Balik

Package leaflet: Information for the patient

Balik 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 others, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Balik is and what it is used 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

1. What Balik is and what it is used for

Balik contains as its active substances ethyl esters of polyunsaturated fatty acids (derived from fish oil) of high concentration and purity, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
Balik is indicated for the reduction of elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient.
Treatment with Balik must always be accompanied by appropriate dietary measures.

2. What you should 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.
Inform your doctor before taking Balik if:

• you are allergic to fish, as the active substance in Balik is derived from fish oil;
• you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Balik;
• you have conditions that make you prone to bleeding;
• you have or have had heart problems;
• you experience dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of an

irregular and often very rapid heart rhythm (atrial fibrillation).
Other medicines and Balik
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, breastfeeding and fertility Do not use Balik if you are pregnant or breastfeeding. Driving and using machines Balik does not affect the ability to drive or operate machinery.

3. How to take Balik

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

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.

Use in children and adolescents
There are no data available on the use of Balik in the paediatric 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 Balik (see section “Warnings and precautions”).

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

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

If you stop taking Balik
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
• Indigestion
• Upper abdominal pain
• Diarrhoea

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

• Allergic reactions (hypersensitivity), allergy to 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the blister to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Balik contains
Balik 1000 mg soft capsules

• The active substances 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 not less than 85% and in a ratio of 0.9 - 1.5 between them. The other components are alfa-tocopherol, gelatin, glycerol, medium-chain triglycerides and purified water. Description of the appearance of Balik and contents of the pack Balik 1000 mg soft capsules Soft, transparent, oblong capsules containing a clear, light yellow oil with a characteristic fish odour.
  Each pack contains 20 or 30 soft capsules in white, opaque thermoformed blisters in PVC/PVDC-AL.
  It is possible that not all pack sizes 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)