Ovulastan Forte

Leaflet attached to the packaging: information for the user

Ovulastan Forte, 0.15 mg + 0.03 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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, a doctor or pharmacist should be consulted.
• 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 Forte and what is it used for
• 2. Important information before using Ovulastan Forte
• 3. How to use Ovulastan Forte
• 4. Possible side effects
• 5. How to store Ovulastan Forte
• 6. Contents of the pack and other information

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

Ovulastan Forte 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 a fertilized egg implanting.

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, it is necessary to read the sections "Important information before using Ovulastan Forte" and "How to use Ovulastan Forte" very carefully.

2. Important information before using Ovulastan Forte

General notes

Before starting to take Ovulastan Forte, it is necessary to 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").

When not to use Ovulastan Forte

Ovulastan Forte should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their 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 they have 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 (see section "Blood clots").
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) 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).
• hyperhomocysteinemia
• if the patient has (or has had) a type of migraine called "migraine with aura";
• if the patient has (or has had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood
• if the patient has (or has had) severe liver disease, and liver function has not yet normalized,
• if the patient has (or has had) a liver tumor (benign or malignant),
• if the patient has (or has had) cancer or is suspected of having cancer (e.g., breast cancer or genital cancer), which may depend on 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 Forte and other medicines").

Warnings and precautions

When to exercise special caution when using Ovulastan Forte

In some situations, special caution should be exercised when using Ovulastan Forte or another combined hormonal contraceptive, and regular medical check-ups may be necessary.

When to contact a doctor

A doctor should be contacted immediately

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

To find a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Necessary to tell the doctor if any of the following conditions occur

If these symptoms occur or worsen while using Ovulastan Forte, the doctor should also be informed.

• 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 their 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 recently given birth, as they are at increased risk of blood clots. The doctor should be consulted to determine how soon Ovulastan Forte can be started 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 "Interactions with other medicines"),
• a disease that first appeared or worsened during pregnancy or while taking 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 herpes (a skin rash with blisters that occurs during pregnancy), Sydenham's chorea (a nerve disease that causes sudden movements of the body).

Patients who have experienced symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and difficulty swallowing or hives that may occur with difficulty breathing, should contact their doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood clots

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

How to recognize a blood clot

A doctor should be contacted immediately if any of the following symptoms are noticed.

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• change in skin color of the leg, such as pallor, redness, or cyanosis
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism

Blood clots in veins

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they 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 breaks loose from the leg and travels to 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 veins 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.

What factors increase the risk of blood clots in veins?

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

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

It is essential to inform the doctor if any of these factors are present, even if the patient is unsure. The doctor may decide to stop using Ovulastan Forte.

Blood clots in arteries

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

Similar to blood clots in veins, blood clots in arteries can cause serious consequences, 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 Ovulastan Forte is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.When using a hormonal contraceptive like Ovulastan Forte, it is recommended to quit smoking. If the patient is unable to quit 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 someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or their close relatives have 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 these conditions or if any of them are severe, the risk of a blood clot may be even higher.

Ovulastan Forte and other medicines

The patient should tell the doctor who prescribed Ovulastan Forte about all medicines and herbal products they are currently taking or have recently taken, including those that are available without a prescription.

• 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 infection),
• griseofulvin (an antifungal medicine),
• bozentan (a medicine used to treat high blood pressure in the blood vessels of the lungs)
• St. John's Wort (herbal products). The patient should consult their doctor if they plan to use products containing St. John's Wort while using Ovulastan Forte.

In the case of using medicines or herbal products that may reduce the effectiveness of Ovulastan Forte, it is recommended to use additional barrier methods of contraception. The effect of other medicines on Ovulastan Forte may last up to 28 days, so additional barrier methods should be used for the entire period.

Pregnancy and breastfeeding

Women who are pregnant should not take Ovulastan Forte. If the patient becomes pregnant or suspects they are pregnant while using Ovulastan Forte, they should stop using the medicine and contact their doctor immediately.

Driving and using machines

Ovulastan Forte can be used while driving and operating machines.

Lab tests

The doctor or laboratory staff should be informed 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, they should contact their doctor before taking the medicine.

Children and adolescents

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

3. How to use Ovulastan Forte

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

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

One tablet should be taken every day, following the direction of the arrow printed on the blister, for 21 consecutive days, until the blister is empty.

Then, a 7-day break follows, during which no tablets are taken. During this break, bleeding similar to menstruation occurs, called withdrawal bleeding.

