Indications/Uses

For the relief of mild to moderate pain, including headache, migraine, backache, muscular aches, menstrual cramps, arthritis pain, toothache and pain associated with common cold and flu; For fever reduction.

Dosage/Direction for Use

Adults and children 12 years and above: 1-2 tablets every 6 hours, as needed for pain and/or fever, or, as directed by a doctor.
Do not take more than 4 g of Paracetamol and 520 mg of Caffeine (8 tablets) in each 24-hour period
Missed dose: If a dose is missed, give the next dose for pain and/or fever and the subsequent doses every 6 hours thereafter.
Do not double the dose.
If more than the recommended dosage has been given, consult a doctor or contact Poison Control Center right away. Quick medical attention is important for adults as well as for children even if no notice of any signs or symptoms because of the risk of delayed, serious liver damage.

Overdosage

Overdosage of Paracetamol usually involves 4 phases with the following signs and symptoms: Eating disorder, nausea, vomiting, malaise and excessive sweating;
Right upper abdominal pain or tenderness, liver enlargement which may be characterized by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentration, prolongation of prothrombin time, and occasionally decreased urine output;
Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure; IV. Recovery or progression to fatal complete liver failure;
Signs of acute overdose of Caffeine include vomit similar to ground of coffee, frequent urination, increased heart rate, tremors and convulsion. Metabolic acidosis, ketosis and hyperglycemia have also been reported.
Chronic intake of 500mg of Caffeine a day may be associated with caffeinism, a symptom of low grade irregular fever, difficulty in sleeping, anorexia, anxiety, and irritability.

Administration

May be taken with or without food.

Contraindications

If the patient is allergic to Paracetamol, Caffeine or any ingredient in the product; If the patient has high blood pressure or irregular heartbeat; Avoid long term use of Paracetamol in patients with anemia or with heart, lung, kidney, or liver disease; If the patient is recovering from severe alcoholism and taking Disulfiram. Disulfiram reduces Caffeine clearance, which might complicate alcohol withdrawal, increasing nervousness and restlessness; If the patient is below 12 years old; If the patient is taking these medicines: Medicines for high blood pressure (e.g., Propranolol, Atenolol) ; Caffeine can increase blood pressure and counter the blood pressure-lowering action of these medicines. Medicines for depression and anxiety (e.g., Sertraline, Clozapine), Lithium Carbonate. Decongestants containing Ephedrine Theophylline (for breathing problems); Caffeine and Theophylline share the same metabolic pathway which leads to increased clearance time for Theophylline when used together with Caffeine. Levothyroxine (for thyroid problems).

Special Precautions

Liver Warning: This product contains Paracetamol. Sever liver damage may occur if: An adult or child 12 years old and above takes more than 4 g (8 tablets) in 24 hours, which is the maximum daily amount; Taken with other medicines containing Paracetamol (or Acetaminophen); An adult has 3 or more alcoholic drinks everyday while taking this product.
Caffeine Warning: The recommended dose of this product (65-130 mg Caffeine) contains about as much Caffeine as 1-2 cups (150-300 mL) of instant coffee. The use of Caffeine containing medicine, food (e.g., chocolate) or beverages (e.g., coffee, tea, cola) should be limited while taking this product. (See Table.)

Do not use with any other medicines containing Paracetamol (prescription or non-prescription).
If the patient is not sure whether a medicine contains Paracetamol, ask a doctor.
Ask the doctor before use if the patient has kidney or liver problems.
Ask the doctor before use if the patient is taking Warfarin, a blood thinning medicine.If you are pregnant or breastfeeding, consult your doctor before use.
Consult a doctor: If the patient is pregnant or breastfeeding, consult the doctor before use.
Stop use and ask a doctor if: New symptoms occur; Symptoms do not get better; Headache is persistent; Pain gets worse or lasts more than 10 days; Fever gets worst or lasts more than 3 days.

Adverse Reactions

Paracetamol, when taking with the recommended dose and duration of treatment, has low incidence of side effects. Hypersensitivity including skin rashes and minor stomach and intestinal disturbances have been reported with Paracetamol use. In doses up to 520 mg/day, undesirable effects of Caffeine are not usually observed in healthy individuals. However, some users who are not used to Caffeine, who have abstained from Caffeine for a long period of time and who are more sensitive to Caffeine may experience effect more commonly seen with higher doses. Effects of Caffeine include tremor, difficulty in sleeping, nervousness, restlessness, irritability, anxiety, headache, ringing in the ears, fast or irregular heartbeat, rapid breathing, frequent urination, and stomach upset. Caffeine use may also increase blood pressure. Those who experience these signs must discontinue taking these medicine and other dietary Caffeine-containing products.
Following regular use of Caffeine, end of intake may lead to withdrawal symptoms which could last one week. Signs include headache, tiredness and decreased alertness.

Drug Interactions

Paracetamol: The speed of absorption of Paracetamol may be accelerated by Metoclopramide or Domperidone and absorption reduced by Cholestyramine; Medicines which stimulate the enzymes responsible for the metabolic activation or Paracetamol such as medicines for convulsion (e.g., Phenobarbital, Phenytoin, Carbamazepine) may increase susceptibility to the harmful effects of the liver; Warfarin, a blood thinning medicine; an increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk of bleeding, may be observed when using Paracetamol and Warfarin at the same time. Paracetamol increases the anticoagulation effect of Warfarin; An increased risk of liver toxicity may be expected when used together with alcohol (e.g., Ethanol) or Isoniazid (for tuberculosis); The possibility of severe hypothermia (abnormally low body temperature) may occur if Phenothiazine is taken together with Paracetamol; Pretreatment with Probenecid may decrease Paracetamol clearance and increase the effects of Paracetamol.
Caffeine: Xanthine derivatives such as Caffeine can weaken the vasodilating effect of substances used for myocardial imaging (e.g., Adenosine, Dipyridamole). Thus, Caffeine should be avoided 24 hours before myocardial imaging; Caffeine, as a central nervous system stimulant, has an antagonistic effect on the action of sedatives and tranquilizers (e.g., Diazepam, Zolpidem); Caffeine may further increase the action of Phenylpropanolamine in increasing heart rate; Caffeine competitively inhibits Clozapine metabolism. Hence, Clozapine and Caffeine must not be used together; Lithium carbonate and Caffeine should not be used together because their combination may cause small to moderate increase in Serum Lithium Level; The use of Monoamine Oxidase inhibitors (e.g., Phenelzine, Moclobemide, Selegiline) with Caffeine should be avoided since it may increase stimulant effects of Caffeine; Methoxsalen (for psoriasis) reduces Caffeine clearance and may increase the effects of Caffeine; Pipemidic acid (for infections) reduces Caffeine clearance, thus enhancing the action of Caffeine; Levothyroxine, like Caffeine, can increase blood pressure; hence they should not be used together. Phenytoin (for epilepsy) increases Caffeine clearance and decreases effects of Caffeine; The use of Ephedrine and Caffeine should be avoided since it could lead to increased blood sugar and lactate concentrations.

Storage

Do not store above 30°C.

Action

Contains Paracetamol, a fever reducer and pain reliever. Caffeine enhances and prolongs the effect of Paracetamol on pain relief.

MedsGo Class

Analgesics (Non-Opioid) & Antipyretics

	CODE	Dosage Strength	Drug Packaging	Availability	Price
	NONRXDRUG-DR-XY46238-1pc	500 mg / 65 mg	Tablet 1's	In stock	₱7⁰⁰	+ −

REXIDOL FORTE Paracetamol / Caffeine 500mg / 65mg Tablet 1's