CLORMADINONE/ETHINYLESTRADIOL STADAFARMA 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clormadinona/Ethinylestradiol Stadafarma 2 mg/0.03 mg film-coated tablets EFG

Clormadinona, acetate/ethinylestradiol

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

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 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 medicine, as it contains important information for you.

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

Contents of the package leaflet

1. What is Clormadinona/Ethinylestradiol Stadafarma and what is it used for
2. What you need to know before taking Clormadinona/Ethinylestradiol Stadafarma
3. How to take Clormadinona/Ethinylestradiol Stadafarma
4. Possible side effects
5. Storage of Clormadinona/Ethinylestradiol Stadafarma
6. Contents of the pack and further information

1. What is Clormadinona/Ethinylestradiol Stadafarma and what is it used for

Clormadinona/Ethinylestradiol Stadafarma is an oral hormonal contraceptive. If this type of hormonal contraceptive contains two hormones like clormadinona/ethinylestradiol, it is also called a "combined hormonal contraceptive" (CHC). The 21 tablets in the blister pack for one cycle contain the same amount of both hormones, so clormadinona/ethinylestradiol is also called a "monophasic preparation".

Hormonal contraceptives like clormadinona/ethinylestradiol will not protect you against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help you with this.

2. What you need to know before starting to take Clormadinona/Etinilestradiol Stadafarma

General considerations

Before starting to use clormadinona/etinilestradiol, 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").

Before starting to take clormadinona/etinilestradiol, your doctor will perform a general examination and a gynecological review, rule out the existence of pregnancy, and considering the contraindications and precautions, decide if clormadinona/etinilestradiol is suitable for you. These medical reviews should be performed annually while you are taking clormadinona/etinilestradiol.

Do not take Clormadinona/Etinilestradiol Stadafarma

You should not use clormadinona/etinilestradiol 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.

• 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 a meningioma or have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull).

If one of these disorders occurs during the administration of clormadinona/etinilestradiol, you should stop taking clormadinona/etinilestradiol immediately.

You should not take clormadinona/etinilestradiol or should stop taking it immediately if you have a serious risk factor or multiple risk factors for blood coagulation disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clormadinona/Etinilestradiol Stadafarma.

When should you consult your doctor?

Seek urgent medical attention

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

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

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like clormadinona/etinilestradiol increases your risk of suffering from 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 (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (which 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 clormadinona/etinilestradiol 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.
• 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after an interruption 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 clormadinona/etinilestradiol, 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 clormadinona/etinilestradiol is small.

• of every 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.
• of every 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.
• of every 10,000 women who use a combined hormonal contraceptive that contains clormadinona, such as clormadinona/etinilestradiol, between 6 and 9 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)

If you notice an increase in the frequency or intensity of migraine attacks during the administration of clormadinona/etinilestradiol (which may indicate a disturbance in blood supply to the brain), consult your doctor as soon as possible, who may advise you to stop taking clormadinona/etinilestradiol immediately.

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

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

• with increasing age (especially over 35 years old).

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

Long-distance flights (more than 4 hours) can 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 unsure. Your doctor may decide to interrupt the use of clormadinona/etinilestradiol.

If any of the above conditions change while you are using clormadinona/etinilestradiol, 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 a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to clormadinona/etinilestradiol is very small, but it can increase:

• with age (over 35 years old).

Taking a blood clot can be further increased.

If any of the above conditions change while you are using clormadinone/ethinylestradiol, 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.

Tumors

In some studies, a risk factor for cervical cancer has been observed in women infected with a sexually transmitted virus (human papillomavirus) and who have been taking the pill for a long time. However, it is not clear to what extent these results may be due to other factors (e.g., multiple sexual partners, use of barrier contraceptive methods).

Studies have shown a slight increase in the risk of breast cancer in women taking combined hormonal contraceptives. During the 10 years following discontinuation of use, this risk gradually returns to the basic risk associated with age. Since breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent users of CHC is small in relation to the overall risk of breast cancer.

Rarely, cases of benign and more rarely malignant liver tumors have been reported with hormonal contraceptive treatment. These can cause dangerous internal bleeding. If you experience severe abdominal pain in the stomach that does not resolve spontaneously, you should consult your doctor.

