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HRA Pharma UK and Ireland Limited

Haines House, Ground Floor Office, 21 John Street, London, WC1N 2BF, UK
Telephone: +44 (0)20 8969 4383
WWW: https://www.hra-pharma.com
Medical Information Direct Line: 1 800 812 984
Medical Information e-mail: med.info.ie@hra-pharma.com
Summary of Product Characteristics last updated on medicines.ie: 13/02/2017
SPC Norlevo 1.5mg tablet

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 13/02/2017 and displayed until Current
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 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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:   08-Jan-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



SECTION 2: QUALITATIVE AND QUANTITATIVE COMPOSITION

Deletion of:

“Excipients”

Addition of:

“Excipient with known effect”

 

SECTION 4.2: POSOLOGY AND METHOD OF ADMINISTRATION

Deletion of:

“Oral use”

Addition of:

“Posology”

 

Deletion of:

“Norlevo 1.5 mg”

Addition of:

“Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5)”

 

Change of:

“Norlevo” to “NorLevo”

 

Addition of:

Paediatric population

There is no relevant use of NorLevo for children of prepubertal age in the indication emergency contraception”.

Addition of:

“Method of Administration

Oral use”.

 

SECTION 4.3: CONTRAINDICATIONS

Deletion of:

“Hypersensitivity to levonorgestrel or any of the excipients”

Addition of:

“Hypersensitivity to the active substance or to any of the excipients listed in section 6.1”.

 

SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Removal of the below text from the text box:

“Limited and inconclusive data suggest that there may be reduced efficacy of Norlevo with increasing body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI”.

Addition of the above, as a new paragraph (paragraph 2).

 

Change of:

“Norlevo” to “NorLevo”

 

SECTION 4.5: INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Deletion of:

“anticonvulsant, phenobarbital”

Addition of:

“mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%”

to the following sentence: “The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers…”

 

Addition of:

Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates (including primidone)”

Deletion of:

primidone, rifabutin; rifampicin; griseofulvin; ritonavir;”

Addition of:

herbal medicines containing”

Deletion of:

“The efficacy of Norlevo 1.5 mg may be decreased”

Addition of:

“, rifampicin, ritonavir, rifabutin, and griseofulvin”

 

Addition of:

“For women who have used enzyme-inducing drugs”

Deletion of:

“case of”

Addition of:

“the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception (i.e. a Cu-IUD) should be considered. Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during”

Deletion of:

“intake of these active substances”

Addition of:

“use of an enzyme inducer) has not been studied”.

 

Addition of:

“Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism”.

 

 

SECTION 4.6: FERTILITY, PREGNANCY AND LACTATION

Change of:

“Breastfeeding” to “Breast-feeding”

Change of:

“Norlevo” to “NorLevo”

SECTION 4.7: EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Change of:

“Norlevo” to “NorLevo”

 

SECTION 4.8: UNDESIRABLE EFFECTS

Change of:

“Delay in menses3” to “Delay in menses4” (change in reference)

Change of:

“Norlevo” to “NorLevo”

 

Addition of:

“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 the national reporting system listed in Appendix V”.

 

SECTION 5.1: PHARMACODYNAMIC PROPERTIES

Addition of:

“ATC Code” in “Pharmacotherapeutic group: EMERGENCY CONTRACEPTIVES”

Addition of:

“Mechanism of action” as a title before paragraph 1

Addition of:

“Clinical efficacy and safety” as a title before paragraph 2

Addition of:

Paediatric population

A prospective observational study showed that out of 305 treatments with levonorgestrel emergency contraceptive tablets, seven women became pregnant resulting in an overall failure rate of 2.3%. The failure rate in women under 18 years (2.6% or 4/153) was comparable to the failure rate in women 18 years and over (2.0% or 3/152)”.

 

SECTION 5.2:  PHARMACOKINETIC PROPERTIES

Removal of:

 “Bioavailability of oral levonorgestrel is approximately 100 percent. In the plasma, it is strongly bound to SHBG. Levonorgestrel is eliminated via kidney (60-80%) and liver (40-50%)”.

Addition of:

“Absorption” as a title before paragraph 1

Addition of:

“Distribution/Biotransformation” as a title before paragraph 2

Addition of:

“Elimination” as a title before paragraph 3

Removal then replaced as paragraph 3:

“Bioavailability of oral levonorgestrel is approximately 100 percent. In the plasma, it is strongly bound to SHBG. Levonorgestrel is eliminated via kidney (60-80%) and liver (40-50%)”.

