Lemsip Max All Night Cold & Flu

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Lemsip Max All Night Cold & Flu

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Overview of Lemsip Max All Night Cold & Flu

This fixed-dose combination (FDC) product is an over-the-counter (OTC) oral medication specifically formulated to provide comprehensive symptomatic relief from cold and flu discomforts, particularly those that interfere with sleep.

Property Description
Active Ingredients Ibuprofen and Phenylephrine Hydrochloride
Form Oral Hard Capsule
Pharmacological Class Analgesic, NSAID, and Sympathomimetic Decongestant Combination
Common Use Symptomatic relief of cold and flu aches, fever, and congestion at night
Origin Synthetic (Pharmaceutical Active Substances)

Defining the Entity and Pharmacological Class

Lemsip Max All Night Cold & Flu is an FDC product containing two distinct, synthetic active pharmaceutical ingredients: Ibuprofen and Phenylephrine Hydrochloride. Ibuprofen belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) class, which is clinically recognized for its capacity to reduce pain and fever by modulating biological processes.

The product's classification as an analgesic, antipyretic, and anti-inflammatory agent combined with a sympathomimetic decongestant defines its dual-action capability. This specific combination distinguishes it from simpler preparations by offering the benefit of both powerful pain relief and effective congestion management in one hard capsule dosage form. The medication is specifically marketed to adults and adolescents seeking relief from the acute symptoms of illness.

The inclusion of Phenylephrine Hydrochloride provides the essential decongestant function, acting as an alpha-adrenergic agonist to reduce swelling in the nasal passages and sinuses. This synergistic, nocturnal formulation is designed to provide comprehensive relief from systemic discomfort and localized congestion, with the overall purpose of minimizing the disturbances that interrupt rest when suffering from a cold or flu.

Regulatory References

  1. NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
  2. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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What side effects are possible with Lemsip Max All Night Cold & Flu?

Possible Side Effects and Safety Information

The safety profile for this combination medicine is primarily defined by the risks associated with its active components: paracetamol, caffeine, and phenylephrine.

Serious Adverse Reactions and Safety Warnings

The most significant safety concern is the risk of delayed, serious liver damage resulting from paracetamol overdose, requiring immediate medical attention even if the individual feels well. Other serious risks documented in regulatory sources include:

  • Serious Skin Reactions: Cases of severe mucocutaneous reactions have been reported, classified as Very Rare.
  • Blood Disorders: Reports of blood dyscrasias such as thrombocytopenia, leucopenia, and agranulocytosis (reduction in specific blood cell types) are known, with frequency not estimable from available data.
  • Metabolic Acidosis: High anion gap metabolic acidosis has been reported, particularly in patients with pre-existing risk factors such as severe renal impairment, sepsis, or malnutrition.

Reported Adverse Reactions

Adverse reactions with a "frequency not known" (cannot be estimated from the available data) include hypersensitivity reactions (e.g., skin rashes), gastrointestinal issues (nausea, vomiting, abdominal discomfort), nervous system and psychiatric effects (headache, dizziness, insomnia, restlessness, anxiety), and cardiovascular effects (hypertension and palpitations).

Contraindications and Restrictions

Use of this product is contraindicated in patients with severe coronary artery disease, hypertension, hyperthyroidism, closed-angle glaucoma, diabetes mellitus, or those currently taking or having recently stopped Monoamine Oxidase Inhibitors (MAOIs). Patients should not take this product with other paracetamol-containing medicines or other sympathomimetic decongestants.

Caution is advised for patients with pre-existing liver or kidney problems. Due to the potential for CNS effects, such as nervousness and mental confusion, individuals are advised not to drive or operate machinery if affected.

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Overdose and Emergency Response

The official overdose profile for this fixed-dose combination product is defined by the acute toxicity risks of its components, Ibuprofen and Phenylephrine Hydrochloride, as documented in regulatory labeling.

Overdose Scope

Domain Official Regulatory Statement
Documented Overdose Presentations Symptoms include nausea, vomiting, abdominal pain, lethargy, drowsiness, headache, tinnitus, and nystagmus (Ibuprofen-related). May also present with hypertension, tremor, and palpitations (Phenylephrine-related).
Physiological Systems Affected The Central Nervous System, Cardiovascular, Gastrointestinal, and Renal systems are documented to be critically affected.
Emergency-response statements Management is primarily symptomatic and supportive. Interventions such as activated charcoal or an alpha-adrenergic blocking agent (for severe Phenylephrine toxicity) may be documented as warranted.
When immediate medical help is required Regulatory labeling strictly mandates to seek immediate medical attention or call a Poison Control Center right away if overdosage is suspected.

