PACKAGE LEAFLET

Package leaflet: Information for the patient

Toomee 1.5 mg Tablets

levonorgestrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

•    - Keep this leaflet. You may need to read it again.

•    - Ask your pharmacist if you need more information or advice.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Toomee is and what it is used for

2.    What you need to know before you take Toomee

3.    How to take Toomee

4.    Possible side effects

5.    How to store Toomee

6.    Contents of the pack and other information

1. What Toomee is and what it is used for

Toomee is an oral emergency contraceptive.

What is emergency contraception?

Emergency contraception is a rescue method intended to prevent pregnancy after unprotected intercourse or in case of failure of a contraceptive method.

When should emergency contraception be used?

This contraceptive method should be used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days), after unprotected sexual intercourse or failure of a contraceptive method. It is more effective if you take it as soon as possible after unprotected sex. Toomee 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 Toomee, it will not stop you from becoming pregnant.

Toomee has been shown to prevent 52% to 85% of expected pregnancies.

Toomee may be used in these cases:

•    if you have had sexual intercourse without any contraception;

•    if you have forgotten to take your regular contraceptive pill on time;

•    if your partner’s condom has broken, slipped or came off;

•    if you fear that your intrauterine device has been expelled;

•    if your vaginal diaphragm or your contraceptive cap has moved or if you have removed it early;

•    if you are worried that the method of coitus interruptus or the rhythm method has failed;

•    in the event of rape.

Toomee works by stopping your ovaries from releasing an egg. It cannot stop a fertilized egg from attaching to the womb.

This tablet is only for emergency contraception, not for regular contraception as it is less effective than the regular contraceptive pill (“the pill”).

Toomee is not indicated for use before the first menstrual bleeding (menarche).

2. What you need to know before you take Toomee Do not take Toomee

•    - if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Toomee.

The use of Toomee is not recommended in the following cases:

•    - if you have had a tubal (ectopic) pregnancy,

•    - if you have had an infection in your fallopian tubes (salpingitis),

•    - if you have personal or family history of known risk factor for thrombosis (blood clotting).

•    - if you have a severe digestive disease which impairs absorption of food and medications,

•    - if you have severe liver problems or severe disease of the small bowel, such as Crohn’s disease.

A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. Therefore, if you have had an ectopic pregnancy or an infection of the fallopian tubes you should contact your doctor before taking Toomee.

If you have had another act of unprotected intercourse more than 72 hours ago, you may already be pregnant. Treatment with Toomee following the second act of intercourse may therefore be ineffective in preventing pregnancy.

Repeated administration of Toomee within a menstrual cycle is not advisable because it may upset your cycle.

Toomee does not work as well as regular methods of contraception. Your doctor can tell you about long-term methods of contraception which are more effective in preventing from getting pregnant.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Toomee may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Toomee is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

After taking this medicine:

It is mandatory to exclude pregnancy by performing a pregnancy test:

• if your next menstrual period is delayed more than five days,

•    in case of abnormal bleeding even at the date of expected menstrual period.

If you did not use a condom (or if it split or slipped off) during intercourse, it might be possible that you have contracted a sexually transmitted disease or the HIV virus. The use of emergency contraception does not protect against sexually transmitted diseases and cannot replace the necessary precautions and measures to be taken in case of risk of transmission.

Children and adolescents

Children

Toomee is not indicated for use before the first menstrual bleeding (menarche).

Other medicines and Toomee

Tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Toomee from working effectively. If you have used any of the medicines below during the last 4 weeks, Toomee may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Toomee:

•    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 (ritonavir, efavirenz)

•    a medicine used to treat fungal infections (griseofulvin)

•    herbal remedies containing St John’s wort (Hypericum perforatum).

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See also section 3 “How to take Toomee” for further advice).

Toomee may also affect how well other medicines work

• a medicine called cyclosporin (suppresses the immune system).

Toomee should not be used together with drugs containing ulipristal acetate.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine

If you are pregnant:

This medication does not end an ongoing pregnancy.

