Omega 3 Doc Generici
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEGA 3 DOC 1000 mg soft capsules
ethyl esters of polyunsaturated fatty acids
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 only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What OMEGA 3 DOC is and what it is used for
- What you need to know before taking OMEGA 3 DOC
- How to take OMEGA 3 DOC
- Possible side effects
- How to store OMEGA 3 DOC
- Contents of the pack and other information
1. What OMEGA 3 DOC is and what it is used for
OMEGA 3 DOC contains, as active substances, ethyl esters of highly concentrated and purified polyunsaturated fatty acids (derived from fish oil), which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
OMEGA 3 DOC is indicated:
for reducing elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with OMEGA 3 DOC should always be accompanied by appropriate dietary measures;
2. What you should know before taking OMEGA 3 DOC
Do not take OMEGA 3 DOC
if you are allergic to ethyl esters of polyunsaturated fatty acids (derived from fish oil) or to
any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking OMEGA 3 DOC.
Inform your doctor before taking OMEGA 3 DOC:
- if you are allergic to fish.
- if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 DOC.
- if you have conditions that make you more prone to bleeding.
Other medicines and OMEGA 3 DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are being treated with:
- medicines to thin the blood (anticoagulants), e.g. coumarin anticoagulants
- other medicines that affect blood clotting, as this may lead to an increased bleeding time.
Pregnancy and breastfeeding
Do not use OMEGA 3 DOC if you are pregnant or breastfeeding.
Driving and using machines
OMEGA 3 DOC does not affect the ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
3. How to take OMEGA 3 DOC
Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Take the OMEGA 3 DOC capsules whole with some water.
Use in adults
For the reduction of high levels of fats (triglycerides) in the blood
The recommended dose is 1 capsule of 1000 mg taken 1 to 3 times daily, according to your doctor's prescription.
Use in the paediatric population
There are no data available on the use of polyunsaturated fatty acid ethyl esters in the paediatric population for the approved indications.
Use in elderly patients and patients with impaired kidney function
No dose adjustment is required in these patients.
Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 DOC (see section “Warnings and precautions”).
If you take more OMEGA 3 DOC than you should
If you accidentally take too much OMEGA 3 DOC, inform your doctor or pharmacist.
If you forget to take OMEGA 3 DOC
Do not take a double dose to make up for the missed dose.
If you stop taking OMEGA 3 DOC
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
- stomach and/or intestinal disorders
Uncommon side effects (may affect up to 1 in 100 people)
- nausea
- indigestion
- upper abdominal pain
- diarrhoea
Rare side effects (may affect up to 1 in 1,000 people)
- allergic reactions (hypersensitivity), allergy to the components
- dizziness
- inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
- abdominal pain
- heartburn
- changes in liver function
- skin reactions
- weakness
Other side effects that have occurred in a very small number of people, but whose exact frequency is unknown:
- Itching
- Skin rash with itching (urticaria)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects can help provide more information on the safety of this medicine.
5. How to store OMEGA 3 DOC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What OMEGA 3 DOC contains
The active substances are ethyl esters of polyunsaturated fatty acids.
Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with a content of
EPA and DHA not less than 85%, and in a ratio to each other of 0.9 - 1.5.
The other components are: D,L α-tocopherol, gelatin, glycerol.
Description of the appearance of OMEGA 3 DOC and contents of the pack
Soft gelatin capsules, elastic, transparent, oblong, containing a clear yellowish oil with a characteristic fishy odor.
Each pack contains 20 or 30 soft capsules in blisters.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (PC)