Ovulastan

Patient Information Leaflet

Ovulastan, 0.15 mg + 0.02 mg, tablets
Desogestrelum + Ethinylestradiolum
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Ovulastan is and what it is used for

Ovulastan is a combined oral contraceptive medicine, also known as a contraceptive pill. It contains small amounts of two female hormones: desogestrel (a progestogen) and ethinylestradiol (an oestrogen). These hormones are intended to prevent pregnancy. Like natural hormones, they prevent fertilisation during pregnancy by:

• inhibiting the development and release of an egg from the ovary each month (ovulation),
• thickening cervical mucus, making it more difficult for sperm to pass through the cervix and reach the egg,
• altering the shedding of the endometrium, thereby reducing the likelihood of implantation of a fertilised egg.

General information
Oral contraceptives are an effective method of birth control. If taken correctly (without missing a tablet), the chance of becoming pregnant is very low. However, this leaflet describes several situations in which effectiveness may be reduced. Therefore, please read carefully the sections: "Important information before taking Ovulastan" and "How to take Ovulastan".
In such cases, abstain from sexual intercourse or use additional non-hormonal contraceptive methods (such as condoms or spermicides).
Do not use calendar or temperature methods. These methods may be ineffective because Ovulastan disrupts the normal changes in body temperature and vaginal mucus that occur during the menstrual cycle.
Remember that combined oral contraceptives, such as Ovulastan, do not protect against sexually transmitted infections (such as AIDS). Only condoms can provide protection against these infections.

2. Important information before using Ovulastan

General notes
Before starting to take Ovulastan, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before starting treatment with Ovulastan, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual health status, may recommend certain additional tests.

When not to use Ovulastan
Do not use Ovulastan if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have a disorder affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia.
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have (or have previously had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you currently have (or have previously had) severe liver disease and liver function has not yet returned to normal;
• if you currently have (or have previously had) a liver tumour (benign or malignant);
• if you currently have, have previously had, or are suspected of having a hormone-dependent cancer (e.g. breast cancer or reproductive organ cancers);
• unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or desogestrel, or to any of the other ingredients of this medicine (listed in section 6).

if you have hepatitis C virus infection and you are 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 exercise special caution when using Ovulastan
In certain situations, special caution is required when using Ovulastan or another combined hormonal contraceptive, and regular check-ups with your doctor may be necessary.

When to contact your doctor
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Psychiatric disorders:
Some women using hormonal contraceptives, including Ovulastan, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Ovulastan, inform your doctor.

• if you smoke;
• if you are obese;
• if you have high blood pressure;
• if you have a heart valve disorder or heart rhythm disorders (atrial fibrillation);
• if you or your close relatives have:
  • breast cancer;
  • liver or gallbladder disease;
  • diabetes;
  • depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Ovulastan;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins;
• if anyone in your immediate family has had thrombosis, heart attack, or stroke;
• if you have migraines;
• if you have epilepsy (see "Use with other medicines");
• if you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones, such as:
  • itching all over the body (pruritus);
  • jaundice (yellowing of the skin or eyes) not caused by infection;
  • gallstones;
  • systemic lupus erythematosus;
  • haemolytic uraemic syndrome;
  • hearing loss;
  • porphyria (a blood disorder);
  • herpes gestationis (a blistering skin rash occurring during pregnancy);
  • Sydenham's chorea (a nervous system disorder with sudden involuntary movements).

Women who experience symptoms of hereditary or acquired angioedema, such as swelling of the face, tongue, and (or) throat and (or) difficulty swallowing, or urticaria possibly associated with breathing difficulties, should contact their doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Avoid direct exposure to sunlight or ultraviolet light if you have or have ever had chloasma (golden-brown, pigmented patches, known as "melasma", 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 such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders"). Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. Remember that the overall risk of harmful blood clots associated with the use of Ovulastan is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot – deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased temperature in the affected leg;
• change in skin colour of the leg, e.g. paleness, redness, or blueness.

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women not using combined hormonal contraceptives.
If a patient stops taking Ovulastan, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Ovulastan is low.

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Ovulastan is low, however
certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Ovulastan several weeks before surgery or during immobilization. If the patient must stop taking Ovulastan, consult the doctor about when it is safe to resume taking the medicine.
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the last few weeks). The risk of blood clots increases with the number of risk factors present in the patient.

