AGNUCASTON 20 mg film-coated tablets, 60 pcs

Instructions for use for AGNUCASTON 20 mg film-coated tablets, 60 pcs

Application instructions

Adult

1 Tablet

1 Tablet per day

at the same time every day, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The ingredients come from the monk's pepper plant and act as a natural mixture. About the plant itself:

- Appearance: tree or shrub up to 6 m high, the pinnate leaves of which are hairy on the underside, the small fragrant purple flowers form spike-like inflorescences, the fruits are small, reddish-black
- Occurrence: Southern Europe, Asia
- Main ingredients: essential oil (limonene, pinene), iridoid glycosides (aucubin, agnoside), flavonoids
- Plant parts and preparations used: mainly fruit extracts
Chasteberry extracts suppress the release of prolactin. The concentration of this substance is often increased before menstruation and is one of the causes of premenstrual symptoms. Additionally, chasteberry appears to restore the balance between estrogen and progesterone.

Composition

Contraindications

What speaks against an application?

- Hypersensitivity to the ingredients

Special caution:
- Breast tumors
- Tumors of the pituitary gland (pituitary gland tumors)

Which age group should be taken into account?
- Children and adolescents under 18 years of age: The medicine should generally not be used in this age group.

What about pregnancy and lactation?
- Pregnancy: According to current knowledge, the medicine should not be used.
- Breastfeeding: According to current knowledge, use is not recommended. You may be to consider a weaning.

If you have been prescribed this medicine despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may be greater than the risk associated with use if there is a contraindication.

Side effects

What adverse effects may occur?

- Skin rash
- Itching
- Hives

If you notice any discomfort or change during treatment, contact your doctor or pharmacist.

The information provided here primarily takes into account side effects that occur in at least one in 1,000 treated patients.

Hints

What should you pay attention to?
- Be careful if you are allergic to binding agents (e.g. carboxymethyl cellulose with the E number E 466)!
- Be careful if you have intolerance to lactose. If you have to follow a diabetes diet, you should consider the sugar content.

Detailed instructions for AGNUCASTON 20 mg film-coated tablets, 60 pcs

Field of use

• The preparation is a herbal medicine for the treatment of premenstrual syndrome (monthly recurring symptoms before the start of menstruation) in women aged 18 and over.

Active ingredients / ingredients / ingredients

20 mg chasteberry fruit dry extract, (7-11:1), extractant: ethanol 70% (V/V)
Cellulose, microcrystalline excipient (+)
Croscarmellose, sodium salt excipient (+)
Potato starch excipient (+)
50 mg lactose 1-water excipient (+)
Magnesium stearate (Ph. Eur.) [pflanzlich] excipient (+)
Opadry AMB II Excipient (+)
Poly(vinyl alcohol) excipient (+)
Talc excipient (+)
Titanium dioxide auxiliary (+)
Glycerol monocaprylocaprate excipient (+)
Sodium dodecyl sulfate excipient (+)
Povidone K30 excipient (+)
Silicon dioxide, highly disperse auxiliary (+)
1 mmol total sodium ion excipient (+)
Total Sodium Ion Excipient (+)

Contraindications

• The medicine must not be taken:
  • if you are hypersensitive (allergic) to chasteberry fruit dry extract (Agnus castus fructus) or any of the other ingredients of this medicine.

dosage

• Always take this medicine exactly as described or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
• The recommended dose for women aged 18 and over is 1 film-coated tablet once daily.
• Use in children and adolescents
  • There is no reason for use in children before puberty.
  • Use in children and adolescents under 18 years of age is not recommended due to a lack of adequate data.
• Certain patient groups
  • There are no data available to support dosage recommendations in impaired renal/hepatic function.
  • Consult your doctor before taking the product if you have existing kidney/liver dysfunction.

 

• Duration of application
  • For an optimal treatment effect, continuous consumption over 3 months is recommended (including during menstruation).
  • If symptoms persist after continuous use for more than three months, contact your doctor or pharmacist.

 

• If you have taken more than you should
  • If you take more than you should, or if children accidentally take this medicine, contact your doctor or nearest hospital.

 

• If you forget to take it
  • Do not take a double dose if you have forgotten a previous dose.

Intake

• Take the film-coated tablets with sufficient liquid (e.g. with a glass of water). Do not chew the tablets.

Patient information

• Warnings and Precautions
  • Please talk to your doctor before taking the medicine
    • if you have or have had an estrogen-sensitive tumor in the past.
    • if you are taking any of the following medicines: dopamine agonists (e.g. certain medicines used to treat Parkinson's disease), dopamine antagonists (certain medicines used to treat schizophrenia, bipolar disorder, nausea and vomiting), estrogens (e.g. as part of a... hormone replacement therapy) or antiestrogens (e.g. certain medicines used to treat breast cancer).
    • if you have had a pituitary gland disorder in the past.
  • Talk to your doctor if symptoms worsen while using the medicine.
  • If you experience any signs of an allergic reaction, you should stop taking this medicine and contact your doctor immediately.
  • Children and young people
    • There is no reason to use this medicine in children before puberty. Use in children during puberty and adolescents under 18 years of age is not recommended due to a lack of adequate data.

 

• Ability to drive and use machines
  • No studies have been conducted on the effects on the ability to drive and use machines. There is currently no evidence that the ability to drive and use machines is impaired by taking it. However, in patients who experience dizziness, the ability to drive and use machines may be impaired.

Pregnancy

• Pregnancy
  • There is no reason to use this medicine during pregnancy. It is not recommended during pregnancy.
• Lactation
  • Due to a lack of adequate data, its use during breastfeeding is not recommended.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Hints

Manufacturer:  Bionorica SE, Kerschensteinerstraße 11-15