Rubidelle

Package leaflet: Information for the user

Rubidelle 0.02 mg/3 mg film-coated tablets

Ethinylestradiol/drospirenone
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others. It may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

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

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 "Blood clots").

1. What Rubidelle is and what it is used for

• Rubidelle is a contraceptive pill used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white tablets do not contain any active ingredients and are also called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. What you should know before taking Rubidelle

General information
Before starting to use Rubidelle, you must read the information about blood clots in
section 2. It is particularly important that you read about the symptoms of a blood clot
(see section 2 “Blood clots”).
Before taking Rubidelle, your doctor will ask you some questions about your personal
health history and that of your family members. Your doctor will also measure your
blood pressure and, depending on your individual situation, may carry out further tests.
This leaflet describes various conditions that require you to stop using
Rubidelle, or in which the safety of Rubidelle may be reduced. In such situations, you must avoid sexual intercourse or use additional non-hormonal contraceptive measures, for example, use a condom or another barrier method.
Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Rubidelle alters the monthly fluctuations in body temperature and cervical mucus.
Rubidelle, like other hormonal contraceptives, does not protect against
HIV (AIDS) infection or other sexually transmitted diseases.
Do not take Rubidelle
Do not use Rubidelle if you have any of the conditions listed below. If you have any of the
conditions listed below, consult your doctor. Your doctor will discuss with you other
birth control methods that might be more suitable for your situation.

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be confined to bed for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”
• if you have (or have ever had) a liver disease and liver function is still abnormal
• if your kidneys do not work properly (renal failure)
• if you have (or have ever had) a liver tumour
• if you have (or have ever had) or are suspected of having breast or genital organ cancer
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This condition may cause itching, skin rashes, or swelling. Do not use Rubidelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Rubidelle”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Rubidelle.
When should you contact a doctor?
Seek urgent medical advice if:

• you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clots"). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In some situations, you must be particularly careful when using Rubidelle or any other
combined pill, and regular medical check-ups may be necessary.
If any of these conditions appear or worsen while you are using Rubidelle, you must inform your doctor.

• if a close relative has or has ever had breast cancer

• if you have liver or gallbladder disease

• if you have diabetes

• if you suffer from depression

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)

• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)

• if you have sickle cell anaemia (an inherited red blood cell disorder)

• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)

• if you are scheduled for surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”)

• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Rubidelle

• if you have inflammation of the veins under the skin (superficial thrombophlebitis)

• if you have varicose veins

• if you suffer from epilepsy (see also "Other medicines and Rubidelle")

• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)

• if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nerve disorder causing sudden jerky movements (Sydenham’s chorea))

• if you have or have ever had patchy brownish-yellow skin discoloration (chloasma), known as “melasma”, especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation.

• If you have hereditary angioedema, products containing oestrogens may trigger or worsen your symptoms. If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties, seek immediate medical attention.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Rubidelle increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, these effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Rubidelle is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Rubidelle, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Rubidelle is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Rubidelle, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Rubidelle is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Rubidelle several weeks before surgery or during periods of reduced mobility. If you need to stop taking Rubidelle, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Rubidelle.
If any of the above conditions change while you are using Rubidelle—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Rubidelle is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Rubidelle, it is advisable to stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Rubidelle—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Rubidelle and cancer
Breast cancer has been observed slightly more frequently in women using combined pills, but it is not known whether this is due to the treatment. For example, it is possible that more tumors are diagnosed in women taking the combined pill because they undergo more frequent medical check-ups. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you feel any lump.
Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been observed in women using the pill. Contact your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Rubidelle, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Rubidelle, unexpected bleeding (bleeding outside the placebo tablet days) may occur. If this bleeding continues for more than a few months or starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the active pink tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are certain you are not pregnant.

Other medicines and Rubidelle
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Also, tell any other doctor or dentist who prescribes you a medicine (or the pharmacist) that you are taking Rubidelle. They will advise you whether you need to use additional contraceptive measures (e.g., condom) and for how long, or whether the use of another medicine you require needs to be changed.

• Some medicines can affect blood levels of Rubidelle and may reduce its effectiveness in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:
  o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate)
  o tuberculosis (e.g., rifampicin)
  o HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  o fungal infections (e.g., griseofulvin, ketoconazole)
  o arthritis, osteoarthritis (etoricoxib)
  o high blood pressure in the lung vessels (bosentan)
  o the herbal remedy “St. John’s wort”
• Rubidelle may affect the action of other medicines, for example:
  o medicines containing cyclosporine
  o the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures)
  o theophylline (used to treat respiratory problems)
  o tizanidine (used to treat muscle pain and/or muscle cramps)

Do not use Rubidelle if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause an increase in liver function test results in blood tests (increase in liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Rubidelle may be restarted approximately 2 weeks after completing this treatment.
See the section “Do not take Rubidelle”.

Ask your doctor or pharmacist for advice before taking any medicine.

