ESSENTIALE Capsule 300 mg

Essentiale forte capsules. Active ingredient: Phospholipids from soybeans. Indications: For the improvement of subjective symptoms such as loss of appetite and a feeling of pressure in the right upper abdomen, in cases of liver damage caused by the ingestion of liver-damaging substances (e.g., alcohol), in cases of poor nutrition, and in cases of chronic liver inflammation (hepatitis).

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Essentiale forte capsules
Active ingredient: Phospholipids from soybeans

Read the entire package insert carefully before you start taking this medicine, as it contains important information.

• Keep this leaflet. You may want 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 share it with anyone else. It may harm others, 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 is in this leaflet:

1. WHAT IS ESSENTIALE FORTE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ESSENTIALE FORTE?
3. HOW SHOULD YOU TAKE ESSENTIALE FORTE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ESSENTIALE FORTE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ESSENTIALE FORTE AND WHAT IS IT USED FOR?

Essentiale forte is a herbal medicinal product for liver diseases. Essentiale forte is used in adults and adolescents aged 12 years and older to improve subjective symptoms such as loss of appetite and pressure in the right upper abdomen, in cases of liver damage caused by the ingestion of liver-damaging substances (e.g., alcohol), in cases of poor nutrition, and in cases of chronic liver inflammation (hepatitis). If you do not feel better or if you feel worse despite taking Essentiale regularly, consult your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ESSENTIALE FORTE?

Do not take Essentiale forte if you are allergic to soy, 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 is required when taking Essentiale forte:

• If you plan to consume alcohol: Liver damage caused by alcohol cannot be prevented by taking Essentiale forte at the same time. If you already have liver problems, you should not consume alcohol.
• If your symptoms worsen, or if other unclear symptoms occur, you should consult a doctor.

Please talk to your doctor about the success of the treatment, as you should only use Essentiale forte if it contributes 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:
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use 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 become pregnant, consult your doctor before taking this medicine. The use of this medicine during pregnancy or breastfeeding is not recommended as there are insufficient studies on this.

Ability to drive and use machines:
Essentiale forte has no influence on the ability to drive and use machines.

• Essentiale forte contains small amounts of ethanol (alcohol), less than 100 mg per capsule.
• Essentiale forte contains soybean oil. Do not take it if you are hypersensitive (allergic) to peanuts or soy.
• Essentiale forte contains castor oil, which can cause stomach upset and diarrhea.
• Essentiale forte contains less than 1 mmol sodium (23 mg) per capsule, meaning it is virtually ###sodium-free###.

3. HOW TO TAKE ESSENTIALE FORTE?

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose for adults and adolescents 12 years and older is:

• At the start of treatment: 2 capsules 3 times daily.
• As a maintenance dose: 1 capsule 3 times daily.

Method of administration:
For oral use. Take the capsules whole with meals and drink plenty of liquid, preferably a glass of water.

Duration of use:
You may need to take Essentiale forte for a longer period of time. Please follow your doctor's instructions.

If you take more Essentiale forte than you should:
No symptoms of overdose or poisoning are known with Essentiale forte. The side effects listed below may be more severe. If this happens, please notify a doctor.

If you forget to take Essentiale forte:
Do not take a double dose to make up for a forgotten dose, but continue taking it as directed 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 from the available data):
• Increased blood pressure.
• Heart palpitations.
• Dizziness.
• Gastrointestinal complaints such as diarrhea, loose stools, nausea, and vomiting.
• Allergic reactions such as rash or hives%%% itching.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package 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, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD ESSENTIALE FORTE BE STORED?

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 ###essential### 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 Entrepreneur
Opella Healthcare Austria GmbH
Turm A, 29th Floor
Wienerbergstraße 11
1100 Vienna
Austria

Manufacturer:
A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne
Germany

This package leaflet was last revised in August 2024.

Source: Information from the package leaflet.
Version: 12/2024

Active ingredient: Phospholipids from soybeans. Indications: For the improvement of subjective symptoms such as loss of appetite and pressure in the right upper abdomen, in cases of liver damage caused by the ingestion of liver-damaging substances (e.g., alcohol), in cases of poor nutrition, and in cases of chronic liver inflammation (hepatitis).