Antioxidants with Omega 3 Fatty Acids Capsules

Each soft gelatin capsule contains:

Alpha Lipoic Acid NF 50 mg

Eicosapentaenoic Acid 45 mg

Docosahexaenoic Acid 30 mg

Mixed Carotenoids - 30% oily suspension 10 mg

Zinc 7.5 mg

(as Zinc Sulphate Monohydrate IP)

Lycopene 10% 25 mg

Manganese 1.5 mg (as Manganese Sulfate Monohydrate USP)

Copper (as Cupric Sulfate USP) 1 mg

Chromium 200 mcg

(as Chromium Nicotinate) Selenium 150 mcg

(as Selenium Dioxide USP)

Excipients q.s.

Colours: Sunset Yellow FCF, Ponceau 4R Supra IH, Erythrosine Supra IH, Brilliant Blue FCF IH & Titanium Dioxide IP

Soft gelatin capsule

Alpha Lipoic Acid (50 mg), Eicosapentaenoic Acid (45 mg), Docosahexaenoic Acid (30 mg), Mixed Carotenoids (10 mg), Zinc (7.5 mg), Lycopene (25 mg), Manganese (1.5 mg), Copper (1 mg), Chromium (200 mcg), Selenium (150 mcg)

4.1 Therapeutic indication

Antioxidants with Omega 3 Fatty Acids capsules for nutritional supplements in cardiovascular diseases and diabetes.

4.2 Posology and method of administration

Adults and the Elderly: One capsule daily, preferably taken after meals. Capsules should be swallowed whole & not to be opened, chewed, or crushed.

4.3 Contraindications

Patients with hypersensitivity reactions to any of its components.

4.4 Special warnings and precautions for use

Whilst taking Bevon-CD Capsules both protein and energy are also required to provide complete nutrition in the daily diet.

Other vitamins, minerals or supplements should be taken with this preparation only under medical supervision.

Do not take Bevon-CD Capsules on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.

4.5 Drugs interactions

Copper: Zinc may inhibit the absorption of copper.

Tetracycline Antibacterials:

Zinc may reduce the absorption of concurrently administered tetracyclines, also the absorption of zinc may be reduced by tetracyclines; when both are being given an interval of at least three hours should be allowed.

Quinolone Antibacterials:

Zinc may reduce the absorption of quinolones; ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.

Calcium Salts: The absorption of zinc may be reduced by calcium salts.

Iron: The absorption of zinc may be reduced by oral iron, also the absorption of oral iron may be reduced by zinc.

4.6 Use in special populations

Children under 12 years of age

Bevon-CD Capsules are not recommended for this age group.

Pregnancy and lactation

Bevon-CD Capsules may be administered during pregnancy and lactation at the recommendation of the physician.

4.7 Effects on ability to drive and use machines

None anticipated. Bevon-CD has no influence on the ability to drive and use machines.

4.8 Undesirable effects

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. Administer symptomatic treatment.

5.1 Pharmacodynamic properties

Alpha-lipoic acid (ALA)

It is a potent antioxidant naturally produced in the body and found in foods like spinach, broccoli, and potatoes. It plays a crucial role in energy metabolism and helps regenerate other antioxidants, such as vitamins C and E.

ALA helps neutralize free radicals, reducing oxidative stress and inflammation, which are key factors in cardiovascular diseases. It can improve the function of the endothelium (the inner lining of blood vessels), which is essential for maintaining vascular health. Studies suggest that ALA can help prevent the progression of atherosclerosis, a condition characterized by the build-up of plaques in the arteries.

ALA has been shown to improve insulin sensitivity, which helps in better glucose uptake by cells, thereby lowering blood sugar levels. It can alleviate symptoms of diabetic neuropathy, such as pain and numbness, by reducing oxidative stress and improving nerve function. ALA may help protect against various complications of diabetes, including cardiovascular issues and kidney damage.

Omega-3 fatty acids (Eicosapentaenoic Acid and Docosahexaenoic Acid)

Omega-3 fatty acids (ω-3 FA) may help reduce the risk of cardiovascular disease (CVD) in patients with diabetes.

Omega-3 fatty acids, especially EPA and DHA, are known to lower triglyceride levels, which can reduce the risk of heart disease. They help reduce inflammation, a key factor in the development of atherosclerosis. Regular consumption of omega-3s is associated with a lower risk of myocardial infarction, strokes, and other cardiovascular events.

Omega-3 fatty acids may improve insulin sensitivity, helping to manage blood sugar levels. Reduces Inflammation: Chronic inflammation is a common issue in diabetes, and omega-3s can help mitigate this.

Mixed Carotenoids

Carotenoids are naturally occurring pigments found in many fruits and vegetables, giving them their vibrant colors. They are powerful antioxidants and play a significant role in human health.

Carotenoids include compounds like beta-carotene, lycopene, lutein, and zeaxanthin. These pigments are found in high concentrations in foods such as carrots, tomatoes, spinach, and kale (leaf cabbage). Carotenoids help reduce oxidative stress, which is a major factor in the development of cardiovascular diseases. They support the health of the endothelium, the inner lining of blood vessels, which is crucial for maintaining vascular health.

Carotenoids have anti-inflammatory effects that can help prevent atherosclerosis, the build-up of plaques in the arteries. Carotenoids can help reduce blood sugar levels and improve insulin sensitivity, which is beneficial for managing diabetes. Higher dietary intake of carotenoids, particularly beta-carotene, has been linked to a lower risk of developing type 2 diabetes. By reducing oxidative stress and inflammation, carotenoids can help protect against complications associated with diabetes.

