Offline SmPC Documentation — Indications and Dosage Without Internet Access

It’s 11:40 p.m. Your child has a 39 °C fever. You reach for paracetamol, then remember you gave them ibuprofen an hour ago. Can the two be combined? What about the dose — the syrup is 120 mg per 5 ml, and your child weighs 18 kg? You open Google. Loading. Loading. Finally, a list of results appears — a mum’s blog, a pharmacists’ forum, an NFZ page with a PDF five clicks deep. Every answer is different.

This is the moment when offline SmPC documentation stops being “a nice extra” and becomes something you genuinely need.

SmPC — an official document, not a pharmacy blog

An SmPC (summary of product characteristics), known in Poland as ChPL (Charakterystyka Produktu Leczniczego), is the official pharmaceutical document approved by the regulator — in Poland, URPL, the Office for Registration of Medicinal Products. Every registered medicine has its own SmPC, and this document defines what the medicine may be used for, at what doses, and under what conditions.

Unlike the patient information leaflet (PIL), an SmPC is not a simplified version for lay readers. It is written in technical language for doctors, pharmacists, and nurses. That is why it contains considerably more information — detailed mechanisms of action, pharmacokinetic profiles, interaction tables for specific substances, and frequency classifications for adverse reactions.

For someone at home, that difference matters in practice: in an SmPC you will find precise paediatric dosage by body weight, a list of medicines that must not be combined with a given product, and specific situations in which the medicine is contraindicated. The PIL is a summary. The SmPC is the full picture.

Why offline — instead of Google or the URPL website?

When you need to check a dose, signal can be the problem. Typical situations:

• Countryside, mountains, holiday cabin — 3G/4G works but a 500 KB–2 MB PDF takes forever to load
• Flights and connections — aeroplane mode, and a child who cannot sleep because of an infection
• Hospital — an on-call ward corridor with one patient Wi-Fi network and three hundred people online
• Blackouts and storms — 2022 showed that power and internet can both disappear for dozens of hours

In each of these situations, offline SmPC documentation is the only reliable source that does not force you to trade clinical accuracy for “whatever Google returned first”.

mojApteczka syncs documentation for more than 8 000 Polish medicinal products straight to your phone. On first launch, the app downloads the data gradually in the background, grouped by ATC therapeutic class (the WHO Anatomical Therapeutic Chemical classification). The total is roughly 35 MB compressed — less than one iPhone photo. Once downloaded, it is all in your pocket.

Nine clinical sections — what you find in the app

Each SmPC entry in mojApteczka is split into nine collapsible sections, visible as cards on the medicine page. You can expand or collapse each one independently — so you can jump straight to whatever you need.

• Indications — what the medicine is intended for, which conditions it treats, and when it is used
• Dosage — recommended doses for adults, children, and special groups (people with renal impairment, older adults, pregnant women)
• Contraindications — when the medicine must not be used (allergies, comorbidities)
• Warnings and precautions — situations that require particular attention, monitoring, or dose adjustment
• Drug interactions — which substances the medicine interacts with and what those interactions look like in practice
• Pregnancy and lactation — safety classification for pregnant women and recommendations for breastfeeding mothers
• Adverse reactions — classified by frequency (very common, common, uncommon, rare, very rare)
• Overdose — symptoms of exceeding the dose and the recommended response
• Storage — storage conditions, shelf life after opening, stability

All of it is available in two taps: open the medicine card, tap “Active ingredient information”, then scroll to the section you need.

On-demand translation — without sending data to the cloud

The documentation is stored only in Polish. That is a deliberate decision: shipping four language versions on the phone would quadruple the database size and introduce the risk of machine translation errors.

Instead, every SmPC section has a “Translate” button. Translation happens locally, on your device, via the Apple Translation Framework (iOS 18 or newer). Supported languages are Polish, English, Ukrainian, and Russian — the same four as in the rest of the app.

What it gives you in practice:

• Privacy — data never leaves the device
• No cost — you do not pay for machine translation because it uses a built-in iOS library
• Works offline — the language pack (40–50 MB) is downloaded once for the whole system, after which translation runs without internet

This matters especially if you care for an older adult who speaks Ukrainian, or if your doctor is English-speaking — you do not have to worry that the medicine documentation will be unreadable for them.

How synchronisation works in practice

When you open the app for the first time, you will see a banner showing SmPC synchronisation progress. Data downloads in the background, but you can already use the therapeutic groups that have been fetched — there is no need to wait for the whole process to finish.

After the first sync, the app refreshes the database every 24 hours in the background, but only incrementally. That means it fetches only the ATC groups whose documentation has changed — for example, where new interactions have appeared, contraindications have been updated, or new studies have been added to the pregnancy and lactation section. Each update uses minimal data.

Data lands in a local SwiftData store on your phone. That means access is immediate — millisecond response times, comparable to opening a note.

When SmPC documentation is particularly useful

A new prescription

The doctor prescribes a new medicine. Before you fill the prescription at the pharmacy, you check the “Drug interactions” section in the app — does the new medicine conflict with anything you already take? You read the “Contraindications” section — is there a comorbidity that rules this medicine out? You check “Adverse reactions” — so you know what to expect and when to call the doctor.

A child with a fever

Paediatric dosage for paracetamol and ibuprofen depends on body weight. The SmPC sets out the ranges precisely — how many mg per kg, how often per day, maximum daily dose, and the minimum interval between doses. No searching through forums, no guessing.

Caring for an older adult

In older patients, many medicines need dose adjustment. The SmPC has a dedicated section on special populations — that is where you learn, for example, whether a renally cleared medicine needs a dose reduction below a creatinine clearance of 60 ml/min.

Travel medicine cabinet

You are travelling abroad. You bring four medicines. On the plane, nobody has internet. Offline SmPC documentation lets you check, before giving a dose, whether a medicine stays stable at the current temperature, what to do if a dose is missed, and whether it can be combined with an antihistamine for symptoms triggered by a change in climate.

SmPC as part of a larger system

SmPC documentation in mojApteczka is not a standalone feature — it is the clinical layer beneath other tools. When you add a new medicine via AI recognition, the app automatically links the scan to the matching SmPC entry. When you search the NFZ database through medicine search, each result comes with inline documentation. When the system checks drug interactions inside your home medicine cabinet, it reads from the “Drug interactions” section of the same SmPCs. If you want to open the original PDF published by URPL, the leaflets and ChPL view also links to the full document.

That’s the difference between an app that only knows the names of your medicines and an app that understands what they do.

Availability

Offline SmPC documentation works in the iOS mobile app. The minimum system version is iOS 17.0, and on-demand translation through the Apple Translation Framework requires iOS 18.0 or newer. The feature is part of the standard toolset and does not require an additional subscription — it works as soon as you sign in.

Technical details and the full list of supported sections are on the Offline SmPC documentation feature page.

Download mojApteczka on the App Store and keep a clinical database of 8 000 medicines in your pocket — whether or not you have signal.

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Questions about SmPC documentation or other mojApteczka features? Write to us at kontakt@mojapteczka.pl.