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Chlorphenamine Sugar Free 2mg/5ml 150ml Suspension

Chlorphenamine Sugar Free 2mg/5ml 150ml Suspension

Generic

Pharmaceutical Product
  • UK MHRA Licensed medicinal product: chlorphenamine (chlorpheniramine) maleate 2 mg/5 ml oral solution is authorised under multiple product licences (e.g. PL 20416/0610 and related licences) for 100 ml and 150 ml pack sizes.
  • Manufactured and released under EU/UK Good Manufacturing Practice (GMP) standards.
  • Legal classification in the UK: Pharmacy (P) medicine for licensed chlorphenamine maleate 2 mg/5 ml oral solution, available over the counter from pharmacies following pharmacist assessment.
  • Complies with relevant quality, safety, and risk management requirements as detailed in MHRA Public Assessment Reports and the approved SmPC and PIL for chlorphenamine maleate 2 mg/5 ml oral solution.
Oral antihistamine solution/suspension (sugar free)

Description

Chlorphenamine Sugar Free 2mg/5ml 150ml Suspension is a pharmacy antihistamine oral solution/suspension containing 2 mg of chlorphenamine (chlorpheniramine) maleate per 5 ml in a sugar-free vehicle. It is used for the symptomatic control of allergic conditions responsive to H1 antihistamines, including hay fever, other allergic rhinitis, urticaria, skin allergies and rashes, and the itch associated with chickenpox. This generic product is supplied in a 150 ml bottle and is suitable for adults and children over 1 year, with age-adjusted dosing.

Bnefits

  • Provides symptomatic relief from hay fever and other upper respiratory allergies, including sneezing, runny or blocked nose, and itchy, watery eyes.
  • Relieves itch, redness, swelling, and irritation associated with skin allergies, nettle rash (hives), and insect bites and stings.
  • Helps reduce itch and discomfort associated with chickenpox.
  • Sugar-free formulation, suitable for patients who need to avoid sucrose and some diabetics (subject to individual clinical advice).
  • Oral liquid/suspension form is easier to take for children and adults who have difficulty swallowing tablets.
  • Fast onset of action, generally within about 30–60 minutes, with symptomatic relief lasting several hours.
  • Can be purchased as a pharmacy medicine for short-term use following pharmacist assessment and advice.

Indications

  • Symptomatic control of allergic conditions responsive to antihistamines, including hay fever (allergic rhinitis) and vasomotor rhinitis.
  • Relief of symptoms due to other allergies such as pet, house dust mite, and mould spore allergies.
  • Treatment of nettle rash and hives (urticaria).
  • Relief of skin allergies and dermatitis presenting with itch, redness, and swelling.
  • Relief of prickly heat and heat rash.
  • Management of reactions to food, food additives, or medicines, when an H1 antihistamine is suitable.
  • Relief of itch and rash associated with chickenpox.
  • Relief of itch, redness, and swelling from insect bites and stings.

Composition

  • Active ingredient: Chlorphenamine (chlorpheniramine) maleate 2 mg per 5 ml oral solution/suspension (equivalent to 0.4 mg/ml).
  • Sugar-free oral vehicle (brand-dependent) typically containing polyols such as sorbitol solution and other standard excipients used in sugar-free oral solutions.
  • Additional excipients vary by manufacturer and may include purified water, flavourings, acids/buffers, sweeteners (e.g. sodium saccharin), and preservatives as specified in the individual product’s SmPC and PIL.

Formulation

  • Pharmaceutical form: Oral solution/suspension (listed as "S/F SUSPENSION" and "Oral Solution" in product descriptions and regulatory documents).
  • Strength: 2 mg chlorphenamine maleate per 5 ml (0.4 mg/ml).
  • Sugar-free formulation (no added sucrose).
  • Flavour and exact excipient profile may vary by generic brand (commonly fruit- or banana-flavoured to aid palatability).
  • Pack size: 150 ml bottle.

Packaging

  • Supplied in an amber Type III glass or suitable plastic bottle (depending on generic brand), with a child-resistant, tamper-evident cap, as per MHRA-licensed chlorphenamine maleate 2 mg/5 ml oral solution products.
  • Nominal fill volume: 150 ml.
  • Usually supplied with a graduated oral dosing spoon or syringe (2.5 ml / 5 ml) as per licensed preparations, though the exact measuring device may vary by manufacturer.
  • Outer carton and label include product name, strength, dosing instructions, batch number, and expiry date.
  • Pack size listing on distributor site: "CHLORPHENAMINE 2MG/5ML S/F SUSPENSION X 150ML X 1" (single bottle per pack).

