NORMITEN 100

Israel - English - Ministry of Health

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Active ingredient:
ATENOLOL
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
C07AB03
Pharmaceutical form:
TABLETS
Composition:
ATENOLOL 100 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
ATENOLOL
Therapeutic area:
ATENOLOL
Therapeutic indications:
Management of angina pectoris and hypertension,including hypertension of renal origin. Late intervention after acute myocardial infarction.
Authorization number:
045 35 24916 00
Authorization date:
2010-04-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

19-12-2016

Patient Information leaflet Patient Information leaflet - Hebrew

15-12-2016

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

Normiten

®

25 mg

Tablets

Composition

Each tablet contains atenolol as follows:

Atenolol 25 mg

Normiten

®

50 mg

Tablets

Composition

Each tablet contains atenolol as follows:

Atenolol 50 mg

Normiten

®

100 mg

Tablets

Composition

Each tablet contains atenolol as follows:

Atenolol 100 mg

For the list of inactive ingredients in the

preparation, see section 6 – “Further

Information”.

Read this leaflet carefully in its entirety

before using the medicine. This leaflet

contains concise information about the

medicine. If you have further questions, refer

to the doctor or pharmacist.

This medicine has been prescribed for the

treatment of your ailment. Do not pass it

on to others. It may harm them even if it

seems to you that their medical condition

is similar.

This medicine is not intended for use in

children.

1. WHAT IS THE MEDICINE INTENDED

FOR?

A preparation from the beta-adrenergic receptor

blocker group (beta blockers), for the treatment

of angina pectoris, acute myocardial infarction

(after a heart attack) and hypertension.

Therapeutic group

Selective beta 1 receptor blocker.

2. BEFORE USING THE MEDICINE

Do not use Normiten if:

∙ you are sensitive (allergic) to atenolol

or any of the other ingredients of the

medicine (see section 6).

∙ you have suffered in the past from heart

problems, especially uncontrollable heart

failure (which usually causes shortness

of breath and swelling of the ankles),

second- or third-degree heart block (a

condition which can be treated by a

pacemaker), very slow or irregular heart

beats/rate, very low blood pressure or

severe disturbances in blood circulation.

∙ you are suffering from cardiogenic shock,

manifested by a significant reduction

in blood pressure, pallor, restlessness,

fast and weak heartbeat, clammy skin,

stupor.

∙ you have low blood pressure.

∙ you are being treated with intravenous

verapamil or diltiazem.

∙ you have pheochromocytoma (high

blood pressure caused by a tumor

usually located near the kidney) that is

not being treated. If you are being treated

for pheochromocytoma, the doctor will

give you another medicine, called an alpha

blocker, to take in addition to Normiten.

∙ you have metabolic acidosis (higher than

normal levels of blood acidity).

∙ you have severe blood circulation

disturbances in the peripheral arteries.

∙ you have severe asthma or severe

pulmonary disease (e.g., severe and

chronic obstructive pulmonary diseases).

This preparation is not intended for

children.

Special warnings regarding use of the

medicine

Before starting treatment, tell the doctor

if you are suffering, or have suffered in the

past, from the following health problems:

∙ asthma, wheezing, other similar respiratory

problems, or allergic reactions, for example,

to insect stings. If you have suffered in the

past from asthma or wheezing, do not take

this medicine unless you have checked these

effects with the doctor who prescribed this

medicine for you.

∙ a type of chest pain called Prinzmetal’s

angina.

∙ impaired blood circulation, which can

manifest by a sense of cold in the fingers or

toes, pain, cramp or numbness/tiredness in

the legs while walking – these conditions

may worsen with use of this medicine.

∙ heart failure of first-degree heart block,

ischemic heart disease, or impaired heart

function.

∙ diabetes – Normiten may change your usual

reaction to a decrease in blood sugar level.

You may feel an increase in heart beats/

rate.

∙ thyrotoxicosis (a disease caused by an

overactive thyroid gland). Normiten may

mask the symptoms of thyrotoxicosis,

such as rapid heartbeat, tremor or excessive

sweating.

∙ kidney problems. In this case, you may need

to undergo certain tests during the course of

treatment.

∙ slow heart beats/rate (50-55 beats per

minute at rest).

∙ you are elderly (over 65 years old) – dosage

adjustment should be considered.

∙ you have psoriasis.

∙ allergic reactions. Normiten may increase

them; use of adrenaline may not be effective

in treating these allergic reactions.

If you are not sure, consult the doctor or

pharmacist if you suffer from any of the

aforementioned effects.

Additional warnings

If you go to a hospital or are due to undergo

surgery, inform the anesthesiologist and

medical staff that you are taking this

medicine, since administration of anesthetics

in combination with Normiten may cause a

drop in blood pressure.

If you are uncertain, consult the doctor or

pharmacist.

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements, tell

the doctor or pharmacist. In particular, inform

the doctor of pharmacist if you are taking:

∙ Clonidine (to treat hypertension or migraine).

If you are taking clonidine with Normiten, do

not stop taking clonidine or Normiten before

receiving instructions from the doctor.

∙ Calcium channel blockers such as verapamil,

nifedipine or diltiazem (used to treat

hypertension or chest pain). Consult with

the doctor or pharmacist if you are taking

these medicines.

∙ Disopyramide, quinidine or amiodarone (for

heart rate disturbances).

∙ Digoxin (for heart failure).

∙ Adrenaline (also known as epinephrine, that

stimulates heart activity).

∙ Ibuprofen and indomethacin (for pain and

inflammation).

∙ Insulin

oral

medicines

treat

diabetes.

∙ Nasal decongestants or other cold medicines

(including non-prescription medicines you

can buy at a pharmacy). If you are taking

other medicines, including medicines which

you purchased in a pharmacy and herbal

medicines, inform the doctor.

