Agnufem

Agnufem 20 mg film-coated tablets

For the treatment of menstrual cycle disorders and pre-menstrual syndrome symptoms

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Package leaflet: information for the user

Agnufem 20 mg film-coated tablets

Dry extract of chaste tree fruit

Read all the information in this leaflet carefully before you start taking this medicinal product 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.

If you have any further questions, ask a pharmacist.

If you experience any side effects (even if it is not listed in this leaflet), consult your doctor or a pharmacist.

If your condition did not improve within 20–30 days or even worsened, contact your doctor.

What is in this leaflet?

1. What Agnufem is and what it is used for?

2. What do you need to know before you use Agnufem?

3. How to use Agnufem?

4. Possible side effects

5. How to store Agnufem?

6. Contents of the package and other information.

1. What Agnufem is and what it is used for?

Agnufem’s active substance is chaste tree (Vitex agnus-castus L.) fruit dry extract.

Agnufem is used to relieve pre-menstrual syndrome ailments. These ailments include irritability, tension, mood swings, breast tenderness and painful spasms.

2. What do you need to know before you use Agnufem?

Do not use Agnufem:

If you are allergic (hypersensitive) to the active substance or any excipient of Agnufem;

If your medical history shows that there have been or still are symptoms of pituitary gland disorder;

if you are pregnant or breastfeeding;

if you are younger than 18 years of age.

Take special care with Agnufem:

If you had or have oestrogen-dependent tumours, consult your doctor before taking Agnufem.

Patients should consult their doctor before taking Agnufem if they take dopamine receptor agonists and antagonists, oestrogens and anti-oestrogens (see chapter 4.5).

It is not recommended for use in children and adolescents under 18 years of age because there is insufficient data in this group of patients.

If the symptoms worsen while taking Agnufem, consult your doctor or a pharmacist.

It is believed that chaste tree fruit extract affects the function of the hypothalamus-pituitary gland; therefore, patients with pituitary gland disorders should consult their doctor before taking this medication.

In the case of prolactin-releasing pituitary tumours, the use of chaste tree fruit extract can hide tumour-induced symptoms.

Other medicines

When Agnufem is used in combination with dopamine receptor agonists and antagonists, oestrogen and antioestrogens, the effect of both medicinal products may be reduced.

Pregnancy and breastfeeding

Before taking any medicine, you must consult your doctor or a pharmacist.

It is purposeless to take Agnufem during pregnancy.

You must not take Agnufem if you are breastfeeding because this can reduce the amount of milk.

Fertility

Chaste tree fruit extract reduces the amount of luteinising hormone through the dopaminergic system. This can have a negative effect on fertility.

Driving and using machines

Agnufem does not influence the ability to drive and use machines.

Important information on some excipients of Agnufem.

3. How to use Agnufem?

Always use this medicine exactly as directed by your doctor. If in doubt, consult your doctor or a pharmacist.

For adult women

It is recommended to take 1 tablet a day, with liquid.

It is recommended to take the tablets for at least 3 months, without interruptions, during menstruation as well.

If you feel that the effect of Agnufem is too strong or too weak, consult your doctor or a pharmacist.

If you take more Agnufem than you should

In the event of an accidental overdose, consult your doctor or the nearest hospital emergency department.

If you forget to take Agnufem

Do not take a double dose to make up for a forgotten dose.

If you stop using Agnufem

Not determined

If you have any further questions on the use of this medicinal product, consult your doctor or a pharmacist.

4. Possible side effects.

Agnufem, like all medicinal products, can cause side effects, although not everybody experiences them.

Serious allergic reactions may occur: facial swelling, trouble swallowing or breathing. Skin allergies (itching and hives), headache, dizziness, digestive disorders (nausea, abdominal pain), acne and menstrual disorder have been reported. The frequency is unknown.

Reporting of side effects

If you experience any side effects, including those not indicated in this leaflet, tell your doctor or a pharmacist. You can also report a side effect directly, via the form on www.vvkt.lt website, by mail to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, Žirmūnų str. 139A, LT 09120 Vilnius, phone: 8 800 73568, fax: 8 800 20131 or via email: NepageidaujamaR@vvkt.lt. By reporting a side effect, you can help us get more information about the safety of this medicinal product.

5. How to store Agnufem?

Keep out of reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use this medicinal product after the expiry date stated on the carton and blister pack. This medicinal product is suitable for use until the last day of the indicated month.

Medicinal products should not be disposed to drainage or with household waste. Ask a pharmacist how to dispose of unnecessary medicinal products. These measures will help protect the environment.

6. Contents of the package and other information.

Agnufem composition

- The active substance is dry extract of chaste tree fruit.

Each film-coated tablet contains 20 mg of Vitex agnus-castus L., fructus (chaste tree fruit) dry extract (6-8:1).

Extraction solvent: 75 % (V/V) ethanol.

- Excipients. The core of the tablet contains calcium hydrogen phosphate dihydrate, microcrystalline cellulose, copovidone, croscarmellose sodium, stearic acid, magnesium stearate, anhydrous colloidal silicon dioxide. The coating of the tablet contains hypromellose 606, hypromellose 615, talc, macrogol 6000, titanium dioxide (E171).

Agnufem appearance and amount in the pack

Agnufem film-coated tablets are white or almost white, round, convex, with a diameter of 11 mm.

Agnufem is packed in blister packs of 20 tablets. Blister packs are packed in cartons of 20, 40, 60, 80 or 100 tablets.

Not all package sizes might be available.

Manufacturer: UAB Aconitum, Inovaciju str. 4, Biruliskes village, Kaunas district, Lithuania

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