 

SECTION 5.3: PRECLINICAL SAFETY DATA

Change of:

“Nonclinical” to “Non-clinical”

Addition of:

based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential”

Change of:

“SPC” to “SmPC”



SECTION 10: DATE OF REVISION OF TEXT

08 January 2017

Updated on 27/01/2015 and displayed until 13/02/2017
Reasons for adding or 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Jan-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



 Change in the SmPC intended to implement the outcome of a Union referral procedure on emergency contraception (medicinal product covered by the defined scope of the procedure)
4.4 Remove of special population
4.4 Update of the table content in the warning section
5.1. Update of clinical trials information on BMI following the Union referral Procedure on emergency contraception
10. Update of the date of revision of the text

Updated on 17/12/2013 and displayed until 27/01/2015
Reasons for adding or 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Nov-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



 

In section 4.2. text added was:

 

Special population: body weight 75 kg or more

 

In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more, and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.4 and 5.1).

 

In section 4.4, two additions of the text have been added as follow:

In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.2 and 5.1).

Concomitant use of Norlevo 1.5 mg and drugs containing ulipristal acetate is not recommended (see section 4.5).

 

In section 4.5 the following text has been added:

Ulipristal acetate is a progesterone receptor modulator that may interact with the progestational activity of levonorgestrel. Therefore the concomitant use of levonorgestrel and drugs containing ulipristal acetate is not recommended.

Section 4.8.

The table of side effects has been updated and the following text has been added:

Hypersensitivity reactions such as pharyngeal/face oedema and cutaneous reactions have been reported after the intake of Norlevo.

 

Section 5.1 the mechanisme of action has been updated with the following text:

The primary mechanism of action is blockade and/or delay of ovulation via suppression of the luteinizing hormone (LH) peak. Levonorgestrel interferes with the ovulatory process only if it is administered before the onset of the LH surge. Levonorgestrel has no emergency contraceptive effect when administered later in the cycle.

 In clinical trials, the proportion of pregnancies avoided after the use of levonorgestrel varied from 52% (Glasier, 2010) to 85% (Von Hertzen, 2002) of expected pregnancies. Efficacy appears to decline with time after intercourse.

 

In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.2 and 4.4).

 

Pregnancy rate (95% CI) according to weight categories

Weight (kg)

< 55

[55-65[

 

[65-75[

 

[75-85[

 

≥ 85

N total

349

608

426

155

193

N pregnancies

3

8

6

10

11

Pregnancy rate

0.9%

1.3%

1.4%

6.4%

5.7%

Confidence Interval

[0.2-2.5]

[0.6 - 2.6]

[0.5 - 3.0]

[3.1 - 11.5]

[2.9 - 10.0]

Pooled database from studies HRA2914-507 and HRA2914-513 (HRA Pharma, internal data)

 

 

Section 10. Date of revision of the text is now:

November 2013

 

Updated on 19/07/2011 and displayed until 17/12/2013
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • 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
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


  • In section 4.6 (Fertility, pregancy and lactation) : we have added

    Fertility

         A rapid return to fertility is likely following treatment with Norlevo for emergency contraception; therefore, regular contraception should be continued or initiated as soon as possible following  the use of Norlevo to ensure ongoing prevention of pregnancy. 

    Clinical experience reveal no effect on fertility in humans after use of levonorgestrel. Similarly nonclinical studies show no evidence of adverse effects in animals (see section 5.3)

  • In section 5.1 - New Pharmacotherapeutic group : EMERGENCY CONTRACEPTIVES - G03AD01

  • In section 5.3 - Preclinical Data is replaced by Nonclinical Data and we have added

    A preclinical study conducted in mice showed no effect on fertility in the progeny of treated dams. Two studies investigating the consequence of exposure to levonorgestrel on the development of pre-embryos before implantation, showed that levonorgestrel had no adverse effects on fertilisation and the in vitro growth of mouse pre-embryos.

  • In section 10 - date of revision of the text has been changed : July 2011

Updated on 08/04/2011 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Feb-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

10 -  DATE OF REVISION OF THE TEXT = February 2011
Updated on 14/03/2011 and displayed until 08/04/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   30-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

- in section 5.1 (Pharmacodynamic properties) - Pharmacotherapeutic group : PROGESTOGENS (instead of PROGESTOAGENS)
Updated on 08/10/2009 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   18-Sep-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4:  Addition of "Cases of thromboembolic events have been reported after Norlevo intake. The possibility of occurrence of a thromboembolic event should be considered in women with other pre-existing thromboembolic risk factor(s), especially personal or family history suggesting thrombophilia."

Section 4.8:  Reformatted
Updated on 28/08/2007 and displayed until 08/10/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/03/2007 and displayed until 28/08/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Levonorgestrel