OPTALGIN CAPLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIPYRONE

Available from:

TEVA ISRAEL LTD

ATC code:

N02BB02

Pharmaceutical form:

CAPLETS

Composition:

DIPYRONE 500 MG

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 date:

2015-01-31

Patient Information leaflet

DOR-Opt-Tab-Cap-PIL-0622-11
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed without a doctor’s prescription
OPTALGIN
® 500 MG CAPLETS
OPTALGIN
® 500 MG TABLETS
COMPOSITION
Each caplet/tablet contains:
dipyrone 500 mg
For
information
about
inactive
ingredients,
see
section
6,
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
Take this medicine according to the instructions in the section about
dose in this
leaflet. Consult your pharmacist if you need further information.
BABIES AND CHILDREN CAN BE GIVEN THIS MEDICINE IN DROPS.
CONSULT YOUR DOCTOR IF YOUR FEVER LASTS MORE THAN 3 DAYS OR PAIN
PERSISTS
FOR MORE THAN 7 DAYS, EVEN THOUGH YOU ARE USING THE MEDICINE. THERE IS
A GREATER RISK OF AGRANULOCYTOSIS IF TREATMENT CONTINUES FOR LONGER
THAN
7 DAYS (SEE SECTION 4, ‘SIDE EFFECTS’).
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for relieving moderate to severe pain, such
as
headache, toothache, and menstrual pain, and for reducing high fever
that
does not respond to other treatment measures.
THERAPEUTIC GROUP: pyrazolone group.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
·
You are sensitive (allergic) to the active ingredient dipyrone
(metamizole)
or
other
pyrazolones
(such
as
propyphenazone,
phenazone)
or
pyrazolidines
)such
as
phenylbutazone,
oxyphenbutazone(;
this
also
includes patients who have, for example, developed a significant
reduction
in counts of certain white blood cells (agranulocytosis) after using
these
medicines.
·
You are sensitive (allergic) to any of the other ingredients in this
medicine
(see section 6, ‘Additional information’).
·
You
have
a
known
sensitivity
to
pain
relievers
(analgesics
asthma
syndrome
or
sensitivity
to
pain
relievers
experienced
as
rash/
angioedema). This applies to patients who r

Summary of Product characteristics

Optalgin Caplets/Tablets SPC, SZ, 6/2022 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 (Metamizole sodium).
_ _
_ _
_Optalgin Tablets _
Each tablet contains 500 mg
_ _
Dipyrone (Metamizole sodium).
_ _
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.
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.
2
Optalgin Caplets/Tablets SPC, SZ, 6/2022 NOTIFICATION
_Children and infants _
Other pharmaceutical forms are available that allow for adequate
dosing in young children and infants
such as 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 pati