Agnolyt capsules

This data sheet conforms in all essential parts with the user information as prescribed by law in Germany.

Gynaecological agent - Capsules to be taken by mouth

Active ingredient

Dry extract of chaste tree fruits


Composition

1 capsule contains:
Pharmacologically active ingredients: dry extract from chaste tree fruits (Agni casti fructus) [9.58- 11.5:1] 3.5-4.2 mg (extractant: ethanol 60% by weight).

Other ingredients: gelatin, isopropyl myristate, lactose, magnesium stearate, polysorbate 20, crospovidone, propylene glycol, silicon dioxide, titanium dioxide.
Original packs of 30, 60 and 100 capsules.


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).


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?
Patients who have sensations of tension and swelling in the breasts or menstrual disorders should first of all consult a doctor, such symptoms might arise from illnesses that require medical investigation.


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 action when it is taken at the same time as dopamine receptor antagonists.
Please remember that this advice may also apply to recently administered medicines.


Dosage guidance, mode and duration of administration

The following recommendations 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 1 capsule once daily.

How and when should you take Agnolyt?
Take 1 capsule every morning with some liquid.

For 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.


Side effects

What side effects may occur during the use of Agnolyt?
There have been occasional instances of itching skin eruptions with blistering. If you observe any side effects not mentioned in this package insert please report them to your doctor or pharmacist.


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 the ovarian follicle ruptures and 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 there, thus enabling the pregnancy to continue.

If fertilisation does not take place, the corpus luteum shrinks and 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 derange the smooth progress of 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. Such cases are frequently due to 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 sometimes occur in the days before menstruation begins likewise point to similar 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, and does not contain any 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 have shown that the action of Agnolyt depends 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 relieved.

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.

Agnolyt is also available in the form of solution.

M. No. 211467/1.95