APRIETAL COMPROMIDOS 160mg PROSPECTUS
COMPOSITION
By tablet:
Paracetamol (D.C.I)……………….160mg
Excipìents: Sodium Saccharin, povidone, manitol, sodium carboxymethyl (type A),
potato starch, talc, raspberry essence and azorubine (E-122)
ACTION
Analgesic, antipyretic.
POSOLOGY
Children:
From 0 to 3 months: ¼ of a tablet (40 mg)
From 4 to 11 months: ½ of a tablet (80 mg)
From 1 to 2 years:
¾ of a table (120 mg)
From 2 to 3 years:
1 tablet (160 mg)
From 4 to 5 years:
1 ½ tablet (240 mg)
From 6 to 8 years:
2 tablets (320 mg)
From 9 to 10 years: 2 ½ tablets (400 mg)
This dose can be repeated 4 or 5 times a day without exceeding a total of 5 doses in 24
hours. A dosage scheme of 10 mg/kg can also be applied.
The administration of the product is recommended at the onset of symptoms of pain or
fever. When these symptoms disappear, treatment should be discontinued.
INSTRUCTIONS FOR CORRECT ADMINISTRATION
The tablets may be chewed, before a drink of water or other liquid. They may also be
administered broken into a little water, milk or fruit juice.
COUNTERINDICATIONS
Disorders of the liver.
PRECAUTIONS
In patients with hepatic and/or renal insufficiency, anaemia, cardiac or pulmonary
disorders, long treatments should be avoided.
Do not exceed the stated dose.
It is advisable to consult a doctor before using this product in under-threes or in
treatments exceeding 10 days.
WARNING
IMPORTANT FOR WOMEN:
IF you are pregnant, or believe that you may be so, consult your doctor before taking
this medicine. The consumption of medication during pregnancy can be dangerous for
the embryo or foetus, and must be monitored by your doctor.
Warning regarding excipients: This medicine contains azorubine as an excipient. It can
cause allergic reactions, including asthma, especially in patients allergic to
acetylsalicylic acid.
SECONDARY EFFECTS
Hepatoxicity with high doses or prolonged treatments.
Occasionally cutaneous eruptions and haematological alterations, such as leucopenia
and neutropenia, may occur.
INTERACTIONS
It can increase the toxicity of chloramphenicol.
In the case of treatment with oral anticoagulants it may be administered occasionally as
analgesic of choice.
INTOXICATION AND ITS TREATMENT
The symptomology of overdose includes sickness, vomiting, loss of appetite, jaundice
and abdominal pain. In case of an overdose the affected person must go to a Medical
Centre immediately, even if no symptoms have yet appeared. Even though the
symptoms of overdose are very severe, they do not usually appear until the third day
after it occurs.
In adults, an overdose of paracetamol is considered to be a single dose of more than 6g,
and in children a dose of more than 100mg/kg of weight. Patients undergoing treatment
with barbiturates or chronic alcoholics may be more susceptible to an overdose of
paracetamol.
The treatment consists of aspiration and gastric lavage, activated charcoal orally,
intravenous administration of an adequate dose of N-acetylcysteine, and if necessary
haemodialysis.
The period in which the treatment offers most guarantee of success is during the 12
hours after the ingestion of the overdose.
In the event of overdose or accidental ingestion consult El Servicio de Información
Toxocológica. Tel (91) 562 04 20.
PRESENTATION AND PRICE
Packet with 20 x 160mg paracetamol tablets.
P.V.P IVA 225 ptas. (1.36 EUR) C. N. 947457
Available without prescription. Can be financed by S.N.S. S.N.S subsidy at normal rate.