OPTALGIN DROPS

Israel - English - Ministry of Health

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Active ingredient:
DIPYRONE
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N02BB02
Pharmaceutical form:
DROPS
Composition:
DIPYRONE 500 MG/ML
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
METAMIZOLE SODIUM
Therapeutic area:
METAMIZOLE SODIUM
Therapeutic indications:
Relief of moderate to severe pain as in headache, toothache, dysmenorrhea andfor high fever that does not respond to other measures.
Authorization number:
020 15 20487 00
Authorization date:
2011-08-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

31-07-2017

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The preparation shall be sold

without a doctor’s prescription

OPTALGIN

®

Drops for oral administration

Composition

Each 1 ml (25 drops) contains:

Dipyrone 500 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 is given without need

for a doctor's prescription. You should

take the medicine correctly. The drops

are not intended for infants weighing

less than 5 kg. Consult a pharmacist

if you need further information. You

should refer to the doctor if the

fever lasts for more than 3 days or

pain persists for more than 7 days,

despite use of the medicine. The risk of

agranulocytosis increases if treatment

continues for more than 7 days (see

“Side Effects” section).

1.

WHAT

IS

THE

MEDICINE

INTENDED FOR?

The medicine is intended for the relief

of moderate to strong pain, such as

headache, toothache and menstrual

pain, and for lowering high fever that

does not respond to other measures

of treatment.

Therapeutic group: Optalgin

Drops

contain an active ingredient belonging

to the pyrazoline group.

2.

BEFORE USING THE MEDICINE

Do not use the preparation if:

∙ Do not use the medicine when you

are pregnant or breastfeeding.

∙ Do not use this medicine if you

have

known

sensitivity

the active ingredient dipyrone

(metamizole), propyphenazone,

phenazone, phenylbutazone or to

any of the inactive ingredients of the

medicine.

∙ Do not use this medicine for mild

pains.

∙ Do not use this medicine if you

have a known deficiency of the

G6PD enzyme (“sensitivity to fava

beans”).

∙ Do not use if you suffer from a blood

system impairment.

∙ Do not use this medicine if you

suffer from acute hepatic porphyria

(an inherited disease in which

there is increased production

and accumulation of porphyrin,

causing disorders, for instance of

the nervous system).

Do not use the medicine if you

have bone marrow depression (for

instance, following chemotherapy).

Special warnings regarding use of

the medicine

Inform the doctor before commencing

treatment if you are suffering, or have

suffered in the past, from:

∙ A tendency for hypersensitivity to

painkillers, medicines for treatment

of arthritis and other medicines.

Allergy related symptoms: in such

cases, the risk of anaphylactic shock

increases (see “Side Effects” section).

∙ If you are prone to allergies: such as

allergies to food, alcoholic beverages,

animals, preservatives, hair dyes,

various medicines, allergy that

causes asthma or chronic skin rash

(urticaria) – Optalgin

should only be

taken under medical supervision.

∙ Impairment in function of the liver,

kidney, blood system (e.g., coagulation

or anemia).

∙ If you suffer from diseases that are

accompanied by a decrease in white

blood cells.

∙ If you suffer from asthma or chronic

respiratory airway infections.

Warnings

Dipyrone may cause rare but life-

threatening effects of anaphylactic

shock and/or agranulocytosis (see

“Side Effects” section).

∙ Do not use this medicine frequently or

for a prolonged period of time without

consulting the doctor.

∙ If you are sensitive to any type of food

or medicine, inform the doctor before

taking the medicine.

∙ Rarely, hypersensitivity to this medicine

may cause leucopenia (too few white

blood cells), thrombocytopenia

(manifested by an increased tendency

to bleed) or agranulocytosis (toxic

damage to white blood cells) and

shock. This reaction is manifested by

high fever, chills, sore throat, difficulty

swallowing and inflammation of the

mouth cavity, the nose or genitals.

When one of these signs occur, and

they may already occur in the first

hour after taking the medicine, stop

taking the medicine immediately and

consult the doctor. When consulting

the doctor you must inform him if

you have taken another medicine

concomitantly with Optalgin

∙ This medicine may cause a red color

in acidic urine. This effect should not

be a cause for concern.

If you are taking, or have recently

taken other medicines

including non-prescription medicines,

nutritional supplements and vitamins,

tell the doctor or pharmacist. You

should especially inform the doctor or

pharmacist if you are taking or have just

finished treatment with a medicine from

one of the following groups:

∙ non-steroidal anti-inflammatory drugs

(NSAIDs) such as aspirin.

∙ anticoagulants (warfarin).

∙ ciclosporin (for transplantations) - the

ciclosporin level may be reduced.

∙ chlorpromazine (an antipsychotic

medicine).

Use of Optalgin

®

and food

Take the medicine with a glass of water.

It can be taken before or after a meal.

Pregnancy

Do not use this medicine if you are

pregnant.

Breastfeeding

Do not breastfeed during treatment with

this medicine.

Use in children

This medicine is not intended for infants

weighing less than 5 kg.

Driving

Use of this medicine at higher than

recommended dosages may affect

your reaction time, your ability to drive

and to operate machinery. Therefore,

avoid driving a vehicle, operating

machinery and any other activity

requiring alertness. The risk increases

if the medicine is taken together with

alcohol.

3.

HOW SHOULD YOU USE THE

MEDICINE?

Always use the medicine according to

the doctor’s instructions. Check with the

doctor or pharmacist if you are unsure.

The dosage and treatment regimen will

be determined by the doctor only.

The usual dosage unless otherwise

instructed by the doctor:

Take the appropriate dosage according

to the table below.

Take the medicine at intervals of

6-8 hours.

It is recommended that the dosage

be given by the weight of the child in

accordance with the table. Only if the

child’s weight is unknown will the dosage

be determined by the child’s age.

Do not take a dose more than 3 times

hours.

The drops are not intended for infants

weighing less than 5 kg.

Do not exceed the recommended

dose.

Make sure the bottle cap is tightly

closed after use.

If the fever lasts for more than 3 days

or pain persists for more than 7 days,

despite use of the medicine, refer to

the doctor.

The risk of agranulocytosis increases

if treatment continues for more than 7

days (see “Side Effects” section).

Adults and adolescents from 15 years

of age and above (above 53 kg body

weight):

25-50 drops up to 3 times a day.

Infants and children:

Age

Body

weight

(Kg)

Dosage

(No. of drops)

3-11

months

2-5 drops up to

3 times daily

1-3 years

9-15

4-12 drops up to

3 times daily

4-6 years

16-23

6-19 drops up to

3 times daily

7-9 years

24-30 10-25 drops up to

3 times daily

10-12 years 31-45 12-37 drops up to

3 times daily

13-14 years 46-53 19-44 drops up to

3 times daily

If you accidently took an overdose, or

if a child accidentally swallowed the

medicine, immediately refer to a doctor

or proceed to a hospital emergency room

and bring the package of medicine with

you.

Effects of overdose:

Nausea, vomiting, abdominal pain,

impairment of kidney function, and in

rarer cases: dizziness, convulsions,

unconsciousness, drop in blood pressure,

shock, heart rhythm disorders.

When taking a very high dosage of the

medicine your urine may turn red.

If you forget to take the medicine: do

not take two doses together to make up

for a missed dose.

Adhere

to

the

treatment

as

recommended by the doctor.

4.

SIDE EFFECTS

As with any medicine, use of Optalgin

may cause side effects in some users.

Do not be alarmed when reading the list

of side effects. You may not suffer from

any of them.

