(Hard Gelatin Capsules)
Name of medicinal product :
Biotin Forte 5 mg hard gelatin capsules
Qualitative and Quantitative composition :
Each capsule contains: Biotin 5 mg
Inactive: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Capsule shell: ntanium dioxide, Gelatin, Carmoisine red.
Pharmaceutical Form :
Hard Gelatin Capsules.
Clinical Data :
1- Therapeutic indications
– Biotin Forte capsules helps in cases of hair loss (Alopecia).
– Biotin Forte capsules acts as hair volumizer giving the appearance of fullness to the hair.
– Biotin Forte capsules increases the nail thickness, improves nail structure and reduce nail breakage in people with brittle nails.
-Biotin Forte capsules combination with chromium might lower blood sugar in people with type 11 diabetes.
2- Posology and method of administration
– 1 -2 capsules to be taken once daily or as directed by physician.
– The capsules should be swallowed with a glass of water.
3- Contra indications
Hyper-sensitivity to one of the compounds.
4- Special warnings and precautions for use
5- Interaction with other medicinal products and other forms of interaction
6- Pregnancy and breast feeding
Pregnancy: There are no reliable data on teratogenesis in animals.
In clinical studies, no particular malformative or fetotoxic effect has appeared to date. However, monitoring pregnancies exposed to this drug is insufficient to rule out any risk. Therefore, as a precaution, it is preferable not to use this medication during pregnancy.
Feeding: in the absence of data, it is preferable not to use this medication during lactation.
7- Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
8- Side effects
Allergy-related hypersensitivity reactions (mainly urticaria, angioedema, rash, pruritus) have been reported.
No specific risk of overdose in biotin has been described.
Pharmacological Properties :
1- Pharmacodynamic Properties
Vitamin H (Dermatology).
2- Pharmacokinetic Properties
3- Preclinical safety data
Absence of toxicity study results in animals. However, biotin tolerance is widely documented.
Pharmaceutical Data :
2- The duration of the conversation
3- Special precautions for storage
Store at temperature not exceeding 30° C in dry place.
4- Nature and contents of container
Box of 6 strips each one contains 10 capsules & leaftet.
5- Special precautions for disposal and other handling
No special requirements.
Produced by :
UNIPHARMA (Universal Pharmaceutical Industries)
AI Obour City-Cairo-Egypt