Lagosa
Poland
Table of Contents
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Lagosa
Silybi mariani extractum siccum
Film-coated tablets
Please read the entire leaflet carefully as it contains important information for the patient.
This medicine is available without a prescription. However, to achieve the best treatment outcome, Lagosa should be used with caution.
- Keep this leaflet so that you can read it again if necessary.
- Consult your pharmacist if you need advice or further information.
- If symptoms worsen or do not improve, consult your doctor.
- If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor, pharmacist, or nurse. See section 4.
Contents of the package leaflet:
- What Lagosa is and what it is used for
- Important information before taking Lagosa
- How to take Lagosa
- Possible side effects
- How to store Lagosa
- Contents of the pack and other information
1. WHAT LAGOSA IS AND WHAT IT IS USED FOR
Lagosa is a medicine that protects the liver from the effects of toxic substances, stimulates its regenerative capacity, hinders the penetration of hepatotoxic agents into liver cells, and stabilizes and normalizes the functions of hepatocytes.
Indications:
Conditions following liver damage caused by toxic substances; as supportive treatment in chronic inflammatory liver diseases.
2. IMPORTANT INFORMATION BEFORE USING LAGOSA MEDICINAL PRODUCT
Do not use in case of hypersensitivity to the active or excipient substances contained in the product.
Use in children:
Due to lack of safety data, use in children under 12 years of age is not recommended.
The product contains lactose and sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicinal product.
The product contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the product is considered "sodium-free".
Use with other medicinal products
No interactions with other medicinal products have been reported.
Pregnancy and breastfeeding
Due to lack of safety data, use during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
No data available.
3. HOW TO USE LAGOSA
Adults and children over 12 years: one effervescent tablet twice daily.
The tablets should be taken with an adequate amount of liquid.
Use of a higher than recommended dose of Lagosa
No cases of poisoning have been reported.
There is no known antidote in case of overdose. Symptomatic treatment should be initiated.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Lagosa may cause adverse reactions, although not everyone experiences them.
If adverse reactions occur, discontinue use of the medicine and consult a doctor.
Mild laxative effect may occasionally occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. HOW TO STORE LAGOSA
Keep this medicine 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 specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.
6. CONTENTS OF THE PACKAGE 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 silibinin.
Excipients:
monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose,
povidone K 30, talc, magnesium stearate, partial long-chain glycerides; coating:
shellac, sucrose, calcium carbonate, talc, gum arabic, corn starch, titanium dioxide,
anhydrous colloidal silicon dioxide, povidone K 30, macrogol 6000, glycerol 85%, polysorbate 80,
glycol wax Montana.
Does not contain gluten.
Contains lactose and sucrose (see section 2).
The medicine is considered "sodium-free".
What Lagosa looks like and contents of the pack
Round coated tablets.
Al/PVC blisters in a cardboard box.
Pack sizes: 25, 50 or 100 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, 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
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation Number in the Czech Republic, country of export: 94/409/97-C
Parallel Import Licence Number: 297/19