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:
Complex treatment and prophylaxis of diseases caused by Biotin deficiency in adults and children:
- Hair diseases (high hair thinness, hair fragility, hair falling, increased greasiness or dryness of hair, grey hair);
- Skin diseases (dermatitis, seborrhea oleosa, dryness and peeling of skin);
- Nails diseases (fragility, exfoliation, ingrown nail or structure abnormality);
- Gastro-intestinal tract functional disorders (including malabsorption syndrome);
- Biotinidase deficiency;
- Psycho-emotional disorders (expressed irritation and fatigability, somnolence, apathy, muscle weakness).

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
In this section undesirable effects are defined as follows:
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Because of the potential for side effects and interactions with medications, dietary supplements should be taken only under the supervision of a knowledgeable healthcare provider. That said, biotin has not been associated with side effects (even in high doses) and is considered to be nontoxic.

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 Biotin or other drug components, children age less than 12 years old.

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

Overdose
By the moment there are no reports of Biotin overdosing even in case of high doses.

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 all medicines out of reach of children.

Drug Description

Each film coated tablet contains:
Biotin USP……..5 mg
For excipients, see section 6.1

Indications and dosage.

Therapeutic indications
Complex treatment and prophylaxis of diseases caused by Biotin deficiency in adults and children:
- Hair diseases (high hair thinness, hair fragility, hair falling, increased greasiness or dryness of hair, grey hair);
- Skin diseases (dermatitis, seborrhea oleosa, dryness and peeling of skin);
- Nails diseases (fragility, exfoliation, ingrown nail or structure abnormality);
- Gastro-intestinal tract functional disorders (including malabsorption syndrome);
- Biotinidase deficiency;
- Psycho-emotional disorders (expressed irritation and fatigability, somnolence, apathy, muscle weakness).

Posology and method of administration.
Tablets WOLVIT are taken peroral, before meals with a small portion of water.
Adults:
The recommended dose in the treatment of diseases of nails, hairs and skin, and neurology disorders is 5 mg of Biotin per day.
In malabsorbtion syndrome the recommended dose is 10 mg.
In Biotin deficiency symptoms the recommended dose is 5–20 mg per day.
In biotinidase deficiency the recommended dose is 5–10 mg per day.
Elderly patients
The same dose range as in younger patients may be used in the elderly.
Children
In children with Biotin deficiency symptoms the recommended dose is 5–20 mg per day.
In biotinidase deficiency in children the recommended dose is 5–10 mg per day.
In case of biotin-dependent enzymes insufficiency caused by genetics (multiple deficiency of carboxylases) the recommended dose is 20 mg per day.
The drug may be used for a long period; one continuous treatment course is about one month.

Side effects and drug interactions.

Undesirable effects
In this section undesirable effects are defined as follows:
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Because of the potential for side effects and interactions with medications, dietary supplements should be taken only under the supervision of a knowledgeable healthcare provider. That said, biotin has not been associated with side effects (even in high doses) and is considered to be nontoxic.

Interaction with other medicinal products and other forms of interaction
Interactions:
Although there is no evidence that biotin interacts with any medication, there are some medications that may deplete biotin levels. If you are being treated with any of the following medications, you should not use biotin without first talking to your health care provider.
Antibiotics
Long-term antibiotic use may lower biotin levels by destroying the bacteria in the gut that produces biotin.
Anticonvulsant Medications
Long-term use of anticonvulsant medications can reduce the body's stores of biotin. Valproic acid can cause biotinidase deficiency, which may be helped by biotin supplements.
Anticonvulsant medications include:
* Carbamazepine
* Phenobarbital
* Phenytoin
* Primidone

Warnings and precautions

Special warnings and precautions for use
Allergic reactions are possible in case of individual intolerance to Biotin.
Do not administer the drug for children under 12 years old.
Do not violate the duration of the treatment course prescribed by physician; in a case of interrupted or prematurely stopped treatment the efficacy of the treatment can be decreased. Because of good Biotin tolerability the treatment can be prolonged for a long time.
There is no data indicating negative medication influence on psychomotor actions velocity.

Pregnancy and lactation
Pregnancy
Pregnant women and nursing mothers should avoid supplemental doses of biotin greater than the adequate intakes (AI) recommended by the Food and Nutrition Board, unless higher doses are prescribed by their physicians. The AIs are 30 micrograms/day for pregnant women and 35 micrograms/day for nursing mothers.
The use of biotin for the treatment of a biotin-responsive medical conditions requires medical supervision Individual doctor's advice is necessary if the preparation administration is required during pregnancy periods.

* Pregnant females: 30 mcg.

Lactation
Individual doctor's advice is necessary if the preparation administration is required during lactation periods.
* Breastfeeding females: 35 mcg.

Effects on ability to drive and use machines.
There is no data indicating negative medication influence on psychomotor actions

Overdosage and Contraindications

Overdose
By the moment there are no reports of Biotin overdosing even in case of high doses.

Contraindications
Hypersensitivity to Biotin or other drug components, children age less than 12 years old.

Clinical pharmacology.

PHARMACEUTICAL FORM
Film coated tablet
Pink colored film coated round biconvex tablets plain on both sides.

PHARMACEUTICAL PARTICULARS
List of excipients
Excipients: Cellactose 80, Sodium Laurylsulfate, Croscarmellose sodium, Magnesium stearate, Colloidal anhydrous silica, Opadry II 85 G 54348 pink and purified water.
Incompatibilities
Not applicable.

Shelf life
3 years.

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

Nature and contents of container
10 tablets are packed in an Alu/Alu blister pack and such 10 blisters 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
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DATE OF REVISION OF THE TEXT
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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