Overdose Classifications (High-Level)

Classification Aspect Official Regulatory Statement
Severity classification Overdose can result in severe or life-threatening outcomes, including metabolic acidosis, hypotension, coma, cardiac arrest, and hypertensive crisis.
Overdose-context constraints Regulatory information notes that no specific antidote is known for Ibuprofen overdosage, and mandates hospital monitoring of vital signs.

Resulting Overdose Structure

The documented manifestations range from gastrointestinal distress to severe systemic events, including convulsions, coma, and hypertensive crisis. The official regulatory profile mandates that urgent medical help must be sought in all cases of suspected overdosage, regardless of initial symptom severity, due to the potential for life-threatening complications. Treatment focuses on supportive care and monitoring.

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Therapeutic Uses of Lemsip Max All Night Cold & Flu

What Lemsip Max All Night Cold & Flu Treats: Main Uses and Benefits

The formulation is applied across domains where additional symptomatic support is needed for acute upper respiratory tract infections, and is commonly used for managing symptoms that interfere with daily functioning. This combination is commonly used to temporarily relieve multiple symptoms associated with the common cold or flu.

It helps address symptom clusters that may become intense or disruptive, including fever, generalized body aches and pains, headache, sore throat pain, and nasal and sinus congestion.

“This product is applied in scenarios where additional management of discomfort is required; it supports the patient during difficult episodes by easing distress and helps improve day-to-day comfort when symptoms are more noticeable.”

Quick Fact: Relief for Systemic Discomfort

This medication is applied in clinical settings that involve acute symptom patterns, specifically when discomfort arises from systemic imbalance and localized inflammatory or irritative states. The overall benefit provides support that helps ease the symptom burden during symptomatic phases, and may assist with maintaining functional stability when symptoms interfere with routine activities.

Regulatory References

  1. DailyMed label for Ibuprofen and Phenylephrine Hydrochloride
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Eligibility and Restrictions for Use

This product is officially designated for use by Adults and Children aged 16 years and over.

Contraindicated (Must Not Use)

Official regulatory documents establish strict prohibitions for several groups due to the active ingredients (paracetamol and phenylephrine hydrochloride). You must not take this medicine if you have:

  • Hypersensitivity or Allergy to paracetamol, phenylephrine, or any other component.
  • Severe Cardiovascular Conditions, including severe coronary heart disease, high blood pressure (hypertension), or an overactive thyroid (hyperthyroidism).
  • Other Serious Conditions, such as closed-angle glaucoma, phaeochromocytoma, or prostatic enlargement.
  • Medication Conflicts, specifically if you are currently taking or have stopped taking a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days, or if you are taking other sympathomimetic decongestants.

Special Consideration (Should Consult a Doctor)

Medical advice must be sought before use if you have certain conditions, as the product is generally not recommended or requires caution:

  • Pregnancy and Lactation: The product should be avoided during pregnancy and breastfeeding unless a healthcare professional specifically recommends it. Use is specifically cautioned against in women with a history of pre-eclampsia.
  • Organ Function Impairment: Patients with severe renal or severe hepatic impairment (kidney or liver problems).
  • Other Conditions: Including Raynaud's phenomenon or diabetes mellitus.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for the Ibuprofen and Phenylephrine combination product documents several crucial interaction constraints.

Classification Interacting Agents Official Interaction Statement
Contraindicated Combinations Monoamine Oxidase Inhibitors (MAOIs), Other Sympathomimetic Decongestants Co-administration with MAOIs is strictly prohibited due to the risk of hypertensive crisis; this restriction applies for 14 days after MAOI discontinuation. Other sympathomimetics are prohibited due to increased cardiovascular risk (e.g., blood pressure changes).
Pharmacodynamic Risk Anticoagulants (e.g., Warfarin), Corticosteroids, Other NSAIDs Concomitant use increases the officially documented risk of serious gastrointestinal bleeding and ulceration.
Efficacy Alteration Low-dose Aspirin (for antiplatelet benefit) Ibuprofen may diminish the antiplatelet benefit of low-dose aspirin. A specific timing separation is mandated: the ibuprofen dose must be taken at least 8 hours before or 30 minutes after the aspirin dose.
Antihypertensive Interference Beta-blockers and other Antihypertensives Phenylephrine may reduce the efficacy of these medicines, increasing the risk of hypertension and associated cardiovascular side effects.

