OMEGA 1000 mg Soft Capsule

Зміст інструкції

1. OMEGA 3 SANDOZ 1000 mg soft capsules
   1. What is OMEGA 3 SANDOZ and what is it used for
   2. What you need to know before taking OMEGA 3 SANDOZ
   3. How to take OMEGA 3 SANDOZ
   4. Possible side effects
   5. How to store OMEGA 3 SANDOZ
   6. Contents of the pack and other information

OMEGA 3 SANDOZ 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What OMEGA 3 SANDOZ is and what it is used for
• 2. What you need to know before you take OMEGA 3 SANDOZ
• 3. How to take OMEGA 3 SANDOZ
• 4. Possible side effects
• 5. How to store OMEGA 3 SANDOZ
• 6. Contents of the pack and other information

1. What is OMEGA 3 SANDOZ and what is it used for

OMEGA 3 SANDOZ contains as active ingredients ethyl esters of polyunsaturated fatty acids (derived from
fish oil) with high concentration and purity, which reduce the level of certain fats in the blood
(triglycerides) and which have positive effects on the heart and blood vessels.
OMEGA 3 SANDOZ is indicated:

• to reduce high levels of fats (triglycerides) in the blood, in cases where diet and other non-pharmacological measures alone have not been sufficient. Treatment with OMEGA 3 SANDOZ must always be associated with adequate dietary rules.

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.
Tell your doctor before taking OMEGA 3 SANDOZ:

• if you are allergic to fish, as the active ingredient of OMEGA 3 SANDOZ is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during the

treatment, especially if you are using high doses of OMEGA 3 SANDOZ;

• if you have bleeding disorders.

Other medicines and OMEGA 3 SANDOZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are being treated with:

• medicines to thin the blood (anticoagulants) e.g. coumarin anticoagulants
• other medicines that affect blood clotting because an increase in bleeding time may occur.

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 use machines.

3. How to take OMEGA 3 SANDOZ

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Take the OMEGA 3 SANDOZ capsules whole with a little water.

Use in adults
For the reduction of elevated levels of fats (triglycerides) in the blood.
The recommended dose is 1 capsule of 1000 mg 1-3 times a day, as prescribed by your doctor.

Use in the paediatric population
No data are available on the use of OMEGA 3 SANDOZ in the paediatric population in the
authorised indications.

Use in elderly patients and patients with impaired renal function
No dose adjustment is required in these patients.

Use in patients with impaired hepatic function
Your doctor will monitor your liver function during treatment, particularly if you are using
high doses of OMEGA 3 SANDOZ (see section “Warnings and precautions”).

If you take more OMEGA 3 SANDOZ than you should
In case of accidental ingestion of an excessive dose of OMEGA 3 SANDOZ, inform your doctor or
pharmacist.

If you forget to take OMEGA 3 SANDOZ
Do not take a double dose to make up for a missed dose.

If you stop taking OMEGA 3 SANDOZ
If you have any doubts about the use of this medicine, ask 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 part of the abdomen
• diarrhea

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 intestines (gastritis, gastroenteritis)
• abdominal pain
• heartburn
• altered 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 30 ° C. Store in the blister to protect from light.
Do not dispose of any medicine in 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 pack and other information

What OMEGA 3 SANDOZ contains

• The active ingredients are polyunsaturated fatty acid ethyl esters. Each soft capsule contains 1000 mg of polyunsaturated fatty acid ethyl esters, with an EPA and DHA content of 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 oil, of a light yellow colour, with a
characteristic fishy odour.
Each pack contains 20 or 30 soft capsules in a white-opaque heat-sealed blister made of PVC/PVDC-
AL.
Not all pack sizes may be marketed.

Marketing Authorisation 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)