Orlifique

Leaflet accompanying the packaging: patient information

Orlifique, 0.10 mg + 0.02 mg, coated tablets
Levonorgestrel + Ethinylestradiol

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

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 the veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2, "Blood clots").

Table of contents of the leaflet

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

1. What is Orlifique and what is it used for

Orlifique is a contraceptive pill used to prevent pregnancy.
Each pink tablet contains a small amount of two different female hormones:
levonorgestrel (progestagen) and ethinylestradiol (estrogen).
The white tablets do not contain active substances and are called placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.
Orlifique is called a low-dose contraceptive pill because it contains only a small amount of hormones.

2. Important information before taking Orlifique

General notes

Before starting to take Orlifique, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots - see section 2, "Blood clots".
Before you can start taking Orlifique, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, in individual cases, may perform other tests.
This patient leaflet describes several situations in which you should stop taking Orlifique or in which the effectiveness of Orlifique may be reduced.
In such situations, you should not have sexual intercourse or use additional non-hormonal contraceptives, such as condoms or other mechanical methods.
During this time, you should also not use the calendar method or the temperature measurement method.
These methods may be ineffective because Orlifique affects the monthly changes in body temperature and cervical mucus.
When used correctly, the failure rate of combined oral contraceptives is about 1% per year.
The failure rate may increase if tablets are missed or taken incorrectly, in case of gastrointestinal disorders or when taking other medicines or herbal preparations.

Orlifique, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Orlifique:

You should not take Orlifique if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have 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 you have been diagnosed with any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• hyperhomocysteinemia;
• if you have (or have ever had) a certain type of migraine (so-called migraine with aura);
• if you have (or have ever had) severe liver disease and liver function has not returned to normal;
• if you have (or have ever had) liver tumors;
• if you currently have (or have ever had) breast cancer or cancer of the genital organs;

if you have any vaginal bleeding of unknown cause;

• if you are pregnant or think you may be pregnant;
• if you have been diagnosed with hypersensitivity to levonorgestrel or ethinylestradiol, soy, or peanut, azo dyes, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• You should not take Orlifique if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also "Orlifique and other medicines"). If any of these conditions occur while taking Orlifique, you should stop taking the tablets immediately and consult a doctor.

Warnings and precautions

When should you contact your doctor?

• if you notice any symptoms of a blood clot, which may indicate a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To learn about the description of these serious side effects, see the subsection "How to recognize a blood clot".

You should inform your doctor if any of the following conditions apply to you.

In certain situations, you should be particularly careful when taking Orlifique or any other combined contraceptive, and regular medical check-ups may be necessary. If any of the following conditions occur or worsen while taking Orlifique, you should also consult a doctor:

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that damages the kidneys);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Orlifique after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if a close relative has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have epilepsy (see "Orlifique and other medicines");
• if you have a disease that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease that causes uncontrolled body movements (Sydenham's chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face and neck, also known as "pregnancy spots"). In this case, you should avoid direct exposure to sunlight and ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

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

• in the veins (also known as "venous thrombosis" or "venous thromboembolism")
• in the arteries (also known as "arterial thrombosis" or "arterial thromboembolism")

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

RECOGNIZING A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.

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

When is the risk of blood clots in 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.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If you stop taking Orlifique, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your immediate family has had blood clots in the leg, lungs, or other organs at a young age (e.g., under 50). In this case, you may have hereditary coagulation disorders;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Orlifique for a few weeks before surgery or immobilization. If you need to stop taking Orlifique, you should ask your doctor when you can resume taking it.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have other risk factors.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Orlifique.
You should inform your doctor if any of the above conditions change while taking Orlifique, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

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

Similarly 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 heart attack or stroke associated with Orlifique is very small, but it may increase:

• with age (over about 35 years);
• if you smoke.When taking a hormonal contraceptive like Orlifique, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or a close relative have been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Orlifique, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Orlifique and cancer

Women taking combined contraceptives have been found to have a slightly higher incidence of breast cancer, but it is not known whether this is caused by these medicines. It is possible, for example, that more tumors are detected in women taking contraceptives because they visit their doctors more often.
The incidence of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is essential to regularly examine your breasts and contact your doctor if you find any lumps.
Women taking combined contraceptives have rarely been found to have benign liver tumors (non-cancerous) and, in even rarer cases, malignant liver tumors (cancer). You should contact your doctor if you experience severe stomach pain.

