Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Omega 3-acid-ethyl esters 1000mg soft capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Omega-3-acid ethyl esters 90 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Omega 3-acid-ethyl esters contains highly purified omega-3 polyunsaturated fatty acids. Omega 3-acid-ethyl esters belongs to a group of so called 'reducers of cholesterol and triglycerides'.
Older people There is limited data on the use of Omega3-acid ethyl esters in older people above 70 years of age. Use Omega 3-acid-ethyl esters with care if you are over 70 years. Other medicines and Omega 3-acid-ethyl esters Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are using a medicine to stop blood clotting in your arteries, such as warfarin, you may need extra blood tests and your usual dose of your blood thinning medicine may have to be changed. Omega 3-acid-ethyl esters with food You should take the capsules at meal times. This is to help lower the chances of side effects that affect the area in and around the stomach (the gastro-intestinal area). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine if you are pregnant or breast-feeding, unless your doctor decides it is absolutely necessary.
Omega 3-acid-ethyl esters is used:
- to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked.
Driving and using machines This medicine is not likely to affect you being able to drive or use any tools or machines.
What you need to know before you take it
e Omega 3-acid-ethyl esters Do not take Omega 3-acid-ethyl esters:
- if you are allergic to omega-3-acid ethyl esters or any of the other ingredients of this medicine (listed in section 6).
How to take it
Omega 3-acid-ethyl esters Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Warnings and precautions Talk to your doctor or pharmacist before taking Omega 3-acid-ethyl esters if:
- you are due to have or have recently had surgery;
- you have recently had a trauma;
- you have a kidney problem;
- you have diabetes which is not controlled;
- you have problems with your liver. Your doctor will monitor any effects Omega 3-acid-ethyl esters may have on your liver with blood tests.
- you are allergic to fish.
- you have, or have had, heart problems
- you develop light-headedness, asthenia (feeling of weakness), palpitations or shortness of breath as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).
- Swallow the capsules with a drink of water.
- Take the capsules at meal times to help reduce gastro-intestinal side effects.
- Your doctor will decide how long you should take this medicine. Dose to treat high blood triglyceride levels (high levels of fat in the blood or hypertriglyceridaemia) The recommended dose is 2 capsules a day. If the medicine is not working well enough at this dose, your doctor may increase this to 4 capsules a day. If you take more of Omega 3-acid-ethyl esters than you should If you accidentally take more of this medicine than you should, do not worry, as this is unlikely that you will need special treatment. However, you should contact your doctor or pharmacist for further advice.
Dimension – 135 x 295 mm
Front Side NON PRINTING COLOUR
Omega-3-acid ethyl esters 1000 mg soft capsules SPUK
PACK INSERT
135 x 295 mm 1049841
—-1049297
BLACK
1
PC-ODF/2023/788 – Record Number: 406546 & PC-ODF/2023/836 – Record Number: 408433
9.0
Front & Back side printing. To be supplied in the Un-folded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
If you forget to take Omega 3-acid-ethyl esters If you miss a dose, take it when you remember, unless it is almost time for your next dose, in which case take the next dose as usual. Do not take a double dose (twice the dose recommended by your doctor) to make up for a forgotten dose.
Possible side effects
, although not everybody gets them. The following are side effects that may happen with this medicine: Common side effects (may affect up to 1 in 10 people):
- stomach problems like abdominal distension, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching (eructation), acid reflux, feeling sick (nausea) and being sick (vomiting) − Irregular, rapid rhythm of the heart Uncommon side effects (may affect up to 1 in 100 people):
- high blood sugar levels
- gout
- dizziness
- problems with taste
- headache
- low blood pressure
- nose bleed
- blood in your stools
- rash Rare side effects (may affect up to 1 in 1,000 people):
- allergic reactions
- raised red skin rash (hives or urticaria)
- liver disorders, with possible changes in the results of certain blood tests Frequency not known: Other side effects have occurred in a very small number of people but their exact frequency is unknown
- Itching
- Itchy rash (hives or urticaria)
Do not use Omega 3-acid-ethyl esters after the expiry date which is printed on the carton and the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
How to store it
Omega 3-acid-ethyl esters Keep this medicine out of the sight and reach of children.
If you stop using Omega-3-acid ethyl esters Do not stop the treatment without consulting your doctor. Talk to your doctor if you are not satisfied with the effects of Omega-3-acid ethyl esters.
Store Omega 3-acid-ethyl esters capsules below 30°C. Shelf life after first opening of HDPE container is 120 days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause
Contents of the pack and other information
What Omega 3-acid-ethyl esters contains
- The active substance is Omega-3-Acid Ethyl Esters 90. Each capsule contains 1000 mg of omega-3-acid ethyl esters 90 comprising principally 840 mg ethylesters of eicosapentaenoic acid (EPA) (465 mg) and docosahexaenoic acid (DHA) (375 mg).
- The other ingredients are alphatocopherol, gelatin, glycerol, mediumchain triglycerides and ink (composition of ink is dewaxed bleach shellac resin, isopropyl alcohol, propylene glycol, titanium dioxide, sodium lauryl sulphate, twin 80. What Omega 3-acid-ethyl esters looks like and contents of the pack Omega 3-acid-ethyl esters is a soft, oblong, transparent gelatin capsule containing pale yellow colored oily liquid, imprinted with '740'. Omega 3-acid-ethyl esters is available in the following pack sizes: − White opaque HDPE container with white opaque HDPE screw closure with induction sealing. Each bottle contains 20, 28, 100 or 120 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre Dwight Road, Watford, WD 189 SS United Kingdom The leaflet was last revised on 01/2024.
