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ROSEMAR 150/30 COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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Package leaflet: Information for the user
Rosemar 150/30 Coated Tablets
(Levonorgestrel / Ethinylestradiol)
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Rosemar is and what it is used for
2. What you need to know before you take Rosemar
3. How to take Rosemar
4. Possible side effects
5. How to store Rosemar
6. Contents of the pack and other information








If you have (had) an inflammation of the pancreas (pancreatitis)
If you have or have had in the past a liver disease and your liver function is still
not normal.
If you have or have had a tumour in the liver.
If you have (had) or if you are suspected to having breast cancer or cancer of the
genital organs.
If you have any unexplained bleeding from the vagina.
If you have absence of menstrual period and the cause is unknown

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Rosemar. In some situations
you need to take special care while using Rosemar or any other combined hormonal
contraceptive, and it may be necessary that you are regularly checked by your
doctor. If any of the following conditions applies to you, you must inform your
doctor before starting to use Rosemar. Also is any of the following conditions
develops or worsens during the use of Rosemar you must consult your doctor.






1. What Rosemar is and what it is used for



Rosemar coated tablets are a combined oral contraceptive and belongs to a group of
products often referred to as “the Pill”. Rosemar contains two hormones: estrogen
(Ethinylestradiol) and progestogen (Levonorgestrel). These hormones prevent
you from getting pregnant, just as your natural hormones would prevent you from
conceiving again when you are already pregnant.
You must talk to a doctor if you do not feel better or if you feel worse.





2. What you need to know before you use Rosemar
General notes
Package leaflet: Information for the user
Rosemar 150/30 Coated Tablets
(Levonorgestrel / Ethinylestradiol)



Before you can begin taking Rosemar, your doctor will ask you some questions about
your personal health and that of your close relatives. The doctor will also measure
your blood pressure and depending upon your personal situation, may also carry out
some other tests.
In this leaflet, several situations are described where you should stop using Rosemar,
or where the reliability of Rosemar may be decreased. In such situations you should
either not have intercourse or you should take extra non-hormonal contraceptive
precautions, e.g., use a condom, or another barrier method. Do not use rhythm or
temperature methods. These methods can be unreliable because Rosemar alters the
monthly changes of the cervical mucus.
Rosemar, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.
Do not take Rosemar









if you are allergic to Levonorgestrel or Ethinylestradiol or any of the other
ingredients of this medicine (listed in section 6).
If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel
of the leg, lung (embolus) or other organs,
If you have (or have had in the past) a heart attack or stroke
If you have (or have had in the past) a disease that can be a predictor of a heart
attack (for example, angina pectoris, which causes severe pain in the chest) or of
a stroke (for example, a transient slight stroke with no residual effects).
If you have a disease that may increase the risk of a thrombosis in the arteries.
This applies to the following diseases:
o Diabetes mellitus with damaged blood vessels
o Very high blood pressure
o A very high level of fat in the blood (cholesterol or triglycerides)
If you have a disturbance of blood clotting (for example, protein C deficiency)
If you have (had) a certain form of migraine (with so-called focal neurological
symptoms).






If a close relative has or has had breast cancer
If you have a disease of the liver or the gallbladder
If you have diabetes
If you have depression
If you have Crohn’s disease or ulcerative colitis (inflammatory bowel
disease)
If you have HUS (haemolytic uraemic syndrome; a blood disease that
causes kidney damage)
If you have epilepsy (see “Taking other medicines”)
If you have SLE (systemic lupus erythematosus; a disease of the immune
system)
If you have a disease that first appeared during pregnancy or earlier use
of sex hormones (for Example, hearing loss, porphyria (a disease of the
blood), gestational herpes (skin rash with vesicles during pregnancy),
Sydenham’s chorea (a disease of the nerves in which sudden movements of
the body occur)
If you have or have ever had chloasma (golden brown pigment patches, so
called “pregnancy patches”, especially on the face). If this is the case, avoid
direct exposure to sunlight or ultraviolet light.
If you have hereditary angioedema, products containing estrogens may
induce or worsen symptoms of angioedema. You should see your doctor
immediately if you experience symptoms of angioedema such as swollen
face, tongue and/or pharynx and/or difficulty swallowing or hives together
with difficulty breathing.
If a pre-existing high blood pressure condition worsens
If a pre-existing high level of fat in blood worsens

Rosemar and thrombosis
Venous thrombosis
The use of any combination pill, including Rosemar, increases a woman’s risk of
developing a venous thrombosis (formation of a blood clot in vessels) compared with
a woman who does not take any (contraceptive) pill.
The risk of venous thrombosis in users of combined pills increases:





with increasing age
If you are overweight,
If one of your close relatives has had a blood clot (thrombosis) in the leg, lung,
or other organ at a young age,
If you must have an operation (surgery), any prolonged period of immobilization,
or if you have had a serious accident. It is important to tell your doctor in advance
that you are using Rosemar as the treatment may have to be stopped. Your doctor
will tell you when to start again. This is usually about two weeks after you are
back on your feet.

