HEPAR-SL

HEPAR-SL 320 mg hard capsules

Important notes (mandatory information)

Hepar SL 320 mg hard capsules. Active ingredient: Artichoke leaf dry extract. Areas of application: for digestive disorders (dyspeptic complaints), especially for functional disorders of the biliary system.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hepar SL 320 mg hard capsules for use in adults and adolescents over 12 years of age
Active ingredient: Artichoke leaf dry extract

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Hepar-SL 320 mg must be used as directed in order to achieve 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 your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the side effects listed occur to a significant extent 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 HEPAR—SL 320 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HEPAR—SL 320 MG?
3. HOW SHOULD HEPAR—SL 320 MG BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEPAR—SL 320 MG BE STORED?
6. FURTHER INFORMATION

1. WHAT IS HEPAR-SL 320 MG AND WHAT IS IT USED FOR?

Hepar-SL 320 mg is a herbal medicine for digestive problems. Hepar-SL 320 mg is used for digestive disorders (dyspeptic complaints), especially for functional disorders of the biliary system.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HEPAR—SL 320 MG?

Hepar-SL 320 mg must not be taken if you are known to be hypersensitive to artichokes and/or other members of the daisy family or to any of the other ingredients of the medicine and if the bile ducts are blocked.

Special care should be taken when taking Hepar-SL 320 mg

In children

There are no adequate studies on the use of Hepar-SL 320 mg in children. It should therefore not be used in children under 12 years of age.

Pregnancy and breast-feeding

Hepar-SL 320 mg should not be used during pregnancy and breast-feeding due to insufficient studies.

When should you only take Hepar-SL 320 mg after consulting your doctor?
Hepar-SL 320 mg should only be taken after consulting a doctor if you have gallstones. The effectiveness of coumarin-type anticoagulants (phenprocoumon, warfarin) may be reduced if Hepar-SL 320 mg is taken at the same time. It may therefore be necessary to adjust the dosage of these medicines. Patients taking Hepar-SL 320 mg and medicines containing one of these active ingredients at the same time should therefore see their doctor. If symptoms persist for more than a week or recur regularly, a doctor should be consulted, as with all unclear symptoms.

When taking Hepar-SL 320 mg with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effectiveness of coumarin-type anticoagulants (phenprocoumon, warfarin) may be reduced if Hepar-SL 320 mg is taken at the same time.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Hepar-SL 320 mg

This medicine contains lactose. Therefore, please only take Hepar-SL 320 mg after consulting your doctor if you know that you are intolerant to certain sugars.

3. HOW SHOULD HEPAR-SL 320 MG BE TAKEN?

Always take Hepar-SL 320 mg exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents aged 12 years and over take 2 hard capsules twice a day. Take Hepar-SL 320 mg with the main meals, unchewed, with sufficient liquid (preferably a glass of drinking water). Please talk to your doctor or pharmacist if you have the impression that the effect of Hepar-SL 320 mg is too strong or too weak.

If you have taken more Hepar-SL 320 mg than you should

Poisoning with artichoke leaf preparations has not been reported to date. If larger amounts of Hepar-SL 320 mg are taken, a doctor should be notified who can decide on any necessary measures. The side effects listed below may occur more frequently.

If you forget to take Hepar-SL 320 mg

If you have taken too little Hepar-SL 320 mg or have forgotten to take Hepar-SL 320 mg, do not take twice the amount the next time, but continue taking it as prescribed by your doctor or as described in the package leaflet.

If you stop taking Hepar-SL 320 mg

The digestive problems may recur, so you should inform your doctor.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Hepar-SL 320 mg can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Very rarely, mild diarrhoea with typical accompanying symptoms (e.g. abdominal cramps) and upper abdominal discomfort, nausea and heartburn have been reported. Very rarely, hypersensitivity reactions such as skin rashes may occur. If you observe any of the side effects listed above, please inform a doctor so that they can decide on the severity and any necessary measures. Hepar-SL 320 mg must not be taken again at the first signs of a hypersensitivity reaction.

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 leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD HEPAR-SL 320 MG BE STORED?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton and the container (blister pack). Storage conditions: Do not store above 25°C.

6. FURTHER INFORMATION

What Hepar-SL 320 mg contains

1 hard capsule contains 320 mg dry extract of artichoke leaves (4-6:1); Extraction agent: water. The other ingredients are: hypromellose, lactose monohydrate, magnesium stearate (Ph. Eur.), highly dispersed silicon dioxide, talc, titanium dioxide, quinoline yellow, brilliant blue FCF.

What Hepar-SL 320 mg looks like and contents of the pack

Hepar-SL 320 mg are green hard capsules. Hepar-SL 320 mg is available in packs of 20 hard capsules, 50 hard capsules, 100 hard capsules and 200 hard capsules.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne

Manufacturer

Klosterfrau Berlin GmbH
Motzener Straße 41
12277 Berlin

This leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 11/2019
Active ingredient: Artichoke leaf dry extract. Areas of application: for digestive disorders (dyspeptic complaints), especially for functional disorders of the biliary system.