MARIENDISTEL LEBERSCHUTZ

MILK THISTLE LIVER PROTECTION Capsules

Important notes (mandatory information)

Mariendistel capsule. Active ingredient: Milk thistle fruit dry extract.

Indications

traditionally used to support digestive function by stimulating the function of the liver-bile system.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mariendistel capsule
Active ingredient: Milk thistle fruit dry extract

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Mariendistel capsules must be taken as directed to ensure the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS MARIENDISTEL CAPSULE AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING MARIENDISTEL CAPSULE?
3. HOW TO TAKE MARIENDISTEL CAPSULE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MARIENDISTEL CAPSULE?
6. FURTHER INFORMATION

1. WHAT IS MARIENDISTEL CAPSULE AND WHAT IS IT USED FOR?

Mariendistel capsule is a traditional herbal medicine.

Indications

Traditionally used to support digestive function by stimulating the function of the liver-bile system. The medicine is a traditional medicine that is registered exclusively on the basis of many years of use for the field of application. If symptoms of illness persist or if side effects occur other than those mentioned in the package leaflet, a doctor or other qualified person in a medical profession should be consulted.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MARIENDISTEL CAPSULE?

Mariendistel capsule must not be taken:

• if you are known to be hypersensitive to milk thistle and other composites,
• if you are known to be hypersensitive to soya, peanuts or any of the other ingredients,
• in case of liver disease,
• in case of gallstone disease,
• in case of obstruction of the bile ducts,
• in case of inflammation of the bile ducts or gallbladder.

Special care must be taken when taking Mariendistel capsule

This medicine is not suitable for people with fructose intolerance (hereditary fructose intolerance). If you have persistent, unclear or new symptoms, you should see a doctor, as these may be symptoms of a medical condition that requires medical clarification.

The following should be noted when taking Mariendistel capsule with other medicines

Studies with Mariendistel capsule on possible interactions with other medicines are not available. If Mariendistel capsule and amiodarone (a medicine for heart rhythm disorders) are taken at the same time, it cannot be ruled out that the antiarrhythmic effect of amiodarone will be increased. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Taking Mariendistel capsule with food and drink

No interactions with food and drink are known.

Pregnancy and breast-feeding

Mariendistel capsule should not be used during pregnancy and breast-feeding due to insufficient studies.

Children and adolescents

There are no adequate studies on the use of this medicine in children and adolescents. Mariendistel capsule should therefore not be used in children and adolescents under 18 years of age.

Driving and using machines

No impairments are known.

Important information about certain other ingredients of Mariendistel capsule

This medicine contains sorbitol. Therefore, please only take Mariendistel capsule after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE MARIENDISTEL CAPSULE?

Always take Mariendistel capsule exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The usual dose for adults is: 1 soft capsule 2 times a day. There are no sufficient data for specific dosage recommendations in case of impaired renal function.

Type of use

Please take the soft capsules unchewed with sufficient liquid, preferably a glass of water, before meals.

Children and adolescents

There are no adequate studies on the use of this medicine in children and adolescents. Mariendistel capsule should therefore not be used in children and adolescents under 18 years of age.

Duration of use

In case of complaints of unclear origin, self-medication should be discontinued after two weeks.

If symptoms of illness persist or if side effects occur other than those mentioned in the package leaflet, a doctor or other qualified person in a medical profession should be consulted. Please also note the information under section 2. "Special care must be taken when taking Mariendistel capsule". Please talk to your doctor or pharmacist if you have the impression that the effect of Mariendistel capsule is too strong or too weak.

If you have taken more Mariendistel capsule than you should

If you have accidentally taken this medicine in a higher dosage, a mild laxative (laxative) effect may occur. If you experience any other symptoms, please notify your doctor. He/she can decide on any necessary measures.

If you forget to take Mariendistel capsule

Do not take a double dose, but continue taking as directed in this package leaflet or as directed by your doctor.

If you stop taking Mariendistel capsule

Interrupting or prematurely terminating treatment is generally harmless. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Gastrointestinal complaints and hypersensitivity reactions, e.g. skin rash and shortness of breath, may occur. The frequency of these possible side effects is not known. Soya proteins can very rarely trigger allergic reactions. Please inform your doctor or pharmacist if you notice any side effects not listed in this leaflet. At the first signs of a hypersensitivity reaction, Mariendistel capsule must not be taken again.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MARIENDISTEL CAPSULE?

Keep medicine out of reach of children. Do not use the medicine after the expiry date which is stated on the label after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 25ºC. Note on shelf life after opening: Shelf life after opening the pack is 6 months.

6. FURTHER INFORMATION

What Mariendistel capsule contains

The active ingredient is: Milk thistle fruit dry extract. 1 soft capsule contains: 200.00 mg dry extract from defatted milk thistle fruits (30-40:1), extraction agent: Ethanol 96% (V/V). The other ingredients are: Maltodextrin, highly dispersed silicon dioxide, phospholipids from soya beans, refined soya oil, refined coconut fat, refined palm kernel fat, yellow wax, milk fat, gelatine, glycerol, sorbitol solution 70% (non-crystallising), quinoline yellow (E 104), titanium dioxide (E 171), iron(III) hydroxide-oxide (E 172), purified water. The medicine contains less than 0.1 BE. One soft capsule contains 23.48 mg sorbitol (equivalent to 5.87 mg fructose).

Pharmaceutical entrepreneur + manufacturer:
ascopharm gmbh
Im Bruchanger 6
38845 Wernigerode

Registration holder

Aenova IP GmbH
Temmlerstraße 2
D-35039 Marburg

This leaflet was last revised in November 2016.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Milk thistle fruit dry extract. Indications: traditionally used to support digestive function by stimulating the function of the liver-bile system.