Read the whole of this prospectus in detail, because it contains information that
will be important to you.
This medication can be obtained without a prescription for the treatment of minor
afflictions without the intervention of a doctor. However, you must use APRIETAL
SUPOSITORIOS NINOS with care to obtain the best results.
-Keep this prospectus, you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm
them, even when their symptoms are the same as yours.
In this prospectus:
1. WHAT ARE APIRETAL SUPOSITORIOS NINOS AND WHAT ARE
THEY USED FOR?
2. BEFORE USING APIRETAL SUPOSITORIOS NINOS
3. HOW TO USE APIRETAL SUPOSITORIOS NINOS
4. POSSIBLE ADVERSE EFFECTS
5. STORAGE OF APIRETAL SUPOSITORIOS NINOS
APIRETAL SUPOSITORIOS NINOS 250mg
Paracetamol (D.C.I)
APIRETAL SUPOSITORIOS NINOS is presented in suppository form. Its active
principle is paracetamol. Each suppository contains 250 mg of paracetamol (D.C.I)
The remaining components are solid semisynthetic glycerides.
COMMERCIALIZATION AND PRODUCTION
The owners of the commercialization and production rights for this product are
Laboratorios ERN SA
Pedro IV, 499-08020 Barcelona, España
1. WHAT ARE APIRETAL SUPOSITORIOS NINOS AND WHAT IS IT
USED FOR?
APIRETAL SUPOSITORIOS NINOS is a medication which is presented in
suppository form. It comes in a pouch containing 5 suppositories.
APIRETAL SUPOSITORIOS NINOS belongs to the Non-narcotic Analgesic and
Antipyretic pharmacotherapeutic group.
APIRETAL SUPOSITORIOS NINOS is used in the treatment of:
- Pain of light and moderate intensity
- Fevers
2. BEFORE USING APRIETAL SUPOSITORIOS NINOS
Don’t use APRIETAL SUPOSITORIOS NINOS:
- If the patient suffers from any hepatic illness
- If the patient is hypersensitive to paracetamol
Take special care with APRIETAL SUPOSITORIOS NINOS:
If the patient suffers from hepatic or renal weakness, anaemia, serious heart disease or
chronic alcoholism. In these cases administration must be under the supervision of a
doctor, and prolonged treatments must be avoided.
Pregnancy:
Consult your doctor or pharmacist before taking this medication.
There have been no problems described for pregnant women who have taken
paracetamol.
Breastfeeding:
Consult your doctor or pharmacist before taking this medication.
Paracetamol is excreted in small quantities through breast milk. Its use is accepted
during breastfeeding.
Driving and use of machinery:
No effects have been described on the capacity to drive and use machinery.
Use of other medication:
Inform your doctor or pharmacist if the patient is taking or has recently taken any other
medication- including those which do not require a prescription.
Remember that these instructions apply equally to medicines that might be taken before
and those taken after this product.
It can increase the toxicity of chloramphenicol.
In the case of treatment with oral anticoagulants it may be administered occasionally as
analgesic of choice.
Paracetamol can alter the value of the following analytical determinations: In blood:
(biological) increase in transaminases (ALT and AST), alkaline phosphatase, ammonia,
bilirrubine, creatine, dehydrogenase lactate (LDH) and urea: increase (analytical
interference) of glucose, teophiline and uric acid.
The chronic use of barbiturates (except butalbital) or primidone diminishes the
therapeutic effects of paracetamol. It must be taken into account that hepatic enzyme
inducers may produce similar effects,
Prolonged simultaneous use of paracetamol and salicylates due to chronic
administration of elevated doses of both analgesics significantly increases the risk of
nephropathy, renal papillary necrosis, terminal kidney illnesses and bladder or kidney
cancer caused by analgesics.
3. HOW TO USE APIRETAL SUPOSITORIOS NINOS
Follow these instructions unless your doctor has advised you otherwise.
Remember to take your medication.
If you believe APIRETAL SUPOSITORIOS NINOS is too weak or too strong, advise
your pharmacist or doctor.
APIRETAL SUPOSITORIOS NINOS is administered rectally.
Do not exceed the recommended dose.
Administration:
The recommended dose for paracetamol in paediatrics is as follows:
From 0 to 3 months
From 4 to 11 months
From 1 to 2 years
From 2 to 3 years
From 4 to 5 years
From 6 to 8 years
From 9 to 10 years
Above 10 years
40 mg
80 mg
120 mg
160 mg
240 mg
320 mg
400 mg
480 mg
This dosage 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. This dosage is equivalent to 1
APIRETAL SUPOSITORIOS NINOS suppository (250 mg of paracetamol) for
children of 4-6 years and 1 APIRETAL SUPOSITORIOS ADULTOS suppository (500
mg of paracetamol) for children over 10 years old.
The administration of the product is recommended at the onset of symptoms of pain or
fever. When these symptoms disappear, treatment should be discontinued.
If you exceed the stated dose of APIRETAL SUPOSITORIOS NINOS, consult your
doctor or pharmacist immediately. Overdoses of paracetamol cause hepatoxicity
(sickness, nausea, vomiting, anorexia, jaundice, abdominal pain). In adults, an overdose
is considered to be a single dose of more than 6g, and in children a dose of more than
100mg/kg of weight. The hepatoxic dose may be less in the case of chronic alcoholism,
in patients with liver disorders and if the patient is undergoing concomitant treatment
with barbiturates.
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.
If you forget to use APIRETAL SUPOSITORIOS NINOS:
Don’t take a double dose to compensate.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines APIRETAL SUPOSITORIOS NINOS can have adverse effects.
It may produce hepatoxicity in high doses or with prolonged treatment.
Occasionally cutaneous eruptions and haematological alterations, such as leucopenia
and neutropenia, may occur.
If you observe any reaction not described in this prospectus, please consult your doctor
or pharmacist.
5. STORAGE OF APIRETAL SUPOSITORIES
Maintain APIRETAL SUPOSITORIOS NINOS out of the sight and reach of children.
No special conditions are needed for their storage or preservation.
Expiry Date: Don’t use APIRETAL SUPOSITORIES NINOS after the expiry date
indicated on the packaging.
This prospectus has been approved in