∙ Alpha blockers such as prazosin, terazosin,

alfuzosin (to lower blood pressure or treat

Raynaud’s disease).

Tricyclic antidepressants (e.g., amitryptyline

∙ Isoprenaline or dobutamine (to dilate blood

vessels).

∙ Barbiturates (to treat insomnia, epilepsy or

as anesthetics, e.g., phenobarbital).

∙ Phenothiazines (e.g., chlorpromazine, to

treat mental illnesses).

Use

of

the

medicine

and

alcohol

consumption

Abstain from or minimize alcohol consumption

when taking this medicine, as your blood

pressure may drop markedly as a result of the

combination.

Pregnancy and breastfeeding

Consult a doctor before using this medicine

if you are pregnant, considering becoming

pregnant, or are breastfeeding.

Breastfeeding during the course of treatment

with this medicine is not recommended.

Use in children

This medicine is not intended for use in

children.

Driving and use of machinery

This medicine may cause dizziness, tiredness,

vision disturbances. If these effects occur, do

not drive or use machines.

3. HOW

SHOULD

yOU

USE

THE

MEDICINE?

Always use this medicine according to the

doctor’s instructions. Check with the doctor

or pharmacist if you are uncertain.

The dosage and treatment regimen will be

determined by the doctor only.

Do not exceed the recommended dose.

This medicine is not intended for use in

children.

Try to take the tablet at the same time each

day.

It is very important not to skip any dose,

especially when the dosage is once a day.

Use this medicine at specified time intervals,

as determined by the attending doctor.

Do not chew or crush!

Normiten 100 mg: Do not halve.

Normiten 25 mg and 50 mg: can be halved

on the score line.

Swallow the tablets whole with water.

Tests and follow-up

If you have kidney problems, you may need

to undergo certain tests during the course of

treatment.

If you took an overdose of the medicine, or if

a child swallowed the medicine, immediately

refer to a doctor or proceed to a hospital

emergency room and bring the package of

the medicine.

Overdose effects: reduced heartbeat and

blood pressure, irregular heart rate, sensation

of pressure in the chest due to contraction of

the airway muscles and difficulty breathing,

impaired heart function and shock, or

sometimes fainting.

If you forgot to take this medicine

If you forgot to take this medicine at the

scheduled time, do not take a double dose.

Take the next dose at the usual time and

consult the doctor.

Do not take two doses together! If you took,

consult a doctor or pharmacist.

Adhere to the treatment as recommended by

the doctor. Even if there is an improvement in

your health, do not stop treatment with this

medicine without first consulting the doctor

or pharmacist.

If you stop taking the medicine

Do not stop taking this medicine before

consulting the doctor. In some cases,

discontinuation of treatment will be performed

gradually over 7-14 days, with monitoring.

How can you contribute to the success of

this treatment?

Do not take medicines in the dark! Check

the label and the dose each time you take a

medicine. Wear glasses if you need them.

If you have further questions regarding

use of the medicine, consult a doctor or

pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Normiten may

cause side effects in some users. Do not be

alarmed by the list of side effects. You may not

suffer from any of them.

Stop the treatment and refer to a doctor

immediately if you experience any of the

following side effects:

∙ Occurrence of allergic reactions (signs

include: lumps on the skin, swelling of the

face, lips, mouth, tongue or throat).

∙ Irregular heartbeat, dizziness, tiredness or

fainting – may be signs of heart block.

∙ When taking this preparation, you may

experience a slowed heart rate; this is a

normal effect, but if you are concerned, refer

to a doctor.

∙ Shortness of breath or swelling of the

ankles – may be signs of heart failure or its

exacerbation.

Additional side effects that may occur

Common side effects (affect up to 1 in 10

patients)

∙ When taking the preparation, you may

experience a slowed heartbeat; this is a

normal effect, but if you are concerned, refer

to a doctor.

∙ Cold hands and feet.

∙ Diarrhea.

∙ Nausea.

∙ Abdominal pain.

∙ Heartburn.

∙ Digestion problems.

∙ Constipation.

∙ Tiredness and muscle aches.

Uncommon side effects (affect up to 1 in

100 patients)

∙ Sleep disturbances, such as insomnia.

∙ Increased liver enzyme levels.

Rare side effects (affect up to 1 in 1,000

patients)

∙ Heart block (manifested by dizziness,

irregular heartbeat, tiredness or fainting).

∙ Numbness and cramps in the fingers,

accompanied

cold

sensation,

blue discoloration and pain (Raynaud’s

disease).

∙ Mood changes.

∙ Depression.

∙ Nightmares.

∙ Confusion, anxiety or fear.

∙ Changes in personality (psychoses – mental

disorders) or hallucinations.

∙ Headache.

∙ Dizziness.

∙ Tingling in the hands and feet.

∙ Impotence.

∙ Dry mouth.

∙ Dry eyes.

∙ Vision disturbances.

∙ Hair loss.

∙ Skin rash.

∙ Worsening of psoriasis or psoriasis-like skin

reaction.

∙ Tendency to bruise more easily (due to

reduced numbers of platelets in the blood).

∙ Jaundice (manifested by yellowing of the

skin or the whites of the eyes).

∙ Very low blood pressure when standing

∙ Insomnia.

∙ Worsening of heart failure.

∙ Constriction of the airways in asthma patients

or in patients with a history of asthma.

Very rare side effects (affect up to 1 in 10,000

patients)

∙ Changes to some blood components and

cells. The doctor may refer you for blood

tests, at his discretion, to check whether

Normiten has any effect on your blood

system.

Side effects of unknown frequency

∙ Lupus-like condition (a disease where the

immune system produces antibodies that

attack mainly skin and joints).

∙ Allergic reactions, including urticaria and

angioedema.

