To relieve mild to moderate pain and to reduce fever in many conditions including headache, toothache, teething, feverishness, colds, influenza, and following vaccination.

Posology

The dose should be weight-related dosing in the label instructions. If the weight of the child is unknown, age-related dosing is provided (See table 1 below).

Taking this medicine

Check the tables below to see how much of the medicine to use

•       This medicine contains 160mg of paracetamol in one 5ml spoonful (32 mg/mL).

•       Take this medicine by mouth only.

•       Never give more medicine than shown in table.

•       It is important to shake the bottle for at least 10 seconds before use.

•       Always use the spoon supplied with the pack. Do not overfill the spoon.

•       Do not give this medicine with any other paracetamol-containing product.

•       Seek medical advice before giving to the preterm neonate or term neonates <10 days.

•       Repeat 4 – 6 hourly up to 5 times per day if required.

•       No more than 5 doses in any 24-hour period, unless directed by physician.

•       Should not be used for more than 5 days for children ≥2 years and 3 days for infants (<2 years) except on medical advice.

Method of administration

For oral administration only

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

•       Contains paracetamol.

•       Do not give with any other paracetamol-containing products.

•       For oral use only.

•       Never give more medicine than shown in the table.

•       Always use the spoon supplied with the pack. Do not overfill the spoon.

•       Do not give to babies less than 2 months of age.

•       For infants 2-3 months no more than 2 doses should be given.

•       Do not give more than 4 doses in any 24 hour period.

•       Leave at least 4 hours between doses.

•       Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

•       As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

•       Do not store above 30°C.

•       Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed serious liver damage.

•       If symptoms persist consult your doctor.

•       Keep out of the sight and reach of children.

Liver warning: “This product contains paracetamol. Maximum daily dose is shown in table 1(section 4.2 Posology and method of administration), Severe or possibly fatal liver damage may occur if you take more than the recommended dose in 24 hours or with other drugs containing paracetamol.”

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).

The use of drugs that induce hepatic microsomal enzymes such as anticonvulsants and oral contraceptives may increase the extent of metabolism of paracetamol resulting in reduced plasma concentrations of the drug and a faster elimination rate.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)

Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite of paracetamol leading to increased risk of hepatotoxicity.

Pregnancy

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Breast-feeding

Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not contraindicate breast feeding.

To report any side effect(s):

 The National Pharmacovigilance and Drug Safety Centre (NPC)

o Fax: +966-11-205-7662

o Toll free phone: 19999

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)

ATC Code: N02 BE01.

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

Oral absorption is rapid and almost complete, it may be decreased if Paracetamol is taken following a high carbohydrate meal.

There is no significant protein binding with doses producing plasma concentrations of below 60mcg (µg)/ml, but may reach moderate levels with high or toxic doses.

Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 - 20mcg (µg)/ml (with doses up to 650mg); time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.

Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.

Peak concentration of 10 - 15mcg(µg)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion of a single 650mg dose. Half life in breast milk is 1.35 - 3.5 hours.

Sorbitol 70% Non-Cryst, Polyethylene Glycol 1500, Propylene Glycol, Citric Acid Anhydrous, Sodium Benzoate, Saccharin Sodium, Trisodium Citrate Dihydrate, Butylated Hydroxyanisole, Sicovit Azorubine 85E122, Strawberry Flavour, Apricot Flavour, and Purified Water q.s to (ml)

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard to be protected from light.

Do not refrigerate it.

Do not store above 30°C.

This medicine will be expired after 30 days from the first opening.

Each pack of Fevadol 160mg/5ml SF Syrup contains 100ml in amber bottle.

Each pack of Fevadol 160mg/5ml SF Syrup contains 145ml in amber bottle.

The material of construction and type of cap.: Type III Soda Lime Glass with child resistant cap (CRC).