Lagosa

PATIENT LEAFLET: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Lagosa

Silybi mariani extractum siccum
Coated tablets

Please read this leaflet carefully, as it contains important information for the patient.

This medicinal product is available without a prescription. However, to achieve the best treatment result, the medicinal product Lagosa should be used cautiously.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If symptoms worsen or do not improve, a doctor should be consulted.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS LAGOSA AND WHAT IS IT USED FOR

Lagosa is a medicinal product that protects the liver from the effects of toxic compounds, stimulates its regenerative ability, prevents the penetration of hepatotoxic factors into liver cells, stabilizes and normalizes liver cell functions.
Indications for use:
Conditions after liver damage caused by toxic compounds; as a supportive treatment in chronic inflammatory liver conditions.

2. IMPORTANT INFORMATION BEFORE USING LAGOSA

Do not use if you are hypersensitive to the active substances or excipients contained in the product.
Use in children:
Due to the lack of safety data, it is not recommended to use in children under 12 years of age.
The medicinal product contains lactose and sucrose; if the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicinal product.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicinal product is considered "sodium-free".

Use with other medicinal products

No interactions with other medicinal products have been found.

Pregnancy and breastfeeding

Due to the lack of safety data, it is not recommended to use during pregnancy and breastfeeding.

Driving and using machines

No data available.

3. HOW TO USE LAGOSA

Adults and children over 12 years: one coated tablet twice a day.
Tablets should be taken with a sufficient amount of liquid.

Overdose of Lagosa

No cases of poisoning have been reported.
No antidote is known in case of overdose. Symptomatic treatment should be initiated.

4. POSSIBLE SIDE EFFECTS

Like all medicinal products, Lagosa can cause side effects, although they may not occur in everyone.
If side effects occur, the use of the medicinal product should be stopped and a doctor consulted.
Occasional mild laxative effect may occur.

Reporting of side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. HOW TO STORE LAGOSA

The medicinal product should be stored out of sight and reach of children.
Do not use Lagosa after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Store in a temperature below 25°C.
Medicinal products should not be disposed of via wastewater or household waste containers. A pharmacist should be consulted on how to dispose of unused medicinal products. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lagosa contains

The active substance is 240.0 mg of dry extract of milk thistle ( Frukt. Cardui mariae)
corresponding to 150 mg of silymarin calculated as silybin.
Excipients:
lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, povidone K 30, talc, magnesium stearate, partial glycerides; coating:
shellac, sucrose, calcium carbonate, talc, arabic gum, maize starch, titanium dioxide, anhydrous colloidal silica, povidone K 30, macrogol 6000, glycerol 85%, polysorbate 80, montan glycol wax.
Does not contain gluten.
Contains lactose and sucrose (see section 2).
The medicinal product is considered "sodium-free".

What Lagosa looks like and contents of the pack

Round coated tablets.
Al/PVC blisters in a cardboard box.
Packs contain 25, 50, or 100 coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in the Czech Republic, the country of export:

Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer:

Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1, 84529 Tittmoning, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in the Czech Republic, the country of export: 94/409/97-C

Parallel import authorization number: 297/19

Date of leaflet approval: 04.07.2024

[Information about the trademark]