The use of clormadinone acetate has been associated with the development of a generally benign tumor of the tissue layer between the brain and the skull (meningioma). The risk increases especially when used at high doses for a prolonged period (several years). If you are diagnosed with a meningioma, your doctor will discontinue your treatment with (see section “Do not take Clormadinona/Etinilestradiol Stadafarma”). If you notice symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in arms or legs, you should immediately inform your doctor.

Other diseases

Psychiatric disorders

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

Many users experience a slight increase in blood pressure during the use of hormonal contraceptives. If your blood pressure increases considerably while taking clormadinone/ethinylestradiol, you should consult your doctor, who will advise you to discontinue treatment and prescribe a medication to reduce blood pressure. The use of clormadinone/ethinylestradiol can be resumed once blood pressure returns to normal values.

If you have suffered from gestational herpes in a previous pregnancy, it may reappear during the use of hormonal contraceptives.

If you have lipid metabolism disorders (hypertriglyceridemia) or a family history, there is a greater risk of pancreatitis. In case of acute or chronic liver function disorders, your doctor may advise you to discontinue treatment with clormadinone/ethinylestradiol until liver function values return to normal. If you have had jaundice during a previous pregnancy or while taking a hormonal contraceptive, and it reappears, your doctor will advise you to stop taking clormadinone/ethinilestradiol.

If you are diabetic and your blood sugar level is controlledand you take clormadinone/ethinilestradiol, your doctor will closely monitor you while you are taking clormadinone/ethinilestradiol. It may be necessary to modify your diabetes treatment.

Infrequently, brown spots may appear on the skin (chloasma), especially if they appeared in a previous pregnancy. If you know you are prone to this, you should avoid long periods of sun exposure or ultraviolet radiation when taking clormadinone/ethinilestradiol.

Diseases that may be negatively affected

You will also need special medical supervision:

Consult your doctor if you have, or have had, any of the disorders mentioned or if they occur during the administration of clormadinone/ethinylestradiol.

Effectiveness

If you do not take the contraceptive regularly, have vomiting or diarrhea after administration (see section 3) or take other medications simultaneously (see section 2), the effectiveness of the contraceptive may be affected. In very rare cases, metabolic disorders can affect the contraceptive efficacy.

Even taking hormonal contraceptives correctly, they do not completely guarantee that you will not become pregnant.

Irregular bleeding

Particularly in the first months of using hormonal contraceptives, irregular vaginal bleeding (bleeding or intermenstrual spotting) may appear. If the bleeding persists or occurs for 3 months, or reappears after several consecutive cycles, consult your doctor.

Spotting may also be a sign of reduced contraceptive effect. In these cases, withdrawal bleeding may not appear after taking clormadinone/ethinylestradiol for 21 days. If you have taken clormadinone/ethinylestradiol following the instructions described below in section 3, it is unlikely that you are pregnant. If you have not taken clormadinone/ethinylestradiol following these instructions before the first absence of withdrawal bleeding, you should rule out pregnancy before continuing use.

Other medications and Clormadinona/Etinilestradiol Stadafarma

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

Do not use clormadinone/ethinylestradiol if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in blood parameters that measure liver function (increase in liver enzyme ALT).

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

Clormadinone/ethinylestradiol can be restarted approximately 2 weeks after completing this treatment. See section “Do not take Clormadinona/Etinilestradiol Stadafarma”.

Some medications may have some influence on the blood levels of clormadinone/ethinylestradiol and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used to treat:

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• preparations containing St. John's Wort (Hypericum perforatum). If you need to take preparations containing St. John's Wort while taking clormadinone/ethinylestradiol, you should consult your doctor first.

Medications that stimulate intestinal movement (e.g., metoclopramide) and activated charcoal may affect the absorption of the active substances of clormadinone/ethinylestradiol.

During treatment with these medications, you should use additional barrier contraceptive methods (e.g., condoms). These additional barrier contraceptive methods should be used throughout the duration of concomitant treatment and for 28 days after the end of treatment. If concomitant treatment with another medication is prolonged beyond the days for which the hormonal contraceptive pills are provided, you should start with the next blister of clormadinone/ethinylestradiol without leaving the usual rest interval.