Conditions which may worsen

If you have any of the following problems,

they may worsen at the beginning of Normiten

treatment (rare: affect less than 1 in 1,000

people)

∙ Psoriasis (a skin disease)

∙ Shortness of breath, swelling of the ankles

(in patients with heart failure).

∙ Asthma or breathing problems.

∙ Blood circulation disturbances.

∙ Cramping which causes limping.

If a side effect occurs, if any of the side

effects worsen, or if you are suffering from

a side effect not mentioned in the leaflet,

consult the doctor.

Side effects can be reported to the Ministry

of Health by clicking on the link “Report

Side Effects of Drug Treatment” found

Ministry

Health

homepage

(www.health.gov.il) that directs you to the

online form for reporting side effects, or by

entering the link:

https://forms.gov.il/globaldata/getsequence/

getsequence.aspx?formType=AdversEffectMe

dic@moh.gov.il

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine, and any other

medicine, should be kept in a safe place out

of the reach of children and/or infants in order

to avoid poisoning. Do not induce vomiting

without explicit instruction from the doctor.

Do not use the medicine after the expiry date

that appears on the package. The expiry date

refers to the last day of that month.

Store in a dry and dark place, below 25ºC.

Do not discard medicines in the wastewater or

waste bin. Ask the pharmacist how to dispose

of medicines no longer in use. These measures

will help protect the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Magnesium

carbonate

heavy,

starch,

magnesium stearate, sodium lauryl sulphate,

gelatin.

The sodium content per tablet:

Normiten 25 mg:

0.13 mg

Normiten 50 mg:

0.26 mg

Normiten 100 mg: 0.52 mg

What the medicine looks like and the

contents of the package

Normiten 25 mg: an octagonal, white to

off-white tablet, with “Abic” debossed on one

side and “25” with a score line on the other

side.

Normiten 50 mg: an octagonal, white to

off-white tablet, with “Abic” debossed on one

side and “50” with a score line on the other

side.

Normiten 100 mg: an octagonal, white to

off-white tablet, with “Abic” debossed on one

side and “100” on the other side.

License holder

Abic Ltd., P.O.B. 8077, Netanya

Manufacturer and address

Manufactured by Teva Pharmaceutical

Industries Ltd., P.O.B. 3190, Petach Tikva

This leaflet was checked and approved by the

Ministry of Health in March 2016.

Registration numbers of the medicine in

the National Drug Registry of the Ministry

of Health:

Normiten 25 mg:

104.02.28834

Normiten 50 mg:

051.72.24149

Normiten 100 mg: 045.35.24916

This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked approved on March 2016

1. Name of the medicinal product

Normiten 25, 50, 100

2. Qualitative and quantitative composition

Atenolol 25, 50, 100 mg.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablets.

4. Clinical particulars

4.1 Therapeutic indications

Normiten is indicated in the treatment of:

Hypertension.

Angina pectoris.

Myocardial infarction.

4.2 Posology and method of administration

Posology

The dose must always be adjusted to individual requirements of the patients, with the lowest

possible starting dosage.

The following are guidelines:

Adults

Hypertension

Initially 25-50 mg once a day, the dosage being increased gradually to 100 mg a day

after two weeks, as needed and tolerated.

Angina

Initially 50 mg once a day, the dosage being increased gradually to 100 mg after

1 week, as needed and tolerated.

Myocardial infarction

For patients who present some days after suffering an acute myocardial infarction, an

oral dose of Normiten 100 mg daily is recommended for long-term prophylaxis of

myocardial infarction

Older population

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

Paediatric population

There is no paediatric experience with Atenolol and for this reason Normiten is not recommended

for use in children.

Renal failure

Since Atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe

impairment of renal function.

No significant accumulation of Atenolol occurs in patients who have a creatinine clearance greater

than 35 ml/min/1.73 m

(normal range is 100–150 ml/min/1.73 m

For patients with a creatinine clearance of 15–35 ml/min/1.73 m

(equivalent to serum creatinine of

300–600 micromol/litre), the oral dose should be 50 mg daily.

For patients with a creatinine clearance of less than 15 ml/min/1.73 m

(equivalent to serum

creatinine of greater than 600 micromol/litre), the oral dose should be 25 mg daily or 50 mg on

alternate days.

Patients on haemodialysis should be given 50 mg orally after each dialysis; this should be done

under hospital supervision as marked falls in blood pressure can occur.

Method of administration

For administration by the oral route.

4.3 Contraindication

Normiten, as with other beta blockers, should not be used in patients with any of the following:

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

cardiogenic shock

uncontrolled heart failure

sick sinus syndrome

second or third degree heart block

untreated phaeochromocytoma

metabolic acidosis

bradycardia (<45 bpm)

hypotension

severe peripheral arterial circulatory disturbances.

4.4 Special warnings and precautions for use

Normiten 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 contraindicated in uncontrolled heart failure (see section 4.3), may be used in patients

whose signs of heart failure have been controlled. Caution must be exercised 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. Normiten 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.

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 should 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.

Should be used with caution in the elderly, starting with a lesser dose (see Section 4.2).

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

clearance of below 35 ml/min/1.73 m

Although cardio selective (beta

) beta blockers may have less effect on lung function than

nonselective beta blockers, as with all beta blockers, these should be avoided in patients with

reversible obstructive airways disease, unless there are compelling clinical reasons for their use.

Where such reasons exist, Normiten may be used with caution.

Occasionally, some increase in airways resistance may occur in asthmatic patients however, and

this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or

isoprenaline. The label and patient information leaflet for this product state the following warning:

“If you have ever had asthma or wheezing, you should not take this medicine unless you have

discussed these symptoms with the prescribing doctor”.

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

given concomitantly.

4.5 Interaction with other medicinal products and other forms of interaction

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

verapamil and 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.