If you take this medication and you still become pregnant, studies to date have not shown any risk of malformation for the developing foetus. However this medication should not be taken if you are pregnant.

If you do become pregnant after taking Toomee, you should contact your doctor. Your doctor might want to check that the pregnancy is not ectopic (the baby develops somewhere outside your womb). This is especially important if you develop severe pain in your abdomen after taking Toomee or if you ever had an ectopic pregnancy, surgery to your fallopian tubes or pelvic inflammation disease.

If you are breast-feeding:

Breast-feeding is possible. However, since levonorgestrel passes into breast milk, it is suggested that you breastfeed immediately before taking the Toomee tablet and refrain from nursing for at least 8 hours following Toomee administration.

Driving and using machines

After Toomee intake, some women experienced fatigue and dizziness (see section 4 “Possible side effects”): do not drive or use machines if you experience these symptoms.

No studies on the effect on the ability to drive and use machines have been reported.

Toomee contains lactose

Toomee contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Toomee

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

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.

Toomee can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex.

If you are using one of the medicines that may prevent Toomee from working properly (see section above “Other medicines and Toomee”) or if you have used one of these medicines in the past 4 weeks, Toomee may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Toomee (i.e. 2 tablets taken together at the same time).

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. In case you do not have menstrual bleeding in the next pill-free period, perform a pregnancy test to exclude pregnancy, and see your doctor.

If you vomit within three hours of taking the tablet, you should take another tablet immediately. Contact your pharmacist or doctor to obtain another tablet.

After using emergency contraception, you should use a local contraceptive method (condom, spermicide, cervical cap) until your next menstrual period. If another unprotected intercourse takes place after the use of Toomee (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

Use in children

Toomee is not indicated for use before the first menstrual bleeding (menarche).

Your next period after you have taken Toomee

After the use of Toomee, your period is usually normal and will start on the expected day; however sometimes, this will be a few days later or earlier.

If your period is more than 5 days late or is unusually light or unusually heavy, or if you think that you might be pregnant for any other reason, you should check whether you are pregnant by performing a pregnancy test. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

If you take more Toomee than you should

No acute toxicity or serious harmful effects has been demonstrated with this medicine in case of intake of several doses. However, you may feel sick, actually be sick (vomit) or have vaginal bleeding. You should contact your doctor or pharmacist for advice.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

Very common: may affect more than 1 in 10 people

•    - dizziness, headache

•    - nausea, abdominal pain

•    - breast tenderness, delay of period, heavy period, bleeding, uterine pain

•    - fatigue

Common: may affect up to 1 in 10 people

•    - diarrhea, vomiting

•    - painful periods

Not known: frequency cannot be estimated from the available data

•    - cases of thromboembolic events (blood clotting) have been reported during the postmarketing period

•    - allergic reactions such as swelling of throat and face and skin rash can occur after taking this medicine

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Toomee

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of deterioration; it should then be returned to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Toomee contains

The active substance is levonorgestrel. Each tablet contains 1.5 mg levonorgestrel.

The other ingredients are lactose monohydrate (see section 2 “Toomee contains lactose”), povidone, maize starch, silica colloidal anhydrous and magnesium stearate.

Levonorgestrel belongs to a group of medicines called emergency contraceptives.

What Toomee looks like and contents of the pack

Toomee is a round, white to off-white, uncoated flat tablet of 8 mm debossed with ‘145’ on one side and the other side plain.

Each pack of Toomee contains one tablet of 1.5 mg of levonorgestrel.

Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom *OR

Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany *OR

Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands *OR

Teva Pharma S.L.U, 4 Poligono Malpica, Zaragoza, Spain *OR

TEVA UK Ltd, Brampton road, Hampden park. Eastbourne, East Sussex, BN22 9AG This leaflet was last revised in 10/2016

PL 00289/1763

* Only the actual site of batch release will appear on the printed version of the leaflet