Gracial tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gracial tablets

desogestrel / ethinylestradiol

Important things you need to 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 developing a blood clot in veins and arteries, especially during 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 leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Gracial belongs to a group of medicines called combined biphasic oral contraceptives ("combined pill"). The active substances are combined in different doses in the blue and white tablets.

Gracial is indicated to prevent pregnancy.

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

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 about 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 which other form of contraception would be more suitable. See also section “When you should be especially 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you are going to be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of forming a blood 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 ever had inflammation of the pancreas (pancreatitis), together with high levels of fats in your blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have ever had a cancer that grows under the influence of sex hormones (e.g. breast or genital organs).
• If you have or have ever had a tumour in the liver.
• If you have any unexplained vaginal bleeding.
• If you have abnormal growth of the internal tissue of the uterus.
• If you are pregnant or think you might be pregnant.
• If you are allergic to desogestrel or ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6).

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

Do not take Gracial if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Gracial with other medicines”).

Warnings and precautions

When you should be especially careful with Gracial

Before starting treatment with Gracial

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Gracial, you must 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 hives with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
• If you are a smoker.
• If you have diabetes.
• 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 beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close family member has had thrombosis, heart attack, or stroke.
• If you have migraine.
• If you have 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 pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. 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 Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anemia (a hereditary red blood cell disorder).
• If you have a condition that appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disorder called porphyria, a skin condition called herpes gestationis, or a condition called Sydenham’s chorea).
• If you have or have had chloasma (yellowish-brown patches on the skin, particularly on the face); in this case, avoid intense exposure to sunlight or ultraviolet radiation.

Psychiatric disorders:

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

If any of the above conditions occur for the first time, recur, or worsen during treatment with the pill, consult your doctor, who may advise you to stop taking the pill.

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

Once treatment with Gracial has started

While taking the pill, your doctor will require you to undergo periodic 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, which may indicate you are experiencing 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 adverse effects, see “How to recognize a blood clot”.

• If you notice any change in your health, especially regarding any of the points mentioned in this leaflet (see also “When not to use Gracial” and “What you need to know before starting Gracial”); do not forget to mention any relevant family history;
• If you detect a lump in your breast;
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives accompanied by difficulty breathing;
• If you are to take other medications (see also “Taking Gracial with other medicines”);
• If you are to be immobilized or are undergoing surgery, as your risk of thrombosis temporarily increases in these cases; consult your doctor at least four weeks in advance;
• If you have unusual and heavy vaginal bleeding;
• If you miss tablets in the first week of the pack and have had sexual intercourse in the previous seven days;
• If you have severe diarrhea;
• If you miss two periods in a row or suspect you are pregnant, do not start the next pack until your doctor advises you to do so.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Gracial increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, they may 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 veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may 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 developing 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 also be increased if you restart taking a combined hormonal contraceptive (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 still slightly higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

The risk depends on your natural 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 a 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, between 9 and 12 women will develop a blood clot in one year.

• Your individual risk of developing a blood clot will depend on your personal medical 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 certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury, illness, or having 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 again.
• With increasing age (especially over approximately 35 years).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you should stop taking Gracial.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

It is important to note that the risk of heart attack or stroke while using Gracial is very small, but it may increase:

• With age (especially over approximately 35 years).
• If you smoke. When using 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 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 migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorders such as 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 developing a blood clot may be further increased.

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

Blood pressure

If you have hypertension (high blood pressure) or any condition related to hypertension (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use hormonal contraceptives, your blood pressure should be monitored regularly. However, if your blood pressure increases and cannot be controlled with medication, you should stop treatment.

Tumors

A slightly higher number of breast cancer cases have been observed in women using contraceptive pills compared to women of the same age who do not use them. This slight increase in diagnosed breast tumors gradually decreases over the ten years following discontinuation of treatment. It is not known whether this difference is due to the pill treatment. It could be that women who use contraceptive pills visit their doctor more frequently.

Benign liver tumors have been rarely reported, and malignant liver tumors even more rarely, in women using contraceptive pills. This may lead to internal bleeding causing severe abdominal pain. If this occurs, you should contact your doctor immediately.

