Description
Qualitative & Quantitative Composition:
Each Hard Gelatin Capsules contains:
Active Ingredient:
- Biotin 5 mg
Inactive Ingredients:
- Microcrystalline cellulose (Avicel PH 101)
- Talc
- – Magnesium stearate
Capsule shell:
Cap.: (Opaque mauve rose):
- – Gelatin
- – Methylparaben
- – Sodium lauryl sulfate
- – Aerosil
- -Titanium Dioxide C.I.No 77891
- – Erythrosine red C.I.No 45430
Body: (Opaque mauve rose):
- -Gelatin
- -Methylparaben
- -propylparaben
- -Sodium lauryl sulfate
- -Aerosil
- -Titanium Dioxide C.I.No 77891
- -Erythrosine red C.I.No 45430
Clinical particulars:
Therapeutic indications:
- Adjunctive treatment of diffuse alopecia.
Dosage:
- 3 capsules daily for 6 weeks.
- The pills must be swallowed with a glass of water.
Administration mode:
- Oral way.
Pregnancy
- There is no reliable data for teratogenesis in animals.
In clinical, no malformative or foetotoxic effect has appeared to data.
However, the monitoring of pregnancies exposed to this drug is insufficient to exclude any risk.
Therefore, as a precaution, it is best not to use this medicine during pregnancy
Feeding
- In the absence of data, it is best not to use this medicine during breastfeeding
Side effects:
- Hypersensitivity manifestations of allergic appearance, mainly cutaneous (urticaria,
angioedema, rash, pruritus), have been reported.
Overdose:
- No specific risk of biotin overdose has been described
5- Pharmacological Properties:
5.1. Pharmacodynamic properties:
Pharmacotherapeutic group: VITAMIN H (D: Dermatology)
5.2. Pharmacokinetic properties:
Not applicable.
6- Pharmaceutical Particulars:
6.1. Shelf life:
3 years.
6.2. Special precautions for storage:
Store at temperature not exceeding 30°C in dry place.
6.3. Nature and contents of container:
Carton Box containing 6 (Al/transparent colorless PVC) strips each of 10 hard gelatin
capsules & leaflet.
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