Calindir

Package leaflet: Information for the user

CALINDIR 0,03 mg/3 mg film-coated tablets

Ethinylestradiol / Drospirenone
Equivalent medicine
Please read all of this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell 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, if 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 CALINDIR is and what it is used for
2. What you need to know before taking CALINDIR

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

3. How to take CALINDIR

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

4. Possible side effects
5. How to store CALINDIR
6. Contents of the pack and other information
1. What CALINDIR is and what it is used for

• CALINDIR 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 CALINDIR

General information
Before starting to use CALINDIR, 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 CALINDIR, 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 must stop taking CALINDIR or in which the safety of CALINDIR may be reduced. In these situations, you must not have sexual intercourse or must use additional non-hormonal contraceptive measures, such as using a condom or another barrier method.
Do not use the rhythm method or basal body temperature method. These methods may be unreliable because CALINDIR alters the monthly fluctuations in body temperature and cervical mucus.
Like other hormonal contraceptives, CALINDIR does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to use CALINDIR
Do not use CALINDIR 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 may be more suitable for your case.
Do not use Calindir:

• 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 that may be an early sign of a heart attack) or a 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 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 your liver function has not yet returned to normal;
• if your kidneys are not working properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or suspect you have a tumour of the breast or genital organs;
• 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 may cause itching, rash or swelling.

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

Additional information for specific populations
Children and adolescents
CALINDIR is not indicated for women whose menstrual cycle has not yet started.

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice

• if you notice possible signs of a blood clot, which may indicate 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”.
Contact your doctor before taking Calindir.

Psychiatric disorders
Some women using hormonal contraceptives, including CALINDIR, 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, 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 must be particularly careful when using CALINDIR or any other combined pill, and your doctor may need to examine you regularly. If any of the following conditions apply to you, inform your doctor before starting CALINDIR. Furthermore, if any of the following conditions affect you, develop, or worsen while using CALINDIR, consult 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 delivery you can start taking Calindir;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Other medicines and Calindir”);
• if you have a condition that first occurred during pregnancy or during previous use of sex steroids (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham’s chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, medicines containing oestrogens may trigger or worsen 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 CALINDIR 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, long-term serious effects may occur, and very rarely, such effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
CALINDIR is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention 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 Deep vein thrombosis in the foot, especially if accompanied by:
  • pain or tenderness in the leg, felt only while standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as paleness, redness, or bluish discoloration.
• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain that worsens 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 more frequently occurring in the eye: Retinal vein thrombosis (blood clot in the eye)

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

Symptoms of heart attack

• pain, discomfort, pressure, or heaviness in the chest;
• squeezing sensation 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;

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, the 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 when restarting a combined hormonal contraceptive (the same medication or a different one) 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 CALINDIR, 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 baseline risk of VTE (venous thromboembolism) 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 CALINDIR 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 CALINDIR, about 9–12 will develop a blood clot in one year.
• The 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 CALINDIR 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 long time due to injury or illness, or if you have a leg in a cast. You may need to stop taking CALINDIR several weeks before surgery or during periods of reduced mobility. If you need to stop taking CALINDIR, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• 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, 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 stop your use of CALINDIR.
If any of the above conditions change while you are using CALINDIR—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 CALINDIR is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as CALINDIR, 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 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 CALINDIR—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.

CALINDIR and cancer
Breast cancer has been observed slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, it is possible that more cancers are diagnosed in women taking combined pills because they see their doctor more frequently. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice 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
During the first few months of taking CALINDIR, 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 medicines, 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 CALINDIR
Always inform your doctor if you are taking other medicines or herbal products. Also inform any other doctor, dentist, or pharmacist who prescribes you another medicine that you are using CALINDIR. They may advise you whether additional contraceptive measures (e.g., condoms) are needed, and for how long, or whether the use of another medicine you may require should be adjusted.
Some medicines:

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

These include:

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

CALINDIR may affect the effect of other medicines, such as:

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

Do not use CALINDIR 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 tests (elevated liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
CALINDIR can be restarted approximately 2 weeks after completing this treatment.
See section “Do not use CALINDIR”.
Ask your doctor or pharmacist for advice before taking any medicine.

CALINDIR with food and drink
CALINDIR can 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 can affect the results of certain tests.

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

Breast-feeding
The use of CALINDIR 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 CALINDIR affects the ability to drive or use machines.

