Consumer medicine information

1. Why am I using Iscover?

Iscover contains the active ingredient clopidogrel. Iscover is used to prevent blood clots forming in hardened blood vessels (a process known as atherothrombosis) which can lead to events such as stroke, heart attack or death. For more information, see Section 1. Why am I using Iscover? in the full CMI.

2. What should I know before I use Iscover?

Do not use if you have ever had an allergic reaction to Iscover or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Iscover? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Iscover and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Iscover?

• Take Iscover only as prescribed by your doctor and follow his or her directions carefully.

5. What should I know while using Iscover?

6. Are there any side effects?

Like other medicines Iscover can cause some side effects. Most are likely to be minor and temporary. However, some may be serious and need medical attention such as bleeding or bruising more easily, blood in the urine and in the eye, coughing up blood, diarrhoea with blood, tightness of the chest, swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Clopidogrel hydrogen sulfate.

2 Qualitative and Quantitative Composition

Iscover 75 mg contains 97.875 mg of clopidogrel hydrogen sulfate which is the molar equivalent of 75 mg of clopidogrel base.
Excipient with known effect. The coating contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

75 mg film coated tablets. Pink, round, slightly biconvex, film coated tablets, engraved with "75" on one side and "1171" on the other side.

4 Clinical Particulars

4.9 Overdose

In animals, clopidogrel at single oral doses ≥ 1500 mg/kg caused necrotic haemorrhagic gastritis, oesophagitis and enteritis in mice, rats and baboons. Necrotic tubulopathy and tubulointerstitial nephritis were also noted in mice.
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleeding is observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts and metaphase chromosome analysis of human lymphocytes) and in one in vivo test (micronucleus test by the oral route in mice).
Carcinogenicity. There was no evidence of carcinogenic effects when clopidogrel was given in the diet for 78 weeks to mice and 104 weeks to rats at doses up to 77 mg/kg per day (representing an exposure ≈ 18 times the anticipated patient exposure, based on plasma AUC for the main circulating metabolite in elderly subjects).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Clopidogrel hydrogen sulfate is a white to off white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It is freely soluble in methanol, sparingly soluble in methylene chloride and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.
Chemical structure. Clopidogrel hydrogen sulfate has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLOPHS.gif Molecular formula: C₁₆H₁₆ClNO₂S.H₂SO₄.
Molecular weight: 419.9.
Chemical name: methyl (+)-(S)-α-(2-chlorophenyl)- 6,7-dihydrothieno[3,2-c] pyridine- 5(4H)-acetate sulfate (1:1).
CAS number. 120202-66-6 (clopidogrel hydrogen sulfate), 113665-84-2 (clopidogrel base).

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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