Foundayo Prescribing Information, SmPC and Patient Leaflet: Which Document You Need and Where to Find It

• Plain-English explanation of PI, SmPC, SPC and PIL, and which one applies in the UK
• Key facts from Foundayo's official UK patient leaflet, including dosing, side effects and tablet descriptions
• How the US Prescribing Information differs from the UK documents, and why it matters
• Online consultation with UK-registered prescribers if you have questions about treatment

If you have searched for "Foundayo PI", "Foundayo SmPC", "Foundayo SPC" or "Foundayo PIL", you are looking for the official product information for Foundayo (orforglipron), Eli Lilly's once-daily GLP-1 tablet. These terms are often used as if they mean the same thing, but they refer to different documents, written for different readers, and in some cases produced for different countries.

In the US, Prescribing Information (PI) is the FDA-approved professional product label. In the UK, the corresponding professional document is the Summary of Product Characteristics (SmPC), while patients receive the Patient Information Leaflet (PIL).

Key things to know

• PI is the US term; in the UK the equivalents are the SmPC (for healthcare professionals) and the PIL (for patients).
• The current UK Foundayo PIL and SmPCs were revised in August 2026; check the current emc version because regulatory documents can be updated.
• The UK SmPC is published as a separate document for each of the six tablet strengths.
• US and UK documents are not interchangeable: the licensed uses, warnings and some wording differ.
• Foundayo is under additional monitoring in the UK, so reporting suspected side effects through the Yellow Card scheme is especially useful.
• If you take Foundayo in the UK, the leaflet in your pack is the version that applies to you.

What Each Foundayo Document Is

Every licensed medicine comes with official product information agreed with the regulator. The content is based on the evidence submitted for approval, and the company cannot change it without regulatory review. What differs between countries is the format, the terminology and sometimes the content itself.

PI: US Prescribing Information

US FDA-approved prescribing information for healthcare professionals. It opens with a one-page "Highlights" summary, followed by the full prescribing information in numbered sections, from indications and dosing through to clinical studies and patient counselling. Where the FDA requires it, a boxed warning appears at the very top. The PI applies to Foundayo as supplied in the United States.

Medication Guide: the US patient document

US patient information may be provided through a Medication Guide or other FDA-required patient information, depending on the product labelling.

SmPC or SPC: UK Summary of Product Characteristics

The SmPC is the UK's authoritative document for healthcare professionals. SmPC and SPC are two abbreviations for the same thing. It follows a fixed structure used across the UK and EU, and it is the reference prescribers and pharmacists use for dosing, contraindications, interactions, adverse reactions and pharmacology.

PIL: UK Patient Information Leaflet

The PIL is the leaflet folded inside every UK pack of Foundayo. It contains the key information patients need from the authorised product information, presented in patient-friendly language, but in plain language, organised around the questions patients ask: what the medicine is for, what to check before taking it, how to take it, possible side effects, how to store it, and what the tablets contain.

RMM: Risk Minimisation Materials

Some medicines also have additional Risk Minimisation Materials, such as patient cards or prescriber materials. If Foundayo has current additional materials, they should be checked on the relevant regulatory listing.

Document types compared

Which Document Applies to You?

If you are a patient in the UK, the PIL in your pack is the document written for you. It reflects the UK licence, UK dosing instructions and UK safety wording. You are free to read the SmPC too, and some people find its extra detail useful, but it assumes clinical training and uses technical language.

If you are a UK prescriber or pharmacist, the SmPC is your primary reference. If you are reading US sources, including many news articles, trial summaries and US-based websites, be aware that they usually reflect the US PI, which differs from the UK documents in several important ways covered below.

What Foundayo's UK Leaflet Says: The Key Facts

The following points come directly from the UK Patient Information Leaflet, last revised in August 2026. They are the details people most often search for, but they are not a substitute for reading the leaflet supplied with your own medicine.