Refer to the doctor immediately if you

experience:

The main side effects of the medicine

are hypersensitivity reactions. They

include:

Anaphylactic shock and agranulocytosis.

These are rare but life-threatening

effects. They can occur even if you

took the medicine in the past with no

complications. They can already occur

in the first hour after taking the medicine,

but also a few hours later.

∙ Anaphylactic shock - an acute

hypersensitivity reaction manifested

by cold sweat, severe rash all over

the body, swelling of the skin or the

pharynx, mucosal blisters, dizziness,

severe shortness of breath, nausea,

vomiting, stomach irritation, rapid

pulse, feeling of tightness in the chest

and a sharp drop in blood pressure

(rare): stop treatment and call for

medical help immediately!

Meanwhile, until the doctor arrives,

lay the patient down on his back and

raise his legs. It is advisable to warm

his body with a blanket.

∙ Rarely, hypersensitivity to this medicine

may cause leucopenia (too few white

blood cells), thrombocytopenia

(reduction in platelets manifested by

an increased tendency for bleeding)

or agranulocytosis (toxic damage

of the white blood cells). The risk

of agranulocytosis increases if the

medicine is taken for more than 7

days. This reaction is manifested by

high fever, chills, sore throat, difficulty

swallowing and inflammation of the

mouth cavity, the nose or genitals,

worsening of your general condition

(such as tiredness or weakness).

taking

antibiotics

concomitantly – it is possible that

these signs will be weaker. If any of

the above signs occurs, stop taking

the medicine immediately and consult

with the doctor.

∙ Skin or mucosal effects: In isolated

cases there may be:

Stevens-Johnson

syndrome

Lyell's syndrome - these are acute

and life-threatening skin reactions

including rash or mucosal blisters -

stop treatment and refer to the doctor

immediately!

∙ In rare cases, mainly in cases of a

drop in blood volume, in patients

with a history of kidney diseases and

in cases of overdose, there may be:

kidney dysfunction, such as reduction

in or absence of urinary output, kidney

inflammation or secretion of protein

into the urine (rare): stop treatment

immediately and refer to the doctor!

If a side effect occurs, if any of the side

effects worsen, or if you are suffering

from 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 on the Ministry of

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/getsequ

ence/getsequence.aspx?formType=Ad

versEffectMedic@moh.gov.il

5.

HOW SHOULD THE MEDICINE BE

STORED?

∙ Avoid poisoning! This medicine and

any other medicine should be kept

in a closed place out of the reach

of children and/or infants in order

to avoid poisoning. Do not induce

vomiting unless explicitly instructed

to do so by the doctor.

∙ 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.

∙ Do not use the medicine after the

expiry date (Exp. Date) that appears

on the package. The expiry date refers

to the last day of that month.

Store in a dry place, below 25°C.

The medicine can be used for up

to 3 months after first opening the

bottle, but not after the expiry date

of the preparation.

6.

FURTHER INFORMATION

In addition to the active ingredient the

medicine also contains: water

What does the medicine look like and

what are the contents of the package:

The medicine comes in two packages:

10 ml and 15 ml. The medicine drops

are yellowish in color.

Manufacturer:

Teva Pharmaceutical Industries Ltd.,

P.O.B. 3190, Petach-Tikva.

This

leaflet

checked

approved by the Ministry of Health in

September 2014.

Registration number of the medicine

in the National Drug Registry of the

Ministry of Health: 020.15.20487.00

34O161034-03

34O161034-03

OPTA DROP PL SH 160517

OPTA DROP PL SH 160517

Optalgin Caplets/Tablets SPC, SZ, 10/2019 Notification

SUMMARY OF PRODUCT CHARACTERISTICS

Optalgin

®

Caplets

Optalgin

®

Tablets

1.

NAME OF THE MEDICINAL PRODUCT

Optalgin

Caplets

Optalgin

Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Optalgin Caplets

Each caplet contains 500 mg Dipyrone.

Optalgin Tablets

Each tablet contains 500 mg Dipyrone.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Caplets

Optalgin caplets are white to creamy, oblong film coated caplets, scored on one side.

The caplet can be

divided into equal halves.

Tablets

Optalgin tablets are white to off-white, round flat beveled tablets with a score line on one side and

engraved "TEVA" on the other side. The tablet can be divided into equal halves.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications

Relief of moderate to severe pain as in headache, toothache, dysmenorrhea, and for high fever that does not

respond to other measures.

4.2.

Posology and method of administration

Posology

Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to

Optalgin.

It is essential to choose the lowest dose that controls pain and fever.

Adults

1-2 caplets or 1-2 tablets up to 4 times daily.

Do not exceed 8 caplets or 8 tablets daily.

Depending on the maximum daily dose, the single dose can be taken in intervals of 6 to 8 hours.

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

Adults and adolescents aged 15 years and over (> 53 kg) can take up to 1000 mg per single dose. Where

the effect is inadequate, the respective single dose can be administered up to 4 times daily, depending on

the maximum daily dose.

Children and infants

For children and infants dosage refer to Optalgin drops.

Elderly patients

The dose should be reduced in the elderly, since elimination of the metabolites of Optalgin may be

prolonged.

Debilitated patients and patients with reduced creatinine clearance

The dose should be reduced in debilitated patients and in patients with reduced creatinine clearance,

since elimination of the metabolites of Optalgin may be prolonged.

Impaired renal or hepatic function

Since the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses

should be avoided. No dose reduction is required when only used for a short time. There is no

experience with long-term use.

Method of administration

The tablets are to be swallowed whole with sufficient liquid (e.g., a glass of water).

Duration of use

The duration of use depends upon the type and severity of the disease. In the event of longer-term treatment

with Optalgin, regular monitoring of blood count is required, including differential blood count.

4.3. Contraindications

Hypersensitivity to the active substance Dipyrone (metamizole), other pyrazolones or pyrazolidines

(this also includes patients who have developed agranulocytosis following use of such substances), or to

any of the excipients listed in section 6.1.

Patients with known analgesic-asthma-syndrome or analgesic-intolerance of urticaria-angioedema type,

i.e. patients who react to salicylates, paracetamol or other non-narcotic analgesics (e.g., diclofenac,

ibuprofen, indomethacin, naproxen) with bronchospasm or other anaphylactoid symptoms (e.g.,

urticaria, rhinitis, angioedema).

Bone marrow failure (e.g., after treatment with cytostatics) or hematopoietic disorders.

Acute intermittent hepatic porphyria (risk of triggering an attack of porphyria).

In children under 4 years of age or in patients with a body weight of less than 16 kg.

4.4

Special warnings and precautions for use

Optalgin contains the pyrazolone derivative Dipyrone and are associated with rare but life-threatening risks

of shock and agranulocytosis (see section 4.8).

Patients who experience anaphylactoid reactions to Dipyrone are at particular risk of experiencing similar

reactions to other non-narcotic analgesics.

Patients who experience an anaphylactic reaction or another immunologically mediated reaction to

Dipyrone (e.g., agranulocytosis) are at particular risk of experiencing similar reactions to other

pyrazolones and pyrazolidines.

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

Agranulocytosis

If signs of agranulocytosis or thrombocytopenia occur (see section 4.8), administration of Optalgin must be

discontinued immediately and blood count (including differential blood count) must be monitored.

Treatment must be discontinued even before laboratory test results become available.

Pancytopenia

If pancytopenia occurs, treatment must be discontinued immediately and complete blood count must be

monitored until it normalizes (see section 4.8). All patients should be instructed to consult their doctor

immediately if signs and symptoms occur during treatment which may indicate blood dyscrasia (e.g.,

malaise, infection, persistent fever, bruising, bleeding, pallor).