Air travel (>4 hours) may temporarily increase the risk of venous blood clots,
especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Ovulastan.
Inform the doctor if any of the above conditions change during treatment with Ovulastan, e.g. if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Ovulastan is very low, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Ovulastan, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Ovulastan, e.g. if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Oral contraceptives and cancer
Breast cancer has been observed slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. It is not known whether this is caused by the use of oral contraceptives. It is possible that breast cancer is detected earlier in women using these medicines because they are examined more frequently by a doctor due to their treatment. The incidence of breast cancer gradually decreases over a period of 10 years after stopping combined oral contraceptives. Regular breast examinations are important.
Contact the doctor if any lump is detected.
In rare cases, benign liver tumors have been observed in women using oral contraceptives, and even more rarely, malignant liver tumors.

Cervical cancer may be associated with human papillomavirus infection.
It has been noted that cervical cancer occurs more frequently in women who have used combined oral contraceptives for a long time. 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 examinations).

Intermenstrual bleeding
During the first few months of taking Ovulastan, unexpected bleeding may occur, such as bleeding outside the 7-day break period (see section 3 "How to take Ovulastan"). If this bleeding persists for longer than a few months or starts after several months, the doctor must investigate the cause.

What to do if bleeding does not occur during the 7-day break
If all tablets have been taken correctly, there have been no vomiting or severe diarrhea, and no other medicines have been taken concurrently, the likelihood of pregnancy is low. If withdrawal bleeding does not occur consecutively for two cycles, this may indicate pregnancy. Contact the doctor immediately. Do not start the next blister pack until pregnancy has been ruled out.

Ovulastan and other medicines
Inform the doctor who prescribed Ovulastan about all medicines and herbal products currently or recently taken by the patient, including those available without a prescription. Also inform other specialists or dentists who prescribe other medicines (or the pharmacist dispensing the medicine) about the use of Ovulastan. They can advise whether additional contraceptive methods (e.g. condoms) are needed and, if so, for how long.

Some medicines may reduce the effectiveness of Ovulastan 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 (medicines 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),
• bosentan (a medicine used to treat high blood pressure in the pulmonary blood vessels),
• St. John's wort (herbal products). Consult the doctor if the patient intends to use herbal products containing St. John's wort during treatment with Ovulastan.

When taking medicines or herbal products that may reduce the effectiveness of Ovulastan, it is recommended to additionally use barrier contraceptive methods. The effect of other medicines on Ovulastan may last up to 28 days; therefore, additional barrier methods should be used throughout this period.

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, Ovulastan should not be used, as this may lead to increased liver function parameters in blood laboratory tests (elevation of liver enzyme ALT).

Before starting these medicines, the treating doctor will prescribe a different type of contraceptive.
Ovulastan may be restarted approximately 2 weeks after completion of such treatment. See section "When not to use Ovulastan".

Ovulastan may affect the effectiveness of other medicines, such as:

• cyclosporine (a medicine used in organ transplantation),
• lamotrigine (an antiepileptic medicine). Seizures may increase in frequency.
• Medicinal products containing troleandomycin may increase the risk of liver disorders causing gallbladder dysfunction (intrahepatic cholestasis).

Pregnancy and breastfeeding
Ovulastan must not be taken during pregnancy. If the patient becomes pregnant or suspects pregnancy while taking Ovulastan, she should stop taking it and contact the doctor immediately.
Ovulastan should not be used during breastfeeding. If the patient intends to use Ovulastan while breastfeeding, she should consult the doctor.

Driving and operating machinery
It is safe to drive and operate machinery while taking Ovulastan.

Laboratory tests
Inform the doctor or laboratory personnel that you are taking a combined oral contraceptive, as these medicines may affect the results of certain tests.

This medicinal product contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the doctor before taking this medicine.

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

3. How to use Ovulastan

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor. Each Ovulastan pack contains 1, 3, or 6 blisters, each with 21 tablets printed with a calendar.
The calendar blister is designed to help you remember to take your tablet.
The day of the week on which each tablet should be taken is printed on the blister.
Take one tablet daily, following the direction of the arrow printed on the blister, for 21 consecutive
days, until the blister is empty.
Then, take a 7-day break during which no tablets should be taken. During this break, a withdrawal
bleeding, similar to menstruation, usually occurs on the 2nd or 3rd day. This is called withdrawal
bleeding.
On the 8th day (the day after the 7-day tablet-free interval), start taking tablets from the next blister,
even if bleeding has not yet stopped.
As long as Ovulastan is taken correctly, each new blister will always be started on the same day of
the week, and withdrawal bleeding will occur on the same day of the week every month (every 28
days).
Take the tablet at the same time each day. To make taking the medicine easier, the tablet may be
taken as the last evening activity or the first morning activity.
Swallow each tablet whole with water.

