Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
MAKLITIO 20 mg (film-coated).
| Pharmaceutical Form |
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Oral film-coated tablet. MAKLITIO 20 mg: White to off white, round shaped, film coated tablets debossed with ‘!/service/image/get?id=maklitio_tab-i1!’ on one side and plain on the other |
MAKLITIO 20 mg.
Each film-coated tablet contains Sildenafil citrate equivalent to 20 mg active base. Sugar free.
Excipients: For a full list of excipients, see Section 6.1.
| Active Ingredient |
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Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. |
| List of Excipients |
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Croscarmellose sodium Film coating containing: Hypromellose |
HDPE container:
Round, white, HDPE container (30 ml) with 28 mm neck finish, containing 90 tablets, closed with white a polypropylene child resistant with pulp and heat seal liner and packed in a pre-printed unit carton.
Blister pack:
Clear 250 μ PVC/60 gsmPVdC as the forming material and silver coloured plain 25μ aluminium foil/6-8 gsm HSL as the lidding material, packed in a pre-printed unit carton.
Pack sizes 10s, 28’s, 30’s and 90’s.
Not all pack sizes will be marketed.
Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
MAKLITIO 20 MG: 51/7.1.5/0406
19 JULY 2022
| Drug | Countries | |
|---|---|---|
| MAKLITIO | South Africa |
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