Blumeg

Package leaflet: Information for the patient

BLUMEG 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BLUMEG is and what it is used for
2. What you need to know before taking BLUMEG
3. How to take BLUMEG
4. Possible side effects
5. How to store BLUMEG
6. Contents of the pack and other information

1. What BLUMEG is and what it is used for

BLUMEG contains highly concentrated and purified ethyl esters of polyunsaturated fatty acids (derived from fish oil), which reduce levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
BLUMEG is indicated:

• for reducing high levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with BLUMEG must always be accompanied by appropriate dietary measures.

2. What you need to know before taking BLUMEG

Do not take BLUMEG

• if you are allergic to ethyl esters of polyunsaturated fatty acids (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking BLUMEG.
Inform your doctor before taking BLUMEG:

• if you are allergic to fish, since the active substance in BLUMEG is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of BLUMEG;
• if you have conditions that make you prone to bleeding;
• if you have or have had heart problems;
• if you experience dizziness, asthenia, palpitations, or shortness of breath, as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).

Other medicines and BLUMEG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are being treated with:

• medicines to thin the blood (anticoagulants), e.g. coumarin anticoagulants;
• other medicines that affect blood clotting, as this may lead to an increased bleeding time.

Pregnancy and breastfeeding
Do not use BLUMEG if you are pregnant or breastfeeding.
Driving and using machines
BLUMEG does not affect the ability to drive vehicles or operate machinery.

3. How to take BLUMEG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the BLUMEG capsules whole with some water.

Use in adults
For the reduction of elevated levels of fats (triglycerides) in the blood.
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.

Use in pediatric population
There are no data available on the use of BLUMEG in the pediatric population for the approved indications.

Use in elderly patients and patients with impaired kidney function
No dose adjustment is required in these patients.

Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of BLUMEG (see section “Warnings and precautions”).

If you take more BLUMEG than you should
In case of accidental overdose, contact your doctor or pharmacist immediately.

If you forget to take BLUMEG
Do not take a double dose to make up for the missed dose.

If you stop taking BLUMEG
If you have any questions about the use of this medicine, consult 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 10 people)

• Stomach and/or intestinal disturbances
• Fast, irregular heartbeat

Uncommon side effects (may affect up to 1 in 100 people)

• Nausea
• Difficulty digesting
• Pain in the upper abdomen
• Diarrhoea

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions (hypersensitivity), allergy to the ingredients
• Dizziness
• Inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
• Abdominal pain
• Stomach burning
• Changes in liver function
• Skin reactions
• Weakness

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

• Itching
• Itchy skin rash (urticaria)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BLUMEG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the blister pack to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BLUMEG contains

• The active substances are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with a content of EPA and DHA of not less than 85%, and a ratio between them of 0.9 - 1.5.
• The other components are alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides, purified water.

Description of the appearance of BLUMEG and contents of the pack
Soft capsules, transparent, oblong, containing a clear, light yellow oil with a characteristic fishy odor.
Each pack contains 20 or 30 soft capsules in white opaque thermoformed blisters made of PVC/PVDC-Al.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Ipso Pharma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Exclusive distributor for sale
NEOPHARMED GENTILI S.p.a. - Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (Piacenza)
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milano)