Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ethypharm, 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud Cedex, France
Nyzamac SR 40 mg Capsules.
Nyzamac SR 50 mg Capsules.
Nyzamac SR 60 mg Capsules.
| Pharmaceutical Form |
|---|
|
Prolonged-release capsule, hard. The 40mg capsule is a size 2 capsules and has an opaque white cap printed with «ISMN SR» in black ink and an opaque white body printed with «40» in black ink, containing off-white to yellowish microgranules. The 50mg capsule is a size 1 capsule and has an opaque white cap printed with «ISMN SR» in black ink and an opaque white body printed with «50» in black ink, containing off-white to yellowish microgranules. The 60mg capsule is a size 1 capsule and has an opaque white cap printed with «ISMN SR» in black ink and an opaque white body printed with «60» in black ink, containing off-white to yellowish microgranules. |
Each 40 mg prolonged-release capsule contains 40 mg of isosorbide mononitrate.
Each 50 mg prolonged-release capsule contains 50 mg of isosorbide mononitrate.
Each 60 mg prolonged-release capsule contains 60 mg of isosorbide mononitrate.
Excipients with known effect:
Each 40mg capsule contains: Lactose (120 mg/ capsule), Sucrose (38.5mg/capsule)
Each 50mg capsule contains: Lactose (150mg/capsule), Sucrose (48.15 mg/capsule)
Each 60mg capsule contains: Lactose (180mg/capsule), Sucrose (57.75 mg/capsule)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Isosorbide mononitrate |
Isosorbide mononitrate is an organic nitrate, which, in common with other cardioactive nitrates, is a vasodilator. It produces decreased left and right ventricular end-diastolic pressures to a greater extent than the decrease in systemic arterial pressure, thereby reducing afterload and especially the preload of the heart. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell (40, 50 and 60 mg): Gelatin Black printing ink: Shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172) |
The capsules are packed in in blister packs (20 μm aluminium/250 μm PVC) and boxed in cardboard cartons containing 28, 30, 56 or 60 capsules.
Sample blister pack of 8 capsules.
Not all pack sizes may be marketed.
Ethypharm, 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud Cedex, France
PL 06934/0200
PL 06934/0207
PL 06934/0201
PL 06934/0200: 2nd April 1996, 1st August 2001
PL 06934/0207: 24th June 2002, 17th March 2009
PL 06934/0201: 2nd April 1996, 1st August 2001
| Drug | Countries | |
|---|---|---|
| NYZAMAC | United Kingdom |
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