BALIK 1000 mg Soft Capsule

Зміст інструкції

1. Balik 1000 mg soft capsules
   1. What is Balik and what is it for
   2. What you need to know before taking Balik
   3. How to take Balik
   4. Possible side effects
   5. How to store Balik
   6. Contents of the pack and other information

Balik 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Generic medicine

Read 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could 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 is Balik and what it is used for
• 2. What you need to know before you take Balik
• 3. How to take Balik
• 4. Possible side effects
• 5. How to store Balik
• 6. Contents of the pack and other information

1. What is Balik and what is it for

Balik contains as active ingredients ethyl esters of polyunsaturated fatty acids (derived from fish oil) at
high concentration and purity, which reduce the level of certain fats in the blood (triglycerides) and which have
positive effects at the level of the heart and blood vessels.
Balik is indicated to reduce high levels of fats (triglycerides) in the blood, in cases where diet and other
non-pharmacological measures alone have not been sufficient.
Treatment with Balik must always be associated with adequate dietary rules

2. What you need to know before taking Balik

Do not take Balik

• 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 Balik.
Tell your doctor before taking Balik if:

• you are allergic to fish, as the active ingredient of Balik is derived from fish oil;
• you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of Balik;
• you have bleeding disorders;
• you have, or have had, heart problems;
• you experience dizziness, asthenia, palpitations or shortness of breath, as these may be symptoms of an

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irregular and often very rapid heartbeat (atrial fibrillation).

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

• medicines to thin the blood (anticoagulants) e.g. coumarin anticoagulants
• other medicines that affect blood clotting because an increase in bleeding time may occur. Pregnancy, breastfeeding and fertilityDo not use Balik if you are pregnant or breastfeeding. Driving and operating machineryBalik does not affect the ability to drive vehicles or operate machinery.

3. How to take Balik

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Take the Balik capsules whole with a little water.

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times a day, as prescribed by your doctor.

Use in children and adolescents
No data are available on the use of Balik in the pediatric population in the authorized indications.

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

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

If you take more Balik than you should
If you accidentally ingest an excessive dose of Balik, inform your doctor or pharmacist.

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

If you stop taking Balik
If you have any doubts about using 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 disorders

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• fast, irregular heartbeat

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

• nausea
• difficulty digesting
• upper abdominal pain
• diarrhoea

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

• allergic reactions (hypersensitivity), allergy to the components
• dizziness
• inflammation of the stomach and/or intestines (gastritis, gastroenteritis)
• abdominal pain
• heartburn
• altered liver function
• skin reactions
• weakness

Other side effects that have been reported in a very small number of people, but whose exact
frequency is unknown

• itching
• itchy rash (urticaria)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 Balik

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 packaging after Scad. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the blister to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Balik contains
Balik 1000 mg soft capsules

• The active ingredients are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with an EPA and DHA content 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 and purified water. Description of the appearance of Balik and contents of the packBalik 1000 mg soft capsules Soft capsules, transparent, oblong containing a clear oil, of a light yellow colour, with characteristic

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fishy odour.
Each pack contains 20 or 30 soft capsules in a white-opaque heat-sealed blister made of PVC/PVDC-AL.
It is possible that not all packs are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MEDINITALY Pharma Progress Srl
Viale di Villa Massimo, 37
00161 Roma

Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)
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