Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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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:
e Teromeg capsules
Do not take Teromeg capsules and tell your doctor if:
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.
Teromeg capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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):
Rare side effects (may affect up to 1 in 1000 people):
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.
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.
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:
Manufacturer: One-Pharma S.A 60th km National Road Athens-Lamia 320 09 Schimatari, Viotia GREECE This leaflet was last updated in January 2024
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.
The active substance in Teromeg 1000 mg Capsules is omega-3-acid ethyl esters 90.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1.
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.
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.
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.
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.
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
There are no special recommendations.
Treatment should be symptomatic.
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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