Zinc

Zinc is an essential mineral that plays a crucial role in various bodily functions, including immune response, protein synthesis, and cell division. Its importance extends to cardiovascular health and diabetes management.

Zinc helps reduce oxidative stress, which is a significant factor in the development of cardiovascular diseases. It supports the proper functioning of the antioxidant system, helping to protect the heart and blood vessels. Zinc can suppress inflammatory mediators, reducing inflammation that contributes to atherosclerosis. Adequate zinc levels are essential for maintaining endothelial function, which is crucial for vascular health.

Zinc is involved in the formation, storage, and release of insulin, making it vital for blood glucose regulation. It acts as a cofactor for enzymes that are crucial in insulin signaling pathways. Zinc helps mitigate oxidative stress and inflammation, both of which are common in diabetes and its complications. Adequate zinc levels can reduce the risk of developing complications associated with diabetes, such as cardiovascular issues and neuropathy.

Lycopene

Lycopene is a powerful antioxidant found in red and pink fruits and vegetables, such as tomatoes, watermelon, and pink grapefruit. It is a type of carotenoid, which gives these foods their vibrant color.

Lycopene helps neutralize free radicals, reducing oxidative stress and inflammation, which are key factors in the development of cardiovascular diseases. It supports the health of the endothelium, the inner lining of blood vessels, which is crucial for maintaining vascular health. Higher blood levels of lycopene have been associated with a significantly lower risk of stroke.

Lycopene helps mitigate oxidative stress, which is a common issue in diabetes and its complications. Some studies suggest that lycopene can improve insulin sensitivity, helping to manage blood sugar levels more effectively. By reducing inflammation and oxidative stress, lycopene can help protect against complications associated with diabetes, such as cardiovascular issues.

Manganese

Manganese is an essential trace mineral that plays a significant role in various bodily functions, including enzyme activation, bone formation, and glucose metabolism. Its importance extends to cardiovascular health and diabetes management.

Manganese is a component of the antioxidant enzyme superoxide dismutase (SOD), which helps protect cells from oxidative damage. This is crucial in preventing cardiovascular diseases. By reducing inflammation, manganese can help prevent the development of atherosclerosis. Adequate manganese levels are associated with better regulation of blood pressure, which is vital for cardiovascular health.

Glucose Metabolism: Manganese is involved in the metabolism of carbohydrates and the regulation of blood sugar levels. It helps in the synthesis and secretion of insulin, which is crucial for glucose homeostasis. Low levels of manganese can impair insulin secretion and increase insulin resistance, while adequate manganese intake can improve insulin sensitivity and glucose metabolism. Manganese helps reduce oxidative stress and inflammation, which are common issues in diabetes and its complications.

Copper

Copper is an essential trace mineral that plays a significant role in various physiological processes, including cardiovascular health and diabetes management.

Copper is a component of several antioxidant enzymes, such as superoxide dismutase (SOD), which help protect cells from oxidative damage. This is crucial in preventing cardiovascular diseases. Copper helps reduce inflammation, which can prevent the development of atherosclerosis. Adequate copper levels are essential for maintaining proper heart function. Copper deficiency can lead to heart issues such as cardiac hypertrophy and heart failure.

Copper is involved in the metabolism of insulin, which is crucial for blood glucose regulation. It helps in the proper functioning of enzymes that are important for insulin signaling. Copper helps mitigate oxidative stress and inflammation, both of which are common in diabetes and its complications.

Chromium

Chromium is an essential trace mineral that plays a vital role in various bodily functions, particularly in the metabolism of carbohydrates, fats, and proteins. It is often found in foods like whole grains, nuts, broccoli, and meat.

Chromium supplementation has been shown to improve lipid profiles by reducing total cholesterol and triglycerides, which are risk factors for cardiovascular diseases. Chromium helps reduce inflammation, which is a key factor in the development of atherosclerosis. Some studies suggest that chromium can help regulate blood pressure, contributing to overall cardiovascular health.

Chromium is known to enhance insulin sensitivity, which helps in better glucose uptake by cells, thereby lowering blood sugar levels. Supplementation with chromium has been shown to improve glycemic control in people with type 2 diabetes by reducing fasting blood glucose and insulin levels. Chromium helps mitigate oxidative stress, which is common in diabetes and its complications.

Selenium

Selenium is an essential trace mineral that plays a crucial role in various bodily functions, including antioxidant defense, thyroid hormone metabolism, and immune function. It is found in foods like nuts, seafood, and whole grains.

Selenium is a component of antioxidant enzymes like glutathione peroxidase, which help protect cells from oxidative damage. This is important in preventing cardiovascular diseases. Selenium helps reduce inflammation, which can prevent the development of atherosclerosis.

Adequate selenium levels are associated with a lower risk of heart disease. Selenium deficiency has been linked to an increased risk of cardiovascular issues.

Selenium may improve insulin sensitivity, helping to regulate blood sugar levels more effectively. By mitigating oxidative stress, selenium can help protect against complications associated with diabetes, such as cardiovascular problems. While selenium has benefits, excessive intake can lead to toxicity and may increase the risk of type 2 diabetes. It’s important to maintain a balanced intake.

5.3 Pharmacokinetic properties

Zinc Sulfate (Zinc): Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Manganese Sulfate (Manganese): Manganese salts are poorly absorbed.

Copper Sulfate (Copper): Copper is absorbed from the gastro-intestinal tract and its major route of excretion is in the bile.

