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Temperate®650-NF
Product Composition
Packaging Details
Product Description
TEMPERATE-650 NF Tablets
Paracetamol 650 mg + Caffeine (Anhydrous) 50 mg
TEMPERATE-650 NF is an oral analgesic combination containing Paracetamol 650 mg and Caffeine (Anhydrous) 50 mg per tablet. It is formulated for symptomatic relief of pain and fever, with caffeine used as an analgesic adjuvant. Clinical literature indicates that caffeine can enhance the analgesic effect of paracetamol in some acute-pain settings.
1. Product Information
| Parameter | Details |
|---|---|
| Brand Name | TEMPERATE-650 NF |
| Dosage Form | Tablet |
| Route | Oral |
| Composition | Paracetamol 650 mg + Caffeine (Anhydrous) 50 mg |
| Therapeutic Category | Analgesic & Antipyretic |
| Primary Action | Pain relief and reduction of fever |
| Pack Shown | 20 × 5 Tablets |
| Prescription Status | Rx, as shown on the pack |
Composition
Each tablet contains:
- Paracetamol IP — 650 mg
- Caffeine (Anhydrous) — 50 mg
- Excipients — q.s.
2. What is TEMPERATE-650 NF used for?
TEMPERATE-650 NF is intended for symptomatic relief of pain and fever. Depending on the clinical situation and prescribing decision, paracetamol-containing analgesics may be used for conditions such as:
- Headache
- Tension-type headache
- Toothache
- Musculoskeletal pain
- Body ache
- Mild-to-moderate acute pain
- Pain associated with fever
- Cold- or flu-associated aches and fever
- Menstrual pain
- Other short-term painful conditions where paracetamol is considered appropriate
The combination of paracetamol with caffeine has been studied particularly in acute pain and headache, with evidence that caffeine can provide a modest additional analgesic effect in some settings.
Important: The exact approved indications for the marketed product should be taken from its current approved prescribing information and local regulatory labeling.
3. Mechanism of Action
A. Paracetamol 650 mg
Paracetamol is an analgesic and antipyretic medicine.
It produces:
Analgesic action
Paracetamol acts predominantly through central mechanisms involved in pain processing, reducing the perception of pain.
It is therefore useful for symptomatic management of various mild-to-moderate painful conditions.
Antipyretic action
Paracetamol acts centrally to reduce elevated body temperature during fever.
Unlike conventional NSAIDs, paracetamol has relatively limited peripheral anti-inflammatory activity at therapeutic doses.
B. Caffeine 50 mg
Caffeine is included as an analgesic adjuvant.
It may enhance the analgesic response to paracetamol through effects involving the central nervous system and adenosine receptors. Clinical research has found that adding caffeine to analgesics can provide a modest improvement in acute pain relief, although the magnitude of benefit varies according to the pain condition and formulation.
Caffeine may also contribute to:
- Enhancement of analgesic response
- Potentially faster perceived relief in some settings
- Reduction of headache-associated symptoms in certain patients
- Improved analgesic efficacy compared with the analgesic alone in some clinical situations
4. Combined Action
Paracetamol + Caffeine
The formulation combines the primary analgesic and antipyretic action of paracetamol with the adjuvant analgesic effect of caffeine.
Paracetamol
↓
Reduces pain and fever
Caffeine
↓
Provides analgesic adjuvant activity
Combined effect
↓
Enhanced symptomatic pain-relief potential compared with paracetamol alone in some acute pain settings.
Clinical studies and reviews have reported that caffeine can increase the analgesic efficacy of paracetamol, particularly when used in acute pain and headache-related conditions.
5. Therapeutic Benefits
TEMPERATE-650 NF may provide:
✔ Effective symptomatic pain relief
Paracetamol provides the principal analgesic action.
✔ Fever reduction
Paracetamol provides antipyretic activity.
✔ Analgesic adjuvant effect
Caffeine may enhance the analgesic response to paracetamol.
✔ Headache support
Paracetamol-caffeine combinations have been studied in acute headache conditions.
✔ Convenient combination therapy
Two complementary ingredients are provided in a single oral dosage form.
6. Common Clinical Applications
Depending on the physician’s assessment, TEMPERATE-650 NF may be considered for symptomatic treatment of:
| Condition | Potential therapeutic role |
|---|---|
| Headache | Analgesic |
| Tension-type headache | Analgesic + caffeine adjuvant |
| Toothache | Analgesic |
| Musculoskeletal pain | Symptomatic pain relief |
| Body ache | Symptomatic pain relief |
| Fever with body ache | Analgesic + antipyretic |
| Cold/flu-associated aches | Symptomatic relief |
| Menstrual pain | Analgesic |
| Mild-to-moderate acute pain | Analgesic |
The exact indication and duration should be determined according to the patient’s condition and approved product information.
7. Suggested Use & Dosage
TEMPERATE-650 NF should be used strictly according to the physician’s recommendation.
The artwork specifies the strength but does not provide a dosing schedule, so a product-specific dosing regimen should not be inferred from the pack.
Administration
- Take orally with water.
- Swallow the tablet as directed.
- It may be taken with or without food unless otherwise advised.
- Do not exceed the prescribed dose.
- Do not take additional paracetamol-containing medicines without checking the total daily amount.
