Ovulastan forte

Package leaflet: Information for the user

Ovulastan Forte, 0.15 mg + 0.03 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 developing blood clots in veins and arteries, especially during the first year of use or after restarting the medication following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please contact your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms appear identical.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Ovulastan Forte is and what it is used for

Ovulastan Forte is a combined oral contraceptive medicine, also known as a "birth control 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 during pregnancy, they prevent fertilization by:

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

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

2. Important information before using Ovulastan Forte.

General notes
Before starting to take Ovulastan Forte, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use Ovulastan Forte, 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 Forte
Do not use Ovulastan Forte 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 contraceptive method 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 blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require 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 that 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 have (or have previously had) a type of migraine called "migraine with aura";
• if you have (or have previously had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you have (or have previously had) severe liver disease and liver function has not yet returned to normal;
• if you have (or have previously had) a liver tumour (benign or malignant);
• if you have, have had, or are suspected of having a hormone-dependent cancer (e.g. breast cancer or reproductive organ cancer);
• 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 are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Ovulastan Forte and other medicines").

Warnings and precautions
When to exercise particular caution when using Ovulastan Forte
In certain situations, particular caution is required when using Ovulastan Forte or another combined hormonal contraceptive, and regular medical check-ups may be necessary.

When should you contact your doctor?
You should contact your doctor immediately:

• if you notice possible symptoms of a blood clot, 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 events, 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, in some cases, may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

You should inform your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Ovulastan Forte, you should also 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 body's 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 family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Ovulastan Forte;
• if you have superficial thrombophlebitis (inflammation of 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");
• any condition that first occurred or worsened during pregnancy or previous use of sex hormones, such as:
  • generalized itching (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),
  • pemphigoid gestationis (a blistering skin rash occurring during pregnancy),
  • Sydenham's chorea (a nervous system disorder involving 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 accompanied by 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 Forte 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 events").

Complete 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 caused by using Ovulastan Forte is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience 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 warmth in the affected leg;
• change in skin colour of the leg, e.g. paleness, redness, or blueness;
• sudden unexplained shortness of breath or rapid breathing—pulmonary embolism;

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). 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 the development of 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is highest 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 who do not use combined hormonal contraceptives.
If a woman stops taking Ovulastan Forte, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots?
The risk depends on the woman'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 Forte is low.

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

Factors increasing the risk of venous blood clots
The risk of venous blood clots associated with the use of Ovulastan Forte 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 had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue the use of Ovulastan Forte several weeks before surgery or immobilization. If the patient must stop taking Ovulastan Forte, she should consult her doctor about when it is safe to resume treatment.
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks). The risk of venous blood clots increases with the number of risk factors present. Air travel (>4 hours) may temporarily increase the risk of venous blood clots, particularly if the patient has another risk factor listed above.

It is important to inform the doctor if any of these factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Ovulastan Forte.
The patient should inform her doctor if any of the above conditions change during treatment with Ovulastan Forte, for example, if a close family member develops thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to 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 Forte is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Ovulastan Forte, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, 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 high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of arterial blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Ovulastan Forte, for example, if she starts smoking, if a close family member develops unexplained thrombosis, or if she gains significant weight.

Oral contraceptives and cancer
Breast cancer has been observed slightly more frequently in women using oral contraceptives compared to 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 drugs because they undergo more frequent medical examinations. The incidence of breast cancer gradually decreases over a 10-year period after stopping combined oral contraceptives. Regular breast examinations are important. The patient should contact her doctor if she detects any lump.

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 (HPV) infection. It has been noted that cervical cancer occurs more frequently in women who have used 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 screening).

Intermenstrual bleeding
During the first few months of taking Ovulastan Forte, unexpected bleeding may occur, such as bleeding outside the 7-day tablet-free interval (see section 3 “How to use Ovulastan Forte”). If such bleeding persists for longer than a few months or starts after several months of use, the doctor must investigate the cause.

