Gracial

Package leaflet: Information for the patient

Gracial 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, 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 may be experiencing symptoms of a blood clot (see section 2 "Blood clots").

Read this leaflet carefully before using 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. WHAT GRACIAL IS AND WHAT IT IS USED FOR
Composition and type of pill
Gracial is a combined oral contraceptive, also known as "the 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, Gracial is considered a low-dose oral contraceptive. Since the two hormones are present in different doses in the blue tablets compared to the white tablets, Gracial is considered a biphasic combined oral contraceptive.

Why use Gracial
Gracial is used to prevent pregnancy.
When taken correctly (without missing any tablets), the chance of pregnancy is very low.
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2. WHAT YOU SHOULD KNOW BEFORE TAKING GRACIAL

General information
Before starting to use Gracial, 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 use Gracial
Do not use Gracial 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 methods of birth control that might be more suitable for your case.

• 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 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 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 hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you have jaundice (yellowing of the skin) or suffer from severe liver disease;
• if you have or have previously suffered from a type of cancer that grows under the influence of sex hormones (such as breast or genital organ cancer);
• if you have or have previously suffered from liver tumours;
• if you have 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 might be pregnant;
• if you are allergic to the active substances or to any of the components of Gracial.

If any of these conditions occurs for the first time while taking the pill, stop taking it immediately and inform your doctor. In the meantime, use non-hormonal contraceptive methods. See also section "General information".
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Do not use Gracial if you have hepatitis C and are taking medications containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Other medicines and Gracial").

When to be especially careful with Gracial
General information
This patient leaflet describes certain situations in which you should stop taking the pill or in which its effectiveness may be reduced. In these situations, you must 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?
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 clot (thrombosis)"). For a description of the symptoms of these serious adverse effects, refer to the section "How to recognize a blood clot".

Gracial, like all combined oral contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Gracial should not normally be used to delay a 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 Gracial, inform your doctor.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties, contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• 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 beneath the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a close family history of thrombosis, heart attack, or stroke;
• if you suffer from migraine;
• if you suffer from depression;
• if you suffer from epilepsy;

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• 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 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 Gracial;
• if any of your close relatives has had breast cancer;
• if you have had conditions that first appeared or worsened during pregnancy or following 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 (brown-yellow patches on the skin, particularly on the face). In this case, avoid excessive exposure to sunlight or ultraviolet radiation.

Psychiatric disorders
Some women using hormonal contraceptives, including Gracial, have reported depression or low 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 any of the above conditions appears for the first time, recurs, or worsens during use of the pill, consult your doctor.

Pill and thrombosis
BLOOD CLOTS
Using a combined hormonal contraceptive such as Gracial 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 TEA).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal.
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It is important to remember that the overall risk of a harmful blood clot associated with Gracial 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 one of these symptoms? You may have:

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

  • severe 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
    → Deep vein thrombosis (DVT)

• sudden and unexplained shortness of breath

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

• sharp chest pain that may worsen when breathing deeply

• severe dizziness or fainting

• rapid or irregular heartbeat

• severe stomach pain
  → Pulmonary embolism

Symptoms occurring more frequently in the eye:

• sudden loss of vision

• painless blurring of vision that may progress to vision loss
  → Retinal vein thrombosis (blood clot in the eye)

• pain, discomfort, pressure, or heaviness in the chest

• squeezing sensation or fullness in the chest, in one arm, or under the breastbone

• feeling of fullness, indigestion, or choking

• 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
  → Heart attack

• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body

• sudden confusion, trouble speaking, or difficulty understanding speech

• sudden trouble seeing in one or both eyes

• sudden severe headache with no known cause

• sudden trouble walking, dizziness, loss of balance, or coordination
  → Stroke 5 of 18

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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to 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 medication or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women who are not using a combined hormonal contraceptive.
When you stop taking Gracial, the risk of developing a blood clot returns to normal levels within a few weeks.
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What is the risk of developing a blood clot?
The risk depends on your individual baseline 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 Gracial 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 Gracial, 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 Gracial 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 need to undergo surgery or must remain bedridden due to injury, illness, or have a plaster cast on your leg. You may need to stop taking Gracial several weeks before surgery or during periods of reduced mobility. If you need to stop taking Gracial, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given 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 clots forming, 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 stop your use of Gracial.
If any of the conditions listed above change while you are using Gracial, 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 Gracial is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Gracial, it is advisable to stop smoking. If you cannot 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 any of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Gracial, 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 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.
Benign liver tumors have been observed rarely in women using the pill, and even more rarely, malignant liver tumors. 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 or to sexual behavior or other factors (such as improved cervical screening).

