OMACOR soft capsules

Indication OMACOR soft capsules /Application

• The medicinal product contains highly purified omega-3 polyunsaturated fatty acids.
• It belongs to a group of drugs called cholesterol and triglyceride lowering agents.
  • The preparation is applied
    • for prevention after heart attack, in addition to other standard treatment.
    • to treat certain forms of increased blood fat levels (endogenous hypertriglyceridemia) when suitable dietary measures alone are not sufficient.

OMACOR soft capsules dosage

• Always take the preparation exactly as your doctor has told you. Please check with your doctor or pharmacist if you are not sure.
• dosing after myocardial infarction
  • The usual dose is 1 capsule per day.
• Dose used to treat high blood fat levels (high blood triglyceride levels or hypertriglyceridemia)
  • The usual daily dose recommended by the doctor is 2 capsules. In case of insufficient effect, the dose can be increased by your doctor to 4 capsules per day.
• Your doctor will decide how long you should take this medicine.

• If you take more than you should
  • If you accidentally take more than you should, don't worry.
  • It is unlikely that any special treatment will be required. In such a case, please contact your doctor or pharmacist.

• If you forget to take a dose
  • If you forget to take your daily dose, take it as soon as possible unless it is already time for your next dose. In this case, take the next dose as usual. Do not take a double dose (twice the amount recommended by your doctor) to make up for a forgotten dose.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

   

OMACOR capsule way

• Swallow the capsules with a glass of water.
• You should take the capsules with meals to avoid side effects in the gastrointestinal tract.

side effects

• Like all medicines, the preparation can have side effects, although not everyone gets them. The following side effects may occur when using this medicine:
• Common side effects (affects 1 to 10 users in 100):
  • Stomach problems and digestive disorders such as upper abdominal distension, pain, constipation, diarrhea, dyspepsia, flatulence, belching and heartburn
  • nausea (feeling sick) and vomiting
• Uncommon side effects (affects 1 to 10 users in 1000):
  • High blood sugar levels
  • gout
  • dizziness
  • Taste disturbance
  • headache
  • Low blood pressure
  • nosebleeds
  • blood in the stool
  • skin rash
• Rare side effects (affects 1 to 10 users in 10,000):
  • Allergic reaction
  • Itchy rash (itching, hives)
  • Liver disease, with abnormal values ​​in certain blood tests
• Other side effects have occurred in a very small number of patients with an unknown frequency.
  • itching
• Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

OMACOR capsule interactions

• Taking with other medicines
  • If you are taking anticoagulants (medicines used to thin the blood such as warfarin), additional blood tests may be required and the dose of the anticoagulant may need to be adjusted.
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
• Take with food and drink
  • You should take the capsules with meals. This reduces the likelihood of adverse effects occurring in the gastrointestinal tract.

Contraindications

• The drug must not be taken
  • if you are allergic (hypersensitive) to the active substance or any of the other ingredients.
• If the above applies to you, you should not take the preparation and ask your doctor for advice.

pregnancy and breast feeding period

• You should not take the preparation if you are pregnant or breastfeeding unless your doctor considers it absolutely necessary.
• Ask your doctor or pharmacist for advice before taking any medicine.

patient OMACOR capsule notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine
    • if you are going to have or have recently had an operation
    • if you have recently suffered an injury (trauma).
    • if you have problems with your kidneys
    • if you suffer from diabetes that is not optimally controlled
    • if you have problems with your liver. Your doctor will do blood tests to check possible effects on your liver
    • if you have a fish allergy.
  • Elderly people
    • If you are over 70 years of age, caution is required when taking it.
  • children
    • The preparation should not be taken by children.

• Ability to drive and use machines
  • It is unlikely that this drug will affect your ability to drive or use any tools or machines.

additional Information

The preparation is not indicated in certain forms of elevated blood lipid levels (exogenous hypertriglyceridemia, especially type I hyperchylomicronemia).
There is limited experience in certain forms of elevated blood lipid levels (secondary endogenous hypertriglyceridaemia, particularly in untreated diabetes).
There is no experience in the treatment of hypertriglyceridaemia in combination with fibrates.

active ingredients

• 1000 mg omega-3 acid ethyl ester 90

excipients

• 4 mg (R,R,R)-α-tocopherol
• soybean oil
• gelatin
• glycerol
• water, purified
• Triglycerides, medium chain
• Lecithin (soybean)

Areas of application:
- Increased fat concentration in the blood (especially triglycerides)
- Prevention of recurrence of a heart attack Instructions for

use:
The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water).

Duration of use?
The duration of use depends on the type of symptoms and/or the course of the disease. In principle, the duration of use is not limited in time, the drug should be used for a longer period of time.

overdose?
Overdose can cause nausea and discomfort, among other things. If you suspect an overdose, contact a doctor immediately.

Forgot to take?
Continue taking it as normal (i.e. not double the amount) at the next prescribed time.

In general, pay attention to a conscientious dosage, especially for infants, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

Mode of action:
How does the ingredient in the drug work?

The active substance lowers blood fat levels by preventing the body from producing certain fats in the liver, so-called neutral fats or triglycerides. The proportion of fats circulating in the bloodstream is thus reduced and their accumulation on the inner walls of the vessels ("calcification") is reduced.

Contraindications:
What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - talk to your doctor or pharmacist about this:
- Restricted kidney function
- Restricted liver function, such as:
- Cirrhosis of the liver (damage to liver tissue)

Which age group should be considered?
- Children and adolescents under the age of 18: The medicine should not normally be used in this age group.
- Elderly patients over 70 years of age: The medicine may only be used after consulting a doctor or under medical supervision.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: According to current knowledge, it is not recommended to use it. You may be to consider a weaning.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use involves in the event of a contraindication.

Side effects:
What side effects can occur?

- Gastrointestinal complaints, such as:
- nausea
- abdominal pain
- taste disorders
- inflammation of the mucous membranes of the stomach and small intestine
- dizziness

.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Important information:
What should you consider?
- Be careful with allergies to peanuts, soy and legumes, possibly also to lupines (as flour in ready-made dough for pizza and rolls)!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.