We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

HRA Pharma UK and Ireland Limited

Unit 7 - RB Building, 557 Harrow Road, Kensal Green, London, W10 4RH, 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: 17/12/2013
SPC Norlevo 1.5mg tablet



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

NORLEVO 1.5 mg tablet


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 1.5 mg levonorgestrel

Excipients: each tablet contains 90.90 mg lactose monohydrate.

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Tablet

White, round biconvex tablet engraved with code NL 1.5 on one face.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

• Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method.


Go to top of the page
4.2 Posology and method of administration

Oral use

The treatment necessitates the intake of one tablet. The efficacy of the method is higher the sooner after the unprotected intercourse the treatment is initiated. Therefore, the tablet must be taken as soon as possible, preferably within 12 hours after the unprotected intercourse, and no longer than 72 hours (3 days) after the intercourse.

Norlevo 1.5 mg can be taken at any moment during the menstrual cycle.

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.

After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, cervical cap) until the next menstrual periods resume. The use of Norlevo 1.5 mg does not contraindicate the continuation of regular hormonal contraception.

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).


Go to top of the page
4.3 Contraindications

Hypersensitivity to levonorgestrel or any of the excipients.


Go to top of the page
4.4 Special warnings and precautions for use

 

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.

Emergency contraception does not prevent a pregnancy to occur in every instance, especially if uncertainty about the timing of the unprotected intercourse. In case of doubt (menstrual periods delayed by more than five days or abnormal bleeding at the expected date of menstrual periods, symptoms of pregnancy), it is mandatory to check the absence of pregnancy by performing a pregnancy test.

If the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Norlevo 1.5 mg following the second act of intercourse may therefore be ineffective in preventing pregnancy.

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).

If pregnancy occurs after treatment with Norlevo 1.5 mg, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low as Norlevo 1.5 mg prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, Norlevo 1.5 mg is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).

Norlevo 1.5 mg is not recommended in patients with severe hepatic dysfunction. Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of Norlevo 1.5 mg.

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.

After Norlevo 1.5 mg intake, menstrual periods are usually of normal abundance and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. It is recommended to have a medical visit to initiate or adapt a method of regular contraception. In case no menstrual period occurs in the next pill-free period following the use of Norlevo 1.5 mg after regular hormonal contraception, pregnancy should be ruled out.

Repeated administration within a menstrual cycle is not advisable, because of an undesirable high load of hormones for the patient and the possibility of severe disturbances of the cycle. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.

The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.

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

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

Associations to be taken into consideration:

The metabolism of levonorgestrel is enhanced by the concomitant use of liver enzyme inducers: anticonvulsant (phenobarbital, phenytoin, primidone, carbamazepine); rifabutin; rifampicin; griseofulvin; ritonavir; Hypericum perforatum (St. John's wort). The efficacy of Norlevo 1.5 mg may be decreased in case of concomitant intake of these active substances.

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.


Go to top of the page
4.6 Pregnancy and lactation

Pregnancy

This medicinal product cannot interrupt an ongoing pregnancy.

In case of failure of this contraceptive mean with persisting pregnancy, epidemiological studies indicate no malformative effects of progestins on foetus.

Nothing is known on the consequences for the child if doses higher than 1.5 mg levonorgestrel are taken.

Breastfeeding

Levonorgestrel is excreted into breast milk. Therefore, it is suggested to breastfeed immediately before taking the Norlevo 1.5 mg, tablet and to skip nursing at least 8 hours following Norlevo 1.5 mg administration.

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)


Go to top of the page
4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been reported. Nevertheless, if women experience fatigue and dizziness after taking Norlevo, they should not drive or use machines.


Go to top of the page
4.8 Undesirable effects

The following table gives the frequency of undesirable effects after intake of 1.5 mg levonorgestrel reported in clinical trials*.

Body System

Frequency of adverse reactions

Very common (≥ 1/10)

Common (≥ 1/100 to 1/10)

Nervous system disorders

Dizziness

Headache

 

Gastrointestinal disorders

Nausea

Abdominal pain

Diarrhoea1

Vomiting

Reproductive system and Breast disorders

Uterine pain

Breast tenderness

Delay of menses3

Heavy menses2

Bleeding1

Dysmenorrhoea3

General disorders and administration site conditions

Fatigue1

 

* Trial 1 (n=544): Contraception, 2002, 66, 269-273

* Trial 2 (n=1359): Lancet, 2002, 360:1803-10

* Trial 3 (n=1117): Lancet 2010; 375:555-62

* Trial 4 (n=840): Obstetrics and Gynecology 2006; 108:1089-1097

1 Not recorded in Trial 1

2 Not recorded in Trial 2

3 Not reported in Trial 1 or 2

4 Delay defined as more than 7 days.

These undesirable effects usually disappear within 48 hours after the intake of Norlevo 1.5 mg. Breast tenderness, spotting and irregular bleeding are reported in up to 30 percent of patients and can last until the next menstrual period which can be delayed.

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

Cases of thromboembolic events have been reported during the postmarketing period (see section 4.4).


Go to top of the page
4.9 Overdose

Serious effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: EMERGENCY CONTRACEPTIVES - G03AD01

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)

At the used regimen, levonorgestrel is not expected to induce significant modifications of blood clotting factors, and lipid and carbohydrate metabolism.


Go to top of the page
5.2 Pharmacokinetic properties

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%).

After oral administration of 1.5 mg levonorgestrel, the plasma terminal half-life of the product is estimated to 43 hours. The maximal plasma concentration of levonorgestrel (approximately 40 nmol/l) is reached within 3 hours. Levonorgestrel is hydroxylated in the liver and the metabolites are excreted as glucuronide conjugates.


Go to top of the page
5.3 Preclinical safety data

Nonclinical data reveal no special hazard for humans, beyond the information included in other sections of the SPC. Animal experiments with levonorgestrel have shown virilization of female fetuses at high doses.

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.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

Lactose monohydrate,

Maize starch,

Povidone,

Colloidal anhydrous silica,

Magnesium stearate.


Go to top of the page
6.2 Incompatibilities

Not applicable


Go to top of the page
6.3 Shelf life

3 years


Go to top of the page
6.4 Special precautions for storage

Keep the blister in the outer carton in order to protect from light.


Go to top of the page
6.5 Nature and contents of container

PVC/PE/PVDC/Aluminium blister of 1 tablet.

Pack sizes with 1 tablet and 5 10, 25 or 50 tablets as hospital packs only.

Not all pack sizes may be marketed.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Laboratoire HRA Pharma

15 rue Béranger

75003 Paris

France


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 1166/2/1


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26 August 2005

Date of renewal: 19 April 2009


Go to top of the page
10. DATE OF REVISION OF THE TEXT

November 2013



Link to this document from your website:
http://www.medicines.ie/medicine/11933/SPC/Norlevo+1.5mg+tablet/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
   Levonorgestrel