hard capsules
dry raspberry leaf extract

What Ladiva is and what it is used for

Ladiva contains raspberry leaf extract.

Traditional herbal medicine for symptomatic relief of mild cramps associated with menstruation in adult women. The indications for traditional herbal medicine are based solely on the experience of long-term use.

What you need to know before taking Ladiva

Do not 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 cautions

Talk to your doctor or pharmacist before taking Ladiva.

Patients with renal and/or hepatic impairment:

Due to a lack of data in these patient groups, a dose recommendation cannot be established.

Children and young people

Use in children and adolescents under 18 years of age has not been established due to insufficient data.

Other medicines and Ladiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Drugs can sometimes affect each other if used at the same time. No such interactions have been reported for Ladiva.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Safety during pregnancy has not been established. In the absence of adequate data, use during pregnancy is not recommended.

Breast-feeding

Safety during breastfeeding has not been established. In the absence of adequate data, use during breastfeeding is not recommended.

Fertility

No studies have been performed on the effect on fertility.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Ladiva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

Adult women

The recommended dose is one capsule up to 3 to 4 times daily with water.

Patients with renal and/or hepatic impairment:

Due to the lack of data from these patient groups, no dose recommendation can be made.

Method of administration

Swallow the capsules with water.

Usage time

Contact a doctor if the symptoms persist for more than 7 days when using the medicine.

Use for children and adolescents

Use in children and adolescents under 18 years of age has not been established due to insufficient data.

If you take more Ladiva than you should

No cases of overdose have been reported.

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Ladiva

Do not take a double dose to make up for a forgotten dose. Take the usual dose at the usual time.

Possible side effects

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

There are no known side effects. If you get any side effects, talk to your doctor or nurse.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

How to store Ladiva

Keep this medicine out of the sight and reach of children.

The medicine has no special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active ingredient is raspberry leaf extract.

Each hard capsule contains 226 mg of dry extract of Rubus idaeus L., folium (raspberry leaves), equivalent to 678-1130 mg of dried raspberry leaves.

Extractant: water.

Other excipients are:

Capsule content: cellulose (microcrystalline), talc, magnesium stearate, maize starch, silica ( colloidal, anhydrous)

– capsule housing, base: hypromellose, titanium dioxide (E171), red iron oxide (E172)

capsule cover, cap: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).

What the medicine looks like and contents of the pack

Ladiva is a hard capsule with a light pink base and a beige lid and is filled with a light brown powder.

Ladiva is supplied in cartons of 1 or 2 PVC / PVDC aluminum blisters. Pack size: 8 or 16 capsules.

Not all pack sizes may be marketed.

Holder of registration for sale and manufacturer

Holder of registration for sale

Medis GmbH

Europaring F15

2345 Fountain in the mountains

Austria

Manufacturer

Medis, doo

Brnčičeva Ulica 1

1231 Ljubljana-Črnuče

Slovenia

with a place of manufacture:

Brnčičeva Ulica 3,

1231 Ljubljana- Črnuče,

Slovenia

This medicinal product is authorized under the European Economic Area under the names:

Ladiva: Austria, Bulgaria, Croatia, Czech Republic, Denmark, Finland, Hungary, Norway, Poland, Spain, Slovakia, Sweden, Slovenia.

Muhammad Nadeem

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