Psychiatric disorders

Some women taking hormonal contraceptives, including Orlifique, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking Orlifique, you may experience unexpected bleeding (outside of the week of taking placebo tablets). If bleeding occurs for longer than a few months or if it occurs after several months, you should contact your doctor to determine the cause.

What to do if bleeding does not occur during the placebo tablet period

If you have taken all the pink active tablets correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medicines, it is unlikely that you are pregnant.
If this is not the case or if two consecutive bleedings do not occur, you may be pregnant. In this case, you should contact your doctor immediately, as you will need to rule out pregnancy before continuing to take Orlifique. Before starting the next pack of Orlifique, you should make sure you are not pregnant.

Orlifique and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including herbal products available without a prescription. You should also inform any other doctor, including your dentist, who prescribes another medicine, and your pharmacist who dispenses the medicine, that you are taking Orlifique. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long.
Some medicines may affect the level of Orlifique in your blood and make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin, azole antifungal medicines, such as itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin);
• certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem);
• arthritis, degenerative joint disease (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal medicines containing St. John's Wort (Hypericum perforatum);
• grapefruit juice.

Orlifique may affect the action of other medicines, such as:

• medicines containing cyclosporin (a medicine that reduces the body's immune response);
• the antiepileptic medicine lamotrigine (this may lead to an increased frequency of seizures);
• melatonin (a medicine for insomnia);
• theophylline (a medicine used to treat breathing problems);
• midazolam (a sedative medicine, also used to treat epilepsy);
• tizanidine (a muscle relaxant).

You should not take Orlifique if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results in the blood (increased liver enzyme activity ALT). Before starting these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Orlifique again about 2 weeks after finishing the above treatment. See the section "When not to take Orlifique".
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take Orlifique. If you become pregnant while taking Orlifique, you should stop taking it immediately and contact your doctor. If you plan to become pregnant, you can stop taking Orlifique at any time (see also "Stopping Orlifique").
Before taking any medicine, you should consult your doctor or pharmacist.

Breastfeeding

Orlifique should not be used during breastfeeding, unless your doctor advises you to do so. If you want to take a contraceptive while breastfeeding, you should consult your doctor.

Driving and using machines

There is no information to suggest that taking Orlifique affects your ability to drive or use machines.

Orlifique contains lactose, soy, Allura Red AC (E129), and indigo carmine (E132)

Orlifique contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
Orlifique contains azo dyes - Allura Red AC (E129) and indigo carmine (E132). The medicine may cause allergic reactions.
Orlifique contains soybean oil. Do not take if you are hypersensitive to peanuts or soy.

3. How to take Orlifique

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor. If you are in doubt, you should consult your doctor or pharmacist.
If you were taking another contraceptive before starting Orlifique (a 28-tablet system), remember that most contraceptives contain 21 tablets.
When taking this type of contraceptive, you take the tablets for 21 days, followed by a 7-day break from taking the medicine.
The regimen for Orlifique 28 tablets is different. After taking 21 pink active tablets, you should continue taking the medicine and take 7 placebo tablets. This means that there is no break in taking the tablets, but there is a "placebo" week (a week during which you take the placebo tablets from the 4th row).
Taking the tablets every day, without a break between packs, becomes a routine and thus reduces the risk of forgetting to take a tablet.
The tablets of Orlifique with two different colors are arranged in a blister in a specific order. Each blister contains 28 tablets.
You should take one Orlifique tablet per day, if necessary with a small amount of water. You should take the tablets every day at the same time.
Do not confuse the tablets:you should take the pink tablets for the first 21 days, followed by the white tablets for the next 7 days. You should start a new blister immediately (21 pink, followed by 7 white tablets). You should not take a break between the two blisters.
The blister contains 28 tablets. It is essential to take the medicine every day for 28 consecutive days to maintain the contraceptive effect.
Day-of-the-week stickers are provided with the blisters. You should choose a sticker starting with the day of the week you want to start taking the medicine. You should stick the sticker in the top part of the blister, where indicated by the arrow next to "Place the sticker here". Under each day of the week, you will see a row of tablets. It is essential to take the tablets every day. You should start taking the tablets from the first tablet in the first row, indicated by the word "START".
You should take the tablets according to the direction indicated by the arrows on the blister. First, you should take the pink tablets for 21 days, followed by the white tablets for 7 days, until you have taken all 28 tablets. Then, you should start the next pack.
During the 7 days when you take the white placebo tablets (placebo days), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last pink active tablet of Orlifique.
After taking the last white tablet, you should start the next blister, regardless of whether the bleeding has stopped. This means that each new blister will be started on the same day of the week, and the bleeding should occur on the same days every month.
Taking Orlifique according to these instructions will also protect you from pregnancy during the 7 days of taking the placebo tablets.