Anaphylactic/anaphylactoid reactions

The risk of potentially severe anaphylactoid reactions to Optalgin is significantly increased in patients

with:

Analgesic-asthma-syndrome or analgesic-intolerance of urticaria-angioedema type (see section 4.3).

Bronchial asthma, particularly with concurrent rhinosinusitis and nasal polyps.

Chronic urticaria.

Intolerance to coloring agents (e.g., tartrazine) or preservatives (e.g., benzoates).

Alcohol intolerance. Such patients react to even minimal amounts of alcohol with symptoms such as

sneezing, watery eyes and severe flushing. Alcohol intolerance of this kind may be indicative of as yet

undiagnosed analgesic-asthma-syndrome

(see section 4.3).

Anaphylactic shock may occur, primarily in susceptible patients. Special care should therefore be taken

when administered to patients with asthma or atopy.

Severe skin reactions

There have been reports of the life-threatening skin reactions Stevens-Johnson syndrome (SJS) and toxic

epidermal necrolysis (TEN) following use of Dipyrone. If symptoms or signs of SJS or TEN develop (such

as progressive rash, often associated with blisters or mucosal lesions), treatment with Optalgin must be

discontinued immediately and not resumed at any stage.

Patients should be advised of the signs and symptoms and should be monitored closely for skin reactions,

especially in the first few weeks of treatment.

Isolated hypotensive reactions

Optalgin may induce hypotensive reactions (see also section 4.8).

These reactions may be dose-dependent. This is more likely with parenteral than enteral administration.

The risk of such reactions is also increased in:

Patients

with, for example, pre-existing hypotension, volume depletion or dehydration, unstable

circulation or incipient circulatory failure (e.g., in patients with myocardial infarction or multiple

trauma).

Patients with high fever.

Careful indication testing and close monitoring are therefore required in such patients. Preventive measures

(e.g., circulatory stabilization) may be required to reduce the risk of hypotensive reactions.

Optalgin should only be used with careful monitoring of hemodynamic parameters in patients in whom a

reduction in blood pressure must be avoided at all costs, e.g., patients with severe coronary heart disease or

relevant cerebrovascular stenosis.

Optalgin should only be used after careful risk-benefit assessment and appropriate precautions in patients

with renal or hepatic impairment (see section 4.2).

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

Patients should be asked relevant questions prior to the administration of Optalgin. Optalgin should only be

used after carefully weighing the potential risks against the anticipated benefits in patients at increased risk

of anaphylactoid reactions. If Optalgin are administered in such cases, patients should be placed under

close medical supervision, with emergency facilities available.

4.5

Interaction with other medicinal products and other forms of interaction

Dipyrone may cause a decrease in serum cyclosporine levels. These must therefore be monitored if

Optalgin is used concomitantly.

Severe hypothermia may develop following concomitant use of Optalgin and chlorpromazine.

Co-administration of Dipyrone and methotrexate may increase the hematotoxicity of methotrexate,

especially in elderly patients. This combination should therefore be avoided.

Dipyrone may reduce the anti-platelet activity of low-dose aspirin in the event of concomitant use.

Dipyrone should therefore be used with caution in patients taking low-dose aspirin for cardioprotection.

Dipyrone may reduce bupropion blood levels. Caution should therefore be exercised with concomitant

administration of Dipyrone and bupropion.

The pyrazolones are known to interact with oral anticoagulants, captopril, lithium and triamterene, and

to cause potential changes in the effectiveness of antihypertensives and diuretics. It is not known to

what extent Dipyrone also triggers such interactions.

Effect on assay methods

There have been reports of Dipyrone interference with Trinder and Trinder-like reaction assays (e.g.,

determination of serum levels of creatinine, triglyceride, HDL cholesterol or uric acid).Therefore, In cases

of these tests the patient should take Optalgin only after giving a blood sample.

4.6. Pregnancy and breast-feeding

Pregnancy

There are no adequate data from the use of Dipyrone in pregnant women. Dipyrone crosses the placental

barrier. Dipyrone has not been associated with teratogenic effects in animal studies (see section 5.3).

Although Dipyrone is a weak inhibitor of prostaglandin synthesis, the possibility of premature closure of

the ductus arteriosus (Botalli) and perinatal complications due to a reduction in platelet aggregability in the

mother and child cannot be excluded.

The use of Dipyrone in the third trimester (after week 28) should be used at the lowest effective dose. The

daily dose should be up to 3 grams, for only 3-4 days. Longer treatment needs close medical supervision

Breast-feeding

The metabolites of Dipyrone are excreted in breast milk.

The use of Dipyrone should be limited to cases

which do not respond to the use of paracetamol or ibuprofen.

4.7

Effects on ability to drive and use machines

Within the recommended dosage range there is no known impairment of the ability to concentrate and

react. As a precaution, however, at least at higher dosages, the possibility of impairment of the ability

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

to concentrate and react should be taken into account, and patients should avoid using machines,

driving or other hazardous activities. This applies in particular in conjunction with alcohol.

4.8

Undesirable effects

The frequency of adverse reactions is defined using the following convention:

Very common

1/10

Common

1/100, < 1/10

Uncommon

1/1,000, < 1/100

Rare

1/10,000, < 1/1,000

Very rare

< 1/10,000

Not known

Frequency cannot be estimated from available data

Blood and Lymphatic System Disorders

Rare:

Leukocytopenia.

Very rare:

Agranulocytosis (including fatal cases), thrombocytopenia.

Not known:

Aplastic anemia, pancytopenia (including fatal cases).

These reactions can occur even if Dipyrone was previously administered without complications.

There is isolated evidence that the risk of agranulocytosis may increase if Dipyrone is used for more than

one week.

This reaction is not dose-dependent and can occur at any time during treatment. It is manifested by high

fever, chills, sore throat, dysphagia and inflammation of the mouth, nose, throat and genital or anal

area. These signs may be minimal, however, in patients receiving antibiotics. There is little or no

swelling of the lymph nodes or spleen. Erythrocyte sedimentation rate is significantly accelerated, whilst

granulocytes are considerably reduced or completely absent. Hemoglobin, erythrocyte and platelet

values are generally, but not always, normal (see section 4.4).

Immediate discontinuation is essential for recovery. Therefore optalgin treatment must be discontinued

immediately, without waiting for the results of laboratory-diagnostic tests, in the event of unexpected

deterioration in general condition, persistent or recurrent fever, or painful mucosal changes (especially in

the mouth, nose and throat region).

If pancytopenia occurs, treatment must be discontinued immediately and complete blood count must be

monitored until it normalizes (see section 4.4).

Immune System Disorders

Rare:

Anaphylactoid or anaphylactic reactions*.

Very rare:

Analgesic-asthma-syndrome

In patients with analgesic-asthma-syndrome, intolerance

reactions are typically manifested in the form of asthma

attacks.

Not known:

Anaphylactic shock*.

*These reactions may occur in particular following parenteral application and may be severe and life-

threatening, in some cases even fatal. They can also occur if Dipyrone was previously administered

without complications.

Such reactions may occur during injection or immediately after administration, but may also develop hours

later. In the majority of cases, however, they develop within the first hour of administration. Milder

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

reactions are typically manifested in the form of skin and mucosal reactions (e.g., itching, burning

sensation, redness, urticaria, swelling), dyspnea and (in rarer cases) gastrointestinal complaints. Such

milder reactions may become more severe, progressing to generalized urticaria, severe angioedema (also in

the laryngeal region), severe bronchospasm, cardiac arrhythmias, hypotension (sometimes with preceding

hypertension) and circulatory shock.

