What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 15905/0002.

Dualtis

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dualtis®

1000 mg soft capsules

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.

In this leaflet:

1. What Dualtis is and what it is used for
2. Before you take Dualtis
3. How to take Dualtis
4. Possible side effects
5. How to store Dualtis
6. Further information

1. WHAT DUALTIS IS AND WHAT IT IS USED FOR

Dualtis contains highly purified omega-3 polyunsaturated fatty acids.

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

Dualtis is used:

  • together with other medicines for treatment after a heart attack.
  • to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked.

2. BEFORE YOU TAKE DUALTIS

Do not take Dualtis, if

  • you are allergic (hypersensitive) to the main ingredient or any of the other ingredients of Dualtis (see Section: Important information about some of the ingredients, and Section 6: Further Information).

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

Take special care with Dualtis 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 Dualtis may have on your liver with blood tests.

If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Using 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.

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

Taking Dualtis with food or 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).

Use in elderly

Use Dualtis with care if you are over 70 years.

Use in children

Children should not take this medicine.

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.

Driving and using machines

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

Important Information about some of the ingredients

Dualtis may contain soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.

3. HOW TO TAKE DUALTIS

Always take Dualtis 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 gastro-intestinal side effects.
  • Your doctor will decide how long you should take this medicine.

Dose after a heart attack

The usual dose is one capsule a day.

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 of Dualtis 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 Dualtis

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dualtis 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)

Uncommon side effects

(occur in 1 to 10 users in 1,000):

  • high blood sugar levels
  • gout
  • dizziness
  • problems with taste
  • headache
  • low blood pressure
  • nose bleed
  • blood in your stools
  • rash

Rare side effects

(occur in 1 to 10 users in 10,000):

  • allergic reactions
  • raised red skin rash (hives or urticaria)
  • liver disorders, with possible changes in the results of certain blood tests

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DUALTIS

  • Keep out of the reach and sight of children.
  • Do not use Dualtis after the expiry date which is printed on the carton and the label. The expiry date refers to the last day of the month.
  • Do not store Dualtis 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.

6. FURTHER INFORMATION

What Dualtis 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) and 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty acids) including as antioxidant 4 mg d-alpha- tocopherol (mixed with a vegetable oil e.g. soya-bean oil).

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

What Dualtis looks like and contents of the pack

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

Dualtis is available in the following pack sizes:

  • 1 x 20 capsules
  • 1 x 28 capsules
  • 1 x 60 capsules
  • 1 x 100 capsules
  • 10 x 28 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer of Dualtis is :

Pronova BioPharma Norge AS
P.O. Box 420
NO -1327 Lysaker
Norway

This leaflet was last updated: September 2016

Dualtis is supplied in the United Kingdom by

BGP Products Ltd.
Abbott House
Vanwall Business Park
Vanwall Road
Maidenhead
SL6 4XE
UK

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