India Product

Aclotol Fast Gel

Aclotol Fast Gel

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Ascozin is administered in habitude to cold, infectious diseases and immune deficit diseases, hypo- and avitaminosis of vitamin C, hemorrhage (metrorrhagia, bronchial, nasal, hemorrhage in radiation sickness), hepatic diseases (hepatitis A, chronic hepatitis, cirrhosis), nephropathy of pregnancy, Addison's disease, anticoagulant overdose, bone fracture and wounds, which are not healed for a long period, dystrophy. Ascozin can be administered in complex treatment of diseases, which are accompanied with decreased immunity, connective tissue injury, impairment of carbohydrate metabolism and lipid metabolism, dysfunction of endocrine gland, increased penetration and fragility of blood vessel, and also in hypofunction of prostate gland. The preparation can be used in atherosclerosis, bronchial asthma, connective tissues diseases (rheumatoid arthritis, systemic lupus erythematosus, and scleroderma).

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:
GIT:
nausea, vomiting, heartburn, diarrhea.
CNS:
hyperexcitability of CNS, headache.
Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue:
allergic reactions.
Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

Когда Вы должны проконсультироваться с вашим врачем ?

Если приближается время для принятия следующей дозы , проигнорируйте пропущенную дозу и примите следующую дозу как вам назначено.
В противном случае , примите дозу сразу , как только Вы вспомнили о ней и далее принимайте как обычно.

Things you MUST NOT DO while on this medicine?

Contraindications
Hypersensitivity to ascorbic acid. Hyperoxaluria. Thrombophlebitis, inclination to thrombosis, pancreatic diabetes. Children age less than 18 years old.

What to do if you accidentally take too much (overdose) of the medicine?

Overdose
Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.
Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30°C. Keep out of reach of children.

Drug Description

Each chewable tablet coated contains:
Ascorbic Acid USP      100mg
Sodium Ascorbate USP      450mg
(Equivalent to Ascorbic Acid      400 mg)
Zinc Oxide BP      18.67mg
(Equivalent to Zinc      15mg)
For excipients, see section 6.1

Indications and dosage.

Therapeutic indications
Ascozin is administered in habitude to cold, infectious diseases and immune deficit diseases, hypo- and avitaminosis of vitamin C, hemorrhage (metrorrhagia, bronchial, nasal, hemorrhage in radiation sickness), hepatic diseases (hepatitis A, chronic hepatitis, cirrhosis), nephropathy of pregnancy, Addison's disease, anticoagulant overdose, bone fracture and wounds, which are not healed for a long period, dystrophy. Ascozin can be administered in complex treatment of diseases, which are accompanied with decreased immunity, connective tissue injury, impairment of carbohydrate metabolism and lipid metabolism, dysfunction of endocrine gland, increased penetration and fragility of blood vessel, and also in hypofunction of prostate gland. The preparation can be used in atherosclerosis, bronchial asthma, connective tissues diseases (rheumatoid arthritis, systemic lupus erythematosus, and scleroderma).

Posology and method of administration
Ascozin is used after meal; a tablet is chewed and took with enough water. For adults it is administered 1 tablet once a day. In severe avitaminosis and infectious disease treatment it can be used 1 tablet twice a day for a short term (during 5–7 days). The treatment course depends on the treatment character and clinical course.

Side effects and drug interactions.

Undesirable effects
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:
GIT:
nausea, vomiting, heartburn, diarrhea.
CNS:
hyperexcitability of CNS, headache.
Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue:
allergic reactions.
Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

Warnings and precautions

Special warnings and precautions for use
Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance and deficiency may result if it is withdrawn too rapidly.

Pregnancy and lactation
Vitamin C long-term administration in high dose during pregnancy can cause a negative influence on fetus development. Use during pregnancy may be possible only in a case when the benefit for a mother overweight's a potential risk for a fetus. Ascorbic acid penetrates into breast milk, therefore during lactation period the preparation must be used under the doctor's control.

Effects on ability to drive and use machines
There are no reports that the preparation can have a negative influence on drivers or people who work with sophisticated mechanisms.

Overdosage and Contraindications

Overdose
Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.
Treatment:
It is symptomatic.

Contraindications
Hypersensitivity to ascorbic acid. Hyperoxaluria. Thrombophlebitis, inclination to thrombosis, pancreatic diabetes. Children age less than 18 years old.

Clinical pharmacology.

