Vitomeg 1000 Mg Soft Capsules
Patient Information Leaflet: Information for the patient
Vitomeg 1000 mg Soft Capsules
Omega-3-acid ethyl esters 90
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What is Vitomeg 1000 mg Soft Capsules and what it is used for
2. What you need to know before you take Vitomeg 1000 mg Soft Capsules
3. How to take Vitomeg 1000 mg Soft Capsules?
4. Possible side effects
5. How to store Vitomeg 1000 mg Soft Capsules
6. Contents of the pack and other information
1. What Vitomeg 1000 mg Soft Capsules is and what it is used for
The active ingredients of Vitomeg 1000 mg Soft Capsules are the poly unsaturated omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Vitomeg 1000 mg Soft Capsules reduces certain blood fats (triglycerides) and is used for prevention after a heart attack.
Vitomeg 1000 mg Soft Capsules is used:
• together with other medicines for treatment after a heart attack.
• to treat certain forms of increased fats in the blood (endogenous hypertriglyceridemia) after changes to the diet alone have not worked.
2. What you need to know before you take Vitomeg 1000 mg Soft Capsules
Do not take Vitomeg 1000 mg Soft Capsules
• if you are allergic to omega-3-acid ethyl esters 90, soya, peanut, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Vitomeg 1000 mg Soft Capsules if
- you are using a medicine to stop blood clotting, so-called anticoagulants, because at a high dosage intake of 4 soft capsules of Vitomeg 1000 mg Soft Capsules per day, Vitomeg 1000 mg Soft Capsules leads to a prolonged bleeding time.
- you are due to have surgery, please inform your doctor that you are taking Vitomeg 1000 mg Soft Capsules
Vitomeg 1000 mg Soft Capsules is not indicated for certain kinds of elevated blood fat values (exogenous
hypertriglyceridaemia, especially type 1 hyperchylomicronaemia).
There is only limited experience for certain kinds of elevated blood fat values (secondary endogenous
hypertriglyceridaemia, especially with uncontrolled diabetes).
There is no experience regarding the treatment of hypertriglyceridaemia in combination with fibrates. Patients with known liver disease
A control of the liver enzyme values in the blood at regular intervals is required especially at high doses (4 soft capsules per day).
Children and adolescents
Because there are no data on the efficacy and safety, use of this medicinal product in children is not recommended.
Elderly Persons
There is no data on the use of Vitomeg 1000 mg Soft Capsules in elderly patients above 70 years of age. Patient with kidney problems
There is only limited data for the use of Vitomeg 1000 mg Soft Capsules in patients with kidney disorders.
Other medicines and Vitomeg 1000 mg Soft Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Vitomeg 1000 mg Soft Capsules may increase the bleeding time. If you are using Vitomeg 1000 mg Soft Capsules together with a medicine which stops blood clotting (anticoagulants), your doctor will closely supervise your treatment, and adjust the dose if required.
Pregnancy, breast-feeding and fertility
There is no adequate data concerning the use of Vitomeg 1000 mg Soft Capsules for pregnant women. Studies have so far not shown reproductive toxicity of Vitomeg 1000 mg Soft Capsules. Since the potential risk for humans is unknown, Vitomeg 1000 mg Soft Capsules should not be given during pregnancy if it is not clearly necessary. Please follow the instructions of your doctor.
Since it is unknown whether Vitomeg 1000 mg Soft Capsules is excreted in human milk, Vitomeg 1000 mg Soft Capsules should not be used during lactation.
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.
Vitomeg 1000 mg Soft Capsules contains soya oil
If you are allergic to peanut or soya, do not take this medicine.
3. How to take Vitomeg 1000 mg Soft Capsules?
Always take this medicine exactly as your doctor or pharmacist has told you. Please check with your doctor or pharmacist if you are not sure.
The recommended dose is:
After heart attack:
1 soft capsule per day
For elevated blood fat values:
2 soft capsules per day. In the case of insufficient effect, the dose can be increased to 4 soft capsules per day.
Please talk to your doctor or pharmacist if you have the impression that the effect of Vitomeg 1000 mg Soft Capsules is too strong or too weak.
How to take:
The soft capsules should be swallowed together with a sufficient amount of fluid at meal times. This way, you can avoid possible gastro-intestinal side effects.
If you take more Vitomeg 1000 mg Soft Capsules than you should
If you accidentally take more of this medicinal product than you should and you are experiencing negative effects, please contact your doctor.
If you forget to take Vitomeg 1000 mg Soft Capsules
Do not take a double dose to make up for a forgotten dose. Instead, take the next soft capsules as prescribed.
If you stop taking Vitomeg 1000 mg Soft Capsules
Do not stop the treatment without consulting your doctor. Talk to your doctor if you are not satisfied with the effects of Vitomeg 1000 mg Soft Capsules.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10people):
• stomach problems such as feeling bloated (abdominal distension), pain, constipation, diarrhoea, indigestion (dyspepsia), wind, belching (eructation), acid reflux, feeling sick (nausea) and being sick (vomiting)
Uncommon side effects (may affect up to 1 in 100people):
• raised blood sugar
• gout
• dizziness
• taste impairment
• low blood pressure
• nose bleed
• blood in your faeces
• rash
Rare side effects (may affect up to 1 in 1,000people):
• itchy lumpy rash
• liver problems with possible changes in the results of certain blood tests 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 national reporting system Yellow Card Scheme;
Website: 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 Vitomeg 1000 mg Soft Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.
Storage conditions:
Do not store above 25°C.
Do not freeze.
Shelf life after first opening:
20caps-75ml: 20 days
28caps-75ml: 28 days
100caps-250ml: 100 days
20 caps x 10 bottles each bottle 20 days
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Vitomeg 1000 mg Soft Capsules contains
The active substance is omega-3-acid ethyl esters 90.
Each soft capsule contains 1000 mg omega-3-acid ethyl esters 90, comprising principally 840 mg ethyl esters of eicosapentaenoic acid (EPA) (460 mg) and docosahexaenoic acid (DHA) ethyl esters (380 mg).
The further components are:
- Capsule filling: alpha tocopherol (Ph. Eur)
- Capsule shell: gelatine, glycerol, purified water, medium chain triglycerides, sunflower lecithin. What Vitomeg 1000 mg Soft Capsules looks like and contents of the pack
Vitomeg 1000 mg Soft Capsules 1000 mg are slightly yellow oblong soft capsules approximately 24 mm in length and 10 mm in width. The capsules are packed in white (HDPE) bottles of 75 ml with a LDPE push-fit tamper-evident cap and white (HDPE) bottles of 250 ml with a white PE flip-top cap or a white PE screw cap.
Vitomeg 1000 mg Soft Capsules is available in packs of
75 ml bottles:
20 capsules 28 capsules
200 capsules (10 bottles each with 20 capsules)
250 ml bottles :
100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder NTC Srl
Via Luigi Razza 3 20124 Milan Italy
Manufacturer
Dragenopharm Apotheker Puschl GmbH GollstraBe 1
84529 Tittmoning Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
PT Esteres etilicos 90 do acido omega-3 NTC RO VASOTERAN 1000 mg capsule moi UK Vitomeg 1000 mg Soft Capsules
This leaflet was last revised in 05/2015
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