Effiprev

PATIENT LEAFLET: INFORMATION FOR THE USER

Effiprev 2 mg/0.03 mg film-coated tablets

dienogest and ethinylestradiol
EQUIVALENT MEDICINE
Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).
• Read this leaflet carefully before taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Effiprev is and what it is used for

Effiprev is a medicine used for:

• Preventing pregnancy (contraceptive pill)
• Treating moderate acne in women who are willing to use a contraceptive pill after failure of appropriate topical treatments or oral antibiotics.

Effiprev film-coated tablets (referred to briefly as Effiprev) is a combined oral contraceptive containing two hormones.

Effiprev contains two types of female sex hormones in small amounts: ethinylestradiol (with effects similar to estrogens) and dienogest (with effects similar to the natural luteal hormone, progesterone). Due to its low hormone content, this medicine belongs to the family of "micro-pills", i.e. combined hormonal contraceptives containing two types of hormones, monophasic, meaning that each tablet contains the same amount of hormones.

2. What you should know before using Effiprev

General notes
Before starting to use Effiprev, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
This Patient Information Leaflet describes various situations regarding when to stop taking Effiprev or when contraceptive effectiveness may be reduced. In these cases, you must abstain from sexual intercourse or use non-hormonal contraceptive methods (e.g. condoms) or another non-barrier contraceptive method. Do not use fertility awareness-based methods or body temperature monitoring, as these methods may be unreliable.
Like other combined oral contraceptives, taking Effiprev does not protect against HIV (AIDS) or other sexually transmitted infections.

Oral contraceptives and risk of cancer
Breast cancer has been observed slightly more frequently in women who use the pill compared to those who do not, although it is not certain whether this is due to taking the pill. Women who use the pill undergo more frequent medical check-ups, so any breast cancer may be detected at an earlier stage than in women not using the pill.
Ten years after stopping the pill, this slight difference disappears.
In rare cases, benign liver tumours—and even more rarely, malignant liver tumours—have been reported in women using the pill. These tumours can cause internal bleeding (abdominal). If you experience severe pain in the upper abdomen, contact your doctor immediately.
Some studies have shown a higher incidence of cervical cancer in women who use the pill for a long time. However, it is not entirely certain that this is caused by the pill, as the incidence of cervical cancer is influenced by many other factors, such as sexual behaviour (e.g. frequent change of partners).
Acne usually improves after three to six months and may continue to improve even after six months of treatment. Discuss with your doctor the need to continue treatment three to six months after starting therapy and periodically thereafter.

Do not use Effiprev:
Do not use Effiprev if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA—temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of forming clots in the arteries:
  o severe diabetes with blood vessel damage, or very high blood pressure, or very high levels of fats (cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinaemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6);
• active severe liver disease, ongoing jaundice, or jaundice in your family history; jaundice or generalized itching may be early signs of liver disease;
• active liver tumour (benign or malignant) or liver tumour in your family history;
• confirmed or suspected cancers of the genital organs or breast;
• unexplained vaginal bleeding;
• pancreatitis or history of pancreatitis if associated with severe hypertriglyceridaemia;
• severe renal insufficiency or acute renal failure;
• if you have hepatitis C and are taking medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see also section “Other medicines and Effiprev”).

If you have any of the conditions listed above, inform your doctor before starting Effiprev.
Your doctor may recommend another type of oral contraceptive pill or a non-hormonal contraceptive method.

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice:

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, refer to section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while using Effiprev, inform your doctor.

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Effiprev;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have diabetes mellitus;
• if you have obesity (body mass index over 30 kg/m²);
• if you have not yet reached full adult height;
• if you have hypertension;
• if you have heart valve disease or heart rhythm disorders;
• if any of your close relatives have had thrombosis, heart attack, or stroke;
• if you suffer from migraine;
• if you suffer from seizures (epilepsy, Sydenham's chorea);
• if you have liver disease or bile disorders;
• if you have jaundice and/or generalized itching;
• if you have a rare disorder of haemoglobin metabolism (porphyria);
• if you have hereditary angioedema;
• if you have endogenous depression. Some women using hormonal contraceptives, including Effiprev, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice;
• if you had a blistering skin rash in the last stage of pregnancy (herpes gestationis);
• if you have hearing problems known as otosclerosis;
• if you have had or have previously had yellowish-brown skin spots, especially on the face (chloasma); if this affects you, avoid exposure to direct sunlight or ultraviolet light;
• if you smoke. Cigarette smoking increases the risk of serious side effects associated with the use of oral contraceptives, such as heart attack and stroke. The risk increases further if you are a heavy smoker and with increasing age.

