Yvidually 0,02 mg/3 mg, filmomhulde tabletten

General advice

Always use Yvidually exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The Clyk tablet dispenser will guide you through the regimen.

Take one tablet of Yvidually 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.

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Tablet intake

1) Mandatory phase (day 1-24):

When starting Yvidually, tablets must be taken continuously for a minimum of 24 days, after which you can either:

• stop taking tablets for a 4-day tablet-free interval
• or continue taking them for up to 120 days (see flexible phase).

During the first 24 days the Clyk tablet dispenser does not allow a 4-day tablet-free interval.

2) Flexible phase (day 25-120):

During days 25-120, the tablets can be taken continuously up to a maximum of 120 days. Within this period, you may decide yourself when to take the 4-day tablet-free interval. This will usually cause bleeding.

During the flexible phase, the Clyk tablet dispenser allows you to initiate a 4-day tablet-free interval at any time.

If you do not initiate the 4-day tablet-free interval yourself, the Clyk dispenser automatically initiates a 4-day tablet-free interval after 120 days of continuous tablet intake.

In the event of continued bleeding (three consecutive days) during days 25-120, it is advisable to take the 4-day tablet-free interval. This will reduce the total number of days with bleeding.

Tablet-free interval

A tablet-free interval should never be longer than 4 days and it should only be started if tablet taking has been continuous for 24 days.

During the 4-day tablet-free interval bleeding usually occurs and may not have finished before you start the next tablet intake cycle.

After each 4-day tablet-free interval, you will start a new intake cycle of a minimum of 24 days to a maximum of 120 days. After the mandatory phase of 24 days of continuous tablet taking, you again may choose when to have the tablet-free 4 day interval between days 25 and 120.

Preparing the Clyk tablet dispenser for use

Yvidually can only be used in combination with the Clyk dispenser.

The separate document instructions for use of the Clyk dispenser should be carefully read before and during use.

1. Remove the OC dispenser from its package
2. Remove a cartridge (containing 30 tablets) from its blister immediately prior to insertion
3. Hold the dispenser in the palm of your hand so you see the viewing window for the tablets (see picture)
4. Hold the cartridge in your other hand so that you can see the tablets.
5. Insert the cartridge in the dispenser, pushing it in all the way and leave in. The tablets are now visible through the viewing window.

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6. Turn the dispenser over to view the display screen on the front. This now tells you that your OC dispenser is turned on and ready to use.

Replacing an empty cartridge with a new cartridge

When the cartridge is empty release it from the tablet dispenser by pressing the cartridge release button (the button with a blue circle on it). Only remove the new cartridge from its blister immediately prior to insertion.

Dispose of the empty cartridge and insert a new one as described above.

When can you start with Yvidually?

• If you have not used a contraceptive with hormones in the previous month Begin with Yvidually on the first day of the cycle (that is, the first day of your period). If you start Yvidually on the first day of your period 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 Yvidually preferably on the day after the last tablet-free interval or after the last hormone-free 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 an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.

• After a miscarriage or abortion Follow the advice of your doctor.
• After having a baby

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You can start Yvidually between 21 and 28 days after having a baby. 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 Yvidually use.

If, after having a baby, you have had sex before starting Yvidually (again), you must first be sure that you are not pregnant or you must wait until your next period.

• If you are breast-feeding and want to start Yvidually (again) after having a baby Read the section on “Breast-feeding” on page X.

Ask your doctor what to do if you are not sure when to start.

If you take more Yvidually than you should

There are no reports of serious harmful results of taking too many Yvidually 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 Yvidually tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Yvidually

IMPORTANT: If you have missed one or more pills, check if the ‘Use an additional method of contraception’ symbol (an exclamation mark in a box) is displayed on your Clyk dispenser’s home screen.

Whenever the home screen displays the exclamation mark, you should use an additional non-hormonal method of contraception (e.g. condoms). You should use an additional method of non-hormonal contraception until the exclamation mark disappears.

