Securgin

Package leaflet: Information for the user

SECURGIN 0.15 mg + 0.02 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 blood clots forming in the 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SECURGIN is and what it is used for

Composition and type of pill
SECURGIN 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, SECURGIN is considered a low-dose oral contraceptive. Since all tablets in the pack contain the same hormones in the same dosage, SECURGIN is classified as a monophasic combined oral contraceptive.
Why use SECURGIN
SECURGIN 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 SECURGIN

General notes
Before starting to take SECURGIN, you must read the information about blood clots in
paragraph 2. It is particularly important that you read about the symptoms of a blood clot (see
paragraph 2 “Blood clots”).
Do not take SECURGIN
Do not take SECURGIN 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 components of this medicine (listed in paragraph 6);
• if you have (or have ever had) a blood clot in a blood vessel 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 due 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 stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which 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 could increase the risk of clots forming 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 hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer or have previously suffered from 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 severe liver disease (liver disease);
• if you have or have ever had a cancer that may grow under the influence of sex hormones (e.g. breast or genital organs);
• if you have or have ever had a liver tumour;
• if you have any type of 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 (see also paragraph “Other medicines and Securgin”).

If any of these conditions occurs for the first time while using the pill, stop taking it immediately and
inform your doctor. In the meantime, use non-hormonal contraceptive methods. See also paragraph “General notes”.
Warnings and precautions
Talk to your doctor or pharmacist before taking SECURGIN.
General notes
This leaflet describes some situations in which you must stop taking the pill or in which the pill’s effectiveness may be reduced. In these situations, you should not have sexual intercourse or must use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. 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 signs of a possible 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, go to the section “How to recognize a blood clot”.

SECURGIN, like all combined oral contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.
SECURGIN should not normally be used to delay menstruation. 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 occurs or worsens while you are using SECURGIN, 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 near the skin surface (superficial thrombophlebitis);
• If you have varicose veins;
• If you have a family history of thrombosis, heart attack, or stroke in close relatives;
• 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 due to undergo surgery or if you will be bedridden for a prolonged period (see paragraph 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 SECURGIN;
• If any of your close relatives has had breast cancer;
• If you have conditions that first appeared or worsened during pregnancy or previous treatment with sex hormones (e.g. hearing loss, a disease called porphyria, a skin condition called herpes gestationis, 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, reappears, or worsens during use of the pill, consult your doctor.
Pill and thrombosis
BLOOD CLOTS
Using a combined hormonal contraceptive such as SECURGIN 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 can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
SECURGIN 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 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, felt only when standing or walking
• increased warmth in the affected leg
• change in skin colour of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath or rapid breathing Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up of 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, 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 infection (e.g. a “common cold”).
Symptoms occurring more frequently in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless blurring of vision that may progress to loss of vision
• pain, discomfort, pressure, or heaviness in the chest Heart attack
• feeling of tightness, fullness, or pressure in the chest, arm, or under the breastbone
• feeling of fullness, indigestion, or suffocation
• 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

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 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, a 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 in which you
start taking a combined hormonal contraceptive for the first time. The risk may also be higher
if you restart taking 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 SECURGIN, 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 on 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 SECURGIN 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 a 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 a year.
• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as SECURGIN, about 9–12 will develop a blood clot in a 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 SECURGIN is low, but certain conditions can increase it. 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, illness, or if you have a leg in a cast. You may need to stop taking SECURGIN several weeks before surgery or during periods of reduced mobility. If you need to stop taking SECURGIN, 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) can temporarily increase the risk of blood clot formation, especially if you have any of the other risk factors listed above.
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 SECURGIN.
If any of the above conditions change while you are using SECURGIN—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 SECURGIN is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as SECURGIN, 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 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 SECURGIN—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 cause serious permanent disability or be fatal.

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 10 years after stopping the pill. It is not known whether the pill causes this difference. It could be due to the fact that women using the pill are examined more frequently, making early diagnosis of breast cancer more likely.
Rarely, benign liver tumors have been observed in women using the pill, and even more rarely, malignant ones. 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 a long time. It is not known whether this is due to hormonal contraceptive use, sexual behavior, or other factors (such as better cervical monitoring).

Psychiatric disorders
Some women using hormonal contraceptives, including SECURGIN, have reported depression or depressed mood. Depression can be severe and 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
No clinical data on efficacy and safety are available for adolescents under 18 years of age.

Other medicines and SECURGIN
Always inform your doctor about any medicines or herbal products you are currently using. Also inform any other doctors, dentists, or pharmacists prescribing other medicines that you are taking SECURGIN, so they can advise whether additional contraceptive precautions (e.g., a condom) are needed and for how long, or whether the use of another medicine you require should be adjusted.
Do not use Securgin if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increased liver function blood test values (elevated liver enzymes ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Securgin can be resumed approximately 2 weeks after completing such treatment. See section “Do not take Securgin”.
Some medicines:

• may affect blood levels of SECURGIN;
• 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);
• depression (herbal remedy St. John’s wort).

If you are taking medicines or herbal products that may reduce the effectiveness of SECURGIN, you must also use a barrier contraceptive method. Since the effect of other medicines on SECURGIN may last up to 28 days after stopping them, you must use an additional barrier contraceptive method throughout this period.
SECURGIN may affect the action of other medicines, for example:

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

Laboratory tests
If you need 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 breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Breastfeeding
The use of SECURGIN is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.

