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ROSEMAR 150/30 COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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(Levonorgestrel / Ethinylestradiol)

Size : 390 x 270mm
After Folding 34x65mm

Rosemar contains lactose and sucrose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
3. How to take Rosemar
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Take one tablet of Rosemar every day, if necessary with a small amount of
water. You may take the tablets with or without food, but you should take the
tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week
that it should be taken. If, for example you start on a Wednesday, take a tablet
with “WED” next to it. Follow the direction of the arrow on the strip until all
21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days
(otherwise called a stop or gap week) bleeding
should begin. This so-called
“withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
th

On the 8 day after the last Rosemar tablet (that is, after the 7-day gap week),
start the following strip, even if the bleeding has not stopped. This means that
you should start the following strip on the same day of the week and that the
withdrawal bleed should occur on the same days each month.
If you use Rosemar in this manner, you are also protected against pregnancy
during the 7 days that you are not taking a tablet.
Starting the first pack of Rosemar
• If you have not used a contraceptive with hormones in the previous month.
Begin with Rosemar tablet on the first day of the cycle (that is the first day
of your menstruation). If you start Rosemar tablet on the first day of your
menstruation you are immediately protected against pregnancy. You may
also begin on day 2-5 of the cycle, but then you must use extra protective
measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or combined
contraceptive, vaginal ring or patch.
You can start Rosemar preferably on the day after the last active tablet (the
last tablet containing the active substance) of your previous pill, but at the
latest on the day after the tablet-free days of your previous pill finish (or
after the last inactive tablet of your previous pill). When changing from a
combined contraceptive vaginal ring or patch, follow the advice of your
doctor.
• Changing from a progestogen-only-method (progestogen-only pill,
injection, implant or a progestogen-releasing IUD).
You may switch any day from the progestogen-only pill (from an implant or
the IUD on the day of its removal, from an injectable when the next
injection would be due) but in all of these cases you must use extra
protective measures (for example, a condom) for the first 7 days of tablettaking.

vomiting. Young girls may have bleeding from the vagina.
If you have taken too many Rosemar tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.
If you forget to take Rosemar
If you are less than 12 hours late in taking your pill, the protection from
pregnancy is not reduced. Take the tablet as soon as you remember, and further
pills again at the usual time.
If you are more than 12 hours late taking a tablet, the protection from
pregnancy may be reduced. The greater the number of tablets that you have
forgotten, the greater is the risk that the protection from pregnancy is reduced.

What must you do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea,
there is a risk that the active substances in the pill are not fully adsorbed into
your body. The situation is similar to if you forget a tablet. After vomiting or
diarrhoea, you must take another tablet from a reserve strip as soon as
possible. If possible take it within 12 hours of when you normally take your
pill. If this is not possible or 12 hours have passed, you should follow the
advice given under 'if you forget to take Rosemar.

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.

Delay of menstrual period: what must you know
5. How to store Rosemar

The risk of incomplete protection against pregnancy is greatest if you forget a
tablet at the beginning or the end of the strip. Therefore, you should adhere to
the following rules:
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Take the tablets again at the
usual time and use extra precautions for the next 7 days, for example, a
condom. If you have had intercourse in the week before the oversight or you
have forgotten to start a new strip after the tablet-free period, you must
realize that there is a risk of pregnancy. In that case, contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Take the tablets again at the
usual time. The protection from pregnancy is not reduced, given that you
have taken the tablets correctly in the previous 7 days, otherwise extra
precaution should be used for the next 7 days.
• One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Take the tablets again at the
usual time. Instead of the tablet-free period go straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second
strip but you may also have spotting or breakthrough bleeding during the
second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7 days
(record the day on which you forgot your tablet). If you want to start a new
strip on your fixed start day, make the tablet-free period less than 7 days.
If you follow either of these two recommendations, you will remain protected
against pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have
bleeding in the first tablet-free period, this may mean that you are pregnant.
You must contact your doctor before you go on to the next strip.

