Omega-3 Doc Generici
Italy
Table of Contents
Package leaflet: Information for the user
OMEGA 3 DOC Generici 1000 mg soft capsules
Omega-3 ethyl esters 90
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What OMEGA 3 DOC Generici is and what it is used for
- What you need to know before taking OMEGA 3 DOC Generici
- How to take OMEGA 3 DOC Generici
- Possible side effects
- How to store OMEGA 3 DOC Generici
- Contents of the pack and other information
1. What OMEGA 3 DOC Generici is and what it is used for
OMEGA 3 DOC Generici 1000 mg soft capsules contain highly purified omega-3 polyunsaturated fatty acids.
OMEGA 3 DOC Generici 1000 mg soft capsules belongs to a group of medicines called cholesterol- and triglyceride-lowering agents.
OMEGA 3 DOC Generici is used:
for the treatment of certain forms of elevated triglycerides (fats) in the blood, after dietary changes have not proven effective.
2. What you need to know before taking OMEGA 3 DOC Generici
Do not take OMEGA 3 DOC Generici 1000 mg soft capsules
if you are allergic to omega-3 ethyl esters 90 or to any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking OMEGA 3 DOC Generici 1000 mg soft capsules:
if you are scheduled for or have recently undergone surgery;
if you have recently suffered trauma;
if you have kidney problems;
if you have uncontrolled diabetes;
if you are allergic to fish;
if you have liver problems. Your doctor will monitor any potential effects of OMEGA 3 DOC Generici 1000
mg soft capsules on your liver through blood tests.
Use in elderly patients
Take OMEGA 3 DOC Generici 1000 mg soft capsules with caution if you are over 70 years old.
Children and adolescents
Children and adolescents must not take this medicine.
Other medicines and OMEGA 3 DOC Generici 1000 mg soft capsules
If you are taking a medicine to prevent blood clots from forming in the arteries, such as
warfarin, additional blood tests may be required and the usual dose of your anticoagulant may need to be adjusted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
OMEGA 3 DOC Generici 1000 mg soft capsules with food and drink
You may take the capsules with meals. This will help reduce the likelihood of gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, you must not take this medicine unless your doctor considers it absolutely essential. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.
3. How to take OMEGA 3 DOC Generici
Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the capsules with water.
You may take the capsules during meals to help reduce gastrointestinal side effects.
Your doctor will determine the duration of your treatment with this medicine.
Dosage for the treatment of high levels of triglycerides in the blood (high blood fat levels or hypertriglyceridemia)
The recommended dose is 2 capsules daily, as prescribed by your doctor.
If the medicine is not sufficiently effective at this dose, your doctor may increase the dose up to 4 capsules daily.
If you take more OMEGA 3 DOC Generici 1000 mg soft capsules than you should
If you accidentally take more capsules than you should, do not worry, as it is unlikely that you will require specific treatment.
However, contact your doctor or pharmacist for further advice.
If you forget to take OMEGA 3 DOC Generici 1000 mg soft capsules
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose; in this case, take the next dose as usual. Do not take a double dose (twice the prescribed amount) to make up for a forgotten dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may affect up to 1 in 10 people):
stomach problems such as bloating (abdominal distension), pain, constipation, diarrhoea, indigestion (dyspepsia), flatulence, belching, acid reflux, nausea and vomiting
Uncommon adverse reactions (may affect up to 1 in 100 people):
increased blood glucose levels
gout
dizziness
taste disturbances
headache
low blood pressure
nosebleeds
blood in the stool
rash
Rare adverse reactions (may affect up to 1 in 1,000 people):
allergic reactions
pruritic rash (skin eruption with redness, raised areas and itching)
liver problems with possible abnormalities in the results of certain blood tests
Adverse reactions not known (frequency cannot be estimated from the available data):
itching
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store OMEGA 3 DOC Generici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack after “Exp.”. The expiry date refers to the last day of that month.
Store OMEGA 3 DOC Generici 1000 mg soft capsules at a temperature not exceeding 30°C.
Do not freeze. Keep the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine 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 package and other information
What OMEGA 3 DOC Generici 1000 mg soft capsules contains
The active substances are omega-3 fatty acid ethyl esters.
Each soft capsule contains 1000 mg of omega-3 acid ethyl esters 90, which mainly comprise
840 mg of eicosapentaenoic acid (EPA) as ethyl ester (460 mg) and docosahexaenoic acid (DHA)
as ethyl ester (380 mg) (these substances are known as omega-3 polyunsaturated fatty acids), and contains as antioxidant 4 mg of the excipient d-alpha-tocopherol.
The other components are: the soft capsule shell is composed of gelatin, glycerol, and traces of medium-chain triglycerides.
Description of the appearance of OMEGA 3 DOC Generici 1000 mg soft capsules and contents of the package
OMEGA 3 DOC Generici 1000 mg soft capsules are transparent soft gelatin capsules containing pale yellow oil.
OMEGA 3 DOC Generici 1000 mg soft capsules are available in the following pack sizes:
Transparent PVC/Aclar®–aluminum blisters, available in packs of 20, 28, 30, 3x10, 60, 90, 9x10, 100, and 120 capsules.
HDPE containers with HDPE child-resistant screw caps, available in packs of 20, 28, 30, 90, 98, and 100 capsules, and in a hospital pack of 280 (10x28) capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy
Manufacturer responsible for batch release:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
Merckle GmbH
Graf-Arco-Straße 3
89079 Ulm
Baden-Württemberg
Germany
Doppel Farmaceutici S.r.l.
Via Martiri Delle Foibe 1
29016 Cortemaggiore (PC)
Italy