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

As long as Ovulastan Forte 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).

A tablet should be taken every day at the same time. To make using the medicine easier, taking a tablet can be the last thing done in the evening or the first thing done in the morning.

Starting the first pack If no oral contraceptives were used in the previous month

Tablet intake should be started on the first day of the woman's menstrual cycle, i.e., the first day of menstrual bleeding. The tablet marked with the day of the week on which Ovulastan Forte is started should be taken (e.g., if the medicine is started on a Tuesday, the tablet marked with the symbol TU should be taken). The next tablets should be taken daily in the order indicated on the blister, until the blister is empty.

Switching from another combined hormonal contraceptive to Ovulastan Forte

The use of Ovulastan Forte can be started the day after taking the last tablet of the previous combined hormonal contraceptive (this means no break in taking tablets) or after taking the last active tablet.

Switching from a progestogen-only contraceptive to Ovulastan Forte

The switch from an injection can be made on the day the next injection is scheduled. In the case of an implant or intrauterine device (IUD), the switch can be made on the day the implant or IUD is removed. In all cases, if sexual intercourse has taken place, additional contraceptive methods (e.g., a condom) should be used for the first 7 days of tablet intake.

After a miscarriage

The patient should follow the doctor's instructions.

After childbirth, if the woman is not breastfeeding

The doctor will advise the patient to wait for the first menstrual bleeding before starting to use Ovulastan Forte. Sometimes, it may be possible to start earlier. The patient should follow the doctor's instructions.

After childbirth, if the woman is breastfeeding

See the section "Breastfeeding".

What to do if more than one tablet is missed from a blister

The patient should consult their doctor.

What to do if one tablet is missed in the 1st week

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, and additional contraceptive methods (e.g., a condom) should be used for the next 7 days.

What to do if one tablet is missed in the 2nd week

The 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 effectiveness has not been reduced, and there is no need to use additional contraceptive methods.

What to do if one tablet is missed in the 3rd week

One of the following options can be applied. 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, the next blister should be started immediately, without taking a break. 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. The patient can also stop taking the tablets from the current blister and go directly to the 7-day break (the day the tablet was missed should be noted, which corresponds to the first day of the break). If the patient wants to start the next blister on their usual start day, the break should be shorter than 7 days.

Or

• 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

If the patient has missed any of the tablets from the blister and has not had withdrawal bleeding during the first break, it may mean that they are pregnant. In this case, the patient should consult their doctor before starting the next pack.

What to do if vomiting or severe diarrhea occurs

If vomiting or severe diarrhea occurs 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, the patient should take a tablet from a spare blister as soon as possible.

4. Possible side effects

Like all medicines, Ovulastan Forte can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think may be related to the use of Ovulastan Forte, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism).
You should immediately contact a doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may occur with difficulty breathing (see "Warnings and precautions").
To get detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before using Ovulastan Forte".

You should discontinue the use of Ovulastan Forte and immediately contact a doctor if you notice any of the following symptoms that may indicate thrombosis:

• 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.

You should contact a doctor if:

• you experience unusual severe abdominal pain,
• you experience yellowing of the skin,
• you feel 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 Forte 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)
• hives
• fluid retention
• high 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)
• itching
• skin disorder (erythema nodosum, erythema multiforme)
• vaginal discharge
• breast discharge
• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack o blood clots in the liver, stomach/intestine, kidneys, or eye The risk of developing blood clots may be higher if you have 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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, you can help gather more information on the safety of the drug.

5. How to store Ovulastan Forte

Store the medicine in a place inaccessible and invisible to children.
Do not use Ovulastan Forte after the expiry date (EXPIRY DATE):
stated on the carton or blister pack. The expiry date refers to the last day of the given month.
There are no special precautions for storage temperature of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ovulastan Forte contains

The active substances of the drug are desogestrel and ethinylestradiol.
One tablet of Ovulastan Forte contains 30 micrograms of ethinylestradiol and 150 micrograms of desogestrel.
Other ingredients are:
Potato starch; stearic acid; all-rac-α-Tocopherol (E307); lactose monohydrate; povidone K25.

What Ovulastan Forte looks like and what the pack contains

Ovulastan Forte is available in the form of white, round, biconvex tablets.
Each cardboard box 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
Pharbil Waltrop GmbH
Im Wirrigen 25 D-45731 Waltrop
Germany

This product is authorized for marketing 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