Prospect: information for the user

Gracial tablets

desogestrel / etinilestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this prospect thoroughly before starting to take this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect. See section 4.

1. What Gracial tablets are and for what they are used

2.What you need to know before starting to take Gracial tablets

3.How to take Gracial tablets

4.Possible adverse effects

5.Storage of Gracial tablets

6.Contents of the package and additional information

Gracial belongs to a group of medicines called combined oral contraceptives biphasic (“Combined Pill”). The active principles are combined in different doses in the blue and white tablets.

Gracial is indicated to prevent pregnancy.

General Considerations

Before starting to use Gracial, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

Do not take Gracial

If you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.See also the section “When to have special care with Gracial”.

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs. If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have or have had pancreatitis (inflammation of the pancreas), along with high levels of fat in your blood.
• If you have jaundice (yellowish discoloration of the skin) or severe liver disease.
• If you have or have had a cancer that grows in response to sex hormones (for example, breast or genital organ cancer).
• If you have or have had a tumor in the liver.
• If there is any unexplained vaginal bleeding.
• If you have an abnormal growth of the internal lining of the uterus.
• If you are pregnant or think you may be.
• If you are allergic to desogestrel or ethinylestradiol or to any of the other components of this medication (including in section 6).

If any of these circumstances occur for the first time while using the pill, do not take more and consult your doctor immediately. In the meantime, use non-hormonal contraceptive measures.

Do not take Gracial if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section Taking Gracial with other medications).

Warnings and Precautions

When to have special care with Gracial

Before starting treatment with Gracial

Inform your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while using Gracial, you must also inform your doctor.

• If you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
• If you are a smoker.
• If you are diabetic.
• If you are overweight.
• If you have high blood pressure.
• If you have heart rhythm disorders or certain heart diseases.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If a close family member has had thrombosis, heart attack or cerebral embolism.
• If you have migraines.
• If you have epilepsy.
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without standing up (see section “Blood Clots”).
• If you are at higher risk of blood clots after childbirth. You should ask your doctor when you can start taking Gracial after childbirth.
• If a close family member has had breast cancer.
• If you have liver or gallbladder disease.
• If you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have a disease that appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestational, a disease called Sydenham’s chorea).
• If you have melasma (brownish-yellow skin patches, particularly on the face); in this case, you should avoid intense exposure to the sun or ultraviolet radiation.

Mental disorders:

Some women who use hormonal contraceptives like Gracial have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

If any of the above situations occur for the first time, recur or worsen with treatment with the pill, you should consult your doctor, who may recommend that you stop taking the pill.

Gracial, like all contraceptive pills, does not protect against HIV or any other sexually transmitted disease.

Once treatment with Gracial has started

While taking the pill, your doctor will require you to undergo regular check-ups, usually once a year.

Contact your doctor as soon as possible in the following cases:

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section “Blood Clots” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

• If you notice any change in your health, especially in any of the points mentioned in this leaflet (see also “When not to use Gracial” and “What you need to know before starting to take Gracial”); do not forget to mention the points related to your close relatives;
• If you find any lump in the breasts;
• If you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, or urticaria with difficulty breathing;
• If you are going to take other medications (see also “Taking Gracial with other medications”);
• If you need to be immobilized or are going to undergo surgery, as in these cases your risk of thrombosis increases temporarily; consult your doctor at least four weeks in advance;
• If you have unexplained vaginal bleeding;
• If you forget to take pills in the first week of the pack and have had sex in the seven days beforehand;
• If you have severe diarrhea;
• If you have two consecutive missed pills or suspect you may be pregnant, do not start the next pack until your doctor tells you to.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Gracial increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Gracial is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistanceif you notice any of the following signs or symptoms.

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 blood clots in veins (venous thromboembolism or VTE). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a leg vein or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Gracial, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Gracial is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive containing desogestrel like Gracial, between 9 and 12 women will develop a blood clot in a year.

• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

Factors that increase your risk of a blood clot in a vein

Your risk of a blood clot is higher:

• If you are overweight (body mass index or BMI above 30 kg/m2).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop taking Gracial for several weeks before the operation or while you have limited mobility. If you need to stop taking Gracial, ask your doctor when you can start taking it again.
• With increasing age (especially above about 35 years).
• If you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (more than 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking Gracial.

If any of the above conditions change while you are using Gracial, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Gracial is very small, but it may increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Gracial, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend that you use 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 (i.e., before about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or a close relative have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the above conditions change while you are using Gracial, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Blood pressure

If you have high blood pressure or a related disease, it is recommended that you use a different type of contraceptive. If you decide to use hormonal contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medication, you should stop treatment.

Tumors

Cases of breast tumors have been observed in women who use oral contraceptives, with a slightly higher frequency than in women of the same age who do not use them. This slight increase in breast tumors diagnosed decreases gradually over the next ten years after stopping treatment. It is not known whether this difference is due to treatment with the pill. Women who use oral contraceptives may be more likely to visit their doctor.

Rare cases of benign liver tumors and even more rarely malignant liver tumors have been reported in women who use oral contraceptives. This can cause internal bleeding, leading to severe abdominal pain. If this occurs, you should contact your doctor immediately.

The situation that most affects the risk of cervical cancer is the continued infection with the human papillomavirus. In women who use oral contraceptives for many years, the risk of cervical cancer is slightly higher. However, it is not clear whether the oral contraceptive plays a direct role in this risk or if other factors (such as sexual habits and other factors, such as better medical control) do.

Vaginal bleeding

You may not have your “period” during the week of rest. If you have taken the pill correctly, it is very unlikely that you are pregnant. However, if you have two missed pills, you should consult your doctor as you may need to rule out pregnancy. If you have not taken the pill as instructed in section “3. How to take Gracial tablets” and have a missed pill, you should stop treatment and use a non-hormonal contraceptive method until pregnancy has been ruled out.

Gracial can cause vaginal bleeding or spotting between periods. If this happens, continue taking Gracial and if the bleeding continues after three cycles, consult your doctor immediately. Errors in using the pill can also cause light vaginal bleeding or spotting.

When you stop using Gracial, you may experience irregular, light, or no bleeding, especially in the first three months and especially if your periods were irregular before starting hormone treatment.

Children and adolescents

There are no available clinical data on safety and efficacy in adolescents under 18 years old.

Taking Gracial with other medications

Some medications can affect the levels of Gracial in the blood and may make it less effective in preventing pregnancy or cause unexpected bleeding. This can occur with medications used to treat:

• Medications for the treatment of epilepsy and narcolepsy (e.g., primidone, phenytoin, barbiturates (phenobarbital), carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil).
• Medications for the treatment of tuberculosis (e.g., rifampicin).
• Infections with HIV (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), and/or in combination with medications against hepatitis C virus (HCV) (e.g., boceprevir and telaprevir) or other infections (griseofulvin, rifabutin).
• Medications for high blood pressure in the blood vessels that carry blood to the lungs (bosentan).
• St. John’s Wort (a medicinal herb used to treat mood disorders).

Do not take Gracial if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver function parameters in the blood (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Gracial can be restarted approximately 2 weeks after completing this treatment. See section “Do not take Gracial”.

It is recommended that you use a non-hormonal, reliable contraceptive method if you take any of the above medications. The effect of some of these medications may last up to 28 days after stopping treatment.

Hormonal contraceptives can interfere with the activity of other medications (such as ciclosporin and lamotrigine).

Always inform your doctor who prescribes the pill about the medications you are already taking, and also inform any other doctor or dentist who prescribes another medication (or pharmacist) that you are taking Gracial. They can advise you if you need to take additional contraceptive measures and for how long, if necessary.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Laboratory tests

The use of hormonal contraceptives may affect the results of certain laboratory tests. If you are told to undergo any laboratory test, inform your doctor that you are taking Gracial.

