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.

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Teromeg 1000 mg 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.

Active substance: Omega-3-acid ethyl esters 90

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Teromeg capsules contain highly purified omega-3 polyunsaturated fatty acids and belong to a group of so called reducers of cholesterol and triglycerides. They are used:

  • to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked.

What you need to know before you take it

e Teromeg capsules

Do not take Teromeg capsules and tell your doctor if:

  • you are allergic (hypersensitive) to omega-3-acid ethyl esters 90 or any of the other ingredients of this medicine (listed in section 6). If any of the above applies to you, do not take this medicine, and talk to your doctor. Warnings and precautions: Talk to your doctor or pharmacist before taking Teromeg capsules if:
  • you are due to have or have had surgery recently
  • you have had a trauma recently
  • you have a kidney problem
  • you have diabetes which is not controlled
  • you have problems with your liver. Your doctor will monitor any effects this medicine 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). If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine. Children Children should not take this medicine. Elderly

Use Teromeg capsules with care if you are over 70 years. 1

Other medicines and Teromeg capsules 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. Teromeg capsules with food and drink 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, breast-feeding and fertility 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. Driving and using machines This medicine is not likely to affect you being able to drive or use any tools or machines. Teromeg contains soya bean oil. Teromeg may contain soya-bean oil. If you are allergic to peanut or soya, do not use this product.

How to take it

Teromeg capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

  • Swallow the capsules with a drink of water.
  • You may 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 usual dose is 2 capsules a day, as recommended by a doctor. 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 Teromeg capsules than you should If you accidentally take more of this medicine than you should, do not worry, as this is unlikely to need special treatment. However, you should contact your doctor or pharmacist for further advice. If you forget to take Teromeg capsules 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause 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 and 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 1000 people):

  • allergic reactions
  • Itchy rash (hives or urticaria)
  • liver disorders, with possible changes in the results of certain blood tests Not known (frequency cannot be estimated from the available data): 

Itching

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Teromeg capsules

Keep this medicine out of the sight and reach of children. Do not store Teromeg above 25°C. Do not freeze. Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of the month. Teromeg capsules should be used within 100 days of opening the bottle. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Teromeg capsules contain: The active substance is omega-3-acid ethyl esters 90, comprising principally 840 mg ethylesters of eicosapentaenoic acid (EPA) 460 mg and docosahexaenoic acid (DHA) 380 mg. The capsule core is made of alpha-tocopherol (which may contain vegetable oil e.g. soya oil). The capsule shell is made up of gelatin, glycerol, purified water, medium-chain triglycerides and lecithin (sunflower). What Teromeg capsules look like and the contents of the pack Teromeg capsules are transparent soft gelatin capsules containing slightly yellow oil. Teromeg capsules are available in the following pack sizes:

  • 1 x 20 soft gel capsules
  • 1 x 28 soft gel capsules
  • 1 x 30 soft gel capsules
  • 1 x 60 soft gel capsules
  • 1 x 100 soft gel capsules
  • 10 x 28 soft gel capsules Not all pack sizes may be marketed. Marketing Authorisation Holder: Mercury Pharmaceuticals Ltd, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

Manufacturer: One-Pharma S.A 60th km National Road Athens-Lamia 320 09 Schimatari, Viotia GREECE This leaflet was last updated in January 2024

Frequently asked questions about Teromeg 1000 mg Capsules

How do I take Teromeg 1000 mg Capsules?

Teromeg 1000 mg 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 Teromeg 1000 mg Capsules?

The active substance in Teromeg 1000 mg Capsules is omega-3-acid ethyl esters 90.

Are there equivalent medicines to Teromeg 1000 mg Capsules?

Medicines with the same active substance, strength and form include: Omacor 1000 mg Soft Capsules, Omega 3-acid-ethyl esters 1000mg soft 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 Teromeg 1000 mg 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 Teromeg 1000 mg 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Omega-3-acid ethyl esters 90 (4 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

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

Posology

Hypertriglyceridaemia

Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily.

Older people (Over the age of 70 years)

There is limited clinical data regarding the use of Teromeg 1000 mg Capsules.

Renal Impairment

There is limited clinical data regarding the use of Teromeg 1000 mg Capsules (see section 4.4).

Hepatic Impairment

There is no information regarding the use of Teromeg 1000 mg Capsules in patients with hepatic impairment (see section 4.4).

Paediatric population and adolescents

There is no information regarding the use of Teromeg 1000 mg Capsules in children and adolescents.

Method of administration

The capsules may be taken with food to avoid gastrointestinal disturbances.

4.3. Contraindications

Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules), 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).

In the absence of efficacy and safety data, use of this medication in children 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.

Clinical data regarding the use of Omega 3-acid-ethyl esters 90 in elderly patients 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).

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 hypertriglyceridaemia in combination with fibrates.

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.

Teromeg capsules should be used with caution in patients with known sensitivity or allergy to fish.

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 are stopped.

4.6. Fertility, pregnancy and lactation

Pregnancy

Adequate data from the use of Omega-3-acid ethyl esters 90 in pregnant women is not available.

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

No data on the excretion of Omega-3-acid ethyl esters 90 in animal and human milk is available. Omega-3-acid ethyl esters 90 should not be used during lactation.

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 (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

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, diarrhea, 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 known (cannot be estimated from the available data): 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. Website: www.mhra.gov.uk/yellowcard

4.9. Overdose

There are no special recommendations.

Treatment should be symptomatic.

💬 Ask about this leaflet

Ask anything about Teromeg 1000 mg 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.

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