RiteMED Paracetamol

Tablet: RiteMED Paracetamol 500 mg tablet is a white, round, flat beveled edge and plain on both sides tablet.
Each tablet contains: Paracetamol, USP 500 mg.
120 mg/5 mL Syrup: Paracetamol 120 mg/5 mL Syrup is a clear, green, lemon flavored syrup with a sweet to bitter after taste.
Each 5 mL (one teaspoonful) contains: Paracetamol, USP 120 mg.
250 mg/5 mL Syrup: Each 5 mL (1 teaspoonful) contains: Paracetamol 250 mg (Alcohol Free).
Rectal suppository: RiteMED Paracetamol 125 mg and 250 mg Rectal Suppository: White to off-white spindle-shaped suppository.
Each rectal suppository contains: Paracetamol, USP 125 mg or 250 mg.

Analgesic/Antipyretic.
Tablet, 120 mg/5 mL Syrup and Rectal suppository: This product contains Paracetamol, a fever reducer and pain reliver.
250 mg/5 mL Syrup: Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 10 minutes to 60 minutes after oral administration. It is metabolized in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 3 hours. Plasma protein binding is negligible at unusual therapeutic concentration but increases with increasing concentrations.

Tablet and 120 mg/5 mL Syrup: For the relief of minor aches and pains such as headache, backache, menstrual cramps, muscular aches, minor arthritis pain, toothache, and pain associated with the common cold and flu; for fever reduction.
250 mg/5 mL Syrup: For the treatment of minor febrile conditions, reduction of temperature and relief of headache and joint muscle pains.
Rectal suppository: For the relief of fever and mild to moderate pain.

Tablet: Adults and children 12 years old and above: 1 to 2 tablets every 4 to 6 hours, as needed for pain and/or fever, or, as directed by a doctor.
Do not take more than 4 g (8 tablets) of paracetamol in each 24-hour period.
Missed Dose: If a dose is missed, give the next dose if still needed for pain and/or fever and the subsequent dose every 4 to 6 hours thereafter.
Do not double the dose.
120 mg/5 mL Syrup: 1 to 5 years old: 5 mL (1 teaspoonful) to 10 mL (2 teaspoonfuls).
6 to 12 years old: 10 mL (2 teaspoonfuls) to 20 mL (4 teaspoonfuls) to be taken 3 to 4 times a day. Or, as prescribed by the physician.
Do not take more than 4 g of paracetamol in each 24-hour period.
250 mg/5 mL Syrup: Children: 2 to 6 years: 2.5 mL (1/2 teaspoon) to 5 ml (1 teaspoonful).
7 to 12 years: 5 mL (1 teaspoonful) to 10 mL (2 teaspoonfuls).
To be taken 3 to 4 times a day, or as prescribed by the physician.
Adults: 15 mL (1 tablespoonful) 3 to 4 times a day or, as prescribed by the physician.
Rectal suppository: General Recommendations: Infants and children should not exceed 5 doses in each 24-hour period.
Adults should not exceed 4 g in each 24-hour period.
Leave at least 4 hours between doses.
Do not use continuously for more than 5 days at a time unless directed by a doctor.
Do not use more than the recommended dose.
Avoid potential liver damage by giving lower doses of paracetamol in patients classified under the lower body weight group.
Each suppository should be inserted deep into the rectum. (See table.)

Click on icon to see table/diagram/image

Missed Dose: If the patient missed a dose, take the next dose if still needed for pain and/or fever and the subsequent doses every 4 hours thereafter.
Do not double dose.

Tablet, 120 mg/5 mL Syrup and Rectal suppository: Sign/Symptoms: 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 concentrations, 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. Recovery or progression to fatal complete liver failure.
Metabolic acidosis (excessive acid in the body), encephalopathy (abnormal brain function), coma, and death may also occur. Clinical and laboratory evidence of hepatic toxicity may not be apparent 48 to 72 hours post-ingestion, and reach a maximum after 4 to 6 days (for rectal suppository only).
What to do if the patient has taken more than the recommended dosage: If more than the recommended dosage has been given, consult a doctor or contact a Poison Control Center right away. Quick medical attention is important for adults as well as for children even if any signs or symptoms were not notice.

