Diagesic-P Tablet

About Diagesic-P Tablet

Diagesic-P Tablet Uses

• Mild to moderate pain including tension headaches, migraine headaches, and anxiety-related headaches.
• Musculoskeletal pain including backache, neck pain, joint pain, and muscle aches.
• Toothache and dental pain.
• Menstrual cramps (primary dysmenorrhea).
• Fever and body aches associated with viral and bacterial infections.
• Cold and flu-related aches, pains, and elevated temperature.
• Ear pain (otalgia) associated with mild inflammatory conditions.

Diagesic-P Tablet Benefits

• Combines three ingredients with different mechanisms to address pain, fever, and the anxiety component that frequently accompanies painful conditions.
• Caffeine enhances the analgesic effectiveness of Paracetamol, allowing pain relief at a dose that would be less effective without the caffeine component.
• The low dose of Thioridazine (3mg) at analgesic combination doses is intended to reduce the anxiety and muscle tension that amplify pain perception, particularly in tension headaches.
• Once-daily or twice-daily dosing for most indications.
• Widely available and affordable across Pakistan.

What Experts Say

Diagesic-P is a triple combination analgesic that has been used in Pakistan for decades. Each ingredient targets a different aspect of the pain experience.

How Paracetamol and Caffeine Work

Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, raising the pain threshold and reducing the hypothalamic set point for temperature. Caffeine Anhydrous enhances this analgesic effect through several mechanisms: it blocks adenosine receptors in the brain, which reduces the perception of pain; it increases the rate of Paracetamol absorption from the gastrointestinal tract; and it promotes cerebral vasoconstriction, which is particularly useful in relieving vascular headaches such as migraines. Clinical studies show that adding 65 to 130mg of caffeine to a standard analgesic dose increases its effectiveness by approximately 40%.

The Role of Thioridazine

Thioridazine is a phenothiazine antipsychotic that blocks dopamine receptors in the central nervous system. At the low 3mg dose used in Diagesic-P, the intent is to provide mild anxiolytic and muscle-relaxing effects rather than antipsychotic activity. Anxiety and muscular tension are significant amplifiers of pain, particularly in tension headaches and musculoskeletal conditions. By reducing this component, the low-dose Thioridazine is intended to augment the analgesic effect of Paracetamol. However, even at 3mg, Thioridazine retains its class-wide cardiovascular effect of QTc interval prolongation.

DRAP Safety Disclosure

In June 2022, the Drug Regulatory Authority of Pakistan (DRAP) issued Safety Alert No. 19, suspending the registrations of all drug combinations containing Paracetamol 500mg, Thioridazine 3mg, and Caffeine 70mg for a period of one year, citing the absence of approval by any reference regulatory authority and unavailability of safety and efficacy data. DRAP noted that Thioridazine was voluntarily withdrawn worldwide by its brand originator Novartis following WHO newsletter reporting on serious cardiac arrhythmia risk. The suspension was issued under the Drugs Act 1976 with direction to halt manufacturing and withdraw available stocks. Patients currently using Diagesic-P should consult a doctor to discuss alternative analgesic options.

Drug Class

• Combination Analgesic and Antipyretic.
• Paracetamol: Non-Opioid Analgesic and Antipyretic.
• Thioridazine Hydrochloride: Phenothiazine Antipsychotic (low dose).
• Caffeine Anhydrous: CNS Stimulant and Analgesic Adjuvant.

Packaging and Quantity

• Pack of 100 tablets (10 strips of 10 tablets each).
• Also available in single strips of 10 tablets.

When Not to Use Diagesic-P

• Known allergy or hypersensitivity to Paracetamol, Thioridazine, Caffeine, or any phenothiazine antipsychotic.
• Known QT interval prolongation or personal or family history of sudden cardiac death.
• Concurrent use of other QT-prolonging medicines.
• Severe liver disease, as Paracetamol metabolism is impaired.
• Children under 12 years of age.
• Pregnancy, particularly the third trimester.
• Patients with a history of cardiac arrhythmias or significant heart disease.

How to Use

• Diagesic-P may be taken with or without food, though taking it with food reduces the risk of stomach upset.
• The tablet should be swallowed whole with a full glass of water.
• Alcohol must be avoided during treatment as it increases the risk of Paracetamol-induced liver damage.
• No other Paracetamol-containing products should be taken at the same time as Diagesic-P, as combined doses can exceed the safe daily maximum and cause liver damage.
• The standard adult dose is 1 to 2 tablets every 4 to 6 hours as needed, not exceeding 8 tablets in any 24-hour period.
• The dose should not be exceeded and treatment should be limited to the shortest period necessary to control symptoms. A doctor should be consulted if pain or fever does not improve within 3 days.