Management of missed tablets

• If you are less than 24 hours late when taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets again at the usual time.
• If you are more than 24 hours late in taking any tablet your protection against pregnancy may be reduced. The following advice can be given in daily practice:
  • More than one tablet forgotten Check if the ‘Use an additional method of contraception’ symbol (an exclamation mark in a box) is displayed on your Clyk dispenser’s home screen and follow the above instructions. If you are unsure what to do, ask your doctor for advice.
  • 1 tablet missed during Day 1-7

You should take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take tablets at the usual time. In addition check if the ‘Use an additional method of contraception’ symbol (an exclamation mark in a box) is displayed on your Clyk dispenser’s home screen and follow the above instructions. If you have had sex in the week before forgetting the tablet you must realize that there is a risk of pregnancy. In that case, contact your doctor.

• 1 tablet missed during Day 8-24

You should take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take tablets at your usual time. If you have taken your tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case or if you have missed more than 1 tablet, you should

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check if the ‘Use an additional method of contraception’ symbol (an exclamation mark in a box) is displayed on your Clyk dispenser’s home screen and follow the above instructions. If you are unsure what to do, ask your doctor for advice.

• 1 tablet missed during Day 25-120

You may choose either of the following options, without the need for extra contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time until you have taken at least 7 tablets in a row without interruption.

or

2. Stop taking tablets, have a 4-day pill-free break (also count the day you missed your tablet) and continue with a new intake cycle of Yvidually

• If you have forgotten tablets, and you do not have a bleeding during your 4-day pill-free break, you may be pregnant. Contact your doctor before you continue to take the tablets, (see also section “What to do if no bleeding occurs during the 4-day interval”).

What to 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 will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet as soon as possible. If possible take it within 24 hours of when you normally take your pill. If this is not possible or 24 hours have passed, use extra protection (e.g. a condom) for the next 7 days.

If you want to stop taking Yvidually

You can stop taking Yvidually whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Yvidually and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.

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

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

The following is a list of the side effects that have been linked with the use of Yvidually:

Common side effects (affects 1 to 10 users in 100):

• mood swings, depression, decreased interest in or loss of interest in sex
• headache
• migraine
• nausea
• breast pain, problems with your periods, such as irregular periods, absence of periods

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Uncommon side effects (affects 1 to 10 users in 1,000)

• nervousness, sleepiness
• dizziness, ‘pins and needles’
• varicose veins, increased blood pressure
• stomach ache, vomiting, indigestion, intestinal gas, inflammation of the stomach, diarrhoea
• acne, itching, rash
• aches and pains, e.g. back pain, limb pain, muscle cramps
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flushes, inflammation of the vagina (vaginitis), problems with your periods, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear
• lack of energy, increased sweating, fluid retention
• weight increase

Rare side effects (affects 1 to 10 users in 10,000):

• candida (fungal infection)
• anemia, increase in the number of platelets in the blood
• allergic reaction
• hormonal (endocrine) disorder
• increased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood
• failure to experience an orgasm, insomnia
• giddiness, tremor
• eye disorders, e.g. inflammation of the eyelid, dry eyes
• abnormally rapid heartbeat
• inflammation of a vein, nosebleed, fainting
• enlarged abdomen, bowel disorder, feeling bloated, stomach hernia, fungal infection of the mouth, constipation, dry mouth
• pain of bile ducts or the gallbladder, inflammation of the gallbladder
• yellow brown patches on the skin, eczema, hair loss, acne-like inflammation of the skin, dry skin, lumpy inflammation of the skin, excessive hair growth, skin disorder, stretch marks on the skin, skin inflammation, light-sensitive skin inflammation, skin nodules
• difficult or painful sex, inflammation of the vagina (vulvovaginitis), bleeding following intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant lumps in the breast, abnormal growth on the mucosal surface of the neck of the womb, shrinkage or wasting of the lining of the womb, ovarian cysts, enlargement of the womb
• feeling generally unwell
• weight loss

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (rash with target-shaped reddening or sores).

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet or if you think that this may be the case, please tell your doctor or pharmacist.

Keep Yvidually out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

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The tablet dispenser is not watertight and should always be kept dry.

Expiry date

Do not take Yvidually after the expiry date which is stated on the folding box and the blister of the cartridge (see “EXP”). Once you have removed the cartridge from the blister, insert it immediately into the dispenser and take the tablets within 40 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.