Starting the first pack
If you have not used any oral hormonal contraceptives in the previous month
Begin taking tablets on the first day of your menstrual cycle, i.e., the first day of menstrual bleeding.
Take the tablet marked with the day of the week on which you start taking Ovulastan (e.g., if you
start on Tuesday, take the tablet marked TU on the blister). Take the following tablets once daily in
the order indicated by the arrow on the blister until the blister is empty.
If you start taking the tablets between day 2 and day 5 of your cycle, use additional contraceptive
methods (e.g., condoms) for the first 7 days of tablet-taking, but only for the first pack.

Switching from another combined oral hormonal contraceptive to Ovulastan
You may start taking Ovulastan the day after taking the last active tablet of your previous combined
oral contraceptive (this means no break between tablets) or after the last active tablet of your previous
product.
Start taking Ovulastan no later than the first day after the tablet-free interval of the previous product.
If in doubt, consult your doctor.

Switching from a previously used combined vaginal contraceptive ring or transdermal contraceptive
patch (patch) to Ovulastan
Start taking Ovulastan on the day of removal of the vaginal ring or patch, but no later than the day the
next ring or patch would normally be applied.

Switching from a previously used progestogen-only contraceptive (progestogen-only pills, injection,
implant, or intrauterine device (IUD) releasing progestogen) to Ovulastan
Switching from an injection can occur on the day the next injection is due. For an implant or IUD,
switch on the day of removal. In all cases, if sexual intercourse has occurred, use additional
contraceptive methods (e.g., condoms) for the first 7 days of tablet-taking.

After miscarriage
Follow your doctor’s advice.

After childbirth, if not breastfeeding
Your doctor will advise you to wait for the first menstrual bleeding before starting Ovulastan. Sometimes
this may occur earlier. Follow your doctor’s advice.

After childbirth, if breastfeeding
See section “Breastfeeding”.

Taking more Ovulastan than prescribed
There are no reports of serious harmful effects from taking too many Ovulastan tablets. If several
tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. If you take too many
Ovulastan tablets or if a child has swallowed any tablets, contact your doctor or pharmacist for advice.

Missing a dose of Ovulastan

• If you are less than 12 hours late taking a tablet, contraceptive effectiveness is not reduced. Take the missed tablet as soon as you remember, then take the next tablet at your usual time.
• If you are more than 12 hours late taking a tablet, contraceptive effectiveness may be reduced. The greater the number of missed tablets, the higher the risk of reduced protection against pregnancy.

The risk of inadequate protection against pregnancy is greatest if a tablet is missed at the beginning
or end of the blister. In such cases, follow the rules below (see the algorithm below).

• More than one tablet missed from the blister Contact your doctor.
• One tablet missed in week 1 Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following 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 or failed to start the next blister after the break, be aware that pregnancy may have occurred. In such a case, contact your doctor.
• One tablet missed in week 2 Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. From then on, take the remaining tablets at your usual time. Contraceptive effectiveness is not reduced, and there is no need to use additional contraceptive methods.
• One tablet missed in week 3 Follow one of the recommendations below. If you follow either of these, there is no need to use additional contraceptive methods.
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. After finishing the current blister, start the next blister immediately without observing the 7-day tablet-free interval. Withdrawal bleeding will most likely occur at the end of the second blister, but spotting or breakthrough bleeding may occur during the second blister.
  2. You may also stop taking tablets from the current blister and go directly to the 7-day tablet-free interval (note the day the tablet was missed, which corresponds to the first day of the tablet-free interval). If you wish to start the new blister on your usual starting day, the tablet-free interval should be shorter than 7 days.

Missed several
Seek medical advice
tablets from
1 blister
If you forgot to take any of the tablets in the blister and no bleeding occurred during the first tablet-free
interval, you may be pregnant. In this case, consult your doctor before starting the next pack.

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours of taking a tablet, there is a risk that the active
substances have not been completely absorbed. This situation is similar to missing a tablet. After
vomiting or diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take
the tablet within 12 hours of your usual tablet-taking time. If this is not possible or if 12 hours have
already passed, follow the instructions under “Missing a dose of Ovulastan”.

