Class 2 Drug Alert (Action within 48 hours): P.I.E. Pharma Limited and Star Pharmaceuticals Limited - Multiple product Drug Alert, parallel imports - EL (10)A/08

---

Dear Healthcare Professional,

P.I.E.Pharma Limited

Product name	Generic name	PLPI number	Pack size	Expiry date range, from and to inclusive
Cozaar Tabs 50mg	Losartan Potassium	15631/0097	28	Apr 2012 only
Cozaar Tabs 50mg	Losartan Potassium	15631/0571	28	Jun 2011 to Apr 2012
Innovace Tabs 5mg	Enalapril Maleate	15361/0018	28	Jan 2011 to Jul 2011
Lamictal Tabs 50mg	Lamotrigine	15361/0419	60	Sep 2011 to Jan 2012
Lamictal Tabs 100mg	Lamotrigine	15361/0420	60	Jan 2012 to Dec 2012
Lamictal Tabs 200mg	Lamotrigine	15361/0173	30	Nov 2011 only
Neurontin Caps 100mg	Gabapentin	15361/0258	90, 100	Jul 2011 to Jun 2012
Neurontin Caps 300mg	Gabapentin	15361/0427	100	Nov 2011 to Aug 2012
Neurontin Caps 300mg	Gabapentin	15361/0574	90, 100	Jul 2011 to Sep 2012
Neurontin Caps 400mg	Gabapentin	15361/0428	100	Nov 2011 only
Neurontin Caps 400mg	Gabapentin	15361/0575	100	Jul 2011 to Jun 2012
Neurontin Caps 600mg	Gabapentin	15361/0576	100	Jul 2011 only
Staril Tabs 10mg	Fosinopril Sodium	15361/0287	30	Jun 2010 only
Topamax Tabs 200mg	Topiramate	15361/0229	60	Oct 2011 only

Star Pharmaceuticals Limited

Product name	Generic name	PLPI number	Pack size	Expiry date range, from and to inclusive
Depixol Inj 100mg/ml	Flupentixol Decanoate	20636/1528	1	Apr 2010 only
Diovan Caps 80mg	Valsartan	20636/1616	28	Dec 2011 to Feb 2012
Diovan Caps 80mg	Valsartan	20636/0918	28	Feb 2012 to Jun 2012
Diovan Caps 160mg	Valsartan	20636/1617	28	Apr 2012 only
Diovan Caps 160mg	Valsartan	20636/0927	28	Apr 2012 to Jul 2012
Efexor XL Caps 75mg	Venlafaxine HCl	20636/1119	14	Sep 2011 to Jul 2012
Efexor XL Caps 75mg	Venlafaxine HCl	20636/1150	14	Dec 2010 to Mar 2011
Efexor XL Caps 150mg	Venlafaxine HCl	20636/1167	10	Jul 2010 to May 2012
Frisium Tabs 10mg	Clobazam	20636/1227	30	Oct 2011 to Jul 2012
Innovace Tabs 10mg	Enalapril Maleate	20636/1649	28	Aug 2011 only
Innovace Tabs 20mg	Enalapril Maleate	20636/1650	28	Feb 2011 to Aug 2011
Innozide Tabs 20/12.5mg	Enalapril Maleate/ Hydrochorothiazide	20636/1764	28	Nov 2011 to Dec 2011
Olmetec Tabs 10mg	Olmesartan Medoxomil	20636/1229	30	Mar 2012 to Jun 2012
Tegretol Retard Tabs 200mg	Carbamazepine	20636/1577	50	Nov 2011 to Aug 2012
Tegretol Retard Tabs 200mg	Carbamazepine	20636/1759	50	Feb 2011 to Jan 2012
Tegretol Retard Tabs 400mg	Carbamazepine	20636/1578	30	Mar 2011 to Aug 2012
Tegretol Retard Tabs 400mg	Carbamazepine	20636/1760	30	Mar 2011 to Feb 2012
Vascace Tabs 5mg	Cilazapril Monohydrate	20636/1280	14	Jul 2012 only

P.I.E. Pharma Limited / Star Pharmaceuticals Limited are recalling unused stock from batches of products with the PLPI numbers shown above and with expiry dates within the stated ranges because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency. Details of the safety warnings which should have been included in the PILs are provided in the Appendix.

Pharmacists are asked to quarantine all unused stocks of the above products and email (recall@drugsrus.co.uk) or fax (020 8424 8731) details of products, PLPI numbers, batch numbers and quantities to Jumbogate Limited. A form for this purpose may be downloaded via the link: http://www.drugsrusrecall.tk (external link) or alternatively may be obtained by telephoning Jumbogate Limited on 020 8427 4354. Once this information is received, the company will check the batch numbers and provide instructions on returning the stock where applicable. Wholesalers are asked to quarantine stock and notify Jumbogate Limited who will then arrange collection. For further stock enquiries, the above telephone number should be used.

Please note other parallel importers may have imported the same products. Only products over-labelled or re-cartoned by P.I.E. Pharma Limited or Star Pharmaceuticals Limited and with the PLPI numbers and expiry dates listed should be returned.

For medical information enquiries, please contact Jumbogate Limited on 020 8423 2111 or email vikas@drugsrus.co.uk.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics, general practitioners and community pharmacists.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

Appendix: Safety warnings which should have been included in patient information leaflets (PILs) for specified batches of P.I.E. Pharma Limited and Star Pharmaceuticals Limited Products.

All Anti-epileptics
(Clobazam, Gabapentin, Lamotrigine, Topiramate)

Under “Before taking your medicine” or “Take special care with [Product]” addition of the following:
“A small number of people being treated with anti-epileptics such as << drug substance >> have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.”

Carbamazepine
Under “Before taking your medicine” or “Take special care with [Product]” addition of the following:
“A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious skin side effects can rarely occur during treatment with carbamazepine. This risk can be predicted with a blood sample in people of Chinese and Thai origin. Discuss this with your doctor before taking carbamazepine if you are of such origin.”

Ace Inhibitors / Angiotensin II Receptor Inhibitors
(Cilaprizil Monohydrate, Enalapril Maleate, Fosinopril Sodium, Losartan Potassium, Valsartan, Olmesartan Medoximil )

Under “Before you take [Product]”
Do not take [Product]
If you are more than 3 months pregnant. (It is also better to avoid [Product] in early pregnancy – see pregnancy section.)

Take special care with [Product]
You must tell your doctor if you think you are (or might become) pregnant. [Product] is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Pregnancy and breast feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking [Product] before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of [Product]. [Product] is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. [Product] is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Antidepressants
(Flupentixol Decanoate, Venlafaxine HCl)

Under “Before you take [Product]”
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

MHRA Distribution (further recipients by cascade):
Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)