The factor most affecting the risk of cervical (neck of the womb) cancer is persistent infection with human papillomavirus (HPV). In women who use contraceptive pills for many years, the likelihood of developing cervical cancer is slightly higher. However, it is unclear whether the contraceptive pill plays a direct role in this risk, or whether sexual habits and other factors (such as more frequent medical check-ups) are responsible.

Vaginal bleeding

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

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

When you stop using Gracial, you may experience irregular or light bleeding, or no bleeding at all, especially during the first 3 months and particularly if your periods were already irregular before starting hormonal treatment.

Children and adolescents

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

Taking Gracial with other medicines

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

• epilepsy and narcolepsy (e.g., primidone, phenytoin, barbiturates (phenobarbital), carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil)
• tuberculosis (e.g., rifampicin)
• HIV infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), and/or in combination with drugs against hepatitis C virus (HCV) (e.g., boceprevir and telaprevir) or other infections (griseofulvin, rifabutin)
• high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension) (bosentan)
• St. John’s wort (a herbal medicine used to treat mood disorders).

Do not take Gracial if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood tests measuring liver function (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 advisable to use another reliable non-hormonal contraceptive method if you are taking any of the above-mentioned medicines. The effect of some of these medicines may last up to 28 days after stopping treatment.

Hormonal contraceptives may interfere with the activity of other medicines (e.g., cyclosporine and lamotrigine).

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

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Laboratory tests

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

Pregnancy and breastfeeding

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

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects have been observed.

Gracial contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gracial tablets

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Each time you start a new Gracial blister pack, take the blue tablet number 1, located in the upper left corner of the blister. Mark the day of the week by piercing the aluminum foil corresponding to that day on the left side of the blister. This will help you easily track whether you have taken your tablet each day. Follow the direction of the arrows until all 22 tablets are taken. This way, you will first take all the blue tablets, followed by all the white tablets. For the next 6 days, do not take Gracial tablets. During this time, you will experience a withdrawal bleed (menstrual-like bleeding), which usually begins two or three days after taking the last Gracial tablet. Start the next blister pack on the seventh day, even if you are still bleeding. This ensures that you always start a new blister pack on the same day of the week and have your withdrawal bleeding around the same days each month.

Starting 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, that is, the first day of your menstrual period. Gracial will become effective immediately, and you do not need to use additional contraceptive measures. You may also start between days 2 and 5 of your cycle; however, in this case, make sure to use an additional contraceptive method (e.g., a barrier method) during the first 7 days of taking tablets in the first cycle. Do not use fertility awareness-based or temperature methods, as these are not reliable while taking the pill.

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

You may start taking Gracial the day after taking the last tablet of your current pack. This means you do not need a break period. If your current product contains inactive (placebo) tablets, start Gracial the day after the last active tablet (if you are unsure, consult your doctor or pharmacist). You may also start later, but never later than the end of the break period of your current product (or after the last inactive tablet of your current product). If you are using a vaginal ring or transdermal patch, you should preferably start taking Gracial on the same day the ring is removed or the patch is taken off. Alternatively, you may start, but no later than the day the next patch or ring application would have been due.

If you have been taking the pill, or using the vaginal ring or patch correctly and continuously, and are certain you are not pregnant, you may stop taking your current method or remove the ring or patch on any day of your cycle and start Gracial immediately.

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

Switching from a progestogen-only pill

You may stop taking your current pill on any day and start taking Gracial the next day at the same time. However, ensure you use an additional contraceptive method (e.g., a barrier method) during the first 7 days of tablet-taking if you have sexual intercourse.

Switching from a progestogen-only injectable, implant, or intrauterine system (IUS)

Start using Gracial at the time when your next injection is due, or on the day your implant or IUS is removed. However, ensure you use an additional contraceptive method (barrier method) during the first 7 days of tablet-taking if you have sexual intercourse.

After childbirth

If you have recently given birth, your doctor may advise you to wait until you have had your first natural menstrual period before starting Gracial. Sometimes it may be possible to start earlier, but your doctor will advise you accordingly. If you are breastfeeding and wish to use Gracial, discuss this first with your doctor.

After an abortion

Consult your doctor.

You may stop taking Gracial at any time. If you stop Gracial because you wish to become pregnant, it is generally recommended to wait until you have had your first natural menstrual period before trying to conceive, as this will help determine the due date of the pregnancy.

