Omega 3 Sandoz
Italy
Package leaflet: Information for the patient
OMEGA 3 SANDOZ 1000 mg soft capsules
Ethyl esters of polyunsaturated fatty acids
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What OMEGA 3 SANDOZ is and what it is used for
- What you need to know before taking OMEGA 3 SANDOZ
- How to take OMEGA 3 SANDOZ
- Possible side effects
- How to store OMEGA 3 SANDOZ
- Contents of the pack and other information
1. What OMEGA 3 SANDOZ is and what it is used for
OMEGA 3 SANDOZ contains as active substances ethyl esters of polyunsaturated fatty acids (derived from fish oil) in high concentration and purity, which reduce the level of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
OMEGA 3 SANDOZ 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 SANDOZ must always be accompanied by appropriate dietary measures.
2. What you need to know before taking OMEGA 3 SANDOZ
Do not take OMEGA 3 SANDOZ
- 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 SANDOZ.
Inform your doctor before taking OMEGA 3 SANDOZ:
- if you are allergic to fish, since the active substance in OMEGA 3 SANDOZ 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 SANDOZ;
- if you have conditions that make you prone to bleeding.
Other medicines and OMEGA 3 SANDOZ
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), for example, 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 SANDOZ if you are pregnant or breastfeeding.
Driving and using machines
OMEGA 3 SANDOZ does not affect the ability to drive vehicles or operate machinery.
3. How to take OMEGA 3 SANDOZ
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Swallow the OMEGA 3 SANDOZ 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 1-3 times daily, according to your doctor's prescription.
Use in paediatric population
There are no data available on the use of OMEGA 3 SANDOZ 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 SANDOZ (see section “Warnings and precautions”).
If you take more OMEGA 3 SANDOZ than you should
If you accidentally take too much OMEGA 3 SANDOZ, tell your doctor or pharmacist.
If you forget to take OMEGA 3 SANDOZ
Do not take a double dose to make up for the missed dose.
If you stop taking OMEGA 3 SANDOZ
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people)
- Stomach and/or intestinal disturbances
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 ingredients
- 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 whose exact frequency is unknown
- Itching
- Itchy skin rash (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 may also report side effects directly via the national reporting system at 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 SANDOZ
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry
date refers to the last day of that month.
Store below 30 °C. Keep in the blister pack to protect from light.
Do not dispose of medicines 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 SANDOZ 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 a ratio between them of 0.9 - 1.5.
- The other components are alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides, purified water.
Description of the appearance of OMEGA 3 SANDOZ and contents of the pack
Soft, transparent, oblong capsules containing a clear, light yellow oil with a characteristic fishy odour.
Each pack contains 20 or 30 soft capsules in white-opaque thermoformed PVC/PVDC-Al blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA)
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)