Cynara® Artichoke
Product Characteristics
Read all of this leaflet carefully because it contains important information for you.This medicine is available without prescription. However, you still need to take Cynara® Artichoke carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 7 days.
In this leaflet:
1. What Cynara® Artichoke is and what it is used for
2. Before you take Cynara® Artichoke
3. How to take Cynara® Artichoke
4. Possible side effects
5. How to store Cynara® Artichoke
6. Further information
Cynara® Artichoke
Active substance: Dry extract of artichoke leaves
The active pharmaceutical ingredient is a dry extract of artichoke leaves.
1 hard capsule contains: 320 mg dry extract of artichoke leaves (4-6:1). Extraction solvent: Water.
The other ingredients are:
Lactose monohydrate, magnesium stearate, talcum, highly dispersed silicon dioxide, gelatine, quinoline yellow (E 104), indigo carmine (E 132), titanium dioxide (E 171), sodium dodecylsulfate.
Cynara® Artichoke is available in packs of 50 hard capsules (N2), 100 hard capsules (N3), or 200 hard capsules (bulk pack).
1. WHAT Cynara® Artichoke IS AND WHAT IT IS USED FOR
1.1 Cynara® Artichoke is a herbal drug used to treat indigestion.
1.2 From: Cassella-med GmbH & Co. KG, Gereonsmühlengasse 1, 50670 Cologne.
Manufacturer:
Klosterfrau Berlin GmbH, Motzener Straße 41, 12277 Berlin, Germany
1.3 Cynara® Artichoke is used for treating indigestion (dyspeptic complaints), in particular lower biliary tract dysfunction.
2. BEFORE YOU TAKE Cynara® Artichoke
2.1 Do not take Cynara® Artichoke
if you are known to be hypersensitive to artichokes and/or other plants of the daisy family, or any of the other ingredients of this medicine, and/or if you are suffering from a biliary tract obstruction.
2.2 Take special care with Cynara® Artichoke
Patients with gallstones should consult their doctor before using Cynara® Artichoke.
The effectiveness of coumarin-type anticoagulants (phenprocoumon, warfarin) may be reduced by concomitant use of Cynara® Artichoke. It may therefore be necessary to adjust the dosage of these drugs. Patients who are using Cynara® Artichoke concurrently with medicines containing any of these active substances should consult their doctor for this purpose.
If complaints persist longer than 1 week or keep recurring at regular intervals, or if any unclear complaints are experienced, a doctor should be consulted.
a) Children:
No appropriate studies have been conducted on the use of Cynara® Artichoke in children. It should therefore not be used for children under 12 years of age.
b) Pregnancy and breast-feeding
Cynara® Artichoke should not be used during pregnancy and breast-feeding, as no adequate studies have been conducted.
c) Driving and using machines:
No special precautions are required.
2.3 Taking other medicines:
The effectiveness of coumarin-type anticoagulants (phenprocoumon, warfarin) may be reduced by concomitant use of Cynara® Artichoke. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
3. HOW TO TAKE Cynara® Artichoke
Always take Cynara® Artichoke exactly as directed in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
3.1 Method of administration
For oral use.
3.2 The usual dose is
two hard capsules twice per day for adults and adolescents from 12 years of age.
Take Cynara® Artichoke with your principal meals. Swallow it whole with a sufficient amount of liquid (preferably a glass of drinking water).
3.3 If you take more Cynara® Artichoke than you should:
Intoxications from preparations of artichoke leaves have not been reported to date.
Patients who use larger amounts of Cynara® Artichoke should notify a doctor, who may then decide on the action that may have to be taken.
There might be an increased occurrence of the side effects listed below.
3.4 If you forget to take Cynara® Artichoke
If you have taken too little Cynara® Artichoke, or if you missed a scheduled dose of Cynara® Artichoke, do not take a double dose the next time, but continue with your regular dosage regimen as prescribed by your doctor or as described in the package leaflet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cynara® Artichoke can cause side effects.
4.1 Side effects:
There have been some very rare reports (fewer than 1 of 10,000 patients treated) of mild diarrhoea with typical accompanying symptoms (e.g. abdominal cramps), as well as upper abdominal complaints, nausea, and heartburn. There may be some very rare instances of hypersensitivity reactions, e.g. skin rashes.
4.2 Counteractive measures:
If you experience any of the side effects mentioned above, please tell a doctor, who will then determine the degree of severity, as well as any action that may have to be taken.
At the first signs of a hypersensitivity reaction, you must stop taking Cynara® Artichoke.
4.3 If you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Cynara® Artichoke
Keep out of the reach and sight of children.
Do not use Cynara® Artichoke after the expiry date which is stated on the carton/container.
Storage conditions:
Do not store above 25°C.
This leaflet was last approved in:
August 2006.
6. FURTHER INFORMATION
Dear patient,
There are various potential causes of indigestion (dyspeptic complaints). One potential cause is a disorder of bile formation and bile flow. The bile fluid, which is produced in the liver and then released into the intestine via the gall bladder and bile duct, is involved in the digestion of food. Cynara® Artichoke is a herbal drug that contains a dry extract of artichoke leaves as its active pharmaceutical ingredient. Preparations of this kind are supposed to have a positive effect on bile secretion. Cynara® Artichoke is used to treat indigestion (dyspeptic complaints), in particular lower biliary tract dysfunction.
For sale in pharmacies only
Marketing authorisation No.: 6163618.01.00
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Countries
Cynara® Artichoke is available in the following countries:
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