Selenium: Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism.

Chromium Nicotinate

Most chromium compounds are soluble at the pH of the stomach, but less soluble hydroxides may form as pH is increased. The environment of the gastrointestinal tract and ligands provided by foods and supplements are important for mineral absorption.

Mixed Carotenoids

Carotenoids are fat-soluble compounds, meaning they are absorbed more efficiently when consumed with dietary fats. They are absorbed in the small intestine through passive diffusion and are incorporated into chylomicrons, which are lipoprotein particles that transport dietary lipids. Once absorbed, carotenoids are transported via the lymphatic system into the bloodstream. Carotenoids undergo metabolic conversion in the liver. Carotenoids and their metabolites are primarily excreted through bile and feces. A small amount may also be excreted through urine.

Alpha Lipoic Acid (ALA)

ALA is absorbed in the small intestine. Its oral bioavailability is relatively low, around 30%, due to its instability in the stomach and rapid hepatic degradation. Once absorbed, ALA is distributed throughout the body and can cross the blood-brain barrier. It is converted to its reduced form, dihydrolipoic acid (DHLA), in various tissues. ALA undergoes extensive metabolism in the liver. It is reduced to DHLA, which has potent antioxidant properties. Both ALA and DHLA can regenerate other antioxidants like vitamins C and E. ALA and its metabolites are primarily excreted through the kidneys. The compound has a relatively short half-life, which limits its duration of action.

Lycopene

Lycopene absorption occurs via passive diffusion or facilitated by scavenger receptor class B type 1 (SR-B1) in enterocytes, potentially alongside other carotenoids. Partial cleavage by enzymes like Beta-Carotene Oxygenase 1 (BCO1) and Beta-Carotene Oxygenase 2 (BCO2) in enterocytes may occur. Transport involves packaging into chylomicrons, then release into the lymph and portal circulation. Lycopene primarily associates with LDL and is distributed to various organs, notably accumulating in the liver but also present in adipose tissue, adrenal glands, testes, ovaries, kidneys, lungs, skin, and the prostate. Lycopene and its metabolites are primarily eliminated from the body through fecal excretion, a smaller portion may be excreted via urine.

6.1 Animal Toxicology or Pharmacology

Not available

Bevon -CD Capsules contains Antioxidants with Omega 3 Fatty Acids.

Alpha Lipoic Acid (50 mg): An antioxidant that helps protect cells from damage and supports energy production in the body.

Eicosapentaenoic Acid (EPA, 45 mg): An Omega-3 fatty acid that supports heart health, reduces inflammation, and may improve mental health.

Docosahexaenoic Acid (DHA, 30 mg): Another Omega-3 fatty acid crucial for brain and eye health, as well as reducing inflammation.

Mixed Carotenoids (10 mg): These are antioxidants that can help protect your cells from damage and support eye health.

Zinc (7.5 mg): An essential mineral that supports immune function, wound healing, and DNA synthesis.

Lycopene (25 mg): An antioxidant found in tomatoes and other red fruits and vegetables, known for its potential to reduce the risk of certain cancers and support heart health.

Manganese (1.5 mg): A mineral important for bone formation, blood clotting, and reducing inflammation.

Copper (1 mg): Essential for iron metabolism, energy production, and maintaining healthy connective tissues.

Chromium (200 mcg): Helps regulate blood sugar levels by enhancing the action of insulin.

Selenium (150 mcg): An antioxidant that plays a role in DNA synthesis, thyroid function, and protecting the body from oxidative damage and infection.

These ingredients work together to provide a range of health benefits, from supporting heart and boosting your immune system and protecting your cells from damage.

8.1 Incompatibilities

Not Applicable

8.2 Shelf-life

Refer on pack

8.3 Packaging information

10 Blister strips of 10 Capsules each

8.4 Storage and handing instructions

Store in a dry place below 25°C.

Protected from direct sunlight.

Keep out of reach of children.

The capsule should be swallowed whole and not be opened, chewed, or crushed.

10th October 2024

Multivitamin, Multimineral & Antioxidant Suspension

Each 5 ml contains :

• Cholecalciferol IP (As stabilized) 200 IU
• Pyridoxine Hydrochloride IP 1 mg
• Niacinamide IP 15 mg
• Cyanocobalamin IP 1 mcg
• Zinc Sulphate Monohydrate IP
• Equivalent to elemental Zinc 3 mg
• Betacarotene dispersion 2.5% 38 mg
• Manganese Sulfate Monohydrate USP
• Equivalent to elemental Manganese 0.8 mg
• Sodium Molybdate Dihydrate BP
• Equivalent to elemental Molybdenum 8 mcg
• Sodium Selenite Pentahydrate BP
• Equivalent to elemental Selenium 10 mcg
• L-Lysine Hydrochloride USP 30 mg
• Potassium Iodide IP
• Equivalent to elemental Iodine 50 mcg
• Biotin USP 10 mcg
• Chromium Picolinate USP
• Equivalent to elemental Chromium 10 mcg
• Myo-Inositol IP 10 mg
• Excipients q.s.
• Colour : Quinoline Yellow FCF
• In a flavoured syrupy base
• Appropriate overages of vitamins added.

Oral suspension

4.1 Therapeutic indication

For vitamin and mineral deficiency states in adults and children.

4.2 Posology and method of administration

One teaspoonful (5 ml) to be taken once daily.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the formulation.

