Agnolyt solution
This data sheet conforms in all essential parts with the user information as prescribed by
law in Germany.
Agnolyt Solution to be taken by mouth - A medicine of plant origin for menstrual
symptoms.
Active ingredient
Tincture of chaste tree fruits.
Composition
100 g of solution contains:
Pharmacologically active ingredients:
Tincture of chaste tree fruits [1:5] 9 g
Extractant: ethanol 68 vol.%
Other ingredients: water, ethanol
Original packs of 50, 100 and 150 ml solution
Uses
Disorders of menstrual rhythm (menstrual irregularities), sensations of tension and
swelling in the breasts (mastodynia), recurrent monthly symptoms before the onset of
menstruation (premenstrual syndrome).
Warning:
Patients with sensations of tension and swelling in the breasts or with menstrual disorders
should first of all consult a doctor, because such symptoms might arise from illnesses that
require medical investigation.
Contraindications
When must you not use Agnolyt?
No restrictions.
What must you remember in the event of pregnancy or lactation?
Agnolyt must not be used during pregnancy or lactation.
Precautions and warnings
What precautionary measures must be remembered?
This medicine contains alcohol 58 vol.%. When taken in accordance with the dosage
guidance, each dose (40 drops) will contain 0.8 g alcohol.
A health risk from alcohol exists in patients with liver diseases, alcohol-related
conditions, epilepsy or brain damage, among other conditions. Agnolyt can interfere with
the action of other medicines.
If the use of Agnolyt solution is considered inadvisable, Agnolyt capsules offer an
equally effective alternative.
Interactions with other drugs
What other medicines affect the action of Agnolyt?
If you are taking any other medicines you should consult your doctor before starting
Agnolyt because there is some evidence of reciprocal weakening of the action when it is
taken at the same time as dopamine receptor antagonists.
Please remember that this advice can also apply to recently administered medicines.
Dosage guidance, mode and duration of administration
The following instructions apply unless your doctor has directed otherwise. Please adhere
to the directions for use, otherwise Agnolyt cannot act properly.
How much Agnolyt should you take and how often?
Unless otherwise directed, take 40 drops once daily.
How and when should you take Agnolyt?
Take the drops in a small amount of liquid every morning.
How long should you go on taking Agnolyt?
Agnolyt should be taken for several months without a break. Once the symptoms have
improved, treatment should be continued for a few weeks.
Incorrect Use and Overdoses
What should be done if Agnolyt has been inadvertently taken in unduly large amounts?
The signs of overdosage and poisoning are not yet known.
Intake of this medicine in large amounts may cause alcohol poisoning, especially in
children; in such an event life is at risk and a doctor must be consulted immediately.
Consumption of the entire contents of a bottle would mean an alcohol intake of about 25,
49 or 74 g depending on the bottle size.
Side effects
What side effects may occur during the use of Agnolyt?
There have been itching skin eruptions with blistering in occasional instances.
If you observe any side effects not mentioned in this package insert please report them to
your doctor or pharmacist.
Information and statements regarding storage life
The expiry date of this pack is printed on the carton and the label.
Do not use this pack after that date! Date of information as at December 1996.
Further information
Agnolyt is a medicine of purely plant origin. Acting on a natural basis, it regulates the
monthly cycle and alleviates or completely relieves premenstrual symptoms occurring
one to two weeks before menstruation.
This is how the female cycle operates:
The menstrual cycle has only one purpose: to prepare for a pregnancy. Every month one
ovum matures in one or other of the ovaries. It is released when an ovarian follicle
ruptures and it is taken up by the Fallopian tube, where it may be fertilised by male sperm
cells. The site of the ruptured follicle in the ovary is marked by a kind of scar which,
because of its yellowish colour, is called the corpus luteum. This corpus luteum or yellow
body, in response to orders from the brain, produces the corpus luteum hormone
progesterone. This hormone ensures adequate blood flow through the mucosa of the
uterus so that the fertilised ovum can become implanted in the uterus and the pregnancy
can continue.
If fertilisation does not take place, the corpus luteum shrinks, hormone production
decreases, the uterine mucosa no longer has an adequate blood supply and is ultimately
cast off; menstrual bleeding begins.
How do menstrual disorders originate?
The control of hormones and their interplay are extremely complicated and their balance
can all too easily be disturbed. An inadequate signal from the brain or unduly low
hormone production by the ovaries can upset the sequence of events in the menstrual
cycle. Should these disorders cause the cycle to be too short or too long, such
abnormalities are spoken of as disorders of menstrual rhythm. In such cases the cause is
frequently to be found in inadequate development and maturation of the corpus luteum,
with consequent interference with progesterone release.
When problems arise in the days before the period:
The characteristic symptoms which occur in the days before menstruation likewise point
to derangements of the hormonal regulatory circuit. Many women find that their
equilibrium is upset on the days before menstruation begins. Some women feel physically
unwell, with pain in the lower abdomen, and tension or pain in the breasts, and they feel
swollen up, tired or have headaches. Other women are troubled by psychological
disorders such as irritability, nervousness, depression and apathy. Almost every woman
experiences such symptoms occasionally to a greater or lesser degree. When the
problems occur regularly before each menstrual period and then disappear spontaneously
when bleeding commences, the condition is spoken of as the 'premenstrual syndrome' or
PMS.
The cause is frequently to be found in an upset in the interplay between oestrogen and
progesterone, so that their balance is disturbed; for example, the progesterone level may
be too low.
How does Agnolyt work?
Agnolyt is a natural product, free from hormones. The active ingredients are extracted
from the fruit of the chaste tree. The chaste tree is an aromatic shrub or small tree, 2 - 4
metres in height, growing wild in the Mediterranean area, the Crimea and Central Asia.
Investigations in laboratory animals have shown that the action of Agnolyt is based on its
power to stabilise the female hormonal regulatory cycle. Fine tuning between the brain
(the pituitary gland) and the ovaries is improved. The cycle stabilises and the symptoms
are alleviated or completely disappear.
The same applies to the troublesome symptoms of PMS.
Please remember that this regulatory biological intervention cannot take effect overnight,
and you must therefore take Agnolyt regularly for several months before you can expect a
response.
If the intake of alcohol should be forbidden, Agnolyt capsules provide an equally
effective alternative.