Paracetamol 500mg, Phenylephrine Hydrochloride 5mg & Chlorpheniramine Maleate 2mg & Caffeine 30mg Tablets Tablet

What is Paracetamol 500mg, Phenylephrine Hydrochloride 5mg & Chlorpheniramine Maleate 2mg & Caffeine 30mg Tablets Tablet?

Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg and Caffeine 30 mg Tablets is a combination oral formulation for symptomatic relief of selected cold and upper respiratory symptoms. It combines analgesic-antipyretic, nasal decongestant, antihistamine and supportive caffeine effects in a single tablet.

Uses / Indications

This combination may be used for the symptomatic management of:

• Fever and body aches associated with common cold symptoms
• Headache associated with cold or upper respiratory symptoms
• Nasal congestion
• Runny nose and sneezing
• Watery eyes associated with cold or allergy-related symptoms
• Other selected cold-related symptoms where the combination is clinically appropriate

The specific indication should follow the approved product information.

Benefits

• Paracetamol provides analgesic and antipyretic activity for pain and fever.
• Phenylephrine hydrochloride provides nasal decongestant activity.
• Chlorpheniramine maleate provides antihistamine activity that may help reduce sneezing, runny nose and watery eyes.
• Caffeine provides a supportive stimulant effect and may enhance the analgesic activity of paracetamol in combination formulations.
• Provides multiple symptomatic actions in a single oral tablet.

Side Effects

Common Side Effects

Possible side effects may include:

• Drowsiness
• Dry mouth, nose or throat
• Dizziness
• Nausea
• Stomach discomfort
• Headache
• Blurred vision
• Nervousness or restlessness
• Difficulty sleeping

Less Common or Serious Side Effects

Less common but clinically important reactions may include:

• Increased blood pressure
• Palpitations or rapid heartbeat
• Urinary retention
• Severe allergic reactions
• Serious skin reactions
• Significant confusion or excessive sedation
• Liver injury associated with excessive paracetamol exposure

Medical attention should be sought if severe allergic symptoms, significant cardiovascular symptoms, severe drowsiness or other serious reactions occur.

How Does It Work?

Paracetamol

Paracetamol provides analgesic and antipyretic activity through central effects involved in pain perception and regulation of body temperature.

Phenylephrine Hydrochloride

Phenylephrine is a sympathomimetic decongestant that stimulates alpha-adrenergic receptors, producing vasoconstriction of nasal blood vessels and helping reduce nasal congestion.

Chlorpheniramine Maleate

Chlorpheniramine is an H1 antihistamine. It reduces the effects of histamine and helps relieve symptoms such as sneezing, runny nose and watery eyes.

Caffeine

Caffeine is a central nervous system stimulant. In combination analgesic products, it may provide supportive effects and enhance the analgesic action of paracetamol.

Together, these ingredients provide complementary symptomatic effects for selected combinations of pain, fever, nasal congestion and allergy-like symptoms.

Dosage Guidelines

The appropriate dosage depends on age, clinical condition, other medicines being taken and the approved product information.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For oral administration:

• Take exactly as directed.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not exceed the recommended dose.
• Avoid taking other products containing paracetamol or similar cold and decongestant ingredients unless advised.
• Do not crush, split, chew or dissolve the tablet unless permitted by the approved product information.
• Follow the recommended treatment schedule.

Particular caution may be required in patients with liver disease, hypertension, cardiovascular conditions, glaucoma or urinary retention.

When Not to Use

This combination should generally not be used in patients with known hypersensitivity to paracetamol, phenylephrine, chlorpheniramine, caffeine or any component of the formulation.

Medical advice should be obtained before use in patients with:

• Severe or uncontrolled hypertension
• Significant cardiovascular disease
• Hyperthyroidism
• Glaucoma
• Urinary retention or significant prostate-related urinary problems
• Severe liver impairment
• Severe renal impairment
• Previous serious reactions to antihistamines or sympathomimetic medicines

Phenylephrine-containing products should not be used with monoamine oxidase inhibitors unless specifically permitted by the approved product information.

Drug / Product Interactions

Potentially relevant interactions may occur with:

• Other paracetamol-containing medicines
• Other cold, flu or decongestant products
• Monoamine oxidase inhibitors
• Sedatives and other CNS-depressant medicines
• Other antihistamines
• Certain medicines affecting blood pressure or heart rate
• Medicines that may affect liver function
• Products containing additional caffeine

Patients taking multiple medicines should inform their healthcare professional before using this combination.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Paracetamol overdose can cause serious liver injury even when symptoms may not be immediately apparent.

Missed Dose

If the medicine is being taken on a scheduled basis, take the missed dose when remembered unless it is nearly time for the next dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose.

Driving

Chlorpheniramine may cause drowsiness and reduced alertness. Patients should understand their individual response before driving or operating machinery.

