Rubira

Patient Information Leaflet

RUBIRA 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, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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 blood clots forming 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”).

Contents of this leaflet:
1. What RUBIRA is and what it is used for
2. What you need to know before taking RUBIRA

• When you must not take RUBIRA
• Warnings and precautions
• Blood clots
• Blood clots in a vein
• Blood clots in an artery
• RUBIRA and cancer
• Breakthrough bleeding
• What to do if your period does not occur during the tablet-free week
• Other medicines and RUBIRA
• RUBIRA with food and drink
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• RUBIRA contains lactose and sodium

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3. How to take RUBIRA

• When to start the first pack
• If you take more RUBIRA than you should
• If you forget to take RUBIRA
• What to do in case of vomiting or severe diarrhoea
• To delay menstruation: what you need to know
• To change the first day of menstruation: what you need to know
• If you want to stop treatment with RUBIRA

4. Possible side effects
5. How to store RUBIRA
6. Contents of the pack and other information
1. What RUBIRA is and what it is used for
RUBIRA is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, drospirenone and
ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined" pills.

2. What you should know before taking RUBIRA

General information
Before starting to use RUBIRA, 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 you start taking RUBIRA, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.

This patient information leaflet describes various situations in which you should stop taking RUBIRA or in which the effectiveness of RUBIRA may be reduced. In these situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive measures, such as a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because RUBIRA alters the monthly fluctuations in body temperature and cervical mucus.
Like other hormonal contraceptives, RUBIRA does not protect against HIV (AIDS)
or other sexually transmitted infections.

When not to take RUBIRA
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Do not take RUBIRA 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 methods of birth control that may be more suitable for your situation.
Do not take RUBIRA:

• 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 about to undergo surgery or will be bedridden 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 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 may increase the risk of arterial blood clots:
• 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 hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) liver disease and liver function has not yet returned to normal;
• 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 suspect you may have a tumour of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.

Do not use RUBIRA if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and RUBIRA”).

Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently:

• 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”.

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

Inform your doctor if any of the following conditions apply to you.
In certain situations, you need to be particularly careful when using RUBIRA or any other combined pill, and your doctor may need to examine you regularly.
If any of these conditions develop or worsen while you are using RUBIRA, 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 systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• 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 about to undergo surgery or will be bedridden 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 childbirth you can start taking RUBIRA;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see “Other medicines and RUBIRA”);
• if you have had a condition for the first time 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 involuntary movements (Sydenham’s chorea));
• if you have or have ever had chloasma (skin discolouration, especially on the face or neck, also known as “pregnancy mask”). In this case, you should avoid direct exposure to sunlight or ultraviolet light;
• if you have hereditary angioedema, products containing oestrogens may trigger or worsen symptoms. You should consult your doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulties.

BLOOD CLOTS
Using a combined hormonal contraceptive such as RUBIRA 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)

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• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such events may be fatal. It is important to remember that the overall risk of a harmful blood clot associated with RUBIRA is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as paleness, redness or bluish discolouration;
• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, inform your doctor, as some of these
symptoms, such as cough or shortness of breath, may be
mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

Symptoms occurring more frequently in an eye: Retinal vein thrombosis
(coagulation in the eye)

• sudden loss of vision or
• painless blurring of vision that may progress to loss of vision

Chest pain, discomfort, pressure or heaviness: Heart attack

• sensation of tightness or fullness in the chest, arm, or under the breastbone;
• feeling of fullness, indigestion, or suffocation;
• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat

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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 may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may 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 first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different product) 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 RUBIRA, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
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The risk depends on your individual baseline risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with RUBIRA 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 RUBIRA, about 9–12 will develop a blood clot in one year.
• Your risk 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 RUBIRA 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 a 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 a cast. You may need to stop taking RUBIRA several weeks before surgery or during periods of reduced mobility. If you need to stop taking RUBIRA, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given 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, particularly if you have any 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 RUBIRA.
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If any of the above conditions change while you are using RUBIRA, 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 RUBIRA is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as RUBIRA, it is advisable to stop smoking. If you are unable to stop smoking and 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 fats 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 RUBIRA—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.

