ELANTAN LA Prolonged release capsule Ref.[49650] Active ingredients: Isosorbide mononitrate

For oral administration.

Adults

One capsule to be taken in the morning.

For patients with higher nitrate requirements the dose may be increased to two capsules taken simultaneously. Dosage regime should be designed according to the clinical response of the patient. The lowest effective dose should be used.

Older people

There is no evidence to suggest an adjustment of dosage is necessary.

Paediatric population

The safety and efficacy of these capsules has yet to be established in children.

Attenuation of effect has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see section 4.4).

Treatment with Elantan LA, as with any other nitrate, should not be stopped suddenly. Both dosage and frequency should be tapered gradually (see section 4.4).

Animal experience

In rats and mice, significant lethality at oral doses of 1965 mg/kg and 2581 mg/kg, respectively, was observed.

Human experience

Symptoms:

• Fall of blood pressure ≤90 mmHg
• Paleness
• Sweating
• Weak pulse
• Tachycardia
• Light-headedness on standing
• Headache
• Weakness
• Dizziness
• Nausea
• Vomiting
• Diarrhoea

Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During isosorbide mononitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It cannot be excluded that an overdose of isosorbide mononitrate may cause this adverse reaction.

In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.

General procedure

• Stop intake of the drug
• General procedures in the event of nitrate-related hypotension
  • Patients should be kept horizontal with the head lowered and legs raised
  • Supply oxygen
  • Expand plasma volume (i.v. fluids)
  • Specific treatment for shock (admit patient to intensive care unit)

Special procedure:

• Raising the blood pressure if the blood pressure is very low.
• Treatment of methaemoglobinaemia
  • Reduction therapy of choice with vitamin C, methylene-blue or toluidine-blue
  • Administer oxygen (if necessary)
  • Initiate artificial ventilation
  • Hemodialysis (if necessary)
• Resuscitation measures

In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.

5 years.

Do not store above 30°C.

Cartons of blister strips of PVC and aluminium or of PP and aluminium.

Aluminium foil thickness 20 μm or 16 μm.

Pack size: 28 capsules.

None.