The leaflet is not a formality folded up inside the box, but the official document that tells you how to use the medicine safely. Learn to read it correctly and you avoid common mistakes: wrong doses, dangerous combinations, side effects you could have prevented. This guide shows you what each section means, which symbols to recognise and when you should call your doctor rather than just closing the box again.
Leaflet vs. SmPC: two documents, two audiences
Every medicine approved in Romania has two official texts, validated by ANMDMR (the National Agency for Medicines and Medical Devices of Romania):
- The leaflet (the Patient Information Leaflet) — written for the patient, in accessible language. It is the sheet inside the box.
- The SmPC — Summary of Product Characteristics (abbreviated RCP in Romanian) — a technical document intended for doctors and pharmacists, with detailed data on pharmacology, studies and special doses.
The two are consistent with each other, but the SmPC contains additional information (for example, dose adjustments in renal impairment or data from clinical trials). If you have a question the leaflet does not answer clearly, the official SmPC is publicly available in the ANMDMR Nomenclature — your pharmacist can consult it together with you.
The standard structure of the leaflet
In the European Union, including Romania, leaflets follow a uniform format set by the EMA (the European Medicines Agency). Once you know the order, you can quickly find what you are looking for:
| Section | What it contains | Why it matters |
|---|---|---|
| 1. What it is and what it is used for | INN, therapeutic class, approved indications | You confirm that the medicine is right for your problem |
| 2. What you need to know before | Contraindications, warnings, interactions, pregnancy/breastfeeding | The most important section for safety |
| 3. How to use it | Dose, frequency, route of administration, duration | Effectiveness depends on following it |
| 4. Possible side effects | Unwanted effects, ordered by frequency | You recognise what is normal and what is an alarm |
| 5. How to store it | Temperature, light, shelf life | A degraded medicine may be ineffective or harmful |
| 6. Contents and other information | Excipients, form, marketing authorisation holder | Useful for excipient allergies (lactose, dyes) |
Composition and the INN
The INN (International Nonproprietary Name) is the name of the active substance — for example paracetamol, ibuprofen or amoxicillin. The brand name differs: the same paracetamol appears as Panadol, Efferalgan or Paracetamol Sintofarm. Always check the INN, not just the brand, so you do not accidentally take two products with the same substance (a real risk of overdose). We detail the difference in our guide on generic vs. brand.
Also read the list of excipients in section 6: lactose, gluten, certain dyes (for example tartrazine) or sorbitol can matter if you have intolerances.
Indications: what it is approved for
This is where it states exactly which conditions the medicine treats, according to the authorisation. If you were given it for something other than what is written here, do not panic — your doctor may prescribe it with justification “outside the approved indication” (off-label), but it is a good idea to ask why.
Doses and method of administration
This section answers four questions: how much, how often, how and for how long. Pay attention to frequently overlooked details:
- The relationship with meals — “before meals”, “with meals” or “on an empty stomach” changes absorption. Levothyroxine, for example, is taken in the morning on an empty stomach.
- The time interval — “every 8 hours” is not the same as “3 times a day with meals”.
- The duration — with antibiotics, take the treatment exactly as your doctor prescribed it and do not stop the course on your own when you feel better; the correct duration is set by your doctor, not by how you feel at the moment.
- The form — prolonged-release tablets (marked “retard”, “SR”, “XL”) must not be broken or chewed.
For the correct technique (with water, standing up, not lying down immediately for certain tablets) see the guide on correct administration.
Contraindications and warnings
Distinguish two levels of severity:
- Contraindications — situations in which the medicine must not be taken at all (for example, a known allergy to the substance). These are absolute.
- “To be administered with caution” — this is not a ban, but a signal that in a certain situation (liver disease, advanced age, pregnancy) the benefit/risk ratio must be weighed. The decision is made by the doctor.
Here you will also find the section on pregnancy and breastfeeding and the warning about driving, if the substance causes drowsiness.
