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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 13/01/2012
SPC Cozaar - Comp 50/12.5mg, 100/12.5mg and 100/25mg Film-Coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 13/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following changes have been made to the SmPC:

Section 4.4 (Special warnings and precautions for use)

There have been minor typographical corrections made to this section

Section 4.5 (Interaction with other medicinal products and other forms of interaction)

The following changes have been made to this section:

- A paragraph regarding the combined use of angiotensin receptor blockers (ARBs) with ACEIs has been added as follows:

Dual blockade (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should be limited to individually defined cases with close monitoring of renal function. Some studies have shown that in patients with established atherosclerotic disease, heart failure, or with diabetes with end organ damage, dual blockade of the renin-angiotensin-aldosterone system is associated with a higher frequency of hypotension, syncope, hyperkalaemia, and changes in renal function (including acute renal failure) as compared to use of a single renin-angiotensin-aldosterone system.

- Glycyrrhizin (found in liquorice) has been added to the list of the drugs when given concurrently, may interact with thiazide diuretics.

- Minor typographical corrections

 

Section 4.6 (Pregnancy and lactation)

The sub-heading 'lactation' has been updated as follows:

Lactation

Because n

 

o

information is available regarding the use of Cozaar Comp during breastfeeding. Cozaar Comp is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.

 

Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit the milk production. The use of Cozaar Comp during breast feeding is not recommended. If Cozaar Comp is used during beast feeding.

 

Section 4.8 (Undesirable effects)

This section has been completely re-formatted. The adverse event have been tabulated and separated according to Losartan and Hydrochlorothiazide. See annotated SmPC for a full list of changes

Section 5.1 (Pharmacodynamic properties)

There have been minor typographical corrections made to this section

Section 5.2 (Pharmacokinetic properties)

(

- There have been minor typographical corrections made to this section

- A new paragraph has been added to this section stating "

Pharmacokinetic studies showed that the AUC of losartan in Japanese and non-Japanese healthy male subjects is not different. However, the AUC of the carboxylic acid metabolite (E-3174) appears to be different between the two groups, with an approximately 1.5 fold higher exposure in Japanese subjects than in non-Japanese subjects. The clinical significance of these results is not known."

 

 

Section 6.4 (Special precautions for storage)

(

The storage conditions for the HDPE bottles have been updated as follows: HDPE bottle: Do not store above 25 oC. Store in the original container

in order to protect from light. Keep the bottle tightly closed in order to protect from moisture

 

Section 6.5 (Nature and contents of container)

The nature and contents of container for Cozaar Comp 100　mg/12.5　mg has been updated as follows: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets. HDPE bottles

with white polypropylene, tamper evident screw cap closure containing 100 tablets

 
Updated on 18/10/2011 and displayed until 13/01/2012
Reasons for adding or updating:
  • Extra statutory information
Date of revision of text on the SPC:   17-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to trademark statement
Updated on 02/08/2010 and displayed until 18/10/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   02-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 18/01/2010 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   22-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The primary changes are to update the pregnancy and lactation warnings to standard wordings for the AIIRAs and hydrochlorothiazide containing products.

Section 4.3: Contraindications
Lactation is removed as a contraindication. 

Section 4.6: Pregnancy and Lactation
Changes largely to the hydrochlorothiazide information in line with standard wording for both pregnancy and lactation advice.

Other changes:
6.4: Special precautions for storage:  Advice now includes to store in  original package in order to protect from light and moisture.

6.5: Nature and contents of container:
Additional hospital unit dose pack sizes added for other European markets- not available in UK.
6.5
Updated on 18/02/2009 and displayed until 18/01/2010
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   08-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The losartan range of products has been through an Article 30 referral procedure, which is a process of harmonisation of the SPC and PILs during which the European regulators assessed the available data and came to a concensus on what should be licenced through the EU in terms of indications and warnings, precautions and side-effects. The three strengths strengths of Cozaar Comp now have the same SPC. Changes have been made to most parts of the SPC, the main ones are as follows:

 

The indication  is:
For the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.

'Cozaar'-Comp no longer has the following indication:
In hypertensive patients with left ventricular hypertrophy a reduced risk of stroke was demonstrated with losartan administered usually in combination with HCTZ.

Section 4.3 now includes additional contraindications to use in patients with: therapy resistant hypokalaemia or hypercalcaemia, severe hepatic impairment, cholestasis and biliary obstructive disorders, refractory hyponatraemia, symptomatic hyperuricaemia/gout, severe renal impairment and anuria.

Section 4.4 now includes statements with regards to use in further special populations and in further detail.

Section 4.5 now includes a more extensive list of potential and known drug interactions with the components of 'Cozaar'-Comp.

Section 4.8 is now more extensively defined and also includes information on post-marketing experience. It is now presented in a format as required by current guidelines.
Updated on 25/01/2007 and displayed until 18/02/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 of the SPC has been updated with new wording on interaction with NSAIDs and with Lithium. The new wording relates to the possible interaction between AIIAs and NSAIDS leading to impaired renal function.
In addition a new warning on a possibility of a Lithium interaction with AIIAs has been added and the existing warning of  a risk of lithium toxicity with concomitant use with hydrochlorothiazide has been expanded to include a recommendation to monitor serum lithium levels if concomitant use is deemed essential.  This wording is class-labelling for all the AIIAs imposed by the European Medicines Agency Pharmacovigilance working party.
Updated on 31/10/2005 and displayed until 25/01/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 26/01/2005 and displayed until 31/10/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/12/2004 and displayed until 26/01/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 21/02/2004 and displayed until 23/12/2004
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 06/11/2002 and displayed until 21/02/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.8 - Undesirable Effects
Updated on 17/07/2001 and displayed until 06/11/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 09/04/2001 and displayed until 17/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 09/04/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydrochlorothiazide
  losartan potassium