Tablet and 120 mg/5 mL Syrup: If the patient is allergic to paracetamol or any ingredient in the product.
Avoid long-term use of paracetamol in patients with anemia or with heart, lung, kidney or liver disease.
250 mg/5 mL Syrup: Known hypersensitivity to paracetamol. Long term use in patients with anemia or with cardiac, pulmonary, renal or hepatic disease is also contraindicated.
Patients with ulceration or inflammation of gastrointestinal tract.
Rectal Suppository: If the patient is allergic to paracetamol or any ingredient of the product.
If the patient is taking other medicines that contain paracetamol.

250 mg/5 mL Syrup: If fever persists for more than 3 days or if pain continues for more than 5 days, physician should be consulted.

Tablet and 120 mg/5 mL Syrup: Liver Warning: This product contains paracetamol. Severe liver damage may occur if: An adult or child 12 years old and above takes more than 4 g 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 using this product.
Ask a doctor before use if the patient has liver disease.
Ask a doctor before use if the patient is taking warfarin, a blood thinning medicine.
When to 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 worse or lasts more than 3 days.
250 mg/5 mL Syrup: Paracetamol should be given with caution to patients with impaired kidney or liver functions as well as to patients taking other drugs that affect the liver and to patients with alcohol dependence.
Rectal Suppository: Liver Warning: This product contains paracetamol. Severe liver damage may occur if: A child takes more than 5 doses in 24 hours, which is the maximum daily amount.
An adult or child 12 years old and above takes more than 4 g of paracetamol in 24 hours.
Taken with other medicine containing paracetamol (or acetaminophen).
An adult has 3 or more alcoholic drinks everyday while using these products.
Allergy alert: Paracetamol may cause allergic reactions. Symptoms may include: Skin redness, Blisters, Skin rash or hives, Swelling of the face, tongue or throat, Difficulty swallowing, Unexplained wheezing or shortness of breath.
Ask a doctor before use if patient has liver or kidney disease.
Use with caution in patients with glucose-6-phosphate deficiency (G6PD), a hereditary condition which can lead to decreased blood cell count and possible hemolytic anemia (anemia resulting from destruction of red blood cells).
Do not take more than the recommended dose.
Ask a doctor before use if: The patient has kidney or liver problems (including alcoholic liver disease).
The patient is taking other pain killers or any other medicines (See Interactions).
The patient has G6PD.
The patient is pregnant or breastfeeding.
The cause of the patient's illness is not clear or it is accompanied by a rash, breathing difficulties, diarrhea or excessive tiredness or lethargy.
The patient is severely malnourished, anorexic, have a low body mass index (underweight), or excessively drinks alcohol.
Stop use and ask a doctor if: Symptoms of allergic reaction occur (such as skin redness, blisters, or rash), stop use and seek medical help right away (See previous text).
Symptoms worsen or do not improve; New symptoms occur; Any undesirable effect occurs; Redness or swelling is present; Fever gets worse or lasts more than 3 days; Pain gets worse or lasts more than 5 days in children (<12 years old) and 10 days in adults; Patient had unexpected bruising or bleeding, and had more infections than usual; Consult a doctor promptly if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Tablet and 120 mg/5 mL Syrup: Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects.
Skin rashes, hypersensitivity reactions, changes in the number of white blood cells and platelets, and minor stomach and intestinal disturbances have been reported.
250 mg/5 mL Syrup: When taken in recommended dose, paracetamol is usually free from side effects. Skin reactions, e.g., urticaria have been described rarely. Overdosage with paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential.
Rectal Suppository: Paracetamol, when used within the recommended dose and duration of treatment, has low incidence of side effects. The most common side effects associated with the use of paracetamol suppositories are redness of the rectal mucous membranes.
Blood and lymphatic system disorders: Anemia (decreased number of healthy red blood cells), changes in the number of white blood cells and platelets such as agranulocytosis (decrease in the number of granulocytes), leukopenia (decrease in the number of leukocytes), methemoglobinemia (presence of methemoglobin in the blood), neutropenia (decrease in the number of neutrophils), pancytopenia (deficiency of all cellular elements in the blood), thrombocytopenia (decrease in the number of platelets); thrombocytopenic purpura (small purple-red marks in the skin or other tissue caused by low number of platelets).
Immune system disorders: Allergic reactions, hives, angioedema (swelling of face, tongue, lips, or throat), proneness to infections, swelling around the eyes.
Metabolism and nutrition disorders: Hyperchloremia (increased chlorine ion in the blood), hyperuricemia (increased uric acid in the blood).
Vascular disorders: Petechiae (pinpoint red spots on skin), unusual bleeding or bruising.
Respiratory, thoracic, and mediastinal disorders: Laryngeal edema (swelling of the voice box), respiratory distress (noisy, congested breathing), sore throat, throat ulcer.
Gastrointestinal disorders: Hematochezia (blood in stools), melena (black, tarry stools), mouth ulcers.
Skin and subcutaneous tissue disorder: Itching, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; skin rash.
Hepatobiliary disorders: Chronic hepatic necrosis (death of liver tissues) in prolonged use, liver injury, liver toxicity.
Renal and urinary disorders: Hematuria (blood in urine), renal colic (severe and/or sharp pain in the lower back and or side with prolonged use of high doses in patients with severe renal function impairment), renal failure, sterile pyuria (cloudy urine), uremia (high levels of urea in the urine).
General disorders and administration site conditions: Fever.
Investigations: Decreases in serum bicarbonate, serum calcium, serum sodium; increases in creatinine levels, lactate dehydrogenase activity, prothrombin levels, serum alkaline phosphatase, serum bilirubin, serum glucose, serum transaminase.