1049841
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Dimension – 135 x 295 mm
Back Side NON PRINTING COLOUR
Omega-3-acid ethyl esters 1000 mg soft capsules SPUK
PACK INSERT
135 x 295 mm 1049841
—-1049297
BLACK
1
PC-ODF/2023/788 – Record Number: 406546 & PC-ODF/2023/836 – Record Number: 408433
9.0
Front & Back side printing. To be supplied in the Un-folded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
Frequently asked questions about Omega 3-acid-ethyl esters 1000mg soft capsules
How do I take Omega 3-acid-ethyl esters 1000mg soft capsules?
Omega 3-acid-ethyl esters 1000mg soft capsules comes as capsule containing 1000mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Omega 3-acid-ethyl esters 1000mg soft capsules?
The active substance in Omega 3-acid-ethyl esters 1000mg soft capsules is omega-3-acid ethyl esters 90.
Are there equivalent medicines to Omega 3-acid-ethyl esters 1000mg soft capsules?
Medicines with the same active substance, strength and form include: Omacor 1000 mg Soft Capsules, Teromeg 1000 mg Capsules. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Omega 3-acid-ethyl esters 1000mg soft capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Omega 3-acid-ethyl esters 1000mg soft capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: omega-3-acid ethyl esters 90
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Hypertriglyceridaemia
Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response:
- type IV in monotherapy,
- typeIIb/III in combination with statins, when control of triglycerides is insufficient.
4.2. Posology and method of administration
Adults
Hypertriglyceridaemia
Initial treatment is two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily.
The capsules may be taken with food to avoid gastrointestinal disturbances.
Special populations
There is limited clinical data regarding the use of Omega 3-acid-ethyl esters Strides 1000mg soft capsules in older people over 70 years of age and patients with renal impairment (see section 4.4).
There is no information regarding the use of Omega 3-acid-ethyl esters Strides 1000mg soft capsules in children and adolescents or in patients with hepatic impairment (see section 4.4).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Warnings
Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules per day), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary (see section 4.5 Interaction with other Medicinal Products and other forms of Interaction). Use of this medication does not eliminate the need for the surveillance usually required for patients of this type.
Make allowance for the increased bleeding time in patients at high risk of haemorrhage (because of severe trauma, surgery, etc).
Omega 3-acid-ethyl esters 1000mg soft capsules should be used with caution in patients with known sensitivity or allergy to fish.
Paediatric population
In the absence of efficacy and safety data, use of this medication in children and adolescents is not recommended.
During treatment with Omega-3-acid ethyl esters 90, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.
Systematic reviews and meta-analyses of randomized controlled clinical trials highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl esters compared to placebo. The observed risk is highest with a dose of 4 g/daily (see section 4.8). If atrial fibrillation develops, treatment should be permanently discontinued.
Clinical data regarding the use of Omega-3-acid ethyl esters 90 in older people over 70 years of age are limited.
Only limited information regarding the use in patients with renal impairment is available.
In some patients a small but significant increase (within normal values) in ASAT and ALAT was reported, but there are no data indicating an increased risk for patients with hepatic impairment. ALAT and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage, i.e. 4 capsules per day).
Omega-3-acid ethyl esters 90 is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).
There is no experience regarding the treatment of hypertriglyceridaemia in combination with fibrates.
4.5. Interaction with other medicinal products and other forms of interaction
Oral anticoagulants: See Section 4.4 Special warnings and precautions for use.
Omega-3-acid ethyl esters 90 have been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Omega-3-acid ethyl esters 90 are combined with warfarin or when treatment with Omega-3-acid ethyl esters 90 is stopped.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of Omega-3-acid ethyl esters 90 in pregnant women.
Studies in animals have not shown reproductive toxicity. The potential risk for humans is unknown and therefore Omega-3-acid ethyl esters 90 should not be used during pregnancy unless clearly necessary.
Breast-feeding
There are no data on the excretion of Omega-3-acid ethyl esters 90 in animal and human milk. Omega-3-acid ethyl esters 90 should not be used during lactation.
Fertility
No data available
4.7. Effects on ability to drive and use machines
Effects on ability to drive and use machines have not been studied. Nevertheless, Omega-3- acid ethyl esters 90 is expected to have no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥1/1000 to < 1/100); rare (≥1/10000 to < 1/1,000); very rare (< 1/10,000).
Immune system disorders:
Rare: hypersensitivity
Metabolism and nutrition disorders:
Uncommon: hyperglycaemia, gout
Nervous system disorders:
Uncommon: dizziness, dysgeusia, headache
Cardiac disorders
Common: Atrial fibrillation
Vascular disorders:
Uncommon: hypotension
Respiratory thoracic and mediastinal disorders:
Uncommon: epistaxis
Gastrointestinal disorders:
Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting)
Uncommon: gastrointestinal haemorrhage
Hepatobiliary disorders:
Rare: liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased)
Skin and subcutaneous tissue disorders:
Uncommon: rash
Rare: urticaria
Not unknown: pruritus
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
There are no special recommendations. Treatment should be symptomatic.
💬 Ask about this leaflet
Ask anything about Omega 3-acid-ethyl esters 1000mg soft capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.