| TACHIPIRINA®
1000 mg
Effervescent tablets
N02BE01- Paracetamol
COMPOSITION
Each effervescent tablet contains:
Active ingredient: paracetamol 1000 mg.
Excipients: citric acid – sodium carbonate – sodium bicarbonate
– sorbitol – sodium benzoate – orange flavour –
acesulfame K – dimethicone – sodium docusate.
PHARMACEUTICAL
FORMS
Effervescent tablets:
box containing 12 effervescent tablets of 1000 mg.
PHARMACOTHERAPEUTIC
GROUP
Analgesic -
antipyretic.
MARKETING
AUTHORIZATION HOLDER
Aziende Chimiche Riunite Angelini Francesco
A.C.R.A.F. S.p.A.
Viale Amelia 70 - 00181 Rome.
MANUFACTURER
AND FINAL INSPECTOR
Manufacturing:
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona
E-Pharma Trento S.p.A. – Via Provina, 2 – 38040 Ravina –
TN (primary and secondary packaging excluded)
Release
and final inspection:
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona
THERAPEUTIC INDICATIONS
Symptomatic treatment for painful affections of various origin (such as
headache, tooth ache, torticollis, articular and lumbosacral pains, menstrual
pain and minor surgery).
CONTRAINDICATIONS
Hypersensitivity to any of the product constituents.
Subjects under the age of 15.
Products containing paracetamol are contraindicated in patients with severe
hemolytic anemia.
Severe hepatocellular impairment.
The product contains sorbitol: it is therefore contraindicated in cases
of hereditary intolerance to fructose.
PRECAUTIONS
FOR USE
In rare cases of allergic
reactions, the administration should be discontinued and appropriate treatment
set up.
Use with caution in subjects with glucose 6-phosphate dehydrogenase deficit.
Use with caution in subjects with kidney or liver failure and in patients
with Gilbert syndrome.
High doses or prolonged use of the product may cause high-risk hepatopathy
and even serious alteration in kidney and blood.
While under treatment with paracetamol, prior to taking any other drugs,
make sure these do not contain the same active ingredient, as high doses
of paracetamol may cause serious adverse reactions.
Patients should be warned to consult with the doctor prior to associating
any other drugs. See also the "Interaction" section.
Do not use for longer than 10 days where not previously advised by your
doctor.
In cases of prolonged use, monitoring is recommended of hepatic and renal
functions and blood crasis.
INTERACTION
WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Reduced doses are recommended during treatment with oral anticoagulants.
Use with extreme caution and under close medical surveillance during chronic
treatment with drugs which can cause induction of hepatic monooxygenases
or in cases of exposure to substances able to develop that effect (e.g.,
rifampicin, cimetidine and antiepileptic agents such as glutethimide,
phenobarbital and carbamazepine). The same applies in cases of ethylism
and patients treated with zidovudine.
Medications slackening gastric depletion (such as anticholinergic agents)
can cause antral stasis, with paracetamol absorption and thus onset of
analgesic effect consequently slowed up. The administration of paracetamol
may affect the determination of uricaemia (through the phosphotungstic
acid method) and that of glycaemia (through the glucose-oxydase-peroxydase
method).
The concomitant administration of chloramphenicol may prolong paracetamol
half-life, with risk of increased toxicity.
SPECIAL
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In patients
following low sodium diets, it should be borne in mind that each effervescent
tablet of Tachipirina 1000 mg provides approx. 24 mEq of sodium. The product
contains sorbitol: thus, it may cause gastric disorders and diarrhea.
Pregnancy and lactation: Use of the product is only recommended
where strictly necessary and under close medical surveillance.
Effects on ability to drive and use machines: The medicinal
product does not alter the ability to drive or use machines.
KEEP
THE PRODUCT OUT OF THE REACH OF CHILDREN.
POSOLOGY,
METHOD AND TIME OF ADMINISTRATION
Adults (over the age
of 15): 1 effervescent tablet dissolved in a glass of water, 1 to 2 times
daily; in more serious cases, the daily dosage may be increased up to
3 tablets daily.
The interval in between doses should not be less than four hours.
OVERDOSE
In case very high doses
are accidentally taken, the acute poisoning develops with anorexia, nausea,
vomiting, pallor, abdominal pain followed by severe decay of the general
condition; those symptoms usually appear within the first 24 hours. In
case of overdosing (more than 10 g of paracetamol in adults and 150 mg/kg
body weight in children), paracetamol can cause hepatic cytolysis that
may evolve to massive and irreversible necrosis with consequent hepato-cellular
impairment, metabolic acidosis and encephalopathy, which in turn can lead
to coma and death. Increased levels are simultaneously observed of hepatic
transaminases, lactate dehydrogenase and bilirubinemia, and reduced levels
of prothrombin, which may show within 12 to 48 hours from ingestion.
Early gastric depletion and hospitalization for proper treatment are the
measures to be taken.
UNDESIRABLE
EFFECTS
Cutaneous reactions of various type and severity have been reported following
use of paracetamol, including cases of erythema multiforme, Stevens Johnson's
syndrome and epidermic necrosis.
Hypersensitivity reactions have been reported, such as, for instance,
skin rush with erythema or urticaria, angioedema, laryngeal edema and
anaphylactic shock. The following undesirable effects have also been reported:
thrombocytopenia, leukopenia, anemia, agranulocytosis, altered hepatic
function and hepatitis, kidney alterations (acute kidney failure, interstitial
nephritis, hematuria, anuresis), gastrointestinal reactions and dizziness.
The development of allergic reactions calls for discontinuation of treatment.
Where observed, the directions contained in the explanatory leaflet herein
help reducing the development of undesirable effects.
It is important that any undesirable effect, even where not included in
this explanatory leaflet, be reported to your physician or pharmacist.
SHELF
LIFE AND STORAGE
Check the date
of expiry shown on the package; that date refers to the unopened and properly
stored packaging.
Warning: do not use the product after the date of expiry shown on the
package.
Keep the product in the original container, away from moisture; keep away
from heat.
DATE
OF LAST REVISION OF THE TEXT : September 30, 2004
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