Co-administration with Tricyclic Antidepressants or Cardiac Glycosides may also increase the risk of cardiovascular side effects. Furthermore, regulatory documents specify that consumption of three or more alcoholic drinks per day is associated with an increased risk of stomach bleeding when using ibuprofen-containing products.

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Mechanism of Action

Central Modulation of Thermoregulation and Pain Signaling

This mechanism is achieved by Paracetamol through the selective inhibition of Cyclooxygenase (COX) enzymes primarily within the Central Nervous System (CNS). This targeted molecular action reduces the synthesis of prostaglandin E2 ( PGE2) in the hypothalamus, chemically resetting the body’s elevated temperature set-point and reducing the sensitization of central pain pathways. The physiological consequence of this CNS modulation is a downward adjustment of the elevated temperature set-point and an alteration in pain threshold signaling.

Localized Sympathetic Vascular Control

The mechanism for localized vascular control is produced by Phenylephrine, which acts as a direct agonist on Alpha-1 (alpha1) Adrenergic Receptors located on the vascular smooth muscle of the nasal mucosa. This receptor activation triggers a localized cascade that causes vasoconstriction, physically restricting blood flow and volume in the small vessels of the nasal and sinus lining. The resulting physiological change is the reduction of mucosal edema and associated fluid extravasation.

Mechanistic Complementarity

The two active ingredients exhibit mechanistic complementarity by influencing separate physiological systems without competition for the same molecular targets. This non-overlapping action provides a dual mechanism profile, resulting in a coordinated, dual-domain physiological adjustment.

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Dosage and Administration Information

The administration of the Ibuprofen and Phenylephrine HCl fixed-dose combination is governed by specific parameters intended for acute, short-term use. This medication is administered via the oral route as a hard capsule or tablet.

Dosage and Frequency Parameters

The regimen for individuals 12 years of age and over begins with a standard dose of one unit. If symptoms do not adequately respond to the initial amount, the dose may be increased to a maximum of two units per intake. This dosing pattern is repeated every four hours while symptoms persist.

A strict upper boundary is established for the total amount of medication used: administration must not exceed six units in any 24-hour period. This constraint ensures that the total amount of both active components is limited and requires that the smallest effective dose be utilized in all cases.

Administration Conditions and Duration

The contextual instruction for use specifies that the unit should be swallowed whole. To address potential gastric irritation, the medication may be administered with food or milk when stomach upset occurs. Critically, the product is indicated solely for short-term symptomatic relief, and the maximum continuous duration of use is constrained to seven days for the management of pain, fever, or nasal congestion.

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Recent Clinical Evidence

Lemsip Max All Night Cold & Flu: Recent Clinical Evidence


Evidence for Systemic Symptom Relief (Pain and Fever)

Research examined how short-term use of the product's main pain-relieving ingredient, Ibuprofen, was associated with outcomes related to physical discomfort and systemic imbalance experienced during conditions characterized by fluctuating or episodic manifestations. The key outcomes monitored included the total score of all reported symptoms, as well as specific outcomes related to physical discomfort such as headaches, body aches, and fever. Findings describe patterns observed in the studies where the analgesic and fever-reducing component was observed in research exploring short-term symptom changes, incorporating evidence patterns from the research base for the single ingredient, Ibuprofen. However, there is limited information for long-term outcomes or the consequences of repeated use beyond a single acute episode.

Evidence for Nasal and Sinus Congestion

Research has explored what was studied for the oral decongestant component, Phenylephrine, regarding outcomes linked to inflammatory or irritative states in the nasal passages. Studies monitored patient-reported outcomes describing perceived discomfort, such as the feeling of a "plugged nose." Studies report how symptoms evolved, but findings were mixed when evaluating outcomes related to systemic or functional imbalance associated with oral Phenylephrine. Regulatory reviews have detailed that certainty remains low regarding observed patterns related to nasal congestion compared to placebo.

Evidence on Pharmacokinetics and Combination Bioequivalence

Bioequivalence (BE) studies was evaluated in healthy adult volunteers. These studies monitored specific outcomes related to the absorption of both Ibuprofen and Phenylephrine, tracking peak concentrations and total drug exposure. Findings describe patterns observed in these studies which generally reported that the total drug exposure of both active ingredients was associated with exposure comparable to taking them separately. The limitation of these studies is that they focus exclusively on drug absorption; they do not provide context on clinical outcomes in patients experiencing symptoms.

Key Studies & References DailyMed Labeling for Ibuprofen and Phenylephrine Combination Products (Example of regulatory-mandated content)

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Frequently Asked Questions (FAQ)

Common questions about Lemsip Max All Night Cold & Flu (FAQ)

Q: What is Lemsip Max All Night Cold & Flu and what is it used for?

