Canesten Duopak
- Name:
Canesten Duopak
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/09/20
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Bayer Limited
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 22 September 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Site transfer to Grenzach
Updated on 2 July 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
BCH19058- Transfer in production to Grenzach- Mockup version
Updated on 2 July 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
BCH19058- Transfer in production to Grenzach
Updated on 18 January 2019 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - excipient warnings
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 3 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 3 May 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 July 2015 PIL
Reasons for updating
- Improved electronic presentation
Updated on 9 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 April 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.8. Undesirable effects
…
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.
10. DATE OF REVISION OF THE TEXT
May 2014March 2015
Updated on 9 April 2015
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 10 June 2014 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives. Antifungals for topical use – imidazole and triazole derivatives.
ATC Code: D01A CF01 G01AF02
10. DATE OF (PARTIAL) REVISION OF THE TEXT
February May 2014
Updated on 29 April 2014 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 February 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
- Clarity on some usage instructions are included in section 4.2.
- Section 4.3 contraindication is reworded.
- Section 4.5 is updated with interaction information with sirolimus.
- Additional information on fertility, pregnancy and lactation isinlcudced in section 4.6.
- Section 4.7 is reworded in line with appropriate template.
- Adverse reactions vaginal haemorrhage and erythema are added to section 4.8.
- Section 5.1 includes the pharmcotherapeutic group and ATC code. Additionally, it provides update to the microorganisms that clotrimazole acts on.
- Section 5.3 is reworded.
- Section 10 updated with the new approval date.
Updated on 13 November 2013 PIL
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 12 May 2011 PIL
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 23 November 2010 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2
The following text was deleted:
‘A second treatment may be carried out if necessary.’
and the following text was added:
’…and children of 12 years of age and over:
If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent infections may
indicate an underlying medical cause, including diabetes or HIV infection.
Patient should seek medical advice if symptoms return within 2 months.
Do not use tampons, intravaginal douches, spermicides or other vaginal products
while using this product.
Avoidance of vaginal intercourse is recommended while using this product
because the infection could be transferred to your partner, and the effectiveness
and safety of latex products such as condoms and diaphragms may be reduced.
Children under 12 years of age:
To insert the pessary:
1. Pull out plunger until it stops. Place the pessary into the applicator.
2. Carefully insert the applicator containing the pessary as deeply as is comfortable into the vagina. This is best done with the patient lying on her back with the knees bent up.
3. Push plunger A until it stops, thereby depositing the pessary into the vagina.
4. Withdraw the applicator and dispose of it hygienically.’
Section 4.4
The following text was deleted:
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Pessary. Canesten Pessary can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.
and the following text was added:
Canesten Pessaries should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:
abnormal vaginal bleeding (vaginal haemorrhage)
fever (temperature of 38oC or above)
back pain.
associated shoulder pain.
Avoid contact with eyes and do not swallow.
Section 4.5
The following text was added:
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506 immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacromilus overdosage, if necessary by determination of the respective plasma levels.
Section 4.8
The entire section was revised to the following:
The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories is not possible.
Immune system disorders
Allergic reaction (ME) with symptoms such as dyspnea (PT), hypotension (PT),
syncope (PT), and urticaria (ME),
Reproductive system and breast disorders
Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME)
Gastrointestinal disorders
Abdominal pain (ME)
Section 5.1
The following text was updated to:
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 8.0 mg/ml substrate.
Section 6.6:
The diagrams were deleted and the following statement was added:
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how dispose of medicines no longer required. These measures will
help to protect the environment.
Updated on 11 June 2010 PIL
Reasons for updating
- Change to improve clarity and readability
- Change to name of manufacturer
Updated on 4 September 2009 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 31 August 2009 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 7: MA holder is now Bayer Ltd
Section 8: MA number is now 1410/39/5
Updated on 24 July 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and quantitative composition, following added:
Excipients: Cream contains 10% w/w cetostearyl alcohol.
For a full list of excipients, see 6.1.
Section 4.2 Posology and method of administration:
Pictures and instructions for use previously in section 6.6 added here.
Section 6.6 Instructions for use/handling:
Pictures and instructions for use deleted and moved to section 4.2.
Section 9 Date of first authorisation / Renewal of Authorisation changed to:
Date of First Authorisation: 1 April 1977
Date of Last Renewal: 1 April 2007
Updated on 14 November 2006 PIL
Reasons for updating
- Change to date of revision
Updated on 19 January 2006 SPC
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Updated on 3 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 August 2003 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through pharmacy only
Updated on 27 May 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only