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

and cardiac failure may occur in patients with latent cardiac insufficiency.

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

time.

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. (See

also prescribing information for clonidine.)

Class I antiarrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect

on atrialconduction time and induce negative inotropic effect.

Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the

effect of beta blockers.

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).

Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen and indometacin,

may decrease the hypotensive effects of beta blockers.

Caution must be exercised when using anaesthetic agents with Normiten. 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.

Alpha blockers – some patients experience acute postural hypotension, tachycardia and

palpitations when they start to take certain alpha blockers (e.g. prazosin, alfuzosin, and

terazosin), this can be exacerbated if they are already taking a beta-blocker. It is

recommended that they should start with a low dose of these alpha blockers, and the first

dose should be taken just before they go to bed. Patients should be warned about the

possibility of postural hypotension and how to manage it (lay down, raise legs and get up

slowly). When adding a beta-blocker to an alpha blocker it may be advisable to decrease the

dose of the alpha blocker and re-titrate as necessary.

Concomitant use with antihypertensive agents as well as other drugs with blood pressure

lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase

the risk of hypotension.

4.6 Fertility, pregnancy and lactation

Caution should be exercised when Normiten is administered during pregnancy or to a woman who

is breastfeeding.

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 intrauterine growth retardation.

The use of Normiten 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, since

beta blockers, in general, have been associated with a decrease in placental perfusion which may

result in intrauterine deaths, immature and premature deliveries.

Breastfeeding

There is significant accumulation of Atenolol in breast milk.

Neonates born to mothers who are receiving Atenolol at parturition or breastfeeding may be at risk

of hypoglycaemia

and bradycardia.

4.7 Effects on ability to drive and use machines

Atenolol has no or negligible influence on the ability to drive and use machines. 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 its pharmacological actions.

The following undesired events, listed by body system, have been reported 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) including isolated reports, not known (cannot

be estimated from the available data).

System Organ Class

Frequency

Undesirable Effect

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

Uncommon

Elevations of transaminase levels

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

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 wellbeing

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.

Any suspected adverse events should be reported to the Ministry of Health according

to the National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffec

tMedic@moh.gov.il

4.9 Overdose

The symptoms of over dosage 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/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, plain, selective, ATC code: CO7A B03.

Mechanism of action

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 sympathomimetic and membrane stabilising activities and as with other

betablockers, has negative inotropic effects (and is therefore contraindicated in uncontrolled heart

failure).

As with other betablockers, 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.

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. Normiten

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

acts preferentially on beta receptors in the heart, Normiten may, with care, be used successfully in

the treatment of patients with respiratory disease, who cannot tolerate nonselective beta blockers.

Early intervention with Atenolol in acute myocardial infarction reduces infarct size and decreases

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

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 reaches the systemic circulation unaltered.

Distribution

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%).

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 Prescribing Information.

6. Pharmaceutical particulars

6.1 List of excipients

Magnesium carbonate heavy

Starch

Magnesium stearate

Sodium lauryl sulphate

Gelatin.

Sodium content per tablet:

Normiten 25 mg: 0.13 mg; Normiten 50 mg: 0.26 mg; Normiten 100 mg: 0.52 mg

6.2 Incompatibilities

Not applicable

6.4 Special precautions for storage

Store in a cool, dark place below

7. Marketing authorisation holder

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL Ltd

P.O.Box 3190, Petah -Tikva,

הרמחה לע העדוה

(

תוחיטב עדימ

)

אפורל ןולעב

ןכדועמ(

.102.50

ךיראת

:

.03..30.60

Normiten 100

:תילגנאב רישכת םש רפסמ

:םושירה

/01

00

045 35 24916

Normiten 50

:תילגנאב רישכת םש רפסמ

:םושירה

/01

051 72 24149 00

Normiten 25

שכת םש :תילגנאב רי

רפסמ

:םושירה

/01

00

104 02 28834

םש םושירה לעב

:

Ltd

Abic

ה טורפל דעוימ הז ספוט דבלב תורמחה

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Indication

Management of angina pectoris.

Management of hypertension including

hypertension of renal origin.

iii. Late

Intervention

after

acute

myocardial infarction..

Normiten is indicated in the treatment of:

Hypertension.

Angina pectoris.

Myocardial infarction.

Posology and

Method of

Administration

Angina Pectoris

Initially 50 mg once a day, the

dosage being increased

gradually to 100 mg after

1 week, as needed and

tolerated.

Hypertension

Initially 25-50 mg once a day,

the dosage being increased

gradually to 100 mg a day after

two weeks, as needed and

tolerated.

Late Intervention after Acute

Myocardial Infarction

For patients who present some

days after suffering an acute

myocardial infarction, an oral

dose of Normiten 100 mg daily

is recommended for long-term

prophylaxis of myocardial

infarction.

Angina

Most patients with angina pectoris will respond to 100

mg given orally once daily or 50 mg given twice daily.

It is unlikely that additional benefit will be gained by

increasing the dose.

Hypertension

One tablet daily. Most patients respond to 100 mg

daily given orally as a single dose. Some patients,

however, will respond to 50 mg given as a single daily

dose. The effect will be fully established after one to

two weeks. A further reduction in blood pressure may

be achieved by combining Normiten with other

antihypertensive agents. For example co

administration of

Normiten with a diuretic, provides a highly effective

and convenient antihypertensive therapy.

Myocardial infarction

For patients suitable for treatment with intravenous

beta blockade and presenting within 12 hours of

the onset of chest pain, Atenolol 5–10 mg should

be given by slow intravenous injection (1

mg/minute) followed by Normiten 50 mg orally

about 15 minutes later, provided no untoward

effects have occurred from the intravenous dose.

