Description

Composition:

Paracetamol: 500mg

Caffeine: 65 mg

Eragel, wheat starch, magnesium stearate, PVP q.s for 1 tablets

Indications:

Frantamol Extra is indicated to:

– Reduce mild to moderate pain, including: headache, migraine, menstrual cramps, sore throat, musculoskeletal pain, fever and pain after vaccination, pain after dental procedures/ tooth extractions, toothache, pain caused by a cold or the flu, pain in arthritis.

– Reduce fever.

Contraindications:

– Patients with anemia or heart, lung, or liver disease.

– Hypersensitivity to paracetamol.

– Patients with glucose 6 phosphate dehydrogenase deficiency

Adverse Side Effects:

– Skin rash and other allergic reactions sometimes occur. Rash or hives are most often, but serious incidence may include drug – induced fever and mucosal lesions.

– In a few cases Paracetamol has caused decreased neutrophils, thrombocytopenia, and decreased blood cells.

– It can cause kidney toxicity if the drug is overused for a long time. Inform your doctor of unwanted effects related to drug use

Dose and Method of administrations

For adults (including the elderly) and children> 12 years: 1-2 tablets / time x 2 -3 times / day, no more than 8 tablets / day unless ordered by a physician. Keep the doses at least 4 hours apart.

Should not be combined with other medicines containing paracetamol.

Interactions:

– Concurrent use with phenothiazines and therapeutic hypothermia can cause severe hypothermia.

– Drinking too much alcohol for too long can increase the risk of liver toxicity of paracetamol.

– Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid may increase the hepatotoxicity of paracetamol. Often there is no need to reduce the dosage in patients using paracetamol and anticonvulsants concomitantly but patients must limit themselves while taking Paracetamol and using anticonvulsants or isoniazid

Use in pregnancy and lactation:

– Studies of paracetamol on humans and animals has not yet identified any risk of Paracetamol for pregnant women or the development of the embryo.

– The studies on humans also not identified any risk of Paracetamol for breastfeeding mothers or babies.

– Studies on animals suggest correlation between the use of caffeine and abnormalities in the fetus, but only at very high doses that are never used in humans. No clear conclusions can be made from available data on human. However the amount of caffeine in Frantamol Extra staff when used in a short period of time is equivalent to the normal daily intake from food and beverage.

– Paracetamol and Caffeine can cross the placental barrier and is excreted in breast milk.

Effects on ability to drive and use machines:

Extra Frantamol has no effect on the ability to drive or use machines.

Overdose:

– Apply immediate medical measures when overdosed even if the symptoms may not appear.

– Paracetamol overdose can cause liver failure.

– There may be a need to use N-acetylcysteine ​​or methiolin.

– Caffeine overdose is rare, because the caffeine level in Extra Frantamol is low – equivalent to the amount of caffeine in food or drink normally. If it occurs, the symptoms can be insomnia, restlessness, excitation, and can lead to mild delirium, convulsions and rapid heart rate.

Pharmacology: 

– Paracetamol is an effective analgesic – antipyretic that can replace aspirin; however paracetamol does not effectively treat inflammatory like aspirin. With an equal dose per gram paracetamol has similar analgesic, antipyretic effects to aspirin.

– Paracetamol reduces the body temperature in fever patients, but rarely in a healthy person. The drugs act on the hypothalamus to reduce body temperature, disperse heat by vasodilation and increase peripheral blood flow.

– Caffeine acts on the nervous system, causing contraction of blood vessels, reduce the intensity and duration of pain in general, especially headaches. So when combined with paracetamol, caffeine also create a stronger analgesic effect, giving patients more alert.

Pharmacokinetics

– Paracetamol is absorbed rapidly and almost completely through the digestive tract. Food can lengthen the absorption time of the tablets, partially slowing down paracetamol absorption. Hydrated carbon-rich foods reduce the rate of absorption of paracetamol. Peak plasma concentrations are reached within 30 to 60 minutes after ingestion of therapeutic doses.

– Paracetamol is distributed quickly and evenly in most tissues of the body. Approximately 25% of paracetamol is combined with blood plasma proteins. The half-life of Paracetamol is 1.25 to 3 hours.

– Paracetamol is metabolized primarily in the liver and a small part in the kidneys, forming derivatives conjugated glucuronic and sulfonic. The clearance of paracetamol in the urine as glucuronic combined is about 50 to 80%, as conjugate sulfonic about 20 to 30%, unchanged <5%. A small fraction (<4%) are metabolized by cytochrome P450 under the action of acetyl metabolite N parabenzoquinonimin, which is then detoxified quickly by liver’s glutathione. However, if high dose of paracetamol is taken, these metabolites are formed at the high = enough level to deplete hepatic glutathione, in that condition, its reaction with sulfhydryl of liver protein increase and so can lead to liver necrosis.

– Caffeine is rapidly absorbed after oral administration and is widely distributed throughout the body, enter the CNS and saliva. Caffeine also cross the placental barrier and a small amount is also found in breast milk.

– In adult caffeine is metabolized almost completely by oxidization, demethylating and acetylation. It is excreted in urine as acid 1 – methyluric, 1 – methylxanthin, 7 – methylxanthin, 1.7 – dimethylxanthin, 5 – acetylamino – 6 – formylamino – 3 – methyluracil and other metabolites, and only about 1% excreted is not metabolized.

Shelf life: 36 months from date of manufacture.

Do not use beyond time limit on the packaging.

Storage: cool and dry place. Protect from light.

Specification: Manufacture’s standard.