Emerres Una 1.5 Mg Tablet
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use 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.
• You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Emerres Una is and what it is used for
2. What you need to know before you take Emerres Una
3. How to take Emerres Una
4. Possible side effects
5. How to store Emerres Una
6. Contents of the pack and other information
1. What Emerres Una is and what it is used for
Emerres Una is commonly known as 'the morning after Pill'. It is used to reduce the chances of becoming pregnant after unprotected sex or failure of a contraceptive method.
Emerres Una contains the active ingredient levonorgestrel, which is a synthetic derivative of the naturally occurring female sex hormone and it is not fully understood how this medicine prevents pregnancy. It is thought to work by preventing ovulation and fertilisation and also by altering the lining of the womb, depending on which stage of the menstrual cycle the woman is at.
It is estimated that 84 per cent of pregnancies will be prevented if this morning-after Pill is taken within 72 hours of unprotected sex. The tablet is more effective at preventing pregnancy the earlier it is taken, so it is important to take it as soon as possible after unprotected sex, rather than delay to the third day.
2. What you need to know before you take Emerres Una
Do not take Emerres Una
• If you are allergic (hypersensitive) to levonorgestrel or any of the other ingredients of Emerres Una (see section 6).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Emerres Una.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Emerres Una may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Emerres Una 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.
If any of the following applies to you, talk to your doctor before taking this medication 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, Emerres Una cannot terminate pregnancy, as Emerres Una 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 Emerres Una 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 a history of salpingitis (inflammation of the Fallopian tubes).
A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.
If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.
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 Emerres Una
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
The medicines listed below, including non-prescription drugs, can reduce or inhibit the effect of Emerres Una:
• some drugs used to treat epilepsy (phenobarbital, phenytoin, primidone, carbamazepine);
• some drugs used to treat HIV infection (ritonavir);
• some drugs used to treat infections (rifabutin, rifampicin, griseofulvin);
• herbal products containing St. John's Wort (Hypericum perforatum).
Pregnancy breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You should not take this medicine if you are 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 Emerres Una will harm a baby that develops in your uterus/womb if you use Emerres Una as described.
Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Emerres Una or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.
Breast-feeding
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. If you are worried you can take your tablet immediately after a breast-feed and avoid nursing for at least 8 hours after taking Emerres Una. In this way you can reduce the amount of active ingredient your baby may take in with the breast milk.
Fertility
Emerres Una increases the chances of menstruation disturbances which can alter when your egg is released and therefore effect when you can become pregnant, however, there are no fertility data in the long term.
Driving and using machines
Emerres Una 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.
Emerres Una contains lactose
Emerres Una contains lactose. If you have been told by your doctor that you have an intolerance to sugars, contact your doctor before taking this medicine.
3. How to take Emerres Una
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one Emerres Una tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Emerres Una 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 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.
If another unprotected intercourse takes place after the use of Emerres Una (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.
Use in children and adolescents This medicine is not recommended for use in children. Very limited data are available in women under 16 years of age.
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.
Once you have taken this medicine, talk to a pharmacist or doctor if your next period is more than 5 days late or you suspect you may be pregnant.
If you get any lower stomach pain or discomfort, talk to a doctor straight away.
If you take more Emerres Una 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.
4. Possible side effects
Like all medicines, Emerres Una 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 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. 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 effects (may affect up to 1 in 10000 people):
• Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.
If you get any of the side effects or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Emerres Una
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 that month.
This medicinal product does not require any special storage conditions.
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 protect the environment.
6. Contents of the pack and other information
What Emerres Una contains
• The active substance is levonorgestrel.
• The other ingredients are lactose monohydrate, povidone (E1201), maize starch, silica colloidal anhydrous (E551) and magnesium stearate (E572).
What Emerres Una looks like and contents of the pack
Emerres Una is a round, white to off-white, uncoated flat tablet debossed '145' on one side and plain on the other side.
Each pack contains a blister with one tablet.
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road Leicester, LE3 OPA, UK
Manufacturer
Morningside Pharmaceuticals Ltd 5 Pavilion Way Loughborough, UK
This leaflet was last revised in April 2015.