Practil

PACKAGE LEAFLET

Package leaflet: information for the user

Practil 0.15 mg + 0.03 mg tablets

desogestrel/ethinylestradiol

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, particularly 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 may be experiencing symptoms of a blood clot (see section 2, "Blood clots").

Please read this leaflet carefully before taking this medicine, as 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 others, even if they have the same symptoms as you, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Practil is and what it is used for

Composition and type of pill
Practil is a combined oral contraceptive pill. Each tablet contains a small amount of two different female hormones: desogestrel (a progestogen) and ethinylestradiol (an oestrogen).
Due to its low hormone content, Practil is considered a low-dose oral contraceptive. Since all tablets in the pack contain the same hormones in the same dosage, Practil is classified as a monophasic combined oral contraceptive.
Why use Practil
Practil is used to prevent pregnancy.
When used correctly (without missing any tablets), the likelihood of pregnancy is very low.

2. What you should know before taking Practil

General notes
Before starting to take Practil, 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").

Do not take Practil
Do not take Practil 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 contraceptive methods that might be more suitable for your case.

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a blood vessel in the leg (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE), or in 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 about to undergo surgery or if you will be bedridden for a prolonged period (see "Blood clots");
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain which may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of developing blood clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you currently have or have previously had pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood;
• if you have jaundice (yellowing of the skin) or a serious liver disease;
• if you have or have ever had a cancer that can grow under the influence of sex hormones (e.g. of the breast or genital organs);
• if you have or have ever had a liver tumour;
• if you have any vaginal bleeding of unknown origin;
• if you have endometrial hyperplasia (abnormal growth of the inner lining of the uterus);
• if you are pregnant or suspect you may be pregnant;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Other medicines and Practil").

If any of these conditions occurs for the first time while you are taking the pill, stop taking it immediately and inform your doctor. In the meantime, use non-hormonal contraceptive methods. See also section "General notes".

Warnings and precautions
Talk to your doctor or pharmacist before taking Practil.

General notes
This patient information leaflet describes certain situations in which you must stop taking the pill or in which its effectiveness may be reduced. In these situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods. These methods may not be reliable because the pill alters the normal changes in body temperature and cervical mucus that occur during the menstrual cycle.

When should you contact a doctor?
Contact a doctor urgently if:

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

For a description of the symptoms of these serious side effects, refer to section "How to recognize a blood clot".

Practil, like all combined oral contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Practil should not normally be used to delay a menstrual period. However, if in exceptional cases it is necessary to delay a period, contact your doctor.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are taking Practil, inform your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have a heart valve disorder or certain heart rhythm disorders;
• if you have inflammation of veins just under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if close family members have had blood clots, heart attack, or stroke;
• if you suffer from migraine;
• if you suffer from depression;
• if you suffer from epilepsy;
• if you have liver or gallbladder disease;
• 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 about to undergo surgery or if you 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 Practil;
• if any of your close family members have had breast cancer;
• if you have conditions that first appeared or worsened during pregnancy or during previous treatment with sex hormones (e.g. hearing loss, a condition called porphyria, a skin disease called pemphigoid gestationis, or a condition called Sydenham's chorea);
• if you have or have ever had chloasma (brownish-yellow patches on the skin, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet rays.

If any of the above conditions appears for the first time, or reappears or worsens during use of the pill, consult your doctor.

The pill and thrombosis

BLOOD CLOTS
Taking a combined hormonal contraceptive such as Practil increases the risk of developing a blood clot compared to not taking 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, these effects can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have one of these signs? What might you be 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 paleness, redness, or bluish discolouration
• 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 or lightheadedness
• rapid or irregular heartbeat
• severe stomach pain

If you are unsure, contact 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 the eye: Retinal vein thrombosis

• sudden loss of vision or
• painless blurring of vision that may progress to vision loss

Chest pain: Heart attack

• pain, discomfort, pressure, or heaviness in the chest
• sensation of tightness or fullness in the chest, arm, or under the breastbone
• fullness, indigestion, or choking sensation
• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach
• sweating, nausea, vomiting, or dizziness
• extreme weakness, anxiety, or shortness of breath
• rapid or irregular heartbeat