If you take more Gracial than you should

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

No serious effects have been reported from taking an excessive number of Gracial tablets at once. If you have taken several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding.

If you forget to take Gracial

If less than 12 hours have passed since the usual time, contraceptive protection remains effective. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

If more than 12 hours have passed since the usual time, contraceptive effectiveness may be reduced. The more consecutive tablets you miss, the higher the risk of reduced contraceptive efficacy. The risk of pregnancy is particularly higher if you miss tablets at the beginning or end of the pack. Therefore, follow the recommendations below (see also the diagram).

If you miss more than one tablet in a pack

Consult your doctor.

If you miss 1 tablet in the first week

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Use additional contraceptive precautions (barrier method) for the next 7 days.

If you had sexual intercourse during the previous week, there is a possibility you may be pregnant. Inform your doctor immediately.

If you miss 1 tablet in the second week

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Contraceptive protection remains effective, and you do not need to use additional contraceptive precautions.

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

You may choose either of the following options; additional contraceptive precautions are not required.

1 – Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Start the next blister pack the day after finishing the current pack, without a break between packs. You may not have a withdrawal bleed until the end of the second pack, although you may experience spotting or light bleeding during the second pack.

Or,

2 – Stop taking tablets from the current pack, take a break of up to 6 days (including the day you missed the tablet), and then start the next pack. With this method, you can always start the next pack on the same day of the week as usual.

If you have missed tablets in a pack and do not have the expected withdrawal bleed during the first break period, you may be pregnant.

Consult your doctor before starting the next pack.

If you vomit or have severe diarrhoea

If you vomit or have severe diarrhoea within 3 to 4 hours after taking your Gracial tablet, the active ingredients may not be fully absorbed, which is equivalent to missing a tablet. Therefore, follow the instructions for a missed tablet.

In case of severe diarrhoea, consult your doctor.

If you wish to change the day your period starts

If you take the tablets as directed, your period will occur approximately on the same day every 4 weeks. If you wish to change this day, you must shorten (but never extend) the next hormone-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday instead (i.e. three days earlier), you should start the next blister pack three days earlier than usual. If the hormone-free interval becomes very short (1 to 3 days), you may not have bleeding during the interval and may experience some spotting during the next active tablet-taking period.

If you experience unexpected bleeding

As with all oral contraceptives, irregular vaginal bleeding (also called spotting or intermenstrual bleeding) may occur between periods during the first few months. In this case, continue taking the tablets as usual. This irregular vaginal bleeding usually stops once your body has adjusted to the pill, typically after three cycles.

If the bleeding continues, becomes heavier, or recurs, consult your doctor.

If your period does not occur

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

If you miss two consecutive periods, you may be pregnant and should inform your doctor immediately. Do not start the next blister pack of Gracial until your doctor has confirmed that you are not pregnant.

4. Possible adverse effects

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

All women who take combined hormonal contraceptives have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Gracial”.

Serious 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

The adverse effects listed below are classified according to their frequency using 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):

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

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

• fluid retention
• decreased libido
• migraine
• vomiting, diarrhoea
• 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,

• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),

• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• allergic reactions
• increased libido
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (which are skin disorders)
• altered menstrual bleeding, galactorrhoea
• weight loss

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 above 30 ºC.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice, for example, any change in colour, broken tablets, or any other visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gracial

The active substances are: desogestrel and ethinylestradiol.

Blue tablets: 0.025 mg desogestrel and 0.04 mg ethinylestradiol.

White tablets: 0.125 mg desogestrel and 0.03 mg ethinylestradiol.

The other components are:

Blue tablets: anhydrous colloidal silica, all-rac-alpha-tocopherol, indigo carmine (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.

Nature of the product and contents of the pack

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

Gracial is available in aluminium/PVC blisters of 22 tablets (7 blue and 15 white), packed in a sealed laminated aluminium pouch. The pouches are packaged in cartons containing 1x22 and 3x22 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

or

Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Ólvega 42110 (Soria)
Spain

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Aspen Pharmacare España S.L.
Avenida Diagonal, 512
Planta Interior 1, Oficina 4
08006 Barcelona
Spain

Date of the most recent revision of this package leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/