KELZY 2 MG/0.02 MG PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Kelzy 2 mg/0.02 mg prolonged-release tablets

dienogest/ethinylestradiol

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things 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 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 see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is Kelzy and what is it used for
2. What you need to know before you start taking Kelzy
3. How to take Kelzy
4. Possible side effects
5. Storing Kelzy
6. Package contents and further information

1. What is Kelzy and what is it used for

Kelzy is a combined oral contraceptive and is used to prevent pregnancy.

Each of the 24 pale yellow tablets contains a small amount of two different female hormones, called dienogest and ethinylestradiol. The 4 green tablets do not contain active substances and are also known as placebo tablets.

Oral contraceptives that contain two hormones are called “combined pills”.

2. What you need to know before starting to take Kelzy

If you are taking the pill, your doctor will ask you to have periodic tests. Normally, you should consult your doctor at least once a year.

Do not use Kelzy

You should not use Kelzy 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.

Do not take Kelzy if you:

• are allergic to ethinylestradiol, dienogest, or any of the other components of this medicine (listed in section 6);
• 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;
• 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;
• need an operation or will be immobile for a long time (see section 2 "Blood clots");
• have ever had a heart attack or stroke;
• 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);
• 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
• have (or have ever had) a type of migraine called "migraine with aura";
• have or have had liver disease, if your liver blood tests are not normalized;
• have or have had a liver tumor (benign or malignant);
• have, have had, or suspect you have cancer (such as breast cancer or endometrial cancer) that may be affected by your sex hormones;
• have any type of vaginal bleeding of unknown cause;
• have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 2 "Other medicines and Kelzy").

If any of the above situations occur while taking Kelzy, you should stop taking the medicine immediately and consult your doctor. In the meantime, you should use another non-hormonal contraceptive method. For more information, see also the section "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kelzy.

When you need to be especially careful with Kelzy

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

In some situations, special care is required when taking Kelzy or any other combined pill, and it may be necessary for your doctor to examine you regularly.

If the condition develops or worsens while you are using Kelzy, you should also inform your doctor if:

• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);
• you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• you have sickle cell anemia (a hereditary disease of red blood cells),
• 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);
• you need an operation or spend a lot of time without getting up (see section 2 "Blood clots");
• you have just given birth and are at a higher risk of blood clots. You should ask your doctor when you can start taking Kelzy after childbirth;
• you have inflammation of the veins that are under the skin (superficial thrombophlebitis);
• you have varicose veins;
• you have heart valve abnormalities or heart rhythm disorders;
• you have close relatives with breast cancer;
• you have liver or gallbladder disease or gallstones;
• you have jaundice or itching due to bile congestion;
• you have yellow-brown spots on the skin, especially on the face (chloasma), or if you have had them during a previous pregnancy; in this case, you should avoid intense sunlight and UV radiation;
• you have certain problems with hemoglobin formation (porphyria);
• you suffer from depression;
• you suffer from epilepsy;
• you suffer from Sydenham's chorea;
• you have had blisters during a previous pregnancy (herpes gestationis);
• you suffer from hearing loss in the inner ear (hearing loss related to otosclerosis);
• you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria potentially with difficulty breathing, contact a doctor immediately. Products that contain estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about the use of Kelzy.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Kelzy 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 lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Kelzy 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 of 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 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 Kelzy, 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 developing VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of having a blood clot in your leg or lung (DVT or PE) with Kelzy 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 dienogest and ethinylestradiol, like Kelzy, between 8 and 11 women will develop a blood clot in a year.

The risk of having 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

The risk of having a blood clot with Kelzy 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 their leg, lung, or other organ at a young age (i.e., before the age of about 50); in this case, you may have a hereditary blood clotting disorder;
• if you need an operation or will be immobile for a long time due to an injury or illness, or if you have your leg in a cast. You may need to stop using Kelzy several weeks before surgery or while you are less mobile. If you need to stop using Kelzy, 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-haul 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 essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you need to stop using Kelzy.

If any of the above conditions change while you are using Kelzy, for example, 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 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 Kelzy is very small, but it can increase:

• with age (above about 35 years)
• if you smoke. When using a combined hormonal contraceptive like Kelzy, 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 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, the risk of having a blood clot may be increased further.

If any of the above conditions change while you are using Kelzy, 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.