Sudden numbness or weakness of the face, arm, or leg, especially on one side of the body
Sudden confusion, difficulty speaking or understanding
Sudden difficulty seeing with one or both eyes
Sudden difficulty walking, dizziness, loss of balance or coordination
Sudden, severe or prolonged headache without known cause
Stroke

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 can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can 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 first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart a combined hormonal contraceptive (the same medicine or a different one) 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 Practil, 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 VTE (venous thromboembolism) 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 Practil 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.
• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as Practil, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot 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 Practil is low, but certain conditions can increase it. Your risk is higher:

• if you are significantly 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 may have an inherited blood clotting disorder;
• if you are scheduled for surgery or must remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Practil several weeks before surgery or during periods of reduced mobility. If you need to stop taking Practil, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases when you have multiple such conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of blood clot formation, especially if you have any of the 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 discontinue your use of Practil.
If any of the above conditions change while you are using Practil—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 may 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 Practil is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Practil, it is advisable to stop smoking. If you are unable to quit 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 have high levels of fat 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 Practil—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.
Very rarely, thrombosis can lead to serious permanent disability or be fatal.

The Pill and Cancer
Breast cancer is diagnosed slightly more frequently in women using the pill compared to those who do not. This slight increase in risk gradually disappears over the 10 years following discontinuation of the pill. It is not known whether the pill causes this difference. It could be due to the fact that women are examined more frequently, making it more likely that breast cancer is diagnosed earlier.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been observed in women using the pill. These tumors can cause internal bleeding. Contact your doctor immediately if you experience any severe abdominal pain.
Cervical cancer is caused by human papillomavirus (HPV) infection. It is more common in women who use the pill for long periods. It is not known whether this is due to the use of hormonal contraceptives, sexual behavior, or other factors (such as more frequent cervical screening).

Psychiatric Disorders
Some women using hormonal contraceptives, including Practil, 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, consult your doctor as soon as possible for further medical advice.

Children and Adolescents
Clinical data on efficacy and safety in adolescents under 18 years of age are not available.

Other Medicines and Practil
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors or dentists (or pharmacist) who prescribe other medicines that you are taking Practil, so they can advise whether additional contraceptive precautions (e.g., a condom) are needed, for how long, or whether the use of another required medicine should be modified.
Do not use Practil if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as these products may cause increases in liver function blood tests (elevated ALT liver enzymes).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Practil may be resumed approximately 2 weeks after completion of such treatment. See section “Do not take Practil.”

Some medicines

• may affect blood levels of Practil
• may reduce contraceptive effectiveness
• may cause unexpected bleeding
  These include medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the lung blood vessels (bosentan);
• depressive mood (herbal remedy St. John’s wort).

If you are taking medicines or herbal products that may reduce the effectiveness of Practil, you must also use a barrier contraceptive method. Since the effect of other medicines on Practil may last up to 28 days after discontinuation, you must use an additional barrier contraceptive method throughout this period.

Practil may affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Laboratory Tests
If you require a blood test, inform your doctor or laboratory that you are taking the pill, as oral contraceptives may influence the results of certain blood tests.

Pregnancy and Breast-feeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Practil must not be used by pregnant women or women who suspect they are pregnant. If you suspect you are pregnant while taking Practil, stop treatment immediately and contact your doctor as soon as possible.

Breast-feeding
The use of Practil is not recommended during breast-feeding. If you wish to take the pill while breast-feeding, consult your doctor.

Driving and Use of Machines
Practil does not affect the ability to drive vehicles or operate machinery.

Practil contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

When to Contact Your Doctor
Regular Check-ups
While using the pill, your doctor will ask you to attend periodic check-ups. You should generally have a check-up at least once a year.

Contact your doctor as soon as possible if:

• you notice any change in your health, particularly related to what is reported in this leaflet (see also sections “Do not take Practil” and “What you need to know before taking Practil”). Do not forget changes in the health status of your close family members;
• you detect a breast lump;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties;
• you need to take other medicines (see also section “Other medicines and Practil”);
• you are to be immobilized or undergo surgery (inform your doctor at least 4 weeks in advance);
• you experience heavy and unusual vaginal bleeding;
• during the first week you missed taking the tablets in the pack and had sexual intercourse in the preceding 7 days;
• you suffer from severe diarrhoea;
• you have missed two consecutive menstrual periods or suspect you are pregnant (do not start a new pack without first consulting your doctor).

