Carsil 22,5 mg (80 tablets)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No interaction studies have been performed with other medicinal products. To date, no interactions have been reported with other medicinal products.

If you have accidentally taken a double or triple dose of the medicine at one time (for example 4-12 chewable tablets), this should not lead to any side effects. In this case, continue taking as directed. In case of significant drug overdose, adverse reactions may be exacerbated (see section 4. Adverse drug reactions). In this case, please consult your doctor or pharmacist.

Driving and using machines:

No special instructions required.

Possible side effects:

Like all medicines, Carsil can cause side effects, although not everybody gets them.
The product has good tolerability. Rarely, in isolated cases and with individual hypersensitivity, side effects such as: digestive disorders, diarrhea are possible; in isolated cases – skin rash and itching; very rarely it is possible to aggravate existing vestibular disorders (nausea, dizziness).

CARSIL tablets 22.5 mg * 80 SOPHARMA

Package leaflet: patient information

Carsil® 22.5 mg film-coated tablets
Carsil® 22.5 mg film-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 have 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 includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Carsil is and what it is used for

2. What you need to know before you use Carcil
3. How to take Carcil
4. Possible side effects
5. How to store Carcil
6. Contents of the pack and other information

1. What Carsil is and what it is used for

Carcil 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 action). Its main action is to protect liver cells from the harmful effects of various factors such as alcohol, medications, viral infections, industrial pollutants. With liver cell damage, it helps to restore them faster.
It is used for symptomatic treatment of chronic toxic liver damage; for maintenance treatment in patients with chronic inflammatory diseases of the liver and liver cirrhosis.

2. What you need to know before you use Carcil

Do not use Carcil:

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6);
• children under 12 years of age due to a lack of sufficient clinical experience to administer 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 cancer, prostate cancer) due to a possible estrogen-like effect of silymarin.

Treatment with Carcil 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 use any other medicines.
Carcil may reduce the effectiveness of oral contraceptive drugs and drugs that are used in hormone replacement treatment.
May enhance the effects of medicines such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine-

Pregnancy, breast-feeding and fertility

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 taking this medicine. During pregnancy and lactation, Carcil may be used only medically and if the benefit to the mother outweighs the risk of administration of the product to the foetus or infant.

Driving and using machines

Carcil does not adversely affect 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 celiac disease (gluten intolerance). One tablet contains no more than 3.95 micrograms of gluten.
If you have an allergy to wheat (a condition other than celiac disease), you should not take this medicine.

Carcil contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Carcil contains mannitol

Mannitol may have a weak laxative effect.

3. How to take Carcil

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children over 12 years of age

The recommended dose for more severe conditions is 4 film-coated tablets 3 times a day. In milder cases and as maintenance treatment, the dose is 2 film-coated tablets 3 times a day.
The duration of the course of treatment is determined by your doctor. Carsil is taken orally, with a sufficient amount of liquid.

Use in children under 12 years of age

There are insufficient clinical data for use in children.

The course of treatment lasts not less than three months. If your complaints persist, seek the advice of your doctor.

If you take more Carcil than you should

If you have taken a dose greater than prescribed, ask your doctor for advice.

If you forget to take Carcil

Do not take a double dose to make up for a forgotten dose.

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. Side effects 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 patients in 10,000): intensification of existing vestibular disorders; diarrhoea due to enhanced function of the liver and bile.

Not known (frequency cannot be estimated from the available data): anaphylactic shock, nausea, vomiting, dyspepsia, decreased appetite, gas.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carcil

Keep out of the reach of children.
Store below 25°C.

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 throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Carcil contains

• Each film-coated tablet contains 40.90 – 50.00 mg purified and standardized milk thistle dry extract, refined and standardised, equivalent to 22.5 mg silymarin, expressed as silibinin.
• The other ingredients are: lactose monohydrate; wheat starch; povidone; microcrystalline cellulose; magnesium stearate; Talc; Mannitol; crospovidone; polysorbate 80; sodium hydrogen carbonate.

Wrapper – film coating:

• Opadrai AMB II 88A265025 brown: polyvinyl alcohol, talc, red iron oxide, (E 172) yellow iron oxide (E 172), black iron oxide (E 172), glycerol monocaprylocaprat, titanium dioxide (E 172), purified water, sodium lauryl sulfate.

What Carcil looks like and contents of the pack

Brown round film-coated tablets. 10 (ten) film-coated tablets in clear blisters PVC/PE/PVdC/AL foil; 8 blisters per cardboard box, together with a package leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria