Patient Information Leaflet

Ladiva, hard capsules
Raspberry leaf extract
Rubi folii extractum siccum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or other healthcare professional.

Keep this leaflet so that you can read it again if needed.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or other healthcare professional. See section 4.
If there is no improvement within 7 days, or if you feel worse, you should contact your doctor.

If symptoms persist during treatment with this medicinal product, or if any adverse reactions not mentioned in this leaflet occur, consult your doctor,
pharmacist, or other qualified healthcare professional.
Table of contents

What Ladiva is and what it is used for
What you need to know before taking Ladiva
How to take Ladiva
Possible side effects
How to store Ladiva
Contents of the pack and other information

1. What Ladiva is and what it is used for

Ladiva contains raspberry leaf extract.
It is a traditional herbal medicinal product used for the symptomatic relief of mild menstrual
cramps in adult women.
This traditional herbal medicinal product is intended for use in specific indications based exclusively on long-standing use.
If there is no improvement within 7 days, or if you feel worse, you should contact your doctor.

2. Information before taking Ladiva

When not to take Ladiva:

if the patient is allergic to the extract of leaves of Rubus idaeus or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Ladiva, discuss this with a doctor, qualified healthcare professional, or pharmacist.
If symptoms worsen during treatment with this medicine, contact a doctor, qualified healthcare professional, or pharmacist.

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to insufficient data.

Ladiva and other medicines
Tell your doctor, qualified healthcare professional, or pharmacist about all medicines the patient is currently taking and/or using, has recently taken and/or used, or plans to take and/or use.
Medicines may interact with each other when used simultaneously. No such interactions have been reported with Ladiva.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor, qualified healthcare professional, or pharmacist before using this medicine.
Due to insufficient data, use of Ladiva is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
No studies have been conducted regarding the influence on the ability to drive vehicles and operate machinery.

3. How to take Ladiva

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a doctor, qualified healthcare professional, or pharmacist. If in doubt, consult a doctor, qualified healthcare professional, or pharmacist.

Dosage
Adult women:
The recommended dose is one capsule 3 to 4 times daily, taken with water.
Do not take more capsules than recommended.

Patients with renal and/or hepatic impairment:
Due to lack of sufficient data in these patient groups, a recommended dosage cannot be established.

Method of administration
Oral administration.

Duration of treatment
If symptoms persist for longer than 7 days during treatment with this medicinal product, consult a doctor, qualified healthcare professional, or pharmacist.

Use in children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to insufficient data.

Overdose of Ladiva
In case of ingestion of more than the recommended dose of Ladiva, consult a doctor, qualified healthcare professional, or pharmacist.
No cases of overdose have been reported.

Missed dose of Ladiva
Do not take a double dose to make up for a missed dose. Continue taking the usual dose at the regular time.

If you have any further questions about the use of this medicine, consult your doctor, qualified healthcare professional, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
No adverse reactions are known.
If any adverse reactions occur, consult a doctor or qualified healthcare professional.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Ladiva

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Ladiva contains
The active substance is an extract from the leaf of red raspberry.
Each hard capsule contains 226 mg of extract (as dry extract) from Rubus idaeus L., folium (leaf of red raspberry) (3-5:1). Extraction solvent: water.
The other ingredients are:

capsule filling: microcrystalline cellulose, talc, magnesium stearate, corn starch, colloidal anhydrous silica
capsule shell: hypromellose, titanium dioxide (E171), iron oxide red (E172)
capsule cap: hypromellose, titanium dioxide (E171), iron oxide yellow (E172)

What Ladiva looks like and contents of the pack
Ladiva is a hard capsule with a beige cap and a light pink body, filled with light brown powder.
Ladiva is available in a box containing 1 or 2 PVC/PVDC/Aluminium blisters.
Pack sizes: 8 or 16 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medis GmbH
Europaring F15
2345 Brunn am Gebirge
Austria
Manufacturer
Medis, d.o.o.
Brnčičeva ulica 3
1231 Ljubljana-Črnuče
Slovenia
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Germany: Ladiva Kapseln
Bulgaria, Croatia, Czech Republic, Denmark, Finland, Hungary, Norway, Poland, Spain, Slovakia, Sweden, Slovenia, United Kingdom (Northern Ireland): Ladiva
France: Ladivia