How to read an SmPC quickly

A Summary of Product Characteristics (SmPC) is the licensed product information for a medicine. It has a fixed layout, so once you know where things live you can find an answer in seconds.

What an SmPC is, and where to find one

An SmPC is written for healthcare professionals. The patient information leaflet is the matching document for patients. The electronic medicines compendium (emc) hosts SmPCs for medicines licensed for use in Great Britain, and UK-wide. You can search and read them without registering.

Some practice questions show an extract of product information beside the scenario. Practise finding a fact in a long page under time pressure, because that skill is separate from knowing the fact.

The layout never changes

These are the section numbers as they appear on the emc pages we read. The same numbers turn up in every SmPC you will meet in practice.

1. 1. Name of the medicinal product.
2. 2. Qualitative and quantitative composition. The strength, and what is in each mL or tablet.
3. 3. Pharmaceutical form.
4. 4. Clinical particulars, which holds most of what you will need:
   • 4.1 Therapeutic indications
   • 4.2 Posology and method of administration
   • 4.3 Contraindications
   • 4.4 Special warnings and precautions for use
   • 4.5 Interaction with other medicinal products and other forms of interaction
   • 4.6 Fertility, pregnancy and lactation
   • 4.7 Effects on ability to drive and use machines
   • 4.8 Undesirable effects
   • 4.9 Overdose
5. 5. Pharmacological properties (5.1 pharmacodynamics, 5.2 pharmacokinetics, 5.3 preclinical safety data).
6. 6. Pharmaceutical particulars (6.1 excipients, 6.2 incompatibilities, 6.3 shelf life, 6.4 storage, 6.5 container, 6.6 disposal and other handling).
7. 7 to 10. Marketing authorisation holder, authorisation numbers, dates of authorisation, and the date of revision of the text.

Which section answers which question

• What strength is this? Section 2. The 0.9% sodium chloride infusion SmPC states it as 9 g per litre. The adrenaline 1 mg/10 mL syringe SmPC states 0.1 mg of adrenaline in each mL.
• Is it licensed for this? Section 4.1.
• How much, how often, how fast? Section 4.2. A good example is an intravenous paracetamol and ibuprofen product. Its 4.2 splits adults by weight: one 100 mL vial for those over 50 kg, and 1.5 mL/kg for those of 50 kg or under, with a stated maximum single dose of 75 mL.
• Who must not have it? Section 4.3. Who needs care? Section 4.4.
• Does it interact? Section 4.5. Pregnancy or breastfeeding? Section 4.6.
• How do I make it up and how long does it keep? Sections 6.3 to 6.6 (and the method of administration part of 4.2). The ceftriaxone 1 g powder SmPC has its reconstitution table in section 6.6, with route, diluent, volume of diluent to add, approximate available volume and approximate displacement volume.
• How recent is this? Section 10, the date of revision.

Check the date

When we opened them on 22 October 2026, the SmPC for the adrenaline 1 mg/10 mL pre-filled syringe gave its date of revision of the text as 11 March 2019. The ceftriaxone one was dated 23 January 2025 and the paracetamol and ibuprofen one 16 June 2025. The date tells you when the text last changed, not whether anything in it is out of date. When a question shows you an extract, find the date and ask whether newer guidance or a safety update could have changed the answer since.

A routine for resource questions

1. Read the question first and decide what you are looking for, in one phrase ("dose for a child", "interaction with warfarin").
2. Go straight to the section number. Do not read from the top.
3. Read the whole sentence around your hit, and the one before and after. Doses carry conditions: weight, age, kidney function, route.
4. Check for a second place that might change the answer. Dose in 4.2 may be limited by 4.3 or 4.4.
5. Match your finding back to the patient in the scenario.

Practice

Pick any medicine you are revising, open its SmPC and time yourself finding five facts: the strength, the licensed indication, the maximum dose, one contraindication and the storage condition. Do it for a different medicine each day. After a fortnight you will know where each of these sits on the page.

The pregnancy prevention programmes guide covers two medicines that have pregnancy prevention programmes.

Sources

• Adrenaline 1 mg/10 ml (1:10,000) solution for injection in pre-filled syringe, Summary of Product Characteristics (emc). https://www.medicines.org.uk/emc/product/2024/smpc. Accessed 22 October 2026.
• Ceftriaxone 1g Powder for Solution for Injection or Infusion, Summary of Product Characteristics (emc). https://www.medicines.org.uk/emc/product/1361/smpc. Accessed 22 October 2026.
• Combogesic IV 10 mg/ml + 3 mg/ml solution for infusion, Summary of Product Characteristics (emc). https://www.medicines.org.uk/emc/product/15054/smpc. Accessed 22 October 2026.
• 0.9% Sodium Chloride Intravenous Infusion Solution, Summary of Product Characteristics (emc). https://www.medicines.org.uk/emc/product/13131/smpc. Accessed 22 October 2026.
• About the emc (Datapharm). https://www.medicines.org.uk/emc/about-the-emc. Accessed 22 October 2026.

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Not affiliated with the General Pharmaceutical Council. Revision only, not clinical or legal advice. Worked examples use invented numbers and products. Every source above was read on 22 October 2026; check anything that matters against a current source. See our terms of use and privacy notice.