When can you start the first blister?

• If you have not taken a hormonal contraceptive in the previous month. You should start taking Orlifique on the first day of your cycle (i.e., on the first day of your menstrual bleeding). If you start taking Orlifique on the first day of your menstrual bleeding, you are immediately protected from pregnancy. You can also start taking Orlifique on days 2-5 of your cycle, but you will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.

If you are not sure when to start taking Orlifique, you should consult your doctor.

• Changing from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or transdermal patch system. You should start taking Orlifique the next day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the tablet-free period of the previous hormonal contraceptive (or after the last tablet of the previous contraceptive that does not contain active substances). When changing from a combined hormonal contraceptive vaginal ring or transdermal patch system, you should start taking Orlifique on the day the ring or patch is removed, or at the latest when the next ring or patch would have been applied.
• Changing from a progestogen-only method (mini-pill, injection, implant, or intrauterine system). You can switch at any time from a progestogen-only pill (from an implant or intrauterine system on the day it is removed, from injections when the next injection would be due), but in all these cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Orlifique.
• After a miscarriage or abortion in the first trimester of pregnancy. You should follow your doctor's advice.
• After childbirth or miscarriage or abortion in the second trimester of pregnancy. You can start taking Orlifique between 21 and 28 days after childbirth or miscarriage or abortion in the second trimester. If you start taking Orlifique later than 28 days, you should use an additional mechanical contraceptive method (e.g., condoms) for the first 7 days of taking Orlifique. If you have had sexual intercourse after childbirth before (re)starting Orlifique, you must first ensure that you are not pregnant or wait for your next menstrual bleeding.
• If you are breastfeeding and want to (re)start taking Orlifique after childbirth. You should read the section "Breastfeeding".

If you are not sure when to start taking Orlifique, you should consult your doctor.
Children and adolescents
Orlifique should not be used before the onset of menstruation.
Women of advanced age
Orlifique should not be used after menopause.
Women with liver function disorders
Orlifique should not be used in women with severe liver disease.
Women with kidney function disorders
If you have kidney function disorders, you should consult your doctor before taking Orlifique.

Overdose of Orlifique

There are no reports of serious harmful effects from taking too many Orlifique tablets. If you take several tablets at once, you may experience nausea and vomiting. In young girls, vaginal bleeding may occur. This type of bleeding can occur even in girls who have not yet started menstruating but have taken the medicine by mistake.
If you take too many Orlifique tablets or if a child swallows them, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Orlifique can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones, or changes in health that the patient considers to be related to the use of Orlifique, the patient should consult a doctor.

Severe Side Effects

The patient should immediately consult a doctor if they experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also "Warnings and Precautions").
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 thrombosis). To get detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2. "Important Information Before Taking Orlifique".
The following is a list of side effects associated with the use of Orlifique:
Common(may occur in less than 1 in 10 women):

• mood swings; depression;
• headache;
• nausea, abdominal pain;
• breast pain or tenderness;
• weight gain.

Uncommon(may occur in less than 1 in 100 women):

• decreased libido;
• rash;
• migraine;
• vomiting, diarrhea;
• itching or raised bumps on the skin;
• breast swelling;
• fluid retention.

