ACAMOL

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

PARACETAMOL

Disponible des:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Codi ATC:

N02BE01

formulario farmacéutico:

CAPLETS

Composición:

PARACETAMOL 500 MG

Vía de administración:

PER OS

tipo de receta:

Not required

Fabricat per:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapéutico:

PARACETAMOL

Área terapéutica:

PARACETAMOL

indicaciones terapéuticas:

Relief of pain and fever of different etiologies such as headache, toothache, colds, influenza, rheumatic pain and dysmenorrhea.

Data d'autorització:

2013-03-31

Informació per a l'usuari

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS(
–
1986
The medicine is dispensed without a
doctor’s prescription
ACAMOL
®
Tablets
ACAMOL
®
Caplets
Composition
Each tablet/caplet contains:
Paracetamol 500 mg
For information on the inactive ingredients
in the preparations, see section 6 –
“Further Information”.
Read the leaflet carefully in its entirety
before using this medicine. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This
medicine
is
administered
without a doctor’s prescription and is
intended for adults and children aged
6 years and older. Take the medicine
in accordance with section 3 in this
leaflet. Consult a pharmacist if you
need further information.
Refer to a doctor if the fever persists for
more than 3 days or if the symptoms
worsen or do not pass within 5 days,
despite use of the medicine.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for relief of pain
and fever of different etiologies such as
headache, toothache, colds, influenza,
rheumatic pain and menstrual pain.
Therapeutic group:
Analgesic and antipyretic.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• There is a known sensitivity to
paracetamol or to any of the other
ingredients of the medicine.
Special warnings regarding use of the
medicine
• If you have developed skin side effects in
the past as a result of taking preparations
containing paracetamol, do not take
preparations containing paracetamol,
so that severe skin effects will not recur.
• The preparation contains paracetamol,
which may cause liver damage when:
∘
Given
at
a
dosage
higher
than
recommended or for a prolonged period.
∘ Alcoholic beverages are consumed
during the course of treatment.
∘ Other medicines which affect liver
function, are taken.
•
Do
not
use
this
medicine
frequently
without consulting a doctor.
•
Do
not
take
other
antipyretics
and
analgesics or cold medicines without
consulting a d

Fitxa tècnica

Acamol TC, 9. 4. 2008, RH
"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
ץרמ
2008
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: March 2008.
ACAMOL
TABLETS - CAPLETS
COMPOSITION
_ACAMOL TABLETS _
Each tablet contains:
_Active Ingredient _
Paracetamol
500 mg
_Other Ingredients_
Maize starch, povidone, stearic acid.
_ACAMOL CAPLETS _
Each caplet contains:
_Active Ingredient_
Paracetamol coarse granulate powder
equivalent to paracetamol
500 mg
_Other Ingredients_
Pregelatinized
starch,
povidone,
stearic
acid,
hypromellose
(hydroxypropylmethylcellulose),
macrogol
400
and
macrogol
8000 (polyethylene
glycols).
MECHANISM OF ACTION
Paracetamol is a clinically-proven non-salicylate analgesic and
antipyretic with rapid
absorption and action. It produces analgesia by elevation of the pain
threshold, and
antipyresis through action on the hypothalamic heat-regulating center.
Paracetamol is particularly suitable for patients with peptic ulcer as
it does not cause
gastric irritation and also for patients who have salicylate
intolerance.
INDICATIONS
Relief of pain and fever of different etiologies such as headache,
toothache, colds,
influenza, rheumatic pain and dysmenorrhea.
CONTRAINDICATIONS
Known hypersensitivity to paracetamol or to any other ingredient of
the preparation.
WARNINGS
Paracetamol can cause accidental poisoning in toddlers and infants.
Paracetamol-
containing products should be kept well out of reach of children.
Potentially fatal hepatotoxicity can result from paracetamol
overdosage. However, in
rare cases, hepatotoxicity has occurred in patients receiving high or
excessive doses
within therapeutic doses. Certain patients may be more susceptible to
paracetamol
hepatotoxicity, e.g., chronic alcoholics, patients with liver disease,
or those who are
malnourished or taking other drugs that induce hepatic enzymes.
2
Acamol TC, 9. 4. 2008,