Klosterfrau taxofit® neo-angin® dolo-angin® neo-bronchol® sinu-panthol® nasic® Soledum® Aria Bedan® Laxacur® Valerian Cynara® Ameu® Kira® Kwai® Ginkyo® Sedonium® MedEctoin

Product Characteristics

Dear patient,
Please read all of this package leaflet carefully because it contains important information on what you must keep in mind when taking this medicinal product. If you have any questions, please ask your doctor or pharmacist.

Ameu® 500mg
Active substance: Deep-sea fish oil

Composition
1 soft capsule contains:
Active pharmaceutical ingredient: 500 mg deep-sea fish oil, containing 70 mg Icosapent (EPA) and 50 mg Doconexent (DHA) (omega-3 fatty acids).
List of excipients: RRR-tocopherol, -tocopherol acetate, gelatine, glycerol, purified water.

Pharmaceutical form and contents
Original packs of 60 (N1), 120 (N3), or 240 (N3) soft capsules.

Substance or indication group
Lipid-lowering agent

Marketing authorisation holder
Cassella-med GmbH & Co. KG,
Gereonsmühlengasse 1, 50670 Cologne.

Manufacturer
Klosterfrau Berlin GmbH, Motzener Straße 41, 12277 Berlin, Germany

Therapeutic indications
For lowering excessively high blood lipid (triglyceride) levels. This medicinal product is used as a supplement only when a special diet is not effective in lowering blood lipid levels.
Note: An effect of reduced triglyceride levels achieved by this medicinal product on arteriosclerosis or its sequelae has not been established to date. An effect of this medicinal product on the incidence and severity of pancreatitis which may occur as a complication of extreme hypertriglyceridaemia has not been established.

Contraindications
Do not take Ameu® 500 mg soft capsules
You must not take Ameu® 500 mg soft capsules if you are suffering from any of the following:

• acute or subacute pancreatitis,
• acute destruction of pancreatic cells (acute pancreatic necrosis,
• acute or chronic liver intoxication,
• liver shrinkage (cirrhosis of the liver) of any origin,
• acute or chronic inflammation of the gall bladder (choleocystitis),
• a purulent gallbladder (gallbladder empyema),
• fat digestion or fat emulgation disorders in the small intestine due to conditions of the gallbladder and/or pancreas,
• blood coagulation disorders,
• allergic reactions to any ingredient of this medicinal product.

When to take Ameu® 500 mg soft capsules only after consulting with your doctor
The following describes when you should take Ameu® 500 mg soft capsules only under certain conditions and with particular caution. Please ask your doctor. This also applies if you met these criteria at any time in the past.
This medicinal product supplies 10-20 mg (2 mg/g) cholesterol per day; thus a careful benefit/risk assessment is required in patients with concomitant hypercholesterolaemia (elevated blood cholesterol levels), and the additional cholesterol has to be taken into account in the diet regimen.

What to keep in mind during pregnancy
Ameu® 500 mg should not be used during the final 3 months of pregnancy, as it may cause a delay in labour.

Using Ameu® 500 mg in children
As there is no adequate empirical data available, it is not recommended to use this medicine in the treatment of children.

Special warnings and precautions for use
Precautions to be observed
Regular monitoring of liver function (transaminases) is required in patients suffering from liver conditions.

Taking other medicines
Other medicines which influence the effect of Ameu® 500 mg soft capsules
Ameu® 500 mg soft capsules increase bleeding time and may reduce platelet aggregation; therefore patients suffering from coagulation disorders, as well as patients concurrently treated with anticoagulants, should be monitored by a medical professional, in particular with regard to a potential necessity of dosage reduction of the anticoagulants.

Posology and method of administration
The following information applies unless your doctor has given you other instructions for using Ameu® 500 mg. Please follow the instructions for use; otherwise Ameu® 500 mg will not be fully effective!
How many soft capsules of Ameu® 500 mg to take, and how often
Unless otherwise prescribed, the dosage is 10-20 soft capsules per day. These should be taken in 2 individual daily doses of 5-10 capsules each.

How and when to take Ameu® 500 mg
Ameu® 500 mg capsules should be swallowed whole with some liquid immediately before a meal.
How long to take Ameu® 500 mg
Before any treatment for lipid metabolism disorders is initiated, the patient should be counselled by a doctor. In many cases, lipid metabolism disorders can be positively influenced by a change in dietary habits, increased physical exercise, bodyweight reduction, and adequate treatment of potentially coexisting other metabolism disorders (diabetes, gout).

These supportive measures should precede medication for several weeks and then be continued during treatment with Ameu® 500 mg.
As a general rule, medication is indicated only as an additional measure and only if the metabolism disorder cannot be adequately controlled by the above-mentioned measures alone.
The effect of Ameu® 500 mg may be more or less pronounced in each individual instance. A long-term therapy with this medicine used on a regular basis is required to achieve the desired outcome.
Strict adherence to the doctor's prescription and directions is another essential prerequisite. As with any other long-term therapy, continuous monitoring is required. Blood lipid levels must be checked repeatedly at regular intervals. Furthermore, the doctor should review whether continued treatment is still required.

Side effects
Like all medicines, Ameu® 500 mg can cause side effects. The assessment of side effects is based on the following frequency categories:

Very common: more than 1 in 10 patients treated
Common: fewer than 1 in 10, but more than 1 in 100 patients treated
Uncommon: fewer than 1 in 100, but more than 1 in 1,000 patients treated
Rare: fewer than 1 in 1,000, but more than 1 in 10,000 patients treated
Very rare: fewer than 1 in 10,000 patients treated, including isolated reports

Possible side effects from the use of Ameu® 500 mg
Occasional nausea and regurgitation (a fishy odour or taste) may occur with higher doses.
The following side effects may occur in some very rare instances:
- increase in bleeding time and inhibition of blood platelet aggregation. Any occurrence of bruises (bleeding of the skin or mucous membranes, so-called haematoma) must be reported to the attending doctor immediately. Before any surgical procedure, bleeding time must be checked.
- deterioration of lung function in acetylsalicylic acid-sensitive bronchial asthma
- moderate increase in transaminase levels
- allergic skin reactions (redness, swelling, itching).

Counteractive measures to be taken when side effects occur
Reduce the dosage of Ameu® 500 mg or discontinue treatment altogether.

If you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Notes and information on shelf life of the medicinal product
The expiry date of this package is printed on the outer packaging and on the blister strips. Do not use this package after this date!

Circumstances under which Ameu® 500 mg soft capsules must not be used even before their shelf life has expired
Do not use Ameu® 500 mg soft capsules when they are broken, damaged, or discoloured.

How to store Ameu® 500 mg soft capsules
Do not store Ameu® 500 mg soft capsules above 25°C.

This leaflet was last approved in
September 2006.

Keep out of the reach and sight of children!

For sale in pharmacies only

Marketing authorisation No.: 27214.00.00
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