4.4 Special warnings and precautions for use

• Whilst taking Bevon Suspension both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.
• Do not take Bevon Suspension on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor
• Evidence from Randomised Control Trials suggests that high doses (20-30 mg/day) β-carotene intake may increase the risk of lung cancer in current smokers and those previously exposed to asbestos. This high-risk population should consider the potential risks and benefits of Bevon Suspension, which contain 5mg of β-carotene per recommended daily dose, before use.

4.5 Drugs interactions

Zinc sulphate reduce the absorption of tetracyclines.

4.6 Use in special populations

Pregnancy and breastfeeding

Bevon suspension may be administered during pregnancy and lactation at the recommendation of the physician.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Immune system disorders : Hypersensitivity reaction (such as rash) Gastrointestinal disorders : Gastrointestinal disturbances (such as nausea, vomiting and abdominal pain).

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

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

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

4.9 Overdose

No cases of overdosage due to Bevon therapy have been reported. In case of accidental overdose, discontinue use and seek professional assistance immediately. Any symptoms which may be observed due to the ingestion of large quantities of suspension will be due to the fat soluble vitamin content. Gastric lavage may be necessary to remove drug already released into the stomach. Signs and symptoms such as gastrointestinal disorders like diarrhoea may be associated with an overdose of Bevon.

5.1 Pharmacodynamic properties / Mechanism of action

Cholecalciferol

Vitamin D is required for the absorption of calcium and phosphate from the gastro-intestinal tract and for their transport. Its involvement in the control of calcium metabolism and hence the normal calcification of bones is well documented. Deficiency of Vitamin D in children may result in the development of rickets.

Pyridoxine hydrochloride

The active coenzyme form of vitamin B6 (Pyridoxine) is pyridoxal 5 ′-phosphate. Approximately 80% of the body's total vitamin B6 is present as pyridoxal phosphate in muscle. Pyridoxal phosphate is a coenzyme for many enzymes involved in amino acid metabolism. It is also the co-factor for glycogen phosphorylase, where the phosphate group is catalytically important. Vitamin B6 helps the body to make several neurotransmitters. It is needed for normal brain development and function, and helps the body to make the hormones serotonin and norepinephrine, which influence mood, and melatonin, which helps to regulate the body clock. Along with vitamins B12 and B9 (folic acid), B6 helps to control levels of homocysteine in the blood. In addition, vitamin B6 is important in steroid hormone action where it removes the hormone-receptor complex from DNA binding, terminating the action of the hormones. In vitamin B6 deficiency, this results in increased sensitivity to the actions of low concentrations of estrogens, androgens, cortisol and vitamin D.

Niacinamide

Niacin was discovered as a nutrient during studies of pellagra. It is not strictly a vitamin since it can be synthesized in the body from the essential amino acid tryptophan. Two compounds, nicotinic acid and nicotinamide, have the biologic activity of niacin; its metabolic function is as the nicotinamide ring of the coenzymes NAD and NADP in oxidation-reduction reactions. Nicotinamide has important role in DNA repair mechanism.

Cyanocobalamin

Vitamin B12 is found only in foods of animal origin. Vitamin B12 is essential for cellular DNA synthesis and hence contributes to functions of various tissues of the body, formation of myelin sheath, more so the rapidly dividing and proliferating cellular systems such as blood and gastric epithelium. The absorbed inert form of cyanocobalamin is converted into two important active forms. One is methylcobalamininvolved in maturation of red blood corpuscles. The second active form is adenosylcobalamin involved in healthy myelination and neuronal integrity. Methylcobalamin deficiency leads to folate trap resulting in megaloblastic anemia. Deficiency of adenosylcobalamin leads to accumulation of large amount of methylmalonyl-CoA resulting in synthesis and incorporation of nonphysiological fatty acids into neuronal lipids, causing, demyelination, axonal degeneration and neuronal death leading to neurological complications.

Zinc sulfate

Zinc is an essential trace mineral necessary for the proper function of about 300 different enzymes. Therefore, zinc plays a role in virtually all biochemical pathways and physiological processes in the body. Thirty percent of the body's zinc is stored in the bones and 60% in muscles. The other 10% is found in virtually all body tissues. Zinc is important for wound healing, immune system support and to increase fertility (sperm production). It also assists digestion, energy production, growth, cellular repair, collagen synthesis, bone strength, cognitive function, and carbohydrate metabolism (glucose utilization and insulin production). Zinc not only modulates cell-mediated immunity but is also an antioxidant and anti- inflammatory agent. Mild zinc deficiencies are currently thought to cause chronic metabolic derangement leading to or exacerbating immune deficiency, gastrointestinal problems, endocrine disorders, neurologic dysfunction, cancer, accelerated aging, degenerative disease, and more.

Beta carotene

β-carotene is the most prominent and efficient member of the group of carotenoids (natural colorants that occur in the human diet). Carotenoids are red, orange, or yellow, fat-soluble compounds. Alpha, beta, and gamma carotene are considered provitamins because they can be converted to active vitamin A. Beta-carotene is converted to retinol, which is essential for vision and growth. ROS-induced oxidative stress is suggested as being basic to several human diseases. β-carotene has a unique type of antioxidant activity. Beta carotene traps free radicals and studies suggest that it may also reduce tumor development. Studies have shown that vitamin A is essential to the normal growth of epithelial tissues

Manganese sulfate

Manganese is an essential element for humans and is required for growth, development, and maintenance of health. Manganese is necessary for a variety of metabolic functions including those involved in skeletal system development, energy metabolism, activation of certain enzymes, nervous system function, immunological system function, and reproductive hormone function. It is an antioxidant that protects cells from damage due to free radicals. Manganese also plays an essential role in regulation of cellular energy, bone and connective tissue growth and blood clotting. In the brain, Manganese is an important cofactor for a variety of enzymes, including the antioxidant enzyme superoxide dismutase, as well as enzymes involved in neurotransmitter synthesis and metabolism.