RUBIRA and cancer
Breast cancer has been observed with a slightly higher incidence in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it is possible that more breast cancers are diagnosed in women taking combined pills because they are examined more frequently by their doctor. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you detect a lump.
In rare cases, benign liver tumors have been observed in users of the pill, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

Intermenstrual bleeding
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During the first few months of taking RUBIRA, you may experience unexpected bleeding (bleeding outside the pill-free week). 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 pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and RUBIRA
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctor or dentist who prescribes you a new medicine (or the pharmacist) that you are taking RUBIRA. They will advise you whether you need to use additional contraceptive measures (e.g., condoms), and if so, for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

• affect RUBIRA levels in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include:

• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g., rifampicin), HIV or hepatitis C virus infections (ritonavir, nevirapine, efavirenz—known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), high blood pressure in the pulmonary arteries (bosentan), or the herbal remedy St. John’s wort (Hypericum perforatum).

RUBIRA may also affect the action of other medicines, such as:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (potentially increasing the frequency of seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use RUBIRA if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
RUBIRA may be resumed approximately 2 weeks after completion of this treatment. See section “Do not take RUBIRA”.
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Ask your doctor or pharmacist for advice before taking any medicine.

RUBIRA with food and drink
RUBIRA may be taken with or without food, if necessary with a little water.

Laboratory tests
If you need to have 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
If you are pregnant, do not take RUBIRA. If you become pregnant while taking RUBIRA, stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking RUBIRA at any time (see also "If you wish to stop treatment with RUBIRA").
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
The use of RUBIRA is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There is no evidence to suggest that RUBIRA affects the ability to drive or use machinery.

RUBIRA contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take RUBIRA

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Take one RUBIRA tablet daily, if necessary with a small amount of water. You may take the tablets with or without food, but you should take them every day at approximately the same time.
The pack contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet marked “WED” next to it. Follow the direction of the arrow on the pack until all 21 tablets have been taken.
Then do not take any tablets for 7 days. During these 7 tablet-free days (also called the "interval" or "break"), your menstrual period should begin. This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the break.
On the 8th day after the last RUBIRA tablet (i.e., after the 7-day break), you must start a new pack, regardless of whether your menstrual bleeding has stopped or not. This means you should start each pack on the same day of the week, and your period will occur on the same days every month.
If you take RUBIRA in this way, you will be protected against pregnancy even during the 7 days when you do not take tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month
  Start taking RUBIRA on the first day of your cycle (i.e., the first day of your menstrual bleeding). If you start taking RUBIRA on the first day of your period, contraceptive protection is immediate. You may also start taking RUBIRA between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive or from a combined vaginal ring or contraceptive patch
  Start taking RUBIRA preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the tablet-free interval (or after the last inactive tablet of your previous pill). If you previously used a combined vaginal ring or contraceptive patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS))
  You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable product at the time the next injection would have been due), but in all these cases you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet intake.

• After an abortion
  Follow your doctor’s advice.

• After childbirth
  You may start taking RUBIRA between day 21 and day 28 after childbirth. If you start after day 28, use a so-called barrier method (e.g., a condom) during the first seven days of using RUBIRA. If you have had sexual intercourse after childbirth and before starting (again) to take RUBIRA, ensure that you are not pregnant, or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking RUBIRA after childbirth
  Read the section “Breast-feeding”.
  Ask your doctor for advice if you are unsure about when to start.

If you take more RUBIRA than you should
No serious harmful effects have been reported following an overdose of RUBIRA tablets.
If you take several tablets at once, you may experience nausea or vomiting or vaginal bleeding. Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many RUBIRA tablets or if you find that a child has taken some, consult your doctor or pharmacist.

If you forget to take RUBIRA

• If less than 12 hours have passed since your usual time of intake, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and then continue taking the following tablets at your usual time.