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

3. How to take CALINDIR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one CALINDIR tablet daily, with or without a small amount of water if needed.
You may take the tablets with or without food, but you must take them at approximately the same time each day.
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 "tablet-free interval" or "break week"), your menstrual period should begin.
This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the break week.
On the 8th day after the last CALINDIR tablet (i.e., after the 7-day break), start a new pack, regardless of whether your bleeding has stopped or not. This means you will start each new pack on the same day of the week, and your period will occur on the same days every month.
If you take CALINDIR in this way, you will be protected against pregnancy even during the 7 days when you are not taking tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month
  Start taking CALINDIR on the first day of your cycle (i.e., the first day of your menstrual bleeding). If you start taking CALINDIR on the first day of your period, contraceptive protection is immediate. You may also start taking CALINDIR 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 or from a combined vaginal ring or contraceptive patch
  Start taking CALINDIR preferably the day after the last active tablet (i.e., 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, or from an injectable product at the time 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 an abortion
  Follow your doctor’s advice.

• After childbirth
  You may start taking CALINDIR between day 21 and day 28 after delivery. If you start later than day 28, use a barrier method (e.g., condoms) during the first 7 days of taking CALINDIR. If you have had sexual intercourse after childbirth and before starting (or restarting) CALINDIR, make sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking CALINDIR
  Read the section “Breastfeeding”.

Ask your doctor for advice if you are unsure about when to start.

If you take more CALINDIR than you should
No serious harmful effects have been reported with taking too many CALINDIR tablets.
If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.
Even girls who have not yet had their periods but have accidentally taken this medicine may experience such bleeding.
If you have taken too many CALINDIR tablets or if you find that a child has taken any of the tablets, contact your doctor or pharmacist immediately.

If you forget to take CALINDIR

• If less than 12 hours have passed since your usual intake time, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If more than 12 hours have passed since your usual intake time, 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 tablet at the beginning or end of a pack. Therefore, follow these rules (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. Then 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 the missed tablet, you may be pregnant. In this case, consult your doctor.

• One tablet missed in 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 in 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.
   You will probably not have a menstrual period until the end of the second pack, or you may experience light bleeding or spotting during the second pack.

2. You may also stop taking tablets from the current pack 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 your usual starting day, make the tablet-free interval shorter than 7 days.

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

• If you have missed any tablets in the pack and do not have your period 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 CALINDIR”.

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

How to change the day your period starts: what you need to know
If you take the tablets as instructed, your period will start during the tablet-free week. To change the day your period starts, 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 your new pack 3 days earlier than usual. If you shorten the tablet-free interval considerably (e.g., to 3 days or fewer), you may not have a period during that time. You may instead experience light bleeding or spotting.
If you are unsure what to do, consult your doctor.

If you stop taking CALINDIR
You may stop treatment with CALINDIR 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 CALINDIR and wait for a menstrual period before trying to conceive. This will help you estimate the expected delivery date more accurately.
If you have any doubts about how to use CALINDIR, 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 CALINDIR, tell 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 taking CALINDIR”.

The following side effects have been reported with the use of CALINDIR:

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

• menstrual flow disturbances, intermenstrual bleeding, breast pain, breast tenderness;
• headache, depressed mood;
• migraine;
• nausea;
• thick, whitish vaginal discharge, candidiasis.

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

• breast enlargement, changes in sexual desire;
• high blood pressure, low blood pressure;
• vomiting, diarrhoea;
• acne, skin rash, severe itching, hair loss (alopecia);
• vaginal infection;
• fluid retention and changes in body weight;
• urticaria.

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

• allergic reactions (hypersensitivity), asthma;
• breast secretion;
• hearing impairment;
• skin disorders such as nodular erythema (characterized by painful reddish skin nodules) or erythema multiforme (characterized by target-shaped skin lesions or ulcers);
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, or stroke;
• mini-stroke or temporary symptoms similar to stroke, 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).

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 the following website:
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 CALINDIR

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

6. Package contents and other information

What CALINDIR contains
The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
The other components are:
Tablet core: lactose monohydrate, corn starch, pregelatinized starch (corn),
crospovidone, povidone K-30, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc (E553b), yellow iron oxide (E172).
Description of the appearance of CALINDIR and pack contents
Yellow, round, film-coated tablets.
CALINDIR 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 Spa, L.go U. Boccioni, 1, 21040, Origgio (VA), Italy
Manufacturer responsible for batch release
Laboratorios León Farma, S.A., Pol. Ind. Navatejera. C/ La Vallina s/n 24008 - Villaquilambre,
León, Spain
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany