Paracetamol regulations

Pack sizes

The Medicinal Products (Control of Paracetamol) Regulations came into force in 2001 (SI 150/2001) and outline the circumstances under which paracetamol can be provided in pharmacies, by or under the personal supervision of the pharmacist.

The Regulations state in relation to tablets, capsules, and suppositories that contain:

• More than 120 mg and no more than 500mg of paracetamol, the maximum pack size that can be sold is 24;
• More than 500mg and no more than 600mg of paracetamol, the maximum pack size that can be sold is 20; and
• More than 600mg, and not more than 1000mg, the maximum pack size that can be sold is 12.

For liquid preparations for paediatric use:

• If the liquid contains 120mg/5ml of paracetamol, the maximum pack size is 140mls; and
• If the liquid contains 250mg/5ml, the maximum pack size is 70mls.

Requests for more than one pack

The regulations specify that a pharmacist may supply up to 50 dosage units, or in the case of liquid formulations, up to two packs, “provided that the pharmacist has conducted an interview with the individual requesting the product and has determined that supplying it is safe under the given circumstances”.

It is important to note, therefore, that any requests by patients for two or more paracetamol-containing medicines must be referred to the pharmacist. This includes the purchase of, for example, a product targeted for pain relief that containing paracetamol with a cold/flu remedy that also contains paracetamol.

It is important to ensure that all staff members are aware of this regulation and that all requests are referred to the pharmacist.

Special warnings and precautions for use

• Always remind patients not to take other medicines that contain paracetamol;
• Always remind them to follow the dosage instructions;
• Prolonged or frequent use is discouraged. Medicines containing paracetamol should only be used for a few days;
• In the case of renal or hepatic insufficiency, the dose should be reduced, and prolonged dosing interval used;
• The daily effective dose should not exceed 60mg/kg/day (max of 2g/day) in patients with body weight less than 50kg, or with mild to moderate hepatic insufficiency, dehydration, or chronic malnutrition;
• A review of oral paracetamol use in adult patients with low body weight identified multiple incidents of overdose (see hssib.org.uk > Patient safety investigations > search ‘Unintentional overdose of paracetamol in adults with low bodyweight’); and
• Immediate medical advice should be sought in the event of an overdose, even if the patient feels well.

Self-harm and suicide prevention

Paracetamol-containing medicines are the drugs most often used for self-harm and can be associated with suicide. A campaign targeted at staff in pharmacies was launched in 2023, by the Department of Health, the HSE National Office for Suicide Prevention, the National Suicide Research Foundation, with support from the IPU, HPRA and PSI.

Information packs for use in your pharmacy, including posters, postcards and stickers are available to download from the IPU website, available at ipu.ie > Professional > Promoting Good Practice, or to order online go to healthpromotion.ie and search for ‘paracetamol’ in Publications.