• If more than 12 hours have passed since your usual time of intake, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant. The risk of incomplete contraceptive protection is greatest if you miss a tablet at the beginning or end of the pack. You must therefore follow the rules below (see also the diagram below):

• More than one tablet missed in a pack
  Contact your doctor.

• One tablet missed in the first week
  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 precautions for the next 7 days, for example a condom. If you had sexual intercourse in the week before the missed tablet, you may be pregnant. In this case, consult your doctor.

• One tablet missed during the second week
  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 remains effective, and no additional precautions are necessary.

• One tablet missed during the third week
  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 starting the tablet-free interval, immediately start the next pack.
     Your menstrual period will most likely not occur until the end of the second blister pack, or you may experience light bleeding or spotting during the second pack.

  2. You may also stop taking tablets and go directly to the 7-day tablet-free interval (including the day of the missed tablet in the count). If you wish to start a new pack on the day you usually start, make the tablet-free interval shorter than 7 days. If you follow either of these recommendations, you will remain protected against pregnancy.

• If you have missed any tablets in the pack and do not have a withdrawal bleed during the first tablet-free interval, you may be pregnant. Consult your doctor before starting a new pack.

What to do in case of vomiting or severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours after taking a tablet, there is a risk that the active ingredients have not been completely absorbed by your body. This situation is similar to missing a tablet.
After vomiting or severe diarrhoea, take another tablet as soon as possible from a spare pack.
If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible, or if more than 12 hours have passed, follow the advice given in the section “If you forget to take RUBIRA”.

How to delay menstruation: what you need to know
Although not recommended, you can delay your period by starting a new pack of RUBIRA immediately, without taking the tablet-free interval, and completing that pack.
During use of this second blister pack, you may experience light bleeding or spotting.
Continue with the next blister pack after the usual 7-day break.
You may consult your doctor before deciding to delay your menstruation.

To change the first day of menstruation: what you need to know
If you take the tablets as instructed, your periods will start during the tablet-free week. If you wish to change the day, shorten the number of tablet-free days (but never extend it—7 days is the maximum!). For example, if your tablet-free interval usually starts on Friday and you wish to move it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you greatly shorten the tablet-free interval (e.g., to 3 days or fewer), you may not have a menstrual period during those days. You may instead experience light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

If you wish to stop taking RUBIRA
You may stop taking RUBIRA at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of birth control. If you wish to become pregnant, stop taking RUBIRA and wait for a menstrual period before trying to conceive. This will help you calculate the expected date of delivery more easily.
If you have any doubts about how to use RUBIRA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to RUBIRA, inform your doctor.
There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) 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 using RUBIRA”.

The following is a list of side effects that have been associated with the use of RUBIRA.

Common side effects (may affect 1–10 women in 100):

• mood changes
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
• weight gain

Uncommon side effects (may affect 1–10 women in 1,000):

• candidiasis (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling, dizziness
• vision problems
• irregular or unusually fast heartbeat
• blood clot (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue and throat) and/or difficulty swallowing or single or multiple hives, with or without breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign and malignant), milk production without pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou test or Pap test), reduced sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

Rare side effects (may affect 1–10 women in 10,000):

• asthma
• hearing impairment
• erythema nodosum (characterised by painful reddish skin nodules)
• erythema multiforme (skin rash with target-like or ulcerative lesions)
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA), or 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).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RUBIRA

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
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.
Do not dispose of any medicine 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 RUBIRA contains
The active substances are ethinylestradiol 0.02 mg and drospirenone 3 mg.
The other components are:
Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone K-30,
sodium croscarmellose, polysorbate 80, magnesium stearate.
Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc
(E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of RUBIRA and pack contents
The tablets are pink, round, film-coated.
RUBIRA is available in packs containing 1, 2, 3, 6 and 13 blisters, each blister containing 21
tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA) Italy
Manufacturers
Laboratorios León Farma, S.A.
C/ La Vallina s/n
Polígono Industrial de Navatejera
24008 - Navatejera, León
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
16/17
17/17