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

This should be followed by a further 50 mg orally

12 hours after the intravenous dose, and then 12

hours later by 100 mg orally, once daily. If

bradycardia and/or hypotension requiring

treatment, or any other untoward effects occur,

Normiten should be discontinued

Renal Failure

For patients with a creatinine clearance of

15-35 ml/min/1.73m2 (equivalent to serum

creatinine of 300-600 micromol/litre) the

oral dose should be 50 mg daily, or 100

mg once every 2 days.

For patients with a creatinine clearance of

less than 15 ml/min/1.73m2 (equivalent to

serum creatinine of more than 600

micromol/litre) the oral dose should be 25

mg daily, or 50 mg on alternate days, or

100 mg every 4 days.

For patients with a creatinine clearance of 15–35

ml/min/1.73 m2 (equivalent to serum creatinine of

300–600 micromol/litre), the oral dose should be 50

mg daily and the intravenous dose should be 10 mg

once every two days.

For patients with a creatinine clearance of less than 15

ml/min/1.73 m

(equivalent to serum creatinine of

greater than 600 micromol/litre), the oral dose should

be 25 mg daily or 50 mg on alternate days and the

intravenous dose should be 10 mg once every four

days.

Contraindication

cardiogenic shock;

uncontrolled heart failure;

sick sinus syndrome;

second or third degree heart block;

untreated phaeochromocytoma;

metabolic acidosis;

bradycardia (<45bpm);

hypotension;

known hypersensitivity to the active

substance, or any of the excipients;

severe peripheral arterial circulatory

disturbances.

severe asthma and severe chronic

obstructive

pulmonary

disorders,

such as airway obstructions

intravenous

application

calcium channel blockers (verapamil

/ diltiazem type) is contraindicated in

patients who use atenolol (except in

intensive care unit)

Hypotension:

Patients

dependent

sympathetic

stimulation to maintain adequate cardiac

output

blood

pressure,

such

patients with hypotension in the setting of

myocardial infarction, may not benefit from

-adrenergic

blockade;

studies

adrenergic blockade in the treatment of

myocardial

infarction

excluded

patients

with systolic pressures less than 100 mm

Normiten, as with other beta blockers, should not be

used in patients with any of the following:

hypersensitivity to the active substance, or to any of

the excipients listed in section 6.1

cardiogenic shock

uncontrolled heart failure

sick sinus syndrome

second or third degree heart block

untreated phaeochromocytoma

metabolic acidosis

bradycardia (<45 bpm)

hypotension

severe peripheral arterial circulatory disturbances

severe asthma and severe chronic obstructive

pulmonary

disorders,

such

airway

obstructions

The intravenous application of calcium channel

blockers

(verapamil

diltiazem

type)

contraindicated

patients

atenolol

(except in intensive care unit)

Hypotension:

Patients

dependent

sympathetic

stimulation to maintain adequate cardiac

output

blood

pressure,

such

patients with hypotension in the setting of

myocardial infarction, may not benefit from

-adrenergic

blockade;

studies

adrenergic blockade in the treatment of

myocardial

infarction

excluded

patients

with systolic pressures less than 100 mm

Special warnings

precautions

for use

should not be withdrawn abruptly. The

dosage should be withdrawn gradually

over a period of 7-14 days, to facilitate a

Should

withdrawn

abruptly.

dosage

should be withdrawn gradually over a period of 7–14

days, to facilitate a reduction in beta blocker dosage.

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

reduction

beta-blocker

dosage.

Patients

should

followed

during

withdrawal,

especially

those

with

ischaemic

heart

disease.

Furthermore

there is a risk of myocardial infarction

and sudden death.

Patients

should

followed

during

withdrawal,

especially

those

with

ischaemic

heart

disease.

Furthermore there is a risk of myocardial infarction

and sudden death.

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. Continuation of beta-

blockade reduces the risk of arrhythmias

during induction and intubation, however

the risk of hypotension may be

increased as well. 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.

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. Continuation of beta-blockade reduces

the risk of arrhythmias during induction and intubation,

however the risk of hypotension may be increased as

well. 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

contraindicated

severe

peripheral

arterial

circulatory

disturbances (see Section 4.3), may

also aggravate less severe peripheral

arterial

circulatory

disturbances

(Raynaud's

disease

syndrome,

intermittent claudication).

Although contraindicated in severe peripheral arterial

circulatory disturbances (see section 4.3), may also

aggravate less severe peripheral arterial circulatory

disturbances (Raynaud's disease or syndrome,

intermittent claudication).

may mask the symptoms of

hypoglycaemia, in particular,

tachycardia. May mask the symptoms of

hypoglycaemia, in particular,

tachycardia.

Insulin sensitivity may be reduced

in patients treated with atenolol.

May mask the symptoms of hypoglycaemia, in

particular, tachycardia.

May mask the symptoms of hypoglycaemia, in

particular, tachycardia.

Insulin sensitivity may be reduced

in patients treated with atenolol

Special warnings

precautions

for use

Although

cardioselective

(beta1)

beta-

blockers may have less effect on lung

function

than

non-selective

beta-

blockers,

with

all,

beta-blockers,

these should be avoided in patients with

reversible obstructive airways disease,

unless

there

compelling

clinical

reasons

their

use.

Where

such

reasons exist, Normiten may be used

with

caution.

Occasionally,

some

increase

airways

resistance

occur

asthmatic

patients,

however,

and this may usually be reversed by

commonly

used

dosage

bronchodilators such as salbutamol or

isoprenaline.

Although cardio selective (beta

) beta blockers may

have less effect on lung function than nonselective

beta blockers, as with all beta blockers, these should

be avoided in patients with reversible obstructive

airways disease, unless there are compelling clinical

reasons for their use. Where such reasons exist,

Normiten may be used with caution.

Occasionally, some increase in airways resistance

may occur in asthmatic patients however, and this

may usually be reversed by commonly used dosage of

bronchodilators such as salbutamol or isoprenaline.

The label and patient information leaflet for this

product state the following warning: “If you have ever

had asthma or wheezing, you should not take this

medicine unless you have discussed these symptoms

with the prescribing doctor”.

Patients

with

anamnestically

known

psoriasis should take atenolol only after

careful consideration.

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Interactions

with

Other

Medicaments

and Other Forms

of Interaction

Caution must be exercised when using

anaesthetic agents with Normiten. 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 such as cyclopropane and

trichlorethylene, lidocaine, procainamide

and beta-adrenoceptor stimulants such

as noradrenaline (norepinephrine) are

best avoided.

Not recommended association with

monoamineoxidase inhibitors (except

MAO-B inhibitors)

Not recommended association with

baclofen (a GABA- gamma-aminobutyric

acid derivative): Causes an increased

antihypertensive activity.

Not recommended association with

contrast media, iodinated: Atenolol may

impede the compensatory

cardiovascular reactions associated with

hypotension or shock induced by

iodinated contrast products.

Amiodarone: 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.

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.

Peripheral muscle relaxants (e.g.

Suxamethonium halogenide,

Tubocurarine): concomitant use of

atenolol could increase and extent the

relaxative effect of muscle relaxants.

Caution must be exercised when using anaesthetic

agents with Normiten. 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

such as cyclopropane

and trichlorethylene, lidocaine, procainamide and

beta-adrenoceptor stimulants such as noradrenaline

(norepinephrine)

are best avoided.

Not recommended association with

monoamineoxidase inhibitors (except MAO-B

inhibitors)

Not recommended association with baclofen (a

GABA- gamma-aminobutyric acid derivative):

Causes an increased antihypertensive activity.

Not recommended association with contrast media,

iodinated: Atenolol may impede the compensatory

cardiovascular reactions associated with

hypotension or shock induced by iodinated contrast

products.

Amiodarone: 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.

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.

Peripheral muscle relaxants (e.g. Suxamethonium

halogenide, Tubocurarine): concomitant use of

atenolol could increase and extent the relaxative effect

of muscle relaxants.

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

Atenolol has no or negligible influence on the ability to

drive and use machines. However, it should be taken

into account that occasionally dizziness or fatigue may

occur.

Undesirable

effects

Psychiatric disorders:

Uncommon: Sleep disturbances of the

type noted with other beta-blockers.

Rare: Mood changes, depression, anxiety,

nightmares, confusion, psychoses and

hallucinations.

Psychiatric disorders:

Uncommon: Sleep disturbances of the type noted with

other beta-blockers.

Rare: Mood changes, depression, anxiety

nightmares, confusion, psychoses and hallucinations.

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Nervous system disorders:

Rare: Dizziness, headache, paraesthesia

of extremities.

Nervous system disorders:

Rare: Dizziness, headache, paraesthesia of

extremities.

Eye disorders:

Rare: Dry eyes, impaired vision, visual

disturbances.

Eye disorders:

Rare: Dry eyes, impaired vision, visual disturbances.

Gastrointestinal disorders:

Common: Gastrointestinal disturbances,

constipation.

Rare: Dry mouth.

Gastrointestinal disorders:

Common: Gastrointestinal disturbances, constipation.

Rare: Dry mouth.

General disorders and administration site

conditions:

Common: Fatigue, sweating.

General disorders and administration site conditions:

Common: Fatigue, sweating.

Musculoskeletal and connective tissue disorders- Not

known- Lupus like syndrome

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 bioavailability is decreased

by 20% when taken with food. There is a

linear relationship between dosage and

plasma concentration. The inter-subject

variability in AUC and Cmax is about 30-

40%. There is no significant hepatic

metabolism of atenolol and more than

90% of that absorbed reaches the

systemic circulation unaltered. Atenolol

penetrates tissues poorly due to its low

lipid solubility and its concentration in

brain tissue is low. The volume of

distribution is 50 to 75 L. The protein

binding is less than 5%. 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.

Absorption

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 reaches the systemic circulation

unaltered.

Distribution

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%).

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.

לע העדוה ( הרמחה

עדימ וחיטב ןכרצל ןולעב )ת

ןכדועמ(

.102.50

ךיראת

:

.03..30.60

Normiten 100

:תילגנאב רישכת םש רפסמ

:םושירה

/01

00

045 35 24916

Normiten 50

:תילגנאב רישכת םש רפסמ

:םושירה

/01

051 72 24149 00

Normiten 25

:תילגנאב רישכת םש

רפסמ

ושירה

/01

00

104 02 28834

םש םושירה לעב

:

Ltd

Abic

ה טורפל דעוימ הז ספוט דבלב תורמחה

תורמחהה שקובמה תו

ןולעב קרפ

יחכונ טסקט

שדח טסקט

תויוותה

1

?הפורתה תדעוימ המל .

אטב ירוטפצר ימסוח תצובקמ רישכת

( םייגרנרדא

beta-blockers

פיטל ,) לו ץחל רתי ,)בלה תקועת( סירוטקפ הניגנאב .בל ףקתה רחאל לופיטלו םד

1

?הפורתה תדעוימ המל .

