LoviOne 1.5mcg Tablet - Levonorgestrel LoviOne 1.5mcg Tablet - Levonorgestrel

Do not use LoviOne

• If you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in ingredients section.

Warnings and precautions.

If any of the following applies to you, talk to your doctor before taking LoviOne as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

• If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, LoviOne cannot terminate pregnancy, so LoviOne is not an ‘abortion pill’.

You may already be pregnant if:

• your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due.
• you have had unprotected sex more than 72 hours ago, and since your last period.

The use of LoviOne is not advised if:

• you have a disease of your small bowel [such as Crohn's disease] that inhibits the absorption of the drug.
• you have severe liver problems.
• you have a history of ectopic pregnancy [where the baby develops somewhere outside the womb).
• you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

A previous ectopic pregnancy or previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.

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

Children and adolescents

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

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

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.

Other medicines and LoviOne

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

Some medicines may prevent LoviOne from working effectively.

If you have used any of the medicines below during the last 4 weeks, LoviOne 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 LoviOne:

• barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (for example, rifampicin, rifabutin]
• a medicine for HIV infection (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 a doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy.

LoviOne may also affect how well other medicines work: 

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

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

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

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

Very common (may affect more than 1 in 10 people):

• feeling sick (nausea)
• you might have some irregular bleeding until your next period
• you might have lower abdominal pain
• tiredness
• headache.

Common (may affect up to 1 in 10 people):

• being sick (vomiting).
• If you are sick, read in directions 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. 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, diarrhoea, feel dizzy after taking this medicine.

Very rare (may affect up to 1 in 10,000 people):

• rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period, abdominal pain.

Always take this medicine exactly as described in the leaflet or as your pharmacist or doctor has told you. Check with your doctor or pharmacist 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. Do not delay taking the tablet. The tablet works better the sooner you take it after having unprotected sex. It can only prevent you becoming pregnant, if you take it within 72 hours of unprotected sex.
• LoviOne 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.
• If you are using one of the medicines that may prevent LoviOne from working properly or if you have used one of these medicines in the past 4 weeks, LoviOne 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 LoviOne (i.e. 2 tablets taken together at the same time).
• f you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

If another unprotected intercourse takes place after the use of LoviOne (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.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception. What to do if you are sick (vomit) If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet.

After you have taken LoviOne

After you have taken LoviOne, if you want to have sex and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because LoviOne will not work if you have unprotected sex again, before your next period is due.

After you have taken LoviOne, you are advised to make an appointment to see your doctor about three weeks later to make sure that LoviOne 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.

Your next period after you took LoviOne

After the use of LoviOne, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an 'abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more LoviOne 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 tablet may not have worked properly.

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

LoviOne contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each LoviOne also contains 120mg 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.

The active substance is levonorgestrel. Each tablet contains 1.5 milligrams of Levonorgestrel.

The other ingredients are: potato starch, maize starch, Silica, colloidal anhydrous, magnesium stearate, talc and lactose monohydrate.