Rubidelle with food and drinks
Rubidelle can be taken with or without food, and if necessary, with a little water.

Laboratory tests
If you are having a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, you must not take Rubidelle. If you become pregnant while being treated with Rubidelle, you must stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking Rubidelle at any time (see also "If you stop taking Rubidelle").
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
The use of Rubidelle is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines
There is no evidence to suggest that Rubidelle affects the ability to drive or use machines.

Rubidelle contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Rubidelle

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The two differently coloured tablets of Rubidelle are arranged in sequence. One blister contains 28 tablets.
Take one tablet of Rubidelle every day, if necessary with a small amount of water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. You must then immediately start a new blister (24 pink tablets followed by 4 white tablets). There is therefore no break between blister packs.
Since the composition of the tablets differs, you must start with the first tablet in the top left corner and take the tablets daily in the correct order.
To follow the correct order, follow the direction of the arrows on the blister.

Preparing the blister pack
To help you keep track, each Rubidelle blister contains 7 adhesive labels, each showing one of the 7 days of the week. Choose the label corresponding to the week starting with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the adhesive label starting with "WED".
Apply the weekly adhesive label along the top edge of the blister, where it says "Place label here", so that the first day of the week appears above the tablet marked "1". This way, each tablet will have a day marked above it, allowing you to visually check whether you have taken a particular tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you take the white placebo tablets (the placebo days), you should experience menstruation (so-called withdrawal bleeding). This usually begins on the second or third day after the last pink active tablet of Rubidelle.
After taking the last white tablet, you must immediately start the next blister pack, regardless of whether your menstruation has stopped or not. This means you must start each new blister pack on the same day of the week, ensuring that your periods occur on the same days every month.
If you take Rubidelle in this way, you are protected against pregnancy even during the 4 days when you take the placebo tablets.

When can you start the first blister pack?

• If you have not used a hormonal contraceptive in the previous month Start taking Rubidelle on the first day of your cycle (i.e., the first day of menstruation). If you start Rubidelle on the first day of your period, contraceptive protection is immediate. You may also start between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive, a combined vaginal ring, or a contraceptive patch Start taking Rubidelle preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the pill-free interval of your previous pill (or after the last inactive tablet of your previous pill). When switching from a combined contraceptive vaginal ring or patch, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUS) You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of removal, from an injectable when the next injection would have been due), but in all these cases you must use additional contraceptive methods (e.g., condoms) for the first 7 days of tablet intake.
• After a spontaneous abortion Follow your doctor's advice.
• After giving birth You may start taking Rubidelle between day 21 and day 28 after giving birth. If you start later than day 28, you must use a so-called barrier method (e.g., condoms) during the first seven days of taking Rubidelle. If you have had sexual intercourse after giving birth but before starting (or restarting) Rubidelle, you must first ensure you are not pregnant or wait until your next menstruation.
• If you are breastfeeding and wish to start (or restart) taking Rubidelle after childbirth Read the section "Breast-feeding".

Consult your doctor if you are unsure about when to start.

If you take more Rubidelle than you should
There are no reports of serious harmful effects following an overdose of Rubidelle tablets.
If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many Rubidelle tablets, or if you discover that a child has taken any tablets, consult your doctor or pharmacist.

If you forget to take Rubidelle
The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, it will not affect the reliability of Rubidelle. Discard the forgotten placebo tablet.
If you forget a pink active tablet (tablets 1 to 24 in the blister), follow the instructions below:

• If the delay in taking a tablet is less than 24 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then continue taking the tablets at your usual time.
• If the delay in taking a tablet is more than 24 hours, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

The risk of incomplete contraceptive protection is greatest if you miss a pink tablet at the beginning or end of the pack. Therefore, follow the instructions below (see also the diagram provided later):

• More than one tablet missed in this pack

Consult your doctor

• One tablet missed between days 1 and 7 (1st row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional contraceptive methods for the next 7 days (e.g., condoms). If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed between days 8 and 14 (2nd row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Contraceptive protection is not reduced, and additional contraceptive methods are not necessary.

• One tablet missed between days 15 and 24 (3rd or 4th row)

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the white placebo tablets of this pack, discard them and immediately start the next pack (your starting day will change).

You will most likely experience menstruation at the end of the second pack—during the intake of the white placebo tablets—but you may also experience light or menstrual-type bleeding during the second pack.

2. You may also stop taking the pink active tablets and proceed directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start the next pack on your usual starting day, take fewer than 4 days of placebo tablets.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablet in the pack and do not have a period during the placebo days, this may indicate that you are pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a pink active tablet or if you have severe diarrhoea, the active ingredients in the tablet may not be fully absorbed by your body. This situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another pink tablet from a spare pack as soon as possible. Ideally, take it within 24 hours of your usual tablet-taking time. If this is not possible, or if more than 24 hours have passed, follow the instructions in the section "If you forget to take Rubidelle".

