Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Hard Capsule Shell:
Hypromellose
Iron Oxide Red (E172)
Titanium Dioxide (E171)
Water, Purified
Carrageenan (E407)
Potassium Chloride
FD&C Yellow 6 (E110)
Carnauba Wax
Maize Starch
Contents in Dutasteride Soft Capsule:
Mono-di-glycerides of caprylic/capric acid (MDC)
Butylhydroxytoluene (BHT)

Soft Capsule Shell:
Gelatin
Glycerol
Titanium dioxide (E171) ferric oxide (E172)
Triglycerides, medium chain
Lecithin (may contain soya oil)

Tamsulosin Pellets:
Cellulose, Microcrystalline
Methacrylic acid - ethyl acrylate copolymer 1:1 dispersion 30 per cent (also contains polysorbate 80 and sodium laurilsulfate)
Talc
Triethyl citrate

Black Inks (SW-9010 or SW-9008):
Shellac
Iron Oxide Black (E172)
Propylene Glycol
Potassium Hydroxide (in Black Ink SW-9008 only)

6.2     Incompatibilities
Not applicable.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Do not use the product after three months from opening.
6.4     Special precautions for storage

Do not store above 30°C.

6.5     Nature and contents of container
Opaque, white high density polyethylene (HDPE) bottles with polypropylene child-resistant closures with polyethylene-faced, foil induction heat-seal liners. The bottles contain either 7, 30, 90 capsules.

6.6     Special precautions for disposal and other handling

Dutasteride is absorbed through the skin, therefore contact with leaking capsules must be avoided. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water (see section 4.4).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.