Rare(may occur in less than 1 in 1,000 women):

• intolerance to contact lenses;
• allergic reactions;
• increased libido;
• breast discharge or vaginal discharge;
• red skin changes or bumps;
• redness or spots on the skin;
• weight loss;
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (deep vein thrombosis),
• in the lungs (pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or temporary stroke-like symptoms, known as a transient ischemic attack (TIA), or blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

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

Description of Selected Side Effects

The following are very rare side effects or side effects that have occurred with a delay, which are considered to be related to the use of combined oral contraceptives (see also "Contraindications" and "Warnings and Precautions").
Cancers

• in women using combined contraceptives, breast cancer has been slightly more common, but it is not known if this is caused by the medication. It is possible, for example, that more tumors are detected in women using combined contraceptives because they are more likely to have medical check-ups. Since breast cancer is rare in women under 40, the number of diagnoses is small compared to the overall risk of breast cancer.
• liver tumors (benign and malignant).

Other Conditions

• women with high levels of fats in the blood (hypertriglyceridemia) that increase the risk of pancreatitis when using combined oral contraceptives
• high blood pressure
• occurrence or worsening of conditions for which the relationship with combined oral contraceptives is not established: jaundice and/or itching, related to blocked bile flow (cholestasis); gallstones; porphyria (a metabolic disorder that causes abdominal pain and mental disorders); systemic lupus erythematosus (a disease in which the body attacks and damages its own organs and tissues); hemolytic-uremic syndrome (a blood clotting disorder); Sydenham's chorea (a nervous system disorder characterized by rapid, involuntary movements or spasms); pregnancy-related rash (a skin condition that occurs during pregnancy); hearing loss (related to otosclerosis)
• in women with hereditary angioedema (symptoms include sudden swelling, e.g., of the eyes, lips, throat, etc.), products containing estrogen may trigger or worsen angioedema symptoms
• liver function disorders
• in women with diabetes, using the medication may affect blood sugar control. Generally, there is no need to change diabetes treatment while using Orlifique
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• chloasma (skin discoloration, especially on the face and/or neck, known as "pregnancy spots").

Interactions
Unintended bleeding and/or contraceptive failure may result from interactions between other medications and oral contraceptives (e.g., St. John's Wort or medications for epilepsy, tuberculosis, HIV, and other infections). See "Orlifique and Other Medications".

During the Use of Oral Contraceptives, the Following Symptoms May Occur or Worsen

Symptoms:Crohn's disease, ulcerative colitis, migraine, cervical cancer, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (a disease in which the body attacks and damages its own organs and tissues), pregnancy-related rash, Sydenham's chorea (a nervous system disorder characterized by rapid, involuntary movements or spasms), hemolytic-uremic syndrome (a blood clotting disorder), liver diseases, manifested by jaundice, gallbladder disorders, or gallstones, hearing loss.

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Orlifique

The medication should be stored out of sight and reach of children.
There are no special storage instructions for the medication.

Expiration Date

Do not use this medication after the expiration date stated on the packaging and blister pack after: EXP. The expiration date indicates the last day of the given month.
The entry on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT indicates the batch number.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Orlifique Contains

Coated Tablets Containing Active Substances (Pink):

• The active substances of Orlifique are levonorgestrel and ethinyl estradiol. Each pink coated tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinyl estradiol.
• Other ingredients are: Core:lactose, povidone K-30, magnesium stearate; Coating:polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, Allura Red AC (E129) lake, soybean lecithin, iron oxide red (E172), indigo carmine (E132) lake.

Coated Placebo Tablets (White):

Each white coated tablet contains only excipients (no active substances).
Core:lactose, povidone K-30, magnesium stearate;
Coating:polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350.

What Orlifique Looks Like and What the Package Contains

The active substance tablets are pink, round, coated tablets.
The placebo tablets are white, round, coated tablets.
Orlifique is available in blister packs of 28 tablets:
21 pink tablets containing active substances and 7 white placebo tablets.
Orlifique is available in packages containing 1, 3, or 6 blister packs, each with 28 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Laboratorios León Farma, S.A.
C/La Vallina s/n, Pol. Ind. Navatejera,
24008 Navatejera - Leon
Spain
Date of Last Revision of the Leaflet:April 2023