Sodium molybdate dihydrate

Molybdenum belongs to a group of essential microelements. Molybdenum-containing enzymes catalyze basic metabolic reactions in the nitrogen, sulfur, and carbon cycles and are important for variety of metabolic pathways.

Sodium selenite

Selenium is incorporated into selenoproteins that have a wide range of pleiotropic effects, ranging from antioxidant, immune functions and anti-inflammatory effects to the production of active thyroid hormone. Low selenium status has been associated with increased risk of mortality, poor immune function, and cognitive decline. Selenium supplementation has antiviral effects, is essential for male and female reproduction, and reduces the risk of autoimmune thyroid disease. Prospective studies have generally shown some benefit of higher selenium status on the risk of various cancers

L-Lysine

L-Lysine is classified as an essential amino acid. Lysine helps in synthesis of connective tissues such as bone, skin, collagen, and elastin; synthesis of carnitine and resultant conversion of fatty acids to energy; support for healthy growth and development in children; and maintenance of healthy immune function, particularly with regard to antiviral activity.

Iodine (Potassium iodide)

Iodine is an essential constituent of the thyroid hormones.

Biotin

Biotin (Vitamin B7 or H) is a water soluble B vitamin that is essential for bodily health. It helps the body to process fat and sugars, and it helps form a critical process in fat production in the body. Biotin is involved in a number of carboxylase reactions. Biotin is often recommended as a dietary supplement for healthy skin, hair and nails. Biotin deficiency is characterized by development of a fine scaly dermatitis, hair loss, conjunctivitis, ataxia and delayed development.

Chromium picolinate

Chromium is a critical cofactor in the action of insulin. Results from some trials have indicated that chromium supplementation increases muscle gain and fat loss associated with exercise and improves glucose metabolism and the serum lipid profile in patients with or without diabetes. Low chromium levels can increase blood sugar, triglycerides, cholesterol levels, and increase the risk for a number of conditions, such as diabetes and heart disease.

Myo-Inositol

Inositol is an essential molecule found ubiquitously in biological systems. Inositol 1,4,5-triphosphate plays an essential role as a secondary messenger in the InsP3/Ca+2 signal transduction pathway, which is responsible for modulating the activity of numerous cellular processes. Biochemical functions elucidated for phosphatidyl inositol in biological membranes include the mediation of cellular responses to external stimuli, nerve transmission, and the regulation of enzyme activity through specific interactions with various proteins.

5.2 Pharmacokinetic properties

Cholecalciferol

Cholecalciferol is absorbed from the gastro-intestinal tract into the circulation. In the liver, it is hydroxylated to 25-hydroxycholecalciferol, is subject to entero-hepatic circulation and is further hydroxylated to 1,25-dihydroxycholecalciferol in the renal tubule cells. Vitamin D metabolites are bound to specific plasma proteins.

Pyridoxine hydrochloride

Pyridoxine is absorbed from the gastro-intestinal tract and converted to the active pyridoxal phosphate which is bound to plasma proteins. It is excreted in the urine as 4-pyridoxic acid.

Niacinamide

Nicotinic acid is absorbed from the gastro-intestinal tract, is widely distributed in the body tissues and has a short half-life.

Cyanocobalamin

Cyanocobalamin is absorbed from the gastro-intestinal tract and is extensively bound to specific plasma proteins. A study with labelled Vitamin B12 showed it was quickly taken up by the intestinal mucosa and held there for 2 - 3 hours. Peak concentrations in the blood and tissues did not occur until 8 - 12 hours after dosage with maximum concentrations in the liver within 24 hours. Cobalamins are stored in the liver, excreted in the bile and undergo enterohepatic recycling. Part of a dose is excreted in the urine, most of it in the first eight hours.

Zinc sulfate

Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Beta carotene

Except when liver function is impaired, Vitamin A is readily absorbed. β-carotene (as in Bevon Suspension) is Provitamin A and is the biological precursor to Vitamin A. It is converted to Vitamin A (Retinol) in the liver; retinol is emulsified by bile salts and phospholipids and absorbed in a micellar form. Part is conjugated with glucuronic acid in the kidney and part is metabolised in the liver and kidney, leaving 30 to 50% of the dose for storage in the liver. It is bound to a globulin in the blood. Metabolites of Vitamin A are excreted in the faeces and the urine.

Manganese sulfate

Manganese salts are poorly absorbed.

Sodium molybdate dihydrate

In humans, molybdenum is known to function as a cofactor for four enzymes : Sulfite oxidase catalyzes the transformation of sulfite to sulfate, a reaction that is necessary for the metabolism of sulfur-containing amino acids (methionine and cysteine).

Sodium selenite

Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism

L-Lysine

L-Lysine absorbed from the lumen of the small intestine into the enterocytes by an active transport process.

Potassium iodide

Potassium salts are absorbed from the gastro-intestinal tract. Potassium is excreted in the urine, the faeces and in perspiration. Urinary excretion of potassium continues even when intake is low.

Biotin

Following absorption, biotin is stored in the liver, kidney and pancreas.