Kelzy and cancer

A slightly higher frequency of breast cancer has been observed in women using combined pills, but it is not known if the cause is the pill. It is possible that these women were examined more thoroughly and frequently, which means that breast cancer was detected earlier. The risk of breast cancer decreases gradually after stopping the use of a combined hormonal contraceptive. It is essential to regularly check your breasts and contact your doctor if you notice any lump.

In women who use combined pills for a relatively long period, some studies have reported cases of cervical cancer. Currently, it is not known if this is caused by the pill or related to sexual behavior (e.g., more frequent changes of partner) and other factors.

In rare cases, benign and, even more rarely, malignant liver tumors have been reported in users of the pill. Contact your doctor if you have unusually severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives like Kelzy have reported depression or depressive 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.

Irregular bleeding

During the first few months you are taking Kelzy, you may have unexpected bleeding (bleeding outside of the placebo days). If this bleeding lasts for more than a few months or comes back after some months, your doctor should investigate the cause.

What to do if you do not have bleeding during the placebo days

If you have taken all the active white tablets correctly, have not had vomiting or severe diarrhea, and have not taken any other medicine, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Other medicines and Kelzy

3. How to take Kelzy

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

Each blister pack contains 28 tablets. Take one Kelzy tablet at the same time every day, for 28 consecutive days, following the direction indicated by the arrows, without fail, as follows: take one active white tablet each of the first 24 days and then one green placebo tablet each day of the last 4 days.

After taking the last tablet, continue taking Kelzy the next day, starting another blister pack without an interval between packs. You will always start a new pack on the same day of the week. Since there are no breaks in taking the medication, it is essential that you have the next pack ready before finishing one.

To help you keep track, there are 7 stickers with the 7 days of the week for each Kelzy strip. Choose the sticker for the week that starts on the day you start taking the tablets. For example, if you start on a Wednesday, use the sticker for the week that starts with "WED". Stick the week sticker on the Kelzy strip where it says "Place the day sticker here:". Now, there is a day indicated above each tablet, and you can see if you have taken a particular tablet. The arrows indicate the order in which you should take the tablets.

During the 4 days when you take the green placebo tablets (the placebo days), you should start bleeding (the so-called withdrawal bleeding). It usually starts on the second or third day after the last active white Kelzy tablet. Once you have taken the last green tablet, you must start with the next strip, whether the bleeding has stopped or not. This means you must start each strip on the same day of the week, and the withdrawal bleeding must occur on the same days each month.

If you use Kelzy in this way, you will also be protected against pregnancy during the 4 days when you are taking a placebo tablet.

Take note of the instructions in section 3 "If you forget to take Kelzy" to maintain the contraceptive effect.

Form and route of administration

Swallow each tablet, if necessary with a small amount of water. It does not matter if you take the tablets on an empty stomach or with meals.

When can you start taking Kelzy

If you have not used a hormonal contraceptive in the previous month

Start with Kelzy on the first day of your cycle (i.e., the first day of your menstruation). If you start with Kelzy on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but then you must use additional protective measures (e.g., a condom) during the first 7 days.

If you are switching from a combined hormonal contraceptive or a combined vaginal ring or patch

You can start taking Kelzy preferably the day after the last active tablet (the last tablet that contains the active ingredients) of your previous pill, but no later than the day after the pill-free days of your previous pill (or after the last inactive tablet of your previous pill). If you are switching from a vaginal ring or patch to Kelzy, you should start taking preferably the day of removal of the last ring or patch from a cycle pack, but no later than the day you would apply the next one.

If you were using a progestogen-only method (progestogen-only pill, injection, implant, or IUD)

You can switch any day from the progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable when the next injection would be due), but in all these cases, you must use additional protective measures (e.g., a condom) during the first 7 days of tablet-taking.

If you start taking Kelzy after an abortion in the first trimester

Normally, you can start immediately, but you must follow your doctor's advice before doing so.

If you start taking Kelzy after giving birth or after an abortion in the second trimester

You can start taking Kelzy between 21 and 28 days after delivery or abortion. If you start later, you are advised to use an additional barrier contraceptive method during the first 7 days of pill-taking. If you have had sexual intercourse before starting Kelzy, make sure you are not pregnant or wait until your next menstruation.

Always take this medication exactly as your doctor or pharmacist has indicated. Consult your doctor or pharmacist if you are unsure.

Duration of treatment

Your doctor will indicate how long you should use this pill.

If you take more Kelzy than you should

There are no reports of serious harmful effects after taking too many Kelzy tablets. If you take several tablets at once, the symptoms that may appear are nausea, vomiting, and mild vaginal bleeding.

