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Novo Nordisk Limited
3/4 Upper Pembroke Street, Dublin 2,
Telephone: +353 1 678 5989
Telephone: 1850 665 665
Fax: +353 1 676 3259
Medical Information e-mail: www.novonordisk.ie
Summary of Product Characteristics last updated on medicines.ie: 18/11/2011
SPC Kliogest

When a pharmaceutical company changes an SPC or PIL, 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 18/11/2011 and displayed until Current
Reasons for adding or updating:
  • 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 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2: Lactose monohydrate 36.3 mg per tablet
Section 4.2 Amended sentences:
Kliogest is a continuous combined hormone replacement product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day.
If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
Section 4.3: Addition
Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency (see section 4.4))
Section 4.4: Additions
Extensive additions to this section.
Section 4.5: Additions
meprobamate, phenylbutazone
Oral contraceptives (OC) containing ethinylestradiol have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered. Similar interaction may exist between HRT containing estradiol and lamotrigine. Therefore, dosage adjustment of lamotrigine may be necessary for seizure control.

Concomitant administration of cyclosporine may cause increased blood levels of cyclosporine, creatinine and transaminases due to decreased metabolism of cyclosporine in the liver.
Some laboratory tests may be influenced by oestrogen therapy, such as tests for glucose tolerance or thyroid function.
Section 4.8 Additions
Extensive additions to this section.
Section 5.1 Amendments
Pharmacotherapeutic group: progestagens and oestrogens, fixed combination, ATC code: G03FA01.
Norethisterone acetate: Synthetic progestagen with actions similar to those of progesterone, a natural female sex hormone.

Updated on 05/08/2010 and displayed until 18/11/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


SmPC changes for Kliogest

 

Gelatine Substitution

 

Note – 1) formatting changed from TrueFrutigerLight to Times New Roman throughout SmPC

              2) All main headers have change from upper & lower case to all UPPER

 

PREVIOUS WORDING

NEW WORDING

4.4  Special Warnings and Precautions for Use

 

4.4  Special warnings and precautions for use

(formatted to lower case)

Ovarian cancer

 

Use of estrogen alone and estrogen plus progestogen therapies for at least 5 or 10 years has been associated with an increased risk of ovarian cancer in some epidemiological studies

 

Ovarian cancer

 

Use of oestrogen alone and oestrogen plus progestogen therapies for at least 5 or 10 years has been associated with an increased risk of ovarian cancer in some epidemiological studies

 

4.6  Pregnancy and Lactation

 

4.6    Pregnancy and lactation

 

(formatted to lower case)

4.7  Effects on Ability to Drive and Use Machines

 

 

4.7    Effects on ability to drive and use machines

 

(formatted to lower case)

 

4.8    Undesirable Effects

 

4.8    Undesirable effects

 

(formatted to lower case)

 

 

5.2  Pharmacokinetic Properties

 

 

5.2    Pharmacokinetic properties

 

(formatted to lower case)

5.3  Preclinical Safety Data

 

 

5.3    Preclinical safety data

(formatted to lower case)

 

6.1  List of Excipients

 

Gelatin

 

6.1    List of excipients

(formatted to lower case)

Hydroxypropylcellulose

6.4  Special Precautions for Storage

 

 

6.4    Special precautions for storage

(formatted to lower case)

 

6.6  Special Precautions for Disposal and other handling

 

 

6.6    Special precautions for disposal of a medicinal product or waste materials derived from such medicinal product and other handling of the product

(p and s formatted to lower case)

9.       Date of Authorisation/renewal of authorisation

Date of first authorisation: 18th November 1987

Date of last renewal: 18th November 2007.

 

 

 

9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 18 November 1987

Date of last renewal: 18 November 2007.

 

10.  DATE OF REVISION OF THE TEXT

October 2009

 

10.    DATE OF REVISION OF THE TEXT

July 2010

 
Updated on 19/03/2010 and displayed until 05/08/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Change in the revision date of text from Aug 2008 to Oct 2009
Updated on 29/10/2008 and displayed until 19/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 4.4    Special warnings and precautions for use

Ovarian cancer

 The following text has been deleted: Long term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than oestrogen-only products

 The following text has been added: Use of estrogen alone and estrogen plus progestogen therapies for at least 5 or 10 years has been associated with an increased risk of ovarian cancer in some epidemiological studies.

 Other conditions

Kliogest tablets contain lactose.

 Monohydrate has been added to the text above to read: Kliogest tablets contain lactose monohydrate.

 4.8    Undesirable Effects

Editorial changes at the top of the table

5.1    Pharmacodynamic properties

ATC code G03F A01

Oestrogen and progestogen for continuous combined hormone replacement therapy (HRT).

 The text above has been replaced with the following text: Pharmacotherapeutic group: Oestrogen and progestogen for continuous combined hormone replacement therapy, ATC code: G03F A01

 6.4    Special Precautions for Storage

 Keep the container in the outer carton. Do not store above 25C. Do not refrigerate or freeze.

 The text above has been replaced with the following text: Do not store above 25C. Do not refrigerate. Keep the container in the outer carton in order to protect from light.

 6.6    Instructions for Use

 This heading has to be changed to: 6.6    Special Precautions for Disposal and other handling
 
Updated on 03/03/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Kliogest 2mg/1mg Film-coated Tablets (IE)

Changes to Summary of Product Characteristics resulting from MA renewal application and lactose warning resubmission.

Section 1, Name of medicinal product

Kliogest film-coated tablet
changed to
Kliogest 2m/1mg Film-coated Tablets

Section 2, Qualitative and quantitative composition

For excipients, see 6.1
changed to
Excipient: Lactose monohydrate 37.4 mg per tablet.
For full list of excipients see section 6.1.

Section 6.4, Special precautions for storage

Store below 25¢ªC.
changed to
Do not store above 25¢ªC.

Do not refrigerate.
changed to
Do not refrigerate or freeze.

Section 4.4, Special warnings and precautions for use

Additional warning in subsection ¡®Other conditions¡¯:
Kliogest tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Section 10: Date of Revision

from
October 2004.
changed to
 February 2008

 
Updated on 06/12/2004 and displayed until 03/03/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Updated on 18/08/2003 and displayed until 06/12/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 30/06/2003 and displayed until 18/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Estradiol Hemihydrate
  Norethisterone acetate