Even if not recommended, delay of your menstrual period (withdrawal bleed)
is possible by going straight on to a new strip of Rosemar instead of the tabletfree period, to the end of the second strip. You may experience spotting (drops
or flecks of blood) or breakthrough bleeding while using the second strip.
After the usual tablet-free period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your
menstrual period

If you take the tablets according to the instructions, then your menstrual
period/withdrawal bleed will begin in the tablet-free week. If you have to
change this day, do this by making the tablet-free period shorter (but never
longer!) For example, if your tablet-free period begins on a Friday, and you
want to change this to a Tuesday (3 days earlier) you must start a new strip 3
days earlier than usual. If you make the tablet-free period very short (for
example, 3 days or less) then it may be that you do not have any bleeding
during this tablet-free period. You may then experience spotting (droplets or
flecks of blood) or breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.

• If you are breastfeeding and want to start Rosemar after having a baby,
Read the section on “Breast feeding”.
Use in children and adolescents

- The active substances are Levonorgestrel
(150 mcg) and Ethinylestradiol (30 mcg)
- The other ingredients are Lactose
Monohydrate, Maize Starch, Povidone K25, Sucrose, Talc, Calcium carbonate,
Povidone K-90, Glycerin, Macrogol 6000,
Titanium dioxide, Magnesium Stearate,
Carnauba Wax.

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.
Common side effects (affecting more than 1 in 100, but less than 1 in 10
women):
Mood swings, headache, abdominal pain (stomach ache), acne, breast pain,
weight gain, nausea

If you take more Rosemar than you should
Additional side effects in children and adolescents

There are no reports of serious harmful results of taking too many Rosemar
tablets.
If you take several tablets at once then you may have symptoms of nausea or

Not relevant

Size : 390 x 270mm
After Folding 34x65mm

6. Contents of the pack and other
information

You can stop taking Rosemar whenever you want. If you do not want to
become pregnant, ask you doctor for advice about other reliable methods of
birth control.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist

There is no data available for use in adolescents below 18 years.

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.

What Rosemar contains

Other serious side effects you should be aware off are also mentioned in
section 2 of this leaflet (Do not take Rosemar if you & Take special care
with Rosemar). These include:
- Blood clot disorders
- High blood pressure;
- Liver tumours;
- Swelling of the skin (angioedema)
- Occurrence or deterioration of conditions such as: Crohn's disease, epilepsy,
migraine Etc.

Let your doctor advice you in case you are not sure when to start.

Do not use this medicine if you notice
description of the visible signs of deterioration.

If you stop taking Rosemar

Rare side effects (affecting less than 1 in 1000 women):
Contact lens intolerance, allergic reactions, weight loss, increased libido
(interest in sex, breast discharge, vaginal discharge, allergic reactions which
can sometimes be severe with swelling of the skin and/or mucous membranes
(erythema nodosum & eruthema multiforme)

• After having a baby.
After having a baby, you can start Rosemar between 21 and 28 days later. If
you start later than day 28, you must use a so-called barrier method (for
example, a condom) during the first seven days of Rosemar use.
If, after having a baby, you have had intercourse before starting Rosemar
(again), you must first be sure that you are not pregnant or you must wait
until the next menstrual bleed.

The expiry date refers to the last day of that
month.

Change of the first day of your menstrual period: what you must know

Uncommon side effects (affecting more than 1 in 1000 but less than 1 in 100
women):
Vomiting, diarrhoea, fluid retention, migraine, decreased libido (interest in
sex), breast enlargement, itchy red rush of the skin (urticaria)

• After a miscarriage .
Follow the advice of your doctor.

Keep this medicine out of the sight and reach
of children.
Store below 25° C
Do not use this medicine after the expiry date
which is stated on the carton.

What Rosemar looks like and contents of
the pack
Rosemar tablets are white, circular, biconvex
and sugar coated.
Each blister pack contains 21 tablets.
Rosemar is sold in cartons of 1, 3, 6 or 13
blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Famy Care Europe Ltd.
One Wood Street
London, EC2V 7WS
United Kingdom
Rosemar is manufactured by:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF,
United Kingdom
This leaflet was last revised in {12/2013}.

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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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