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.

If you forget to take Kelzy

If you forget to take a white active tablet(tablets 1-24 of your blister pack), you should do the following:

• If you realize you have forgotten to take a white tablet within 24 hours of the time you normally take the tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and continue taking the following tablets at the usual time.

• If you realize you have forgotten to take a white tablet more than 24 hours after you normally would have taken it, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is higher if you forget a white tablet at the beginning or end of the strip. Therefore, you must follow these rules:

• More than one forgotten tablet in this strip

Contact your doctor.

• One forgotten tablet between days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if you have to take two tablets at once. Continue taking the tablets at the usual time and take additional precautions during the next 7 days, e.g., a condom. If you have had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. In this case, contact your doctor.

• One forgotten tablet between days 8 and 14 (second row)

Take the forgotten tablet as soon as you remember, even if you have to take two tablets at once. Continue taking the tablets at the usual time. If you have taken the tablets correctly in the 7 days before the first forgotten tablet, the protection against pregnancy is not reduced, and you do not need to take additional precautions.

• One forgotten tablet between days 15-24 (third or fourth row)

You can choose between the following options without needing to use additional contraceptives, provided you have taken the pill correctly in the 7 days before the forgotten tablet. If not, you should follow the first of these two options and use additional protective measures during 7 days.

1. Take the forgotten tablet as soon as you remember, even if you have to take two tablets at once. 2. Continue taking the tablets at the usual time. Instead of taking the green placebo tablets from this strip, discard them and start the next strip (the start day will be different). You will most likely have your period at the end of the second strip - while taking the green placebo tablets - but you may have light bleeding or spotting during the second strip.
2. You can also stop taking the active white tablets and go directly to the 4 green placebo tablets (before taking the placebo tablets, note the day you forgot your tablet). If you want to start a new strip on the day you always start, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten any of the tablets in a strip and do not have bleeding during the placebo days, it may mean that you are pregnant. You must contact your doctor before starting the next strip.

If you have forgotten one or more green tablets, you are still protected as long as the time between the last white tablet of the current blister pack and the first white tablet of the next blister pack is not more than 4 days.

What to do in case of vomiting or severe diarrhea

If you vomit or have severe diarrhea, there is a risk that your body may not fully absorb the active ingredient of the pill, a situation similar to forgetting a tablet. In these cases, you should use an additional contraceptive method; ask your doctor for advice.

If you vomit or have severe diarrhea within 3-4 hours after taking your active white Kelzy tablet, you should take another white tablet from another blister pack as soon as possible. If possible, take it within 24 hours of the normal pill-taking time. No additional contraceptive precautions are necessary. If this is not possible or 24 hours have passed, you should follow the advice given in the section "If you forget to take Kelzy" above.

Delayed menstruation: What you should know

Although it is not recommended, you can delay your menstruation by not taking the green placebo tablets from the 4th row and going directly to a new Kelzy strip and finishing it. You may experience light bleeding or spotting while using this second strip. Finish this second strip by taking the 4 green tablets from the 4th row. Then, start the next strip.

You can ask your doctor for advice before deciding to delay your menstrual period.

Changing the day of the week when your menstruation starts: What you should know

If you take the tablets following the instructions, your menstruation will start during the placebo days. If you need to change this day, reduce the number of placebo days - when you take the green placebo tablets - (but never increase them, 4 is the maximum!). For example, if you start taking the placebo tablets on a Friday and want to change it to a Tuesday (3 days earlier), you should start a new strip 3 days earlier than usual. You may not have any bleeding during this time. Then, you can experience light bleeding or spotting.

If you are unsure what to do, consult your doctor.

If you stop treatment with Kelzy

You can stop taking Kelzy whenever you want. From the day you stop taking it, you will no longer be protected against pregnancy.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

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

All women who take combined hormonal contraceptives have a higher risk of suffering from 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 taking Kelzy".

Severe Adverse Effects

Severe reactions associated with the use of the pill, as well as associated symptoms, are described in the sections: "What you need to know before taking Kelzy", "Blood Clots", and "Kelzy and Cancer".

Read these sections of the prospectus to obtain detailed information and contact your doctor if necessary.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue, and/or throat and/or difficulty swallowing or potentially life-threatening urticaria with difficulty breathing (see also section 2 "Warnings and Precautions").