Stop taking the tablets and contact your doctor immediately if you notice
possible signs of thrombosis such as:

• unusual cough;
• severe chest pain that may radiate to the left arm;
• shortness of breath;
• unusual, severe, or prolonged headache or a migraine attack;
• partial or complete loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in one leg.

For further information, see the section “The Pill and Thrombosis” in this leaflet.

3. How to take Practil

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

When and how to take the tablets

The Practil pack contains 21 tablets, each marked with the day of the week on which it should be taken.
Take one tablet every day at approximately the same time, with a little water if necessary. Follow the direction of the arrows until all 21 tablets are used.
Do not take any tablets during the following 7 days.
Your menstrual period should occur during these 7 days (withdrawal bleeding). It usually starts 2–3 days after taking the last tablet of Practil.
Start the new pack on the eighth day, even if your menstrual bleeding has not yet stopped. By doing so, you will always start the new pack on the same day of the week, and withdrawal bleeding will generally occur on approximately the same days each month.

Use in children and adolescents

There are no clinical data available on the efficacy and safety of Practil in adolescents under 18 years of age.

How to start the first pack of Practil

• If you have not used any hormonal contraceptive pill in the previous month: Start taking Practil on the first day of your cycle, i.e. the first day of your menstrual bleeding, taking the tablet marked with that day of the week. Then continue in the order indicated by the arrows. Practil is effective immediately, so you do not need additional contraceptive methods.

You may also start between the second and fifth day of your cycle, but in this case you must use an additional contraceptive method (barrier method) for the first 7 days of tablet intake during the first cycle.

• Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch): You may start taking Practil the day after the last active pill of the previous contraceptive (i.e. without any pill-free interval). If the previous pack also contains inactive tablets, you may start Practil the day after taking the last active tablet (in case of doubt, consult your doctor or pharmacist). You may start later, but not later than the day after the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you are using a vaginal ring or transdermal patch, it is preferable to start taking Practil on the same day the ring or patch is removed. You may also start, at the latest, on the day scheduled for the next application of the ring or patch.

If you have used the pill, patch, or ring correctly and are certain you are not pregnant, you may stop taking the previous method or remove the ring or patch on any day and start using Practil immediately.
If you follow these instructions, additional contraceptive methods are not required.

• Switching from a progestogen-only pill (mini-pill): You may stop taking the mini-pill on any day and start taking Practil the following day at the same time. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) during the first 7 days of taking Practil.
• Switching from a progestogen-only injectable contraceptive, a progestogen-only implant, or a progestogen-releasing intrauterine system (IUS): You may start taking Practil on the day the next injection is due, or on the day the implant or IUS is removed. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) during the first 7 days of taking Practil.
• After childbirth: Your doctor may advise you to wait until your first normal menstrual cycle before starting Practil. Sometimes it may be possible to start earlier. Your doctor will give you specific instructions. If you are breastfeeding and wish to use Practil, discuss this with your doctor first.
• After a spontaneous or induced abortion: Your doctor will give you instructions.

If you take more Practil than you should

No serious harmful effects have been reported after taking multiple tablets of Practil at once. If you take more tablets than prescribed, you may experience nausea, vomiting, or vaginal bleeding.
If you find that a child has taken Practil, contact your doctor for advice.

If you forget to take Practil

WHAT TO DO IF…

…you forget to take tablets

If less than 12 hours have passed since the usual time of intake, the reliability of the pill is maintained. Take the missed tablet as soon as you remember, and then continue taking the tablets as usual.

If more than 12 hours have passed since the usual time of intake, the contraceptive reliability may be reduced. The greater the number of consecutive missed tablets, the higher the risk that contraceptive protection is reduced.
The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. Therefore, follow the instructions below (see also the chart that follows).

If you have missed more than one tablet in a pack
Contact your doctor for advice.

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) and continue as usual. Use additional contraceptive methods (barrier methods) for the next 7 days.
If you had sexual intercourse during the week before the missed tablet, there is a possibility of pregnancy. 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) and continue as usual. Contraceptive protection is maintained. No additional contraceptive measures are needed.

