Teva UK Limited Launches Lercanidipine Hydrochloride Film-Coated Tablets

CASTLEFORD, England, January 29 - 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."

References

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 www.yellowcard.gov.uk.
        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 media.enquiries@tevauk.com.

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