Propylene glycol (E1520)

Talc (E553b)

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container

Blister pack (PVC /Aluminium) with push-through foil.

Tablet container (HDPE) with plastic cap (HDPE) or plastic screw cap (PP).

Pack sizes:

Blisters (PVC/Al):

/…/ 25 mg film-coated tablets: 20, 30, 90 and 100 film-coated tablets

/…/ 50 mg film-coated tablets: 20, 30, 50, 90 and 100 film-coated tablets

/…/ 100 mg film-coated tablets: 20, 30, 42, 90 and 100 film-coated tablets

Tablet container (HDPE) with plastic screw cap (PP):

/…/ 25 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

/…/ 50 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Tablet container (HDPE) with plastic cap (HDPE):

/…/ 100 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

8.

MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}>

<Date of latest renewal: {DD month YYYY}>

<[To be completed nationally]>

10.

DATE OF REVISION OF THE TEXT

<{MM/YYYY}>

<{DD/MM/YYYY}>

<{DD month YYYY}>

<[To be completed nationally]>

2020-09-10

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