Ovulastan

Leaflet accompanying the packaging: information for the user

Ovulastan, 0.15 mg + 0.02 mg, tablets
Desogestrel+ Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

One should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• One should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ovulastan and what is it used for
• 2. Important information before using Ovulastan
• 3. How to use Ovulastan
• 4. Possible side effects
• 5. How to store Ovulastan
• 6. Contents of the pack and other information

1. What is Ovulastan and what is it used for

Ovulastan is a combined oral contraceptive, also known as the pill. It contains small amounts of two female hormones: desogestrel (progestagen) and ethinylestradiol (estrogen). They are intended to prevent pregnancy. Like natural hormones, they prevent re-fertilization during pregnancy by:

• inhibiting the development and release of an egg from the ovary (ovulation) every month,
• thickening the cervical mucus, making it difficult for sperm to pass through the cervix and reach the egg,
• changing the way the uterine lining sheds, reducing the likelihood of implantation of a fertilized egg.

General information

Oral contraceptives are an effective way to control birth. If the medicine is used correctly (without missing a tablet), the likelihood of becoming pregnant is very low. However, the leaflet describes several situations in which the effectiveness of the medicine may be reduced. Therefore, one should carefully read the sections: "Important information before using Ovulastan" and "How to use Ovulastan".
In such situations, one should refrain from intercourse or use additional non-hormonal methods of contraception (such as condoms or spermicides).
One should not use the calendar or temperature method. These methods may be ineffective because Ovulastan disrupts the temperature changes and vaginal discharge that occur during the menstrual cycle.
One should remember that combined oral contraceptives, like Ovulastan, do not protect against sexually transmitted diseases (such as AIDS). Only condoms can help with this.

2. Important information before using Ovulastan

General notes

Before starting to take Ovulastan, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use Ovulastan, the doctor will ask the patient several questions about her health and that of her close relatives. The doctor will also measure the patient's blood pressure and, depending on the individual state of health, may order some other tests.

When not to use Ovulastan

Ovulastan should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, she should inform her doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows she has a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using Ovulastan for a few weeks before surgery or immobilization. If the patient must stop using Ovulastan, she should ask her doctor when she can resume using the medicine.
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia.
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood
• if the patient has (or has had in the past) severe liver disease, and liver function has not yet normalized,
• if the patient has (or has had in the past) a liver tumor (benign or malignant),
• if the patient has (or has had in the past) or suspects she has a cancer or has a family history of cancer (e.g., breast cancer or genital cancer) that may be influenced by sex hormones,
• unexplained vaginal bleeding,
• if the patient is allergic to ethinylestradiol or desogestrel or any of the other ingredients of this medicine (listed in section 6).

if the patient has a hepatitis C infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Ovulastan and other medicines").

Warnings and precautions

When to be particularly careful when using Ovulastan

In some situations, one should be particularly careful when using Ovulastan or another combined hormonal contraceptive and may need regular check-ups with a doctor.
When should one contact a doctor?
One should contact a doctor immediately

• if the patient notices any of the possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".
Mental disorders:
Some women using hormonal contraceptives, including Ovulastan, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, one should contact a doctor as soon as possible to get further medical advice.
One should tell the doctor if the patient has any of the following conditions.
If these symptoms occur or worsen while using Ovulastan, one should also tell the doctor.

• if the patient smokes;
• if the patient is obese;
• if the patient has high blood pressure;
• if the patient has a heart valve disorder or heart rhythm disorder (atrial fibrillation);
• if the patient or her close relatives have
• breast cancer;
• liver or gallbladder disease;
• diabetes;
• depression;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has just given birth, she is at a higher risk of blood clots. One should consult a doctor to find out how soon she can start using Ovulastan after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if any of the patient's close relatives have had a blood clot, heart attack, or stroke;
• if the patient has migraines; if the patient has epilepsy (see "Using Ovulastan with other medicines"),
• a disease that first appeared or worsened during pregnancy or while using sex hormones, such as:
• itching all over the body (pruritus),
• jaundice (yellowing of the skin or eyes) that was not caused by an infection,
• gallstones,
• systemic lupus erythematosus,
• hemolytic uremic syndrome
• hearing loss,
• porphyria (a blood disorder),
• pregnancy pruritus (a skin rash with blisters that occurs during pregnancy),
• Sydenham's chorea (a nerve disorder that causes sudden movements of the body).

Patients who have experienced symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or hives that may occur with difficulty breathing, should contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary or acquired angioedema.
One should avoid direct exposure to sunlight or ultraviolet light if the patient has or has had chloasma (yellowish-brown pigmentation spots, also known as "pregnancy spots", mainly on the face).

BLOOD CLOTS

Using combined hormonal contraceptives, such as Ovulastan, is associated with an increased risk of blood clots, compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

One should remember that the overall risk of having a harmful blood clot due to using Ovulastan is small.