If you use the pill, stop smoking, especially if you are over 35 years old. If you do not intend to stop smoking, you should use other contraceptive methods, especially if other risk factors are also present.

When medical check-ups are appropriate
Your doctor may recommend regular medical check-ups while you are taking the pill. Depending on your health status and conditions, your doctor will decide the frequency of these check-ups and the type of examinations required.

Contact your doctor as soon as possible if any of the following occur:

• if you notice any change in your health status (particularly check the symptoms described in this leaflet), or if the disorders mentioned in this leaflet occur in a family member;
• if you detect a lump during breast self-examination;
• if you need to take other medicines;
• before any planned surgical procedure or in case of immobilisation (consult your doctor at least 4 weeks beforehand);
• if you experience unusually heavy and irregular vaginal bleeding;
• if you forgot to take one or more pills during the first week of treatment or if you had sexual intercourse within the previous 7 days;
• if withdrawal bleeding does not occur for two consecutive cycles, or if you suspect you are pregnant (combined oral contraceptives may be resumed if your doctor considers it appropriate).

BLOOD CLOTS
Using a combined hormonal contraceptive such as Effiprev increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop:

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Effiprev is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.

Do you have any of these signs? What are you likely suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as pallor, redness, or bluish discolouration
    → Deep vein thrombosis

• sudden and unexplained shortness of breath or rapid breathing

• sudden cough without an obvious cause, possibly with coughing up blood

• sharp chest pain that may worsen when breathing deeply

• severe dizziness

• rapid or irregular heartbeat

• severe stomach pain
  → Pulmonary embolism

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

Symptoms occurring more frequently in an eye:
→ Retinal vein thrombosis

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, the clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Effiprev, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Effiprev is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year. Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• It is not yet known how the risk of developing a blood clot with Effiprev compares to the risk associated with a combined hormonal contraceptive containing levonorgestrel.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Effiprev is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Effiprev several weeks before surgery or during periods of reduced mobility. If you need to stop taking Effiprev, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, particularly if you have other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Effiprev.
If any of the above conditions change while you are using Effiprev—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Effiprev is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Effiprev, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Effiprev—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Other medicines and Effiprev
Do not use Effiprev if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function test results (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Effiprev can be restarted approximately 2 weeks after completion of treatment. See section "Do not take Effiprev".

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may reduce the effectiveness of combined oral contraceptives. One of the first signs of this may be unexpected genital bleeding. These medicines include:

• medicines used to treat epilepsy (e.g. phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate);
• medicines used to treat tuberculosis (e.g. rifampicin);
• antibiotics used to treat fungal infections (e.g. griseofulvin);
• some medicines used to treat HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz);
• the herbal preparation called St. John’s wort (Hypericum perforatum).

Some medicines and grapefruit juice may affect plasma levels of dienogest (e.g. azole antifungals, cimetidine, verapamil, diltiazem, macrolides, antidepressants). Combined oral contraceptives may also reduce the effectiveness of certain medicines, for example, those containing cyclosporine or lamotrigine. The progestogen component may affect the action of certain antihypertensive medicines (drugs that lower blood pressure) and non-steroidal anti-inflammatory drugs.