Optalgin should therefore be discontinued immediately in the event of skin reactions.

Cardiac disorders

Frequency not known: Kounis syndrome.

Vascular Disorders

Uncommon:

Hypotensive reactions during or after administration, which may

be pharmacologically induced and may not be accompanied by

other signs of anaphylactoid or anaphylactic reaction. Such

reactions can lead to severe hypotension. Rapid intravenous

injection increases the risk of hypotensive reactions.

Dose-dependent critical hypotension may also occur in the event of hyperpyrexia, without further signs of

hypersensitivity.

Skin and Subcutaneous Tissue Disorders

Uncommon:

Fixed drug eruption.

Rare:

Rash (e.g., maculopapular exanthema).

Very rare:

Stevens-Johnson syndrome or toxic epidermal necrolysis

(discontinue treatment, see section 4.4).

Renal and urinary disorders

Very rare:

Acute deterioration of renal function, which may progress in

very rare cases to proteinuria, oliguria or anuria, or acute renal

failure, acute interstitial nephritis.

General disorders and administration site conditions

There have been reports of red urine discoloration, which may be attributable to the harmless Dipyrone

metabolite rubazonic acid, present at low concentrations.

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:

https://sideeffects.health.gov.il

4.9 Overdose

Overdose Symptoms:

Nausea, vomiting, abdominal pain, renal impairment/acute renal failure (e.g., in the form of interstitial

nephritis) and (more rarely) central nervous symptoms (dizziness, somnolence, coma, convulsions) and

hypotension, progressing to shock and tachycardia have been observed following acute overdose.

After very high doses, excretion of rubazonic acid may cause red discoloration of the urine.

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

Therapeutic measures following overdose:

No specific antidote is known for Dipyrone. If the Dipyrone was only recently taken, attempts can be made

to limit systemic absorption using primary detoxification measures (e.g., gastric lavage) or absorption-

reducing measures (e.g., activated charcoal). The main metabolite (4-N-methylaminoantipyrine) can be

eliminated by hemodialysis, hemofiltration, hemoperfusion or plasma filtration.

Treatment of intoxication and prevention of severe complications may require general and specialist

intensive care monitoring and treatment.

Emergency measures in the event of severe hypersensitivity reactions (shock):

Stop administration at the first sign of hypersensitivity reactions (e.g., cutaneous reactions such as

urticaria and flushing, agitation, headache, sweating, nausea). In addition to standard emergency measures

such as Trendelenburg positioning, maintenance of patent airways and administration of oxygen, the

administration of sympathomimetics, volume expanders or glucocorticoids may be necessary.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics; Other analgesics and antipyretics; Pyrazolones

ATC code: N02BB02

Dipyrone is a pyrazolone derivative and has analgesic, antipyretic and spasmolytic properties. The

mechanism of action is not fully understood. Some research findings suggest that Dipyrone and the main

metabolite (4-N-methylaminoantipyrine) may have both a central and a peripheral mechanism of action.

5.2

Pharmacokinetic properties

After oral administration, Dipyrone is completely hydrolyzed to the pharmacologically active 4-N-

methylaminoantipyrine (MAA). The bioavailability of MAA is approx. 90% and is slightly higher after

oral administration than after parenteral administration. Concomitant intake of food does not have a

relevant effect on Dipyrone kinetics.

The clinical efficacy is mainly due to MAA, but also to a certain extent to the metabolite 4-

aminoantipyrine (AA). The AUC values for AA represent approx. 25% of the AUC values for MAA. The

metabolites 4-N-acetylaminoantipyrine (AAA) and 4-N-formylaminoantipyrine (FAA) appear to be

pharmacologically inactive.

It should be noted that all of the metabolites display non-linear pharmacokinetics. The clinical significance

of this phenomenon is unknown. Accumulation of the metabolites is of little significance with short-term

treatment.

Dipyrone crosses the placental barrier. The metabolites of Dipyrone are excreted in breast milk.

Plasma protein binding is 58% for MAA, 48% for AA, 18% for FAA and 14% for AAA.

Dipyrone's plasma half-life following intravenous administration is approx. 14 minutes. After intravenous

administration approx. 96% of a radiolabeled dose is recovered in the urine and approx. 6% in the feces.

Following a single oral dose, 85% of the urinary metabolites excreted were identified. Of this percentage,

MAA accounted for 3±1%, AA 6±3%, AAA 26±8% and FAA 23±4%. Renal clearance after a single oral

dose of 1 g Dipyrone was 5±2 mL/min for MAA, 38±13 mL/min for AA, 61±8 mL/min for AAA and

49±5 mL/min for FAA. The associated plasma half-lives were 2.7±0.5 hours for MAA, 3.7±1.3 hours for

AA, 9.5±1.5 hours for AAA and 11.2±1.5 hours for FAA.

Elderly

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

The AUC is 2 to 3 times higher with treatment of elderly patients. Following a single oral administration,

the half-life of MAA and FAA increased approx. 3-fold in patients with hepatic cirrhosis, whereas the half-

lives of AA and AAA did not increase to the same extent. High doses should be avoided in such patients.

Renal impairment

The data available for patients with renal impairment indicate a reduced elimination rate for some

metabolites (AAA and FAA). High doses should therefore be avoided in such patients.

5.3

Preclinical safety data

Subchronic and chronic toxicity studies have been performed on various animal species. Rats were orally

administered with Dipyrone at doses of 100 mg to 900 mg/kg body weight for 6 months. At the highest

dose (900 mg/kg bw), an increase in reticulocytes and Heinz bodies was observed after 13 weeks.

Dogs were administered with Dipyrone at doses of 30 to 600 mg/kg bw for 6 months. Dose-dependent

hemolytic anemia and changes in renal and hepatic function have been observed from 300 mg/kg bw.

There are contradictory results for Dipyrone from in vitro and in vivo studies in the same test systems.

Long-term studies in rats have not produced any evidence of tumorigenic potential. Increased liver cell

adenomas were observed at high doses in two out of three long-term studies in mice.

Embryo toxicity studies in rats and rabbits have not revealed any evidence of teratogenic effects.

Embryolethal effects have been observed in rabbits from a non-maternally toxic daily dose of 100 mg/kg

bw. In rats, embryolethal effects only occurred at doses in the maternally toxic range. Daily doses in excess

of 100 mg/kg bw led to prolonged gestation in rats and impaired parturition with increased maternal and

pup mortality.

Fertility tests revealed a slightly decreased pregnancy rate in the parental generation at doses above 250

mg/kg bw/day. The fertility of the F1 generation was not affected.

The metabolites of Dipyrone are excreted in breast milk. There is no experience with regard to their effects

on suckling pups.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Optalgin Caplets:

Starch, gelatin, magnesium stearate, talc, colloidal silicon dioxide, hydroxypropyl methylcellulose, titanium

dioxide, polyethylene glycol, polysorbate 80.

Optalgin Tablets:

Starch, gelatin, magnesium stearate, talc, colloidal silicon dioxide.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Optalgin Caplets/Tablets SPC, SZ, 10/2019 NOTIFICATION

The expiry date of the product is indicated on the packaging materials.

Optalgin caplets in a bottle: after first opening, the product can be used until the expiry date.

6.4

Special precautions for storage

Optalgin caplets/ tablets: Store in a dry place, below 25

6.5

Nature and contents of container

Optalgin Caplets: Pack containing 21 or 42 caplets in blisters or bottle containing 50 caplets.

Optalgin Tablets: Pack containing 20 tablets in blisters.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements.

