Panda Extra Tablets are indicated for the relief of mild to moderate pain and fever from:

- Headache and migraine.

- Common colds and flu, sore throat and earache.

- Toothache.

- Backache, rheumatic, muscular pain and neuralgia.

- Period pain.

Oral use.

Panda Extra Tablets are suitable for adults and children over 12 years of age.

Adults: Two Tablets up to four times a day.

Not recommended for children under 12 years.

If necessary the dose may be repeated every 4 hours but do not exceed 4g / 24 hours.

This preparation contains Paracetamol. Do not take other Paracetamol containing medications at the same time. Don’t exceed the recommended dose. Avoid drinking too much coffee or tea when taking these Tablets. Use with caution in patients with alcoholic liver disease. It causes severe hepatic toxicity on acute overdose. Chronic daily dosing in adults has resulted in liver damage in some patients.

Consult a doctor if have severe liver or kidney problem before using this product.

Do not take this product for pain more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occurs, or if redness and swelling is present, consult a doctor because these could be signs of a serious condition.

If sore throat is severe and persists for more than 2 days, is accompanied by fever, headache, rash, nausea or vomiting, consult doctor promptly.

Panda Extra Tablet may interact with anticoagulant agents on prothrombin time.

The liver effects of Panda Extra may be increased by the use of alcohol and the concomitant use of certain drugs which enhance the metabolism of Paracetamol in the liver (i.e. barbiturates, tricyclic antidepressants).

Paracetamol may increase the levels/effects of vitamin K antagonists.

Paracetamol possibly inhibits metabolism of IV Buslfan. The levels/effects of Paracetamol may be increased by lmatinib and lsoniazid. The levels/effects of Paracetamol may be decreased by Hydantoin, Barbiturates, Carbamazepine, Cholestyramine Resin, Peg interferon Alfa-2b.

Pregnancy risk factor B. Although there is epidemiological evidence of the safety of Paracetamol in pregnancy and lactation, medical advice should be sought before using this product.

None.

When taken in recommended doses, Panda Extra is usually free from side effects. However, skin reactions such as urticaria have been reported rarely. Blood disorder (including thrombocytopenia, leucopenia, Neutropenia) and hypotension are reported.

To reports any side effect (s):

The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

Paracetamol:
Immediate medical management is required in the event of overdose for the risk of liver failure, even if symptoms of overdose are not present.
In massive over dosage exceeding 10g Paracetamol may cause liver damage. Early symptoms may include pallor, nausea, vomiting, (diaphoresis) and general malaise.

Clinical and laboratory evidence of liver damage may not be apparent until 48 to 72 hours post-ingestion. Overdose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine without waiting for the results of plasma Paracetamol levels. General supportive measures must be available. Additional antidote therapy is normally considered in light of further plasma Paracetamol levels and the time elapsed since ingestion.

Caffeine:

Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with Paracetamol / Caffeine combination tablets, the amount ingested would be associated with serious paracetamol-related liver toxicity. There is no specific antidote is available, but supportive measures such may be used.
In all cases of suspected overdose, prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

ATC code: N02B E51

The combination of Paracetamol and Caffeine is a well established analgesic combination.

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites. Caffeine is absorbed readily after oral administration. Maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered Caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

Panda Extra 500mg/65mg Caplets contain a disintegrant system which accelerates caplet dissolution compared to standard Paracetamol and Caffeine Caplets.

Human pharmacokinetic data demonstrate that the time taken to reach plasma paracetamol threshold (4-7 mcg/ml) is at least 44% faster with Panda Extra 500mg/65mg Caplets compared with standard Paracetamol and Caffeine Caplets.

Total extent of absorption of Paracetamol and Caffeine from Panda Extra 500mg/65mg Caplets is equivalent to that from standard Paracetamol and Caffeine Caplets.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Microcrystalline Cellulose, Croscarmellose Sodium, Povidone, Colloidal Silicon Dioxide & Magnesium Stearate.

None.

Store below 30°C.

PVC with aluminium foil blister packs in an outer cardboard carton, containing 24 Tablets.

None.