A: Lemsip Max All Night Cold & Flu is a medicine used for the short-term relief of symptoms associated with colds and flu. It is a capsule that contains three active ingredients: Paracetamol, which is a pain reliever (analgesic) and fever reducer (antipyretic); Phenylephrine hydrochloride, which is a decongestant that helps to clear blocked noses and sinuses; and Diphenhydramine hydrochloride, which is an antihistamine that can help relieve symptoms like sneezing and a runny nose, and may also cause drowsiness to aid rest.

Q: How does Lemsip Max All Night Cold & Flu work?

A: The medicine works due to the combined action of its active ingredients:

  • Paracetamol targets pain and high temperature by affecting chemical messengers in the body.
  • Phenylephrine hydrochloride is a decongestant that narrows blood vessels in the nasal passages, which reduces swelling and congestion.
  • Diphenhydramine hydrochloride blocks histamine, a substance the body produces during an allergic reaction, which helps to relieve sneezing and runny nose. It is also known to cause sedation.

Q: When is the best time to take Lemsip Max All Night Cold & Flu?

A: This product is specifically formulated for night-time use to help relieve symptoms and aid sleep. It should be taken just before going to bed. The inclusion of the drowsy antihistamine, Diphenhydramine, makes it unsuitable for use during the daytime or when you need to be alert.

Q: What is the recommended dose of Lemsip Max All Night Cold & Flu?

A: For adults and children aged 16 years and over, the usual recommended dose is two capsules taken at night, just before going to sleep. Do not take more than the recommended dose, and be sure to check that you are not taking other medicines containing paracetamol.

Q: Can children take Lemsip Max All Night Cold & Flu?

A: Lemsip Max All Night Cold & Flu capsules are only recommended for use in adults and children aged 16 years and over.

Q: How long can I take Lemsip Max All Night Cold & Flu for?

A: This medicine is intended only for short-term use. If your symptoms persist for more than 3 days, or if new symptoms appear, you should consult a healthcare professional. Do not exceed the maximum duration of use stated on the packaging.

Q: What if I miss a dose of Lemsip Max All Night Cold & Flu?

A: As this medicine is taken just before bedtime, if you forget a dose, do not take it later in the night or the next morning. Simply take the next dose as usual on the following night, if needed. Never take a double dose to make up for a missed one.

Q: Can I drink alcohol while taking Lemsip Max All Night Cold & Flu?

A: Alcohol should be avoided while taking this medication. The Diphenhydramine component can cause drowsiness, and consuming alcohol may significantly increase this sedative effect, making it dangerous. Alcohol can also increase the risk of liver damage when combined with Paracetamol.

Q: What are the main side effects of Lemsip Max All Night Cold & Flu?

A: Due to the presence of Diphenhydramine, the most common side effect is drowsiness or feeling sleepy. Other potential side effects include:

  • Dizziness or blurred vision
  • Dry mouth, nose, or throat
  • Difficulty passing urine (urinary retention)
  • Constipation
  • Nervousness or difficulty sleeping (insomnia) - less common, but possible, due to Phenylephrine If you experience severe side effects or signs of an allergic reaction (such as difficulty breathing, swelling of the face/throat, or rash), seek immediate medical attention.

Q: Is Lemsip Max All Night Cold & Flu safe to take with other cold and flu products?

A: You must not take Lemsip Max All Night Cold & Flu with any other products that contain paracetamol (such as other flu remedies, pain relievers, or decongestants). Combining them can lead to a dangerous overdose of paracetamol. Additionally, due to the decongestant and antihistamine components, you should avoid combining it with other similar cold and flu preparations unless specifically advised by a healthcare professional. Always check the ingredients of all medicines you are taking.

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How should Lemsip Max All Night Cold & Flu be stored and disposed of?

Storage and Disposal of Lemsip Max All Night Cold & Flu

The storage of this medication is defined by regulatory requirements to ensure its stability and safety. The capsules must be stored at a temperature not exceeding 25 C and must be kept in a dry place. It is mandatory to store the medicine in the original package to protect it from environmental degradation.

All Lemsip Max capsules must be kept strictly out of the sight and reach of children.

The product must not be used after the expiry date printed on the packaging.

Disposal Requirements

Official disposal guidelines state that unused or expired medicines must not be thrown away via household waste or wastewater. To comply with environmental regulations, patients should be advised to return the product to a pharmacist or use a local collection system for proper pharmaceutical waste disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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