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Bayer plc

Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 27/11/2012

Levonelle 1500 microgram tablet



1. Name of the medicinal product

Levonelle® 1500 microgram tablet


2. Qualitative and quantitative composition

Each tablet contains 1500 micrograms of levonorgestrel

Excipient with known effect: 142.5 mg lactose monohydrate.

For excipients see section 6.1


3. Pharmaceutical form

Tablet

Almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on one side.


4. Clinical particulars

4.1 Therapeutic indications

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.


4.2 Posology and method of administration

For oral administration:

Posology

One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1).

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

Levonelle 1500 can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

After using emergency contraception it is recommended to use a barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Levonelle 1500 does not contraindicate the continuation of regular hormonal contraception.

Paediatric population:

Levonelle 1500 is not recommended in children.

Very limited data are available in women under 16 years of age.


4.3 Contraindications

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


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 in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Levonelle 1500 following the second act of intercourse may therefore be ineffective in preventing pregnancy. If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded.

If pregnancy occurs after treatment with Levonelle 1500, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as Levonelle 1500 prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.

Therefore, Levonelle 1500 is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).

Levonelle 1500 is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of Levonelle 1500.

Levonelle 1500 contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

After Levonelle 1500 intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. Women should be advised to make a medical appointment to initiate or adopt a method of regular contraception. If no withdrawal bleed occurs in the next pill-free period following the use of Levonelle 1500 after regular hormonal contraception, pregnancy should be ruled out.

Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.

Levonelle 1500 is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.

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


4.5 Interaction with other medicinal products and other forms of interaction

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers.

Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel containing medication include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John's Wort), rifampicin, ritonavir, rifabutin, griseofulvin.

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


4.6 Pregnancy and lactation

Pregnancy

Levonelle 1500 should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the fetus but there are no clinical data on the potential consequences if doses greater than 1.5 mg of levonorgestrel are taken (see section 5.3.).

Breast-feeding

Levonorgestrel is secreted into breast milk. Potential exposure of an infant to levonorgestrel can be reduced if the breast-feeding woman takes the tablet immediately after feeding and avoids nursing following Levonelle 1500 administration.


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 performed.


4.8 Undesirable effects

The most commonly reported undesirable effect was nausea.

Body System

Frequency of adverse reactions

 

Very common (≥ 10%)

Common (≥ 1/100 to <1/10)

Nervous system disorders

Headache

Dizziness

Gastrointestinal disorders

Nausea

Lower abdominal pain

Diarrhoea

Vomiting

Reproductive system and breast disorders

Bleeding not related to menses*

Delay of menses more than 7 days **

Irregular menstruation

Breast tenderness

General disorders and administration site conditions

Fatigue

 

* Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 7 days of the expected time.

** If the next menstrual period is more than 5 days overdue, pregnancy should be excluded.

From Post-marketing surveillance additionally, the following adverse events have been reported:

Gastrointestinal disorders

Very rare (<1/10,000): abdominal pain

Skin and subcutaneous tissue disorders

Very rare (<1/10,000): rash, urticaria, pruritus,

Reproductive system and breast disorders

Very rare (<1/10,000): pelvic pain, dysmenorrhoea

General disorders and administration site conditions

Very rare (<1/10,000): face oedema


4.9 Overdose

Serious undesirable 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.


5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives, ATC code: G03AD01

Mechanism of action

The precise mode of action of Levonelle 1500 as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation. Levonelle 1500 is not effective once the process of implantation has begun.

Clinical efficacy and safety

Results from a randomised, double-blind clinical study conducted in 2001 (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of Levonelle 1500 (taken within 72 hours of unprotected sex) prevented 84% of expected pregnancies (compared with 79% when the two 750 microgram tablets were taken 12 hours apart).

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


5.2 Pharmacokinetic properties

Absorption

Orally administered levonorgestrel is rapidly and almost completely absorbed.

Distribution

Following ingestion of one tablet of Levonelle 1500 maximum drug serum levels of levonorgestrel of 18.5ng/ml were found at 2 hours. After reaching maximum serum levels, the concentration of levonorgestrel decreased with a mean elimination half-life of about 26 hours.

Biotransformation

Levonorgestrel is not excreted in unchanged form but as metabolites.

Elimination

Levonorgestrel metabolites are excreted in about equal proportions with urine and faeces. The biotransformation follows the known pathways of steroid metabolism, the levonorgestrel is hydroxylated in the liver and the metabolites are excreted as glucuronide conjugates.

No pharmacologically active metabolites are known.

Levonorgestrel is bound to serum albumin and sex hormone binding globulin (SHBG). Only about 1.5% of the total serum levels are present as free steroid, but 65% are specifically bound to SHBG.

The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered.

About 0.1% of the maternal dose can be transferred via milk to the nursed infant.


5.3 Preclinical safety data

Animal experiments with levonorgestrel have shown virilisation of female fetuses at high doses.

Preclinical data from conventional studies on chronic toxicity, mutagenicity and carcinogenicity reveal no special hazard for humans, beyond the information included in other section of the SPC.


6. Pharmaceutical particulars

6.1 List of excipients

Potato starch

Maize starch

Colloidal silica anhydrous

Magnesium stearate

Talc

Lactose monohydrate.


6.2 Incompatibilities

Not applicable.


6.3 Shelf life

5 years.


6.4 Special precautions for storage

Store in original packaging in order to protect from light.


6.5 Nature and contents of container

PVC/Aluminium-blister containing one tablet. The blister is packaged in a folded carton.


6.6 Special precautions for disposal and other handling

No special requirements.


7. Marketing authorisation holder

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom


8. Marketing authorisation number(s)

PL05276/0019


9. Date of first authorisation/renewal of the authorisation

14th June 2004


10. Date of revision of the text

16 September 2012