Consumer medicine information

1. Why am I using Lercanidipine-WGR?

Lercanidipine-WGR contains the active ingredient lercanidipine hydrochloride. Lercanidipine-WGR is used to lower high blood pressure, which doctors call hypertension.
For more information, see Section 1. Why am I using Lercanidipine-WGR? in the full CMI.

2. What should I know before I use Lercanidipine-WGR?

Do not use if you have ever had an allergic reaction to lercanidipine hydrochloride 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 Lercanidipine-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Lercanidipine-WGR 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 Lercanidipine-WGR?

• Lercanidipine-WGR should be taken at about the same time each day, at least 15 minutes before a meal.

5. What should I know while using Lercanidipine-WGR?

6. Are there any side effects?

Speak to your doctor if you have any of these less serious side effects and they worry you: flushing, swelling of the ankles, feet or lower legs, palpitations, headache, dizziness or fainting, gastrointestinal disturbances such as heartburn, nausea, epigastric pain or diarrhoea, fatigue or sleepiness. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects: angina (chest pain or tightness), increased heartbeat, signs of allergy such as rash, itching or hives on the skin.
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

Lercanidipine hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride as the active ingredient.
Excipients with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

10 mg. Round biconvex yellow film coated tablets, scored on one side, marked "L" on the other side.
20 mg. Round biconvex pink film coated tablets, scored on one side, marked "L" on the other side.

4 Clinical Particulars

4.9 Overdose

In the post-marketing experience of lercanidipine, some cases of overdose have been reported ranging from 30-40 mg up to 800 mg, including reports of suicide attempt.
Symptoms. As with other dihydropyridines, overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and reflex tachycardia. However, at very high doses, the peripheral selectivity may be lost, causing bradycardia and a negative inotropic effect. In case of severe hypotension, bradycardia and unconsciousness, cardiovascular and respiratory monitoring will be required, and supportive treatment may be necessary. The most common adverse drug reactions associated to cases of overdose have been hypotension, dizziness, headache and palpitations.
Treatment. Clinically significant hypotension requires active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. In view of the prolonged pharmacological effect of lercanidipine, it is essential that the cardiovascular status of the patient is monitored for 24 hours at least. Since the product has a high protein binding, dialysis is not likely to be effective. Patients in whom a moderate to severe intoxication is anticipated should be observed in a high-care setting.
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. No evidence for genotoxic activity was observed with lercanidipine in in vitro assays of gene mutation (reverse mutation in S. typhimurium, forward mutation in Chinese hamster V79 fibroblasts), gene conversion (in Saccharomyces cerevisiae D4) or chromosomal damage (CHO cytogenetic assay). Negative findings were also obtained with lercanidipine in an in vivo assay of chromosomal damage (mouse micronucleus test).
Carcinogenicity. Carcinogenicity studies of lercanidipine (administered via the diet) have been performed in rats and mice (18 months), using doses up to 60 mg/kg/day for mice and 5 mg/kg/day for rats. Plasma concentrations (AUC) of lercanidipine at the highest doses used in these studies were about 2-4 times the highest AUC expected in humans during treatment with lercanidipine. Lercanidipine showed no evidence of carcinogenic activity in these studies.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Lercanidipine hydrochloride is a microcrystalline, odourless, citrine powder, readily soluble in chloroform and methanol, practically insoluble in water. Octanol:water partition coefficient (LogP): 6.4.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLERHYD.gif Lercanidipine is a dihydropyridine derivative. It is a racemate due to the presence of a chiral carbon atom at position 4 of the 1,4-dihydropyridine ring.
Chemical name: 3,5-pyridinedicarboxylic acid, 1,4- dihydro-2, 6-dimethyl-4-(3- nitrophenyl)-2- [(3,3-diphenylpropyl)methylamino]- 1,1-dimethylethyl methyl ester hydrochloride.
Molecular formula: C₃₆H₄₁N₃O₆.HCl.
Molecular weight: 648.2 (free base 611.7).
CAS number. 132866-11-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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