PHARMACEUTICAL FORM
Chewable Tablets
Light orange coloured uniformly spotted circular biconvex tablets.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group and ATC code
Pharmacotherapeutic group:
Ascorbic acid (vitamin C), combinations
ATC code:
А11GB.
As antioxidant, metabolic, and redox processes regulating agent ascorbic acid (vitamin C) increases adaptive capacity of organism, enhances its resistance to infections. It maintains colloidal condition of intercellular substance and normal capillary penetration (it inhibits hyaluronidase). It participates in regulation of redox processes, in carbohydrate metabolism, aromatic amino acid, pigments and cholesterine; in synthesis of steroid hormones, catecholamines, and in blood coagulation. It enhances collagen synthesis, stimulates regeneration processes, and normalizes capillary penetration. Due to activation of respiratory ferments in liver it enhances its detoxification and protein generating functions; it enhances synthesis of collagen and prothrombin. It improves bile excretion, renews exocrine function of pancreas. It inhibits excretion and accelerates histamine degradation, inhibits formation of prostaglandins and other inflammation and anaphylactic mediators. It regulates immunological reactions (it activates synthesis of antibody, C3-component of complement, interferon), facilitates phagocytosis, elevates organism resistance to infections. It has an anti-inflammatory and anti-allergic action. Daily maintenance in ascorbic acid in adults is 70–100 mg, in pregnant women and during lactation – 100–120 mg, in children and adolescents due to their age –30–70 mg. Vitamin C deficit in meal causes a development of C hypo- or avitaminosis as far as this vitamin is not synthesized in organism.
Zinc is a structural component of biological membranes, cell receptors, proteins; it enters into compositions of more than 200 enzyme systems. It takes part in reactions of immune and anti-oxidant protection, blood formation, amino acids synthesis, in genetic information preservation and transmission. Being a component of protein, which transmits retinol, zinc together with vitamin A and vitamin C prevents immune deficit formation, stimulating antibody synthesis and causing antiviral action. It is necessary for formation of erythrocyte and other blood corpuscle. Zinc normalizes lipometabolism, provides normal function of endocrine gland, including synthesis of insulin, growth hormone, corticotropin and somatropin. It maintains sexual and reproductive functions – it is necessary for metabolism of vitamin E, which is a precursor of sexual hormones and is included into testosterone production; zinc is also important for normal prostate gland functioning. Daily maintenance of zinc is 15 mg.
Pharmacokinetic properties
Ascorbic acid is actively absorbed in small intestine. Maximal plasma concentration after oral intake is reached in 4 hours. Normal endogenous plasma concentration is approximately 10–20 mcg/ml. Deposit level in organism is approximately 1.5 g. About 25% of it is bound with plasma proteins, deposited in posthypophysis, adrenal gland cortex, eye epithelium, perineal cells of seminal gland, ovary, liver, brain, spleen, pancreas, pulmones, kidney, intestine wall, heart, muscle, thyroid gland. It easily penetrates into leucocyte, thrombocyte and almost into all tissues from plasma. It is boitransformed in liver into deoxyascorbic acid, then – in oxaloacetic acid and diketogulonic acid. Unchanged ascorbate and metabolites are excreted through kidney, intestine and also with sweat and breast milk. Vitamin C absorption can be impaired in gastro-intestinal tract diseases (gastritis, ulcer, constipation, diarrhea, helminthic invasion, lambliasis), usage of fresh fruit and vegetable juice, alkaline drinking. The preparation excretion is increased during increasing of its concentration in plasma up to 1.4 mg/100 ml. The preparation absorption is decreased when fresh fruit and vegetable juice, alkaline drinking are used. Smoking and ethyl alcohol abuse accelerates ascorbic acid decay (transformation into inactive metabolites), sharply decreasing its reserve in organism.
Absorbed in intestine zinc is distributed in tissues and included to compositions of enzyme series and biologically active substances. 90% of zinc is excreted from organism with faeces and 2–10 – with urine. Calcium additives and ration rich in calcium (dairy products) have an ability to reduce zinc digestion nearly by 50%, and caffeine and alcohol intensively remove it from the organism.

Preclinical safety data
Not applicable

PHARMACEUTICAL PARTICULARS
List of excipients
Mannitol, Povidone, Crospovidone, Lake Sunset Yellow, Ethyl cellulose (Ethocel 7 cps), Isopropyl alcohol, Aspartame, Magnesium stearate & Orange flavour 844763.

Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other drugs.

Shelf life
2 years

Special precautions for storage
Store below 30°C. Keep out of reach of children.

Nature and contents of container
10 Tablets are packed in an aluminium strip & such 10 strips are packed in a carton along with pack insert.

MARKETING AUTHORISATION HOLDER
Kusum Healthcare Private Limited
D-158 A, Okhla Industrial Area,
Phase I, New Delhi-110020,
India.

MARKETING AUTHORISATION NUMBER(S)
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MANUFACTURER NAME
Kusum Healthcare Private Limited
SP 289 (A), RIICO Industrial Area
Chopanki, Bhiwadi
Distt. Alwar - 301707
India

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
-------

11. DATE OF REVISION OF THE TEXT

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780