Cedocard Retard 20 Tablets

1. Name Of The Medicinal Product

Cedocard Retard 20 Tablets

2. Qualitative And Quantitative Composition

Isosorbide Dinitrate BP 20.0 mg

3. Pharmaceutical Form

Uncoated sustained release tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis of angina pectoris.

4.2 Posology And Method Of Administration

By oral administration, the tablets should be swallowed, with a little water without chewing.

Children:

There is no recommended dose for children.

Adults:

One tablet in the morning and one before retiring to sleep.

Elderly:

The dosage of nitrates in cardiovascular disease is usually determined by patient response and stabilisation. Clinical experience has not necessitated alternative advice for use in elderly patients. The pharmacokinetics of isosorbide dinitrate in patients with severe renal failure and liver cirrhosis are similar to those in normal subjects.

The onset of action is 20-30 minutes.

The duration of action is 10-12 minutes.

4.3 Contraindications

A history of sensitivity to the drug.

4.4 Special Warnings And Precautions For Use

Tolerance and cross-tolerance to other nitrates may occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol may potentiate the effect of isosorbide dinitrate.

4.6 Pregnancy And Lactation

No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy however, has not been established. Isosorbide dinitrate should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards. Lactation – there are no data available on the transfer of isosorbide dinitrate in breast milk or its effect on breast-fed children.

4.7 Effects On Ability To Drive And Use Machines

Side effects include throbbing headache and dizziness. Patients are advised not to drive or operate machinery is so affected.

4.8 Undesirable Effects

Headaches may occur (common), these are usually temporary. Less frequent, cutaneous vasodilation with flushing. Transient episodes of dizziness and weakness and other signs of cerebral ischaemia may occur with postural hypotension.

4.9 Overdose

In rare cases of overdosage, gastric lavage is indicated. Passive exercise of the extremities of the recumbent patient will promote venous return.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Vasodilator.

5.2 Pharmacokinetic Properties

After administration of one tablet of Cedocard Retard 20 at least two peak concentration of ISDN occurred in the plasma. The initial peak (mean 1.9 ng/ml, range 1.0-3.4 mg/ml) occurred during 0.5 to 2 hours, and then mean plasma concentrations declined to 1.3 ng/ml at 3 hours. The concentration then increased again to reach a major peak level (mean 6.2 ng/ml, range 1.6-12.3 ng/ml) during 4-6 hours after dosing.

Plasma concentrations of ISDN have been measured after administration of increasing doses in the range 20-100 mg (as Cedocard Retard 20 tablets).

Means of peak concentrations of 4.2 ng/ml, 13.1 ng/ml, 20.7 ng/ml, 36.8 ng/ml and 34.9 ng/ml were measured after doses of 20 mg, 40 mg, 60 mg, 80 mg and 100 mg respectively.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Talc

Magnesium Stearate

Polyvinyl Acetate

Quinoline Yellow (E104)

Yellow Orange S (E110)

Methylene Chloride

Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Protect from heat and moisture.

6.5 Nature And Contents Of Container

PVC/Aluminium foil blister strip.

Pack size: 60 tablets

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

Administrative Data

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

8. Marketing Authorisation Number(S)

PL 00032/0331

9. Date Of First Authorisation/Renewal Of The Authorisation

30 September 2002

10. Date Of Revision Of The Text

August 2007

Company Ref: CD1_0