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Sormon Tablets 60mg

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Isosorbide Mononitrate

    *Additional information is available within the SPC or upon request to the company

Updated on 16 April 2019

File name

ie-pl-se0177-maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 15 April 2019

File name

ie-spc-se0177-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 April 2018

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications
Hypersensitivity to the active substance, other nitrates, or to any of the excipients listed in section 6.1.

Cardiogenic shock, unless a sufficiently high left ventricular end diastolic pressure is ensured either by intra-aortic counterpulsation or positive inotropic drugs.

Acute circulatory collapse (shock, vascular failure).

Constrictive pericarditis, pericardial tamponade, and restrictive cardiomyopathy. 

 

4.8 Undesirable effects

The majority of side effects are pharmacologically mediated and dose dependent.  Headache occurs in approximately 25% of patients at the start of treatment and can be attributed to the vasodilatation effect of the preparation and usually disappears within a week or so. 
Hypotension (with dizziness, reflex tachycardia, fainting and nausea) has been reported but resolves with continued treatment.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:
• Very common (1/10)
• Common (1/100 to <1/10)
• Uncommon (1/1,000 to <1/100)
• Rare (1/10,000 to <1/1,000)
• Very rare (<1/10,000)
• Not known (cannot be estimated from the available data)

Nervous system disorders
Very common: headache
Common: dizziness
Rare: fainting
Not known: somnolence

Cardiac disorders
Common: tachycardia
Not known: (aggravation of) angina pectoris, bradyarrhythmia, orthostatic hypotension

Vascular disorders
Common: hypotension
Uncommon: flushing
Not known: circulatory collapse

Gastrointestinal disorders
Common: nausea
Uncommon: vomiting, diarrhoea.

Skin and subcutaneous tissue disorders
Rare: rash, pruritus
Not known: exfoliative dermatitis, allergic skin reactions

Musculoskeletal and connective tissue disorders
Very rare: myalgia

General disorders and administration site conditions
Common: fatigue

The frequency of headache may be reduced by starting treatment at 30 mg for the first 2-4 days and gradually titrating the dose upwards as required (see section 4.2). 

 

4.9 Overdose

Experience of overdosage is limited.

Symptoms
Throbbing headache, excitation, flushing, cold sweat, nausea, vomiting, vertigo, dizziness, syncope, tachycardia, palpitation and hypotension.  Very large doses may give rise to methaemoglobinaemia (very rare).

No case reports of overdose have been received.

Symptoms of intoxication
(Orthostatic) hypotension, reflex tachycardia and headache, fatigue, dizziness, vertigo, flushing, nausea, vomiting, and diarrhoea may occur. After high doses methaemoglobinaemia, cyanosis, dyspnoea, and tachypnoea may occur based on the nitrite ion. After very high doses an increase in intracranial pressure with cerebral symptoms may occur. In chronic states of overdose elevated levels of methaemoglobin were measured. The clinical relevance of these findings is controversial.

 

Updated on 28 March 2018

File name

PIL_9009_678.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 March 2018

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 22 May 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 May 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

extensive list of changes, please refer to tracked document

Updated on 19 May 2015

Reasons for updating

  • Change of inactive ingredient
  • Change to packaging
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 10 July 2013

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Pack size of 90 added$0$0$0$0Revision date updated to May 2013$0$0$0$0$0$0$0$0$0$0$0(Internal Ref: SE/H/0177/IA/037/G)$0

Updated on 10 July 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 23 February 2011

Reasons for updating

  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 01 June 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 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 revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2. Qualitative and Quantitative Composition

Added:

Contains lactose (0.8 mg per tablet)

 

Section 3. Pharmaceutical Form

Added:

The tablet can be divided into equal halves

 

Section 4.4 Special warnings and precautions for use

Added:

Patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosemia or glucose-galactose malabsorbtion should not take this medicine

 

Section 4.5 Interactions with other medicinal products and other forms of interaction

Added:

Concurrent administration of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel blockers, vasodilators (including neuroleptics and tricyclic antidepressants), alprostadil, aldesleukin, antihypertensives, diuretics, angiotensin II receptor antagonists etc and/or alcohol may potentiate the hypotensive effect of Sormon. This may also occur with neuroleptics and tricyclic antidepressants.

Any blood pressure lowering effect of Sormon will be increased if used together with phosphodiesterase type-5 inhibitors, which are used for erectile dysfunction (see special warnings and contraindications). This might lead to life threatening cardiovascular complications. Patients who are on Sormon therapy therefore must not use phosphodiesterase type-5 inhibitors

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

There is no evidence of interaction with food.

 

Section 6.1 List of excipients

Changed format:

Core

Cellulose, microcrystalline

Kaolin, heavy

Magnesium stearate

Silica, colloidal anhydrous

 

Coat

Synthetic paraffin wax

Hard paraffin wax

Hypromellose

Titanium dioxide (E171)

Lactose monohydrate

Macrogol

Iron oxide, yellow (E172)

Iron oxide, black (E172)

Iron oxide, red (E172)

 

 

6.5. Nature and contents of container

Blister packaging: PVC/PVdC, clear, Aliminium foil blister. Blister packs may be provided in strips of multiple tablets or in unit dose packs

Updated on 01 June 2010

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 18 February 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to packaging
  • Change to date of revision

Updated on 06 September 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reassigned the designated frequency of occurance of side effects to include categories 'Very Common' and 'Rare'.

Updated on 23 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)