Delaying menstruation: what you need to know
Although not recommended, it is possible to delay menstruation by not taking the white placebo tablets in the 4th row and instead continuing directly with a new pack of Rubidelle until completion. During use of this second pack, you may experience light or menstrual-type bleeding. Finish this second pack by taking the 4 white tablets from the 4th row. Then start the next pack.
You may consult your doctor before deciding to delay your menstrual cycle.

Changing the day your menstruation starts: what you need to know
If you take the tablets as directed, your periods will start during the placebo tablet days. If you wish to change this day, reduce the number of placebo days (i.e., the days when you take the white placebo tablets)—but never increase them (4 days is the maximum!). For example, if you usually start taking the placebo tablets on Friday and wish to shift this to Tuesday (3 days earlier), you should start the new pack 3 days earlier than usual. Menstruation may not occur during this period. You may subsequently experience light or menstrual-type bleeding.
Consult your doctor if you are unsure what to do.

If you stop taking Rubidelle
You may stop taking Rubidelle at any time. If you do not wish to become pregnant, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Rubidelle and wait for your next menstruation before trying to conceive. This will allow you to calculate your expected delivery date more easily.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Rubidelle, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, TEA) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Rubidelle”.
The following side effects have been reported with the use of Rubidelle.

• Common (may affect up to 1 in 10 people):
  o mood swings, headache, nausea, or breast tenderness; menstrual cycle changes such as irregular or absent periods
• Uncommon (may affect up to 1 in 100 people):
  o depression, nervousness, drowsiness, or dizziness, tingling sensations, migraine, varicose veins, increased blood pressure, or stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea, or acne, itching, skin rash, or pain, e.g. in the back, limbs, muscle cramps, or vaginal fungal infections, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually decreases with continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual disorders, painful periods, scanty menstruation, very heavy periods, vaginal dryness, abnormal cervical mucus secretion, reduced sexual desire, or lack of energy, increased sweating, fluid retention, or weight gain
• Rare (may affect up to 1 in 1,000 people):
  o candidiasis (a fungal infection), anaemia, increased number of platelets in the blood, allergic reaction, endocrine (hormonal) disorder, increased appetite, loss of appetite, excessively high potassium levels in the blood, excessively low sodium levels in the blood, difficulty achieving orgasm, insomnia, dizziness, tremors, eye disorders, e.g. eyelid inflammation, dry eyes, abnormally rapid heartbeat, vein inflammation, nosebleeds, fainting, abdominal enlargement, intestinal disorders, bloating sensation, hiatus hernia, fungal infection of the mouth, constipation, dry mouth, bile duct or gallbladder pain, gallbladder inflammation, yellowish-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, granulomatous skin inflammation, excessive hair growth, skin changes, stretch marks, skin inflammation, photosensitivity-related skin inflammation, skin nodules
  o difficulty having sexual intercourse or pain during intercourse, vaginal inflammation (vulvovaginitis), bleeding after sexual intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth of the cervical mucosa, reduction or impairment of the mucosa lining the uterus, ovarian cysts, uterine enlargement
  o general malaise
  o weight loss
  o harmful blood clots in a vein or an artery, for example:
  • in a leg or foot (DVT)
  • in a lung (PE)
  • heart attack
  • stroke
  • mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys, or eye

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
The following side effects have also been reported, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (skin rash with target-like redness or sores).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rubidelle

Keep this medicine out of the sight and reach of children.
Expiry date
Do not use this medicine after the expiry date stated on the carton and blister after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Rubidelle contains

• The active substances are ethinylestradiol and drospirenone.
• Each active pink film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• The white film-coated tablets do not contain any active substances.
• The other components are:
• Active pink film-coated tablets:
• Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572).
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• Inactive white film-coated tablets:
• Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of Rubidelle and pack contents

• Each Rubidelle blister contains 24 pink film-coated active tablets in rows 1, 2, 3 and 4 of the blister, and 4 white film-coated placebo tablets in row 4.
• Rubidelle tablets, both pink and white, are film-coated tablets; the tablet core is covered with a coating.
• Rubidelle is available in packs containing 1, 3, 6 and 13 blisters, each blister containing 28 (24 + 4) tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA)
Laboratorios León Farma, S.A.
La Vallina, s/n Polígono Industrial Navatejera
24008 León
Spain
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d,
Verovskova 57
1526 Ljubljana
Slovenia
This medicinal product is authorised in EEA Member States under the following
names:
BE Bradley 20 0.02 mg/3 mg film-coated tablets
CZ Nyssiela 3 mg/0.02 mg
DE Eliza HEXAL
DK Stefaminelle
ES Orelle 0.02 mg/3 mg film-coated tablets EFG
FI Stefaminelle
FR ETHINYLESTRADIOL/DROSPIRENONE GNRPHARMA 0.02 mg/3 mg, film-coated tablet
IT RUBIDELLE
NL Drospirenon/Ethinylestradiol 3/0.02 mg 24+4 Sandoz, film-coated tablets
PT Dioz
SE Stefaminelle