Inform any doctor prescribing other medicines, as well as your dentist, that you are taking Effiprev. Your doctor will advise you whether you need to use additional non-hormonal contraceptive methods and for how long.
Women undergoing short-term treatment (maximum duration of one week) with the medicines listed above should use additional contraceptive measures, such as a barrier method (e.g. condom), during concomitant administration of the medicine and for 7 days after discontinuation.
Concomitant treatment with rifampicin requires the use of additional contraceptive measures (e.g. a barrier method) during administration of the concomitant medicine and for 28 days after its discontinuation. If concomitant administration continues beyond the end of a pack, the next pack should be started without the usual tablet-free interval.
Inform your doctor if you are taking enzyme-inducing medicines for a prolonged period (also read the package leaflets of other products). In some cases, it may be necessary to choose a non-hormonal contraceptive method.

Pregnancy, breastfeeding and fertility
If you are pregnant or think you might be, do not take Effiprev. If pregnancy occurs while taking Effiprev, the pill should be stopped immediately.
The use of Effiprev during breastfeeding may reduce the volume and alter the composition of breast milk. Small amounts of active substances and/or excipients are excreted in breast milk, with potential effects on the newborn. Therefore, breastfeeding mothers are advised not to take Effiprev.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and use of machines
Effiprev does not affect the ability to drive vehicles or operate machinery.

Effiprev contains lactose
This medicine contains lactose, glucose, and lecithin (from soy). If you are allergic to peanuts or soy, do not use this medicine.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Effiprev

Take Effiprev exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Each pack of Effiprev contains 21, 3x21, 6x21, or 13x21 film-coated tablets. The days of the week on which the film-coated tablets should be taken are indicated on the packaging.
Try to take the tablet at the same time every day, with a drink if necessary. Take one tablet daily, following the direction of the arrows, until you have finished the pack. This is followed by a 7-day interval during which no tablets are taken. During this 7-day tablet-free interval, a withdrawal bleed usually occurs 2–3 days after taking the last tablet.
Start the next pack of Effiprev on the 8th day after taking the last tablet. You must start taking the tablets from the next pack even if bleeding is still ongoing. Each new pack should be started on the same day of the week as the previous one, making it easier to remember when to restart the tablets, and ensuring that your period occurs on the same days each month.
If you follow these instructions exactly, the pill will protect you from unwanted pregnancy starting from the first day of treatment.

Taking the first pack of Effiprev

No hormonal contraceptive used in the previous month:
Take one film-coated tablet, starting on the first day of your menstrual cycle (the first day of menstruation, defined as Day 1), removing from the blister the tablet marked with the correct day of the week.

Switching to Effiprev from a combined contraceptive (combined oral contraceptive, vaginal ring, transdermal patch):
The first film-coated tablet of Effiprev should be taken observing the usual tablet-free interval or on the day immediately following the last active tablet of the previous contraceptive (without a "tablet-free" interval).
If the previously used product contained inactive (hormone-free) tablets, start taking Effiprev after observing the usual placebo tablet interval or immediately after the last active (hormone-containing) tablet of the previous contraceptive. If you are unsure which tablets are active, consult your doctor or pharmacist.
If you previously used a vaginal ring or transdermal patch, start taking Effiprev on the day of removal of the ring or patch, or no later than the day the next application would have been due.

Switching from a progestogen-only contraceptive method (minipill):
Women currently taking progestogen-only minipills may switch to Effiprev at any time, taking the first tablet the day after the last dose of the previous contraceptive (at the usual time). An additional contraceptive method (e.g., barrier methods such as condoms) must be used for the first 7 days of taking the tablets.

Previously used contraceptive injections, contraceptive implants, or an intrauterine system releasing a progestogen (IUS):
Women who used implants or IUS may start on the day the implant or IUS is removed. Women who received contraceptive injections may start taking the film-coated tablets on the day the next injection would have been due. An additional contraceptive method (e.g., barrier methods such as condoms) must be used for the first 7 days of taking the tablets.

After childbirth:
If you have recently given birth, your doctor may advise you to start taking Effiprev after the first menstrual period resumes. However, in some cases, hormonal contraception may be started earlier—consult your doctor for advice. If you take Effiprev, you must not breastfeed unless your doctor tells you it is safe to do so.

After an abortion or miscarriage: Follow your doctor’s instructions.