HOW TO RECOGNIZE A BLOOD CLOT

One should contact a doctor immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• change in the color of the leg skin, such as pallor, redness, or discoloration

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Using combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Ovulastan, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with using Ovulastan is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Ovulastan, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with using Ovulastan is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using Ovulastan for a few weeks before surgery or immobilization. If the patient must stop using Ovulastan, she should ask her doctor when she can resume using the medicine.
• with age (especially over 35);
• if the patient has just given birth. The risk of blood clots increases with the number of risk factors present in the patient.

Air travel (more than 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop using Ovulastan.
One should inform the doctor if any of the above conditions change while using Ovulastan, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Like blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with using Ovulastan is very small, but it may increase:

• with age (over about 35);
• if the patient smokes.While using a hormonal contraceptive like Ovulastan, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in her close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation)
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
One should inform the doctor if any of the above conditions change while using Ovulastan, e.g., if the patient starts smoking, someone in her close family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.
Contraceptive pills and cancer
There have been reports of a slightly increased incidence of breast cancer in women using contraceptive pills, compared to women of the same age who do not use them. It is not known whether this is caused by the contraceptive pills. It is possible that breast cancer is detected earlier in women using these medicines because they are examined by a doctor more often.
The incidence of breast cancer after stopping the use of combined oral contraceptives gradually decreases over a period of 10 years. Regular breast examination is essential.
One should contact a doctor if a lump is detected.
In rare cases, women using contraceptive pills have been reported to have benign liver tumors, and even more rarely, malignant liver tumors.
Cervical cancer may be caused by the human papillomavirus.
It has been reported that cervical cancer occurs more frequently in women using oral contraceptives for an extended period. However, it is not known whether this is due to the use of oral contraceptives, sexual behavior, or other factors (e.g., more frequent cervical screening).

Irregular bleeding

During the first few months of using Ovulastan, unexpected bleeding may occur, e.g., bleeding outside the 7-day break (see section 3 "How to use Ovulastan"). If such bleeding persists for more than a few months or starts after a few months, the doctor should investigate the cause.

What to do if bleeding does not occur during the 7-day break

If all the tablets were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were used, the likelihood of pregnancy is low. If the expected bleeding does not occur twice in a row, it may indicate pregnancy. One should contact a doctor immediately. One should not start the next blister pack until it is certain that the patient is not pregnant.

Ovulastan and other medicines

One should tell the doctor who prescribed Ovulastan about all the medicines and herbal products the patient is currently taking or has recently taken, including those that are available without a prescription. One should also inform other doctors or dentists who prescribe other medicines (or the pharmacist who dispenses the medicine) about the use of Ovulastan. These individuals may provide information on whether additional contraceptive methods are necessary (e.g., condoms) and for how long.
Some medicines may make Ovulastan less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, and felbamate (medicines used to treat epilepsy),
• rifampicin, rifabutin (a medicine used to treat tuberculosis),
• ritonavir, nevirapine, nelfinavir, efavirenz (medicines used to treat HIV infection),
• boceprevir, telaprevir (medicines used to treat hepatitis C virus infection),
• griseofulvin (a medicine used to treat infections),
• bozentan (a medicine used to treat high blood pressure in the lungs)
• St. John's Wort (herbal products). One should consult a doctor if they plan to use products containing St. John's Wort while using Ovulastan.

If the patient is taking medicines or herbal products that may reduce the effectiveness of Ovulastan, it is recommended to use additional barrier methods of contraception. The effect of other medicines on Ovulastan may last for up to 28 days, so one should use additional barrier methods for the entire period.
If the patient has a hepatitis C infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, one should not use Ovulastan, as it may cause an increase in liver function test results (elevation of liver enzyme ALT).
Before starting these medicines, the doctor will prescribe a different type of contraceptive.
Ovulastan can affect the effectiveness of other medicines, such as:

• cyclosporin (a medicine used in transplants),
• lamotrigine (an antiepileptic medicine). The frequency of seizures may increase.
• Medicines containing troleandomycin may increase the risk of liver disorders causing bile duct obstruction (intrahepatic cholestasis).

Pregnancy and breastfeeding

Women who are pregnant should not take Ovulastan. If the patient becomes pregnant or suspects she is pregnant while using Ovulastan, she should stop using the medicine and contact a doctor immediately.
Ovulastan should not be used during breastfeeding. If the patient plans to use Ovulastan while breastfeeding, she should consult a doctor.

Driving and using machines

One can drive and use machines while using Ovulastan.

Lab tests

One should inform the doctor or laboratory staff about the use of a combined oral contraceptive, as these medicines may affect the results of some tests.

This medicinal product contains lactose.

If the patient has been diagnosed with intolerance to some sugars, she should contact a doctor before taking Ovulastan.

