panadol

پیناڈول

Written by Dr. Zahira Batool [PharmD, Qauid-e-Azam University, Islamabad, Pakistan]

Active ingredient:

Each tablet contains Paracetamol 500 mg.

Excipients:

• Maize starch

• Potassium sorbate (E 202)

• Purified talc

• Stearic acid

• Povidone

• Starch pregelatinised,

• Hypromellose triacetin.

Pack size:

Box of 10 blisters x 12 tablets.

Price:

4 rs per tablet (0.047 dollars)

Manufacturer:

Haleon Pakistan

Therapeutic class:

Analgesic; Antipyretic

Pharmacological class:

Prostaglandin synthesis inhibitor

Indications:

For fast effective temporary relief of pain and discomfort associated

with headache, muscular aches, period pain, arthritis/osteoarthritis,

toothache, migraine headache, cold & flu symptoms, tension

headache, sinus pain/headache, and backache. Reduces fever.

Dosage and recommendation:

Do not exceed the stated dose. The lowest dose necessary to achieve

efficacy should be used for the shortest duration of time. Do not take

this medicine for more than 3 days without medical advice.

Dosage

Maximum day dose 60 mg/kg to be administered in divided doses of

10-15 mg/kg throughout the 24 hours

1. 12 years to adults:

1 to 2 tablets. Maximum daily dose: 8 tablets

2. 7 to 12 years:

½ to 1 tablet, Maximum daily dose: 4 tablets

3. Under 7 years:

Not recommended

Special population:

Renal Impairment:

Patients who have been diagnosed with renal impairment must seek

medical advice before taking this medication

Hepatic Impairment:

This has dose-related toxicity, so avoid large doses.

Method of administration:

Simply place the tablet(s) in your mouth and swallow them down with

water

Contra-indications:

These products are contraindicated in patients with a previous history

of hypersensitivity to paracetamol or any of the excipients.

Adverse effects:

Stop taking this medicine and tell your doctor immediately if:

• You experience allergic reactions such as skin rash or itching,

sometimes with breathing problems or swelling of the lips, tongue,

throat or face.

• You experience a skin rash or peeling, or mouth ulcers.

• You have previously experienced breathing problems with aspirin

or non-steroidal anti-inflammatory drugs and experience a similar

reaction with this product.

• You experience unexplained bruising or bleeding. These reactions

are rare.

Interactions:

Panadol shows interactions with the following drugs:

• Warfarin and other coumarins

• Chloramphenicol

• Hepatotoxic drugs

• Anticonvulsant drugs

• Probenecid

• Cholestyramine

Warnings and precautions:

1. Contains paracetamol. Do not use with any other

paracetamol-containing products. The concomitant use with

other products containing paracetamol may lead to an

overdose.

2. Paracetamol overdose may cause liver failure which can lead

to liver transplant or death.

3. Paracetamol should be used with caution in patients with:

• Impaired liver function: Underlying liver disease increases the

risk of paracetamol-related liver damage

• Impaired kidney function: Administration of paracetamol to

patients with moderate to severe renal impairment may result in

accumulation of paracetamol conjugates.

4. Patients who have been diagnosed with liver or kidney

impairment must seek medical advice before taking this

medication.

5. 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. In patients with

glutathione-depleted states such as sepsis, the use of

paracetamol may increase the risk of metabolic acidosis.

6. If symptoms persist, medical advice must be sought.

7. Keep out of sight and reach of children.

Overdose:

Important: liver failure and less frequently renal damage can occur

following overdose. Underlying liver disease increases the risk of

paracetamol-related liver damage.

Symptoms and Signs:

Paracetamol overdose may cause liver failure which may require a liver

transplant or lead to death. Acute pancreatitis has been observed,

usually with hepatic dysfunction and liver toxicity. Nausea and

vomiting, the only early features of poisoning, usually settle within 24

hours. Persistence beyond this time, often associated with the onset of

right subcostal pain and tenderness, usually indicates the development of

hepatic necrosis

Treatment:

Immediate medical management is required in the event of an overdose,

even if symptoms of overdose are not present, refer the patient to the

nearest Emergency Medical Centre for management and expert

treatment. If an overdose is confirmed or suspected, seek immediate

advice from your Poison Centre even in patients without symptoms or

signs of overdose due to the risk of delayed liver damage.

Pregnancy:

As with the use of any medicine during pregnancy, pregnant women

should seek medical advice before taking paracetamol. The lowest

effective dose and shortest duration of treatment should be

considered.

Lactation:

Paracetamol is excreted in breast milk but not in a clinically

significant amount at recommended dosages. Available published data

do not contraindicate breastfeeding.

Clinical Pharmacology:

Its mechanism of action is believed to include inhibition of

prostaglandin synthesis, primarily within the central nervous system.

Storage:

Store below 35°C.