Femicur N 60 Capsules

Femicur N 60 Capsules 4 mg

Femicur® N Capsules 4 mg - dry extract of chaste tree fruits, hard capsules

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Femicur® N Capsules carefully to get the best results from them. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 90 days. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Femicur® N Capsules is and what it is used for

2. Before you take Femicur® N Capsules

3. How to take Femicur® N Capsules

4. Possible side effects

5. How to store Femicur® N Capsules

6. Further information

1. What Femicur® N Capsules is and what it is used for

Femicur® N Capsules is a herbal medicine for the treatment of menstrual complaints. Femicur® N Capsules is used for irregularities of the menstrual cycle (abnormal menses), monthly recurring complaints preceding the onset of the menstruation (premenstrual complaints), feeling of tension and swelling in the breasts (mastodynia).

2. Before you take Femicur® N Capsules

2.1 Do not take Femicur® N Capsules

• if you are hypersensitive (allergic) to chaste tree fruits or one of the other ingredients (see under 6. "Further information") of Femicur® N Capsules,

• if you have a tumour of the pituitary gland (hypophysial tumour),

• if you have breast cancer (mamma carcinoma),

• if you are pregnant or nursing.

2.2 Take special care with Femicur® N Capsules

• in case of menstrual disorders,

• in case of feelings of tension and swelling in the breasts.

In these cases you should consult a doctor, because they may be evidence of illnesses that require medical attention.

2.3 Taking other medicines:

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine – even ones obtained without a prescription. There is evidence that there could be a mutual weakening of the efficacy when using medicines inhibiting a certain information system in the brain, the so-called dopamine receptor antagonists.

2.4 Pregnancy and breastfeeding:

Femicur® N Capsules should not be taken during pregnancy and breastfeeding. Animal experiments showed an impaired milk production after intake of chaste tree fruits.

2.5 Driving and operating machines:

No special precautions necessary.

2.6 Important information about some of the other ingredients of Femicur® N Capsules:

This medicine contains lactose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Femicur® N Capsules

Always take Femicur® N Capsules exactly as directed in this package leaflet. Please check with your doctor or pharmacist if you are not sure.

3.1 Unless otherwise prescribed by the doctor, the usual dose is:

Once daily - 1 hard capsule.

3.2 Mode of application:

Please take Femicur® N Capsules with sufficient liquid (preferably a glass of drinking water) without chewing. You can take the hard capsules irrespective of the meals.

3.3 Duration of use:

Take Femicur® N Capsules as curative application for several weeks (at least three menstrual cycles) until the complaints are alleviated or disappear. Please ask your doctor or pharmacist if you have the impression that the effect of Femicur® N Capsules is too strong or too weak.

3.4 If you take more Femicur® N Capsules than you should:

If you take more Femicur® N Capsules than you should, please contact a doctor. Overdose effects have not been observed thus far.

3.5 If you forget to take Femicur® N Capsules:

Do not take a double dose if you forget the previous intake, but continue the intake at the usual time.

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

4. Possible side effects

Like all medicines, Femicur® N Capsules can cause side effects, although not everybody gets them. Assessment of side effects is based on the following frequency rates:

Very common: more than 1 treated patient of 10

Common: 1 to 10 treated patients of 100

Uncommon: 1 to 10 treated patients of 1,000

Rare: 1 to 10 treated patients of 10,000

Very rare: less than 1 treated patient of 10,000

Unknown: frequency not assessable on the basis of the available data

Possible side effects:

After intake of medicines containing chaste tree fruits, you can experience side effects like: headaches, itching or abdominal disorders such as nausea, stomach pain or lower abdominal pain as well as hypersensitivity reactions accompanied by a skin rash and urtication. Severe reactions with face swelling, shortness of breath and swallowing difficulties have also been reported. There are no data on the frequency of these possible side effects.

What measures have to be taken in case of side effects?

Especially if symptoms of hypersensitivity reactions occur, you should discontinue the use of Femicur® N Capsules and immediately consult your doctor. After hypersensitivity reactions have occurred Femicur® N Capsules may not be taken again. Please inform your doctor or pharmacist if any of the listed side effects considerably impairs you, or if you notice any side effects not listed in this leaflet.

5. How to store Femicur® N Capsules

Keep out of the reach and sight of children. You should not use the medicine after the expiry date printed on the outer pack and on the blister after "use before". The expiry date refers to the last day of that month.

Storage conditions: No special storage conditions are necessary for this medicine.

6. Further information

This is the English translation of the German version of the patient leaflet.

What Femicur® N Capsules contains:

Active substance:

1 hard capsule contains 4 mg dry extract of chaste tree fruits (7 - 13 : 1)

Extractant: ethanol 60 % (m/m)

The other ingredients are: glucose syrup (dry substance), lactose monohydrate, talc, maize starch, magnesium stearate, colloidal anhydrous silica, gelatin, sodium laurilsulfate, purified water, colouring agents E 171 and E 172.

Note for diabetics: 1 hard capsule is equivalent to 0.007 bread units (BU).

What Femicur® N Capsules looks like and contents of the pack:

Light rose-coloured hard capsules. Femicur® N Capsules is available in packs containing 30, 60 and 100 hard capsules.

Marketing authorisation holder and manufacturer Schaper & Brümmer GmbH & Co. KG Bahnhofstraße