Tablet and 120 mg/5 mL Syrup: The speed of absorption of paracetamol may be accelerated by metoclopramide or domperidone and reduced by cholestyramine.
Medicines which stimulate the enzymes responsible for the metabolic activation of paracetamol such as medicines for convulsion (e.g., phenobarbital) may increase susceptibility to harmful effects to the liver.
Warfarin, a blood thinning medicine; an increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk for bleeding, may be observed when using paracetamol and warfarin at the same time. Paracetamol increases the anticoagulation effect of warfarin.
250 mg/5 mL Syrup: May interact with alcohol, oral anticoagulants, chloramphenicol, aspirin, phenobarbital, liver enzyme inducer, hepatotoxic agents.
Rectal suppository: Do not use with any other medicine containing paracetamol (prescription or nonprescription). If the patient is not sure whether a medicine contains paracetamol, ask a doctor.
Prolonged use of paracetamol with other painkillers [e.g., drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin] is not recommended since it may increase the risk of toxic effects to the kidneys and eventually of kidney failure.
Chronic intake of alcohol may increase the risk of paracetamol-induced liver toxicity. Acute intake of alcohol may diminish the ability of the body to metabolize large doses of paracetamol. It is advised to consult a doctor before intake of paracetamol.
The absorption of paracetamol may be increased by metoclopramide or domperidone. Cholestyramine, narcotic pain relievers, and some antidepressants that slow down gastric emptying reduce the absorption of paracetamol. If the patient is taking these medicines, talk to the doctor first before taking paracetamol.
Medicines which stimulate the enzymes responsible for the metabolic activation of paracetamol such as medicines for convulsion (e.g., phenobarbital), depression (e.g., tricyclic antidepressants), and oral contraceptives may reduce the efficacy of paracetamol and increase susceptibility to the harmful effects to the liver.
Phenothiazines (medicines for serious mental and emotional disorder) may increase the risk of severe hypothermia (abnormally low body temperature).
Paracetamol increases exposure to chloramphenicol. This interaction should be considered when both medicines are given together in malnourished patients.
Probenecid may affect the elimination of paracetamol.
There may be an increased risk of bleeding when using paracetamol and warfarin (a blood thinning medicine) at the same time. Paracetamol, especially its prolonged regular use, increases the blood thinning effect of warfarin and other coumarins. If the patient is taking warfarin, ask the doctor first before taking paracetamol.
Tell the doctor if the patient is taking other medicines (especially other paracetamol-containing medicines), including vitamins, supplements, and herbal medicines.

Tablet: Do not store above 30°C.
120 mg/5 mL Syrup: Store at temperatures not exceeding 30°C.
Always keep bottle tightly closed.
250 mg/5 mL Syrup: Store at temperatures not exceeding 30°C. Protect from light. Always keep bottle tightly closed.
Rectal suppository: Store at temperature not exceeding 25°C.
Protect from light and moisture.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Tab/120 mg/5 mL syr:Non-Rx; 250 mg/5 mL syr:Rx