What Foundayo is licensed for in the UK, including weight management

The UK licence covers two uses. For weight management, Foundayo is licensed for adults with a BMI of 30 kg/m² or above, and it must be used alongside a reduced-calorie diet and increased activity in adults with a BMI of 30 kg/m² or more, or a BMI of at least 27 but under 30 kg/m² with at least one weight-related health condition. The leaflet lists examples such as prediabetes, type 2 diabetes, high blood pressure, abnormal blood fats, obstructive sleep apnoea, and heart or blood vessel problems. Foundayo is also licensed for adults with type 2 diabetes whose blood sugar is not properly controlled, either on its own or with other diabetes medicines, including insulin.

UK dosing schedule

After 30 days on 0.8 mg, the leaflet says the dose should be increased to 2.5 mg. Foundayo starts with orforglipron 0.8 mg once daily for the first 30 days, giving your body time to adjust before titration continues. Increases beyond 5.5 mg are made only if needed, and each next increase requires at least 30 days on your current dose before moving toward the highest dose, which may reach the top dose of 17.2 mg once daily. You should not change your dose unless your prescriber tells you to.

If every dose increase occurs at the minimum interval, reaching the highest dose would take several months. Not everyone needs or tolerates the highest dose.

How to take Foundayo

One tablet once a day, at any time of day, with or without food. Swallow the tablet whole and do not break, crush or chew it. Never take more than one tablet a day. If you forget a dose, take it as soon as you remember, but never take two doses in one day to make up for it. If you take too much, contact your doctor straight away. If you have type 2 diabetes, do not stop taking Foundayo without speaking to your doctor, as your blood sugar can rise.

Who should not take Foundayo, and when to talk to a prescriber first

The UK SmPC lists hypersensitivity to orforglipron or any of the tablet's ingredients as the formal contraindication.

The product information also contains important warnings and precautions. These include previous pancreatitis, severe gastrointestinal disease such as severe gastroparesis, gallbladder problems, diabetic retinopathy, severe heart failure, and the use of insulin or sulphonylureas. The SmPC also advises caution around surgery requiring anaesthesia and explains circumstances in which blood glucose monitoring or treatment adjustment may be needed.

These warnings are different from formal contraindications. A prescriber should review your medical history, other medicines and individual circumstances before treatment.

The US prescribing information contains additional US-specific contraindications and warnings, including the contraindication relating to personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). These should not automatically be presented as wording from the UK licence.

Medicines that interact with Foundayo

Orforglipron can interact with some medicines, so your prescriber needs to know everything you take, including prescription medicines, over-the-counter products and herbal remedies.

Some strong CYP3A4 inhibitors, including clarithromycin, ketoconazole and itraconazole, can increase orforglipron exposure. The UK SmPC limits the maximum orforglipron dose to 9 mg once daily when it is used with a strong CYP3A4 inhibitor.

Strong CYP3A4 inducers, such as carbamazepine, can substantially reduce orforglipron exposure, and concomitant use should generally be avoided.

Orforglipron can also affect some other medicines. The SmPC states that the dose of simvastatin should be halved when it is given with orforglipron. Caution is advised with rosuvastatin when the dose exceeds 20 mg.

Because orforglipron can delay gastric emptying, it may also affect the rate at which some oral medicines are absorbed. Your prescriber or pharmacist can check your individual medicines for clinically relevant interactions.

Pregnancy, breastfeeding and contraception

Orforglipron should not be used during pregnancy. The UK product information also advises against use during breastfeeding. If pregnancy is planned, the UK PIL advises stopping orforglipron at least 3 weeks beforehand, in discussion with your doctor.

Gastrointestinal side effects listed in the UK leaflet

Gastrointestinal adverse reactions are among the most frequent side effects reported with orforglipron. They are often most noticeable during dose escalation and may improve with continued treatment. Severe gastrointestinal reactions can result in dehydration and, in some cases, acute kidney injury. Acute pancreatitis has also been reported with orforglipron. Seek urgent medical attention for persistent severe abdominal pain, particularly if it radiates to the back.

What each tablet strength looks like

Because colours repeat across strengths, check the marking as well as the colour, especially when your dose has just changed.

Ingredients, packs and storage

Besides orforglipron, the tablet core contains microcrystalline cellulose, crospovidone, copovidone, anhydrous sodium carbonate and magnesium stearate. The film coating contains poly(vinyl alcohol), titanium dioxide, macrogol, talc and iron oxide colourings, which vary by strength. Each tablet contains less than 1 mmol (23 mg) of sodium, so it is essentially sodium-free. Tablets come in blister packs of 30 or 90. Store them in the original package to protect them from light, and do not use them after the expiry date shown after "EXP".

