Healthcare Industry News:  Teva Pharma 

Biopharmaceuticals Generics

 News Release - January 29, 2010

Teva UK Limited Launches Lercanidipine Hydrochloride Film-Coated Tablets

CASTLEFORD, England, January 29 -- (Healthcare Sales & Marketing Network) -- We are pleased to announce the patent expiry launch of lercanidipine hydrochloride film-coated tablets, available in 10mg and 20mg strengths in packs of 28. Lercanidipine hydrochloride film-coated tablets are indicated for the treatment of mild to moderate, essential hypertension(1).

It is a generic version of Zanidip(R) from Recordati and is available immediately in the award-winning Teva 360 livery, which is designed to aid patient safety.

The Teva list price for the product is:

Lercanidipine hydrochloride film-coated tablets - 10mg is GBP5.70

Lercanidipine hydrochloride film-coated tablets - 20mg is GBP10.82

Kim Innes, Commercial Director at Teva UK Limited said "We are pleased to add this product to our ever expanding product portfolio."


1. Lercanidipine hydrochloride film-coated tablets - Summary of Product Characteristics

About Teva UK Limited: Teva UK Limited is one of the UK's top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) which has 38,000 employees based in 70 countries around the world.

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Teva UK Limited.

Lercanidipine tablets Prescribing Information:

Presentation: Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride. Indications: Mild to moderate essential hypertension. Dosage and administration: Tablets should be swallowed with sufficient amount of fluid. 10mg once a day at least 15 minutes before meals, dose may be increased to 20mg depending on patients response. Dose titration should be gradual. Elderly: No adjustment required but special care may be needed. Children: Not recommended for use in children below 18 years. Impaired renal or hepatic function: Special care must be taken in mild to moderate dysfunction. An increase in dose to 20mg must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment; an adjustment of the dose should be considered. Not recommended in patients with severe hepatic or severe renal impairment (GFR < 30ml/min). Contraindications: Hypersensitivity to lercanidipine or to any of the excipients, pregnancy and lactation, women of child-bearing potential that are not using effective contraception, left ventricular outflow tract obstruction, untreated congestive cardiac failure, unstable angina pectoris, severe renal or hepatic impairment, within one month of a myocardial infarction, co-administration with strong inhibitors of CYP3A4, ciclosporin and grapefruit juice. Warnings and Precautions: Special care is required in patients with sick sinus syndrome (if a pacemaker is not in situ), and in patients with LV dysfunction. Caution required in patients with ischaemic heart disease. May rarely lead to precordial pain or angina pectoris. Rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed. Special care should be taken in patients with mild to moderate hepatic and renal dysfunction. Alcohol should be avoided. Inducers of CYP3A4 like anticonvulsants (e.g phenytoin, carbamazepine,) and rifampicin may reduce lercanidipine's plasma levels and may reduce the efficacy. Interactions: Inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination of lercanidipine. Should not be co-administered with ciclosporin and grapefruit juice. Avoid administration with ketoconazole, itraconazole, ritonavir, erythromycin and troleandomycin. Caution when administered with terfenadine, astemizole and class III antiarrhythmic products. Caution with co-administration of midazolam in the elderly. May be safely administered with beta-blocking agents, but dose adjustments may be required. Patients on concomitant digoxin treatment should be closely monitored clinically for signs of digoxin toxicity. Pregnancy and lactation: Should not be used during pregnancy or in women of child bearing potential unless effective contraception is used. Not recommended for nursing mothers. Effects on ability to drive and use machines: Caution should be exercised. Dizziness, weakness and fatigue may affect the ability to drive and use machines. Adverse reactions: Headache, dizziness, peripheral oedema, tachycardia, palpitations, flushing. Rare: Angina pectoris. Isolated cases of myocardial infarction. Prescribers should consult the Summary of Product Characteristics in relation to other side-effects. Overdosage: May cause excessive peripheral vasodilation with marked hypotension and reflux tachycardia. In case of severe hypotension, bradycardia and unconsciousness, cardiovascular support could be helpful, with intravenous atropine for bradycardia. Overdose should be monitored for 24 hours at least. NHS Price: Packs of 28, 10mg tablets GBP5.70; packs of 28, 20mg tablets GBP10.82 Legal category: POM. Marketing Authorisation Numbers: PL 00289/1283-4. Marketing Authorisation Holder: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG. Date of preparation: January 2010. 19/COP/10

For media enquiries, telephone the Teva Communications team on +44(0)1977-628500, or email

Source: Teva UK

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