Important
Because this product contains 650 mg of paracetamol per tablet, all other medicines containing paracetamol/acetaminophen should be considered when calculating the patient’s total daily intake. Excessive paracetamol exposure can cause severe liver injury.
8. Side Effects
Most people tolerate therapeutic doses of paracetamol, but adverse effects can occur.
Possible side effects
- Nausea
- Vomiting
- Stomach discomfort
- Headache
- Dizziness
- Skin rash
- Nervousness
- Restlessness
- Difficulty sleeping
- Palpitations in caffeine-sensitive individuals
Caffeine-containing analgesic combinations can produce caffeine-related effects such as nervousness and dizziness in some patients.
Rare but serious reactions
Seek medical attention for:
- Severe skin rash
- Facial or throat swelling
- Difficulty breathing
- Severe allergic reaction
- Unusual bleeding or bruising
- Signs of liver injury
- Persistent vomiting
- Severe abdominal pain
- Yellowing of the eyes or skin
- Dark urine
9. Important Paracetamol Safety Warning
Do not exceed the recommended dose of paracetamol.
Paracetamol overdose can cause serious and potentially fatal liver injury. The FDA states that the maximum total amount of acetaminophen/paracetamol for adults and children aged 12 years and older should not exceed 4,000 mg in 24 hours from all medicines combined; individual patients may require a lower maximum based on clinical circumstances.
Therefore:
Avoid taking TEMPERATE-650 NF together with another medicine containing Paracetamol/Acetaminophen unless specifically advised by a healthcare professional.
This is particularly important with cold, flu and headache products, many of which may also contain paracetamol.
10. Precautions & Warnings
Inform your doctor before using TEMPERATE-650 NF if you have:
- Liver disease
- Regular or heavy alcohol consumption
- Kidney disease
- Previous reaction to paracetamol
- Caffeine sensitivity
- Heart rhythm problems
- Uncontrolled hypertension
- Anxiety or significant insomnia
- A history of frequent headaches requiring regular analgesics
Caffeine-related precaution
Avoid excessive consumption of additional caffeine from:
- Coffee
- Tea
- Energy drinks
- Cola
- Caffeinated supplements
- Other caffeine-containing medicines
Excess caffeine may increase nervousness, tremor, insomnia or palpitations.
11. Drug Interactions
Tell your doctor or pharmacist about all medicines you are taking.
Particular attention should be given to:
Other paracetamol-containing medicines
May increase the risk of accidental paracetamol overdose.
Other analgesics
Concurrent use should be reviewed to avoid unnecessary duplication.
Medicines affecting the liver
Some medicines can affect hepatic metabolism and may require medical supervision.
Caffeine-containing medicines/products
May increase total caffeine exposure.
Anticoagulant therapy
Regular or prolonged paracetamol use may require monitoring in patients taking certain anticoagulants.
The complete interaction profile should be checked against the patient’s current medication list.
12. Pregnancy & Breastfeeding
Use during pregnancy or breastfeeding should be based on medical advice and an individual risk-benefit assessment.
Do not recommend routine self-medication with this combination during pregnancy without consulting a healthcare professional.
Because the product contains caffeine, total daily caffeine intake from medicines and dietary sources should also be considered.
13. Use in Elderly Patients
Elderly patients may be more likely to have:
- Liver impairment
- Kidney impairment
- Multiple medications
- Increased sensitivity to adverse effects
Dose and duration should therefore be determined by the treating physician where clinically appropriate.
14. Liver & Kidney Impairment
Liver impairment
Particular caution is required because excessive paracetamol exposure can cause significant liver injury.
Patients with existing liver disease or substantial alcohol consumption should consult a healthcare professional before use.
Kidney impairment
Patients with significant renal impairment should use the product only according to medical advice.
15. When to Seek Immediate Medical Attention
Urgent medical evaluation is appropriate if:
- More than the prescribed quantity has been taken.
- Multiple paracetamol-containing medicines were taken accidentally.
- Severe vomiting develops after excessive intake.
- Yellowing of the skin or eyes occurs.
- Severe abdominal pain develops.
- Severe allergic symptoms occur.
- Difficulty breathing occurs.
- Significant palpitations or severe agitation develops.
Paracetamol overdose requires prompt medical assessment even if the patient initially feels well.
16. Storage
Store TEMPERATE-650 NF:
- In a cool, dry place.
- Away from direct sunlight.
- Away from excessive heat and moisture.
- In the original packaging.
- Out of reach of children.
Do not use tablets after the expiry date.
17. Key Product Features
TEMPERATE-650 NF
Dual-action oral analgesic combination
- Paracetamol 650 mg
- Caffeine (Anhydrous) 50 mg
- Tablet dosage form
- Oral administration
- Analgesic and antipyretic action
- Caffeine as an analgesic adjuvant
- Suitable for physician-directed symptomatic management of acute pain and fever
18. Why TEMPERATE-650 NF?
Paracetamol 650 mg
Provides the principal analgesic and antipyretic action.
Caffeine 50 mg
Provides an analgesic adjuvant component that may enhance pain relief from paracetamol in selected acute pain conditions.
Convenient dosage form
A single tablet combines both active ingredients.
Broad symptomatic application
The combination can be considered for several acute pain conditions where paracetamol is clinically appropriate.
