Omega 3 Spa Societa' Prodotti Antibiotici
ItalyTable of Contents
Package leaflet: Information for the patient
OMEGA 3 SPA Società Prodotti Antibiotici 1000 mg soft capsules
ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read all of 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 could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What OMEGA 3 SPA Società Prodotti Antibiotici is and what it is used for
- What you need to know before taking OMEGA 3 SPA Società Prodotti Antibiotici
- How to take OMEGA 3 SPA Società Prodotti Antibiotici
- Possible side effects
- How to store OMEGA 3 SPA Società Prodotti Antibiotici
- Contents of the pack and other information
1. What OMEGA 3 SPA Società Prodotti Antibiotici is and what it is used for
OMEGA 3 SPA Società Prodotti Antibiotici contains, as active substances, ethyl esters of polyunsaturated fatty acids (derived from fish oil) of high concentration and purity, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
OMEGA 3 SPA Società Prodotti Antibiotici is indicated for the reduction of elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with OMEGA 3 SPA Società Prodotti Antibiotici should always be accompanied by appropriate dietary measures.
2. What you need to know before taking OMEGA 3 SPA Società Prodotti Antibiotici
Do not take OMEGA 3 SPA Società Prodotti Antibiotici
- 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”)
- This medicine contains soya. If you are allergic to peanuts or soya, do not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking OMEGA 3 SPA Società Prodotti Antibiotici.
Inform your doctor before taking OMEGA 3 SPA Società Prodotti Antibiotici:
- if you are allergic to fish, since the active ingredient in OMEGA 3 SPA Società Prodotti Antibiotici is derived from fish oil;
- if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 SPA Società Prodotti Antibiotici;
- if you have conditions that make you prone to bleeding.
Other medicines and OMEGA 3 SPA Società Prodotti Antibiotici
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 SPA Società Prodotti Antibiotici if you are pregnant or breastfeeding.
Driving and using machines
OMEGA 3 SPA Società Prodotti Antibiotici does not affect the ability to drive or use machinery.
OMEGA 3 SPA Società Prodotti Antibiotici contains ethyl p-hydroxybenzoate sodium and propyl p-
hydroxybenzoate sodium
OMEGA 3 SPA Società Prodotti Antibiotici contains ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. essentially ‘sodium-free’.
3. How to take OMEGA 3 SPA Società Prodotti Antibiotici
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the OMEGA 3 SPA Società Prodotti Antibiotici capsules whole, with a little water.
Use in adults
The recommended dose is 1 capsule 1-3 times daily, according to your doctor's prescription.
Use in pediatric population
There are no data available on the use of OMEGA 3 SPA Società Prodotti Antibiotici in the pediatric 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 SPA Società Prodotti Antibiotici (see section “Warnings and precautions”).
If you take more OMEGA 3 SPA Società Prodotti Antibiotici than you should
If you accidentally take an excessive dose of OMEGA 3 SPA Società Prodotti Antibiotici, inform your doctor or pharmacist immediately.
If you forget to take OMEGA 3 SPA Società Prodotti Antibiotici
Do not take a double dose to make up for the missed dose.
If you stop taking OMEGA 3 SPA Società Prodotti Antibiotici
If you have any questions about the use of 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
- Difficulty digesting
- Pain in the upper abdomen
- 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
- Stomach burning
- Changes in liver function
- Skin reactions
- Weakness
Other side effects that have occurred in a very small number of people, but for which the 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store OMEGA 3 SPA Società Prodotti Antibiotici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
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. Package contents and other information
What OMEGA 3 SPA Società Prodotti Antibiotici 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%, in a ratio of 0.9 - 1.5 between them.
- The other components are D,L α-tocopherol in soybean oil, succinated gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.
Description of the appearance of OMEGA 3 SPA Società Prodotti Antibiotici and package contents
Soft, transparent, oblong capsules.
Each pack contains 20 or 30 soft capsules in blisters.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
SPA Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 Milan
Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)