Pregnancy and breastfeeding

Gracial should never be used by pregnant women or women who suspect they may be pregnant.

Gracial is generally not recommended during breastfeeding. If you want to take the pill while breastfeeding, consult your doctor.

If you are pregnant or breastfeeding, or think you may be, or have any intention of becoming pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects have been observed.

Gracial contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The Gracial blister has 22 tablets: 7 blue (numbered from 1 to 7) and 15 white (numbered from 8-22). Take your tablet approximately at the same time every day, with liquid if necessary.

Each time you start a new Gracial blister, take the blue tablet number1, which is in the top left corner of the blister and mark the day of the week by perforating the aluminum of the corresponding day on the left side of the blister. In this way, you will be able to control easily if you have taken your tablet every day. Follow the direction of the arrows until you finish the 22tablets. In this way, you will take all the blue tablets first and then all the white tablets. In the 6days that follow, you should not take Gracial, during which a period (bleeding due to deprivation) will appear that usually starts two or three days after the last Gracial tablet. Continue with the next blister on the seventh day, even if you still have a period. In this way, you will always start the blisters on the same day of the week and will have the bleeding due to deprivation approximately on the same days every month.

The first Gracial blister

If you have not used hormonal contraception in the previous month.

Start taking Gracial on the first day of the cycle, that is, the first day of menstruation. Gracial will start acting immediately. You do not need to take additional contraceptive measures. You can also start on days2 to5 of your cycle, but in this case, make sure to use a complementary contraceptive method (for example, a barrier method) while taking the first 7tablets of the first cycle. Do not use menstrual cycle-based methods or temperature methods, as these methods are not reliable while taking thepill.

Change from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch).

You can start taking Gracial the day after taking the last tablet of the current blister. This means that you do not need to leave a break. If your current preparation has inactive tablets, you can start Gracial the day after the lastactivetablet (if you are unsure, consult your doctor or pharmacist). You can also start later, but never after the break of your current preparation, (or well after the last inactive tablet of your current preparation). If you are using a vaginal ring or a transdermal patch, you should start taking Gracial preferably on the same day as the ring is removed, or on the day when the patch should be removed. You can also start, but no later than the day when the next patch or ring should be applied.

You can stop taking Gracial at any time. If you stop Gracial because you want to get pregnant, it is generally recommended to wait until you have had your first natural period before trying to conceive, which will help you calculate the due date.

If you take more Gracial than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

No serious effects have been cited for taking an excess of Gracial tablets at one time. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

If you forgot to take Gracial

If more than12 hourshave passed since the usual time, the pill's reliability is maintained. Take the tablet as soon as you remember it and continue taking the next tablets at the usual time.

If more than12 hourshave passed since the usual time, the pill's reliability may be reduced. The more consecutive tablets you have forgotten, the higher the risk of reduced contraceptive efficacy. The risk of becoming pregnant is particularly higher if you forget the tablets at the beginning or end of the blister. Therefore, you should follow the recommendations that are outlined below (see also the diagram).

If you forget more than one tablet in a blister

Consult your doctor.

If you forget 1 tablet in the first week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. Take complementary contraceptive measures (barrier method) for the next 7days.

If you have had sex in the previous week, there is a possibility that you may be pregnant. Inform your doctor immediately.

If you forget 1 tablet in the second week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. The pill's reliability is maintained and you do not need to take complementary contraceptive measures.

If you forget 1 tablet in the third week (8 days)

You can choose one of the following options, without needing to take complementary contraceptive measures.

1- Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. Start the nextblisterthe day after finishing the current blisterwithout leaving a break betweenblisteres. You may not have a period until the end of the secondblister, although you may have spotting or a small period while taking the tablets of the secondblister.

Or,

2- Stop taking the tablets of theblistercurrent, leave a break of a maximum of 6 days (also count the day you forgot the tablet) and continue with the nextblister. Following this method, you will always start your nextblisteron the same day of the week as you do normally.

