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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: 22/11/2013
SPC Levonelle One Step


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1. Name of the medicinal product

Levonelle® One Step 1500 microgram tablet

(Also available as Boots Emergency Contraceptive 1.5 mg Tablet)


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2. Qualitative and quantitative composition

The tablet contains 1500 microgram of levonorgestrel

For excipients see section 6.1


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3. Pharmaceutical form

Tablet

The tablet is round and white with an impressed mark of G00 on one side.


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4. Clinical particulars

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4.1 Therapeutic indications

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

Levonelle One Step is not recommended for use by young women under 16 years of age without medical supervision.


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4.2 Posology and method of administration

For oral administration: 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. The patient should contact her doctor, family planning clinic or pharmacist for advice and another tablet.

Levonelle One Step 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 One Step does not contraindicate the continuation of regular hormonal contraception.

Children: Levonelle One Step is not recommended for use by young women under 16 years of age without medical supervision.


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4.3 Contraindications

Hypersensitivity to the active substance levonorgestrel or any of the excipients.


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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 One Step 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, women should be referred to a doctor so that pregnancy may be excluded.

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

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

Levonelle One Step is not recommended in patients with severe hepatic dysfunction.

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

Levonelle One Step 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 One Step 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 One Step 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 One Step 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.


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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. Women taking such drugs should be referred to their doctor for advice.

Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism. Women taking cyclosporin containing medication should be referred to their doctor for advice.


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4.6 Pregnancy and lactation

Pregnancy

Levonelle One Step 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 foetus 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.).

Lactation

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 One Step administration.


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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.


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4.8 Undesirable effects

The most commonly reported undesirable effect was nausea. The following undesirable effects were observed in two different studies1, 2.

Body System

Frequency of adverse reactions

 

Very common (>1/10)

Common (>1/100, <1/10)

Reproductive system and breast disorders

Bleeding not related to menses*

Breast tenderness

Delay of menses more than 7 days **

Irregular bleeding and spotting

Nervous system disorders

Headache

Dizziness

Gastrointestinal disorders

Nausea

Low abdominal pain

Diarrhoea

Vomiting

General disorders and administration site conditions

Fatigue

 

1 Task Force on post-ovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet, 1998; 352:428-433

(n=977; data on 0.75 mg levonorgestrel tablet taken as two doses with a 12-hour interval)

2 Hertzen et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet. 2002; 360:1803-1810

(n=1,359; data on Levonelle One Step taken as a single dose of 1.5 mg)

* n=1,011 out of 1,359

** n=1,334 out of 1,359

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:

Skin and subcutaneous tissue disorders

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


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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.


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

PROGESTOGENS

G03AD01

The precise mode of action of Levonelle One Step 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 One Step is not effective once the process of implantation has begun.

Efficacy: Results from a recent clinical study (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of Levonelle One Step (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.


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5.2 Pharmacokinetic properties

Levonorgestrel: orally administered levonorgestrel is rapidly and almost completely absorbed.

Following ingestion of one tablet of Levonelle One Step 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.

Levonorgestrel is not excreted in unchanged form but as metabolites. 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.


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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 informatiom included in other section of the SPC.


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6. Pharmaceutical particulars

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6.1 List of excipients

Potato starch

Maize starch,

Colloidal silica anhydrous,

Magnesium stearate

Talc

Lactose monohydrate.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

5 years.


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6.4 Special precautions for storage

Store in original packaging in order to protect from light.


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6.5 Nature and contents of container

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


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. Marketing authorisation holder

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom


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8. Marketing authorisation number(s)

PL05276/0020


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9. Date of first authorisation/renewal of the authorisation

14 June 2004.


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10. Date of revision of the text

25 October 2013



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