Ecomer

Patient Information Leaflet

Ecomer
250 mg, soft capsules
Selachiorum hepatis oleum
Please read the following information carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 8 days of treatment, or if your condition worsens, consult your doctor.

Table of Contents

1. What Ecomer is and what it is used for
2. Important information before taking Ecomer
3. How to take Ecomer
4. Possible side effects
5. How to store Ecomer
6. Contents of the pack and other information

1. What Ecomer is and what it is used for

Ecomer contains shark liver oil, which includes alkylglycerols – ether lipids of selachyl, batyl, and chimyl alcohols and their methoxyl derivatives. Shark liver oil stimulates the body's immune processes. By enhancing antibody production and stimulating leukocyte formation and phagocytosis, it increases the body's resistance to infections.

Indications:
As an adjunct in conditions of reduced resistance to bacterial and viral infections, in acute and chronic infectious diseases, and for prophylaxis during periods of increased susceptibility to influenza and other infectious diseases.

On the prior decision of the treating physician, the product may be used as an adjunct during radiotherapy and chemotherapy for cancer.

2. Important information before using Ecomer

When not to use Ecomer

• if the patient is allergic to shark liver oil or any of the other ingredients of this medicine (listed in section 6).

Ecomer has not been investigated in clinical trials; therefore, other possible
contraindications apart from the one mentioned are unknown.
Ecomer and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or might take any other medicines.
No studies have been conducted regarding interactions.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Due to lack of data on the use of Ecomer during pregnancy and breastfeeding, this medicine should not be used during pregnancy and breastfeeding.
Driving and operating machinery
Ecomer does not impair psycho-physical performance, the ability to drive vehicles
or operate machinery.

3. How to use Ecomer

This medicine should always be used exactly as described in the patient leaflet or
as recommended by your doctor or pharmacist. If in doubt, consult your doctor
or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age: one or two capsules two to three times
per day.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
There is no data regarding adverse reactions, as appropriate studies have not been conducted. There have been no reports of adverse reactions following the medicine's market authorization.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ecomer

Store below 25°C.
Store in the original packaging to protect from light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ecomer contains

• The active substance is shark liver oil.
• The other ingredients are: gelatin, glycerol, purified water.

What Ecomer looks like and contents of the pack
The pack contains 60, 120 or 240 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zakład Farmaceutyczny „Amara” sp. z o.o.
Stacyjna 5
30-851 Kraków
Tel. 12 657 40 40
[email protected]

Manufacturer:
Natumin Pharma AB
Snickaregatan 10
566 33 Habo
Sweden