Last Updated on eMC 08-01-2015 View medicine  | Concordia International - formerly AMCo 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.

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:29-12-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0To update section 5.2 (Pharmacokinetic properties) of the SPC to bring in line with new clinical data. No changes have been made to the PIL.$0

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC:08-04-2014

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:31-12-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections 1, 2, 3, 4.1 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5, 5.1, 5.2, 5.3, 6, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 7, 8, 9 and 10 of the SmPC in line with the excipient guideline and QRD template

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-05-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



UPDATE TO SPC FOLLOWING CHANGE OF OWNERSHIP FROM WAYMADE TO AMDIPHARM

 

Section 7: MARKETING AUTHORISATION HOLDER

 

Updated to read:

 

Amdipharm PLC

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

UK

 

 

Section 8: MARKETING AUTHORISATION NUMBER(S)

 

Updated to read:

 

PL 20072/0220

 

 

Section 10: DATE OF REVISION OF THE TEXT

 

Updated to read:

 

May 2013

Reasons for adding or updating:

  • 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 10 date of revision of the text

Date of revision of text on the SPC:02-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Updates to sections 4.2, 4.3, 4.4, 4.5 and 4.8 in line with current medical knowledge below in bold.  Also change date in section 10.

 

4.2

There is a risk of tolerance developing to sustained release preparations. In such patients intermittent therapy may be more appropriate.

4.3

 

Hypersensitivity to Isosorbide Mononitrate or to any of the excipients.

 

Acute myocardial infarction with low filling pressures, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, aortic/mitral stenosis and severe anaemia, hypovolaemia, conditions causing raised intracranial pressure (e.g. cerebral haemorrhage, head trauma) and  closed-angle glaucoma.

 

Phosphodiesterase type-5 inhibitors (e.g. sildenafil) have been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.

 

 Severe cerebrovascular insufficiency or hypotension are contra-indications to use.

4.4

The lowest effective dose should be used.

 

There is a risk of tolerance developing to sustained release preparations. In such patients intermittent therapy may be more appropriate.

 

Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see section 4.2).

 

Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.

 

Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.

 

Isosorbide mononitrate modified release tablets are not indicated for relief of acute anginal attacks: in the event of an acute attack, glyceryl trinitrate should be used.

 

The administration of Isosorbide mononitrate causes a decrease of ERPF (Effective Renal Plasma Flow) in cirrhotic patients and should be used with caution.

 

Caution should be used in patients who have a recent history of myocardial infarction and in patients suffering from hypothyroidism, hypothermia, malnutrition, and severe liver or renal disease.

 

Chemydur 60XL tablets contain lactose, and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

4.5

The hypotensive effect of nitrates will be increased if used together with phosphodiesterase type-5 inhibitors (e.g. sildenafil). This might lead to life threatening cardiovascular complications.

 

Any medication which may cause hypotension may have its hypotensive effects potentiated by concurrent administration of Chemydur (e.g.  alcohol, vasodilators, calcium channel blockers, antihypertensives and diuretics).

 

Reports suggest that concomitant administration of Isosorbide Mononitrate may increase the blood level of dihydroergotamine and its hypertensive effect.

4.8

Most of the adverse reactions are pharmacodynamically mediated and dose dependent.

 

Headache is very common (>10%). The incidence of headache usually disappears after 1-2 weeks of treatment. (See section 4.2)

Flushing, dizziness, postural hypotension, tachycardia and paradoxical bradycardia have been reported. These symptoms generally disappear during long-term treatment.

 

Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration. Uncommonly, collapse may occur (sometimes accompanied by bradyarrhythmia, bradycardia and syncope).

Uncommonly severe hypotension may lead to enhanced angina symptoms.

Allergic skin reaction, pruritus, myalgia and, drowsiness, diarrhoea or vomiting may occur.

 

Cases of exfoliative dermatitis have been reported.

10.

August 2010

 

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:11-12-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update section 4.9 in line with current medical knowledge, to update sections 5.3 (Preclinical safety data) following PSUR with consequential changes to section 4.6 (Pregnancy and lactation). Changes below in bold:

 

4.9       Overdose

           

Symptoms and signs

Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur.

 

Methaemoglobinaemia (cyanosis, hypoxaemia, change in mental status, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure and raised intracranial pressure) occurs rarely.

 

Management

Induction of emesis, activated charcoal.

 

In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary, fluids should be administrated intravenously.

 

Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse.

 

If methaemoglobinaemia occurs seek expert advice. Treat with supplemental oxygen and methylene blue. In cases not responding to methylene blue or where methylene blue is contraindicated consider exchange transfusion or red blood cell concentrates. In case of cerebral convulsions, consider diazepam or clonazepam IV or, if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.

 

4.6       Pregnancy and Lactation

 

The safety and efficacy of isosorbide mononitrate modified release tablets during pregnancy or lactation in humans has not been established. Animal studies have shown reproductive toxicity (see section 5.3).

 

It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women.

 

Isosorbide mononitrate should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.

 

5.3       Preclinical Safety Data

 

 High concentrations of isosorbide mononitrate in rats is associated with prolonged gestation and parturition, stillbirths and deaths.

10.       Date of (Partial) Revision of the Text

 

December 2009

 

 

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC