BRAINMAX

OMEGA-3 LIQUID

Nutritional Information:

Each Serving size of 5 ml contains:

• Total Omega-3………… 585 mg
• EPA ……………………. 255 mg
• DHA …………………….180mg

Ingredients: Water, Fructose, Fish Oil, Sunflower Oil, Mango Puree, Stabilizer [INS 414 & INS 415], Flavour - Mango & Peach, Antioxidant [INS 300, INS 301 & INS 307b], Preservative [INS 211] & Acidity regulator [INS 330].

Dosage Form: liquid

Dosage Strength: 585 mg of omega−3 fatty acids per 5ml.

4.1 Therapeutic indication

Usage: BRAINMAX^TM is a source of Omega-3 fatty acids, EPA & DHA, maintains good health, cognitive health and helps brain function. Supports development of the brain, eyes and nerves in children and adolescents.

4.2 Posology and method of administration

This product can be taken directly from the spoon or diluted with water, fruit juice or milk.

AGES 2-4 years: 1 teaspoon (5 ml) daily.

AGES 4-12 years: 1-2 teaspoons (5-10 ml) daily.

ADULTS: 2-4 teaspoons (10-20 ml) daily.

SHAKE WELL BEFORE USE.

4.3 Contraindications

BRAINMAX ^TM is contraindicated in patients known to be allergic to fish oil and ingredient of it.

4.4 Special warnings and precautions for use

• Allergen information: contains fish oil. BRAINMAXTM contain omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to BRAINMAXTM. BRAINMAXTM should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
• It’s a Nutraceutical. NOT FOR MEDICINAL USE. This product is not intended to diagnose, treat, cure or prevent any disease.
• Not to exceed the stated recommended daily usage. Once opened, store refrigerated & use within 90 days.
• Please consult your healthcare provider, if you are taking blood thinners or are diabetic.

4.5 Drug interactions

Anticoagulants or Other Drugs Affecting Coagulation

Because of the moderate increase in bleeding time (with the high dosage), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary.

4.6 Use in special populations

For Pregnant or lactating woman, seek guidance from your Healthcare Professional before using this product.

4.7 Effects on ability to drive and use machines

Effects on ability to drive and use machines have not been studied. Nevertheless, BRAINMAX^TM is expected to have no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

BRAINMAX^TM has no, or minor side effects. When used in recommended doses, no side effects have been reported with BRAINMAX^TM.

However, fish oil supplements can cause mild side effects, including:

• A fishy aftertaste, bad breath
• Heartburn, nausea or diarrhea
• Rash
• BRAINMAX^TM does contain fish. Therefore, people allergic to fish will show allergic reaction to BRAINMAX^TM.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to:medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

There are no special recommendations. Treatment should be symptomatic.

5.1 Mechanism of Action/Pharmacodynamic properties

BRAINMAX^TM contains essential fatty acids, omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) extracted from fish oil. They are essential to health and people must consume them through food. Omega-3 fatty acids are considered as a functional food because of its functional component mainly polyunsaturated fatty acids, which has positive impact on human health when consumed in a sufficient quantity.

Omega-3 fatty acids are essential nutrients that play crucial roles in human health, including in pediatric patients. Here are some key points regarding their use in pediatric populations:

1. Brain Development: Omega-3 fatty acids, especially DHA, are crucial for brain development in infants and young children. DHA supports neuronal growth, synaptogenesis, and cognitive function.

2. Visual Development: DHA is also essential for the development of the retina and visual acuity in infants, contributing to healthy vision.

3. Behavioural Disorders: Some studies suggest that omega-3 supplementation may help in managing symptoms of ADHD (Attention-Deficit/Hyperactivity Disorder) and other behavioural disorders by supporting cognitive function and reducing inflammation.

4. Cardiovascular Health: Omega-3 fatty acids can contribute to cardiovascular health by lowering triglyceride levels and potentially reducing the risk of cardiovascular diseases later in life.

5.3 Pharmacokinetic properties

During and after absorption, there are three main pathways for the metabolism of the omega-3 fatty acids:

- the fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channeled to the peripheral lipid stores;

- the cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids;

- the majority is oxidised to meet energy requirements.

The concentration of omega-3 fatty acids, EPA and DHA, in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.

Animal pharmacokinetic studies have shown that there is a complete hydrolysis of the ethyl ester accompanied by satisfactory absorption and incorporation of EPA and DHA into the plasma phospholipids and cholesterol esters.

6.1 Animal Toxicology

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. In addition, non-clinical literature data on safety pharmacology are indicating that there is no hazard for humans.

Nutritional Information:

Each Serving size of 5 ml contains:

• Total Omega-3………… 585 mg
• EPA ……………………. 255 mg
• DHA …………………….180mg

Ingredients: Water, Fructose, Fish Oil, Sunflower Oil, Mango Puree, Stabilizer [INS 414 & INS 415], Flavour - Mango & Peach, Antioxidant [INS 300, INS 301 & INS 307b], Preservative [INS 211] & Acidity regulator [INS 330].

8.1 Incompatibilities

None applicable

8.2 Shelf-life

Best before 24 months from manufacturing date.

8.3 Packaging information

Net Quantity: 150 ml

8.4 Storage and handing instructions

Store in a cool & dry place.

Once opened, store refrigerated & use within 90 days.

Keep out of reach of children.

• BRAINMAX^TM should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish
• If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use.
• Discontinue use and consult your doctor if any adverse reaction occurs.
• Please consult your healthcare provider, if you are taking blood thinners or are diabetic.

9^th July 2024