GRACIAL TABLETS

Introduction

Package Leaflet: Information for the User

Gracial Tablets

desogestrel / ethinylestradiol

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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What Gracial tablets are and what they are used for
2. What you need to know before you start taking Gracial tablets
3. How to take Gracial tablets
4. Possible side effects
5. Storage of Gracial tablets
6. Package contents and further information

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

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

Gracial is indicated for the prevention of pregnancy.

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

General considerations

Before starting to use Gracial, you should 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 should you be extra careful with Gracial".

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs. If you know 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 long time sitting or lying down (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 stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • Severe diabetes with blood vessel 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 ever had a cancer that is influenced by sex hormones (e.g., breast or genital cancer).
• If you have or have ever had a tumor in the liver.
• If there is any unexplained vaginal bleeding.
• If you have abnormal growth of the lining of the uterus.
• If you are pregnant or think you may be pregnant.
• If you are allergic to desogestrel or ethinylestradiol or any of the other components of this medicine (listed in section 6).

If any of these circumstances occur for the first time while using the pill, do not take any 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 medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking Gracial with other medicines").

Warnings and precautions

When should you be extra careful with Gracial

Before starting treatment with Gracial

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

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

• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products that contain estrogens may cause or worsen the 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 conditions.
• If you have inflammation of the veins that are just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives have had a blood clot, heart attack, or stroke.
• If you have migraines.
• If you suffer from epilepsy.
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time sitting or lying down (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of getting blood clots. You should ask your doctor when you can start taking Gracial after childbirth.
• If any of your close relatives have had breast cancer.
• 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 that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• 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 gestational herpes, a disease called Sydenham's chorea).
• If you have or have had chloasma (yellowish-brown spots on the skin, particularly on the face); in this case, you should avoid intense sun exposure or ultraviolet radiation.

Psychiatric disorders:

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

In case any of the above situations appear 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 AIDS or any other sexually transmitted disease.

Once you have started treatment with Gracial

While you are taking the pill, your doctor will require you to have 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 your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clots" below).

To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

BLOOD CLOTS

The use of a combined hormonal contraceptive like Gracial increases your risk of having 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 the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is important 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 attention if 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 the veins (venous thrombosis). 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 vein in your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of having a blood clot in a vein is higher during the first year that you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine 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 having a blood clot returns to normal within a few weeks.

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

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

• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains desogestrel, like Gracial, between 9 and 12 women will have a blood clot in a year.

• The risk of having a blood clot depends 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

The risk of having a blood clot with Gracial is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50).
• If you need an operation or spend a long time sitting or lying down due to an injury or illness or if you have your leg in a cast. You may need to stop using Gracial several weeks before surgery or while you have reduced mobility. If you need to stop using Gracial, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

The risk of having a blood clot increases with the number of conditions you have.

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

It is important to inform your doctor if you have any of the conditions mentioned above, even if you are not sure. Your doctor may decide that you should stop using Gracial.

If any of the conditions mentioned above change while you are using Gracial, for example, you start smoking, a close relative experiences a thrombosis 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 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 important to note that the risk of a heart attack or stroke due to Gracial is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When you use a combined hormonal contraceptive like Gracial, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives 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 disorders, 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, the risk of having a blood clot may be increased further.

If any of the conditions mentioned above change while you are using Gracial, for example, you start smoking, a close relative experiences a thrombosis without a known cause, inform your doctor.

3. How to take Gracial tablets

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

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

Each time you start a new Gracial blister pack, take the blue tablet number 1, which is in the upper left corner of the blister pack, and mark the day of the week by perforating the aluminum of the corresponding day on the left side of the blister pack. This way, you can easily control if you have taken your tablet every day. Follow the direction of the arrows until you finish the 22 tablets. In this way, you will take all the blue tablets first and then all the white tablets. In the 6 days following, you should not take Gracial, during which a withdrawal bleed (bleeding due to deprivation) will appear, which usually starts 2 or 3 days after the last Gracial tablet. Continue with the next blister pack on the 7th day, even if you still have your period. This way, you will always start the blister packs on the same day of the week and will have the withdrawal bleed approximately on the same days every month.

The first Gracial blister pack

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

Start taking Gracial on the first day of your cycle, i.e., the first day of menstruation. Gracial will start working immediately. You do not need to take additional contraceptive measures. You can also start on days 2 to 5 of your cycle, but in this case, make sure to use a complementary contraceptive method (e.g., a barrier method) while taking the first 7 tablets of the first cycle. Do not use methods based on the menstrual cycle or temperature, as these methods are not reliable while taking the pill.

Changing from another hormonal contraceptive (combined birth control pill, vaginal ring, or transdermal patch).

You can start taking Gracial the day after taking the last tablet of the current blister pack. This means you do not need to leave a period of rest. If your current preparation has inactive tablets, you can start Gracial the day after the last activetablet (if you are unsure, consult your doctor or pharmacist). You can also start later, but never after the rest period of your current preparation (or after the last inactive tablet of your preparation). In the case of using a vaginal ring or transdermal patch, you should start taking Gracial preferably on the same day of ring removal or on the day the patch is to be removed. You can also start, but no later than the day the next patch or ring application is due.