7

LICENCE HOLDER AND MANUFACTURER

Teva Pharmaceutical Industries Ltd.

P.O.Box 3190, Petah Tikva

8

REGISTRATION NUMBER

Optalgin Caplets: 066.25.27767

Optalgin Tablets: 016.87.20611

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

been checked and approved by the Ministry of health in 7/2019 and updated according to

MoH instructions in 11/2019.

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ךיראת

___________________

March 13, 2012

____

םש

רישכת

__תילגנאב

OPTALGIN Tablets, Caplets, Drops

____

רפסמ

__םושיר

Tab: 016 87 20611 11; Cap: 066 2527767 00, 066 25 27767 05

;

Drops: 020 15 20487 00

םש

לעב

םושירה

Teva Pharmaceutical Industries Ltd, P.O.Box 3190, Petach Tikva

םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Indications

As an analgesic for the relief of

moderate to severe pain as in

headache,

toothache,

dysmenorrhea, and as antipyretic

As an analgesic for the relief of moderate

to severe pain as in headache, toothache,

dysmenorrhea, and as antipyretic for high

fever that does not respond to other

measures.

Warnings

Rare cases of hypersensitivity

reactions have been reported;

they

manifested

anaphylactic

shock

agranulocytosis-

Rare cases of hypersensitivity reactions

have been reported; they are manifested by

life-threatening risk of circulatory shock

(anaphylactic shock) or agranulocytosis-due

pyrazolone

derivative

dipyrone

(metamizole).

Patients that show anaphylactoid reactions

to dipyrone are especially prone to react

similarly to other non-narcotic analgesics.

Patients that show anaphylactic or other

immunologically mediated reactions (e.g.

agranulocytosis) to dipyrone are also

especially prone to react similarly to other

pyrazolones and pyrazolidines.

case

symptoms

agranulocytosis or thrombocytopenia,

dipyrone

must

immediately

discontinued even before the results of

the laboratory diagnostic tests become

available.

risk

possibly

severe

anaphylactoid reactions to dipyrone is

significantly increased in patients with:

analgesics-asthma-syndrome

or analgesics intolerance of

the urticaria-angioedema type

bronchial asthma, particularly

with coexisting rhinosinusitis

and nasal polyps

chronic urticaria

intolerance to coloring agents

(e.g.

tartrazine)

preservatives (e.g. benzoates)

intolerance to alcohol. Such

patients react to even small

amounts

alcoholic

beverages

with

symptoms

such as sneezing, watery eyes

and a pronounced redness of

face.

Such

alcohol

intolerance can be a sign of a

previously

undiagnosed

analgesics-asthma-syndrome.

Dipyrone can cause hypotensive

reactions. These reactions are possibly

dose-dependent.

risk

such

reactions is also increased in:

patients

with

preexisting

hypotonia, hypovolemia or dehydration,

unstable

circulation

beginning

circulatory failure (e.g. patients with

cardiac arrest or polytrauma)

patients with high fever.

Therefore, careful indication analysis

and close monitoring are required in

these patients.

Preventive measures

(e.g. circulatory stabilization) may be

necessary

reduce

risk

hypotensive reactions.

In patients, who would be at

particular risk from a reduction in blood

pressure (e.g. patients with severe

coronary heart disease or relevant

stenoses of blood vessels supplying the

brain), dipyrone must only be used

under

careful

monitoring

hemodynamic parameters.

In patients with impaired kidney or

liver function, dipyrone should only be

administered after strict risk-benefit

assessment

with

appropriate

precautions.

Use in Pediatrics

Use of dipyrone is contraindicated in infants

with a body weight less than 5 kg.

Use in Pregnancy and

See Contraindications

See Contraindications.

Breastfeeding

There is insufficient data regarding the

use of dipyrone in pregnant women.

Dipyrone passes into the placenta. In

animal studies, dipyrone showed no

teratogenic effects.

Although dipyrone only slightly

inhibits the prostaglandine synthesis, a

premature (intrauterine) closure of the

Ductus Botalli as well as complications

due to platelet aggregation inhibition

cannot be excluded.

Metabolites of dipyrone enter the

breast milk.

Precautions

Contraindications

Known

hypersensitivity

dipyrone

pyrazolone

derivatives

other

ingredient of the preparation.

Pregnancy and breastfeeding.

Acute porphyria.

Genetic deficiency of the

enzyme

glucose-6-phosphate

dehydrogenase (G6PD).

History of blood dyscrasias or

acute bone marrow suppression.

Known hypersensitivity to dipyrone or to

pyrazolone

and pyrazolidine

derivatives

(e.g.: to medicines containing dipyrone,

propyphenazone,

phenazone

phenylbutazone) or to any other ingredient

of the preparation.

Pregnancy and breastfeeding.

Acute hepatic porphyria.

Genetic deficiency of the enzyme glucose-

6-phosphate dehydrogenase (G6PD).

In case of impaired bone marrow function

(e.g., following a treatment with cytostatics)

or disorders of the hematopoietic system, as

well as history of blood dyscrasias or acute

bone marrow suppression.

In patients with a body weight less than 5 kg

Adverse events

Allergic

Agranulocytosis has rarely

been reported. It is an immuno-

allergic adverse reaction lasting

at least 1 week. Agranulocytosis

is unpredictable, not dose-related

and may occur even after a

single dose.

Anaphylactic shock (see

Warnings).

Dermatological reactions (see

Warnings).

Hematological

Rarely

agranulocytosis,

anemia,

leucopenia

thrombocytopenia,

have

been

reported.

Renal

Isolated cases of acute renal

insufficiency

interstitial

very common

1/10

common

1/100 up to

<1/10

uncommon

> 1/1,000 up to

<1/100

rare

1/10,000 upto

<1/1,000

very rare

<1/10, 000 or

unknown

(frequency

cannot be

estimated from

the available

data)

very common

1/10

The main side effects of dipyrone are

hypersensitivity reactions. The most

important reactions are circulatory and

agranulocytosis. These reactions occur

rarely or very rarely but are life-

nephropathy have been reported.

Other

Drowsiness, tiredness, and

headache have been reported

with dipyrone administration.

Hypotension has been reported

following

intravenous

administration of dipyrone.

Nausea, vomiting, gastric

irritation and xerostomia have

been described with oral and

parenteral

dipyrone

administration

threatening. They can occur even if

metamizole sodium has been formerly

used without any complications.

Immune System Disorders

In rare occasions, anaphylactoid or

anaphylactic reactions can occur that

only very rarely turn out severe and

life-threatening.

Such

reactions

medicines can develop during injection

or immediately after administration, but

also many hours later. However, they

mostly occur within the first hour after

administration.

Minor reactions typically appear

inform of skin and mucous membrane

reactions (such as itching, burning,

redness, urticaria, swellings), dyspnea

and - less frequently - gastrointestinal

complalnts (such as nausea, dyspepsia,

vomiting).

These minor reactions can develop into

severe forms with generalized urticaria,

severe angioedemas (also in the larynx

region), severe bronchospasm, cardiac

arrhythmias, drop in blood pressure

(sometimes preceded by a rise in blood

pressure) and circulatory shock. In

patients

with

analgesics-asthma-

syndrome,

intolerance

reactions

typically appear in form of asthma

attacks.

At the first signs of a state of shock

such as cold sweat, vertigo, dizziness,

skin

discoloration,

feeling

constriction in the heart region, the

appropriate immediate actions must be

taken.

Vascular Disorders

rare

occasions,

hypotensive

reactions may occur during or after the

administration,

that

possibly

pharmacologically induced and are not

accompanied by other signs of an

anaphylactoid or anaphylactic reaction.

