ESSENTIALE FORTE CPS 600MG N30

ATC code: A05BA00 

Active substances: Phospholipida Ex Sojae

Vendor, principal: Rhone-Poulenc Rorer (Sanofi). 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ESSENTIALE FORTE N 600MG N30

Package leaflet: Information for the user

Essentiale forte N 600 mg hard capsules

Soybean phospholipids

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after a while. .

What is in this leaflet

1.   What Essentiale forte N is and what it is used for
2.   What you need to know before you use Essentiale forte N
3.   How to use Essentiale forte N
4.   Possible side effects
5   How to store Essentiale forte N
6.   Contents of the pack and other information

1. What Essentiale forte N is and what it is used for

Essentiale forte N is an herbal preparation for the supportive care of liver diseases.
Essentiale forte N is used as a means of supportive care in case of chronic hepatitis and toxic nutritional liver damage (e.g. damage caused by alcohol etc.). This medicine is not a substitute for the need to avoid substances harmful to the liver (e.g. alcohol). In case of chronic hepatitis, supportive care using soybean phospholipids is only indicated if it improves your subjective sense of well-being. You must talk to a doctor if your symptoms worsen or you develop other unclear complaints.

2. What you need to know before you use Essentiale forte N Do not use Essentiale forte N

-   if you are allergic to soybeans, phosphatidylcholine, soy protein, nuts or any of the other ingredients of this medicine(listed in section 6);

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Essentiale forte N.
-   This medicine is not a substitute for the need to avoid substances harmful to the liver (e.g. alcohol).
-   In case of chronic hepatitis, supportive care using soybean phospholipids is only indicated if the treatment improves the patient’s subjective sense of well-being.
-   You must talk to a doctor if your symptoms worsen or you develop other unclear complaints.

Children and adolescents

Children should not use Essentiale forte N due to insufficient data.

Other medicines and Essentiale forte N

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interaction of Essentiale forte N with anticoagulants (medicines reducing the coagulation of blood) cannot be excluded. As a result of this, it may be necessary to adjust the dosage of the anticoagulant. If you are concomitantly using Essentiale forte N capsules and anticoagulants, talk to your doctor.

Pregnancy, breast-feeding and fertility

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.
Products made from soybeans are widely used in human food and to date, no facts have been uncovered indicating hazard during pregnancy. However, research data are insufficient. Hence, the use of Essentiale forte N is not recommended during pregnancy and breast-feeding.

Driving and using machines

Essentiale forte N has no effect on the ability to drive or use machines.

Essentiale forte N contains ethanol

Essentiale forte N contains a small amount of ethanol (16.2 mg per hard capsule).

Essentiale forte N contains refined soybean oil

Essentiale forte N contains refined soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

Essentiale forte N contains hydrogenated castor oil

Essentiale forte N contains hydrogenated castor oil, which can cause symptoms of stomach irritation, diarrhoea and skin reactions.

3. How to use Essentiale forte N

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Essentiale forte N hard capsules are taken during a meal without chewing and with a sufficient quantity of liquid. Duration of treatment depends on the course of the illness.
Take 1 hard capsule (600 mg of soybean phospholipides) 3 times per day. Do not take more than 3 hard capsules per day (total of 1,800 mg of soybean phospholipids).
If you feel that the effect of Essentiale forte N is too strong or too weak, talk to your doctor or pharmacist.

Use in children

Children should not use Essentiale forte N due to insufficient data.

If you take more Essentiale forte N than you should

No symptoms of toxicity have been reported in case of an overdose of Essentiale forte N. An overdose can exacerbate side effects.

If you forget to use Essentiale forte N

Do not take a double dose to make up for a forgotten dose.
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 classifications, which are based on incidence, are used for the evaluation of side effects:
-   Very common (> 1/10)
-   Common (> 1/100 to < 1/10)
-   Uncommon (> 1/1,000 to < 1/100)
-   Rare (> 1/10,000 to < 1/1,000)
-   Very rare (< 1/10,000)
-   Unknown (cannot be estimated from available data)
Gastrointestinal disorders
Unknown: stomach complaints, soft excrements, diarrhoea.
Skin and subcutaneous tissue disorders Unknown: allergic reaction, e.g. exanthema (rash) or urticaria (hives); pruritus.
In case of the appearance of any side effects, stop the treatment with Essentiale forte N and talk to a doctor, who will determine the severity of the side effect and the necessity for taking any measures.

Reporting of side effects

If you get 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 via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Essentiale forte N

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information What Essentiale forte N contains

-   The active ingredient is soybean phospholipids. One hard capsule contains 600 mg of essential soybean phospholipids, including 76% of (3-sn-phosphatidyl)-choline.
-   The other ingredients are
capsule core: solid fat, refined soybean oil, hydrogenated castor oil, ethanol 96%, ethyl vanillin, 4-methoxyacetophenon.
-   Capsule body: gelatine, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

What Essentiale forte N looks like and contents of the pack

Long opaque reddish-brown hard capsules. The capsule contains a honey- and paste-like mass.
The length of the capsule is 25.0 mm - 25.6 mm; the diameter of the capsule body is 7.9 mm - 8.2 mm.
PVC/PCTFE/PVC/Al blister pack.
The carton contains 30 hard capsules.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
sanofi-aventis Estonia OÜ Pämu mnt. 139 E/2
11317 Tallinn Estonia
Manufacturer
A.Nattermann & Cie. GmbH
Nattermannallee 1
50829 Köln, Nordrhein-Westfalen
Germany
For any information about this medicine, please contact the Marketing Authorisation Holder.
sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2 11317 Tallinn Phone 627 3488

This leaflet was last revised in December 2017 Other sources of information

Detailed information about this medicine is available on the website of the State Agency of Medicines: www.ravimiamet.ee/en