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Imipramine Hydrochloride 25mg/5ml Oral Solution

Last Updated on eMC 04-Jul-2013 View document  | Rosemont Pharmaceuticals Limited Contact details

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 04-Jul-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 29-May-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 6.5 (nature and contents of container): presentation of data changed and additional information of “HDPE, EPE wadded, tamper evident” added.  

 

Section 10 (date of revision of the text): updated to 29/05/2013.

 

Updated on 06-Apr-2011 and displayed until 04-Jul-2013

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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 22-Mar-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



   

In Section 4.4 (Special warnings and precautions for use) the following underlined text was added:

 

Warnings

As improvement in depression may not occur for the first two to four weeks’ treatment, patients should be closely monitored during this period.

 

Hyponatraemia (usually in the elderly) has been associated with all types of antidepressants and should be considered in all patients who develop symptoms such as drowsiness, confusion or convulsions.

 

Suicide/suicidal thoughts or clinical worsening

Risk of suicide is inherent to severe depression and may persist until significant remission occurs. This risk persists until significant remission occurs. As improvement may not occur during the first few

weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients posing a high suicide risk require close supervision. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal

behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

In section 4.5 (Interaction with other medicinal products and other forms of interaction) the following underlined text was added:

 

Beta-blockers: Blood concentrations of imipramine may be increased by drugs such as labetalol and propranolol. The clinical importance of these interactions is uncertain.


Diuretics:
Concurrent use of a tricyclic and a diuretic may increase the risk of postural hypotension.


Alpha2-adrenoceptor stimulants:
concomitant use of apraclonidine or brimonidine should be avoided.


Oe
strogens:
There is evidence that oestrogens can sometimes paradoxically reduce the effects of imipramine yet at the same time cause imipramine toxicity.


Antiviral agents:
Drugs such as ritonavir have been reported to increase plasma concentrations of antidepressant drugs.


Calcium channel blockers:
Blood levels of imipramine may be increased by calcium channel blockers such as diltiazem and verapamil.


Nitrates:
Reduced salivary secretion may lessen the effectiveness of sub-lingual nitrate preparations.


Dopaminergic agents:
CNS toxicity may be enhanced when tricyclic antidepressants are used in conjunction with dopaminergic drugs such as selegiline and entacapone.


Centrally acting appetite suppressants:
Concomitant use is not recommended due to the increased risk of CNS toxicity.


Antineoplastic drugs:
concomitant use of altretamine should be avoided due to the risk of severe postural hypotension.


Tricyclic antidepressants may also interact with the following drug classes:


Analgesics:
Possible increase in risk of side effects (nefopam), convulsions (tramadol), sedation (opioid analgesics) or ventricular arrhythmias.


Anti-arrhythmics:
Increased risk of ventricular arrhythmias with drugs, which prolong the QT interval.


Muscle relaxants:
Enhanced muscle relaxant effect of baclofen

 

In Section 4.8 (Undesirable effects) the following underlined text was added:

 

Central Nervous System

Psychiatric Effects:

Occasionally: fatigue, drowsiness, restlessness, delirium, confusion, disorientation and hallucination (particularly in geriatric patients and those suffering from Parkinson’s disease) increased anxiety, agitation, sleep disturbances, swings from depression to hypomania or mania.

Rarely: activation of psychotic symptoms

Isolated cases: aggressiveness

Paranoid delusion may be exacerbated during treatment with tricyclic

antidepressants. These are more frequently seen in elderly patients or

those on high doses.

Cases of suicidal ideation and suicidal behaviours

have been reported during Imipramine therapy or early after treatment

discontinuation (see section 4.4)

Cardiovascular System:

Frequently: sinus tachycardia and clinically irrelevant ECG changes (T and ST changes) in patients of normal cardiac status, postural hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre-existing heart disease taking normal dosage.

Occasionally: arrhythmias, conduction disorders (widening of QRS complex and PR interval, bundle-branch block), palpitations.

Isolated cases of increased blood pressure, cardiac decompensation, peripheral vasospastic reactions.

 

Hepatic Effect:

Occasionally: elevated transaminases

Rarely: impaired liver function

Isolated cases of hepatitis with or without jaundice

 

Endocrine System and Metabolism:

Frequently: weight gain

Occasionally: disturbances of libido, impotency or abnormal ejaculation.

Isolated cases of enlarged mammary glands, galactorrhoea, SIADH (syndrome of inappropriate antidiuretic hormone secretion), increase or decrease in blood sugar, weight loss.

Hyponatraemia, usually in the elderly, has been associated with all

types of antidepressants (see section 4.4).

Blood:

Isolated cases of bone marrow depression including eosinophilia, leucopenia, agranulocytosis, thrombocytopenia and purpura have been reported. It is advisable to perform blood counts during treatment with

tritetracyclic antidepressants, especially if the patient develops fever,

sore throat or other signs of infection. (See section 4.4).

Miscellaneous:

Occasional withdrawal symptoms following abrupt discontinuation of treatment: nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, nervousness, anxiety, irritability and excessive perspiration (see section 4.4). Contains 1.5g of sorbitol per 5ml spoonful so may cause stomach upset and diarrhoea, particularly at high doses.

 

Respiratory depression, agitation and withdrawal symptoms have been reported in neonates whose mothers received imipramine during the last trimester of pregnancy.

In section 10 (date of revision of the text) the date was changed to:

22nd March 2011

Updated on 05-Oct-2010 and displayed until 06-Apr-2011

Reasons for adding or updating:

  • 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: 26-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 (Undesirable Effects) Class effects have been added.

In section 10 (Date of revision of the text) the date has been updated to 26/07/2010.

Updated on 25-Nov-2009 and displayed until 05-Oct-2010

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Rosemont Pharmaceuticals Limited

Company image
Address

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Fax

+44 (0)113 246 0738

Out of Hours Telephone

+44 (0)7836 557 879

Telephone

+44 (0)113 244 1400

Customer Care direct line

+44 (0)800 919 312

Out of Hours contact

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?

Active ingredients

imipramine hydrochloride

Legal categories

POM - Prescription Only Medicine

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