CARSIL CPS 110MG N30

ATC code: A05BA03 

Active substances: Silymarinum

Vendor, principal: Sopharma Ad. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

CARSIL 110MG N30

Package leaflet: Information for the user

Carsil 110 mg hard capsules

Silymarin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use 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.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What Carsil is and what it is used for
2.   What you need to know before you use Carsil
3.   How to use 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 medicine containing the active substance silymarin, an agent derived from milk thistle seeds. Silymarin activates the synthesis of proteins and phospholipids in damaged hepatic cells, stabilises cell membranes, binds free radicals (antioxydative activity), thereby protecting hepatic cells from harmful effects.
Silymarin is used for the supportive care of liver damage.

2. What you need to know before you use Carsil Do not use Carsil:

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
-   if you are allergic to milk thistle or other plants of the daisy family (Asteraceae);
-   if the patient is a child or adolescent under 18 years of age, as there is insufficient safety and efficiency data regarding the use of the medicine in this age group.

Warnings and precautions

Talk to your doctor or pharmacist before using Carsil.
If you have diabetes or low blood glucose, talk to your doctor before starting treatment with Carsil capsules, as silymarin can decrease blood glucose levels.
Carsil capsules are used in the supportive treatment of liver damage; thus, you must continue eating properly and avoid using alcohol during the treatment.

Other medicines and Carsil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No clinically significant interactions of silymarin with other medicines have been reported.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can use Carsil during pregnancy.
Using Carsil is not recommended if you are breast-feeding.

Driving and using machines

Carsil has no effect on the ability to drive or use machines.

3. How to use Carsil

Always use 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.
The capsules are swallowed whole with a sufficient amount of liquid. Do not chew the capsules.
The recommended dose is 1 capsule 2-3 times per day. The treatment should last for at least 3 months. If you take more Carsil than you should
If you have taken a larger than recommended dose, talk to your doctor.
No cases of overdose have been reported in connection with this medicine.

If you forget to use Carsil

If you have missed a dose, take it as soon as you can. If it is almost time for the dext dose, continue as usual. 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.
Carsil is well tolerated. In very rare cases, allergic skin reactions can occur, such as pruritus and rashes or anaphylactic shock (severe allergic reaction causing breathing difficulties and dizziness). In rare cases, there have been reports of the exacerbation of existing vestibular disorders. In rare cases, diarrhoea can occur. Other possible side effects with an unknown incidence can include headache, vertigo, nausea, vomiting, loss of appetite, dyspeptic disorders with flatulence or stomach pain.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carsil

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
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 protect the environment.

6. Contents of the pack and other information What Carsil contains

-   The active substance is silymarin extracted from the fruits of milk thistle. One hard capsule contains 200-244.4 mg refined and quantified dry extract (35-50:1) of milk thistle (Silybum marianum) fruits, corresponding to 110 mg of silymarin in the form of silibinin. Extraction solvent: methanol.
-   Other excipients are: mannitol (E421), povidone K 25, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate (Type A), magnesium stearate, anhydrous colloidal silica, sodium bicarbonate, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.

What Carsil looks like and contents of the pack

Hard cylindrical pinkish-brown (caramel-coloured) gelatin capsules with an opaque capsule body and a chocolate brown capsule cap.
Capsule core: powdered mass that can contain solid pieces, pale yellow to amber in colour, slightly specific smell.
6 hard capsules in clear transparent PVC/aluminium blister pack, 5 blister packs in a cardboard carton with the package leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD 16 Iliensko Shosse Sofia 1220 Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authoriation Holder:
VIP Pharma Eesti OÜ Uusaru 5 Saue 76505 Estonia

This leaflet was last revised in December 2014