These reactions only rarely lead to a

severe drop in blood pressure. A rapid

intravenous injection increases the risk

of such hypotensive reactions.

Blood and Lymphatic System Disorders

In rare occasions a leukopenia and in

very rare occasions an agranulocytosis

or thrombocytopenia may occur. These

reactions can occur even if metamizole

sodium has been formerly used without

any complications.

The risk of an agranulocytosis rises if

diopyrone is used for a longer than a

week.

typical

signs

agranulocytosis include inflammatory

mucosal changes (e.g. in the mouth,

nose or throat or in the genital or anal

region),

sore

throat,

swallowing

difficulties, fever and chills. In patients

that receive antibiotics, these signs can

however be minimal. Lymph node or

spleen

swellings

minor

completely

absent.

blood

sedimentation is strongly accelerated,

granulocytes

significantly

reduced or completely absent. The

hemoglobin,

erythrocyte

thrombocyte values are usually within

the normal range.

An unexpected deterioration of your

general condition can be an indication

of an agranulocytosis.

The treatment of these reactions

requires immediate discontinuation of

the medicine. Therefore it is strongly

recommended to discontinue dipyrone

upon

first

signs

agranulocytosis and not to wait for the

results of the laboratory diagnostic

tests.

Skin

and

Subcutaneous

Tissue

Disorders

In rare occasions, a fixed drug

eruption or other dermatological (rash)

can occur. In isolated cases, a Stevens-

Johnson

syndrome

(allergy-induced

skin disorder) or Lyell's syndrome (life-

threatening disorder with extensive skin

blistering) can occur.

Therefore,

dipyrone

must

immediately discontinued in case of

skin reactions.

In rare occasions, a fixed drug eruption

or other exanthemas (rash) and in

isolated

cases,

Stevens-Johnson

syndrome or LyclI's syndrome may

occur.

Other Reactions

Very rarely - particularly in case of

hypovolemia, preexisting disorders of

kidneys

overdose

-kidney

function

disorders

with

anuria

oliguria,

proteinuria

interstitial

nephritis may occur.

Allergic

Agranulocytosis has rarely been reported.

It is an immuno-allergic adverse reaction

lasting at least 1 week. Agranulocytosis is

unpredictable, not dose-related and may

occur even after a single dose.

Anaphylactic shock (see Warnings).

Dermatological reactions (see Warnings).

Hematological

Rarely

agranulocytosis,

anemia,

leucopenia and thrombocytopenia,

have

been reported.

Renal

Isolated cases of acute renal insufficiency

interstitial

nephropathy

have

been

reported.

Other

Drowsiness, tiredness, and headache have

been reported with dipyrone administration.

Hypotension has been reported following

intravenous administration of dipyrone.

Nausea, vomiting, gastric irritation and

xerostomia have been described with oral

and parenteral dipyrone administration.

Drug Interactions

Dipyrone/

Chlorpromazine:

Concurrent use of dipyrone and

chlorpromazine

cause

hypothermia;

therefore

combined therapy with these two

drugs should be avoided.

Dipyrone/Cyclosporin:

Dipyrone may cause a reduction

in cyclosporin blood levels, by

an unknown mechanism.

Dipyrone/

Chlorpromazine:

Concurrent

use of dipyrone and chlorpromazine may

cause

severe

hypothermia;

therefore

combined therapy with these two drugs

should be avoided.

Dipyrone/Cyclosporin: Dipyrone may cause

a reduction in cyclosporin blood levels, by

an unknown mechanism. A higher dose of

cyclosporin may be required.

Oral

Anticoagulants/

Pyrazolones/

Captopril/

Lithium/

Methotrexate/Triamterine/Anihypertensive

s/Diuretics:

The substance class of pyrazolones is

known to cause interactions with oral

anticoagulants,

captopril,

lithium,

methotrexate and triamterene as well as to

alter the effectiveness of antihypertensives

and diuretics. To what extent dipyrone

causes

these

interactions

too,

unknown.

Effect on ability to drive

and use machines

Effects on Ability to Drive and Use

Machines

Dipyrone can impair the ability to drive

vehicles or operate machines.

In the recommended dose range no effect

on the ability to concentrate and react is

known.

However,

since

dioyrone

supposed to have a central component of

action and central side effects can occur in

case of overdose, the possibility of an

impairment

should

taken

under

consideration at least at higher doses and

driving vehicles, operating machines or

other potential dangerous activities should

be avoided in this case. This applies

particularly in combination with alcohol.

Pharmacological

properties

Action

Optalgin

non-narcotic

analgesic and antipyretic.

Pharmacological Properties

Pharmacodynamic properties

Pharmacotherapeutic

group:

Analgesics; Other analgesics and

antipyretics;

Pyrazolones

Code: N02BB02

Dipyrone is a pyrazolone derivate

and has analgesic, antipyretic and

minor antiphiogistic as well as

spasmolytic properties. Among the

pyrazolone derivates it has the

strongest analgesic effect. Similar to

other analgesics, the mechanism of

action is not known in detail.

Among other things, metamizole

sodium inhibits the prostaglandin

synthesis (PGE I and PGE2) and

reversibly

aggregation

thrombocytes.

inhibits

cyclooxygenase

affects

effect of the arachidonic acid. At the

same time there seems to be a

central component of action. For the

analgesic

active

component,

attenuation

central

pain

perception by activation of neurons

in the pain inhibition system is also

under consideration.

The antipyretic effect is mediated

central

attack

hypothalamic heat regulation center,

supported

increased

heat

dissipation via the periphery. The

exudations-inhibiting

vessel-

sealing properties of metamizole

sodium

bases

antiphlogistic effect that at least

partly can be explained by an

inhibition

endogenous

prostaglandin synthesis.

Pharmacokinetic properties

After oral administration, dipyrone

is rapidly and virtually completely

absorbed by the gastrointestinal

tract and is rapidly split to 4-

methylaminoantipyrine (MAA) via

a non-enzymatic hydrolysis. The

subsequent

metabolism

process

leads

formation

acetylaminoantipyrine (AAA) via

the active 4-aminoantipyrine (AA).

Another

route

degradation

consists of the incomplete oxidation

of MAA to

4-formylaminoantipyrine

(FAA).

Only 65-70% of the applied dose

detected

these

metabolites.

Maximum plasma concentrations

(with respect to all metabolites) can

be detected after approx. 30-90 min.

After oral administration of 1 g

metamizole sodium, the maximum

plasma

concentration

Cmax

MAA is 10.5 +/-2.8 µg/ml, after

rectal administration of I g dipyrone

it is 6.1 +/-1.9 µg/mI. The degree of

plasma protein binding is 57.6 %

for MAA, for 47.9 % for AA, 17.8

% for FAA and 14.2 % for AAA.

The pharmacokinetic behavior of

metabolites

seems

different depending on the dose.

The excretion is primarily (approx.

90%)

renal

with

main

metabolites

excreted biliary with a half life of

approx. 10 h. In the elderly, the

elimination half life of MAA rises

from 2.6 h (12 probands, 2 1-30

years) to 4.5 h (9 probands, 73-90

years).

Following

intramuscular

injection,

metabolites

metamizole sodium show a similar

behavior.

Action

Optalgin is a non-narcotic analgesic and

antipyretic.

Preclinical Safety Data

Preclinical Safety Data

Acute toxicity

See Overdosage

Subchronic/chronic toxicity

There are studies available on the

subchronic and chronic toxicity in

various animal species. Rats were

orally administered metamizole sodium

in doses of 100-900 mg/kg bw for 6

month. In the highest dose group (900

mg/kg bw), an increase of reticulocytes

and Heinz bodies was observed after 13

weeks.

Dogs were administered dipyrone in

doses of 30-600 mg/kg bw for 6 month.

Depending on the dose, a hemolytic

anemia as well as functional kidney and

liver alterations were observed at doses

from 300 mg/kg bw upwards.

Mutagenic and Carcinogenic Potential

Dipyrone has not been sufficiently

tested for mutagenicity. There are both

indications of mutagenic effects of

dioyrone as well as negative results.

Long term studies in rats showed no

evidence of a carcinogenic potential. In

2 of 3 long term studies in the mouse,

liver cell adenomas were increasingly

observed at high doses.

ReproductiveToxicity

Embryotoxicity studies in rats and

rabbits have shown no evidence of

teratogenic effects.

Embryolethal effects were observed in

rabbits from a maternally subtoxic daily

dose of 100 mg/kg bw upwards. In rats,

embryolethal effects at doses in the

maternal toxic range were observed.

Daily doses above 100 mg/kg bw in rats

led to a prolongation of the gestation

period and to an impairment of the birth

process with increased mortality of

mother and young.

Fertility tests showed a slightly

decreased pregnancy rate in the parent

generation at a dose above 250 mg/kg

bw per day. The fertility of the FI

generation was not affected.

Dosage and

Administration

Optalgin Caplets/Tablets

1-2 caplets or 1-2 tablets up to 4

times daily.

Do not exceed 8 caplets or 8

tablets daily.

Optalgin Drops

25-50 drops up to 4 times daily.

Notes

The dose should be reduced in elderly

patients as well as inpatients with reduced

general condition or limited creatinine, since

the excretion of the metabolic products of

dipyrone may be retarded.

Currently there is no sufficient information

regarding the long term administration of

dipyrone in patients with seriously impaired

liver and kidney function

Duration of Treatment

The duration of administration depends on

thenature and severity of the medical

condition.

Adults and Adolescents over from 15 years

old (over 53 kg body weight)

Optalgin Caplets/Tablets

1-2 caplets or 1-2 tablets up to 4 times

daily.

Do not exceed 8 caplets or 8 tablets daily.

Depending on the maximum daily dose, the

single dose can be taken in intervals of 6 to

8 hours.

The caplets/tablets should be taken with

sufficient liquid. (e.g a glass of water).

Optalgin Drops

The oral drops are taken with a little bit of

water.

Adults and adolescents From 15 years (>53

25-50 drops up to 3 4 times daily.

Infants and Children

For all age groups except babies, 8-16 mg of

dipyrone (metamizole) per kg body weight

can be administered as a single dose. The

table below shows the recommended single

dose and the maximum daily dose as a

function of body weight or age.

Body

weight

(kg)

Dose

(No of

drops)

3-11

months

drops up

to 3

times

daily

years

9-15

4-12

drops up

to 3

times

daily

years

16-23

6-19

drops up

to 3

times

daily

years

24-30

10-25

drops up

to 3

times

daily

10-12

years

31-45

12-37

drops up

to 3

times

daily

13-14

years

46-53

19-44

drops up

to 3

times

daily

The table below shows the recommended

single dose in miligrams of dipyrone and the

maximum daily dose in milligrams , as a

function of body weight and age:

Body

Weight in

Kg

(

Age

)

Single Dose

in Drops

(

Dose in

mg

)

Maximum

Daily Dose

in Drops

(

Max daily

dose in mg

)

3-11

months

drops

40-100

11-15

drops

220-300

9-15

years

4-12

drops

80-240

21-37

drops

420-740

16-23

years

6-19

drops

37-56

drops

740-1120

24-30

years

10-25

drops

200-500

57-75

drops

1140-1500

31-45

10-12

years

12-37

drops

240-740

73-112

drops

1460-2240

46-53

13-14

years

19-44

drops

380-880

110-131

drops

2200-2620

Overdosage

Overdosage

Manifestations :

In connection with acute overdose, nausea,

vomiting, abdominal pains, impaired kidney

fUnction/acute kidney failure (e.g. with

signs of an interstitial nephritis) and —

more rarely — central nervous symptoms

(vertigo, somnolence, coma, spasms) and a

drop in blood pressure up to a shock and

tachycardia were observed.

After administration of very high doses,

the excretion of rubazonic acid may cause a

red discoloration of the urine.

Treatment

No specific antidote is known for

dipyrone. If dipyrone was only recently

administered, it can be tried to limit the

absorption in the body by means of

absorption reducing measures (e.g. activated

carbon).

main

metabolite

(4-N-

methylaminoantipyrine) can be eliminated

by means of hemodialysis, hemofiltration,

hemoperfiision or plasma filtration.

The treatment of the intoxication as well as

the prevention of severe complications, may

require

general

special

intensive

medical monitoring and treatment.

Treatment

of

Severe

Anaphytactic

Reactions (Shock):

Emergency measures according to the

current guidelines must be initiated.

ןכרצל ןולעב ןכרצל ןולעב

ןיגלטפוא

®

תוילפק/תוילבט

תופיט ®ןיגלטפוא םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח םיטרפ

לע

םי/יונישה

םי/שקובמה תוליעפ

תיאופר ךוכישל

םיבאכ

תדרוהלו

.םוח הפורתה

תדעוימ

ךוכישל

באכ םי

ינונב םי

דע םיקזח

ןוגכ

יבאכ

םייניש ,שאר

יבאכו

תסו תדרוהלו

םוח

הובג

וניאש

ביגמ

יעצמאל

לופיט .םירחא יתמ

ןיא

שמתשהל רישכתב לא

ישמתשת

הפורתב

רשאכ

ךניה

ןוירהב

וא .הקינמ ןיא

שמתשהל

הפורתב

וז

םא

העודי

תושיגר דחאל

היביכרממ

ןיא

שמתשהל

הפורתב

םישוחימל

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י/שמתשת

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וז

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םייק

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חמ םצעה

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הפורתב

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ךניה ןוירהב

וא

.הקינמ

ןיא

שמתשהל

הפורתב

וז

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העודי תושיגר

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,)לוזימאטמ( ןוזאטובלינפ,ןוזאנפ,ןוזאנפיפורפ

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יתלבה

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ןיא

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הפורתב

וז

םישוחימל םילק

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.םדה

ןיא

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הפורתב

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ניה

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היטנ

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קושל

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תופורת ,רעיש

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לוטיל ןיגלטפוא

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וז

םיתיעל

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ךניה

ה/שיגר

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הפורת

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םורגל

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יאת

םד

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גאל סיזוטיצולונר

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וז הלולע

עיפוהל

םיתיעל

תורידנ

איהו

תאטבתמ תופייעב

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ךשמב

םימי

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אפורה

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םורגל

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םודא

ןתשב העפותב .יצמוח

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םוקמ

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הפורתב

וז

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וא הפורתל

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םד )םינבל הינפוטיצובמורט ,

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העיגפ

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קושו

הבוגת

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ךשמב

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הנושארה

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הפורתה ירחא

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תינמז-וב

םע .ןיגלטפוא

הפורת

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עבצל

םודא

ןתשב

העפותב .יצמוח

וז ןיא

םוקמ

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תובוגת

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תויתפורת םא

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הפורת

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לופיטה

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,תרחא

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חוודל אפורל

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ידכ

עונמל

םינוכיס

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:תואבה תופורת

דגנ

תשירק

םד

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הדירי

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הפורת(

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תקלד

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NSAIDS

ןוגכ )