What to do if bleeding does not occur during the 7-day tablet-free interval
If all tablets have been taken correctly, without vomiting or severe diarrhea, and no other medications have been used, the likelihood of pregnancy is low. If the expected withdrawal bleeding does not occur for two consecutive cycles, pregnancy may be possible. The patient should contact her doctor immediately. She should not start the next blister pack until pregnancy has been ruled out.

Ovulastan Forte and other medicines
The patient should inform the doctor who prescribed Ovulastan Forte about all currently or recently used medicines and herbal products, including those available without a prescription. She should also inform other doctors, dentists, or pharmacists prescribing other medicines (or dispensing medicines) that she is using Ovulastan Forte. These healthcare providers 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 Forte 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). The patient should consult her doctor before using herbal products containing St. John’s wort while taking Ovulastan Forte.

When using medicines or herbal products that may reduce the effectiveness of Ovulastan Forte, it is recommended to use additional barrier contraceptive methods. The effect of other medicines on Ovulastan Forte 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 Forte should not be used, as this may lead to increased liver function test parameters in blood laboratory tests (elevated liver enzyme ALT).
Before starting these treatments, the treating doctor will prescribe a different type of contraceptive.
Ovulastan Forte may be restarted approximately 2 weeks after completing this treatment. See section “When not to use Ovulastan Forte”.

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

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

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

Ovulastan Forte should not be used during breastfeeding. If the patient intends to use Ovulastan Forte while breastfeeding, she should consult her doctor.

Driving and using machines
The patient may drive and operate machinery while taking Ovulastan Forte.

Laboratory tests
The patient should inform her doctor or laboratory personnel that she is 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 her 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 take Ovulastan Forte

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor. Each package of Ovulastan Forte contains 1, 3, or 6 blisters, each with 21 tablets printed with a calendar. The calendar blister has been 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 every day, following the direction indicated by 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, withdrawal bleeding, similar to menstruation, will usually occur on day 2 or 3.
On the eighth day (the day after the 7-day break), start taking tablets from the next blister, even if bleeding has not yet stopped.
As long as Ovulastan Forte is used 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 as 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 the woman’s menstrual cycle, i.e., the first day of menstrual bleeding. Take the tablet marked with the day of the week on which you started taking Ovulastan Forte (e.g., if you start taking the medicine on Tuesday, take the tablet marked “TU” on the blister). Then continue taking one tablet daily in the order indicated by the arrow on the blister until the blister is empty.
If you start taking the medicine between day 2 and day 5 of the cycle, you should also use another method of contraception (e.g., condom) for the first seven days of tablet use, but only for the first pack.

Switching from another combined oral hormonal contraceptive to Ovulastan Forte
You may start taking Ovulastan Forte the day after taking the last active tablet of the previous combined oral contraceptive (this means no break between tablets) or after the last active tablet.
Start taking Ovulastan Forte 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 contraceptive vaginal ring or transdermal system (patch) to Ovulastan Forte
Start taking Ovulastan Forte 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.

Switching from a previously used progestogen-only product (progestogen-only pills, injection, implant, or progestogen-releasing intrauterine system (IUD)) to Ovulastan Forte
Switching from an injection can be done 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., condom) for the first 7 days of tablet use.

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 Forte. Sometimes it may be possible earlier. Follow your doctor’s instructions.

After childbirth, if breastfeeding
See section “Breast-feeding”.

Taking more Ovulastan Forte than prescribed
There are no reports of serious harmful effects from taking too many Ovulastan Forte tablets. If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. If an overdose of Ovulastan Forte tablets is taken, or if a child has swallowed any tablets, seek advice from a doctor or pharmacist immediately.

Missed dose of Ovulastan Forte

• If the delay in taking the tablet is less than 12 hours, contraceptive effectiveness is not reduced. Take the missed tablet as soon as you remember, then continue taking the next tablets at the usual time.
• If the delay in taking the tablet is more than 12 hours, 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 outlined below (see the algorithm below).

