OpenLegislation

Division UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBAF1

United Kingdom

Original text. Later amendments are not shown.

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.

Annotations

Textual amendments

F1

Inserted by Commission Implementing Decision (EU) 2018/134 of 24 January 2018 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 218) (Text with EEA relevance).