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ESSENTIALE FORTE CPS 300MG N30

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
ESSENTIALE-FORTE-drug/medicine -capsules -tablets aproximate price on "ESSENTIALE FORTE CPS 300MG N30" in Riga city, Latvia is:
  • 8.24€  8.91$  7.07£  952Rub  94.8SEK  36PLN  32.62₪ 

ESSENTIALE FORTE N CPS 300MG N30


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -capsules -tablets  ESSENTIALE FORTE CPS 300MG N30     Recheck

Reģ. Nr.: 99-1036

ATC codeA05BA 

Active substances: Phospholipida Ex Soia

 


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

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ESSENTIALE FORTE N 300 mg kapsulas, 30 gab.

 .

ESSENTIALE FORTE N 300MG N30

Package leaflet: Information for the user

Essentiale forte N 300 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 or pharmacist 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 capsules are 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 avoiding substances that cause liver damage (e.g. alcohol)
-   supportive treatment of chronic hepatitis with soybean phospholipids is only indicated if it improves the patient’s subjective sense of well-being.
-   you must talk to your doctor if the symptoms worsen or you get any other vague 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 which reduce blood clotting) cannot be excluded. It may therefore be necessary to adjust the dosage of the anticoagulant. Talk to your doctor if you are taking Essentiale forte N concomitantly with anticoagulants.

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 capsule is not recommended during pregnancy and breast-feeding.

Driving and using machines

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

Essentiale forte N contains ethanol

Essentiale forte N contains a small amount of ethanol (8.1 mg per hard capsule).

Essentiale forte N contains soybean oil

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

Essentiale forte N contains hydrogenatedcastor oil

Essentiale forte N contains hydrogenated castor oil, which can cause gastric problems, diarrhoea and skin reactions.

3. How to use Essentiale forte N

Always use Essentiale forte N as your doctor or pharmacist. has told you Check with your doctor, pharmacist or nurse if you are not sure.
The 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 2 hard capsules (total of 600 mg of soybean phospholipids) 3 times per day. Do not take more than 6 hard capsules per day (total of 1,800 mg soybean phospholipids).

Use in children

Children should not use Essentiale forte N due to insufficient data.
If you feel that the effect of Essentiale forte N is too strong or too weak, talk to your doctor or pharmacist.

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 take 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, pharmacist or nurse.

4.   Possible side effects

Like all medicines, Essentiale forte N can cause side effects, although not everybody gets them.
The following classification based on frequency is used when evaluating 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).
Digestive tract disorders
Unknown: stomach complaints, soft stools or diarrhoea.
Skin and subcutaneous tissue disorders
Unknown: allergic reaction, e.g. exanthema, rash and urticaria; pruritus.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee/en. 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.
Do not store at a temperature higher than 25 °C. Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the 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 300 mg of essential soybean phospholipids, including 76% of (3-sn-phosphatidyl)-choline.
-   The excipients are
Capsule contents: solid fat, refined soybean oil, alpha tocopherol, hydrogenated castor oil, ethanol 96%, ethyl vanillin, 4-methoxyacetophenone
Capsule body: gelatine, purified water, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), sodium lauryl sulphate.

What Essentiale forte N looks like and contents of the pack

Oblong, opaque, khaki coloured hard capsules. The capsule contains a honey-like paste.
The hard capsules are packaged in a blister pack.
The pack contains 30 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia

Manufacturer

Nattermann & Cie GmbH Nattermannallee 1 50829 Cologne Germany
For any information about this medicine, please contact the Marketing Authorisation Holder.
sanofi-aventis Estonia OÜ Pämu mnt. 139 E/2 11317 Tallinn Phone: +372 627 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





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


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