AGNUS CASTUS STADA

AGNUS CASTUS STADA film-coated tablets

Important notes (mandatory information)

Agnus castus Stada 4 mg film-coated tablets. Active ingredient: Chasteberry dry extract. Areas of application: for the treatment of menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia), monthly recurring symptoms before the onset of menstruation (premenstrual symptoms).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Agnus castus Stada 4 mg film-coated tablets
Active ingredient: Chasteberry dry extract

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 as directed by your doctor or pharmacist.

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

What this leaflet contains

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

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

Agnus castus Stada is a herbal medicine for menstrual problems. Agnus castus Stada is used to treat menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia), 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 STADA?

Agnus castus Stada must not be taken:

• if you are allergic to chasteberry dry extract or any of the other ingredients of this medicine listed in section 6.
• in patients with pituitary tumors (tumors of the pituitary gland).
• in patients with breast cancer.
• during pregnancy and breastfeeding.

Taking Agnus castus Stada with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Since there are no sufficient studies, Agnus castus Stada must not be used during pregnancy and breastfeeding.

Driving and using machines

Effects on the ability to drive and use machines have not been observed to date.

Agnus castus Stada contains glucose and lactose

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

3. HOW TO TAKE AGNUS CASTUS STADA?

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 film-coated tablet once a day.

Method of administration

Agnus castus Stada should be taken at the same time each day if possible. The break notch is only for dividing the tablet to make it easier to swallow, not for dividing it into equal doses.

Duration of use

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

If you have taken more Agnus castus Stada than you should

Overdoses with Agnus castus have not been reported to date.

If you forget to take Agnus castus Stada

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

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Not known (frequency cannot be estimated from the available data):

• Headache.
• Abdominal complaints such as nausea, stomach or lower abdominal pain.
• Itching.
• Hypersensitivity reactions with skin rash and hives. Severe reactions with facial swelling, shortness of breath and difficulty swallowing have also been described.

Significant side effects or signs to watch out for, and measures to take if you are affected

Especially in case of signs of hypersensitivity reactions, please stop taking Agnus castus and consult your doctor immediately. After hypersensitivity reactions occur, Agnus castus must not be used again.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any 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 STADA?

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. Shelf life after opening the container: The shelf life after opening the container is 12 months. 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 this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Agnus castus Stada contains

The active ingredient is: Chasteberry dry extract. 1 film-coated tablet contains 4 mg dry extract from chasteberry (7 - 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 (E171), iron(III) oxide (E172).

Note for diabetics

1 film-coated tablet contains 0.16 g carbohydrates (glucose syrup, lactose monohydrate).

What Agnus castus Stada looks like and contents of the pack

Salmon-colored, round, biconvex film-coated tablet with a break notch on one side. Agnus castus Stada is available in packs of 60 and 100 film-coated tablets.

Marketing Authorisation Holder

Stadapharm GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Phone: 06101 603-0
Fax: 06101 603-3888
Internet: www.stadapharm.de

Distributor

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Phone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in September 2019.

Source: Package leaflet information
Status: 08/2020
Active ingredient: Chasteberry dry extract. Areas of application: for the treatment of menstrual irregularities (menstrual cycle irregularities), tension and swelling in the breasts (mastalgia), monthly recurring symptoms before the onset of menstruation (premenstrual symptoms).