• More than one tablet missed from the blister – Consult 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 remaining tablets at the usual time and use additional contraceptive methods for the next 7 days (e.g., condom). If you had sexual intercourse in the week before missing the tablet or failed to start the next blister after the break, be aware that there is a risk of pregnancy. In such a case, consult 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. Continue taking the remaining tablets at the usual time. Contraceptive effectiveness is not reduced, and there is no need to use additional contraceptive methods.

One tablet missed in week 3
Apply one of the following recommendations. If you follow either of them, 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 the usual time. After taking the last tablet of the current blister, immediately start the next blister without observing the tablet-free interval. Withdrawal bleeding will most likely occur at the end of the second blister, but spotting or breakthrough bleeding may also occur during the second blister.
2. Alternatively, stop taking tablets from the current blister and proceed 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 the woman wishes to start the new blister on her usual starting day, the tablet-free interval should be shorter than 7 days.

Missed tablets from
1 blister
Seek medical advice
If the woman forgot to take any tablet from the blister and no bleeding occurred during the first tablet-free interval, this may indicate pregnancy. In such a case, consult a doctor before starting the next pack.

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs within 3–4 hours after 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 a 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 “Missed dose of Ovulastan Forte”.

Yes
In week 1 Did sexual intercourse occur in the week before
missing the tablet?
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 the 7-day break
• start taking tablets from the next blister

or
in week 3

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

Postponing the menstrual period
Although not recommended, it is possible to delay the onset of menstruation (withdrawal bleeding) until the end of the next blister. To do this, skip the tablet-free interval and proceed directly to the next blister of Ovulastan Forte. During the second blister, spotting (drops or spots of blood) or breakthrough bleeding may occur. Resume regular tablet-taking after observing a proper 7-day tablet-free interval.
Before deciding to delay the onset of bleeding, consult your doctor.

Changing the first day of menstruation
If the woman is taking tablets as directed, menstruation (withdrawal bleeding) will occur during the tablet-free week. If she wishes to change this day, she may do so by shortening (but never lengthening) the tablet-free interval. For example, if the tablet-free interval starts on Friday and the woman wishes to change it to Tuesday (3 days earlier), she should 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 the woman is unsure how to proceed, she should consult her doctor for advice.

Stopping Ovulastan Forte
Ovulastan Forte may be discontinued at any time. If the woman does not wish to become pregnant, she should consult her doctor about alternative 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 Forte may cause adverse effects, although not everyone experiences
them. If any adverse effects occur, especially severe or persistent ones, or changes in health status
that the patient considers related to the use of Ovulastan Forte, 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 attention 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 in
swallowing, or urticaria possibly occurring together with difficulty in breathing (see section
"Warnings and precautions").
For detailed information on various risk factors associated with the use of combined hormonal
contraceptives, refer to section 2, "Important information before using Ovulastan Forte".
The use of Ovulastan Forte 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 which 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 unusually severe abdominal pain,
• the patient develops yellowing of the skin,
• the patient detects the presence of any lump.

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

• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• systemic lupus erythematosus (connective tissue disease),
• epilepsy,
• a skin rash called pemphigoid gestationis,
• blood disorders known as haemolytic-uraemic syndrome (a condition in which blood clots cause kidney damage),
• 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 using Ovulastan Forte and usually resolve as the body adapts
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 or irregular vaginal bleeding
• breast tenderness
• breast pain
• weight gain

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

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

Rare adverse effects (may affect 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)
• 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 or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye
    The likelihood of developing 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 blood clots).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the 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 Forte

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

6. Contents of the package and other information

What Ovulastan Forte contains
The active substances in this medicine are desogestrel and ethinylestradiol.
Each tablet of Ovulastan Forte contains 30 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 Forte looks like and contents of the pack
Ovulastan Forte 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
Poland

Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Pharbil Waltrop GmbH
Im Wirrigen 25, D-45731 Waltrop
Germany

This product is authorised for marketing in the European Economic Area countries under the following names:

(1) 150 μg/20 μg
(2) 150 μg/30 μg