Draft European Union Herbal Monograph On Pistacia Lentiscus L., Resin (Mastix)

Summary

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

7 July 2015

EMA/HMPC/46758/2015

Committee on Herbal Medicinal Products (HMPC)

European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

Draft

Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Pistacia lentiscus L., resin, Mastix, Mastic tree resin

BG (bulgarski): MacTUKC

CS (cestina): list/pryskyrice pistacie lentisku

DA (dansk): Mastiks

DE (Deutsch): Mastix

EL (ellinika): PqTivq MaorixnÇ Xiou

EN (English): Mastic tree resin

ES (espanol): Lentisco, resina de

ET (eesti keel): mastiks

FI (suomi): mastiksipistaasi, hartsi

FR (français): Mastic

HR (hrvatski): Mastiks

HU (magyar): pisztaciagyanta

IT (italiano): lentisco resina

LT (lietuviq kalba): mastika

LV (latviesu valoda): Mastikas pistäcijas sve^i

MT (Malti): rezina tad-Deru

NL (Nederlands): Mastiekboom, hars (mastiek)

PL (polski): Mastyks

PT (portugués): Mastique

RO (romånä):

SK (slovencina): Mastix SL (slovenscina): mastiks SV (svenska): Mastix IS (íslenska):

NO (norsk): Mastiks

Discussion in Working Party on European Union monographs and list (MLWP)	November 2014 January 2015 March 2105 May 2015
Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation	07 July 2015
Start of public consultation	22 July 2015
End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu	31 October 2015
Re-discussion in MLWP
Adoption by HMPC

Keywords

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European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

1. Name of the medicinal product

To be specified for the individual finished product.

2. Qualitative and quantitative composition^{1, 2}

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Pistacia lentiscus L., resin (mastix)

i) Herbal substance Not applicable

ii) Herbal preparations Powdered herbal substance

3. Pharmaceutical form

Well-established use

Traditional use

Powdered herbal substance in solid dosage form for oral use.

Powdered herbal substance in semi-solid dosage form for cutaneous use.

4. Clinical particulars

4.1. Therapeutic indications

Well-established use

Traditional use

Indication 1)

Traditional herbal medicinal product used in mild dyspeptic disorders.

¹ The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.

The material complies with the Ph. Eur. monograph (ref.: 1876)

Well-established use

Traditional use

Indication 2)

Traditional herbal medicinal product used for the symptomatic treatment of minor inflammations of the skin and as an aid in healing of minor wounds.

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

4.2. Posology and method of administration

Well-established use

Traditional use

Posology

Indication 1)

Adults and elderly

Single dose: 0.35-0.5 g Daily dose: 3-4 times daily

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Indication 2)

Adolescents, adults and elderly

Semi-solid preparations containing 9-11% of the powdered herbal substance to be applied as a thin layer on the affected area up to 3 times daily.

The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Duration of use

Indication 1)

If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication 2)

If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Well-established use

Traditional use

Method of administration

Indication 1)

Oral use Indication 2)

Cutaneous use

4.3. Contraindications

Well-established use	Traditional use
	Hypersensitivity to the active substance.

4.4. Special warnings and precautions for use

Well-established use

Traditional use

Indication 1)

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.

Indication 2)

The use in children under 12 years of age has not been established due to lack of adequate data.

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

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

4.5. Interactions with other medicinal products and other forms of interaction

Well-established use	Traditional use
	None reported.

4.6. Fertility, pregnancy and lactation

Well-established use	Traditional use
	No fertility data available.

Well-established use	Traditional use
	Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

4.7. Effects on ability to drive and use machines

Well-established use	Traditional use
	No studies on the effect on the ability to drive and use machines have been performed.

4.8. Undesirable effects

Well-established use

Traditional use

None known.

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

4.9. Overdose

Well-established use	Traditional use
	No case of overdose has been reported.

5. Pharmacological properties

5.1. Pharmacodynamic properties

Well-established use	Traditional use
	Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2. Pharmacokinetic properties

Well-established use	Traditional use
	Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3. Preclinical safety data

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars

Well-established use	Traditional use
	Not applicable.

7. Date of compilation/last revision

7 July 2015

Page 6/6

European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

EMA/HMPC/46758/2015

Draft European Union Herbal Monograph On Pistacia Lentiscus L., Resin (Mastix)

EUROPEAN MEDICINES AGENCY

European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

1. Name of the medicinal product

2. Qualitative and quantitative composition1, 2

3. Pharmaceutical form

4. Clinical particulars

4.1. Therapeutic indications

4.2. Posology and method of administration

4.3. Contraindications

4.4. Special warnings and precautions for use

4.5. Interactions with other medicinal products and other forms of interaction

4.6. Fertility, pregnancy and lactation

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects

4.9. Overdose

5. Pharmacological properties

5.1. Pharmacodynamic properties

5.2. Pharmacokinetic properties

5.3. Preclinical safety data

6. Pharmaceutical particulars

7. Date of compilation/last revision

2. Qualitative and quantitative composition^{1, 2}