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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

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: 11/11/2011
SPC Adizem-XL capsules

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 11/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition

Deleted: Excipients: also contains soya lecithin trace quantities per capsule.

Section 4.3 Contraindications

Deleted: Peanut or soya allergies.

Section 6.1 List of excipients

Deleted: Soya letithin
               2-ethoxyethanol

Dimeticone changed to Simeticone
Updated on 16/03/2011 and displayed until 11/11/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6 - The following paragraph has been added

Diltiazem is excreted in breast milk at low concentrations. Breast‑feeding while taking this drug should be avoided. If use of diltiazem is considered medically essential, an alternative method of infant feeding should be instituted.
Updated on 22/12/2010 and displayed until 16/03/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 : " Excipients: also contains soya lecithin, trace quantities per capsule" has been added

Section 4.3 "Patients with severe bradycardia (less than 40 bpm)" severe has been added and 50 bpm changed to 40 bpm.

Patients with left ventricular dysfunction has been changed to read " patients with left ventricular failure with pulmonary congestion"  "following myocardial infarction" has been removed.
"Hypersensitivity to diltiazem or to any of the excipients" has been added.

Section 4.4 - Has been re-written.

Section 4.5 - Has been re-written.

Section 4.6 - Has been re-written.

Section 4.7 - "Diltiazem may" has been changed to read "Diltiazem has been reported to cause adverse reactions" .....  "However no studies have been performed" has been added.

Section 4.8 - Has been re-written.
Updated on 22/07/2009 and displayed until 22/12/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 update - include 'peanut and soya allergies. Hypersentisivity to diltiazem or to any of the excipients.'
Updated on 26/03/2009 and displayed until 22/07/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 The following replaces the first three paragraphs of the previous SPC.


Diltiazem is extensively metabolised by CYP3A4, and as a result serum levels of diltiazem may be:

Increased by concomitant usage of CYP3A4 inhibitors such as H2 antagonists (e.g. cimetidine, ranitidine) and protease inhibitors (e.g. atazanavir, ritonavir)

Decreased by concomitant usage of CYP3A4 inducers such as barbiturates (phenobarbital, primidone), phenytoin and rifampicin.

Diltiazem is also an inhibitor of CYP3A4, and may therefore increase serum levels of CYP3A4 substrates such as benzodiazepines (especially midazolam and triazolam), carbamazepine, ciclosporin, cilostazol, ivabradine, statins (simvastatin, atorvastatin, lovastatin), sirolimus, tacrolimus and theophylline. Care should be exercised in patients taking these drugs. Concomitant use of diltiazem with cilostazol and ivabradine should be avoided.

There may be an additive effect (increased depression of cardiac conduction with risk of bradycardia and AV block) when diltiazem is prescribed with drugs which may induce bradycardia or other anti-arrhythmic drugs (e.g. amiodarone and beta blockers). Patients with pre-existing conduction defects should not receive the combination of diltiazem and beta-blockers.

Enhanced antihypertensive effect may occur with concomitant use of other antihypertensive drugs (e.g. beta-blockers, diuretics, ACE-inhibitors) or drugs that cause hypotension such as aldesleukin and antipsychotics. Concomitant use with alpha-blockers (e.g. prazosin) should be strictly monitored because of the possible synergistic hypotensive effect of this combination.

Diltiazem hydrochloride may cause small increases in plasma levels of digoxin, requiring careful monitoring of AV conduction.

Diltiazem may increase serum levels of phenytoin.

Diltiazem may increase bioavailability of tricyclic antidepressants.


Section 4.7 the following has been added

However if patients are affected they should not drive or operate machinery. 

 Section 4.8 the following replaces the first paragraph of the previous SPC   

 

Blood and the lymphatic system disorders

 

Uncommon

thrombocytopenia

 

 

Nervous system disorders

 

Common

dizziness

 

headache

 

 

Uncommon

extrapyramidal disorder

 

 

Cardiac disorders

 

Uncommon

atrioventricular block

 

bradycardia

 

palpitations

 

sinoatrial block

 

 

Vascular disorders

 

Common

facial flushing

 

hypotension

 

 

Uncommon

vasculitis

 

 

Gastrointestinal disorders

 

Common

gastrointestinal disorder

 

nausea

 

 

Uncommon

gingival hyperplasia

 

 

Hepatobiliary disorders

 

Uncommon

increased hepatic enzyme

 

clinical hepatitis

 

 

Skin and subcutaneous tissue disorders

 

Uncommon

allergic dermatitis

 

erythema multiforme

 

exfoliative dermatitis

 

photosensitivity reaction

 

 

Reproductive system and breast disorders

 

Uncommon

gynaecomastia

 

 

General disorders and administration site conditions

 

Common

fatigue

 

oedema legs

 

 

 
Updated on 09/12/2008 and displayed until 26/03/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Apr-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 23/04/2007 and displayed until 09/12/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 new paragraph added - ADIZEM-XL capsules should not be taken at the same time as an alcoholic beverage (refer to Section 4.5, Interactions with other Medicinal Products and Other Forms of Interaction).
 
Section 4.5 new paragraph added - ADIZEM-XL capsules should not be taken at the same time as alcohol, as it may increase the rate of release of diltiazem from the prolonged release preparation.  In addition, the combination of alcohol and diltiazem may have an additive vasodilatory effect.
Updated on 22/07/2004 and displayed until 23/04/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/02/2004 and displayed until 22/07/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 5 - Pharmacological Properties
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/02/2004 and displayed until 09/02/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/02/2002 and displayed until 09/02/2004
Reasons for adding or updating:
  • Addition of new strength
Updated on 14/08/2001 and displayed until 15/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 25/09/2000 and displayed until 14/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 25/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  diltiazem hydrochloride