ימסוח תצובקמ רישכת ירוטפצר

םינטלוק

אטב

( םייגרנרדא

beta-blockers

סירוטקפ הניגנאב לופיטל ,) ,)בלה תקועת( רחאל( בלה רירש לש ףירח םטואב בל ףקתה

םד ץחל רתיבו

ה רחאל לופיטל בל ףקת

ןיא יתמ שמתשהל רישכתב

:מ לבוס התא םא רישכתב שמתשהל ןיא

היביכרממ דחאל תושיגר העודי

דחוימב ,בלב תויעבמ רבעב תלבס וא ,הטילשל תנתינ אלש בל תקיפס יא ,תישילש וא היינש הגרדמ בל תמיסח יתלב וא תויטיא דואמ בל תומיעפ וא ךומנ דואמ םד ץחל ,תורידס רומח תוערפה םדה תמירזב תו

יבבל םלה

(cardiogenic

shock)

ץחלב תיתועמשמ הדיריב אטבתמה ריהמ קפוד ,טקש יא ,ןורוויח ,םדה הרכהב לופרע ,חל רוע ,שלחו

ךומנ םד ץחל

םזאיטליד וא לימפרווב לפוטמ ךניה .ידירו ךות ןתמב

םד ץחל( המוטיצומורכואפ תלחממ ללכ ךרדב אצמנה לודיגמ םרגנה הובג ךומס )הילכל

תוניקת אל תומר( תילובטמ תצמחמ )םדב תויצמוח לש

השק תואיר תלחמ וא השק המתסא תושק תויתמיסח תואיר תולחמ ןוגכ( ב שמתשהל ןיא רישכת

ןטימרונ

םא

:

:מ לבוס התא

יביכרממ דחאל תושיגר העודי

הפורתה

וא

דחוימב ,בלב תויעבמ רבעב תלבס

יא הטילשל תנתינ אלש בל תקיפס ךרדב תמרוגה( םיילוסרקב תוחיפנו המישנ רצוקל ללכ

םסח , תישילש וא היינש הגרדמ בל תויהל לוכיש בצמ( בל בצוק ידי לע לפוטמ

תומיעפ

/קפוד

בצק

יטיא דואמ בל תו

רידס יתלב וא תו םד ץחל , םדה תמירזב תורומח תוערפה וא ךומנ דואמ

.

לבוס ךנה

להמ יבבל ם

(cardiogenic shock)

,םדה ץחלב תיתועמשמ הדיריב אטבתמה ,חל רוע ,שלחו ריהמ קפוד ,טקש יא ,ןורוויח הרכהב לופרע

.

לבוס ךנה

ךומנ םד ץחלמ

.

ךות ןתמב םזאיטליד וא לימפרווב לפוטמ ךניה .ידירו

לבוס התא

תלחמ םד ץחל( המוטיצומורכואפ ללכ ךרדב אצמנה לודיגמ םרגנה הובג ךומס

.תלפוטמ הנניאש )הילכל תלחמ םא ךל ןתי אפורה תלפוטמ ךלש המוטיצומורכואפה לוטיל ,אפלא םסוח תארקנה תרחא הפורת

ןטימרונל ףסונב

.

תורמחהה שקובמה תו

ןולעב קרפ

יחכונ טסקט

שדח טסקט

)תוינורכו

םידליל דעוימ וניא רישכתה

לבוס התא

תומר( תילובטמ תצמחמ תוניקת אל

םדב תויצמוח לש המרונהמ תוהובג

.)

םדה תמירזב תורומח תוערפהמ לבוס התא םייפקיהה םיקרועב

.

ס התא לבו

תואיר תלחמ וא השק המתסאמ תושק תויתמיסח תואיר תולחמ ןוגכ( השק )תוינורכו

.

םידליל דעוימ וניא רישכתה

שמתשת דציכ ?הפורתב

תוארוה יפל הפורתב שמתשהל שי דימת חקורה וא אפורה םע קודבל ךילע .אפורה .חוטב ךניא םא

אפורה ידי לע ועבקי לופיטה ןפואו ןונימה .דבלב

עהב ןונימה ,אפורהמ תרחא הארוה רד :ןמקלדכ אוה לבוקמה

לופיטל בלה תקועת( סירוטקפ הניגנאב

)

לש תחא הילבט

םויב םעפ ג"מ ל ןתינ ,הלחתהב

הגרדהב ךרוצה יפל תולע ל עובש רחאלו

םויב ג"מ

םד ץחל רתיב לופיטל

לש יתלחתה ןונימ

20-00

;םויב םעפ ג"מ ל ןתינ

ךרוצה יפל תולע ל םייעובש רחאל

םויל ג"מ

בל ףקתה רחאל לופיט

ןונימ לע ץלמומ בל ףקתהמ ולבסש םילוחב לש יתעינמ

םויל ג"מ

.ךוראה חווטל

לש יוקל דוקפית םע םילוחו םירגובמ הילכה

ןונימה תמאתה לוקשי אפורה

תצלמומה הנמה לע רובעל ןיא

.

ךילע .אפורה תוארוה יפל הפורתב שמתשהל שי דימת .חוטב ךניא םא חקורה וא אפורה םע קודבל

.דבלב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה

אוה לבוקמה ןונימה ,אפורהמ תרחא הארוה רדעהב :ןמקלדכ

לופיטל בלה תקועת( סירוטקפ הניגנאב

)

לש תחא הילבט

ינ ,הלחתהב םויב םעפ ג"מ ןת ל עובש רחאלו הגרדהב ךרוצה יפל תולעהל

ג"מ םויב

איה תצלמומה הנמה

וא םויב ג"מ

םיימעפ ג"מ .םויב

םד ץחל רתיב לופיטל

לש יתלחתה ןונימ

20-00

תולעהל ןתינ ;םויב םעפ ג"מ ל םייעובש רחאל ךרוצה יפל

םויל ג"מ

איה תצלמומה הנמה

דע

.םויל ג"מ

לופיט

ינושאר

בל ףקתה רחאל

)בלה רירש םטוא(

לש יתעינמ ןונימ לע ץלמומ בל ףקתהמ ולבסש םילוחב

.ךוראה חווטל , םויל ג"מ

איה תצלמומה הנמה

דע

.םויב ג"מ

הילכה לש יוקל דוקפית םע םילוח

ו

םירגובמ

ןונימה תמאתה לוקשי אפורה

ותתחפה לע טילחיש ןכתיו

נמה לע רובעל ןיא תצלמומה ה

.