Other medicines and Gracial
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines or herbal preparations, including those without a prescription. This way, they can advise you whether and for how long you need to use additional contraceptive methods.
Some medicines may affect the levels of Gracial in your blood and make it less effective in preventing pregnancy or cause unexpected bleeding.
These include medicines used for the treatment of:

• epilepsy and narcolepsy (e.g., primidone, hydantoins, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV or hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) and/or combinations with medicines against hepatitis C virus (HCV) (e.g., boceprevir, telaprevir) or other infections (griseofulvin);
• high blood pressure in the lung vessels (bosentan) and St. John’s wort (Hypericum perforatum), used especially for treating depression. The pill may also interfere with the activity of other medicines (e.g., cyclosporine and lamotrigine).

Concomitant administration of strong inhibitors of the CYP3A4 enzyme (e.g., ketoconazole, itraconazole, clarithromycin) or moderate inhibitors of the CYP3A4 enzyme (e.g., fluconazole, diltiazem, erythromycin) may increase blood concentrations of estrogens or progestins, including etonogestrel, the active metabolite of desogestrel.
Do not use Gracial if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause increases in blood tests for liver function (increase in liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Gracial may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Gracial”.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Gracial must not be used by pregnant women or women who suspect they are pregnant. If you suspect you are pregnant while taking Gracial, you must stop treatment immediately and contact your doctor as soon as possible.

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

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

Gracial contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 status, particularly related to what is reported in this leaflet (also see sections “Do not use Gracial” and “What you need to know before using Gracial”). Do not forget changes in the health status of your close relatives;
• you detect 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 (also see section “Other medicines and Gracial”);
• you need to be immobilized or undergo surgery (inform your doctor at least four weeks in advance);
• you experience heavy and unusual vaginal bleeding;
• you forgot to take tablets during the first week of the pack and had sexual intercourse in the preceding seven days;
• you have severe diarrhea;
• you have missed your period 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 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 “Pill and thrombosis” in this leaflet.

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

3 HOW TO TAKE GRACIAL
When and how to take the tablets
Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The Gracial pack contains 22 tablets: 7 blue tablets (marked with numbers 1–7) and 15 white tablets (marked with numbers 8–22). Take one tablet every day at about the same time, with water if needed. Each time you start a new pack of Gracial, always begin with the blue tablet number 1 located in the top left corner of the blister. Mark the day of the week you start taking the pill by scratching the aluminum foil of the corresponding blister. This way you can easily check whether tablets have been taken correctly. Follow the direction of the arrows until all 22 tablets are used. Take all the blue tablets first, then all the white ones. Do not take any tablets for the following 6 days. Your period should occur during these 6 days (withdrawal bleeding). It usually starts 2–3 days after taking the last tablet of Gracial. Start the new pack on the seventh day, even if your period has not yet ended. 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.

How to start the first pack of Gracial

• If you have not used any hormonal contraceptive pill in the previous month. Start taking Gracial on the first day of your cycle, i.e., the first day of your period. Gracial is effective immediately. Therefore, you do not need additional contraceptive methods.

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

• Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch)
  You may start taking Gracial the day after the last active pill of the previous contraceptive (i.e., without any pill-free interval). If the previous contraceptive pack contains inactive tablets, you may start Gracial 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 the previous contraceptive. If you are using a vaginal ring or transdermal patch, it is preferable to start Gracial on the same day the ring or patch is removed. At the latest, you may start on the day the next ring or patch application would have been due.

If you have used the pill, patch, or ring consistently and 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 Gracial immediately.
If you follow these instructions, additional contraceptive methods are not required.

• Switching from a progestogen-only pill (minipill)
  You may stop the minipill on any day and start taking Gracial the next 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 Gracial.

• Switching from a progestogen-only injectable or implant or from a progestogen-releasing intrauterine system (IUS)
  You may start taking Gracial 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 Gracial.

• After childbirth
  After giving birth, your doctor may advise you to wait until your first normal menstrual cycle before starting Gracial. Sometimes it is possible to start earlier. Your doctor will give you instructions. If you are breastfeeding and wish to use Gracial, discuss this with your doctor first.

• After a spontaneous or induced abortion
  Your doctor will give you instructions.

If you have taken too many Gracial tablets (overdose)
After taking many Gracial tablets at once, no serious harmful effects have been reported. If you have taken more tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding.
If you find that a child has taken Gracial, contact your doctor for advice.

WHAT TO DO IF…
…you forget to take tablets
If less than 12 hours have passed since your usual intake time, the reliability of the pill is maintained. Take the forgotten tablet as soon as you remember and then continue taking the tablets as usual.
If more than 12 hours have passed since your usual intake time, the reliability of the pill may be reduced. The more consecutive tablets you forget, the higher the risk that contraceptive protection is reduced.
The risk of pregnancy is particularly high if you miss pills at the beginning and end of the pack. Therefore, follow the instructions below (also see the following scheme).
If you have forgotten more than one tablet in a pack
Contact your doctor for advice.

