The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: omega-3-acid ethyl esters 90Official document: view the original leaflet on emc →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.

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Omacor 1000 mg 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.

Active substance: Omega-3-acid ethyl esters 90

Equivalent medicines (same active substance, strength and form)

→ Omega 3-acid-ethyl esters 1000mg soft capsules brand

→ Teromeg 1000 mg Capsules brand

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR Omacor contains highly _ purified omega-3 polyunsaturated fatty acids.

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KNOW

BEFORE

YOU

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If any of the above applies to you, do not take this medicine, and talk to your doctor.

Talk to your doctor or pharmacist before taking Omacor. if you are due to have or have had surgery recently if you have had a trauma recently if you have a kidney problem if you have diabetes which is not controlled if you have problems with your liver. Your doctor will monitor any effects Omacor may have on your liver with blood tests. if you are allergic to fish

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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)

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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.

Warnings and precautions

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How to take it

OMACOR Always take Omacor exactly as your doctor has told you. You should check with your doctor or 5mm pharmacist if you are not sure.

Do not take Omacor: e if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Omacor (listed in Section 6: Contents of the pack and other information).

Omacor contains soya oil Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

Omacor is used: e to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked. TO

Driving and using machines This medicine is not likely to affect you being able to drive or use any tools or machines.

Omacor belongs to a group of so called reducers of cholesterol and triglycerides.

2. WHAT YOU NEED TAKE OMACOR

| Spot 10 x 2mm £ £

Pregnancy and breast-feeding You should not take this medicine if you are pregnant or breast-feeding, unless your doctor decides it is absolutely necessary. Ask your doctor or pharmacist for advice before using any medicine.

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Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including medicines obtained without prescription.

Children Children should not take this medicine.

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blood tests and your usual dose of your thinning medicine may have to be changed.

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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Omega-3-acid ethyl esters 90

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If you take more Omacor 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 Omacor

Other medicines and Omacor

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If you are using a medicine to stop blood clotting in your arteries, such as warfarin you may need extra

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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.

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6. CONTENTS OF INFORMATION What Omacor

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OTHER

contains

The active substances are omega-3-acid ethyl esters, 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA), 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty arnt and including also 4 . mg d-alpha-tocopherol (mixed with a vegetable . ae oil €.g. soya oil) as antioxidant. The soft capsule shell is made up of gelatine, glycerol, medium-chain triglycerides, lecithin (soya) and purified water.

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Omacor capsules are transparent capsules containing pale yellow oil.

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4. POSSIBLE SIDE EFFECTS Like all medicines, Omacor can cause side effects, although not everybody gets them. The following are side effects that may happen with this medicine: : : : 'on

Possible side effects

(occur in 1 to 10 users in : abdominal ' ' ' e . stomach problems like distension, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching (eructation), acid reflux, feeling sick (nausea) and being sick (vomiting)

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Manufacturer

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

BASF AS Framnesveien 41. _NO-3222 Sandefjord Norway

Reporting of side effects

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pharmacist. This includes any possible side effects not listed : in this . leaflet. You: can also . report side effects directly via the national reporting system. By reporting side effects you can help provide

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If you get any side effects, talk to your doctor or

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This leaflet was last updated: September 2023.

In the UK: The Yellow Card Scheme at:

Omacor is supplied in the UK by Viatris UK Healthcare Limited, 20 Station Close, Potters Bar,

Yellow Card in the Google Play or Apple App Store. In Ireland:

Omacor is supplied in Ireland by Mylan IRE Healthcare Limited, Newenham Court, Northern

www.mhra.gov.uk/yellowcard or search for MHRA

Hertfordshire, EN6 1TL.

Reports may be made via freepost, to the following | Cross, Malahide Road, Dublin 17, Ireland.

address:

HPRA Pharmacovigilance

® Registered Trademark

Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected]

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How to store it

OMACOR e e

Keep this medicine out of the sight and reach of children. Do not use Omacor after the expiry date which is stated on the carton and the label. The expiry

date refers to the last day of the month. e

Donot store Omacor above 25°C. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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Date: 22 AUG 2023

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Frequently asked questions about Omacor 1000 mg Soft Capsules

How do I take Omacor 1000 mg Soft Capsules?

Omacor 1000 mg 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 Omacor 1000 mg Soft Capsules?

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

Are there equivalent medicines to Omacor 1000 mg Soft Capsules?

Medicines with the same active substance, strength and form include: Omega 3-acid-ethyl esters 1000mg 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 Omacor 1000 mg 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 Omacor 1000 mg 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 →

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,

- type IIb/III in combination with statins, when control of triglycerides is insufficient.

4.2. Posology and method of administration

Hypertriglyceridaemia

Initial treatment 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.

There is limited clinical data regarding the use of Omacor in elderly patients over 70 years of age and patients with renal impairment (see section 4.4).

There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4).

4.3. Contraindications

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

Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

4.4. Special warnings and precautions for use

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

In the absence of efficacy and safety data, use of this medication in children is not recommended.

Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited.

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).

During treatment with Omacor, 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.

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).

Omacor 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.

4.5. Interaction with other medicinal products and other forms of interaction

Oral anticoagulants: See Section 4.4 Special warnings and precautions for use.

Omacor has been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Omacor is combined with warfarin or when treatment with Omacor is stopped.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Omacor in pregnant women.

Studies in animals have not shown reproductive toxicity. The potential risk for humans is unknown and therefore Omacor should not be used during pregnancy unless clearly necessary.

Breastfeeding

There are no data on the excretion of Omacor in animal and human milk. Omacor should not be used during lactation.

Fertility

There are no adequate data on the effect of Omacor on fertility.

4.7. Effects on ability to drive and use machines

Effects on ability to drive and use machines have not been studied. Nevertheless, Omacor 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 (>1/10,000 to < 1/1000); very rare (< 1/10,000) ; not known

Immune system disorders:

Rare: hypersensitivity

Metabolism and nutrition disorders:

Uncommon: hyperglycaemia, gout

Nervous system disorders:

Uncommon: dizziness, dysgeusia, headache

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 known: 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

There are no special recommendations. Treatment should be symptomatic.

💬 Ask about this leaflet

Ask anything about Omacor 1000 mg 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.

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