ANNEX IISupplementary provisions
ANNEX II A. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE , FRUCTUS Scientific name of the plant Foeniculum vulgare Miller subsp. vulgare var. vulgare Botanical family Apiaceae Herbal substance Fennel, bitter Common name in all EU official languages of herbal substance BG (bălgarski): Горчиво резене, плод CS (čeština): Plod fenyklu obecného pravého DA (dansk): Fennikel, bitter DE (Deutsch): Bitterer Fenchel EL (elliniká): Μαραθόσπορος πικρός EN (English): Bitter fennel, fruit ES (español): Hinojo amargo, fruto de ET (eesti keel): Mõru apteegitill, vili FI (suomi): Karvasfenkoli, hedelmä FR (français): Fruit de fenouil amer HU (magyar): Keserűédeskömény-termés IT (italiano): Finocchio amaro (o selvatico), frutto LT (lietuvių kalba): Karčiųjų pankolių vaisiai LV (latviešu valoda): Rūgtā fenheļa augļi MT (malti): Bużbież morr, frotta NL (nederlands): Venkelvrucht, bitter PL (polski): Owoc kopru włoskiego (odmiana gorzka) PT (português): Fruto de funcho amargo RO (română): Fruct de fenicul amar SK (slovenčina): Feniklový plod horký SL (slovenščina): Plod grenkega navadnega komarčka SV (svenska): Bitterfänkål, frukt IS (íslenska): Bitur fennel aldin NO (norsk): Fenikkel, bitter Herbal preparation(s) Fennel, bitter, dried comminuted ( 1 ) fruit. European Pharmacopoeia monograph reference Foeniculi amari fructus (01/2005:0824). Indication(s) (a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. (b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods. (c) 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. Type of tradition European, Chinese. Specified strength Please see ‘Specified posology’. Specified posology Adults Single dose 1,5 to 2,5 g of (freshly ( 2 ) ) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea. Adolescents over 12 years of age, indication (a) Adult dose Children between four and 12 years of age, indication (a) Average daily dose 3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week). The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’). Route of administration Oral use. Duration of use or any restrictions on the duration of use Adults Adolescents over 12 years of age, indication (a) Not to be taken for more than two weeks. Children between four and 12 years of age, indication (a) For short-term use in mild transitory symptoms only (less than one week). If the symptoms persist 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 the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole. Special warnings and precautions for use The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought. Interactions with other medicinal products and other forms of interaction None reported. Pregnancy and lactation There are no data from the use of fennel fruit in pregnant patients. It is unknown if fennel constituents are excreted in human breast milk. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Undesirable effects Allergic reactions to fennel, 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. Overdose No case of overdose has been reported. Pharmaceutical particulars (if necessary) Not applicable. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable. B. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS Scientific name of the plant Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung Botanical family Apiaceae Herbal substance Fennel, sweet Common name in all EU official languages of herbal substance BG (bălgarski): Сладко резене, плод CS (čeština): Plod fenyklu obecného sladkého DA (dansk): Fennikel, sød DE (Deutsch): Süßer Fenchel EL (elliniká): Μαραθόσπορος γλυκύς EN (English): Sweet fennel, fruit ES (español): Hinojo dulce, fruto de ET (eesti keel): Magus apteegitill, vili FI (suomi): Makea fenkoli, hedelmä FR (français): Fruit de fenouil doux HU (magyar): Édesköménytermés IT (italiano): Finocchio dolce (o romano), frutto LT (lietuvių kalba): Saldžiųjų pankolių vaisiai LV (latviešu valoda): Saldā fenheļa augļi MT (malti): Bużbież ħelu, frotta NL (nederlands): Venkelvrucht, zoet PL (polski): Owoc kopru włoskiego (odmiana słodka) PT (português): Fruto de funcho doce RO (română): Fruct de fenicul dulce SK (slovenčina): Feniklový plod sladký SL (slovenščina): Plod sladkega navadnega komarčka SV (svenska): Sötfänkål, frukt IS (íslenska): Sæt fennel aldin NO (norsk): Fenikkel, søt Herbal preparation(s) Fennel, sweet, dried comminuted ( 3 ) or powdered fruit. European Pharmacopoeia monograph reference Foeniculi dulcis fructus (01/2005:0825). Indication(s) (a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. (b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods. (c) 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. Type of tradition European, Chinese. Specified strength Please see ‘Specified posology’. Specified posology Adults Single dose 1,5 to 2,5 g of (freshly ( 4 ) ) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea. Fennel powder: 400 mg three times a day (with a maximum of 2 g daily). Adolescents over 12 years of age, indication (a) Adult dose Children between four and 12 years of age, indication (a) Average daily dose 3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week). The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’). Route of administration Oral use. Duration of use or any restrictions on the duration of use Adults Adolescents over 12 years of age, indication (a) Not to be taken for more than two weeks. Children between four and 12 years of age, indication (a) For short-term use in mild transitory symptoms only (less than one week). If the symptoms persist 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 the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole. Special warnings and precautions for use The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought. Interactions with other medicinal products and other forms of interaction None reported. Pregnancy and lactation There are no data from the use of fennel fruit in pregnant patients. It is unknown if fennel constituents are excreted in human breast milk. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Undesirable effects Allergic reactions to fennel, 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. Overdose No case of overdose has been reported. Pharmaceutical particulars (if necessary) Not applicable. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable. ( 1 ) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’. ( 2 ) For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components. ( 3 ) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’. ( 4 ) For commercial preparation of comminuted or powdered fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.