If you forgot 1 tablet during the first week
Take the forgotten 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 method) for the next 7 days.
If you had sexual intercourse in the week before forgetting the tablet, there is a possibility that you may be pregnant. Contact your doctor immediately.

If you forgot 1 tablet during the second week
Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. The contraceptive protection of the pill is maintained. No additional contraceptive measures are needed.

If you forgot 1 tablet during the third week (8 days)
You may choose one of the following alternatives, without needing additional contraceptive precautions.

1. Take the forgotten 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 tablets from the current pack and observe an interval of 6 days or less ( including the day of the forgotten tablet ), then continue with a new pack. If you choose this option, you may start the new pack on the same day of the week you usually start.

If you have forgotten to take one or more tablets from a pack and do not have your period during the first pill-free interval, you may be pregnant. In this case, you must contact your doctor before starting the new pack.

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

…if you wish to delay the onset of your period
You can delay the start of your period by starting the white tablets of a new Gracial pack immediately after finishing the current pack. You may continue with the new pack as long as desired, up to the end of the second pack (maximum 15 days). When you want 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 6-day pill-free interval.

…if you want 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 lengthen) the next pill-free interval. For example, if your period usually starts on Friday and you want it to start on Tuesday (3 days earlier), start the next pack 3 days earlier than usual. If you shorten your pill-free interval significantly (e.g., 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 months of use, you may experience irregular vaginal bleeding (spotting or breakthrough bleeding) between periods. You may need to use sanitary pads, but you must 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 Gracial as usual.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start a new pack of Gracial until your doctor has ruled out pregnancy.

If you want to stop using Gracial
You may stop taking Gracial at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other birth control methods.
If you want to stop taking Gracial to become pregnant, wait for a natural period to occur before trying to conceive. This will help you determine when the baby is due.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gracial may cause side effects, although not everyone experiences them. If you notice any side effect, especially if it is severe or persistent, or if you experience any change in your health that you think could be due to Gracial, inform your doctor.

There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) in all women taking combined hormonal contraceptives. For more detailed information on the various risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Gracial”.

As with all COCs, changes in the pattern of vaginal bleeding may occur, particularly during the first few months of treatment. These changes may include alterations in frequency (absent, reduced, more frequent or continuous), intensity (reduced or increased), or duration of bleeding.

Serious reactions related to the use of the pill and their associated symptoms are described in the sections “The pill and thrombosis” and “The pill and cancer”.

Serious side effects

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also “Warnings and precautions”).

The following side effects have been observed in women using the pill:

Common (may affect more than 1 in 100 women):

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

Uncommon (may affect more than 1 in 1,000 women and less than 1 in 100 women):

• fluid retention
• decreased sexual desire
• migraine
• vomiting, diarrhoea
• skin reactions, urticaria (hives)
• breast enlargement.

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

• harmful blood clots in a vein or an artery, for example:
  o in a leg or foot (DVT)
  o in a lung (PE)
  o heart attack
  o stroke
  o mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  o 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 disorders)
• breast discharge, vaginal discharge
• weight loss.

Following the instructions provided 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GRACIAL

Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not store above 30°C. Do not freeze. Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if there are any changes in the colour of the tablets, crumbling of the tablets, or any other visible signs of deterioration.
Keep this medicine out of the sight and reach of children.
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.
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6. PACK CONTENTS AND OTHER INFORMATION

What Gracial contains
The active substances are:
Blue tablets: desogestrel (0.025 mg) and ethinylestradiol (0.040 mg)
White tablets: desogestrel (0.125 mg) and ethinylestradiol (0.030 mg)

The other components are:
Blue tablets: anhydrous colloidal silica, monohydrate lactose, potato starch,
povidone, stearic acid, alpha-tocopherol and indigo carmine (E132);
White tablets: anhydrous colloidal silica, monohydrate lactose, potato starch,
povidone, stearic acid and alpha-tocopherol.

Description of the appearance of Gracial and pack contents
Gracial is available in packs containing 1 or 3 blisters of 22 tablets (7 blue tablets and
15 white tablets), placed in an aluminium pouch and packaged in a cardboard box.
The tablets are biconvex, round and 6 mm in diameter. Each tablet is marked with
TR8 (white tablet) or TR9 (blue tablet) on one side and is smooth on the other side.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: 0039 0687502429

Manufacturer:
Organon (Ireland) Ltd, Drynam Road, PO BOX 2857, Swords, Dublin (Ireland)

Alternative manufacturer for packaging and final control
Cyndea Pharma, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 Ólvega
42110 (Soria), Spain
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