Ladiva

Package Leaflet: Information for the User

Ladiva, Hard Capsules

Raspberry Leaf Extract
Rubi folii extractum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or qualified healthcare professional. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

If symptoms persist during the use of the medicinal product or if side effects not listed in the package leaflet occur, consult a doctor, pharmacist, or qualified healthcare professional.

Table of Contents of the Package Leaflet

• 1. What is Ladiva and what is it used for
• 2. Important information before taking Ladiva
• 3. How to take Ladiva
• 4. Possible side effects
• 5. How to store Ladiva
• 6. Contents of the pack and other information

1. What is Ladiva and what is it used for

Ladiva contains raspberry leaf extract.
This is a traditional herbal medicinal product used for the symptomatic relief of minor menstrual cramps in adult women.
A traditional herbal medicinal product for use in specified indications, based solely on long-standing use.
If after 7 days there is no improvement or you feel worse, you should contact a doctor.

2. Important information before taking Ladiva

When not to take Ladiva:

• if you are allergic to raspberry leaf extract or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Ladiva, discuss it with your doctor, qualified healthcare professional, or pharmacist.
If symptoms worsen during the use of the medicine, contact a doctor, qualified healthcare professional, or pharmacist.

Children and adolescents

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

Ladiva and other medicines

Tell your doctor, qualified healthcare professional, or pharmacist about all medicines you are taking or have recently taken, as well as any you plan to take.
Medicines can interact with each other if taken at the same time. No such interactions have been reported for Ladiva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor, qualified healthcare professional, or pharmacist for advice before taking this medicine.
Due to lack of sufficient data, the use of Ladiva is not recommended during pregnancy and breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

3. How to take Ladiva

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor, qualified healthcare professional, or pharmacist. If you are unsure, consult a doctor, qualified healthcare professional, or pharmacist.
Dosage
Adult women:
The recommended dose is one capsule 3 to 4 times a day, with water.
Do not take more capsules than recommended.
Patients with renal and/or hepatic impairment:
Due to lack of sufficient data, no dosage recommendation can be made.
Method of administration
Oral use.
Duration of use
If symptoms persist for more than 7 days during the use of the medicinal product, contact a doctor, qualified healthcare professional, or pharmacist.

Use in children and adolescents

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

Overdose of Ladiva

In case of overdose, contact 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 usual time.
If you have any further questions on the use of this medicine, ask your doctor, qualified healthcare professional, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects are known.
If you experience side effects, contact a doctor or qualified healthcare professional.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ladiva

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ladiva contains

The active substance is raspberry leaf extract.
Each hard capsule contains 226 mg extract (as dry extract) from Rubus idaeusL., folium(raspberry leaf) (3-5:1). Extraction solvent: water.
The other excipients are:

• capsule filling: microcrystalline cellulose, talc, magnesium stearate, maize starch, colloidal anhydrous silica
• capsule body: 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 light pink body, filled with light brown powder.
Ladiva is available in a carton containing 1 or 2 PVC/PVDC/Aluminium blisters.
Pack sizes: 8 or 16 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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

Date of last revision of the package leaflet: