998 mg capsules, soft
icosapentethyl
What Vazkepa is and what it is used for
Vazkepa contains the active substance icosapentethyl, an extremely pure omega-3 fatty acid from fish oil.
Vazkepa lowers the levels of triglycerides (a type of fat) in the blood and it is used together with a statin medicine (which lowers cholesterol in the blood) to prevent cardiovascular events, such as:
- heart attacks
- stroke
- deaths from heart disease
Vazkepa is used in adults with high blood triglycerides who already have heart disease or who have diabetes or other conditions that put them at a higher risk of cardiovascular events.
What you need to know before you take Vazkepa
Do not take Vazkepa
- If you are allergic to icosapentethyl, soy, or any other ingredient of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Vazkepa:
- If you are allergic to fish or shellfish.
- If you have liver problems.
- If you have problems with irregular heartbeats ( atrial fibrillation or atrial flutter ).
- If you are taking anticoagulant medicine (which prevents the blood from coagulating), medicines that inhibit the platelets in the blood or have an increased risk of bleeding.
If any of the above apply to you, talk to your doctor.
Blood samples
During treatment, the doctor may need to take blood samples to check if you have any problems with your liver and to check your blood’s ability to clot.
Children and young people
Do not give this medicine to children and young people under 18 years of age, as it has not been studied in these people.
Other medicines and Vazkepa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take other medicines at the same time as Vazkepa and these affect the clotting ability of the blood, e.g. an anticoagulant (blood-thinning) medicine, you may provide blood samples during treatment.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Vazkepa should not be used during pregnancy unless your doctor advises you to take it.
Breast-feeding
You should not use Vazpeka if you are breastfeeding, as the effect on your baby is not known. The doctor will help you evaluate the benefits of the treatment against any possible risks for your breastfed baby.
Fertility
Talk to the doctor about fertility during treatment.
Driving ability and use of machinery
This medicine is unlikely to affect your ability to drive or use machines.
Vazkepa contains maltitol, sorbitol and soy lecithin
Maltitol (E965)
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Sorbitol (E420)
This medicine contains 83 mg of sorbitol per capsule.
Sorbitol is a source of fructose. If your doctor has told you that you cannot tolerate certain sugars or if you have hereditary fructose intolerance, a rare hereditary disease, which means that you cannot break down fructose, you should consult a doctor before using this medicine.
Soy lecithin
This medicine contains soy lecithin. If you are allergic to soy or peanuts, you should not use this medicine.
How to take Vazkepa
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Do not change your dose without first talking to your doctor.
How to open the bottle
Press down on the screw cap and turn it counterclockwise.
How much to take
The recommended dose is two capsules by mouth, twice daily, with or after a meal.
Swallow the capsules whole; you should not open, crush, dissolve or chew the capsules.
Older
There is no reason to change the dose in elderly patients. They can take the usual recommended dose of one.
If you have taken too much Vazkepa
If you happen to take more capsules than the doctor has prescribed, you should consult a doctor or pharmacist.
If you forget to take Vazkepa
If you forget to take a dose, take it as soon as you remember. If you forget to take the medicine for an entire day, just take the next scheduled dose. Do not take a double dose to make up for a missed dose. If you have further questions about this medicine, contact your doctor or pharmacist.
If you stop using Vazkepa
Do not stop taking this medicine without first talking to your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor
- if you get palpitations or have irregular heartbeats. These can be symptoms of a serious condition called atrial fibrillation. This is a common side effect (may affect up to 1 in 10 users)
- if you bruise easily or do not stop bleeding. This is a very common side effect (may affect more than 1 in 10 users). Your risk of bleeding may increase if you take an anticoagulant (blood-thinning) medicine at the same time.
Seek medical attention if you experience any of the following side effects. These symptoms can be caused by a serious condition called hypersensitivity, which can occur at any time during treatment. It is an uncommon side effect (may affect up to 1 in 100 users)
- breathing difficulties
- tightening or itching sensation in the throat
- swollen lips
- hives (bumps on the skin)
- rash and itching of the skin
- stomach aches or stomach cramps
- diarrhea
- nausea and vomiting
Other side effects that may occur
Common side effects (may affect up to 1 in 10 users):
- swelling of the hands, arms, legs, and feet
- pain in muscles, bones, or joints
- gout (painful swelling of the joints due to accumulation of uric acid )
- rash
- constipation
- belching
Uncommon side effects (may affect up to 1 in 100 users)
- bad taste in the mouth
How to store Vazkepa
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle label or blister pack after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Bottle: close the bottle well. Moisture sensitive.
Blister packaging: store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is icosapentethyl. 1 Vazkepa capsule contains 998 mg icosapentethyl.
- Other ingredients are
- all-rac-alpha-tocopherol, gelatin, glycerol, maltitol, liquid (E965), sorbitol, liquid (non-crystallizing) (E420), purified water and soy lecithin (see section 2 “Vazkepa contains maltitol, sorbitol, and soy lecithin”).
- printing ink: titanium dioxide, propylene glycol, hypromellose.
Appearance and package sizes of the medicine
In this package you will find oblong, soft capsules, 25 x 10 mm, imprinted with “IPE” in white ink, with a light yellow to amber colored shell containing a colorless to light yellow liquid.
The bottles containing 120 capsules are white 300 ml high-density polyethylene (HDPE) bottles with a child-resistant, heat-sealed polypropylene closure.
Pack size of one bottle or three bottles per carton.
The blister packs contain 4×2 capsules in perforated single-dose blisters made of PVC/PCTFE/Al.
Marketing Authorisation Holder
Amarin Pharmaceuticals Ireland Limited
88 Harcourt Street
Dublin 2, D02DK18
Ireland
Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock,
Co. Dublin
Ireland