Arterial thrombosis
The use of combination pills has been connected with an increase of the risk of arterial

thrombosis (obstruction of an artery), for example, in the blood vessels of the heart
(heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills increases:







With increasing age
If you smoke you are strongly advised to stop smoking when you use
Rosemar, especially if you are older than 35 years.
If you have an increased fat content in your blood (cholesterol or triglycerides)
If you have high blood pressure
If you have migraine
If you have a problem with your heart (valve disorder, a disturbance of the heart
rhythm)

Stop taking Rosemar and tell your doctor immediately if after taking Rosemar
you notice possible signs of thrombosis, such as













any unusual, severe or long-lasting headache or worsening of migraine
partial or complete blindness or double vision
sudden pain and/or swelling in one of your legs
sudden breathlessness
sudden cough without an obvious cause
sudden severe pain in the chest which may reach the left arm
difficulty in speaking or inability to speak
weakness, strange feeling, or numbness in any part of the body
a feeling of dizziness or spinning
collapse with or without focal seizure
motor disturbances
sudden severe abdominal pain

Rosemar and cancer
Breast cancer has been observed slightly more often in women using combined pills,
but it is not known whether this is caused by the treatment. For example it may be that
more tumours are detected in women on combined pills because they are examined
by their doctor more often. The occurrence of breast tumours becomes gradually less
after stopping the combination hormonal contraceptives. It is important to regularly
check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours
have been reported in pill users. Contact your doctor if you have unusual severe
abdominal pain.
Bleeding between periods
During the first few months that you are taking Rosemar, you may have unexpected
bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few
months, or if it begins after some months, your doctor must investigate the cause.
What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea
and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant.
Contact your doctor immediately. Do not start the next strip until you are sure that
you are not pregnant.
Children and adolescents
There is no data available for use in adolescents below 18 years.
Other medicines and Rosemar
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription and herbal
medicines.

Also tell any other doctor or dentist who prescribes another medicine (or the
dispensing pharmacist) that you use Rosemar. They can tell you if you need to take
additional contraceptive precautions (barrier method) and, if so, for how long.







Some medicines that can have an influence on the blood level of Rosemar
150/30 Coated tablets and can make it less effective in preventing pregnancy,
or can cause unexpected bleeding. These include medicines used for the
treatment of:
– epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine,
oxcarbazepine, topiramate, felbamate);
– tuberculosis (e.g. rifampicin);
– HIVand Hepatitis C Virus infections (so-called protease inhibitors and
non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine,
efavirenz)
– other infections (griseofulvin)– high blood pressure in the blood vessels
in the lungs (bosentan).
The herbal product St. John’s wort may also stop Rosemar 150/30 Coated
Tablets from working properly. If you want to use herbal products containing
St. John’s wort while you are already using Rosemar you should consult
your doctor first.
Some medicines can increase the levels of the active substances of Rosemar
in the blood. The effectiveness of the pill is maintained, but tell your doctor
if you are using anti-fungal medicines containing ketoconazole.
Rosemar may also interfere with the working of other medicines – such as
the anti-epileptic lamotrigine.

Effect on laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the
pill, because oral contraceptives can affect the results of some tests.
Pregnancy, breast feeding and fertility
Pregnancy
If you become pregnant while taking Rosemar you must stop immediately and contact
your doctor.
Breast feeding
Use of Rosemar is generally not advisable when a woman is breast feeding. If you
want to take the pill while you are breast-feeding you should contact your doctor.
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 this medicine.
Driving and using machines
Rosemar does not have any known effect on your ability to drive or use machines.
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.

On the 8th 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 tablet-taking.
• After a miscarriage.
Follow the advice of your doctor.
• 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.
Let your doctor advice you in case you are not sure when to start.

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.
Ask your doctor for advice

Several tablets
forgotten in 1strip

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

yes
In
week 1

no

Use in children and adolescents

• Take the forgotten tablet
• Use a barrier method
(condom) for the following
7 days
• And finish strip

There is no data available for use in adolescents below 18 years.
If you take more Rosemar than you should
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
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.

Only 1tablet
forgotten (taken
more than 12
hours late)

In
week 2

• Take the forgotten tablet and
• Finish the strip
• Take the forgotten tablet and
• Finish the strip
• Instead of the gap week
• Go straight on the next strip

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.

Had sex in the previous week
before forgetting?

In
week 3

or
• Stop the strip immediately
• Begin the gap week (not longer
than 7 days, including the
forgotten tablet )
• Then go to the next strip

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.
Delay of menstrual period: what must you know
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 tablet-free
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 tabletfree period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your menstrual
period
Change of the first day of your menstrual period: what you must know
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 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
Additional side effects in children and adolescents
Not relevant
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.
5. How to store Rosemar
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.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice description of the visible signs of deterioration.
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 Rosemar contains

If you stop taking Rosemar

-

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 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
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)
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)
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

The active substances are Levonorgestrel (150 mcg) and Ethinylestradiol (30
mcg)
The other ingredients are Lactose Monohydrate, Maize Starch, Povidone K-25,
Sucrose, Talc, Calcium carbonate, Povidone K-90, Glycerin, Macrogol 6000,
Titanium dioxide, Magnesium Stearate, Carnauba Wax.

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 05/2016

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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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