Interactions
The leaflet lists medicines, foods or supplements that change the effect. Real examples: grapefruit juice increases the concentration of some statins; NSAIDs such as ibuprofen reduce the effect of some antihypertensives; many medicines should not be combined with alcohol (see medicines and alcohol). Always tell your pharmacist everything you take, including teas and supplements — not all interactions appear in the leaflet.
Side effects: how to read the frequency
A common mistake is to be frightened by the long list of effects. The key is the frequency, standardised by the EMA and by the CIOMS guidance:
| Category | How often it occurs |
|---|---|
| Very common | in at least 1 in 10 people |
| Common | between 1 in 100 and 1 in 10 |
| Uncommon | between 1 in 1,000 and 1 in 100 |
| Rare | between 1 in 10,000 and 1 in 1,000 |
| Very rare | in fewer than 1 in 10,000 |
| Not known | cannot be estimated from the available data |
The fact that an effect is listed does not mean you will have it — it means it has been observed and reported. Important: if a side effect occurs, you can report it to ANMDMR through the yellow card, contributing to the safety of all patients.
Symbols you need to recognise
- The inverted black triangle (▼) — appears at the beginning of the leaflet and means that the medicine is under additional monitoring by the EMA. It is not a danger signal, but a firm invitation to report any reaction, because the product is relatively new and safety data is still being collected.
- The dispensing codes — on Romanian packaging, prescription medicines are classified as P-6L (a prescription that is not retained) or P-RF (a prescription that is retained), to which are added PS for narcotics and psychotropics and PR for restricted prescriptions, reserved for specialised fields. “OTC” means dispensing without a prescription. “Rx” is an international symbol, not the official Romanian marking. We explain the difference between prescription and non-prescription medicines in OTC vs. Rx.
- Storage pictograms — a crossed-out thermometer (“not above 25°C”), a light-protection symbol, or the instruction to store in the refrigerator (2–8°C).
Storage and shelf life
Section 5 indicates the temperature and conditions. Pay attention to two aspects:
- The expiry date (EXP) on the packaging refers, unless otherwise specified, to the last day of the month indicated. For what to do with expired products, see the dedicated guide on expired medicines.
- The shelf life after opening differs from the one on the box: a bottle of syrup or a vial of eye drops is usually only used for a few weeks after opening — look for the note in the leaflet.
Red flags: when to call your doctor or go to the emergency room
Stop taking it and seek emergency medical help if the following appear:
- signs of a serious allergic reaction: swelling of the face, lips or tongue, difficulty breathing, an extensive rash (possible angioedema or anaphylaxis);
- severe skin reactions: blisters, peeling, sores in the mouth (signs that may herald serious syndromes such as Stevens-Johnson);
- yellowing of the skin or eyes, dark-coloured urine (possible liver damage);
- irregular heartbeat, fainting, unusual bleeding.
For any less urgent uncertainty — a missed dose, a mild reaction, a question about combinations — call your doctor or ask your pharmacist. In Romania you also have the single emergency number 112.
Where to find the official leaflet
If you have lost the sheet from the box or want to compare versions, the trustworthy source is not a forum, but the approved document. Search by INN or by brand name in the ANMDMR Nomenclature, where the leaflet and the SmPC of every authorised medicine are published. For products authorised centrally at European level, the official leaflet is also available on the EMA website. Information on reimbursement and reference price can be found at CNAS (the National Health Insurance House), while the maximum prices are in the CANAMED list (the national catalogue of maximum medicine prices), which we write about in the guide on the CANAMED reference price. Serious international sources for additional verification are the BNF and NICE (United Kingdom) or the WHO.
In brief: how to read a leaflet in 6 steps
- Check the INN and the form, so you do not double up on the active substance.
- Read section 2 in full (contraindications, warnings, interactions).
- Note the dose, interval and duration from section 3.
- View the side effects through the lens of frequency, not the length of the list.
- Remember the storage conditions and the shelf life after opening.
- Put any remaining questions to your doctor or pharmacist — that is what they are there for.
A leaflet read carefully turns a passive patient into an informed one. But it does not replace personalised advice: for any clinical decision, ask your doctor or pharmacist.