What does the SPC contain?

What does the Summary of Product Characteristics (SPC) for a herbal medicinal product contain?

The approval of a marketing authorisation for a herbal 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 herbal 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 herbal medicinal product which are of importance to the health care professionals.

The SPC contains 10 main headings:

1. Trade name of the herbal medicinal product (ROHDOSVALMISTEEN KAUPPANIMI)

The trade name of the herbal 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 strength of the product is indicated only if the compound or the group of compounds producing the therapeutic effect is known, e.g.: SODHOR 2,5 mg tablet, coated

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

The active agent is indicated by stating the information about the herbal medicinal product (e.g. a dried extract) followed by the quantity of the compound or compound group producing the therapeutic effect in one unit dose (e.g. tablet) or volume, e.g.:
One tablet contains 250 mg of:
Sodhor fol.extr.spir.sicc. (2:1) 100 mg, respond. sodhor. 2,5 mg
For excipients, see section 6.1.

3. Pharmaceutical form (LÄÄKEMUOTO)

The pharmaceutical form should be described by the European Pharmacopoeia full standard term under this heading. The product is also described under this heading, e.g.:
Tablet, coated
The tablet is yellowish, coated, convex and unscored with a diameter of 12 mm.

4. Clinical particulars (KLIINISET TIEDOT)

4.1 Therapeutic indications (Käyttöaiheet)

The paragraph on the therapeutic indications includes the purposes for which the herbal medicinal product may be used in accordance with the conditions of the marketing authorisation, e.g.
A herbal medicinal product for the treatment of mild prostatic symptoms.

4.2 Posology and method of administration (Annostus ja antotapa)

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

4.3 Contraindications (Vasta-aiheet)

This paragraph describes the patients and patient groups which should not under any circumstances use the herbal medicinal product in question (unconditional contraindications), e.g.
Hypersensitivity to sodhorl 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. 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 SODHOR. Liver function is usually restored after discontinuation of medication or reduction of dose.

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

The paragraph gives details of any harmful interactions that may occur, for example between the product and other herbal medicinal products, conventional medicinal products and food, e.g.:
The concomitant use of abcdol and sodhorl has been found to reduce the sodhorl concentrations significantly, and concomitant use should therefore be avoided.

4.6 Pregnancy and lactation (Raskaus ja imetys)

This paragraph contains information relating to the use of the herbal medicinal product during pregnancy and lactation. In the absence of experience of use, the following should be stated, e.g.:
Not recommended during pregnancy and lactation.

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 herbal medicinal product are preferably listed according to organ groups with the aim of stating the prevalence of the effect 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%).
Gastrointestinal:
Uncommon: diarrhoea, nausea, insomnia, fatigue
Rare: hepatic disorders
Isolated cases of severe hepatic disorders have been described.

Skin:
Common: pruritus BR> 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.

5. Pharmacological properties (FARMAKOLOGISET OMINAISUUDET )

5.1 Pharmacodynamic properties (Farmakodynamiikka )

Not required for herbal medicinal products. The following statement is usually sufficient:
Unknown.

5.2 Pharmacokinetic properties (Farmakokinetiikka )

Not required for herbal medicinal products. The following statement is usually sufficient:
Unknown.

5.3 Preclinical safety data (Prekliiniset tiedot turvallisuudesta)

This paragraph describes the findings of animal studies which may have relevance to the use of the herbal medicinal product, e.g.
The tolerability of the product 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.

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
anhydrous colloidal silicon dioxide

6.2 Incompatibilities (Yhteensopimattomuudet)

This section will state if the herbal 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 herbal 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 25 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.
3A package containing 30 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 herbal medicinal product by the pharmaceutical personnel.

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.