If you take more Effiprev than you should
There is limited data available on overdose with Effiprev. Based on information from other combined oral contraceptives, toxicity following overdose is very low in both adults and children. Overdose may cause nausea, vomiting, and vaginal bleeding in girls. If you have taken more tablets than recommended, consult your doctor.
If you suspect a child has ingested several tablets, contact your doctor immediately.

If you forget to take Effiprev

If the missed tablet is taken within 12 hours, no additional precautions are necessary. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time. The contraceptive protection of Effiprev is not reduced.

If the missed tablet is not taken more than 12 hours late, contraceptive protection may be reduced. The risk of unintended pregnancy is particularly high if you miss a tablet at the beginning or end of the pack. In this case, follow the instructions below.

If you miss one tablet during the first week:
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day, and continue taking the tablets as usual. Use additional contraceptive methods (e.g., condoms) for the next 7 days. However, if you had unprotected intercourse during the previous 7 days, pregnancy cannot be ruled out. In this case, contact your doctor immediately.

If you miss one tablet during the second week:
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day, and continue taking the tablets as usual. If you have taken the tablets regularly in the previous 7 days, there is no need to use additional contraceptive methods.

If you miss one tablet during the third week:
Provided you have taken the tablets regularly in the previous 7 days, additional contraceptive methods are not required. You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day, and continue taking the tablets as usual. Start the next pack immediately after finishing the current one—do not observe the usual tablet-free interval. Withdrawal bleeding may not occur until the end of the second pack, and you may experience spotting or breakthrough bleeding during tablet intake.
2. The second option is to stop taking tablets from the current pack, observe a tablet-free interval of up to 7 days (including the day(s) the tablet was missed), and then start a new pack. If you wish to start the new pack on your usual day of the week, the tablet-free interval may be shorter than 7 days.

If you miss more than one tablet:
Consult your doctor. Remember that effective contraception is not guaranteed in this case. If several tablets have been missed from the current pack and no withdrawal bleeding occurs during the first tablet-free interval, the likelihood of pregnancy is high. It is recommended to contact your doctor before starting a new pack of Effiprev.

Gastrointestinal disturbances
If you vomit or have severe diarrhoea within 3–4 hours of taking a tablet, the tablet may not have been fully absorbed by the gastrointestinal tract. This situation is similar to missing a tablet. In this case, take a tablet as soon as possible, preferably within 12 hours.
If more than 12 hours have passed, follow the recommendations in the section “If you forget to take Effiprev” regarding missed tablets.

Delaying your period
You can delay the onset of your period by continuing to take Effiprev after finishing the previous pack, without observing the tablet-free interval. Your period can be delayed until the end of the second pack, or for a shorter period if needed. During the intake of the second pack, you may experience spotting or breakthrough bleeding. After finishing the second pack, resume regular use of Effiprev with a 7-day tablet-free interval.

If you wish your menstrual cycle to occur on a different day
If you have always followed the tablet-taking instructions correctly, your period will occur approximately on the same day every four weeks. If you wish your period to start on a different day of the week, you may shorten the tablet-free interval as needed. Never extend the tablet-free interval! For example, if your period usually occurs on Friday but you wish it to occur on Tuesday (three days earlier), start the next pack three days earlier. However, if the tablet-free interval is very short (3 days or less), bleeding may not be fully suppressed, and you may experience spotting or breakthrough bleeding during the second pack.

What to do if you experience bleeding between periods
Some women taking combined oral contraceptives may experience light withdrawal bleeding or spotting, especially during the first few months of use. You may need to use tampons or sanitary pads, but you must continue taking the tablets. Irregular bleeding usually stops once your body adjusts to the tablets—this typically takes about three cycles. If the bleeding persists, becomes heavier, or recurs, consult your doctor.

What to do if withdrawal bleeding does not occur
If you have taken the tablets correctly as instructed, and there has been no vomiting or diarrhoea, pregnancy is very unlikely. Continue taking Effiprev as usual.
If you do not have a period for two consecutive cycles, pregnancy may have occurred. Contact your doctor immediately. You may continue taking Effiprev after performing a pregnancy test, as advised by your doctor.

