Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

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 marketing authorisation                      With regard to the registration application of
application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
2001/83/EC as amended                                           amended
Linum usitatissimum L., semen (linseed)                         Linum usitatissimum L., semen (linseed)

i) Herbal substance                                             i) Herbal substance
   As defined in the Ph. Eur. monograph                            As defined in the Ph. Eur. monograph

                                                                ii) Herbal preparations
ii) Herbal preparations
                                                                   not applicable
    not applicable


3. Pharmaceutical form
Well-established use                                            Traditional use

Herbal substance for oral use.                                  Herbal substance for oral use.

The pharmaceutical form should be described by                  The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.                  the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

Herbal medicinal product for the treatment of                   Traditional herbal medicinal product used as a
habitual constipation or in conditions in which                 demulcent preparation for the symptomatic relief
easy defaecation with soft stool is desirable.                  of mild gastrointestinal discomfort.

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




1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the Ph. Eur. monograph (ref.: 0095).

European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                                 Page 3/8
4.2. Posology and method of administration

Well-established use                                          Traditional use

Posology                                                      Posology

Adolescents, adults and elderly                               Adolescents, adults and elderly

Single dose                                                   Single dose

10 - 15 g,                                                    5 – 10 g in 250 ml water

Daily dose: 2 - 3 times daily                                 Daily dose: up to three times during the day

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

Duration of use                                               Duration of use

If the constipation does not resolve within 3 days,           If the symptoms persist for longer than 1 week
a doctor or a pharmacist should be consulted.                 during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
Method of administration
                                                              consulted.
Oral use.
                                                              Method of administration
Take 10 - 15 g seeds with 150 ml water, milk,
                                                              Oral use.
fruit juice or similar aqueous liquid 2 - 3 times
daily; then maintain adequate fluid intake. The               For a mucilaginous preparation, soak 5 - 10 g
product should be taken during the day at least ½             whole or broken seeds in 250 ml water for at least
to 1 hour before or after intake of other                     <x min> and take this half an hour before eating.
medicines. The effect starts 12 - 24 hours later.             At the time of consumption the process of swelling
                                                              has to be accomplished [length has to be specified
Warning: not to be taken immediately prior to
                                                              for the individual product]. The mucilaginous
bedtime.
                                                              preparations may be consumed with or without
                                                              the seeds.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

Hypersensitivity to the active substance.                     Hypersensitivity to the active substance.

Linseed should not be used by patients with a                 This product should not be taken by patients,
sudden change in bowel habit that persists for                who have difficulty in swallowing or any throat
more than 2 weeks, undiagnosed rectal bleeding                problems.
and failure to defaecate following the use of a
laxative.

Linseed should also not be used by patients
suffering from abnormal constrictions in the
gastro-intestinal tract, with diseases of the
oesophagus and cardia or existing intestinal
blockage (ileus), paralysis (ileus) of the intestine
or megacolon.


European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                       Page 4/8
Well-established use                                          Traditional use

This product should not be taken by patients, who
have difficulty swallowing or any throat problems.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

The use is not recommended in children under 12               The use in children under 12 years of age has not
years due to insufficient data on safety and                  been established due to lack of adequate data.
efficacy.
                                                              The treatment of debilitated patients and elderly
If abdominal pain occurs or in cases of any                   should be supervised.
irregularity of frequency of faeces, the use of
                                                              Investigations in healthy women suggest that long
linseed should be discontinued and medical advice
                                                              term use of linseed may have an oestrogenic
must be sought.
                                                              effect, and its use is therefore not recommended
Taking this herbal substance without adequate                 in women with hormonally dependent tumours.
fluid, may cause it to swell and block the throat or
oesophagus and may cause choking. Intestinal
obstruction may occur if adequate fluid intake is
not maintained. If experiencing chest pain,
vomiting, or difficulty in swallowing or breathing
after taking this herbal substance, immediate
medical attention should be sought.

The treatment of debilitated patients and elderly
should be supervised.

Investigations in healthy women suggest that long
term use of linseed may have an oestrogenic
effect, and its use is therefore not recommended
in women with hormonally dependent tumours.

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                          Traditional use

Enteral absorption of concomitantly administered              Enteral absorption of concomitantly administered
medicines may be delayed by bulk forming                      medicines may be delayed by a demulcent
laxatives such as linseed.                                    preparation of linseed.

For this reason the product should be taken at                For this reason the product should not be taken ½
least ½ to 1 hour before or after intake of other             to 1 hour before or after intake of other medicinal
medicinal products.                                           products.

In order to decrease the risk of gastrointestinal
obstruction (ileus), linseed should be used
together with medicinal products known to inhibit
peristaltic movement (e.g. opioids, loperamide)
only under medical supervision.


European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                      Page 5/8

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

Meteorism, occurring with the use of the product,             Meteorism, occurring with the use of the product,
is common.                                                    is common.

Reactions of hypersensitivity including                       Reactions of hypersensitivity including
anaphylaxis-like reactions may occur very rarely.             anaphylaxis-like reactions may occur very rarely.

If other adverse reactions not mentioned above                If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be                     occur, a doctor or a qualified health care
consulted.                                                    practitioner should be consulted.