What does the SPC contain?

What does the Summary of Product Characteristics (SPC) contain?

The approval of a marketing authorisation for a medicinal product requires extensive studies on quality, safety and efficacy, which are evaluated by the authorities before the authorisation is granted. Issues pertaining to the properties, efficacy and safety of the medicinal product relating to its use are included in the SPC, which is approved in association with the granting of the marketing authorisation. The SPC contains all the details of the medicinal product which are of importance to the health care professionals.

Close monitoring of the use of the medicinal product will continue even after the granting of the marketing authorisation, and any new properties or undesirable effects emerging on wider use of the product will be recorded in the SPC and the package leaflet (PIL).

The SPC contains 10 main headings:

1. Name of the medicinal product (LÄÄKEVALMISTEEN NIMI)

The trade name of the medicinal product may be an invented name, a generic name together with the brand name, name of the manufacturer, marketing authorisation holder or agent, or a scientific name together with the brand name, name of the manufacturer, marketing authorisation holder or agent. The name of the medicinal product may be accompanied by details descriptive of the strength and pharmaceutical form of the medicinal product, e.g. QWERTYOL 250 mg tablet

2. Qualitative and quantitative composition (VAIKUTTAVAT AINEET JA NIIDEN MÄÄRÄT )

This paragraph contains a list of the international names of the active agents of the medicinal product (preferably INN, International Non-proprietary Name) including their quantities in one unit of distribution (e.g. a tablet) or volume, e.g. One tablet contains 250 mg of wertyol.

3. Pharmaceutical form (LÄÄKEMUOTO)

The pharmaceutical form of the medicinal product is described under this heading detailing whether it is a tablet, capsule, effervescent powder, oral liquid, eye drops, intravenous infusion etc. The appearance of the product may also be represented, e.g. Tablet. The tablet is yellowish, convex and unscored with a diameter of 13 mm.

4. Clinical particulars (KLIINISET TIEDOT)

4.1 Therapeutic indications (Käyttöaiheet)

The paragraph on the therapeutic indications includes the purposes for which the medicinal product may be used in accordance with the conditions of the marketing authorisation, e.g. Indicated for the treatment of hypertension.

4.2 Posology and method of administaration (Annostus ja antotapa)

This section describes the dosage with the various purposes for which it is used, and, as necessary, the maximum recommended doses, dosages in the various age groups and the effect of various conditions on the dose, e.g. Adults: 1 tablet three times daily.

4.3 Contraindications (Vasta-aineet)

This paragraph describes the patients and patient groups which should not under any circumstances use the medicinal product in question (unconditional contraindications), e.g. Hypersensitivity to wertyol or any ingredient of the product. Severe hepatic insufficiency.

4.4 Special warnings and special precautions for use (Varoitukset ja käyttöön liittyvät varotoimet )

This section is a description of the safety issues which require special precautions, for example, in order to call attention to any condition that would expose the patient to an undesirable effect of the product. This section will also include the types of patient, in whom the treatment should be carried out with special precautions (relative contraindications),
e.g. Elevated transaminases and hepatic encephalopathy have been reported in the use of QWERTYOL. Liver function is usually restored after discontinuation of medication or reduction of dose. The transaminases should be monitored at the start of treatment and at monthly intervals.

4.5 Interaction with other medicinal products and other forms of interaction (Yhteisvaikutukset muiden lääkevalmisteiden kanssa sekä muut yhteisvaikutukset)

This paragraph gives details of any harmful interactions that may occur, for example, between the product in question and other medicinal products and with food. E.g. The concomitant use of abcdol and wertyol has been found to reduce the wertyol concentrations significantly, and concomitant use should therefore be avoided.

4.6 Pregnancy and lactation (Raskaus ja imetys)

This paragraph contains the information relating to the use of the medicinal product during pregnancy and lactation. In the absence of experience of use in humans, reference is made to observations in animal studies, e.g. Wertyol caused wavy ribs in rabbits. Studies of its use in pregnant or breastfeeding women have not been carried out. Any potentially harmful effects on the foetus should be considered if the drug is given to pregnant women.

4.7 Effects on ability to drive and use machines (Vaikutus ajokykyyn ja koneiden käyttökykyyn)

This paragraph lists any potential effects the product may have on the ability to drive and on other activities, which require precision, e.g. During the first day of treatment, rare episodes of a sedative effect have been observed, and these may have an adverse effect on the ability to drive and on activities which require precision. Driving a car during the first two days of treatment is consequently prohibited.

