Pflanzenwissen.
Mit Herkunft.

Warnungen, berichtete Effekte und verneinte Studienbefunde werden getrennt ausgewiesen und mit eindeutig bezeichneten Wirkstoffen verknüpft. Jede Aussage gilt im Zubereitungs- und Anwendungskontext der Quelle. Ein klinischer Schweregrad wird daraus nicht abgeleitet.

• carbamazepine

  Berichteter Effekt

  Etablierte Anwendung · Quellenspalte · Keine wirkstoffbezogene Einschränkung abgeleitet · Schweregrad: nicht angegeben

  Die Quelle beschreibt einen möglichen oder beobachteten Effekt; auch ein Verdachtsfall ist damit möglich. Allgemeine Warnungen und weitere Bedingungen bleiben im Originalzitat erhalten. Daraus wurde hier keine zusätzliche Einschränkung für den einzelnen Wirkstoff abgeleitet.

  HOS-215982→HOS-085618RxNorm 2002

  Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B 12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed. For this reason the product should not be taken ½ to 1 hour before or after intake of other medicinal products.

  Original-PDF · Seite 6 ↗Beziehung HOS-216094
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Aussage:

  Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B 12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed.

  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
  application of Article 10(a) of Directive
  2001/83/EC as amended
  
  Plantago ovata Forssk. (P. ispaghula Roxb.),
  semen (ispaghula seed)
  i) Herbal substance
     Dried ripe seeds
  
  ii) Herbal preparations
      Powdered herbal substance
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal substance for oral use; herbal preparation
  in solid dosage forms for oral use.
  
  The pharmaceutical form should be described by
  the European Pharmacopoeia full standard term.
  
  
  
  4. Clinical particulars
  
  4.1. Therapeutic indications
  
  Well-established use                                            Traditional use
  
  Indication 1)
  Herbal medicinal product for the treatment of
  habitual constipation.
  
  Indication 2)
  Herbal medicinal product in conditions in which
  easy defecation with soft stool is desirable, e.g. in
  cases of painful defecation after rectal or anal
  
  1
   The material complies with the Eur. Ph. monograph monograph (ref.: 01/2008:1333).
  2
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
  quality guidance.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                                                               Page 4/10
  Well-established use                                          Traditional use
  
  surgery, anal fissures and haemorrhoids.
  
  
  4.2. Posology and method of administration
  
  Well-established use                                          Traditional use
  
  Posology
  Adolescents, adults and elderly
  
  Daily dose
  8 - 40 g herbal substance/herbal preparation in
  2 - 3 single doses
  Children from 6 to 12 years of age
  
  Daily dose
  4 - 25 g herbal substance/herbal preparation in
  2 – 3 single doses.
  
  The use in children under 6 years of age is not
  recommended (see section 4.4 ‘Special warnings
  and precautions for use’).
  
  Duration of use
  
  If the constipation does not resolve within 3 days,
  a doctor or a pharmacist should be consulted.
  
  See section 4.4 ‘Special warnings and precautions
  for use’.
  
  Method of administration
  
  A sufficient amount of liquid (water, milk, fruit
  juice or similar aqueous liquid) should always be
  taken e.g. 30 ml of water per 1 g of herbal
  substance.
  
  The medicinal product can be mixed with the
  liquids and then swallowed or taken and then
  swallowed with sufficient quantity of liquid.
  Adequate fluid intake has to be maintained.
  
  The product should be taken during the day at
  least ½ to 1 hour before or after intake of other
  medicines, not immediately prior to bed-time.
  
  The effect starts 12 - 24 hours later.
  
  Powder formulations:
  
  When preparing the product for administration, it
  is important to try to avoid inhaling any of the
  powder in order to minimise the risk of
  sensitisation to the active ingredient.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                            Page 5/10
  
  4.5. Interactions with other medicinal products and other forms of
  interaction
  
  Well-established use                                          Traditional use
  
  Enteral absorption of concomitantly administered
  medicines such as minerals, vitamins (B 12),
  cardiac glycosides, coumarin derivatives,
  carbamazepine and lithium may be delayed. For
  this reason the product should not be taken ½ to
  1 hour before or after intake of other medicinal
  products.
  
  Diabetic patients should take ispaghula seeds only
  under medical supervision because adjustment of
  anti-diabetic therapy may be necessary.
  
  Use of ispaghula seed concomitantly with thyroid
  hormones requires medical supervision because
  the dose of the thyroid hormones may have to be
  adjusted.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                            Page 7/10

  PDF SHA-256: 39a176bd67181a7662349d120e50bd9eaa879dda95a76a89f22cce24c86a4969

  Die Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.