Chromium picolinate

Most chromium compounds are soluble at the pH of the stomach, but less soluble hydroxides may form as pH is increased. The environment of the gastrointestinal tract and ligands provided by foods and supplements are important for mineral absorption.

Myo-Inositol

Oral ingestion of inositol is registered to generate a maximal plasma concentration of 36 - 45 mcg. The pharmacokinetic profile of inositol was studied in preterm infants and the estimated volume of distribution was reported to be 0.5115 L/kg. It is thought that inositol can be found bound to plasma proteins.

6.1 Animal toxicology or pharmacology

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the prescribing information.

Bevon suspension contain a comprehensive formula of vitamins, minerals and antioxidants specially designed to support health and wellbeing in adults by unlocking energy and strengthening immunity. Most vitamins, minerals and trace elements are not produced by human body and hence are dependent on dietary supply of these nutrients. Since vitamins, minerals and trace elements are involved in many metabolic processes in the body, an adequate supply of these vital substances contribute to physical and mental well being.

8.1 Incompatibilities

No major incompatibilities are known

8.2 Shelf-life

18 Months

8.3 Packaging information

A bottle of 200 ml.

8.4 Storage and handing instructions

Store protected from light at a temperature not exceeding 25°C.

Do not freeze.

Keep out of reach of children.

SHAKE WELL BEFORE USE.

Do not take Bevon Suspension :

• if you are allergic (hypersensitive) to any of the ingredients of Bevon suspension.
• if you suffer from hypercalcaemia (high level of calcium in the blood)

Take special care with Bevon Suspension

Before you are given Bevon Suspension tell your doctor, dietician or pharmacist if :

• you are pregnant or thinking of becoming pregnant
• you are a smoker
• you have an asbestos related illness such as asbestosis
• you suffer from thyroid problems.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before taking Bevon Suspension.

Taking other medicines

Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Bevon suspension :

• Phenytoin (used to treat epilepsy)
• Tetracycline antibiotics (used to treat infections) such as doxycycline and minocycline.

Please tell your doctor if you are taking or have recently taken/used any other medicines including other vitamin or mineral products medicines obtained without a prescription.

20.04.2022

Multivitamin & Multimineral Drops

Each ml contains :

• Cholecalciferol IP (As stabilized) 200 IU
• Pyridoxine Hydrochloride IP 0.5 mg
• Niacinamide IP 5 mg
• Cyanocobalamin IP 1 mcg
• Zinc Sulphate Monohydrate IP
• Equivalent to elemental Zinc 2 mg
• Betacarotene dispersion 2.5% 18 mg
• Manganese Sulfate Monohydrate USP
• Equivalent to elemental Manganese 3 mcg
• Sodium Molybdate Dihydrate BP
• Equivalent to elemental Molybdenum 1 mcg
• Sodium Selenite Pentahydrate BP
• Equivalent to elemental Selenium 10 mcg
• L-Lysine Hydrochloride USP 30 mg
• Potassium Iodide IP
• Equivalent to elemental Iodine 20 mcg
• Biotin USP 5 mcg
• Chromium Picolinate USP
• Equivalent to elemental Chromium 1 mcg
• Myo-Inositol IP 10 mg
• Excipients 10 mg
• Excipients q.s.
• In a flavoured syrupy base
• Appropriate overages of vitamins added.

Oral drops

4.1 Therapeutic indication

For Vitamins and Minerals deficiency state in infants and children.

4.2 Posology and method of administration

Infants : One ml (approximately 20 drops) once daily.

Children above 1 year : One ml (approximately 20 drops) twice daily.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the formulation.

4.4 Special warnings and precautions for use

• Whilst taking Bevon Drops both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.
• Do not take Bevon Drops on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor
• Evidence from Randomised Control Trials suggests that high doses (20-30 mg/day) β-carotene intake may increase the risk of lung cancer in current smokers and those previously exposed to asbestos. This high-risk population should consider the potential risks and benefits of Bevon Drops, which contain 5mg of β-carotene per recommended daily dose, before use.

4.5 Drugs interactions

Zinc sulphate reduce the absorption of tetracyclines.

4.6 Use in special populations

Pregnancy and Breastfeeding

Not indicated in this age group.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Immune system disorders : Hypersensitivity reaction (such as rash) Gastrointestinal disorders : Gastrointestinal disturbances (such as nausea, vomiting and abdominal pain).

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

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

4.9 Overdose

No cases of overdosage due to Bevon therapy have been reported. In case of accidental overdose, discontinue use and seek professional assistance immediately. Any symptoms which may be observed due to the ingestion of large quantities of drops will be due to the fat soluble vitamin content. Gastric lavage may be necessary to remove drug already released into the stomach. Signs and symptoms such as gastrointestinal disorders like diarrhoea may be associated with an overdose of Bevon.

5.1 Pharmacodynamic properties / Mechanism of action

Cholecalciferol

Vitamin D is required for the absorption of calcium and phosphate from the gastro-intestinal tract and for their transport. Its involvement in the control of calcium metabolism and hence the normal calcification of bones is well documented. Deficiency of Vitamin D in children may result in the development of rickets.

