Withdrawn Voluntarily by MAH Kenya · PPB

Pholtex Forte

Pholcodine

Liquid Spray INN generic

What it does

Pholcodine is a medication used to relieve coughs. It works by suppressing the cough reflex.

Commonly used for: cough (dry cough), cough due to irritation

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
-
Registration date
-
Expiry date
-
Status
Withdrawn Voluntarily by MAH
Active ingredient
Pholcodine
Dosage form
Liquid Spray
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
iNova Pharmaceuticals
Applicant / LTR
-
Country of origin
Foreign
Manufacturer location
15e Riley Rd, Bedfordview, Johannesburg, 2008, South Africa

Source: Pharmacy and Poisons Board · fetched 2026-03-01 02:01:36 · updated 2026-04-14 13:24:14

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Pholcodine is a medication used to relieve coughs. It works by suppressing the cough reflex.

What it treats

  • cough (dry cough)
  • cough due to irritation

How it works

Pholcodine helps to reduce the urge to cough by acting on the brain.

Who it's for

It is suitable for adults and children over 6 years old who have a dry cough.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Pholcodine

BNF-referenced

Pholcodine is an opioid cough suppressant that acts centrally on the cough reflex, specifically targeting the cough center located in the medulla oblongata. It is utilized primarily for the relief of dry cough and is known for its analgesic properties without causing significant respiratory depression, making it a safer alternative to other opioid medications.

Indications

  • Dry cough
  • Cough caused by respiratory infections

Dosage

Children: For children aged 6-11 years, the recommended dose is 2-5 mg taken 3-4 times a day. For children aged 12-17 years, the dosage is 5-10 mg taken 3-4 times a day. Pholcodine should be avoided in children under 6 years.

Adults: For adults, the typical dosage is 5-10 mg taken 3-4 times a day.

Mechanism of action

Pholcodine exerts its effects directly on the cough center in the medulla oblongata, acting on peripheral reflexogenic receptors to suppress the cough reflex. This mechanism allows pholcodine to alleviate coughing without significantly impacting respiratory function.

Pharmacodynamics

Therapeutic doses of pholcodine do not typically cause respiratory depression, CNS excitation, or other side effects commonly associated with narcotics. It selectively targets the cough center while preserving respiratory activity, thus reducing the risk of addiction and psychological dependence. However, it is noted to have a stronger respiratory depression effect compared to codeine and can induce hypotension similar to codeine. Additional pharmacological effects include histamine release induction, anti-histaminic activity, anti-acetylcholinic action, anti-convulsant properties, and mild tranquilizing effects.

Pharmacokinetics

Pholcodine is absorbed well when taken orally and is metabolized in the liver. Its pharmacokinetic profile indicates it is distributed widely throughout the body. The elimination half-life and specific metabolic pathways are not detailed in the provided sources, but it is important to consider hepatic and renal function when prescribing.

Contra-indications

  • Known hypersensitivity to pholcodine or any of its components
  • Severe hepatic impairment
  • Severe renal impairment
  • Children under 6 years of age

Adverse effects

  • Drowsiness
  • Nausea
  • Constipation
  • Dry mouth
  • Dizziness
  • Hypotension

Interactions

  • Caution with other cough and cold preparations that may contain similar active ingredients
  • May interact with central nervous system depressants, enhancing sedative effects
  • Caution is advised when combined with antihistamines

Precautions

  • Use with caution in patients with respiratory conditions
  • Care should be taken to administer the correct dose, especially in children
  • Avoid use in patients with a history of substance abuse

Pregnancy

Pholcodine should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Pholcodine is excreted in breast milk; caution is advised when administering to breastfeeding mothers.

Storage

Store in a cool, dry place away from direct sunlight, and keep out of reach of children.

Formulations

  • Pholcodine 5 mg/5 mL linctus
  • Pholcodine 10 mg/5 mL linctus strong
  • Pholcodine 2 mg/mL oral solution
  • Pholcodine sugar-free linctus
BNF 85 (British National Formulary) p.345 BNF for Children 2019-2020 p.214 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Pholcodine

PubChem CID 5311356

Molecular formula: C23H30N2O4

Mechanism of action

The mechanism of action of pholcodine is directly performed in the medulla oblongata. In this site, it exerts analgesic properties on the peripheric reflexogenic receptors. This site is commonly known as the "cough center."

Pharmacodynamics

The therapeutic doses of pholcodine have been shown not to cause depression of respiration, CNS excitation or other side effects associated with narcotics. It is thought that the impact of pholcodine is selective on the cough center without affecting the respiratory center. Pholcodine is not euphorigenic, and thus, psychological dependence is unlikely. Clinical trials have not shown any evidence of addiction after prolonged administration of pholcodine. It is well reported that pholcodine presents a more considerable respiratory depression effect than codeine and it causes hypotension in the same degree than codeine. Some other noted impacts of pholcodine in preclinical trials are: 1) the induction of histamine release, 2) anti-histaminic effect, 3) anti-acetylcholinic action, 4) anti-convulsant action and 5) mild tranquilizing action.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.