• lithium

  Berichteter Effekt

  Etablierte Anwendung · Quellenspalte · Keine wirkstoffbezogene Einschränkung abgeleitet · Schweregrad: nicht angegeben

  Die Quelle beschreibt einen möglichen oder beobachteten Effekt; auch ein Verdachtsfall ist damit möglich. Allgemeine Warnungen und weitere Bedingungen bleiben im Originalzitat erhalten. Daraus wurde hier keine zusätzliche Einschränkung für den einzelnen Wirkstoff abgeleitet.

  HOS-215982→HOS-085952RxNorm 6448

  Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B 12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed. For this reason the product should not be taken ½ to 1 hour before or after intake of other medicinal products.

  Original-PDF · Seite 6 ↗Beziehung HOS-216095
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Aussage:

  Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B 12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed.

  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
  application of Article 10(a) of Directive
  2001/83/EC as amended
  
  Plantago ovata Forssk. (P. ispaghula Roxb.),
  semen (ispaghula seed)
  i) Herbal substance
     Dried ripe seeds
  
  ii) Herbal preparations
      Powdered herbal substance
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal substance for oral use; herbal preparation
  in solid dosage forms for oral use.
  
  The pharmaceutical form should be described by
  the European Pharmacopoeia full standard term.
  
  
  
  4. Clinical particulars
  
  4.1. Therapeutic indications
  
  Well-established use                                            Traditional use
  
  Indication 1)
  Herbal medicinal product for the treatment of
  habitual constipation.
  
  Indication 2)
  Herbal medicinal product in conditions in which
  easy defecation with soft stool is desirable, e.g. in
  cases of painful defecation after rectal or anal
  
  1
   The material complies with the Eur. Ph. monograph monograph (ref.: 01/2008:1333).
  2
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
  quality guidance.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                                                               Page 4/10
  Well-established use                                          Traditional use
  
  surgery, anal fissures and haemorrhoids.
  
  
  4.2. Posology and method of administration
  
  Well-established use                                          Traditional use
  
  Posology
  Adolescents, adults and elderly
  
  Daily dose
  8 - 40 g herbal substance/herbal preparation in
  2 - 3 single doses
  Children from 6 to 12 years of age
  
  Daily dose
  4 - 25 g herbal substance/herbal preparation in
  2 – 3 single doses.
  
  The use in children under 6 years of age is not
  recommended (see section 4.4 ‘Special warnings
  and precautions for use’).
  
  Duration of use
  
  If the constipation does not resolve within 3 days,
  a doctor or a pharmacist should be consulted.
  
  See section 4.4 ‘Special warnings and precautions
  for use’.
  
  Method of administration
  
  A sufficient amount of liquid (water, milk, fruit
  juice or similar aqueous liquid) should always be
  taken e.g. 30 ml of water per 1 g of herbal
  substance.
  
  The medicinal product can be mixed with the
  liquids and then swallowed or taken and then
  swallowed with sufficient quantity of liquid.
  Adequate fluid intake has to be maintained.
  
  The product should be taken during the day at
  least ½ to 1 hour before or after intake of other
  medicines, not immediately prior to bed-time.
  
  The effect starts 12 - 24 hours later.
  
  Powder formulations:
  
  When preparing the product for administration, it
  is important to try to avoid inhaling any of the
  powder in order to minimise the risk of
  sensitisation to the active ingredient.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                            Page 5/10
  
  4.5. Interactions with other medicinal products and other forms of
  interaction
  
  Well-established use                                          Traditional use
  
  Enteral absorption of concomitantly administered
  medicines such as minerals, vitamins (B 12),
  cardiac glycosides, coumarin derivatives,
  carbamazepine and lithium may be delayed. For
  this reason the product should not be taken ½ to
  1 hour before or after intake of other medicinal
  products.
  
  Diabetic patients should take ispaghula seeds only
  under medical supervision because adjustment of
  anti-diabetic therapy may be necessary.
  
  Use of ispaghula seed concomitantly with thyroid
  hormones requires medical supervision because
  the dose of the thyroid hormones may have to be
  adjusted.
  
  
  Community herbal monograph on Plantago ovata Forssk., semen
  EMA/HMPC/304390/2012                                                            Page 7/10

  PDF SHA-256: 39a176bd67181a7662349d120e50bd9eaa879dda95a76a89f22cce24c86a4969

  Die Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.

Keine oder wenige Zuordnungen bedeuten nicht, dass keine Wechselwirkungen bestehen. Nicht eindeutig zuordenbare Aussagen bleiben im Originalabschnitt nachlesbar; verneinte Befunde gelten nur für die beschriebenen Bedingungen.