Delaying your period
Yes
In week 1 Did sexual intercourse occur in the
week before the missed tablet?
No

• take the missed tablet
• use a barrier method of contraception (condom) for 7 days Missed
• finish taking tablets from blister 1 tablet (break
• take the missed tablet longer than 12 hours) from blister
• take the missed tablet
• finish the blister
• do not take a 7-day break
• start taking tablets from the next blister

or
in week 3

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

Although not recommended, it is possible to delay the onset of your period (withdrawal bleeding) until
the end of the next blister. To do this, skip the tablet-free interval and start the next blister of
Ovulastan immediately. Spotting (drops or spots of blood) or breakthrough bleeding may occur during
the second blister. Resume regular tablet-taking after observing the correct 7-day tablet-free interval.
Before deciding to delay your withdrawal bleeding, consult your doctor.

Changing the day your period starts
If you take the tablets as directed, your period (withdrawal bleeding) will start during the tablet-free
week. If you wish to change this day, you may do so by shortening (but never lengthening) the tablet-
free interval. For example, if your tablet-free interval starts on Friday and you wish to change it to
Tuesday (3 days earlier), start the new blister 3 days earlier than usual. If the tablet-free interval is very
short (e.g., 3 days or less), bleeding may not occur.
Spotting or breakthrough bleeding may occur.
If you are unsure what to do, consult your doctor for advice.

Stopping Ovulastan
You may stop taking Ovulastan at any time. If you do not wish to become pregnant, consult your
doctor about other methods of birth control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ovulastan may cause adverse effects, although not everyone will experience them. If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Ovulastan, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders).

Immediate medical advice should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria possibly occurring together with breathing difficulties (see section "Warnings and precautions").

For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Ovulastan".

Ovulastan must be discontinued and immediate medical advice sought if any of the following symptoms, which may indicate thrombosis, are observed:

• severe pain and (or) swelling in one leg,
• sudden, severe chest pain that may radiate to the left arm,
• sudden shortness of breath,
• sudden cough without apparent cause,
• any 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, unusual sensations or numbness affecting any part of the body.

Medical advice should be sought if:

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

The following serious adverse effects have been reported in women using contraceptive tablets:

• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• systemic lupus erythematosus (connective tissue disease),
• epilepsy,
• a rash called pemphigoid gestationis,
• blood disorders known as haemolytic uraemic syndrome (a condition in which blood clots damage the kidneys),
• development of brown patches on the face and body (chloasma),
• movement disorders known as Sydenham's chorea,
• gynaecological disorders (endometriosis, uterine fibroids).

Other possible adverse effects
The following adverse effects have been reported in women using contraceptive tablets. These may occur during the first few months of taking Ovulastan and usually resolve as the body adjusts to the contraceptive tablets.

Very common adverse effects (may affect more than 1 in 10 women):

• irregular bleeding

Common adverse effects (may affect up to 1 in 10 women):

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

Uncommon adverse effects (may affect up to 1 in 100 women):

• hearing loss (otosclerosis)
• breast enlargement
• decreased libido
• migraine
• vomiting
• rash (skin eruptions with itching)
• urticaria
• fluid retention
• elevated blood pressure

Rare adverse effects (may affect up to 1 in 1,000 women):

• vaginal candidiasis (fungal infection)
• hypersensitivity (which may present as itching, rash or swelling)
• increased libido
• intolerance to contact lenses
• hair loss (alopecia)
• itching
• skin disorders (nodular erythema, erythema multiforme)
• 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
  • transient ischaemic attack (mini-stroke) or transient ischaemic neurological symptoms known as transient ischaemic attack
  • blood clots in the liver, stomach/intestine, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors increasing the likelihood of blood clots and symptoms of thrombosis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ovulastan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXPIRY DATE:) stated on the carton or blister pack. The expiry date refers to the last day of the stated month.
There are no special storage temperature precautions for this medicinal product.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ovulastan contains
The active substances in Ovulastan are desogestrel and ethinylestradiol.
One tablet of Ovulastan 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 as white, round, biconvex tablets.
Each cardboard box contains 1, 3 or 6 blisters (PVC/Aluminium), each blister containing 21 tablets individually packed in sachets (Aluminium/PE).
Not all pack sizes may be marketed.

Marketing Authorisation 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 for marketing in the European Economic Area member states under the following names:

(1) 150 μg/20 μg
(2) 150 μg/30 μg