.ןיריפסא

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תשירק

םד

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ןירופסולקיצ

ןכתית- )תולתשהל(

הדירי תמרב

ןירופסולקיצ

ןיזמורפרולכ

הפורת(

.)תיטוכיספ-יטנא הגיהנ הגיהנ

שומישה

הפורתב

וז

םינונימב

םיהובג ץלמומהמ

לולע

םוגפל

תוריהמב

,הבוגתה תלוכיב

גוהנל

ליעפהלו

תונוכמ

לעו

שי

ענמיהל

הגיהנ

תלעפה ,בכרב

תונוכמ

לכבו

תוליעפ תבייחמה

תונריע ןוכיסה ,

הלוע

םא

הפורתה תחקלנ

בולישב

םע

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יאוול ףסונב

תוליעפל

היוצרה

לש

ןמזב ,הפורתה שומישה

הב

תולולע

עיפוהל

תועפשה

.יאוול תועפות

תובייחמה תוסחייתה

תדחוימ הליחב

וא

יוריג

הביקב

קוש

העפות -יטקליפנא

לש

תושיגר

רתי תאטבתמה

העיזב

רצוק ,תרוחרחס ,הרק וא ,הליחב ,המישנ

קפוד

ריהמ

)רידנ( י/קספה תועפות

יאוולה

תוירקיעה

לש

הפורתה

םה תועפות

לש

תושיגר

ןה .רתי

:תוללוכ קוש

יטקליפאנא

ולא .סיזוטיצולונרגאו

ןה תועפות

תורידנ

ךא

תונכסמ

ןה .םייח

תולוכי םיטרפ

לע

םי/יונישה

םי/שקובמה לופיטה

י/הנפו

אפורל

!דימ םיפקתה

םיפירח

לש

היריפרופ

י/האר (

ןיא" שמתשהל

הפורתב

ילבמ

ץעוויהל

אפורב

ינפל תלחתה

)"לופיט י/קספה :)רידנ(

לופיטה י/הנפו

אפורל

!דימ יבאכ

שאר

הערפה ,םיכשמתמ

תינמז ידוקפתב

תוילכ

םילוחב

םע

רבע

לש

תולחמ הילכ

וא

הבוגת

תיגרלא

רועב

ןוגכ

החירפ

וא תויחופלש

תויריר

י/קספה :)רידנ(

לופיטה י/הנפו

אפורל

!דימ שחרתהל

וליפא

םא

רבעב

תלטנ

תא

הפורתה אלל

ןה .םיכוביס

תולוכי

שחרתהל

רבכ

העשב הנושארה

רחאל

תליטנ

ךא ,הפורתה

םג

'סמ תועש

.הירחאל

קוש

העפות -יטקליפנא

לש

תושיגר

רתי הפירח

תאטבתמה

העיזב

,הרק החירפב הרומח

לכב

תוחיפנ,ףוגה

לש

רועה

וא

לש תויחופלש,עולה

,תויריר

רצוק ,תרוחרחס המישנ

רומח ליחב ,

,האקה

יוריג

הביקב

קפוד

ריהמ תשגרה ,

ץחל

הזחב

הדיריו הדח

ץחלב

.,םדה )רידנ( י/קספה

לופיטה

י/הנפו

אפורל

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הרזע

תיאופר

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דע

תעגה

אפורה

שי

ביכשהל

תא הלוחה

לע

םירהל ,ובג

תא

יוצר .וילגר םמחל

תא

ופוג

י"ע

.הכימש

תושיגר

רתי

הפורת

וז

הלולע

םורגל םיתיעל

תורידנ

הינפוקיול

טועימ(

יאת םד

)םינבל הינפוטיצובמורט ,

הדירי( תויסטב

םדה

תאטבתמ

הילעב

היטנב םימומדל

וא

גאל סיזוטיצולונר

העיגפ

תיסקוט תוירודכב

םד

)תונבל

ןוכיסה

סיזוטיצולונרגאל

הלוע

םא הפורתה

תלטינ

רבעמ

.םימי הבוגת

וז

תאטבתמ

םוח

,הובג ,תרומרמצ באכ

ןורג יישק ,

העילב תוקלדו

ללחב

וא ,ףאב ,הפה

ירבאב ןימה

הערה

השגרהב

תיללכה

ןוגכ( תופייע

וא

.)השלוח םא

ךנה

ת/לטונ

ליבקמב ןכתי -הקיטויביטנא

םינמיסהו

ל"נה ויהי

םישלח

.רתוי םע

תעפוה

דחא

םינמיסה

ל"נה

שי קיספהל

דימ

תליטנ

הפורתה

ץעוויהלו םע

אפורה

תועפות

תוירוע

וא

:תויריר םירקמב

םידדוב

:ןכתיי

Stevens-johnson syndrome

וא

Lyell's syndrom

ולא

םה

תובוגת תוירוע

תופירח

תונכסמו

םייח

ןוגכ החירפ

וא

תויחופלש

קספה - .תויריר לופיטה

הנפו

אפורל

!דיימ יבאכ

שאר

םיכשמתמ

םירקמב

םירידנ

רקיעב ,

םיבצמב

לש הדירי

חפנב

םילוחב,םדה

םע

רבע

לש תולחמ

הילכ

םירקמבו

לש

ןונימ

:ןכתי,רתי הערפה

תינמז

ידוקפתב

תוילכ

םילוחב

םע רבע

לש

תולחמ

הילכ ידוקפתב ,

הילכ ןוגכ

הדירי

וא

רסוח

ןתמב

תקלד ,ןתש וא ,תוילכ

השרפה

לש

ןובלח

.ןתשב וא הבוגת

תיגרלא

הפירח

רועב

ןוגכ

החירפ וא

תויחופלש

תויריר

י/קספה :)רידנ( לופיטה

דימ

י/הנפו

אפורל

הליחב

וא

יוריג

הביקב

םיפקתה

םיפירח

לש

היריפרופ

י/האר ( םיטרפ

לע

םי/יונישה

םי/שקובמה ףיעס

ינפל"

שומישה

)"הפורתב :)רידנ( י/קספה

לופיטה

דימ

י/הנפו

אפורל

ןונימ

רתי באכ ,תואקה ,הליחב

העיגפ,ןטב

ידוקפתב םירקמבו ,הילכ

םירידנ

,תרוחרחס :רתוי רסוח ,תותיווע

הדירי ,הרכה

ץחלב

םדה

,קוש, תוערפה

בצקב

.בלה תליטנב

ןונימ

דאמ

הובג

לש

עבצ ,הפורתה ןתשה

לולע

ךופהל

םודאל ןכרצל ןולעב ןכרצל ןולעב

הפה ךרד ןתמל תופיט ןיגלטפוא םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח ןונימ

3-11

םישדוח

דע ,תופיט

.םוימ םימעפ

3-1

םינש

12-4

דע ,תופיט

םימעפ .םויב

6-4

םינש

19-6

דע ,תופיט

םימעפ .םויב

9-7

םינש

25-10

דע ,תופיט

.םויב םימעפ

12-10

םינש

37-12

דע ,תופיט

.םויב םימעפ

14-13

םינש

44-19

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תא

ןונימה

םיאתמה

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עיפומש

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שי

לוטיל

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3

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.

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15

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53

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:

50-25

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דע

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םימעפ

םינש

תופיט

םימעפ

םינש

דע

םימעפ

םינש

םימעפ

םינש

םימעפ

םינש ןכרצל ןולעב ןכרצל ןולעב

הפה ךרד ןתמל תופיט ןיגלטפוא םיטרפ

לע

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הפורתה

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הקזח

.ידימ

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