Alcohol

Alcohol may increase the sedative effects of chlorpheniramine and may increase the risk of liver injury with excessive paracetamol exposure. Avoid excessive alcohol consumption.

Pregnancy

Use during pregnancy should be based on appropriate medical assessment of the individual components and the clinical need.

Breastfeeding

The suitability of this combination during breastfeeding should be discussed with a qualified healthcare professional.

Children

Paediatric use should follow the age-specific recommendations of the approved product information. This combination should not be given to children unless specifically appropriate for their age and clinically indicated.

Elderly Patients

Older patients may be more susceptible to drowsiness, dizziness, urinary retention and cardiovascular effects and may require appropriate medical assessment.

Renal Impairment

Patients with renal impairment should seek professional advice before use, particularly where antihistamine dose adjustment may be relevant.

Hepatic Impairment

Patients with liver disease should use this paracetamol-containing product only under appropriate professional guidance.

General Instructions

• Take the medicine according to the approved product information or prescribed schedule.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not exceed the recommended dose.
• Check other medicines for paracetamol, antihistamine or decongestant ingredients before concurrent use.
• Avoid excessive alcohol consumption.
• Avoid driving if drowsiness or reduced alertness occurs.
• Do not share prescription medicines with other people.
• Keep the medicine in its original packaging where appropriate.
• Follow healthcare professional and approved product information instructions.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Because the formulation contains caffeine, excessive additional caffeine from coffee, tea, energy drinks or other sources may increase nervousness, restlessness, palpitations or difficulty sleeping in susceptible individuals.

Avoid excessive alcohol consumption because it may increase drowsiness and other risks associated with the formulation.

Comparison with Other Treatments

Combination cold formulations may contain several active ingredients to address different symptoms at the same time. This product combines an analgesic-antipyretic, nasal decongestant, antihistamine and caffeine.

Single-ingredient products may be used when only one symptom requires treatment, while other combination formulations may contain different antihistamines, decongestants or analgesics. The appropriate formulation depends on the symptoms, patient characteristics, concurrent medicines and approved indication.

Precautions & Warnings

• Check all other medicines for paracetamol before use.
• Do not exceed the recommended paracetamol dose.
• Avoid unnecessary duplication with other cold, flu or decongestant products.
• Chlorpheniramine may cause drowsiness and impaired alertness.
• Patients with hypertension or cardiovascular disease should seek professional advice before using phenylephrine-containing products.
• Use caution in patients with glaucoma, hyperthyroidism or urinary retention.
• Patients taking monoamine oxidase inhibitors should seek professional advice before using phenylephrine-containing products.
• Avoid excessive additional caffeine intake.
• Use appropriate caution in patients with liver or renal impairment.
• Seek medical attention for severe allergic reactions or significant cardiovascular symptoms.
• Pregnancy and breastfeeding use should be based on appropriate professional assessment.

Can I Use It With Other Medicines?

Generally Compatible With

This combination may be used with other medicines when clinically appropriate, but compatibility depends on the patient’s complete medication profile.

Use With Caution / Avoid

Particular caution is required with:

• Other paracetamol-containing medicines
• Other antihistamines
• Other cold or decongestant products
• Monoamine oxidase inhibitors
• Sedatives and other CNS-depressant medicines
• Medicines affecting blood pressure or heart rate
• Products containing substantial additional caffeine

Do not start, stop or change concurrent medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What is Paracetamol 500 mg, Phenylephrine 5 mg, Chlorpheniramine 2 mg & Caffeine 30 mg Tablets used for?

It is a combination formulation intended for symptomatic relief of selected cold and upper respiratory symptoms, including fever, headache, nasal congestion, sneezing and runny nose.

2. What are the active ingredients in this tablet?

Each tablet contains Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg and Caffeine 30 mg.

3. How does this combination work?

Paracetamol helps relieve pain and fever, phenylephrine helps reduce nasal congestion, chlorpheniramine reduces histamine-related symptoms, and caffeine provides supportive effects in the combination.

4. Can I take another paracetamol medicine with this product?

Care should be taken because this product already contains paracetamol. Additional paracetamol-containing medicines should not be taken without appropriate professional advice.

5. Can this product cause drowsiness?

Yes. Chlorpheniramine may cause drowsiness or reduced alertness in some individuals. Avoid driving or operating machinery if affected.

6. Can this product be used during pregnancy?

Use during pregnancy should be based on professional medical assessment of the individual ingredients and the clinical need.

7. Can children use this combination tablet?

Paediatric use should follow the age-specific recommendations in the approved product information. It should not be given to children unless appropriate for their age and clinically indicated.

8. How should these tablets be stored?

Store according to the conditions stated on the approved product label and package insert, and keep the product out of reach of children.