In Annex II to Decision 2008/911/EC, the following is inserted:
‘Calendula officinalis L’ is inserted before Foeniculum vulgare Miller subsp. vulgare var. vulgare (Bitter fennel, fruit)
<Strong>COMMUNITY LIST ENTRY ON <Emphasis>CALENDULA OFFICINALIS</Emphasis> L</Strong>
<Strong>Scientific name of the plant</Strong>
Calendula officinalis L.
<Strong>Botanical family</Strong>
Asteraceae
<Strong>Herbal substance</Strong>
Calendula flower
<Strong>Common name in all EU official languages of herbal substance</Strong>
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
<Strong>Herbal preparation(s)</Strong>
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).
<Strong>European Pharmacopoeia monograph reference</Strong>
Calendula flower – Calendulae flos (01/2005:1297)
<Strong>Indication(s)</Strong>
(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.
<Strong>Type of tradition</Strong>
European
<Strong>Specified strength</Strong>
Please see “Specified posology”.
<Strong>Specified posology</Strong>
Herbal preparations:
Liquid extract (DER 1:1)
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
Liquid extract (DER 1:1,8-2,2)
In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.
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”).
<Strong>Route of administration</Strong>
Cutaneous and oromucosal use.
<Strong>Duration of use or any restrictions on the duration of use</Strong>
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.
<Strong>Any other information necessary for the safe use</Strong>
<Emphasis>Contraindications</Emphasis>
Hypersensitivity to members of the Asteraceae (Compositae) family.
<Emphasis>Special warnings and precautions for use</Emphasis>
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.
<Emphasis>Interactions with other medicinal products and other forms of interaction</Emphasis>
None reported.
<Emphasis>Pregnancy and lactation</Emphasis>
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
<Emphasis>Effects on ability to drive and use machines</Emphasis>
Not relevant.
<Emphasis>Undesirable effects</Emphasis>
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.
<Emphasis>Overdose</Emphasis>
None reported.
‘Pimpinella anisum L’ is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (Sweet fennel, fruit)
<Strong>COMMUNITY LIST ENTRY ON <Emphasis>PIMPINELLA ANISUM</Emphasis> L</Strong>
<Strong>Scientific name of the plant</Strong>
Pimpinella anisum L.
<Strong>Botanical family</Strong>
Apiaceae
<Strong>Herbal substance</Strong>
Aniseed
<Strong>Common name in all EU official languages of herbal substance</Strong>
BG (bălgarski): Анасон, плод
CS (čeština): Anýzový plod
DA (dansk): Anisfrø
DE (Deutsch): Anis
EL (elliniká): Γλυκάνισο
EN (English): Aniseed
ES (español): Fruto de anís
ET (eesti keel): Aniis
FI (suomi): Anis
FR (français): Anis (fruit d)
HU (magyar): Ánizsmag
IT (italiano): Anice (Anice verde), frutto
LT (lietuvių kalba): Anyžių sėklos
LV (latviešu valoda): Anīsa sēklas
MT (malti): Frotta tal-Anisi
NL (nederlands): Anijsvrucht
PL (polski): Owoc anyżu
PT (português): Anis
RO (română): Fruct de anason
SK (slovenčina): Anízový plod
SL (slovenščina): Plod vrtnega janeža
SV (svenska): Anis
IS (íslenska): Anís
NO (norsk): Anis
<Strong>Herbal preparation(s)</Strong>
Dried aniseed, comminuted or crushed
<Strong>European Pharmacopoeia monograph reference</Strong>
Anisi fructus (01/2005:0262)
<Strong>Indication(s)</Strong>
(a)
Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b)
Traditional herbal medicinal product used as an expectorant in cough associated with cold.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
<Strong>Type of tradition</Strong>
European
<Strong>Specified strength</Strong>
Please see “Specified posology”
<Strong>Specified posology</Strong>
Adolescents over 12 years of age, adults, elderly:
Indications (a) and (b)
1 to 3,5 g of whole or (freshly) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea
3 times daily
The use in children under 12 years is not recommended of age (see below “Special warnings and precautions for use”).
<Strong>Route of administration</Strong>
Oral use
<Strong>Duration of use or any restrictions on the duration of use</Strong>
Not to be taken for more than 2 weeks.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
<Strong>Any other information necessary for the safe use</Strong>
<Emphasis>Contraindications</Emphasis>
Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (caraway, celery, coriander, dill and fennel) or to anethole.
<Emphasis>Special warnings and precautions for use</Emphasis>
The use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.
<Emphasis>Interactions with other medicinal products and other forms of interaction</Emphasis>
None reported.
<Emphasis>Pregnancy and lactation</Emphasis>
There are no data from the use of aniseed in pregnant patients.
It is unknown if aniseed constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
<Emphasis>Effects on ability to drive and use machines</Emphasis>
No studies on the effect on the ability to drive and use machines have been performed.
<Emphasis>Undesirable effects</Emphasis>
Allergic reactions to aniseed affecting the skin or the respiratory system may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
<Emphasis>Overdose</Emphasis>
No case of overdose has been reported.