If you miss one tablet during the third week
You may choose one of the following options, without needing additional contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack immediately after finishing the current one, without any interval between packs. Withdrawal bleeding may not occur until the end of the second pack, and you may experience intermenstrual bleeding (spotting) or breakthrough bleeding during the second pack. Or
2. Stop taking tablets from the current pack, observe a pill-free interval of 7 days or less ( including the day of the missed tablet ), and then start a new pack. If you choose this option, you may start the new pack on the same day of the week as usual. If you have missed one or more tablets in a pack and do not have menstrual bleeding during the first pill-free interval, pregnancy may have occurred. In this case, contact your doctor before starting the new pack.

……if you experience gastrointestinal disturbances (such as vomiting or severe diarrhoea)
If you vomit or have severe diarrhoea, the active ingredients in Practil may not be completely absorbed. If you vomit within 3–4 hours of taking a tablet, this situation is similar to missing a tablet. You must follow the instructions for missed tablets. If you have severe diarrhoea, contact your doctor.

……if you wish to delay the onset of menstruation
You can delay the start of your period by starting a new pack of Practil immediately after finishing the current one. You may continue taking tablets from the new pack for as long as desired, up to the end of the second pack. When you wish your period to start, stop taking the tablets. During use of the second pack, you may experience breakthrough bleeding or spotting while taking the tablets. Start the next pack after the usual 7-day pill-free interval.

……if you wish to change the day your period starts
If you take the tablets correctly, your period will occur approximately on the same day every 4 weeks. If you wish to change this day, you should only shorten (never extend) the next pill-free interval. For example, if your periods usually start on Fridays and you wish them to start on Tuesdays (3 days earlier), you should start the next pack 3 days earlier than usual. If you shorten your pill-free interval significantly (e.g. to 3 days or less), you may not have bleeding during that interval. You may experience breakthrough bleeding or spotting during the next pack.

……if you have unexpected bleeding
With all oral contraceptives, during the first few months of use, you may experience irregular vaginal bleeding (spotting or breakthrough bleeding) between periods. You may need to use sanitary protection, but you should continue taking the tablets as usual. Irregular bleeding usually stops once your body has adjusted to the pill (usually after about 3 months). Consult your doctor if bleeding persists, becomes heavy, or recurs frequently.

……if your period does not occur
If you have taken all tablets correctly, have not vomited, and have not taken other medicines, it is very unlikely that you are pregnant. Continue taking Practil as usual.
If you do not have a period for two consecutive cycles, pregnancy may have occurred. Contact your doctor immediately. Do not start a new pack of Practil until your doctor has ruled out pregnancy.

If you stop taking Practil

If you have any doubts about using this medicine, consult your doctor or pharmacist.
You may stop taking Practil at any time. If you still wish to avoid pregnancy, consult your doctor for advice on alternative methods of birth control.
If you wish to stop taking Practil in order to become pregnant, wait for a natural menstrual period before trying to conceive. This will help you determine the expected date of delivery.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Practil, inform 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 taking combined hormonal contraceptives, see section 2 "What you need to know before taking Practil".
Serious reactions associated with the use of the pill and their symptoms are described in the sections "The pill and thrombosis" and "The pill and cancer".

Common (may affect up to 1 in 10 people):

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• weight gain

Uncommon (may affect up to 1 in 100 people):

• fluid retention
• decreased sexual desire
• migraine
• vomiting, diarrhoea
• skin reactions, urticaria
• breast enlargement

Rare (may affect more than 1 in 1,000 people):

• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood 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).

• hypersensitivity reactions
• increased sexual desire
• intolerance to contact lenses
• nodular erythema, erythema multiforme (skin disorders)
• breast discharge, vaginal discharge
• weight loss

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

1. How to store Practil

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not freeze.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the carton after “Exp”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any colour changes in the tablets, tablet crumbling, or any other visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Practil contains

• The active substances are: desogestrel (0.150 mg) and ethinylestradiol (0.030 mg).
• The other components are: anhydrous colloidal silica, monohydrate lactose, potato starch, povidone, stearic acid, alpha-tocopherol.

Description of the appearance of Practil and contents of the pack
Practil is available in 1 blister containing 21 tablets, packed in a box.
The tablets are biconvex, round, 6 mm in diameter, marked with "TR5" on one side and
"Organon*" on the other side.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy
Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, the Netherlands