4.8 Undesirable effects (Haittavaikutukset)

The undesirable effects of the medicinal product are preferably listed according to organ groups and the aim is to state their prevalence according to the following scale: very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0,1%) and very rare (<0.01%).

Uncommon : diarrhoea, nausea, insomnia, fatigue
Rare: hepatic disorders
Isolated cases of severe hepatic disorders have been described.

Common: pruritus
Uncommon: rash

4.9 Overdose (Yliannostus)

This section lists the symptoms and possible methods of treatment of overdose,
e.g. There are reports of cases in which patients have taken doses 10-20 times the therapeutic dose. Symptoms following overdose have included nausea, nystagmus and diminished consciousness. The majority of cases of overdose have been associated with liver damage. The patient should be admitted to hospital in the event of an overdose. Elimination of the drug from the body can be accelerated with haemodialysis.

5. Pharmacological properties (FARMAKOLOGISET OMINAISUUDET)

5.1 Pharmacodynamic properties (Farmakodynamiikka)

The section on pharmacodynamic properties describes the main effects of the medicinal product on the organ system and possibly also the mechanism of action and the results of any clinical studies carried out. The pharmacotherapeutic group, i.e. the classification of the product in the ATC system, is also given in this section.
Pharmacotherapeutic group: ACE inhibitors, ATC Code: C09AAXX.

5.2 Pharmacokinetic properties (Farmakokinetiikka)

The paragraph on pharmacokinetic properties describes the various stages of the medicinal product in the organ system; the absorption, distribution, metabolism and excretion,
e.g. Wertyol is well absorbed following oral administration. In healthy volunteers the bioavailability of wertyol is 85%. The peak plasma concentration is achieved within one hour of administration. The elimination half-life is 4 hours. The drug is almost completely excreted unchanged via the kidneys.

5.3 Preclinical safety data (Prekliiniset tiedot turvallisuudesta)

This paragraph describes the findings of animal studies which may have relevance to the prescribing of the medicinal product, e.g.
The tolerability of the drug has been studied by means of multiple dosages in animals.
Mutagenic potential: No mutagenic effects of the substance were found in an extensive test programme.
Effects on the reproductive system: in studies on teratogenicity, wave-like formation of ribs was seen in rabbits (see section 4.6.).

6. Pharmaceutical particulars (FARMASEUTTISET TIEDOT)

6.1 List of excipients (Apuaineet)

The excipients used are listed in this section,
e.g. Lactose monohydrate 20 mg
microcrystalline cellulose
pregelatinised maize starch
silicon dioxide

6.2 Incompatibilities (Yhteensopimattomuudet)

This section will state if the medicinal product should not be mixed in the same solution with another product.

6.3 Shelf life (Kestoaika)

This section will state the shelf life of the medicinal product in a closed package, diluted according to instructions and in an opened package.

6.4 Special precautions for storage (Säilytys)

This section describes the conditions for storage, e.g.
Store below ºC. Store in the original container.

6.5 Nature and contents of container (containers) (Pakkaustyyppi ja pakkauskoko (pakkauskoot))

The paragraph lists all the package sizes and types for which marketing authorisation has been approved, e.g. 33 tablets (PVC/aluminium blister pack).

6.6 Instructions for use and handling and disposal (Käyttö- ja käsittely sekä hävittämisohjeet)

This section gives the instructions necessary for the preparation of the medicinal product by the pharmaceutical personnel. Instructions to the prescriber of the product and to the patient are given in section 4.2.

7. Marketing authorisation holder (MYYNTILUVAN HALTIJA)

The name and address of the marketing authorisation holder are given in this paragraph.

8. Marketing authorisation number (MYYNTILUVAN NUMERO)

The individual number of the marketing authorisation is given in this section.

9. Date of first authorisation /renewal of the authorisation (MYYNTILUVAN MYÖNTÄMISPÄIVÄMÄÄRÄ / UUDISTAMISPÄIVÄMÄÄRÄ)

The paragraph gives the original date of authorisation, or, if the authorisation has been renewed, the renewal date is given.

10. Date of revision of the text (TEKSTIN MUUTTAMISPÄIVÄMÄÄRÄ)

This section contains the date of the most recent revision of the SPC.