How the US Prescribing Information Differs

Foundayo was approved in the US on 1 April 2026 and was authorized by the MHRA in the UK on 10 August 2026. The two licences were reviewed separately, and the documents differ in ways that matter if you are reading US sources in the UK, including how they describe orforglipron as an oral non-peptide daily glp 1 receptor agonist.

Licensed uses

The initial US approval covered weight management, whereas the UK authorisation also covers treatment of adults with insufficiently controlled type 2 diabetes.

Warnings and contraindications

The US prescribing information contains a boxed warning about the risk of thyroid C-cell tumours, based on findings in rats. It also lists a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) as a contraindication in the US.

The UK product information is presented differently. The UK SmPC does not use the US boxed-warning format, and its formal contraindication is hypersensitivity to orforglipron or any of its ingredients. The UK and US documents should therefore be read as separate regulatory documents rather than mixed together.

Dosing wording and interaction limits

The strengths are the same in both countries, from 0.8 mg to 17.2 mg. The US PI describes dose steps in weeks, while the UK leaflet uses days. The US PI also sets specific limits, such as a lower maximum dose when Foundayo is taken with strong CYP3A4 inhibitors and a cap on simvastatin dosing.The UK SmPC also contains specific interaction-related dose restrictions, including a 9 mg maximum dose with strong CYP3A4 inhibitors and with clinical OATP1B inhibitors.

How the UK SmPC Is Organised

Every UK SmPC follows the same numbered layout, which makes it quick to navigate once you know it:

• Sections 1 to 3: name of the medicine, what each tablet contains, and the pharmaceutical form
• Section 4, clinical particulars: indications (4.1), dosing (4.2), contraindications (4.3), warnings (4.4), interactions (4.5), pregnancy and breastfeeding (4.6), driving (4.7), side effects (4.8) and overdose (4.9)
• Section 5: how the medicine works and how the body handles it
• Section 6: ingredients, shelf life, storage and packs
• Sections 7 to 10: licence holder, licence numbers, dates of authorisation and revision

For Foundayo, the SmPC is published as a separate document for each strength, because each strength is its own licensed product. The SmPC specifies that the tablets contain orforglipron calcium equivalent to the stated amount of orforglipron. At the time of writing, the SmPC documents were last updated on emc on 14 August 2026 and the PIL on 12 August 2026.

Where to Find the Official Documents

For the UK, the main free source is the electronic medicines compendium (emc) at medicines.org.uk, run by Datapharm, which publishes SmPCs and PILs supplied by the licence holder. The MHRA also publishes product information for licensed medicines on its own products website. And every pack contains the current PIL at the time it was made.

For the US, the PI and Medication Guide are published by Eli Lilly and on the US government's national label database. Use these only if you want to understand the US licence.

Avoid relying on screenshots, forum posts, or pages that summarise "the Foundayo label" without saying which country's document they mean. Many early articles were written before UK approval and describe only the US position.

Additional Monitoring and the Yellow Card Scheme

The UK leaflet opens with a statement that Foundayo is subject to additional monitoring, shown by a black triangle. This applies to newly authorised medicines post-authorization, and it is not a sign that something is wrong. It means regulators want to identify new safety information quickly. Patients should report suspected side effects through the MHRA Yellow Card scheme online or through the Yellow Card app.

Why Checking the Latest Version Matters

Product information is updated as new safety data, interaction findings or regulatory decisions emerge. Foundayo is a new medicine, so updates in its first years are likely. Before relying on a specific detail, check the "last updated" date on emc or the revision date at the end of the leaflet, and use the current version rather than an old printout or cached page.

Getting Advice on Foundayo

Product documents explain how Foundayo is authorised and used, but they cannot determine whether it is appropriate for a particular person.

A prescriber should review your medical history, current medicines, relevant risk factors and treatment goals before prescribing Foundayo. If you have questions about the product information, dosing, interactions or side effects, speak with your prescriber or pharmacist.