Driving and using machines
SECURGIN does not affect the ability to drive vehicles or operate machinery.

SECURGIN 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-up visits. 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 SECURGIN” and “What you need to know before taking SECURGIN”). Do not forget changes in the health status of your close relatives;
• you feel a lump in your breast;
• 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 SECURGIN”);
• you need to be immobilized or undergo surgery (inform your doctor at least 4 weeks in advance);
• you experience heavy or unusual vaginal bleeding;
• during the first week you missed taking tablets from the pack and had sexual intercourse in the previous 7 days;
• you suffer from severe diarrhea;
• you have missed your periods for two consecutive cycles or suspect pregnancy (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 spread 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 “Pill and thrombosis” in this leaflet.

3. How to take SECURGIN

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 SECURGIN 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 period should occur during these 7 days (withdrawal bleeding). It usually starts 2–3 days after
taking the last SECURGIN tablet.
Start the new pack on the eighth day, even if your period has not yet finished. By doing so, you will
always start the new pack on the same day of the week, and withdrawal bleeding will occur
approximately on the same days each month.

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

Starting the first pack of SECURGIN

• If you have not used any hormonal contraceptive pill in the previous month: Start taking SECURGIN on the first day of your cycle, i.e. the first day of your period, taking the tablet marked with that day of the week. Continue in the order indicated by the arrows. SECURGIN is effective immediately. Therefore, 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 SECURGIN the day after the last active pill of your previous contraceptive, without any pill-free interval. If your previous contraceptive pack contains inactive tablets, you may start SECURGIN the day after the last active tablet (in case of doubt, ask your doctor or pharmacist). You may also start later, but not later than the day after the pill-free interval (or the day after the last inactive tablet) of your previous contraceptive. If you are using a vaginal ring or transdermal patch, it is preferable to start SECURGIN on the same day the ring or patch is removed. You may also start, at the latest, on the day the next ring or patch application would normally occur.

If you have used the pill, patch, or ring correctly and are sure you are not pregnant, you may stop taking the pill or remove the ring or patch on any day and start using SECURGIN immediately.
If you follow these instructions, you do not need to use additional contraceptive methods.

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

If you take more SECURGIN than you should
No serious harmful effects have been reported after taking multiple SECURGIN tablets at once. If you have taken several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding.
If you find that a child has taken SECURGIN, contact a doctor for advice.

If you forget to take SECURGIN
WHAT TO DO IF…
…you forget to take your tablets
If less than 12 hours have passed since your usual intake time, the reliability of the pill is maintained. Take the missed tablet as soon as you remember, then take the following tablets at your usual time.
If more than 12 hours have passed since your usual intake time, 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 following scheme).
If you have missed more than one tablet in a pack
Contact your doctor for advice.
If you missed 1 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 missed 1 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 remains effective. No additional contraceptive measures are needed.
If you missed 1 tablet during the third week
You may choose one of the following alternatives, 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, but you may experience intermenstrual bleeding (spotting) or breakthrough bleeding during the second pack.
   or
2. Stop taking the tablets in 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 can start the new pack on the same day of the week as you normally do.

If you have missed one or more tablets in a pack and do not have your period during the first pill-free interval, pregnancy may have occurred. In this case, you must contact your doctor before starting the next pack.

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

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

……if you wish to change the day your period starts
If you take your tablets correctly, your period will occur approximately on the same day every 4 weeks. To change this day, you should only shorten (never extend) the next pill-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday (3 days earlier), begin 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 must continue taking your 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 SECURGIN as usual.
If you miss two consecutive periods, pregnancy may have occurred. Contact your doctor immediately. Do not start a new pack of SECURGIN until your doctor has ruled out pregnancy.

If you stop taking SECURGIN
If you have any doubts about using this medicine, consult your doctor or pharmacist.
You may stop taking SECURGIN 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 SECURGIN in order to become pregnant, wait for a natural menstrual period before trying to conceive. This will help you determine your due date when you become pregnant.

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 SECURGIN, 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 SECURGIN”.
Serious reactions associated with the use of the pill and their related 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), in a lung (PE), heart attack, stroke, mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, 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 diseases)
• nipple discharge, vaginal discharge
• weight loss.

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

5. How to store SECURGIN

Do not store above 30°C.
Do not freeze.
Keep in the original packaging to protect the medicine from light and moisture.
Keep this medicine out of the sight and reach of children.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What SECURGIN contains

• The active substances are: desogestrel (0.150 mg) and ethinylestradiol (0.020 mg).
• The other components are: anhydrous colloidal silica, monohydrate lactose, potato starch, povidone, stearic acid, alpha-tocopherol.

Description of the appearance of SECURGIN and package contents
SECURGIN is available in packs containing 1, 3 or 6 blisters of 21 tablets each, placed in an aluminum pouch and packaged in a cardboard box.
The tablets are biconvex, round, 6 mm in diameter, and marked with "TR4" on one side and "Organon*" on the other.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi 3 - Florence
under license from Organon

Manufacturer:
N.V. Organon, Kloosterstraat 6, Oss (Netherlands)
A. Menarini Manufacturing Logistics and Services s.r.l., Via Sette Santi 3 - Florence