Lagosa
Poland
Table of Contents
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Lagosa
Film-coated tablets
Silybi mariani extractum siccum
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, as you may need to read it again.
- Consult your pharmacist if you need advice or further information.
- If symptoms worsen or do not improve, consult a doctor.
- If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist. See section 4.
Contents of the 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 package and other information
1. WHAT LAGOSA IS AND WHAT IT IS USED FOR
Lagosa is a hepatoprotective medicine that protects the liver against toxic substances, enhances its regenerative capacity, hinders penetration of hepatotoxic agents into liver cells, and stabilizes and normalizes liver cell functions.
Indications:
For conditions following liver damage caused by toxic substances; as supportive treatment in chronic inflammatory liver diseases.
2. IMPORTANT INFORMATION BEFORE USING LAGOSA
Do not use in case of hypersensitivity to the active substances or excipients contained in the product.
Use in children:
Due to lack of safety data, use is not recommended in children under 12 years of age.
The medicine contains monohydrate lactose and sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Use of other medicines
No interactions with other medicines 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.
A 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 this medicine can be collected.
5. HOW TO STORE LAGOSA MEDICINAL PRODUCT
Keep this medicinal product out of sight and reach of children.
Do not use Lagosa after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Store below 25°C.
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 PACKAGE AND OTHER INFORMATION
What Lagosa contains
The active substance is 240.0 mg of dry extract from milk thistle (Frukt. Cardui mariae),
corresponding to 150 mg of silymarin, calculated as silibin.
Excipients:
Tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
sodium croscarmellose, povidone K 30, talc, magnesium stearate, long-chain partial glycerides.
Tablet 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 monostearate wax.
Does not contain gluten.
Contains monohydrate lactose and sucrose.
This 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 authorization holder or the parallel importer.
Marketing Authorization Holder in the Czech Republic, country of export:
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer:
Dragenopharm Apotheker Püschl GmbH
Göllstr. 1
84529 Tittmoning
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorization Number in the Czech Republic, country of export: 94/409/97-C
Parallel Import Authorization Number: 281/17