If you need to undergo prolonged treatment with the aforementioned substances, you should use non-hormonal contraceptive methods. Consult your doctor or pharmacist.

The interaction between clormadinone/ethinylestradiol and other medications can increase or intensify the side effects of clormadinone/ethinylestradiol. The following medications can negatively affect the tolerability of clormadinone/ethinylestradiol:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (relieves pain and controls fever),
• atorvastatin (lowers high cholesterol levels),
• troleandomycin (an antibiotic),
• imidazole antifungals – e.g., fluconazole (to treat fungal infections),
• indinavir (for the treatment of HIV infection).

Clormadinone/ethinylestradiol can influence the effect of other medications. The efficacy or tolerability of the following medications may be reduced by clormadinone/ethinylestradiol:

• certain benzodiazepines, e.g., diazepam (for the treatment of sleep disorders),
• cyclosporine (an immunosuppressive drug),
• theophylline (treatment of asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medications, e.g., lupus, arthritis, psoriasis),
• lamotrigine (for the treatment of epilepsy),
• clofibrate (lowers high cholesterol levels),
• paracetamol (relieves pain and controls fever),
• morphine (a potent specific analgesic – relieves pain),
• lorazepam (used for the treatment of anxiety).

Read the package insert of the other medications that have been prescribed to you.

Inform your doctor if you are taking insulin or other medications to lower blood sugar levels. It may be necessary to change the dose of these medications.

Please note that the details mentioned above also apply if you have taken any of these medications shortly before starting the administration of clormadinone/ethinylestradiol.

The use of clormadinone/ethinylestradiol can affect some laboratory tests, such as liver, adrenal, and thyroid function tests, plasma concentrations of certain proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Therefore, before undergoing a blood test, inform your doctor that you are taking clormadinone/ethinylestradiol.

Pregnancy and lactation

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

Clormadinone/ethinylestradiol is not indicated during pregnancy.

If you become pregnant while taking clormadinone/ethinylestradiol, you should stop taking it immediately. However, prior use of clormadinone/ethinylestradiol does not justify the interruption of pregnancy.

If you take clormadinone/ethinylestradiol, you should remember that milk production may decrease and its quality may be affected. Very small amounts of the active ingredients pass into breast milk. Hormonal contraceptives like clormadinone/ethinylestradiol should only be used once the breastfeeding period has ended.

Driving and using machines

No negative effects of combined hormonal contraceptives on the ability to drive or operate machinery have been described.

This medication contains lactose

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

3. How to take Clormadinona/Etinilestradiol Stadafarma

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

Method of administration

Take orally.

How and when should you take Clormadinona/Etinilestradiol?

Extract the first tablet, choosing the one marked with the correct day of the week (e.g., "Sun" on Sunday) and swallow it without chewing. Then take another tablet every day, following the direction of the arrow, if possible, at the same time of day, preferably in the evening. If possible, the interval between taking the tablets should always be 24 hours. The printed days on the blister pack of the cycle allow you to check each day if you have already taken the tablet for that day.

Take one tablet daily for 21 consecutive days. This is followed by a 7-day break. Normally, the withdrawal bleeding, equivalent to the menstrual period, will begin 2-4 days after taking the last tablet. After the 7-day break, continue taking the tablets from the next blister pack of Clormadinona/Etinilestradiol, whether or not the bleeding has stopped.

When can you start taking Clormadinona/Etinilestradiol?

If you have not taken any hormonal contraceptive previously (during the last menstrual cycle)

Take your first Clormadinona/Etinilestradiol tablet on the first day of your next menstrual cycle.

Contraception begins on the first day of administration and continues during the 7-day break.

If your period has already started, take the first tablet on the 2nd-5th day of your period, regardless of whether the bleeding has stopped or not. However, in this case, you must use additional barrier contraceptive methods during the first 7 days of administration (7-day rule).

If your period started more than five days ago, please wait until the next period to start taking Clormadinona/Etinilestradiol.

If you have previously taken another combined hormonal contraceptive

Take all the tablets from the old blister pack following the usual guidelines. You should start taking Clormadinona/Etinilestradiol the day after the usual break interval between taking tablets or the day after finishing the placebo tablets from your previous combined hormonal contraceptive.

