‘Calendula officinalis L’ is inserted before Foeniculum vulgare Miller subsp. vulgare var. vulgare (Bitter fennel, fruit)

‘COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

Scientific name of the plant

Calendula officinalis L.

Botanical family

Asteraceae

Herbal substance

Calendula flower

Common name in all EU official languages of herbal substance

— BG (bălgarski): Невен, цвят

— CS (čeština): Měsíčkový květ

— DA (dansk): Morgenfrueblomst

— DE (Deutsch): Ringelblumenblüten

— EL (elliniká): Άνθος καλέντουλας

— EN (English): Calendula flower

— ES (español): Flor de caléndula

— ET (eesti keel): Saialilleõisik

— FI (suomi): Tarhakehäkukan kukka

— FR (français): Souci

— HU (magyar): A körömvirág virága

— IT (italiano): Calendula fiore

— LT (lietuvių kalba): Medetkų žiedai

— LV (latviešu valoda): Kliņģerītes ziedi

— MT (malti): Fjura calendula

— NL (nederlands): Goudsbloem

— PL (polski): Kwiat nagietka

— PT (português): Flor de calêndula

— RO (română): Floare de gălbenele (calendula)

— SK (slovenčina): Nechtíkový kvet

— SL (slovenščina): Cvet vrtnega ognjiča

— SV (svenska): Ringblomma, blomma

— IS (íslenska): Morgunfrú, blóm

— NO (norsk): Ringblomst

Herbal preparation(s)

A. Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).

B. Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).

C. Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).

European Pharmacopoeia monograph reference

Calendula flower – Calendulae flos (01/2005:1297)

Indication(s)

(a) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.

(b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition

European

Specified strength

Please see “Specified posology”.

Specified posology

Herbal preparations:

A. Liquid extract (DER 1:1) In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

B. Liquid extract (DER 1:1,8-2,2) In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.

C. Tincture (DER 1:5)

In compresses diluted at least 1:3 with freshly boiled water.

In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

As a gargle or mouth rinse in a 2 % solution.

2 to 4 times daily

Indication (a)

The use is not recommended in children under 6 years of age (see below “Special warnings and precautions for use”).

Indication (b)

The use in children under 12 years of age is not recommended because there is no experience available (see below “Special warnings and precautions for use”).

Route of administration

Cutaneous and oromucosal use.

Duration of use or any restrictions on the duration of use

Compresses: remove after 30-60 minutes

All herbal preparations: If the symptoms persist after 1 week during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications

Hypersensitivity to members of the Asteraceae (Compositae) family.

Special warnings and precautions for use

Indication (a)

The use in children under 6 years of age is not recommended because there is no experience available.

Indication (b)

The use in children under 12 years of age is not recommended because there is no experience available.

If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Skin sensitisation. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

None reported.’