Cosmofer
*Company:
Pharmacosmos UK LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 April 2023
File name
PIL 03.2023 IE Cosmofer 7.0.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 03 April 2023
File name
SmPC 03.2023 IE Cosmofer 7.0.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 January 2020
File name
IE Cosmofer Jan PIL 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4: Possible side effects: Following changes were done
Allergic reactions (affecting less than 1 in 100 people)
Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: you have an allergic reaction to CosmoFer tell your doctor or nurse straight away so that they can stop it if necessary. The signs of this may include
shortness of breath, •
nettle rash or hives, flushing, rashes, itching, •
nausea and shivering• , and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome..
Reporting of Side effects: Following changes were done
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, Website: www.hpra.ie.IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. ; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
This leaflet was last revised in
Deleted: 11/2018
Added: 01/2020
Updated on 27 January 2020
File name
IE Cosmofer Jan SPC 2020.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Following were added in the first paragraph
“There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).”
4.8 Undesirable effects: in the table- Adverse drug reactions observed during clinical trials and post-marketing experience.
Another column “Not known” were added.
In row two under Cardiac Disorders: Kounis Syndrome was added in the Not known column.
Section 10 Date of revision of the text
Deleted: 18.10.2019
Added: 23.01.2020
Updated on 08 December 2019
File name
ie-cosmofer-spc-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.6 Fertility, pregnancy and lactation: Following were added
“Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.”
In section 4.8 Undesirable effects, reporting of suspected adverse reactions: following were deleted.
“Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517”
And “ e-mail: medsafety@hpra.ie”
In section 10: Date of revision of text: Date updated to “17.10.2019”
Updated on 23 January 2019
File name
ie-cosmofer-pl-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 January 2019
File name
ie-cosmofer-spc-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects:
Change to “Undesirable effects”- addition of Not known column
From:
Organ System |
Uncommon (>1/1,000, <1/100) |
Rare (>1/10,000, <1/1,000) |
Very rare <1/10,000 |
Blood and lymphatic system disorders |
|
|
Haemolysis |
Cardiac disorders |
|
Arrythmia, tachycardia |
Foetal bradycardia, palpitations |
Ear and labyrinth disorders |
|
|
Transient deafness |
Gastrointestinal disorders |
Nausea, emesis, abdominal pain |
Diarrhoea |
|
General disorders and administration site conditions |
Feeling hot
|
Fatigue
Pain and brown pigmentation at injection site |
|
Immune system disorders |
Anaphylactoid reactions including dyspnoea, urticaria, rashes, itching, nausea and shivering
|
|
Acute, severe anaphylactoid reactions (sudden onset of respiratory difficulty and / or cardiovascular collapse) |
Musculoskeletal and connective tissue disorders |
Cramps |
Myalgias |
|
Nervous system disorders |
Blurred vision, numbness |
Loss of consciousness, seizure, dizziness, restlessness, tremor |
Headache, paresthesia |
Respiratory, thoracic and mediastinal disorders |
Dyspnea |
Chest pain |
|
Psychiatric disorders |
|
Mental status changes |
|
Skin and subcutaneous tissue disorders |
Flushing, pruritus, rash |
Angioedema, Sweating |
|
Vascular disorders |
|
Hypotension |
Hypertension |
To:
Organ System |
Uncommon (>1/1,000, <1/100) |
Rare (>1/10,000, <1/1,000) |
Very rare <1/10,000 |
Not known |
Blood and lymphatic system disorders |
|
|
Haemolysis |
|
Cardiac disorders |
|
Arrythmia, tachycardia |
Foetal bradycardia, palpitations |
|
Ear and labyrinth disorders |
|
|
Transient deafness |
|
Gastrointestinal disorders |
Nausea, emesis, abdominal pain |
Diarrhoea |
|
|
General disorders and administration site conditions |
Feeling hot
|
Fatigue
Pain and brown pigmentation at injection site |
|
Influenza like illness whose onset may vary from a few hours to several days |
Immune system disorders |
Anaphylactoid reactions including dyspnoea, urticaria, rashes, itching, nausea and shivering
|
|
Acute, severe anaphylactoid reactions (sudden onset of respiratory difficulty and / or cardiovascular collapse) |
|
Musculoskeletal and connective tissue disorders |
Cramps |
Myalgias |
|
|
Nervous system disorders |
Blurred vision, numbness |
Loss of consciousness, seizure, dizziness, restlessness, tremor |
Headache, paresthesia |
|
Respiratory, thoracic and mediastinal disorders |
Dyspnea |
Chest pain |
|
|
Psychiatric disorders |
|
Mental status changes |
|
|
Skin and subcutaneous tissue disorders |
Flushing, pruritus, rash |
Angioedema, Sweating |
|
|
Vascular disorders |
|
Hypotension |
Hypertension |
|
Updated on 29 November 2018
File name
IE Cosmofer PIL 20.11.2018 4.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 29 November 2018
File name
IE Cosmofer SmPC 20.11.2018 2.0.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects:
Change to “Reporting of suspected adverse reaction”
From:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie
To:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
6.3 Shelf Life:
Change to wording
From:
30 months for 2 ml ampoules
24 months for 5 ml and 10 ml ampoules
To:
24 months for 2 ml, 5 ml and 10 ml ampoules
8 Marketing Authorisation Number(s)
From:
PA982/001/001
To:
PA0982/001/001
9 Date of first authorisation, renewal of authorisation:
Change to wording
From:
Date of first approval: 29 June 2001 / 23 September 2009
To:
Date of first authorisation: 29 June 2001
Date of latest renewal: 23 September 2009
10 Date of revision of the text
Change to wording
From:
February 2014
To:
11/2018
Updated on 24 April 2017
File name
PIL_15646_745.pdf
Reasons for updating
- New PIL for new product
Updated on 24 April 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 April 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 April 2014
Reasons for updating
- Addition of black triangle
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 April 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 27 February 2013
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 February 2013
Reasons for updating
- New PIL for medicines.ie