ESSENTIALE EXPRESS sachets 600mg.x21 / ESSENTIALE EXPRESS

Sanofi Aventis

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Essentiale Express 600 mg oral paste in a sachet contains the active substance: skim, enriched soybean phospholipids.

Each sachet contains 600 mg of defatted, fortified soybean phospholipids.

Purpose:

Essentiale Express is an herbal medicine for liver diseases.

Essentiale Express has been used to improve subjective symptoms, such as loss of appetite or heaviness in the right hypochondrium, in patients with hepatic impairment caused by substances harmful to the liver due to improper diet (toxic or nutritional damage) and those with chronic liver inflammation (hepatitis), in adolescents over 12 years and in adults.

If symptoms do not respond to treatment, medical attention should be sought.

Do not take Essentiale Express:

  • If you are hypersensitive (allergic) to phosphatadylcholine, soy products, peanuts or any of the other ingredients of this medicine (listed in 6);
  • This medicine contains soybean oil. In rare cases, you may have severe allergic reactions.

Warnings and precautions:

The use of this medicine does not replace the use of toxic substances that cause liver damage (eg alcohol).

If you have chronic inflammation of the liver (hepatitis), maintenance treatment with this medicine is only justified if you notice an improvement in your symptoms. If your symptoms worsen or if other vague symptoms occur, you should consult a doctor.

Children and adolescents:

There are no studies on the use of Essentiale Express in children under 12 years of age. Therefore, it should not be used in children under 12 years of age.

Other medicines and Essentiale Express:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

An interaction between Essentiale Express and drugs that suppress blood clotting cannot be ruled out. You may need to adjust the dose of this medicine. If you are taking Essentiale Express at the same time as the medicine that suppresses blood clotting, you must inform your doctor.

Pregnancy, lactation and fertility:

Soy products are widely used as food in humans and so far there is no evidence to suggest any risk during pregnancy and lactation. There are insufficient data from studies. Therefore, the use of this medicinal product is not recommended during pregnancy and lactation.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

There are no data on the effect of Essentiale Express on the ability to drive and use machines.

Essentiale Express contains a small amount of ethanol (less than 100 mg of alcohol per day) and soybean oil. If you are allergic to soy or peanuts, do not take this medicine (see section 2).

How to take Essentiale Express:

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is as follows:

Age and / or body weight Single dose Maximum daily dose

In adolescents over 12 years (approximately 43 kg) and adults 1 sachet (600 mg soybean phospholipids) 1 sachet 3 times daily (1800 mg soybean phospholipids)

The oral paste is swallowed whole with a meal.

In general, there is no limit to the duration of use of this medicine.

Children and adolescents

There are no studies on the use of Essentiale Express in children under 12 years of age. Therefore, it should not be used in children under 12 years of age.

If you take more than the required dose:

There are no symptoms of overdose or poisoning with this drug.

The side effects listed below may occur with greater intensity. If this happens, please inform your doctor. He or she will decide what action to take.

Possible side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, especially allergic reactions, stop taking this medicine and tell your doctor. He or she will assess the severity of the side effect and what measures need to be taken.

  • Uncommon (affects less than 1 in 100 people): gastrointestinal disorders such as soft stools or a disorder.
  • Very rare (affects less than 1 in 10,000 patients): allergic reactions such as exanthema (skin rash), urticaria (hives).
  • Not known (frequency cannot be estimated from the available data): itching.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What Essentiale Express contains:

The active substance is: degreased, enriched phospholipids from soya beans.

Each sachet contains 600 mg of defatted, fortified soybean phospholipids.

The other ingredients are: ethanol, castor oil, hydrogenated, saccharin sodium, coffee aroma, cream aroma.