Pyridoxine hydrochloride

The active coenzyme form of vitamin B6 (Pyridoxine) is pyridoxal 5 ′-phosphate. Approximately 80% of the body's total vitamin B6 is present as pyridoxal phosphate in muscle. Pyridoxal phosphate is a coenzyme for many enzymes involved in amino acid metabolism. It is also the co-factor for glycogen phosphorylase, where the phosphate group is catalytically important. Vitamin B6 helps the body to make several neurotransmitters. It is needed for normal brain development and function, and helps the body to make the hormones serotonin and norepinephrine, which influence mood, and melatonin, which helps to regulate the body clock. Along with vitamins B12 and B9 (folic acid), B6 helps to control levels of homocysteine in the blood. In addition, vitamin B6 is important in steroid hormone action where it removes the hormone-receptor complex from DNA binding, terminating the action of the hormones. In vitamin B6 deficiency, this results in increased sensitivity to the actions of low concentrations of estrogens, androgens, cortisol and vitamin D.

Niacinamide

Niacin was discovered as a nutrient during studies of pellagra. It is not strictly a vitamin since it can be synthesized in the body from the essential amino acid tryptophan. Two compounds, nicotinic acid and nicotinamide, have the biologic activity of niacin; its metabolic function is as the nicotinamide ring of the coenzymes NAD and NADP in oxidation-reduction reactions. Nicotinamide has important role in DNA repair mechanism.

Cyanocobalamin

Vitamin B12 is found only in foods of animal origin. Vitamin B12 is essential for cellular DNA synthesis and hence contributes to functions of various tissues of the body, formation of myelin sheath, more so the rapidly dividing and proliferating cellular systems such as blood and gastric epithelium. The absorbed inert form of cyanocobalamin is converted into two important active forms. One is methylcobalamininvolved in maturation of red blood corpuscles. The second active form is adenosylcobalamin involved in healthy myelination and neuronal integrity. Methylcobalamin deficiency leads to folate trap resulting in megaloblastic anemia. Deficiency of adenosylcobalamin leads to accumulation of large amount of methylmalonyl-CoA resulting in synthesis and incorporation of nonphysiological fatty acids into neuronal lipids, causing, demyelination, axonal degeneration and neuronal death leading to neurological complications.

Zinc sulfate

Zinc is an essential trace mineral necessary for the proper function of about 300 different enzymes. Therefore, zinc plays a role in virtually all biochemical pathways and physiological processes in the body. Thirty percent of the body's zinc is stored in the bones and 60% in muscles. The other 10% is found in virtually all body tissues. Zinc is important for wound healing, immune system support and to increase fertility (sperm production). It also assists digestion, energy production, growth, cellular repair, collagen synthesis, bone strength, cognitive function, and carbohydrate metabolism (glucose utilization and insulin production). Zinc not only modulates cell-mediated immunity but is also an antioxidant and anti- inflammatory agent. Mild zinc deficiencies are currently thought to cause chronic metabolic derangement leading to or exacerbating immune deficiency, gastrointestinal problems, endocrine disorders, neurologic dysfunction, cancer, accelerated aging, degenerative disease, and more.

Beta carotene

β-carotene is the most prominent and efficient member of the group of carotenoids (natural colorants that occur in the human diet). Carotenoids are red, orange, or yellow, fat-soluble compounds. Alpha, beta, and gamma carotene are considered provitamins because they can be converted to active vitamin A. Beta-carotene is converted to retinol, which is essential for vision and growth. ROS-induced oxidative stress is suggested as being basic to several human diseases. β-carotene has a unique type of antioxidant activity. Beta carotene traps free radicals and studies suggest that it may also reduce tumor development. Studies have shown that vitamin A is essential to the normal growth of epithelial tissues.

Manganese sulfate

Manganese is an essential element for humans and is required for growth, development, and maintenance of health. Manganese is necessary for a variety of metabolic functions including those involved in skeletal system development, energy metabolism, activation of certain enzymes, nervous system function, immunological system function, and reproductive hormone function. It is an antioxidant that protects cells from damage due to free radicals. Manganese also plays an essential role in regulation of cellular energy, bone and connective tissue growth and blood clotting. In the brain, Manganese is an important cofactor for a variety of enzymes, including the antioxidant enzyme superoxide dismutase, as well as enzymes involved in neurotransmitter synthesis and metabolism.

Sodium molybdate dihydrate

Molybdenum belongs to a group of essential microelements. Molybdenum-containing enzymes catalyze basic metabolic reactions in the nitrogen, sulfur, and carbon cycles and are important for variety of metabolic pathways.

Sodium selenite

Selenium is incorporated into selenoproteins that have a wide range of pleiotropic effects, ranging from antioxidant, immune functions and anti-inflammatory effects to the production of active thyroid hormone. Low selenium status has been associated with increased risk of mortality, poor immune function, and cognitive decline. Selenium supplementation has antiviral effects, is essential for male and female reproduction, and reduces the risk of autoimmune thyroid disease. Prospective studies have generally shown some benefit of higher selenium status on the risk of various cancers

L-Lysine

L-Lysine is classified as an essential amino acid. Lysine helps in synthesis of connective tissues such as bone, skin, collagen, and elastin; synthesis of carnitine and resultant conversion of fatty acids to energy; support for healthy growth and development in children; and maintenance of healthy immune function, particularly with regard to antiviral activity.

Iodine (Potassium iodide)

Iodine is an essential constituent of the thyroid hormones.

Biotin

Biotin (Vitamin B7 or H) is a water soluble B vitamin that is essential for bodily health. It helps the body to process fat and sugars, and it helps form a critical process in fat production in the body. Biotin is involved in a number of carboxylase reactions. Biotin is often recommended as a dietary supplement for healthy skin, hair and nails. Biotin deficiency is characterized by development of a fine scaly dermatitis, hair loss, conjunctivitis, ataxia and delayed development.

