CARSIL 22.5 mg. x 80 tab.

Carsil 22.5 mg coated tablets Carsil 22.5 mg coated tablets silymarin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist.
This also includes any possible side effects not listed in this leaflet. See section 4.

What this leaflet contains: 1. What Carsil is and what it is used for 2. What you need to know before you use Carsil 3. How to take Carsil 4. Possible side effects 5. How to store Carsil 6. Contents of the pack and other information
1. What Carsil is and what it is used for
Carsil is a medicinal product that contains the active substance silymarin, isolated from the fruits of the milk thistle plant. Silymarin activates protein and phospholipid synthesis in damaged liver cells, stabilizes their cell membranes, binds free radicals (antioxidant effect). Its main action is to protect liver cells from the harmful effects of various factors such as alcohol, medications, viral infections, industrial pollutants. In case of damage to liver cells, it contributes to their faster recovery.
It is used for symptomatic treatment of chronic toxic liver damage; for maintenance treatment in patients with chronic inflammatory liver diseases and liver cirrhosis.
2. What you need to know before you use Carsil
Do not use Carsil

if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6);
 in children under 12 years of age, due to lack of sufficient clinical experience for use in them.

Warnings and precautions Talk to your doctor or pharmacist before taking Carsil. Consult a specialist if you have diseases accompanied by hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma), due to a possible estrogen-like effect of silymarin.
Treatment with Carsil cannot replace diet or abstinence from alcohol in liver damage.
Other medicines and Carsil Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Carsil may reduce the effectiveness of oral contraceptives and drugs used in hormone replacement therapy.
It may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and lactation, Carsil can be used only on medical indications and if the benefit to the mother outweighs the risk of the product to the fetus or infant.
Driving and using machines Carsil does not have an adverse effect on the ability to drive and use machines.
Carsil contains wheat starch. The wheat starch in this medicine contains only very small amounts of gluten and is unlikely to cause problems if you have coeliac disease (gluten intolerance). One tablet contains no more than 3.95 micrograms of gluten.
If you have a wheat allergy (a condition other than celiac disease), you should not take this medicine.
Carsil contains lactose monohydrate and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Carsil contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216). They may cause allergic reactions (possibly delayed).
3. How to take Carsil
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children over 12 years of age
The recommended dose for more severe conditions is 4 coated tablets 3 times daily.
In milder cases and as maintenance treatment, the dose is 2 coated tablets 3 times daily.
The duration of the course of treatment is determined by your doctor. Karsil is taken orally, with sufficient liquid.
Use in children under 12 years of age
There are insufficient clinical data on use in children.
The course of treatment lasts at least three months. If your complaints persist, seek advice from your doctor.
If you take more Carsil than you should If you have taken a dose larger than prescribed, consult your doctor.
If you forget to take Carsil Do not take a double dose to make up for the missed one.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The product is well tolerated. Adverse reactions are transient and resolve after discontinuation of the product.
Very rare (affects less than 1 in 10,000 patients): skin allergic reactions - itching, rash, urticaria.
Rare (affects 1 to 10 in 10,000 patients): worsening of existing vestibular disorders, diarrhea due to increased liver and bile function.
Not known (frequency cannot be estimated from the available data): anaphylactic shock, nausea, vomiting, dyspepsia, decreased appetite, flatulence.
Reporting of side effects If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Bulgarian Medicines Agency, Damyan Gruev Str. 8, 1303 Sofia, tel: +359 28903417, website: www.bda.bg. By reporting side effects, you can contribute to obtaining more information on the safety of this medicine.
5. How to store Carsil
Keep out of the reach of children. Store below 25 °C. Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What does Carsil contain? - The active substance is: 40.9-56.3 mg dry extract of milk thistle fruit (35-50:1), eq. to 22.5 mg silymarin, as silibinin (HPLC). - The other ingredients are: lactose monohydrate; wheat starch; povidone; microcrystalline cellulose; magnesium stearate; talc; mannitol; crospovidone; polysorbate 80; sodium hydrogen carbonate, - Coating: cellulose acetate phthalate; diethyl phthalate; sucrose; gum arabic; gelatin; talc; titanium dioxide; macrogol 6000; glycerol; Opalux brown (sucrose, iron oxide (E172), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)).
What Carsil looks like and what the package contains Coated tablets with a regular round shape, brown color, odorless. 10 coated tablets in a PVC/aluminum foil blister; 8 blisters (80 coated tablets) in a cardboard box, together with a leaflet.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria