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LEVONELLE ONE STEP 1500 MICROGRAMS

Active substance(s): LEVONORGESTREL

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

LEVONELLE® ONE STEP 1500 micrograms
(levonorgestrel)
Patient Information Leaflet
27mm

The name of this product is Levonelle One Step 1500 micrograms but will be referred to as Levonelle One
Step throughout this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet
1. What Levonelle One step is and what it is used for
2. Before you take Levonelle One Step
3. How to take Levonelle One Step
4. Possible side effects
5. How to store Levonelle One Step
6. Further information
1. What Levonelle One Step is and what it is used for
Levonelle One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected
sex or if your usual contraceptive method has failed.
Levonelle One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about
84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent
a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is
better to take it within 12 hours rather than delay until the third day.
Levonelle One Step is thought to work by:
• stopping your ovaries from releasing an egg
• preventing sperm from fertilising any egg you may have already released
• stopping a fertilised egg from attaching itself to your womb lining.

WARNING!

Levonelle One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle One
Step, it will not stop you from becoming pregnant.

Take special care with Levonelle One Step
If any of the following points apply to you, tell your doctor before you take Levonelle One Step as emergency
contraception may not be suitable for you.
• you are pregnant or think that you may already be pregnant, as this medicine will not work if you are
already pregnant
You may already be pregnant if:
• your period is more than 5 days late, or you have suffered unusual bleeding when your next period
is due
• you have had unprotected sex more than 72 hours ago, and since your last period

DATE:
04/11/13
DATE OF PROOF:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Tell your pharmacist if you are taking any of the medicines listed below, as these medicines may prevent
Levonelle One Step from working properly:
• barbiturates and other medicines used to treat epilepsy (for example primidone, phenytoin and
carbamazepine);
• medicines used to treat tuberculosis (for example rifampicin, rifabutin);
• a treatment for HIV infection (ritonavir);
• a medicine used to treat fungal infections (griseofulvin);
• herbal remedies containing St John’s wort (Hypericum perforatum).
• a medicine called ciclosporin (suppresses the immune system)

06464/2850D
CODE:

ARTWORKER:
Levonelle one step 1500 mg
PRODUCT:

CUSTOMER: Waymade

DT

Q.A.
APPROVED:

If you are under 16 years of age, you must visit your doctor or family planning clinic to get emergency
contraception.

PRE-PRESS NO.:

05-0269

You should also tell your doctor if:
• you have a disease of your small bowel (such as Crohn’s disease), that interferes with the way you
digest your food
• you have severe liver problems
• you have ever had an ectopic pregnancy (where the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis (inflammation of the Fallopian tubes)
Your doctor may decide that Levonelle One step is not suitable for you, or that another type of emergency
contraception would be better for you.

If you are worried about sexually transmitted diseases
This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your
doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.
How often can you use Levonelle One Step?
You should only use Levonelle One Step in emergencies and not as a regular method of contraception. If
Levonelle One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual
cycle (period).
Levonelle One Step does not work as well as regular methods of contraception. Your doctor, practice nurse
or family planning clinic can tell you about long-term methods of contraception which are more effective in
preventing you from getting pregnant.
Pregnancy and breast feeding:
Ask your pharmacist for advice before taking any medicine.
You should not take this medicine if you are already pregnant. If you have had unprotected sex which was
more than 72 hours ago, and since your last period, you may already be pregnant and the treatment won’t
work. If your last period was more than 5 days late or was unusually light or unusually heavy, you should
check with your doctor that you are not already pregnant.
If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is
no evidence that Levonelle One Step will harm a baby that develops in your uterus/womb but your doctor
may want to check that the pregnancy is not ectopic. This is especially important if you develop severe
abdominal pain after taking Levonelle One Step or if you have previously had an ectopic pregnancy,
fallopian tube surgery or pelvic inflammatory disease.
Very small amounts of the active ingredient of this medicine may appear in your breast milk.
This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately
after a breast feed. In this way you are taking your tablet well before the next feed and reducing the amount
of active ingredient your baby may take in with the breast milk.

Colour
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WARNING!

DATE:

CUSTOMER
APPROVED:

2. Before you take Levonelle One Step
Do not use Levonelle One Step if:
• If you are allergic (hypersensitive) to levonorgestrel, or any of the other ingredients of Levonelle
One Step (see section 6).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

PROOF HISTORY:
v.4 - waymade - 04/11/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Levonelle One Step carefully
to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact your doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Driving and using machines
Your Levonelle One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if
you feel tired or dizzy do not drive or operate machinery.
Important information about some of the ingredients of Levonelle One Step
Each Levonelle One Step tablet contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

Do not delay taking the tablet. The tablet works better the sooner you take it after having unprotected sex.
• If you are already using a regular method of contraception such as the contraceptive pill, you can
continue to take this at your regular times.
What to do if you are sick (vomit)
• If you are sick (vomit) within three hours of taking the tablet, you should take another tablet.
You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for
advice and another tablet.
After you have taken Levonelle One Step:
After you have taken Levonelle One Step, if you want to have sex, and are not using the contraceptive pill,
you should use condoms or a cap plus spermicide.
After you have taken Levonelle One Step, you are advised to make an appointment to see your doctor about
three weeks later, to make sure that Levonelle One Step has worked. If your period is more than 5 days late
or is unusually light or unusually heavy you should contact your doctor as soon as possible.
If you do become pregnant even after taking this medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term methods of contraception which are more effective in
preventing you from getting pregnant.
If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a
bleed in your pill-free period, see your doctor to make sure you are not pregnant.

WARNING!

Common (equal or more than 1 in 100 women, but less than 1 in 10):
• Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit)’.
• Your period might be different. Most women will have a normal period at the expected time, but
some may have their period later or earlier than normal. You might also have some irregular
bleeding or spotting until your next period.

DATE:
04/11/13

5. How to store Levonelle One Step
Store in the original package in order to protect from light.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of the month.
If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.






06464/2850D



CODE:

DT
ARTWORKER:
Levonelle one step 1500 mg
PRODUCT:

Very rare (less than 1 in 10000 women)
• Skin reactions can occur: generalised itching, rash, itchy rash, swelling of the face
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, headaches, diarrhoea, feel dizzy after taking this medicine. These
symptoms should get better within a few days.

6. Further Information
What Levonelle One step contains
Each tablet contains 1500 micrograms of levonorgestrel.
Levonelle One Step also contains the following:
Lactose monohydrate, maize starch, colloidal silica anhydrous, magnesium stearate, potato starch and talc.
What Levonelle one step looks like and contents of the pack
Your medicine is called Levonelle One Step. This is a white, round tablet, which is marked ‘G00’ on one side
and plain on the other.
Each pack contains 1 tablet. This is the complete treatment.
P

PL No: 06464/2850

This product is manufactured by Bayer Pharma AG, Mullerstrasse 178, D-13353 Berlin, Germany, and/or
Bayer Weimar GmbH, und Co. KG, Dobereinerstrasse 20, D-99427, Weimar, Germany, and/or Gedeon
Richter PLC, Gyomroi ut 19-21, H-1103 Budapest, Hungary and procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 01.11.2013

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LEVONELLE ONE STEP is a registered trademark of BAYER INTELLECTUAL PROPERTY GmbH
Black

000-0000D

WARNING!

4. Possible side effects
Like all medicines, Levonelle One Step can cause side effects, although not everybody gets them.
Very common (equal or more than 1 in 10 women):
• Feeling sick (nausea)
• You might have some irregular bleeding until your next period
• You might have lower abdominal (tummy) pain
• Tiredness (fatigue)

DATE:

CUSTOMER
APPROVED:

If you take more Levonelle One Step than you should:
Although there have been no reports of serious harmful effects from taking too many tablets at once, you
may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor,
practice nurse or family planning clinic for advice, especially if you have been sick, as the tablets may not
have worked properly.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

PROOF HISTORY:
v.4 - waymade - 04/11/13

Leaflet Flat Size = 148 x 400

3. How to take Levonelle One Step:
Always take Levonelle One Step exactly as your pharmacist has told you. You should check with your doctor
or pharmacist if you are not sure. This medicine is not recommended for use in children
• Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex. Swallow the tablet whole, with water if necessary.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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