יאוול תועפות

תורידנ יאוול תועפות

תוחפ לע תועיפשמ(

מ

1

ךותמ

10111

םילפוטמ

)

,תורוחרחסב תאטבתמ( בלב המיסח )ןופלע וא תופייע ,רידס אל קפוד

תועבצאב תויוצווכתהו השוחת רסוח תנומסת( באכו םוחב תוולמה םיידיה ,)ונייר

חורה בצמב םייוניש

םיטויס

דרח ,לובלב דחפ וא ה

תוזוכיספ( תוישיא ייוניש

תוערפה תויזה וא )תוישפנ

שאר באכ

)דמענ ךניהשכ דחוימב( תורוחרחס

תורידנ יאוול תועפות

לע תועיפשמ( מ תוחפ

דע

1

ךותמ

10111

םילפוטמ

)

סח

המי

אל קפוד ,תורוחרחסב אטבתמ( בלב )ןופלע וא תופייע ,רידס

םיידיה תועבצאב תויוצווכתהו השוחת רסוח ,)ונייר תנומסת( באכו םוחב תוולמה

חורה בצמב םייוניש

םיטויס

,לובלב דחפ וא הדרח

תוזוכיספ( תוישיא ייוניש

וא )תוישפנ תוערפה תויזה

שאר באכ

ב( תורוחרחס )דמענ ךניהשכ דחוימ

םיידיב ץוצקע

תורמחהה שקובמה תו

ןולעב קרפ

יחכונ טסקט

שדח טסקט

םיידיב ץוצקע

תונוא ןיא

הפב שבוי

תושבי םייניע

הייאר שוטשט

רעיש לוליד ,

רועב החירפ

תולקב תולבח ינמיס תלבקל הייטנ

וא תורובח

םינמיס

רועב םילוגס

הצהב תאטבתמה( תבהצ רועה לש הב םייניעה וא

ךומנ םד ץחל

הניש ידודנ

בלה דוקפיתב הדירי

קלחב םייוניש

.םדה יאתו יביכרממ תוקידב עצבל ךתונפהל יושע אפורה קודבל תנמ לע ותעד לוקיש יפל םד יהשלכ העפשה תמייק ןטימרונל םאה .ךלש םדה תכרעמ לע

ןואכיד

דואמ תורידנ יאוול תועפות

לע תועיפשמ( תוחפ

מ

1

ךותמ

110111

)םישנא

.םדה יאתו יביכרממ קלחב םייוניש עצבל ךתונפהל יושע אפורה ותעד לוקיש יפל םד תוקידב

לע תמייק ןטימרונל םאה קודבל תנמ םדה תכרעמ לע יהשלכ העפשה .ךלש

רימחהל םילולעה םיבצמ

,תואבה תויעבה תחאמ לבוס ךניה םא נ( לופיטה תליחתב רימחהל לולע םבצמ :ריד מ תוחפ לע עיפשמ

ךותמ

1000

)םישנא

סיזאירוספ( תחפס

)רוע תלחמ

םיילוסרקב תוחיפנ ,המישנ רצוק )בל תקיפס יא םע םילוחב(

המישנ תויעב

וא המטסא

.המישנ תויעב

.םדה תמירזב תוערפה

לגרב העילצל תמרוגה תוצווכתה

תונוא ןיא

הפב שבוי

תושבי םייניע

שוטשט

ב תוערפה הייאר

רעיש לוליד

רועב החירפ

הייטנ תולקב תולבח ינמיס תלבקל

עצפיהל לק רתיב תו

וא רועה לש הבהצהב תאטבתמה( תבהצ לש ןבלה קלחה

םייניע

ךומנ םד ץחל

הניש ידודנ

בלה דוקפיתב הדירי

יוניש קלחב םי

יושע אפורה .םדה יאתו יביכרממ לע ותעד לוקיש יפל םד תוקידב עצבל ךתונפהל העפשה תמייק ןטימרונל םאה קודבל תנמ .ךלש םדה תכרעמ לע יהשלכ

ןואכיד

ילוחב המישנה יכרד לש תוצווכתה

וא המטסא רבעב המטסאמ ולבסש םילוחב

דואמ תורידנ יאוול תועפות

לע תועיפשמ( מ תוחפ

דע

1

ךותמ

110111

םישנא

םילפוטמ

)

יושע אפורה .םדה יאתו יביכרממ קלחב םייוניש ותעד לוקיש יפל םד תוקידב עצבל ךתונפהל

העפשה תמייק ןטימרונל םאה קודבל תנמ לע .ךלש םדה תכרעמ לע יהשלכ

אוול תועפות

י

םע תוחיכש

העודי אל

תרציימ ןוסיחה תכרעמ הב הלחמ( תבאזל המודה בצמ נדגונ )םיקרפמהו רועה תא רקיעב םיפקותה םי

המדאויגנאו תדפרס ללוכ ,תויגרלא תובוגת

רימחהל םילולעה םיבצמ

,תואבה תויעבה תחאמ לבוס ךניה םא םבצמ

ןה

לולע תו

לופיטה תליחתב רימחהל ןטימרונב

לע עיפשמ :רידנ( מ תוחפ

ךותמ

1000

)םישנא

סיזאירוספ( תחפס

)רוע תלחמ

פנ ,המישנ רצוק םע םילוחב( םיילוסרקב תוחי )בל תקיפס יא

המישנ תויעב

וא המטסא

.המישנ תויעב

.םדה תמירזב תוערפה

לגרב העילצל תמרוגה תוצווכתה

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