If you have taken a progestogen-only hormonal contraceptive

If you are taking a progestogen-only hormonal contraceptive, you may not experience withdrawal bleeding, equivalent to the menstrual period. In this case, take the first Clormadinona/Etinilestradiol tablet the day after taking the last minipill. In this case, you must take additional contraceptive measures during the first 7 days.

If you have previously used hormonal injectable contraceptives or contraceptive implants

Take the first Clormadinona/Etinilestradiol tablet on the same day the implant is removed or on the day corresponding to the next injection. In this case, you must take additional contraceptive measures during the first 7 days.

If you have had a spontaneous or induced abortion in the first three months of pregnancy

After a spontaneous or induced abortion, you can start taking Clormadinona/Etinilestradiol immediately. In this case, you do not need to use any additional contraceptive method.

If you have given birth or have had a spontaneous or induced abortion between the third and sixth month of pregnancy

If you are not breastfeeding, you can start taking Clormadinona/Etinilestradiol 21-28 days after giving birth. You do not need to use any additional barrier contraceptive method.

However, if more than 28 days have passed since giving birth, you must use additional barrier contraceptive methods during the first 7 days.

If you have already had sexual intercourse, you should rule out the possibility of pregnancy or wait for your next period before starting to take Clormadinona/Etinilestradiol.

Remember that you should not take Clormadinona/Etinilestradiol if you are breastfeeding (see section "Pregnancy and breastfeeding").

How long can you take Clormadinona/Etinilestradiol?

You can take Clormadinona/Etinilestradiol for as long as you want, as long as there are no health risks (see section 2). Once you stop taking Clormadinona/Etinilestradiol, your ovarian function will be fully restored, and you may become pregnant.

What should you do in case of vomiting or diarrhea while taking Clormadinona/Etinilestradiol?

If vomiting or diarrhea occurs within 4 hours of taking the tablets, the absorption of the active ingredients of Clormadinona/Etinilestradiol may be incomplete. This situation is similar to that which occurs if you forget to take a tablet and need to take a new tablet from a new blister pack immediately. Whenever possible, take the new tablet before 12 hours from the ingestion of the last tablet and then continue taking Clormadinona/Etinilestradiol following your usual schedule. If it is not possible or more than 12 hours have passed, follow the instructions in section 3 "If you forgot to take Clormadinona/Etinilestradiol Stadafarma" or contact your doctor.

If you take more Clormadinona/Etinilestradiol Stadafarma than you should

There is no evidence of serious toxicity symptoms after ingesting a large number of tablets in one dose. Symptoms such as nausea, vomiting, and, particularly in girls, mild vaginal bleeding may appear. In these cases, consult a doctor. If necessary, they will monitor electrolytes and fluid balance, and liver function.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forgot to take Clormadinona/Etinilestradiol Stadafarma

more than 12 hours, the contraceptive effect of Clormadinona/Etinilestradiol is not guaranteed. In this case, take the forgotten tablet immediately and continue taking Clormadinona/Etinilestradiol following your usual schedule. This may even mean that you need to take 2 tablets on the same day. In this case, you must use additional contraceptive methods (e.g., condoms) for the next 7 days. If during these 7 days you finish the blister pack you started, begin taking the tablets from the next Clormadinona/Etinilestradiol blister pack immediately, i.e., there should be no break between blister packs ("7-day rule"). You may not experience withdrawal bleeding (menstruation) until you have finished the next blister pack. However, you may experience intermenstrual bleeding or spotting while taking the tablets from the new blister pack.

The more tablets you forget, the higher the risk that pregnancy protection may be reduced. If you forgot one or more tablets in the first week and had sexual intercourse in the week before forgetting the tablets, you should be aware that there is a risk of pregnancy. The same applies if you forgot one or more tablets and did not have bleeding during the next break interval. In these cases, consult your doctor.

If you want to delay your menstrual period

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister pack if you start taking a second blister pack of Clormadinona/Etinilestradiol instead of continuing with the break interval between taking tablets. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the second blister pack. After the 7-day break interval, you will continue with the next blister pack.

