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ISTERANDA 1.5 MG TABLETS

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / 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

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

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.

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 Isteranda
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.

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 effectively.
If you have used any of the medicines below during the last 4 weeks, Isteranda
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 Isteranda:
• Barbiturates and other medicines used to treat epilepsy (for example,
primidone, phenytoin and carbamazepine).
• Medicines used to treat tuberculosis (for example, rifampicin and 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.

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 contraceptive method has failed.

When should emergency contraception be used?
• 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).

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
(See section 3 “How to take Isteranda” for further advice).

Isteranda contains a synthetic hormone-like active 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.

Isteranda may also affect how well other medicines work:
• A medicine called cyclosporin (suppresses the immune system).

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

Isteranda is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have already released.
Isteranda 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 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.

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.

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

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 levonorgestrel 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.

2. What you need to know before you take Isteranda

Do not take Isteranda
• 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 or pharmacist before taking Isteranda.
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.

Breast-feeding
The active ingredient of this medicine is excreted into your breast milk.
Therefore, it is suggested that you take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours following levonorgestrel
administration then drain your milk with a breast pump for 8 hours following
tablet taking. 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.

• 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,
levonorgestrel cannot terminate pregnancy, so Isteranda 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.

Fertility
levonorgestrel increases the possibility of menstruation disturbances which can
sometimes lead to earlier or later ovulation date resulting in modified fertility
date. Although there are no fertility data in the long term, after treatment with
Isteranda a rapid return to fertility is expected and therefore, regular contraception
should be continued or initiated as soon as possible after Isteranda use.

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).

Driving and using machines
levonorgestrel 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.

A previous ectopic pregnancy or 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 levonorgestrel may
be less effective with increasing body weight or body mass index (BMI), but
these data were limited and inconclusive. Therefore, levonorgestrel is still
recommended for all women regardless of their weight or BMI.

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Isteranda contains lactose
In case of milk sugar (lactose) intolerance it should be considered that each
Isteranda tablet also contains 43.3 mg of lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

You may 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 or feel dizzy after taking this
medicine.

3. How to take Isteranda

Very rare (may affect up to 1 in 10,000 people):
• Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain,
painful 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 you have had 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 best
the sooner you take it after having unprotected sex.
• If you are using one of the medicines that may prevent Isteranda from working
properly (see section above “Other medicines and Isteranda”) or if you have
used one of these medicines in the past 4 weeks, Isteranda 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 Isteranda (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.
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.

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.

5. How to store Isteranda

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

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.

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

Use in children
Isteranda is not indicated for use before the first menstrual bleeding (menarche).

What Isteranda contains
The active substance is levonorgestrel.
Each tablet contains 1.5 mg of levonorgestrel.

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.

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

After you have taken Isteranda
After you have taken Isteranda, 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 levonorgestrel will not work if you have
unprotected sex again, before your next period is due.

After you have taken 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 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.

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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia

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 take Isteranda
After the use of Isteranda, your period is usually normal and will start at the
usual day; however sometimes, this will be 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 that you might be pregnant, you should check
whether you are pregnant by pregnancy test.

or

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

If you take more Isteranda 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 doctor, pharmacist, practice nurse or
family planning clinic for advice, especially if you have been sick, as the tablet
may not have worked properly.

This leaflet was last revised in 02/2017.

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

4. Possible side effects

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

Possible side effects are listed below according to how common they are:
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 might have their period later or earlier than normal.

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SZ00000LT000

Artwork Proof Box
Ref: V011 - To align SPC, PIL & LB in acc to Art 13 ref + app V010 text
Proof no.
006.1

Date prepared:
24/02/2017

Colours:
Black
Dimensions: 222 x 340 mm

Font size:
8pt
Fonts:
Helvetica

Expand Transcript

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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