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ISTERANDA 1.5 MG TABLETS

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Isteranda 1.5 mg Tablet

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

Levonorgestrel

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.

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.

Other medicines and Isteranda
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

What is in this leaflet:
1. What Isteranda is and what it is used for
2. What you need to know before you take Isteranda
3. How to take Isteranda
4. Possible side effects
5. How to store Isteranda
6. Contents of the pack and other information

Some medicines may prevent Isteranda from working properly, these include:
• Barbiturates and other medicines used to treat epilepsy (for example,
primidone, phenytoin and carbamazepine).
• Medicines used to treat tuberculosis (for example, rifampicin and rifabutin).
• Some medicines used to treat HIV infection (ritonavir).
• A medicine used to treat fungal infections (griseofulvin).
• Herbal medicines containing St. John's Wort (Hypericum perforatum).
• A medicine called ciclosporin (used to suppress the immune system).
Consult a doctor or pharmacist before using Isteranda if you use any of the
above mentioned medicine.

1. What Isteranda is and what it is used for

Isteranda is an emergency contraceptive that can be used within 72 hours (3
days) of unprotected sex or if your usual method of contraception has failed.

How often can Isteranda be used
You should only use Isteranda in emergencies, and not as a regular method of
contraception. If you use Isteranda more than once in a menstrual cycle, it is
less reliable and it is more likely to upset your menstrual cycle (period).
Isteranda 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.

It can be used in the following cases:
• No contraception was used during sexual intercourse
• The contraception measure was used incorrectly, for example if a condom
was penetrated, slipped away or used in a wrong way, if vaginal pessary or
diaphragm changed position, burst, was broken or taken out ahead of time,
in the case of a failed interruption during coitus interruptus (e.g. sperm
ejaculated in vagina or on external genitalia).

Pregnancy and breast-feeding
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.

Isteranda contains a synthetic hormone-like substance called levonorgestrel. It
prevents about 85% 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.

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 Isteranda will harm a baby that develops
in your uterus/womb if you use Isteranda 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 Isteranda or if you
have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic
inflammatory disease.

Isteranda is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg that may have already released; or
• stopping a fertilised egg from attaching itself to your womb lining.

Isteranda can only prevent you from becoming pregnant if you take it within 72
hours of having unprotected sex. It does not work if you are already pregnant.
If another unprotected intercourse takes place after the use of Isteranda (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.
This tablet is only for emergency contraception, not for a regular contraception
as it is less effective than the regular contraceptive tablet.

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. However, if you
are worried you can take the tablet immediately after a breast-feed and avoid
nursing following levonorgestrel administration then drain your milk with a
breast pump for 6 hours after taking Isteranda and throw away this milk. In this
way you can reduce the amount of active ingredient your baby may take in with
the breast milk.

2. What you need to know before you take Isteranda

Do not take Isteranda
• if you are allergic (hypersensitive) to levonorgestrel or any of the other
ingredients of this medicine (listed in section 6)

Driving and using machines
Isteranda 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 machines.

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

Isteranda contains lactose
In case of milk sugar (lactose) intolerance it should be considered that each
Isteranda tablet contains 43.3 mg of lactose. If your doctor has told you that
you have intolerance to certain sugars, contact your doctor before taking this
medicine.

• 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,
Isteranda cannot terminate pregnancy, so Isteranda is not an “abortion
tablet”.

3. How to take Isteranda

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.

Always use this medicine exactly as described in the leaflet or as your doctor
or pharmacist 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 having unprotected sex. You can take Isteranda
at any time during 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 tablet, you can continue to take this at your regular times.

The use of Isteranda 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.

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

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5. How to store Isteranda

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

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

Use in children and adolescents
This medicine is not recommended for use in children and only intended for
use in women who had a first menstrual bleeding. Limited data are available in
women under 16 years of age.

Do not use Isteranda after the expiry date which is stated on the pack and
blister. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage condition.

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.

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.

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

6. Contents of the pack and other information
What Isteranda contains
The active substance is levonorgestrel.
Each tablet contains 1.5 mg of levonorgestrel.

After taking Isteranda, you are advised to make an appointment to see your
doctor about three weeks later to make sure that Isteranda has worked. If your
period is more than 5 days late or is unusually light or 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.

The other ingredients are cellulose microcrystalline, lactose monohydrate,
poloxamer 188, croscarmellose sodium and magnesium stearate.

What Isteranda looks like and contents of the pack
Each pack contains one complete treatment of one round, white tablet, of
approximate 6 mm of diameter and marked “C” on one side and “1” on the
other.

Your doctor can also tell you about long-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 tablet and you do not have a bleed in your tablet-free period, see
your doctor to make sure you are not pregnant.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.

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

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia

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

or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany.

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

4. Possible side effects

This leaflet was last revised in 10/2014.

Like all medicines, Isteranda can cause side effects, although not everybody
gets them.
Possible side effects are listed below according to how common they are:

Very common side effects (may affect more than 1 in every 10 users):
• Feeling sick (Nausea)
• You might have some irregular bleeding until your next period
• You might have lower abdominal pain
• Tiredness
• Headache

Common side effects (may affect up to 1 in 10 users):
• Being sick (vomiting). If you are sick, read the section “What to do if you are
sick (vomit)”.
• Your period may 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 may also have irregular bleeding or spotting until your next period. If
your period is more than 5 days late or is unusually light or heavy, you
should contact your doctor as soon as possible.
• You might have tender breasts, diarrhoea or feel dizzy after taking this
medicine.
Very rare side effects (may affect up to 1 in 10,000 users):
• Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

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

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 (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety
of this medicine.

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draft: 44059421
laetus code: supplier to add
mat.no.: 00000000

Artwork Proof Box
Ref: V003 - article 31 referral
Proof no.
003.0

Date prepared:
13/10/2014

Colours:
Black
Dimensions: 222 x 340 mm

Font size:
8pt
Fonts:
Helvetica

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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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