Usage

  • For oral use only.
  • Shake the bottle well before each use to ensure uniform dosing, especially if the product is a suspension.
  • Measure doses carefully using the supplied measuring spoon or oral syringe; do not use a kitchen teaspoon.
  • Typical dosing (may vary depending on brand and national SmPC; follow local product label and pharmacist/doctor advice):
  • • Adults and children over 12 years: 10 ml (4 mg) every 4–6 hours as required, up to a maximum of 60 ml (24 mg) in any 24 hours.
  • • Children 6–12 years: 5 ml every 4–6 hours as required, up to a maximum of 30 ml (12 mg) in any 24 hours.
  • • Children 2–6 years: 2.5 ml every 4–6 hours as required, up to a maximum of 15 ml (6 mg) in any 24 hours.
  • • Children 1–2 years: 2.5 ml twice daily (minimum interval of 4 hours), maximum 5 ml (2 doses) in 24 hours; use only on medical/pharmacist advice.
  • Not recommended for children under 1 year of age.
  • Elderly patients may be more prone to side effects (particularly confusion and sedation); lower total daily doses and cautious use are advised under medical supervision.
  • Do not exceed the stated maximum daily dose.
  • Avoid alcohol while taking this medicine, as drowsiness and impairment may be increased.
  • If symptoms persist for more than a few days, worsen, or are accompanied by high fever, breathing difficulty, or severe rash, seek medical advice promptly.
  • Do not combine with other products containing chlorphenamine or other sedating antihistamines unless directed by a healthcare professional.
  • Always read the patient information leaflet supplied with the specific product before use.

Contraindications

  • Hypersensitivity to chlorphenamine (chlorpheniramine) maleate or to any of the excipients in the specific product.
  • Use in children under 1 year of age.
  • Concomitant use with monoamine oxidase inhibitor (MAOI) antidepressants or within 14 days of stopping an MAOI, due to risk of serious interactions.
  • Severe hepatic impairment where sedating antihistamines are contraindicated, unless advised by a specialist.
  • Known intolerance or contraindication to other first-generation sedating antihistamines where cross-sensitivity is suspected.
  • Acute porphyria (many sedating antihistamines are considered unsuitable or require specialist advice).

Adverse Effects

  • Very common/common: drowsiness or sedation, especially at the start of treatment or at higher doses; dizziness; fatigue; reduced alertness.
  • Common: dry mouth, dry nose or throat, blurred vision, headache, gastrointestinal disturbance (nausea, vomiting, constipation).
  • Anticholinergic effects: urinary retention or difficulty passing urine (particularly in men with prostate enlargement), constipation, tachycardia, palpitations.
  • Central nervous system effects: impaired concentration, psychomotor slowing, confusion (especially in the elderly), irritability, restlessness, or paradoxical excitation in children.
  • Allergic and dermatologic reactions: skin rash, urticaria, photosensitivity; in rare cases, angioedema or more serious hypersensitivity reactions.
  • Haematological (rare): blood dyscrasias such as agranulocytosis or thrombocytopenia have been reported with antihistamines as a class, though very uncommon.
  • Other: respiratory thickening of bronchial secretions, which may be problematic in patients with asthma or chronic bronchitis; rarely, seizures in predisposed individuals.
  • Like all sedating antihistamines, chlorphenamine can impair the ability to drive, use machinery, or perform tasks requiring mental alertness; patients experiencing drowsiness or dizziness should not engage in such activities.

Storage Conditions

  • Do not store above 25°C.
  • Store in the original container to protect from light and to maintain stability.
  • Keep the bottle tightly closed when not in use.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date shown on the bottle and carton.
  • Shelf life for licensed generic chlorphenamine maleate 2 mg/5 ml oral solutions is typically 2 years unopened; in-use shelf life and any specific discard period after first opening should be followed as stated in the individual product’s patient information leaflet.

Duration

Short-term use for symptomatic relief of acute or intermittent allergy and itch; typically used for a few days at a time. Patients should seek medical advice if symptoms do not improve within several days or if long-term, continuous use is required.

Onset

Symptomatic relief generally begins within about 30\u201360 minutes of oral dosing, with peak effect around 1\u20132 hours and duration of action approximately 4\u20136 hours.

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