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OMACOR 1000 MG SOFT CAPSULES - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - OMACOR 1000 MG SOFT CAPSULES

OMACOR® 1000mg SOFT CAPSULES

(omega-3-acid ethyl esters 90)

Your medicine is known as OMACOR 1000mg SOFT CAPSULES but will be referred to as Omacor throughout the following leaflet.

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

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Omacor is and what it is used for

2. What you need to know before you take Omacor

3. How to take Omacor

4. Possible side effects

5. How to store Omacor

6. Contents of the pack and other information

3. how to take omacor

Always take Omacor exactly as your doctor has told you. You should 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 gastrointestinal 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 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

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 product, ask your doctor or pharmacist.

1. what omacor is and what it is used for

Omacor contains highly purified omega-3 polyunsaturated fatty acids.

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

Omacor is used:

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

2. what you need to know before you take omacor

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).

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 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

Other medicines and Omacor

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.

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

Omacor 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).

Elderly

Use Omacor with care if you are over 70 years.

Children

Children should not take this medicine.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or breastfeeding, unless your doctor decides it is absolutely necessary.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

This medicine is not likely to affect you being able to

drive or use any tools or machines.

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

Common side effects (occur in 1 to 10 users in 100):

  • stomach problems like abdominal distension, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching (eructation), acid reflux, feeling sick (nausea) and being sick (vomiting)
  • high blood sugar levels
  • gout
  • dizziness
  • problems with taste
  • headache
  • low blood pressure
  • nose bleed
  • blood in your stools
  • rash
  • allergic reactions
  • itchy rash (hives or urticaria)
  • liver disorders, with possible changes in the results of certain

blood tests

Other side effects have occurred in a very small number of people but their exact frequency is unknown

  • itching

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.

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: 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.

5. how to store omacor keep out of the sight and reach of children. do not store omacor above 25°c. do not freeze.

  • Do not use after the expiry date printed on the on the carton label and the bottle label.
  • If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
  • 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.

Omacor contains soya oil

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

6. contents of the pack and other information

What Omacor contains

  • The active substances are omega-3-acid ethyl esters. Each soft capsule contains 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA) and 380 mg docosahexaenoic acid (DHA) ethyl esters. The other ingredients (excipients) are: alpha-tocopherol (mixed with vegetable oil e.g. soya-bean oil).

The soft capsule shell is made up of gelatin, glycerol and purified water.

What Omacor looks like and contents of the pack

Omacor capsules are transparent soft gelatin capsules containing pale yellow oil.

Omacor is available in pack size of 28 and 100.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Pronova BioPharma Norge AS, P.O. Box 420, N-1327 Lysaker, Norway.

[p PL: 19488/1704

Leaflet revision date: 16 March 2020

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Omacor® is a registered trademark of BASF AS, Norway.

S1704 LEAFLET Omacor 20200316

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What are OMACOR capsules used for?

OMACOR capsules contain omega-3 fatty acids that are primarily used to lower triglyceride levels in the blood and support heart health.

How should I take OMACOR 1000 mg capsules?

It is usually recommended to take OMACOR 1000 mg capsules with meals to enhance absorption. Follow your doctor's instructions regarding dosage.

What are the common side effects of OMACOR?

Common side effects may include gastrointestinal issues like stomach upset, diarrhea, or fishy aftertaste. If you experience severe side effects, contact your doctor.

Can I take OMACOR with other medications?

Always consult your healthcare provider before combining OMACOR with other medications, especially blood thinners, as interactions can occur.

Is OMACOR safe for pregnant or breastfeeding women?

Consult your healthcare provider before using OMACOR if you are pregnant or breastfeeding to ensure it is safe for you.

What should I do if I miss a dose of OMACOR?

If you miss a dose of OMACOR, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and resume your regular schedule.

Are there any dietary restrictions while taking OMACOR?

While taking OMACOR, it is advised to maintain a balanced diet low in saturated fats and sugars to optimize heart health.

How long does it take to see results from taking OMACOR?

Patients may start to see improvements in triglyceride levels within a few weeks, but it is best to discuss individual progress with your healthcare provider.

Can children take OMACOR capsules?

OMACOR is generally not recommended for children without a doctor's prescription. Always consult a pediatrician before giving any supplements.

Is there a specific time of day that's best to take OMACOR?

There is no specific time that's best for everyone; however, taking it with meals can help improve absorption.

Can I crush or chew my OMACOR capsule?

No, do not crush or chew the capsule. Swallow it whole for best results.

Is there an alternative to taking OMACOR if I don't like swallowing pills?

If you have difficulty swallowing pills, discuss alternative forms such as liquid omega-3 supplements with your healthcare provider.

What should I do if I experience allergic reactions while taking OMACOR?

If you suspect an allergic reaction such as rash, itching, or swelling after taking OMACOR, seek medical attention immediately.

Can I continue my exercise routine while taking OMACOR?

Yes, continuing your regular exercise routine can be beneficial while taking OMACOR; however, consult your doctor for personalized advice.

How should I store my OMACOR capsules?

Store OMACOR capsules in a cool, dry place away from direct sunlight and out of reach of children.

Can older adults safely use OMACOR 1000 mg capsules?

Yes, older adults can generally use OMACOR safely, but they should consult their healthcare provider regarding appropriate dosage and any potential interactions.

Does insurance typically cover the cost of OMACOR?

Insurance coverage for OMACOR varies by plan; check with your insurance provider about coverage for prescription medications.

How does omega-3 in OMACOR benefit my heart health?

The omega-3 fatty acids in OMACOR help lower triglycerides, reduce inflammation, and improve overall heart health when combined with a proper diet and exercise.

Are there specific foods that complement the benefits of taking OMACOR?

Foods rich in omega-3s like fatty fish (salmon, mackerel), walnuts, and flaxseeds can complement the benefits of taking OMACOR.

Where can I buy OMACOR 1000 mg capsules online or at pharmacies?

OMACOR 1000 mg capsules are available at most pharmacies and can also be purchased online; ensure you're buying from reputable sources.