Chromium picolinate

Chromium is a critical cofactor in the action of insulin. Results from some trials have indicated that chromium supplementation increases muscle gain and fat loss associated with exercise and improves glucose metabolism and the serum lipid profile in patients with or without diabetes. Low chromium levels can increase blood sugar, triglycerides, cholesterol levels, and increase the risk for a number of conditions, such as diabetes and heart disease.

Myo-Inositol

Inositol is an essential molecule found ubiquitously in biological systems. Inositol 1,4,5-triphosphate plays an essential role as a secondary messenger in the InsP3/Ca+2 signal transduction pathway, which is responsible for modulating the activity of numerous cellular processes. Biochemical functions elucidated for phosphatidyl inositol in biological membranes include the mediation of cellular responses to external stimuli, nerve transmission, and the regulation of enzyme activity through specific interactions with various proteins.

5.2 Pharmacokinetic properties

Cholecalciferol

Cholecalciferol is absorbed from the gastro-intestinal tract into the circulation. In the liver, it is hydroxylated to 25-hydroxycholecalciferol, is subject to entero-hepatic circulation and is further hydroxylated to 1,25-dihydroxycholecalciferol in the renal tubule cells. Vitamin D metabolites are bound to specific plasma proteins.

Pyridoxine hydrochloride

Pyridoxine is absorbed from the gastro-intestinal tract and converted to the active pyridoxal phosphate which is bound to plasma proteins. It is excreted in the urine as 4-pyridoxic acid.

Niacinamide

Nicotinic acid is absorbed from the gastro-intestinal tract, is widely distributed in the body tissues and has a short half-life.

Cyanocobalamin

Cyanocobalamin is absorbed from the gastro-intestinal tract and is extensively bound to specific plasma proteins. A study with labelled Vitamin B12 showed it was quickly taken up by the intestinal mucosa and held there for 2 - 3 hours. Peak concentrations in the blood and tissues did not occur until 8 - 12 hours after dosage with maximum concentrations in the liver within 24 hours. Cobalamins are stored in the liver, excreted in the bile and undergo enterohepatic recycling. Part of a dose is excreted in the urine, most of it in the first eight hours.

Zinc sulfate

Zinc is poorly absorbed from the gastro-intestinal tract. It is widely distributed throughout the body. It is excreted in the faeces with traces appearing in the urine.

Beta carotene

Except when liver function is impaired, Vitamin A is readily absorbed. β-carotene (as in Bevon Drops) is Provitamin A and is the biological precursor to Vitamin A. It is converted to Vitamin A (Retinol) in the liver; retinol is emulsified by bile salts and phospholipids and absorbed in a micellar form. Part is conjugated with glucuronic acid in the kidney and part is metabolised in the liver and kidney, leaving 30 to 50% of the dose for storage in the liver. It is bound to a globulin in the blood. Metabolites of Vitamin A are excreted in the faeces and the urine.

Manganese sulfate

Manganese salts are poorly absorbed.

Sodium molybdate dihydrate

In humans, molybdenum is known to function as a cofactor for four enzymes: Sulfite oxidase catalyzes the transformation of sulfite to sulfate, a reaction that is necessary for the metabolism of sulfur-containing amino acids (methionine and cysteine).

Sodium selenite

Although it has been established that selenium is essential to human life, very little information is available on its function and metabolism.

L-Lysine

L-Lysine absorbed from the lumen of the small intestine into the enterocytes by an active transport process.

Potassium iodide

Potassium salts are absorbed from the gastro-intestinal tract. Potassium is excreted in the urine, the faeces and in perspiration. Urinary excretion of potassium continues even when intake is low.

Biotin

Following absorption, biotin is stored in the liver, kidney and pancreas.

Chromium picolinate

Most chromium compounds are soluble at the pH of the stomach, but less soluble hydroxides may form as pH is increased. The environment of the gastrointestinal tract and ligands provided by foods and supplements are important for mineral absorption.

Myo-Inositol

Oral ingestion of inositol is registered to generate a maximal plasma concentration of 36 - 45 mcg. The pharmacokinetic profile of inositol was studied in preterm infants and the estimated volume of distribution was reported to be 0.5115 L/kg. It is thought that inositol can be found bound to plasma proteins.

6.1 Animal toxicology or pharmacology

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the prescribing information.

Bevon drops contain a comprehensive formula of vitamins, minerals and antioxidants specially designed to support health and well-being in adults by unlocking energy and strengthening immunity. Most vitamins, minerals and trace elements are not produced by human body and hence are dependent on dietary supply of these nutrients. Since vitamins, minerals and trace elements are involved in many metabolic processes in the body, an adequate supply of these vital substances contribute to physical and mental well being.

8.1 Incompatibilities

No major incompatibilities are known.

8.2 Shelf-life

18 Months

8.3 Packaging information

A bottle of 15 ml.

8.4 Storage and handing instructions

Store below 25°C. Protect from light. Do not Freeze.

Keep out of reach of children.

FOR PAEDIATRIC USE ONLY.

SHAKE WELL BEFORE USE.

Do not take Bevon Drops :

• if you are allergic (hypersensitive) to any of the ingredients of Bevon drops
• if you suffer from hypercalcaemia (high level of calcium in the blood).

Taking other medicines

Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Bevon drops :

• Phenytoin (used to treat epilepsy).
• Tetracycline antibiotics (used to treat infections) such as doxycycline and minocycline.

Please tell your doctor if you are taking or have recently taken/used any other medicines including other vitamin or mineral products medicines obtained without a prescription.

20.04.2022