Bayer Limited

Redoxon Double Action 1000mg/10mg Effervescent Tablets

1 effervescent tablet contains:

Excipients:

For a full list of excipients, see section 6.1

Effervescent Tablet.

Light orange round tablet with bevelled edges and flat faces with a smell of orange.

Treatment of ascorbic acid and zinc deficiency.

Adults and children over 12 years: 1 effervescent tablet a day dissolved in a glass of water.

In nephrolithiasis accompanied by oxaluria with aciduria or normal urinary pH, vitamin C should not be given if the dose of vitamin C is > 1g/day.

REDOXON DOUBLE ACTION must not be taken by persons known to be hypersensitive to any of its ingredients.

REDOXON Double Action contains a source of phenylalanine and, therefore, may be harmful to people with phenylketonuria.

Patients suffering from renal insufficiency should consult a physician prior to intake of large doses of ascorbic acid.

At high doses (more than 2 g/day) vitamin C may interfere with the following biological tests: plasmatic and urinary dosages of creatinine and glucose (control with glucose-oxydase device) as well as with tests for occult bleeding in stool.

No teratogenicity study in animals is available.

Clinical observations of a great number of exposed pregnant women have not shown any malformative or toxic effect of REDOXON Double Action on the fœtus. However, only epidemiological studies could check the absence of any risk.

Consequently, REDOXON Double Action should only be used during pregnancy if necessary.

The vitamin and mineral of REDOXON Double Action effervescent tablets are excreted in the milk, but harmful effect on the child are unlikely at the therapeutic doses.

None.

The most commonly found adverse reactions are mild transient multivitamin/mineral gastrointestinal disturbances (>=1/100 - <1/10).

Allergic reactions are very rare (<1/10,000). Urticaria, throat swelling and rash have been reported in isolate cases.

Ascorbic acid may cause haemolytic anaemia in certain individuals with a deficiency of glucose-6-phosphate dehydrogenase.

No cases of overdose are known.

ATC Code: A11GB

Vitamin C

Ascorbic acid is an important water-soluble vitamin and antioxidant. Due to the low storage capacity of the body for vitamin C, a regular intake of sufficient amounts is essential to humans.

Ascorbic acid and its metabolite dehydroascorbic acid form a reversible redox system that is involved in many enzymatic reactions and forms the basis for the spectrum of action of vitamin C. Ascorbic acid functions as a cofactor in a number of hydroxylation and amidation reactions by transferring electrons to enzymes that provide reducing equivalents.

The importance of ascorbic acid to the human body is most clearly evident in clinically manifest vitamin C deficiency, i.e. scurvy. Ascorbic acid plays a key role in the production of hydroxyproline from proline, which in turn is essential to the development of functionally active collagen. The symptoms seen in scurvy, such as delayed wound healing, disturbances of bone growth, vascular fragility, and disorders of dentine formation, are the result of impaired collagen formation.

Zinc

As with vitamin C, low levels of zinc may also adversely affect the healing rate of wounds, ulcers and decubitus.

Zinc status is of major importance in maintenance of effective immune response, particularly T-cell-mediated response.

Absorption: Ascorbic acid is absorbed primarily in the upper part of the small intestine via sodium-dependent active transport. When ascorbic acid is present in high concentrations, uptake occurs by means of passive diffusion. After oral administration of doses of 1-12 g, the proportion of ascorbic acid absorbed falls from approximately 50% to about 15%, though the absolute quantity of substance taken up continues to increase.

Zinc is absorbed all along the small intestine. The absorption of zinc (ionic) administered in solution on an empty stomach ranges from 41-79%, while the zinc present in foods or that given as a supplement with meals is absorbed in the range of 10–40%.

Distribution: Plasma protein binding of ascorbic acid is approximately 24%. Serum concentrations are normally 10 mg/l (60 µmol/l). Concentrations below 6 mg/l (35 µmol/l) indicate that the intake of vitamin C is not always adequate, and concentrations below 4 mg/l (20 µmol/l) indicate that the intake is actually inadequate. In clinically manifest scurvy, serum concentrations are below 2 mg/l (10 µmol/l).

Total body zinc content is controlled in part by regulating the efficiency of intestinal absorption and the excretion from endogenous zinc pools to maintain zinc homeostasis. The adult total body zinc content ranges from about 2.3 mmol (1.5 g) in women to 3.8 mmol (2.5 g) in men. Zinc is present in all organs, tissues, fluids, and secretions of the body. Zinc is primarily an intracellular ion, with well over 95% of the total-body zinc found within cells. Zinc is associated with all organelles of the cell, but about 60 to 80% of the cellular zinc is found in the cytosol.

Metabolism: Ascorbic acid is metabolised partly via dehydroascorbic acid to oxalic acid and other products. When ingested in excessive quantities, however, ascorbic acid is largely excreted in unchanged form in the urine and faeces. Ascorbic-acid-2-sulphate also appears as a metabolite in the urine.

Elimination: The physiological body pool of ascorbic acid is about 1500 mg. The elimination half-life of ascorbic acid depends on the route of administration, the quantity administered and the rate of absorption. Following an oral dose of 1 g the half-life is about 13 hours. When 1-3 g vitamin C /day is taken, the main route of excretion is renal. With doses exceeding 3 g, increasing quantities are excreted unchanged in the faeces.

The major route for endogenous zinc excretion is into the gastrointestinal tract with ultimate loss in the faeces. When tracer doses of zinc are given either orally or intravenously, only about 2 to 10% is recovered in the urine; the remainder is lost in the faeces. In humans, endogenous faecal losses may range from <15 μmol/day (1 mg/day) with extremely low intakes to over 80 μmol/day (5 mg/day) with extremely high intakes. Normally, about 6 to 9 μmol (400 to 600 μg) of zinc is excreted daily in the urine.

Not applicable.

Sodium hydrogen carbonate

Anhydrous sodium carbonate

Anhydrous citric acid

Sorbitol (E420)

Aspartame (E951)

Acesulfame potassium

Sodium chloride

Orange flavour (acetaldehyde, ascorbic acid, ethyl butyrate, decanal, dodecanal, hexanal, orange oil, linalol, tetradecanal, nonalal, octanal, acacia and maltodextrin)

Tangerine flavour (ascorbic acid, tangerine oil, acacia and maltodextrin) beta-carotene 1% (beta carotene crystalline, alpha tocopherol, sodium ascorbate crystalline, medium chain triglycerides, acacia, sucrose, maltodextrin and silicon dioxide)

Not applicable.

3 years in plastic tubes or aluminium tubes.

2 years in aluminium foil strip.

Store below 25 °C.

Keep the tube tightly closed, in order to protect from moisture.

10, 15, 20 or 30 tablets in aluminium tube with polyester lacquer closed by a PE stopper containing a desiccant (silica gel) or in polypropylene tube closed by a PE stopper containing a desiccant (silica gel)

Box of 1 or 2 tubes containing 10 or 15 tablets

1 tablet in aluminium / PE strip

Not all pack sizes may be marketed.

No special requirements.

BayerLtd

The Atrium

Blackthorn Road

Dublin 18

PA 1410/50/1

Date of first authorisation: 2^nd November 2001

Date of last authorisation: 1^st April 2009

May 2011