Children and adolescents

There are no clinical data on the efficacy and safety of using Ovulastan in children and adolescents under 18 years of age.

3. How to use Ovulastan

This medicine should always be used as directed by a doctor. In case of doubts, one should consult a doctor. Each pack of Ovulastan contains 1, 3, or 6 blisters with 21 tablets with a printed calendar. The blister with a calendar has been designed to help remember to take a tablet.

The blister is printed with the day of the week on which each tablet should be taken.

One should take one tablet each day, following the direction indicated by the arrow printed on the blister, for 21 consecutive days, until the blister is empty.

Then, there is a 7-day break during which no tablets are taken. During this break, bleeding similar to menstruation, called withdrawal bleeding, occurs on the 2nd or 3rd day.

On the 8th day (following the 7-day break), one should start taking tablets from the next blister, even if the bleeding has not stopped yet.

As long as Ovulastan is used correctly, a new blister is always started on the same day of the week, and withdrawal bleeding occurs on the same day of the week every month (every 28 days).

One should take a tablet every day at the same time. To make using Ovulastan easier, one can take the tablet as the last action of the evening or the first action of the morning.
Each tablet should be swallowed whole, with water.

Starting the first pack If the patient did not use oral contraceptives in the previous month

One should start taking tablets on the first day of the menstrual cycle, i.e., the first day of menstrual bleeding. One should take the tablet marked with the day of the week on which Ovulastan is started (e.g., if the patient starts on a Tuesday, she should take the tablet marked with "TU" on the blister). The next tablets should be taken daily in the order indicated on the blister by an arrow, until the blister is empty.
If the patient starts using Ovulastan between the 2nd and 5th day of the cycle, she should also use additional contraceptive methods (e.g., condoms) for the first 7 days of tablet use, but only during the first pack.
Switching from another combined oral hormonal contraceptive to Ovulastan
One can start using Ovulastan the day after taking the last tablet of the previous combined oral contraceptive (this means no break in tablet use) or after taking the last active tablet.
One should start using Ovulastan no later than the day after the break in tablet use of the previous product.
In case of doubts, one should consult a doctor.
Switching from a previously used combined contraceptive vaginal ring or transdermal patch to Ovulastan
One should start using Ovulastan on the day the vaginal ring or patch is removed, but no later than the day the next ring or patch would have been applied.

What to do if too much Ovulastan is taken

There are no reports of serious harmful effects from taking too many Ovulastan tablets at once. If several tablets are taken at the same time, nausea, vomiting, or vaginal bleeding may occur. If too many Ovulastan tablets are taken, or if it is suspected that a child has taken some, one should consult a doctor or pharmacist.

Missed Ovulastan tablets

• If the delay in taking a tablet is less than 12 hours, the contraceptive effect is not reduced. The missed tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If the delay in taking a tablet is more than 12 hours, the contraceptive effect may be reduced. The more tablets that are missed, the higher the risk of reduced protection against pregnancy.

The risk of reduced protection against pregnancy is highest if a tablet is missed at the beginning or end of the blister. In such a situation, one should follow the rules below (see the scheme below).

• More than one tablet is missed from the blisterOne should contact a doctor.
• A tablet is missed in the 1st weekThe missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and additional contraceptive methods (e.g., condoms) should be used for the next 7 days. If intercourse occurred in the week before the missed tablet, one should be aware that there is a risk of pregnancy. In this case, one should contact a doctor.
• A tablet is missed in the 2nd weekThe missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. From that moment on, the remaining tablets should be taken at the usual time. The contraceptive effect has not been reduced, and there is no need to use additional contraceptive methods.
• A tablet is missed in the 3rd weekOne should follow one of the following recommendations. If one of them is chosen, there is no need to use additional contraceptive methods.
• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. After taking the last tablet from the current blister, one should start the next blister immediately, without a break in tablet use. Withdrawal bleeding will most likely occur at the end of the tablets from the second blister, but spotting or breakthrough bleeding may occur while taking the tablets from the second blister.
• 2. One can also stop taking tablets from the current blister and go directly to the 7-day break ( one should note the day the tablet was missed, which corresponds to the first day of the break in tablet use). If the patient wants to start the next blister on her usual start day, the break should be shorter than 7 days.

If the patient misses a tablet and does not have withdrawal bleeding during the first break in tablet use, it may indicate pregnancy. In this case, one should consult a doctor before starting the next pack.

What to do if vomiting or severe diarrhea occur

If vomiting or severe diarrhea occur within 3-4 hours of taking a tablet, there is a risk that the active substances from the tablet may not have been fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhea, one should take a tablet from a spare blister as soon as possible. If possible, the tablet should be taken within 12 hours of the usual time of tablet intake. If this is not possible or 12 hours have already passed, one should follow the instructions in the section "Missed Ovulastan tablets".

