“Summary of Products Characteristics” (SPC)  – Charakterystyka produktu leczniczego

Poznaj profesjonalną terminologię związaną z charakterystyką produktu leczniczego (SPC). Dowiedz się, jak poprawnie interpretować informacje dotyczące składu leku, jego formy, wskazań terapeutycznych i przeciwwskazań. Zrozum, jak bezpiecznie stosować leki, jakie mogą wystąpić działania niepożądane oraz jak unikać interakcji z innymi produktami leczniczymi. Dzięki tej wiedzy będziesz mógł skuteczniej doradzać pacjentom i wspierać ich w podejmowaniu właściwych decyzji dotyczących leczenia.

VOCABULARY  Part 1

Instructions: Read the text and match the section titles from Summary of Products Characteristics (a-n) with the definitions (1-14):

The Summary of Product Characteristics (SPC) is an important document that covers comprehensive information on a medicinal product. It includes details such as the QUALITATIVE AND QUANTITATIVE COMPOSITION, which informs you about the ingredients in the medicine. It also specifies the PHARAMCEUTICAL FORM, describing what the medicine looks like.

The THERAPEUTIC INDICATIONS explain what conditions the medicine is used to treat. Before taking any medication, check the CONTRAINDICATIONS section to see if there are any reasons why a patient should not use the medicine. Also, it is vital to take note of the POSOLOGY AND METHOD OF ADMINISTRATION for instructions on how to take the medicine.

There are also sections that detail the UNDESIRABLE EFFECTS, which list potential side effects, and the EFFECTS ON ABILITY TO DRIVE AND USE MACHINES, which informs if it’s safe to drive after taking the medicine. It is vital to be cautious with the INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION section to avoid negative interactions with other medications a patient may be taking.

For women, the FERTILITY, PREGNANCY AND LACTATION section is crucial as it provides advice on medicine usage during these periods. In case of an OVERDOSE, this section will guide you on what steps to take.

The LIST OF EXCIPIENTS lists inactive substances in the medicine that could affect a patient. SPECIAL PRECAUTIONS FOR STORAGE offer guidance on how to store the medication safely. The NATURE AND CONTENTS OF CONTAINER describes the packaging, and SPECIAL WARNINGS PRECAUTIONS FOR USE highlight important safety information.

SPS section titles

a. Contraindications;
b. Effects on ability to drive and use machines;
c. Fertility, pregnancy and lactation:;
d. Interaction with other medicinal products and other forms of interaction;
e. List of excipients;
f. Overdose;
g. Pharmaceutical form;
h. Posology and method of administration;
i. Qualitative and quantitative composition;
j. Special precautions for storage;
k. Special warnings and precautions for use;
l. Therapeutic indications;
m. Undesirable effects;|
n. Nature and contents of container;

Definitions:

1. Przedawkowanie
2. Wskazania terapeutyczne
3. Przeciwwskazania
4. Dawkowanie i sposób podawania
5. Skład jakościowy i ilościowy
6. Specjalne ostrzeżenia i środki ostrożności dotyczące stosowania
7. Interakcje z innymi produktami leczniczymi oraz inne rodzaje interakcji
8. Działania niepożądane
9. Postać farmaceutyczna
10. Specjalne środki ostrożności dotyczące przechowywania
11. Płodność, ciąża i laktacja
12. Wpływ na zdolność prowadzenia pojazdów i obsługiwania maszyn
13. Wykaz substancji pomocniczych
14. Rodzaj i zawartość opakowania

VOCABULARY  Part 2

Instructions: Complete the sentences with the following:

undesirable effects, fertility issues, pharmaceutical form,  contraindication, therapeutic indications, special precautions for storage, nature and contents of container, ability to drive and use machines , interaction with other medicinal products, qualitative and quantitative composition, list of excipients, pregnancy and lactation, special warnings precautions for use, overdose, posology and method of administration

1. The SPC includes a section on _______________(1)s that explains when the medication should not be used.

2. Patients should be informed about the effects on _______________(2)after taking this medication for safety reasons.

3. The guide provides important information regarding _______________(3) that may arise from using the medication.

4. It is crucial to check the sections about _______________(4) before taking any new medication in these conditions.

5. A complete _______________(5) can help individuals understand what else is included in their medication besides the active ingredient.

6. In case of _______________(6), it is essential to seek medical attention immediately to prevent serious health complications.

7. The _______________(7) of the drug, whether tablet or liquid, can affect how well a patient responds to treatment.

8. The _______________(8) must be followed closely to ensure the effectiveness of the medication.

9. Understanding the _______________(9) of a drug helps pharmacists provide proper advice to patients.

10. Always review the _______________(10) to maintain the medication’s efficacy over time.

11. There are several _______________(11) that patients need to be aware of before starting the treatment.

12. The _______________(12) listed in the SPC clarify the specific conditions the medication is designed to treat.

13. Patients should report any _______________(13) they experience while using the medication to their healthcare provider.

14. The _______________(14) are critical aspects that determine how safely the medication can be stored at home.

15. It is important to assess _______________(15) to avoid possible adverse events or reduced effectiveness.

ANSWER KEY

VOCABULARY  Part 1

a. Contraindications – Przeciwwskazania
b. Effects on ability to drive and use machines – Wpływ na zdolność prowadzenia pojazdów i obsługiwania maszyn
c. Fertility, pregnancy and lactation – Płodność, ciąża i laktacja
d. Interaction with other medicinal products and other forms of interaction – Interakcje z innymi produktami leczniczymi oraz inne rodzaje interakcji
e. List of excipients – Wykaz substancji pomocniczych
f. Overdose – Przedawkowanie
g. Pharmaceutical form – Postać farmaceutyczna
h. Posology and method of administration – Dawkowanie i sposób podawania
i. Qualitative and quantitative composition – Skład jakościowy i ilościowy
j. Special precautions for storage – Specjalne środki ostrożności dotyczące przechowywania
k. Special warnings and precautions for use – Specjalne ostrzeżenia i środki ostrożności dotyczące stosowania
l. Therapeutic indications – Wskazania terapeutyczne
m. Undesirable effects – Działania niepożądane
n. Nature and contents of container – Rodzaj i zawartość opakowania

VOCABULARY  Part 2

1. The SPC includes a section on contraindication (1)s that explains when the medication should not be used.

2. Patients should be informed about the effects on ability to drive and use machines (2)after taking this medication for safety reasons.

3. The guide provides important information regarding fertility issues (3) that may arise from using the medication.

4. It is crucial to check the sections about pregnancy and lactation (4) before taking any new medication in these conditions.

5. A complete list of excipients (5) can help individuals understand what else is included in their medication besides the active ingredient.

6. In case of overdose (6), it is essential to seek medical attention immediately to prevent serious health complications.

7. The pharmaceutical form (7) of the drug, whether tablet or liquid, can affect how well a patient responds to treatment.

8. The posology and method of administration (8) must be followed closely to ensure the effectiveness of the medication.

9. Understanding the qualitative and quantitative composition (9) of a drug helps pharmacists provide proper advice to patients.

10. Always review the special precautions for storage (10) to maintain the medication’s efficacy over time.

11. There are several special warnings precautions for use (11) that patients need to be aware of before starting the treatment.

12. The therapeutic indications (12) listed in the SPC clarify the specific conditions the medication is designed to treat.

13. Patients should report any undesirable effects (13) they experience while using the medication to their healthcare provider.

14. The nature and contents of container (14) are critical aspects that determine how safely the medication can be stored at home.

15. It is important to assess interaction with other medicinal products (15) to avoid possible adverse events or reduced effectiveness.