If you have forgotten tablets in ablisterand you do not have the expected period in the first break, you may be pregnant.

Consult your doctor before starting the nextblister.

If you vomit or have intense diarrhea

If you vomit or have intense diarrhea in the 3 or 4 hours after taking your Gracial tablet, it may be that the active principles are not absorbed completely, which is equivalent to forgetting a tablet. Therefore, follow the recommendations for a forgotten tablet.

In the case of intense diarrhea, consult your doctor.

If you want to change the day when your period starts

If you take the tablets as indicated, you will have your period approximately on the same day every 4 weeks. If you want to change it, you must shorten (never lengthen) the next break. For example, if your period usually starts on Friday and you want it to start on Tuesday in the future, that is, three days earlier, you should start the nextblisterthree days earlier than the day you started. If the break is too short, from1 to3 days, you may not have a period during the break and you may have spotting or a small period during the nextblister.

If you have unexpected bleeding

As with all pills, you may experience irregular vaginal bleeding between periods during the first months (called spotting or intermenstrual bleeding). In this case, continue taking the tablets normally. This irregular vaginal bleeding usually disappears once your body has adapted to the pill, usually after three cycles.

If it continues, becomes more intense, or appears again, consult your doctor.

If you do not have a period

If you have taken all the tablets at the same time and have not vomited, had intense diarrhea, or taken other medications, it is very unlikely that you are pregnant. Continue taking Gracial as usual.

If you have two consecutive missed periods, you may be pregnant, so you should inform your doctor immediately. Do not start the next Gracial blister until your doctor has confirmed that you are not pregnant.

Like all medicines, Gracial can cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due toGracial, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to useGracial”.

Severe side effects

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

Side effects are listed below classified by frequency according to the following criterion:

Frequent: (may affect up to1in 10 people).

Infrequent:(may affect up to1in 100 people).

Rare:(may affect up to1in 1,000people).

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

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

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

• fluid retention
• decreased libido
• migraines
• vomiting, diarrhea
• skin rash, urticaria
• breast enlargement

Rare (may affect up to1in 1,000people):

• harmful blood clots in a vein or artery, for example:

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).

• allergic reactions
• increased libido
• contact lens intolerance
• erythema nodosum, erythema multiforme (which are skin diseases)
• altered menstrual flow, nipple discharge
• weight loss

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish Medicines Vigilance System:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above30 °C.

Store in the original packaging.

Do not usethis medicationafter the expiration date that appears on the packagingafter the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you notice, for example, a change in color, broken tablets orany other visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE pointofyourpharmacy.In case of doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gracial

The active principles are: desogestrel and etinilestradiol.

Blue tabletsblue: 0.025mg of desogestrel and 0.04mg of etinilestradiol.

White tablets: 0.125mg of desogestrel and 0.03mg of etinilestradiol.

The other components are:

Blue tablets: colloidal anhydrous silica, all-rac-alpha‑tocopherol, indigotin (E‑132), lactose monohydrate, potato starch, povidone, and stearic acid.

White tablets: colloidal anhydrous silica, all-rac-alpha‑tocopherol, lactose monohydrate, potato starch, povidone, and stearic acid.

Appearance of the product and contents of the package

The tablets are round, flat with beveled edges. They measure6mmin diameter. They have a code TR8 (white tablets) or TR9 (blue tablets) on one side and nothing on the other.

Gracial is presented inaluminum/PVCblister packs of 22 tablets (7 blue and 15 white),conditioned in a laminated aluminum foil sealed pouch. The pouches are packagedin boxes with 1x22 and 3x22 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublin24

Ireland

Tel: +34(0)952010137

Responsible for manufacturing

Organon (Ireland) Ltd.,

Drynam Road

Swords, Co. Dublin

Ireland

Or

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31

Ólvega 42110 (Soria)

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Planta Interior 1, Office 4

08006 Barcelona

Spain

Last review date of thisleaflet:February 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/