Other Possible Adverse Effects

The following adverse effects, listed by frequency, were observed in clinical studies with Kelzy:

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

• vaginal infections, including fungal infection of the vulva and vagina and bacterial vaginosis
• changes in sexual desire, mood alteration
• headache
• nausea, abdominal pain
• acne
• breast tenderness or pain, painful menstruation, abnormal bleeding between regular menstrual periods
• weight gain, increased levels of thyroid-stimulating hormone and triglycerides in blood

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

• urinary tract infection, presence of bacteria in the urine (bacteriuria)
• hypothyroidism (underactive thyroid)
• changes in appetite, including decreased or increased appetite, elevated blood glucose levels
• depressive mood, depression, anxiety, mental disorders (including mental deterioration, borderline personality disorder, and panic attack), sleep disorders (such as insomnia or somnolence)
• dizziness, migraine
• high blood pressure (hypertension)
• harmful blood clots in a vein of the leg or foot (deep vein thrombosis)
• abdominal distension
• vomiting, diarrhea, flatulence
• hair loss (alopecia)
• skin itching (pruritus), skin irritation (dermatitis), rash
• increased sweating (hyperhidrosis)
• arm and leg pain
• absence of menstrual periods, abnormal vaginal bleeding, alteration of menstrual bleeding, pelvic pain, ovarian cysts, vaginal discharge, and vulvovaginal discomfort, including itching or dryness, vulvovaginal inflammation, cervical dysplasia (abnormal cell growth on the surface of the cervix), pain/spasms during sexual intercourse (dyspareunia)
• fatigue (tiredness)
• swelling
• weight loss
• altered blood test results: elevated levels of creatine phosphokinase, cholesterol, liver enzyme in blood

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

• eardrum inflammation, which can cause hearing problems and ear pain (myringitis)
• genital herpes
• benign breast tumor (breast fibroadenoma)
• low white blood cell count (leukopenia)
• hyperthyroidism (overactive thyroid)
• fluid retention, blood lipid imbalance (dyslipidemia)
• altered taste perception (dysgeusia)
• partial loss of tactile sensation (hypoesthesia)
• burning or tingling sensation that is usually felt in hands, arms, legs, or feet, but can also occur in other parts of the body (paresthesia)
• eye itching, visual disturbances
• vertigo
• rapid heart rate (palpitations)
• fluctuation in blood pressure
• hematoma (blood accumulation outside blood vessels under the skin)
• hot flashes
• venous disorders, such as spider veins or varicose veins
• harmful blood clots in a vein or artery, for example

in a leg or foot (venous thrombosis)

or in a lung (pulmonary embolism)

• nosebleed (epistaxis)
• indigestion (dyspepsia)
• constipation
• gastroesophageal reflux
• dental sensitivity (hypersensitive teeth)
• skin disorders, dry skin, urticaria, chloasma (brownish discoloration of the skin)
• joint pain (arthralgia)
• altered urine test results: presence of red and white blood cells in the urine
• irregular thickening of the uterine lining
• genital discomfort
• general malaise
• altered blood test results: elevated levels of lactate dehydrogenase, potassium, prolactin, D-dimer in blood
• abnormal blood pressure

Reporting 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 Kelzy

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

Do not use this medicine after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Kelzy Composition

White tablet:

• The active ingredients are dienogest and ethinylestradiol.
• The other excipients are:

Tablet core: lactose monohydrate, hypromellose (E 464), povidone, magnesium stearate (E 470b).

Tablet coating: poly(vinyl alcohol) partially hydrolyzed, titanium dioxide (E 171), macrogol (E 1521), talc (E 553b).

Green tablet:

• Does not contain active ingredients.
• The other excipients are

Tablet core: lactose monohydrate, cornstarch, povidone, colloidal silicon dioxide, magnesium stearate (E 470b).

Tablet coating: hypromellose (E 464), triacetin (E 1518), polysorbate 80, titanium dioxide (E 171), carmine lake aluminum, yellow iron oxide.

Product Appearance and Package Contents

Kelzy is presented in the form of prolonged-release tablets.

Each box contains 1, 3, 6, or 13 blister packs, each containing 28 tablets (24 active white tablets and 4 inactive green tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Miralcampo Avenue, 7

Miralcampo Industrial Estate

19200 Azuqueca de Henares

Guadalajara, Spain

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate

La Vallina s/n

24008 Villaquilambre, León

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Dienogest/Ethinylestradiol Exeltis 2 mg/0.02 mg depottablett

Spain: Kelzy 2 mg/0.02 mg prolonged-release tablets

Date of the last revision of this prospectus:February 2024

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