What Yvidually contains

• The active substances are ethinylestradiol (as betadex clathrate) and drospirenone. Each tablet contains 0.020 milligram ethinylestradiol (as betadex clathrate) and 3 milligram drospirenone.
• The other ingredients are Tablet core: lactose monohydrate, maize starch, magnesium stearate (E470b), Tablet film-coating: hypromellose (E464), talc (E553b), titanium dioxide (E171) and red iron oxide (E172).

What Yvidually looks like and contents of the pack

• The Yvidually tablet is light pink, round with convex surfaces; one side is embossed with the letters "DS" in a regular hexagon. The tablets are presented in a cartridge which is then packed in a blister.
• The Starter pack for Yvidually contains:

1. carton box with 1 blister containing 1 cartridge with 30 tablets and

1. carton box containing 1 dispenser.

The refill packs for Yvidually contain 1, 3, 4 or 12 blisters, each containing a cartridge with 30 tablets

Marketing Authorisation Holder

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

For information:

Bayer B.V., Postbus 80, 3640 AB Mijdrecht, tel.: 0297 280 666

In case of questions about the use of the tablet dispenser please contact the local BAYER subsidiary.

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Manufacturer
Bayer Pharma AG	and	Bayer Weimar GmbH and Co. KG
Berlin, Germany		Weimar, Germany

In het register ingeschreven onder nummer:

RVG 108807

This medicinal product is authorised in the Member States of the EEA under the following names:

Country	Invented name, strength, and pharmaceutical form
Austria (AT)	Flexyess 0,02 mg/3 mg Filmtabletten
Belgium (BE)	Yvidually 0,02 mg/3 mg filmomhulde tabletten
Bulgaria (BG)	Flexyess 0,02 mg/3 mg филмирани таблетки
Cyprus (CY)	Flexyess 0,02 mg/3 mg επικαλυμμένο με λεπτό
	υμένιο δισκίο
Czech Republic (CZ)	Flexyess 0,02 mg/ 3 mg potahované tablety
Denmark (DK)	Flexyess, 0,02 mg/3 mg, filmovertrukne tabletter
Estonia (EE)	Yvidually, 0,02 mg/ 3 mg õhukese
	polümeerikattega tabletid
Finland (FI)	Flexyess 0,02 mg/3 mg kalvopäällysteiset tabletit
France (FR)	Flexyess 0,02 mg / 3 mg, comprimé pelliculé
Germany (DE)	Yvidually 0,02 mg/3 mg Filmtabletten
Greece (EL)	Flexyess 0,02 mg/3 mg επικαλυμμένο με λεπτό
	υμένιο δισκίο
Hungary (HU)	Flexyess 0,02 mg/3 mg filmtabletta
Iceland (IS)	Flexyess, 0,02 mg/3 mg, filmuhúðaðar töflur
Ireland (IE)	Flexyess 0.02 mg/3 mg film-coated tablets
Italy (IT)	YAZFLEX 0,02 mg/3 mg compresse rivestite con
	film
Latvia (LV)	Yvidually 0,02 mg/3 mg apvalkotās tabletes
Lithuania (LT)	Yvidually 0,02 mg/3 mg plėvele dengtos tabletės
Luxembourg (LU)	Flexyess 0,02 mg/3 mg comprimés pelliculés
Malta (MT)	Flexyess 0.02 mg / 3 mg film-coated tablets
The Netherlands (NL)	Yvidually 0,02 mg/3 mg, filmomhulde tabletten
Norway (NO)	Yalisca, 0,02 mg/3 mg, tabletter, filmdrasjerte
Poland (PL)	Flexyess, 0,02 mg+3 mg, tabletki powlekane
Portugal (PT)	Flexyess 3 mg + 0,02 mg comprimido revestido
	por película
Romania (RO)	Yvidually 0,02 mg/3 mg, comprimate filmate
Slovak Republic (SK)	Flexyess, 0,02 mg/3 mg filmom obalená tableta
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Slovenia (SI)	Flexyess 0,02 mg/ 3 mg filmsko obložene tablete
Spain (ES)	Flexyess 0,02 mg/ 3 mg comprimidos recubiertos
	con película
Sweden (SE)	Flexyess, 0,02 mg/3 mg,, filmdragerade tabletter
United Kingdom (UK)	Flexyess 0.02 mg / 3 mg film-coated tablets

Deze bijsluiter is voor het laatst goedgekeurd in {…}.

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