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

This product for infants under 2 years.

Check the table below to see how much of the medicine to use.

§ For oral use only.

§ Never give more medicine than shown in the table

§ Always use the graduated dropper supplied with the pack

§ Check dropper markings carefully before use.

§ Do not overfill the graduated dropper

§ If symptoms do not improve within 24 hours consult your doctor.

§ Prolonged use except under medical supervision may be harmful.

§ Seek medical advice before giving to 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 3 days at a time except on medical advice.

§ Should not be used with other paracetamol-containing products.

§ Do not exceed the stated dose .

Method of administration

adol drops is for oral administration only.

§ Contains paracetamol. Do not give with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

§ Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.

§ 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.

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

§ Caution in patients with glutathione depleted states such as sepsis; the use of paracetamol may increase the risk of metabolic acidosis.

§ Never give more medicine than shown in the table.

§ Do not overfill the graduated dropper

§ Always use the graduated dropper supplied with the pack

§ Do not give more than 5 doses in any 24 hours.

§ Leave at least 4 hours between doses.

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

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

§ Keep out of the sight and reach of children.

§ If symptoms persist, consult your doctor.

§ Prolonged use except under medical supervision may be harmful.

§ If your child has a known intolerance to some sugars, contact your doctor before use as this product contains sorbitol.

§ If your baby was born prematurely consult your doctor prior to use.

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

§ Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of irreversible liver damage.

adol drops contains Sorbitol Solution and saccharin:

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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

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

This product is intended for use in children.

Pregnancy

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Lactation

Paracetamol is excreted in breast milk. However, the level of paracetamol present is not considered to be harmful. Available published data do not contraindicate breastfeeding.

None known

There have been rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

The frequency of adverse events associated with paracetamol is tabulated below.

Healthcare professionals are asked to report any suspected adverse reactions via:

• Saudi Arabia:

The National Pharmacovigilance Centre (NPC):

   - Fax: +966-11-205-7662

   - SFDA Call Centre: 19999

   - E-mail: npc.drug@sfda.gov.sa

   - Website: https://ade.sfda.gov.sa

• Other GCC States:

   - Please contact the relevant competent authority.

Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity

There is a risk of poisoning with paracetamol particularly in elderly subjects, young children, patients with liver disease, cases of chronic alcoholism and in patients with chronic malnutrition. Overdosing may be fatal in these cases.

Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.

Overdose of paracetamol in a single administration in adults or in children can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death.

Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in adults who have taken more than the recommended amounts of

paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity. Risk

Factors include: If the patient;

§ Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

§ Regularly consumes ethanol in excess of recommended amounts

§ Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion.

Administration of activated charcoal should be considered if >150mg/kg paracetamol has been taken within 1 hour.

The antidote N-acetylcysteine, should be administered as soon as possible in accordance with National treatment guidelines

Symptomatic treatment should be implemented.

ATC code/pharmacological group: N02BE01

Paracetamol has analgesic and antipyretic actions.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in 30-60 minutes; plasma half-life is 1-4 hours. It is metabolised in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates.

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available

Not applicable

Store below 30°C, in the original container.

15mL Drops packed in an amber coloured glass bottle with a printed label, provided with CRC Cap packed in a printed carton along with a leaflet and a graduated dropper.

No special requirements