If you stop taking Effiprev
You may stop taking Effiprev at any time. If you wish to avoid pregnancy, consult your doctor about other reliable contraceptive methods.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Effiprev, tell your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with the use of combined hormonal contraceptives, see section 2, "What you should know before taking Effiprev".

The frequency of side effects has been classified as follows:
Very common: occurs in more than 1 in 10 women treated
Common: occurs in 1 to 10 in 100 women treated
Uncommon: occurs in 1 to 10 in 1,000 women treated
Rare: occurs in 1 to 10 in 10,000 women treated
Very rare: occurs in less than 1 in 10,000 women treated, including sporadic cases and those with unknown frequency.

Women taking hormonal contraceptives have an increased risk of thromboembolism. Certain factors may further increase this risk (see section 2).

Serious side effects
For information on the most serious side effects in women taking combined oral contraceptives, see section "Warnings and precautions". If necessary, seek immediate medical help.

Other possible side effects
In the table below, the side effects of Effiprev are listed in decreasing order of frequency. The frequencies refer to side effects possibly related to Effiprev observed during clinical trials. None of the side effects occurred with "very common" frequency.

The possibility of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
The following adverse effects have been observed in women taking combined oral contraceptives (see section 2, “Warnings and precautions”):

• hypertension;
• liver tumours;
• brownish-yellow patches on the face and body (chloasma);
• development or worsening of diseases whose origin is not completely clear, but which are associated with the use of combined oral contraceptives:
• inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• haemoglobin metabolism disorder (porphyria);
• certain diseases of the immune system (systemic lupus erythematosus);
• skin rash with blisters occurring in the late stages of pregnancy (herpes gestationis);
• seizures, Sydenham's chorea;
• blood coagulation disorder associated with kidney disease (haemolytic-uremic syndrome);
• hereditary angioedema;
• jaundice.

The Pill and Breast Cancer
The risk of breast cancer is slightly increased in women who take combined oral contraceptives. However, since the risk of developing breast cancer in women under 40 years of age is low, the additional number of cases is small when compared to the overall risk of breast cancer.
Sex hormones influence the breast gland. Hormonal changes (e.g. due to the use of hormonal contraceptives) may create conditions in which the sensitivity of breast tissue to other factors promoting cancer development is enhanced, thereby increasing the likelihood of developing cancer. Several studies have shown that the development of breast cancer in middle-aged women is associated with early and prolonged use of combined oral contraceptives.

If you experience any of the adverse effects listed above, consult your doctor or pharmacist. This also applies to any adverse effects not listed in this leaflet.

Reporting of Adverse Effects
If you experience any adverse effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Effiprev

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Effiprev contains - The active substances are: dienogest and ethinylestradiol.
One film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.

• Other components are: Tablet core: monohydrate lactose, magnesium stearate, maize starch, povidone 30, talc. Coating: Opaglos 2 Clear containing: sodium carmellose, glucose, maltodextrin, sodium citrate dihydrate, soybean lecithin.

Description of the appearance of Effiprev and package contents
Effiprev is a white, round, biconvex film-coated tablet.
Effiprev is available in packages containing 21, 3x21, 6x21, 13x21 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EFFIK ITALIA S.p.A
Via dei Lavoratori, 54 - 20092 Cinisello Balsamo (MI)
Manufacturers
Laboratorios León Pharma S.A.
La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre 24008, León, Spain
This medicinal product is authorized in the European Economic Area Member States under the following names:
CZ: Callet 2 mg/0.03 mg, potahovaná tableta
ES: Donabel 2 mg/0.03 mg comprimidos recubiertos con película
PT: Denille comprimido revestido
EE: Ammily 2 mg/0.03 mg
LT: Ammily 2 mg / 0.03 mg plėvele dengtos tabletės
LV: Ammily 2 mg/0.03 mg apvalkotās tabletes
IT: Effiprev 2mg / 0.03 mg
FR: Darelena 2mg / 0.03 mg
LU: Louise 2 mg / 0.03 mg
BE: Louise 2 mg / 0.03 mg