Procedure in case of intended delay of menstruation

Missed several
tablets from
1 blister
Seek medical advice
Yes
Did the patient have intercourse in the week before missing the tablet ?
in the 1st week
No

• take the missed tablet
• use a barrier method of contraception (condom) for 7 days
• finish taking the tablets from the blister
• take the missed tablet
• finish taking the tablets from the blister
• take the missed tablet
• finish the blister
• do not take a 7-day break
• start taking tablets from the next blister

or
in the 3rd week

• stop taking the remaining tablets from the blister immediately
• take a break (no more than 7 days, including the day the tablet was missed)
• start taking tablets from the next blister

Although it is not recommended, it is possible to delay the onset of menstruation (withdrawal bleeding) until the end of the next blister. To do this, one should skip the break in tablet use and go directly to a new blister of Ovulastan. While taking tablets from the second blister, spotting or breakthrough bleeding may occur.
Before deciding to delay the onset of bleeding, one should consult a doctor.

4. Possible side effects

Like all medicines, Ovulastan can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Ovulastan, the patient should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism).
The patient should immediately contact a doctor if she experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria that may occur with difficulty breathing (see "Warnings and precautions").
For detailed information on various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before using Ovulastan".

The patient should discontinue the use of Ovulastan and immediately contact a doctor if the following symptoms that may indicate thrombosis are observed:

• severe pain and/or swelling of one leg,
• sudden, severe chest pain that may radiate to the left arm,
• sudden shortness of breath,
• sudden cough without an obvious cause,
• other unusual, severe, or prolonged headache or worsening of migraine,
• partial or complete loss of vision or double vision,
• difficulty speaking or loss of speech,
• dizziness or loss of consciousness,
• weakness, strange feeling, or numbness affecting any part of the body.

The patient should contact a doctor if:

• the patient experiences unusual severe abdominal pain,
• the patient experiences yellowing of the skin,
• the patient feels the presence of any lump.

Below are listed serious side effects reported by patients using oral contraceptives:

• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• systemic lupus erythematosus (connective tissue disease),
• epilepsy,
• herpes gestationis (a skin rash),
• hemolytic-uremic syndrome (a condition in which blood clots cause kidney damage),
• appearance of brown spots on the face and body (chloasma),
• movement disorders called Sydenham's chorea,
• gynecological disorders (endometriosis, uterine fibroids).

Other possible side effects

In the case of women using oral contraceptives, the following side effects have been reported, which may occur in the first few months of using Ovulastan and usually disappear when the body adapts to the oral contraceptives.
Very common side effects(may occur in more than 1 in 10 women):

• irregular bleeding

Common side effects(may occur in up to 1 in 10 women):

• depression or mood changes
• headache
• dizziness
• nervousness
• nausea, abdominal pain
• acne
• absence or irregular vaginal bleeding
• breast tenderness
• breast pain
• weight gain.

Uncommon side effects(may occur in up to 1 in 100 women):

• worsening of hearing (otosclerosis)
• breast enlargement
• decreased libido
• migraine
• vomiting
• rash (skin eruptions with itching)
• urticaria
• fluid retention
• increased blood pressure.

Rare side effects(may occur in up to 1 in 1,000 women):

• vaginal candidiasis (fungal infection)
• hypersensitivity (which may manifest as itching, rash, or swelling)
• increased libido
• intolerance to contact lenses
• hair loss (alopecia)
• pruritus
• skin disorder (erythema multiforme, erythema nodosum)
• vaginal discharge
• breast discharge
• harmful blood clots in a vein or artery, for example:
  in the leg or foot (e.g., deep vein thrombosis)
  in the lungs (e.g., pulmonary embolism)
  heart attack
  stroke
  mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
  blood clots in the liver, stomach/intestine, kidneys, or eye
  The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the use of the medicinal product.

5. How to store Ovulastan

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date (EXPIRY DATE) stated on the carton or blister pack. The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature.
Medicines should not be disposed of via wastewater or household waste. The patient should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ovulastan contains

The active substances of Ovulastan are desogestrel and ethinylestradiol.
One Ovulastan tablet contains 20 micrograms of ethinylestradiol and 150 micrograms of desogestrel.
The other ingredients are:
potato starch; stearic acid; all-rac-α-tocopherol (E307); lactose monohydrate; povidone K25.

What Ovulastan looks like and contents of the pack

Ovulastan is available in the form of white, round, biconvex tablets.
Each carton contains 1, 3, or 6 blisters (PVC/Aluminum) of 21 tablets, packed separately in sachets (Aluminum/PE).
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This product is authorized in the Member States of the European Economic Area under the following names:

• (1)150 μg/20 μg
• (2)150 μg/30 μg

Date of last revision of the leaflet: October 2022