Description

Formula:

Paracetamol: 500 mg

Cafein: 25 mg

Phenylephrin hydroclorid: 5 mg

Microcrystallin cellulose, Pregelatinized starch, Magnesi stearate, PVP, HPMC, PEG 6000, Talcum, Tital dioxide, Ponceau 4R, Tartazin q.s 1 tablet

Indications:

Frantamol flu relieves symptoms of nasal and sinus congestions, colds and flu

Contraindication:

– Patients with a history of anemia or have heart, lung or liver diseases

– Hypersensitivity to paracetamol, phenylephrine, caffeine or any other components of the drug

– Contraindicated uses of phenylephrine in patients with severe coronary artery disease, severe hypertension, heart disease, hyperthyroidism, are using or have used in the previous 2 weeks monoamine oxidase inhibitors.

– Patients with deficiency of glucose – 6 – phosphate dehydrogenase

– Children under 12 years old due to inappropriate dosage forms

Adverse Drugs Reactions (ADR):

The substance is well tolerated when used at the usual doses:

– Paracetamol rarely cause unwanted effects, but sometimes hypersensitivity reactions appear like rash on skin.

– Phenylephrine may cause tachycardia, palpitations, nausea, headaches and changes in blood pressure.

Inform your doctor of any adverse effects occurred during medication

ADR management:

If serious undesired effects occur, stop using the drug. About Treatment read “Overdosage”

Usage:

Adults (including the elderly) and children>12 years: 1-2 tablets/time x 2-3 times/day.

Do not exceed 8 tablets/day unless directed to by a physician. The gap between the dose should be at least 4 hours.

Do not use with other medicines that contain paracetamol.

 Interactions:

– Concomitant uses of phenothiazines and hypothermia therapy can cause severe hypothermia.

– Drinking alcohol too much and too long can increase the chance paracetamol poisons the liver.

– Anticonvulsants (including phenytooin, barbiturates, carbamazephin), isoniazid can increase the liver toxicity of paracetamol. Normally, don’t need to reduce the doses among patients using both paracetamol and anticonvulsants, however, patients must limit their paracetamol intakes when taking anticonvulsants or isoniazid.

– Monoamine oxidase inhibitors increases the systemic effects of phenylephrine.

– Phenylephrine may prevent the effects of hypertension substances.

Precautions and special warnings:

• Toxicity when overdosed is larger for patients with liver disease due to alcohol but have not cirrhosis
• Be careful when used on patients who are using beta – adrenergic receptor inhibiting substances
• Do not use with other medicines that contain paracetamol.

Uses in pregnancy and lactating women:

• Epidemiologic researches on pregnant women show no harms when use Paracetamol as the recommended dosage, but the patient must follow the doctor’s opinion when using the drug. Paracetamol is excreted into breastmilk but at a clinically insignificant level. Existing published figues show that paracetamol is not contraindicated for breastfeeding women
• Do not use phenylephrine during pregnancy because of possible oxygen deficiency for the fetus at high dosage
• Therefore do not use Frantamol Flu during pregnancy unless your doctor required it.

Effects on ability to drive or operate machinery:

Frantamol Flu does not affect driving or machinery operating abilities

Overdose:

• Paracetamol poisoning may happen due to 1 single toxic dose or repeated uses of large doses of Paracetamol. Dosage – dependent liver necrosis is the most severe toxic effect of overdose and can lead to death
• Nausea, vomiting and stomachache usually happens within 2-3 hours after taking a toxic dose of Paracetamol. Quickly take the overdosed patient to hospitals. Remove the drug from stomach by gastrich lavage as soon as possible. The specific antidotes are methonin or acetylcystein.
• Cafein overdose rarely happens, because the level of cafein in Frantamol Flu is as low as the level in normal food or beverage. If it happens, the possible symptoms are insomnia, restlessness, irritability and can lead to mild delirium, convulsions, rapid heart rate
• Phenylephrin overdose can raise blood pressure. However the phenylephrine toxic dose may be bigger than the paracetamol toxic dose

Pharmacology:

Paracetamol is an effective pain – relief and antipyretic drugs that can replace asprin; however in contrast to asprin, paracetamol is not effective in treating inflammation. With the same dose by gram paracetamol has the same pain – relief and antipyretic effects as 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.

– Phenylephrin hydroclorid is a drug affecting like α sympathomimetic, (α, – adrenergic) has direct effects on α receptors, adrenergic contracts blood vessels and raises blood pressure. The α  – adrenergic effect mechanism of phenylephrine is due to inhibiting the production of cyclic AMP (cAMP: cyclic adrenosin 3’, 5’ monophosphate) due to inhibiting adenyl cyclase enzyme, while affecting β-adrenergic í due to activating adenyl cyclase activity.

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 combined glucuronic is about 50 to 80%, as conjugate sulfonic about 20 to 30%, unchanged <5%. A fraction (<4%) is metabolized by cytochrome P450 into N-acetyl parabenzoquinonimin metabolite, which is then detoxified quickly by the 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 which case, 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 manufacture

Do not exceed the dates on packaging

Storage: cool, dry place. Protect from light.

Specifications: Manufacture’s standard.