ESSENTIALE liver damage Capsules 300 mg
Essentiale forte capsules. Active ingredient: Phospholipids from soybeans. Indications: for the improvement of subjective symptoms such as loss of appetite and pressure in the upper right abdomen, in cases of liver damage due to the ingestion of liver-damaging substances (e.g., alcohol), in cases of poor diet, and in cases of chronic hepatitis.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Essentiale forte capsules
Active ingredient: Phospholipids from soybeans
Read the entire package leaflet carefully before you start taking this medicine because it contains important information.
- Keep the package leaflet. You may need to read it again later. - If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not give it to anyone else. It can harm other people, even if they have the same symptoms as you.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What this leaflet contains:
- WHAT IS ESSENTIALE FORTE AND WHAT IS IT USED FOR?
- WHAT SHOULD YOU CONSIDER BEFORE TAKING ESSENTIALE FORTE?
- HOW SHOULD ESSENTIALE FORTE BE TAKED?
- WHAT SIDE EFFECTS ARE POSSIBLE?
- HOW SHOULD ESSENTIALE FORTE BE STORED?
- PACKAGE CONTENTS AND FURTHER INFORMATION
1. WHAT IS ESSENTIALE FORTE AND WHAT IS IT USED FOR?
Essentiale forte is a herbal medicine for liver diseases. Essentiale forte is used in adults and adolescents aged 12 years and over to improve subjective symptoms such as loss of appetite and a feeling of pressure in the upper right abdomen, in cases of liver damage caused by the ingestion of liver-damaging substances (e.g., alcohol), poor diet, and chronic liver inflammation (hepatitis). If you do not feel better or even feel worse despite taking Essentiale regularly, consult your doctor.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ESSENTIALE FORTE?
Do not take Essentiale forte if you are allergic to soya, peanut, or any of the other ingredients of this medicine listed in section 6.
Warnings and precautions:
Please talk to your doctor or pharmacist before taking Essentiale forte.
Special care should be taken when taking Essentiale forte if...
- If you intend to consume alcohol: Liver damage caused by alcohol cannot be prevented by simultaneously taking Essentiale forte. If you already have liver problems, you should not drink alcohol.
- If your symptoms worsen, or if you experience other unexplained symptoms, you should consult a doctor.
Please discuss the treatment's effectiveness with your doctor, as you should only use Essentiale forte if it leads to a noticeable improvement in your symptoms.
Children and adolescents:
The use of Essentiale forte in children under 12 years of age is not recommended, as there is insufficient data on its use in children.
Taking Essentiale forte with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. An interaction between Essentiale forte and medicines that inhibit blood clotting (anticoagulants) cannot be ruled out. Therefore, it may be necessary to adjust the dosage of these medicines.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. The use of this medicine during pregnancy or breastfeeding is not recommended, as there are insufficient studies available.
Driving ability and ability to operate machinery:
Essentiale forte has no influence on the ability to drive and the ability to operate machinery.
- Essentiale forte contains small amounts of ethanol (alcohol), less than 100 mg per capsule.
- Essentiale forte contains soybean oil. It should not be taken if you are hypersensitive (allergic) to peanuts or soy.
- Essentiale forte contains castor oil. This can cause stomach upset and diarrhea.
- Essentiale forte contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is virtually sodium-free.
3. HOW TO TAKE ESSENTIALE FORTE?
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and adolescents aged 12 years and over is:
- At the start of treatment: 2 capsules 3 times a day.
- As a maintenance dose: 1 capsule 3 times daily.
Method of administration:
For oral use. Swallow the capsules whole with sufficient liquid, preferably a glass of water, at mealtimes.
Duration of use:
You may need to take Essentiale forte for an extended period. Please follow your doctor's instructions.
If you have taken more Essentiale forte than you should:
No symptoms of overdose or poisoning are known for Essentiale forte. The side effects listed below may occur more frequently. In this case, please inform a doctor.
If you forget to take Essentiale forte:
Do not take a double dose to make up for a forgotten dose. Continue taking it as prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
- Not known (frequency cannot be estimated based on the available data):
- Elevated blood pressure.
- Heart palpitations.
- Dizziness.
- Gastrointestinal complaints in the form of diarrhea, loose stools, nausea, vomiting.
- Allergic reactions such as skin rash or hives, itching.
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ESSENTIALE FORTE?
Do not store above 25°C. Store in the original packaging to protect from light and moisture. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after ###EXP. The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Essentiale forte capsules contain:
The active ingredient is: Phospholipids from soybeans. 1 capsule contains 300.0 mg of Essentiale forte phospholipids from soybeans, containing 76% (3-sn-phosphatidyl)choline. The other ingredients are: Capsule contents: hard fat, soybean oil, hydrogenated castor oil, ethanol 96%, ethyl vanillin, p-methoxyacetophenone, alpha-tocopherol. Capsule shell: gelatin, titanium dioxide (E 171), red, black and yellow iron oxide
(E 172), sodium lauryl sulfate, purified water.
What Essentiale forte looks like and contents of the pack:
Hard capsules, khaki, opaque, oblong. Pack sizes: 30, 90 and 100 capsules. Not all pack sizes may be marketed.
Pharmaceutical company:
Opella Healthcare Austria GmbH,
Tower A, 29th floor,
Wienerbergstraße 11,
1100 Vienna
, Austria.
Manufacturer:
A. Nattermann & Cie. GmbH,
Nattermannallee 1,
50829 Cologne,
Germany.