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1. FEV ADOL ® SUPPOSITORIES
Antipyretic and analgesic for children.
COMPOSITION:
Suppositories of 100rng, 200mg, and 350mg of paracetamol.
PROPERTIES:
FEVADOL has analgesic and antipyretic effects comparable
to acetyl salicylate while avoiding many of the side effects
of these agents.
THERAPEUTtC INDICATIONS:
FEVADOL is indicated for infants and children ro- the relief
of fever and pain wtUc:h may acoompany oonditions such
as: Tonsillitis, common cold, innuenza, post-immunization
reactions and headache. Fevadol is valuabte also in reducing
pain foItowing tooth extraction, tooth eruption, tonsllectomy
and adenoidectomy.
Instructions for use:
FEVADOl suppositories should be giverl to infants under 3
months only if prescribed by the physician. The same applies
to children of any age if the dnJg Is to be administered for
more than 10 days.
FEVAOOl suppositones liquefy or soften if stored at
temperatures higher than 3S-C, however the quality of the
suj)pOSitories Is not affected at all. Short cooling in running
cokt water will once more make the suppositories ready for
application.
DOSAGE AND ADMINISTRATION:
3 to 6 months: 1 supp. of 100mg, 2 - 3 times a day
6 to 12 months: 1 supp. of 100mg, 3 - 4 times a day
1 to 3 years: 1 supp. of 200mg, 2 - 3 times a day
3 to 6 years: 1 supp. of 200mg, 3 - 4 times a day
over 6 years: 1 supp. of 35Omg, 2 - 4 times a day
CONTRAINDICATIONS:
Hypersensitivity to paracetamol.
WARNINGS:
Do net exceed the recommended dose.
Severe liver damage may occur if your child takes more than
the maximum daily amount.
Sore throat warning: If sore throat is severe, persists for
more than 2 days, is accompanied or followed by fever,
headache, rash, nausea, or vomiting, oonsult a doctor
promptly.
This product should not be used with other paracet.arT'd
containing products.
Alcohol warning: caubon Is to be exercised in case of
chronic alc0hoi intake. Concurrent alcohol and paracetamol
intake may aggravate lNer damage.
Consult a doctor before use if your child has severe liver or
kidney problem.
Stop use and ask a doctor if: Pain gets worse or lasts more
than 5 days, fever gets worse or lasts more than 3 days, or if
new symptoms such as redness, rashes or swelling occur.
INTERACTION WITH OTHER MEDICAL PRODUCTS AND
OTHER FORMS OF INTERACTION:
Anticoagulants: Prolonged regular use of paracetamol
possibty enhances warfarin.
The liver effects of paracetamol may be increased by the
concomitant use of alc0hoi and certain drugs (barbiturates,
tricydic antidepressants) which enhance the metabolism of
paracetamol in the liver.
JfIDIUNDESIRABLE EFFECTS:
When taken as recommended, FEVADOL is usual1y free from
side effects.
Allergic skin rashes and blood disorders (including
thrombocytopenia, leucopenia, neutropenia) have been
reported.
Important: liver damage (and less frequentty renal damage)
may occur foIlO'Aing overdose.
OVERDOSE:
In massive over dosage exceeding 10 g of paracetamol
may cause liver damage. Earty symptoms may include
pallor, nausea, vomiting, (diaphoresis) and general malaise.
Overdose with paracetamol C3l result in severe liver damage
and sometimes acute renal tubular necrosis.
Immediate medal management is required in the event of
overdose, even if symptoms of overdose are not present
Activated charcoal is to be administered if paracetamol is
ingested WIthin 1 hour.
Clinical and laboratory evidence of liver damage may not
be apparent unm 48 to 72 hours past ingestion. Overdose
shoukt be promptty treated by gastric lavage followed by
intravenous N.acetylcysteine or methiontne without waiting
for the results of plasma paracetamol levels.
Additional antidote therapy is normally considered in light
of further plasma paracetamol Ievets and the time elapsed
since ingestion. In al cases of suspected overdose, prompt
medical attention is aitical for adults as we! as for chiktren,
even if you do not notice any signs or symptoms. GeI'l8faI
supportive measures must be available.
STORAGE:
·Store in a refrigerator for 30 minutes prior to use".
AVAILABILITY:
FEVADOL is available as 100 mg, 200 mg and 350 mg
suppository.
Thl. I. a medicament
- A medicament is a product which affects your health,
and its consumption contrary to instructions is
dangerous for you.
- Follow strictly the doctor's prescription, the method of
use and the instructions of the phannacists who sold
the medicament.
The doctor and the phannacists are experts in
medicine, its benefits and risks.
Do not by yourself interrupt the period of treatment
prescribed for you.
00 not repeat the same Pfescription without consulting
your doctor.
Keep medicaments out of the reach of children.
Council of Arab Health Ministers
Union of Arab Pharmacists
Manufactured by SPIMACO
AJ-Qassim Pharmaceutical Plant,
Saudi Pharmaceutical Industries &
Medal Appliances Corporation,
Saudi Arabia.
Revision date: May 2011.
'FEVADOl' is a trade mark
34FE398
Ahmed
Abdelbaky
Digitally signed by Ahmed Abdelbaky
DN: cn=Ahmed Abdelbaky,
o=Pharmacia1.com website, ou=Scanned
doc., email=Listen2Article@gmail.com, c=SA
Date: 2015.08.20 10:42:41 +03'00'
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