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

If you want to change the first day of your menstrual period

If you take the tablets according to the instructions, your menstrual period/withdrawal bleeding will begin during the break interval between taking tablets. If you need to change this day, you can do so by shortening (but never lengthening) the break interval between taking tablets. For example, if your break interval between taking tablets starts on a Friday, and you want to change it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you make the break interval between taking tablets very short (e.g., 3 days or less), you may not experience bleeding during this period. You may then experience spotting (drops or spots of blood) or intermenstrual bleeding.

If you are unsure how to proceed, consult your doctor for advice.

If you interrupt treatment with Clormadinona/Etinilestradiol Stadafarma

When you stop taking Clormadinona/Etinilestradiol, your ovarian function will be fully restored, and you may become pregnant.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Clormadinona/Etinilestradiol, 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 taking Clormadinona/Etinilestradiol Stadafarma".

Severe side 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 potentially with difficulty breathing (see also the section "Warnings and precautions").

The frequencies with which adverse effects have been reported are defined below:

Very common:May affect more than 1 in 10 people.

• nausea,
• vaginal discharge,
• menstrual pain,
• absence of menstruation.

Common:May affect up to 1 in 10 people.

• depression,
• nervousness,
• irritability,
• dizziness,
• migraine (and/or worsening of these),
• visual disturbances,
• vomiting,
• acne,
• feeling of heaviness,
• abdominal pain,
• fatigue,
• fluid retention,
• weight gain,
• increased blood pressure.

Uncommon:May affect up to 1 in 100 people.

• vaginal fungal infection,
• benign changes in breast tissue,
• hypersensitivity to the medication, including allergic skin reactions,
• changes in blood lipids, including increased triglycerides,
• decreased libido,
• stomach pain,
• intestinal noises,
• diarrhea,
• pigmentation problems,
• brown spots on the face,
• hair loss,
• dry skin,
• tendency to sweat,
• back pain,
• muscle disorders,
• breast secretion.

Rare:May affect up to 1 in 1,000 people.

• vaginal inflammation,
• increased appetite,
• conjunctivitis,
• discomfort when wearing contact lenses,
• hearing loss,
• tinnitus,
• hypertension,
• hypotension,
• blockage of blood circulation,
• varicose veins,
• hives,
• eczema,
• skin inflammation,
• itching,
• worsening of psoriasis,
• excessive hair on the body or face,
• breast enlargement,
• prolonged and/or increased menstruation,
• premenstrual syndrome (physical and emotional disorders before starting menstruation).
• 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 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 probability of having a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare:May affect up to 1 in 10,000 people.

• erythema nodosum.

In addition, the following adverse reactions have been reported in association with the active ingredients etinilestradiol and clormadinona in post-marketing experience: weakness and allergic reactions, including inflammation of the deep layers of the skin (angioedema).

Combined hormonal contraceptives have also been associated with an increased risk of the following diseases and serious side effects:

• risk of venous and arterial thrombosis (see section 2),
• risk of bile duct diseases (see section 2),
• risk of tumors (e.g., liver tumors, which in isolated cases have caused bleeding in the abdominal cavity, potentially fatal, cervical or breast cancer (see section 2)),
• worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see section 2).

Read carefully the information presented in section 2, and if necessary, consult your doctor immediately.

Reporting of side effects

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

5. Storage of Clormadinona/Etinilestradiol Stadafarma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the blister pack (cycle pack) after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Clormadinona/Etinilestradiol Stadafarma

• The active ingredients are clormadinona acetate and etinilestradiol.

Each film-coated tablet contains 2.0 mg of clormadinona acetate and 0.03 mg of etinilestradiol.

• The other ingredients are:

Core of the tablet: lactose monohydrate, cornstarch, povidone K 30, magnesium stearate (Ph.Eur.)

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), red iron oxide (E 172).

Appearance of the product and package contents

Clormadinona/Etinilestradiol Stadafarma is available in calendar blister packs containing 1x21, 3x21, and 6x21 film-coated tablets, which are pink, round, and biconvex.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios León Farma, S.A.

Navatejera Industrial Estate,

La Vallina s/n, Villaquilambre 24193 (León)

Spain

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

Germany Bonita AL 0.03 mg/2 mg Filmtabletten

Spain Clormadinona/Etinilestradiol Stadafarma 2 mg/0.03 mg film-coated tablets EFG

Date of the last revision of this leaflet:May 2024

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