Annex

Decision 2008/911/EC is amended as follows:

1. (1)

   In Annex I, the following substance is inserted after Pimpinella anisum L:

   ‘ Sideritis scardica Griseb., herba.’;

2. (2)

   In Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Pimpinella anisum L:

   ‘UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA

   Scientific name of the plant
   Sideritis scardica Griseb.
   Botanical family
   Lamiaceae (Labiatae)
   Herbal substance
   Ironwort (Sideritis herba)
   Common name in all EU official languages of herbal preparation
   BG (bălgarski): Мурсалски чай, стрък CS (čeština): nať hojníku DA (dansk): Kortkroneurt DE (Deutsch): Balkan-Gliedkraut EL (elliniká): Πόα σιδηρίτου EN (English): Ironwort ES (español): Siderita, partes aéreas de ET (eesti keel): haavarohuürt FI (suomi): raudakki, verso FR (français): Crapaudine (parties aériennes de) HR (hrvatska): očistova zelen HU (magyar): sármányvirág virágos hajtása IT (italiano): Stregonia parti aeree fiorite	LT (lietuvių kalba): Timsrų žolė LV (latviešu valoda): Siderītu laksts MT (Malti): ħaxixa tas-Sideritis NL (Nederlands): (Griekse) bergthee, kruid PL (polski): Ziele gojnika PT (português): Siderite, partes aéreas RO (română): iarba de ceaiul muntelui cretan SK (slovenčina): Vňať ránhoja SL (slovenščina): zel sklepnjaka SV (svenska): Sårmynta, ört IS (íslenska): NO (norsk): Gresk fjellte
   Herbal preparations
   Comminuted herbal substance
   European Pharmacopoeia monograph reference
   Not applicable
   Indications
   Indication (1) Traditional herbal medicinal product used for the relief of cough associated with cold. Indication (2) Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort. 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
   Adults and elderly Indication (1) and (2) Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily Daily dose: up to 12 g The use in children and adolescents under 18 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
   Indication (1) If symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indication (2) If symptoms persist longer than 2 weeks 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 and to other plants of the Lamiaceae (Labiatae) family. Special warnings and precautions for use The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Interactions with other medicinal products and other forms of interaction None reported Fertility, pregnancy and lactation Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended. No fertility data available. 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 None known If adverse reactions occur, a doctor or 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.

   ’