URAPIDIL Prolonged-release capsule, hard Ref.[7679] Active ingredients: Urapidil

Product name and form

Urapidil Stragen 30 mg prolonged-release capsule, hard.

Urapidil Stragen 60 mg prolonged-release capsule, hard.

Urapidil Stragen 90 mg prolonged-release capsule, hard.

Pharmaceutical Form

Prolonged-release capsule, hard.

Urapidil Stragen 30 mg: capsule N°4 with a translucent dark yellow body and an opaque white cap filled with small spherical beige pellets.

Urapidil Stragen 60 mg: capsule N°2 with a translucent light blue body and an opaque white cap filled with small spherical beige pellets.

Urapidil Stragen 90 mg: capsule N°1 with a translucent red body and an opaque white cap filled with small spherical beige pellets.

Qualitative and quantitative composition

Each Urapidil Stragen 30 mg prolonged-release capsule, hard contains 30 mg urapidil.

Each Urapidil Stragen 60 mg prolonged-release capsule, hard contains 60 mg urapidil.

Each Urapidil Stragen 90 mg prolonged-release capsule, hard contains 90 mg urapidil.

Excipients with known effect:

  • sucrose
  • 90 mg capsules contain also Ponceau 4R (E124)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Urapidil

Urapidil is a α1-adrenoceptor antagonist and 5-HT1A receptor agonist and consequently inhibits the vasoconstrictor effect of catecholamines. It interacts with peripheral α1-adrenoceptors and central 5-HT1A receptors to produce vasodilation without sympathetic activation.

List of Excipients

Capsule contents:

Sugar spheres (sucrose, maize starch)
Hypromellose
Fumaric acid
Ethylcellulose
Methacrylic acid – Methyl methacrylate copolymer (1:2)
Hypromellose phtalate
Dibutyl sebacate

30 mg capsule shells:

Gelatin
Titanium dioxide
Erythrosine (E127)
Quinoline yellow (E104)

60 mg capsule shells:

Gelatin
Titanium dioxide
Indigo carmine (E132)

90 mg capsule shells:

Gelatin
Titanium dioxide
Ponceau 4 R (E124)

Pack sizes and marketing

Polypropylene bottle with polyethylene desiccant cap.

Box of 30, 50, 90 and 100 prolonged-release capsule, hard.

Not all pack size may be marketed.

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