Diagesic-P Tablet formula

• Paracetamol + Thioridazine + Caffeine

Available forms

• Tablets

How to use Diagesic-P Tablet?

• Take the medicine by mouth with water
• Swallow it whole
• Take it a the same time everyday to help you remember
• Do not use it for more than 3 days unless prescribed by your doctor
• Do not exceed the recommended dosage
• Do not use it after the expiry date has passed

Drug Interactions

All current medicines must be disclosed to the prescribing doctor before taking Diagesic-P. Key interactions include:

• Other Paracetamol-containing medicines: Concurrent use creates a risk of cumulative Paracetamol overdose and liver damage. Only one Paracetamol product should be used at a time.
• QT-prolonging medicines including antiarrhythmics, certain antibiotics (erythromycin, clarithromycin), antipsychotics, and antihistamines: The Thioridazine component adds to QT prolongation risk, raising the risk of cardiac arrhythmia.
• Warfarin: Regular Paracetamol use may enhance the anticoagulant effect of warfarin, increasing bleeding risk. INR should be monitored.
• Alcohol: Significantly raises the risk of Paracetamol hepatotoxicity. Must be avoided during treatment.
• CYP1A2 inducers such as rifampicin and carbamazepine: May increase conversion of Paracetamol to its hepatotoxic metabolite, raising liver damage risk even at standard doses.
• Domperidone and metoclopramide: Concurrent use with Thioridazine can worsen extrapyramidal effects.

Risks and warnings

• DRAP Safety Alert: In June 2022, DRAP issued Safety Alert No. 19 suspending all registrations of the Paracetamol 500mg + Thioridazine 3mg + Caffeine 70mg combination. The combination is not approved by any international reference regulatory authority including the FDA, EMA, MHRA, or TGA. Patients should discuss safer analgesic alternatives with their doctor.
• Thioridazine cardiac risk: Thioridazine was voluntarily withdrawn worldwide by Novartis due to dose-dependent QT interval prolongation causing potentially fatal ventricular arrhythmias including torsades de pointes. Even the low 3mg dose in Diagesic-P prolongs the QT interval. Patients with existing cardiac conditions, electrolyte imbalances, or who are taking other QT-prolonging medicines face significantly elevated risk.
• Paracetamol overdose: Exceeding the recommended dose of Diagesic-P can cause serious and potentially fatal liver damage. Only one Paracetamol-containing product should be used at a time.
• Liver disease: Paracetamol is metabolized by the liver. Patients with liver impairment must use the lowest possible dose under close medical supervision.
• Alcohol: Combining alcohol with Paracetamol significantly raises the risk of liver damage. Alcohol must be completely avoided during treatment.
• Pregnancy: Diagesic-P should not be used during the third trimester. The Thioridazine component carries risks to the fetus including neonatal extrapyramidal effects. Use in early pregnancy should only occur under direct medical supervision.
• Elderly patients: Older adults are more sensitive to the anticholinergic effects of Thioridazine and more vulnerable to cardiac arrhythmias. The lowest effective dose should be used for the shortest possible time.
• Driving and machinery: The Thioridazine component may cause drowsiness. Caution is advised when driving or operating heavy machinery.

Diagesic-P Tablet Side Effects

Most patients tolerate Diagesic-P well at recommended doses for short treatment periods. Side effects are generally mild and dose-dependent.

• Mild drowsiness or sedation from the Thioridazine component.
• Dry mouth or mild anticholinergic effects.
• Nausea or mild stomach discomfort.
• Caffeine-related effects including mild agitation, restlessness, or difficulty sleeping if taken late in the day.
• Mild dizziness or lightheadedness.

Serious side effects are rare at standard doses but require immediate medical attention:

• Irregular heartbeat or palpitations, which may indicate QT interval prolongation caused by the Thioridazine component.
• Fainting or sudden dizziness, which may indicate a cardiac arrhythmia.
• Yellowing of the skin or eyes, severe abdominal pain, or dark urine, which may indicate liver damage from Paracetamol.
• Signs of a severe allergic reaction including facial swelling, difficulty breathing, or widespread rash.
• Involuntary muscle movements or rigidity, which may indicate extrapyramidal effects from Thioridazine.

Storage Conditions

• Store the medicine at room temperature
• Keep out of reach and sight of children
• Protect it from sunlight and moisture