If you have taken the pill, or used the vaginal ring or patch continuously and correctly, and you are sure you are not pregnant, you can also stop taking the pill or remove the ring or patch any day of your current cycle and start with Gracial immediately.

If you follow these instructions, you do not need to use an additional contraceptive method.

Changing from a progestin-only pill.

You can stop taking your current pill any day and start taking Gracial the next day at the same time, but make sure to use a complementary contraceptive method (e.g., a barrier method) while taking the first 7 tablets, in case you have sexual intercourse.

Changing from an injectable, implant, or Intrauterine System (IUS) with progestin only.

Start using Gracial when you would receive the next injection or the day the implant or IUS is removed, but make sure to use a complementary contraceptive method (barrier method) while taking the first 7 tablets, in case you have sexual intercourse.

After childbirth.

If you have just had a baby, your doctor may advise you to wait until your first normal period appears before starting Gracial. Sometimes it is possible to start earlier, but your doctor will advise you on this. If you are breastfeeding and want to use Gracial, you should discuss it with your doctor first.

After an abortion.

Consult your doctor.

You can stop taking Gracial at any time. If you stop Gracial because you want to become 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 date of birth.

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 reported due to 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 forget to take Gracial

If it has been less than 12 hourssince the usual time, the reliability of the pill is maintained. Take the tablet as soon as you remember and continue taking the following tablets at the usual time.

If it has been more than 12 hourssince the usual time, the reliability of the pill may be reduced. The more tablets you have forgotten in a row, the higher the risk that the contraceptive efficacy will decrease. The risk of becoming pregnant is particularly higher if you forget tablets at the beginning or end of the blister pack. Therefore, follow the recommendations outlined below (see also the diagram).

If you forget more than one tablet in a pack

Consult your doctor.

If you forget 1 tablet in the first week

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

If you have had sexual intercourse in the previous week, there is a possibility that you may have become pregnant. Therefore, inform your doctor immediately.

If you forget 1 tablet in the second week

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

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 precautions.

1- Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the following tablets at the usual time. Start the next blister pack the day after finishing the current pack without leaving a period of rest between packs. You may not have your period until the end of the second pack, although you may experience spotting or a small period while taking the tablets from the second pack.

Or,

2- Stop taking the tablets from the current pack, leave a maximum rest period of 6 days (including the day you forgot the tablet), and continue with the next pack. Following this method, you can always start your next pack on the same day of the week that you usually do.

If you have forgotten tablets in a pack and do not have your expected period during the first normal rest period, you may be pregnant.

Consult your doctor before starting the next Gracial pack.

If you vomit or have severe diarrhea

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

In the case of severe diarrhea, consult your doctor.

If you want to change the day 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 should shorten (never lengthen) the next rest period. For example, if your period usually starts on Friday and you want it to start on Tuesday in the future, i.e., three days earlier, you should start the next pack three days earlier than the day you usually start. If the rest period is very short, 1 to 3 days, you may not have bleeding during the rest period, and you may experience spotting during the next pack.

If you have unexpected bleeding

As with all birth control pills, irregular vaginal bleeding or spotting may appear between periods during the first months (called intermenstrual bleeding or spotting). 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 reappears, consult your doctor.

If your period does not appear

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

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

4. Possible Adverse Effects

Like all medicines, Gracial can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Gracial, consult your doctor.

All women who take 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 section 2 "What you need to know before you start using Gracial".

Severe Adverse Effects

Contact a 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 urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

Adverse effects are listed below, classified according to their frequency, based on the following criteria:

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

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

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

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

• depressive 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
• migraines
• vomiting, diarrhea
• skin rash, urticaria
• breast enlargement

Rare (may affect up to 1 in 1,000 people):

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

• in a leg or foot (i.e., DVT),
• in a lung (i.e., PE),
• heart attack,
• stroke,
• mild stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having 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).

• allergic reactions
• increased sexual desire
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (which are skin diseases)
• altered menstrual flow, breast secretion
• weight loss

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gracial Tablets

Keep this medicine out of the sight and reach of children.

Do not store at a temperature above 30 °C.

Store in the original packaging.

Do not use this medicine after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not use this medicine if you observe, for example, a change in color, broken tablets, or any other visible sign of deterioration.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gracial

The active ingredients are: desogestrel and ethinylestradiol.

Blue tablets: 0.025 mg of desogestrel and 0.04 mg of ethinylestradiol.

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

The other components are:

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

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

Appearance of the Product and Package Contents

The tablets are round, flat with beveled edges. They measure 6 mm in diameter. They have a code TR8 (white tablets) or TR9 (blue tablets) on one side and nothing on the other.

Gracial is presented in aluminum/PVC blisters of 22 tablets (7 blue and 15 white), packaged in a sealed aluminum laminate pouch. The pouches are packaged in boxes with 1x22 and 3x22 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublin 24

Ireland

Tel: +34(0)952010137

Manufacturer

Organon (Ireland) Ltd.,

Drynam Road

Swords, Co. Dublin

Ireland

O

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31

Ólvega 42110 (Soria)

Spain

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

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Planta Interior 1, Oficina 4

08006 Barcelona

Spain

Date of the Last Revision of thisProspectus:February 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/