AGNUS CASTUS AL film-coated tablets

Important notes (mandatory information)

Agnus Castus AL Film-coated tablets. Active ingredient: Chasteberry fruit. Areas of application: for menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia) and for monthly recurring symptoms before the onset of menstruation (premenstrual symptoms).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Agnus Castus AL Film-coated tablets
Active ingredient: Chasteberry fruit

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this leaflet contains

1. WHAT IS AGNUS CASTUS AL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING AGNUS CASTUS AL?
3. HOW TO TAKE AGNUS CASTUS AL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE AGNUS CASTUS AL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS AGNUS CASTUS AL AND WHAT IS IT USED FOR?

Agnus Castus AL is a herbal medicine for menstrual problems. Agnus Castus AL is used for menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia) and for monthly recurring symptoms before the onset of menstruation (premenstrual symptoms). Note: In case of tension and swelling in the breasts as well as menstrual irregularities, a doctor should be consulted first, as these may be conditions that require medical examination.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING AGNUS CASTUS AL?

Agnus Castus AL must not be taken:

• if you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6,
• in case of pituitary tumours (tumours of the pituitary gland),
• in case of mammary carcinoma (breast cancer).

Taking Agnus Castus AL together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Since there are indications of a dopaminergic effect of chasteberry fruit, a mutual weakening of the effect could occur when taking dopamine receptor antagonists.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Due to insufficient research, Agnus Castus AL must not be taken during pregnancy and breast-feeding. In animal studies, an impairment of milk production was observed after taking chasteberry fruit.

Agnus Castus AL contains lactose and glucose

Therefore, please only take Agnus Castus AL after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE AGNUS CASTUS AL?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is: Take 1 Agnus Castus AL film-coated tablet once a day.

Method of administration

Agnus Castus AL should be taken at the same time each day if possible.

Duration of use

For a reliable effect, Agnus Castus AL should be taken for at least 3 menstrual cycles.

If you have taken more Agnus Castus AL than you should

No risks are to be expected from accidental overdose, so that no special measures are necessary.

If you forget to take Agnus Castus AL

If you forget to take a dose, do not take the missed dose, but continue with the next dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

After taking medicines containing chasteberry fruit, headaches, itching or abdominal complaints such as nausea, stomach or lower abdominal pain may occur, as well as hypersensitivity reactions with skin rash and hives. Severe reactions with facial swelling, shortness of breath and difficulty swallowing have also been described. The frequency of these possible side effects is not known.

Countermeasures

In particular, if there are signs of hypersensitivity reactions, please stop taking Agnus Castus AL and consult your doctor immediately. After the occurrence of hypersensitivity reactions, Agnus Castus AL must not be taken again.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AGNUS CASTUS AL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after âEURoUse byâEURo. The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions. After opening, Agnus Castus AL can be stored for 12 months if stored properly. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Agnus Castus AL contains

The active substance is: Chasteberry fruit dry extract. 1 film-coated tablet contains 4.0 mg dry extract from chasteberry fruit (7âEUR«13:1), extraction solvent: Ethanol 60% (m/m). The other ingredients are: Carboxymethyl starch sodium (type A) (Ph. Eur.), microcrystalline cellulose, glucose syrup, hypromellose, lactose monohydrate, macrogol 4000, magnesium stearate (Ph. Eur.), maize starch, highly dispersed silicon dioxide, titanium dioxide (E 171), iron(III) oxide (E 172). Note for diabetics: 1 film-coated tablet contains 0.015 bread units (BU).

What Agnus Castus AL looks like and contents of the pack

Salmon-coloured, round, curved film-coated tablet with a break notch on one side. The break notch is only to divide the tablet to make it easier to swallow, not to divide it into equal doses. Agnus Castus AL is available in packs of 30, 60 and 100 film-coated tablets.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2âEUR«18
61118 Bad Vilbel

This leaflet was last revised in April 2014.

Source: Package leaflet information
Status: 09/2017
Active ingredient: Chasteberry fruit. Areas of application: for menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia) and for monthly recurring symptoms before the onset of menstruation (premenstrual symptoms).