Chlormadinone/ethinylestradiol Stadafarma 2 mg/0.03 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Chlormadinone acetate/ethinylestradiol

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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

They are one of the most reliable reversible contraceptive methods if used correctly.
They slightly increase the risk of developing a blood clot in the 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read all of this leaflet carefully before you start taking this medicine, because 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 should not be given to others, even if they have the same symptoms as you, as it could harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

What Chlormadinone/Ethinylestradiol Stadafarma is and what it is used for
What you need to know before taking Chlormadinone/Ethinylestradiol Stadafarma
How to take Chlormadinone/Ethinylestradiol Stadafarma
Possible side effects
How to store Chlormadinone/Ethinylestradiol Stadafarma
Contents of the pack and other information

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

Clormadinona/Etinilestradiol Stadafarma is a hormonal contraceptive taken orally. When hormonal contraceptives of this type contain two hormones, such as clormadinone/ethinylestradiol, they are also known as "combined hormonal contraceptives" (CHCs). The 21 tablets in the blister pack for one cycle contain the same amount of both hormones, so clormadinone/ethinylestradiol is also referred to as a "monophasic preparation".

Hormonal contraceptives such as clormadinone/ethinylestradiol will not protect you against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help protect against these.

2. What you need to know before starting Clormadinone/Ethinylestradiol Stadafarma

General considerations

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

Before starting clormadinone/ethinylestradiol, your doctor will perform a general examination and a gynecological check-up, will rule out pregnancy, and, taking into account contraindications and precautions, will decide whether clormadinone/ethinylestradiol is suitable for you. These medical check-ups should be carried out annually while you are taking clormadinone/ethinylestradiol.

Do not take Clormadinone/Ethinylestradiol Stadafarma

You must not use clormadinone/ethinylestradiol 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 appropriate.

if you are allergic to ethinylestradiol or chlormadinone acetate or to any of the other components of this medicine (listed in section 6).
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 are experiencing early symptoms of thrombosis, vein inflammation, or embolism, such as sudden sharp pain, chest pain, or chest tightness.
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 require surgery or if you remain immobile for long periods (see section “Blood clots”).
if you have diabetes with significant fluctuations in blood sugar levels.
if you have hypertension that is difficult to control or that increases significantly (values consistently above 140/90 mm Hg).
if you have ever had a heart attack or 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 transient ischemic attack (TIA, temporary stroke-like symptoms).
if you have any of the following conditions that may increase your risk of developing an arterial clot:
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 liver inflammation (e.g., due to a virus) or jaundice, as long as your liver values have not returned to normal.
if you have generalized itching or suffer from disturbances in bile flow, especially during a previous pregnancy or during estrogen treatment.
if your bilirubin (a breakdown product of blood pigment) in blood is elevated, for example due to a congenital excretion disorder (Dubin-Johnson Syndrome or Rotor Syndrome).
if you have or have previously had a liver tumor.
if you have severe stomach pain, liver enlargement, or signs of abdominal bleeding.
if you have porphyria (a disorder of blood pigment metabolism), whether or not it is the first occurrence.
if you have, have had, or are suspected of having a hormone-dependent malignant tumor, e.g., breast or uterine cancer.
- if you have meningioma or have ever been diagnosed with meningioma (a tumor

generally benign of the tissue layer between the brain and the skull).

if you have severe disorders of lipid metabolism.
if you have pancreatitis (inflammation of the pancreas) or a history of it, especially if associated with severe hypertriglyceridemia (very high levels of triglycerides in blood).
if you experience frequent or persistent episodes of unusual severe headaches.
if you have sudden disturbances in perception (vision or hearing).
if you have movement disorders (particularly signs of paralysis).
if you notice worsening of epileptic seizures.
if you have severe depression.
if you have a certain type of hearing loss (otosclerosis) that worsened during previous pregnancies.
if you have had absence of menstruation (period) for unknown reasons.
if you have abnormal thickening of the uterine mucous membranes (endometrial hyperplasia).
if, for any reason, unexplained vaginal bleeding occurs.
- if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section 2 “Other medicines and Clormadinone/Ethinylestradiol Stadafarma”).

If any of these conditions occur during treatment with clormadinone/ethinylestradiol, you must stop taking clormadinone/ethinylestradiol immediately.

You must not take clormadinone/ethinylestradiol or must stop taking it immediately if you have a serious or multiple risk factors for blood clotting disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clormadinone/Ethinylestradiol Stadafarma.

When should you consult your doctor?

Seek urgent medical attention

if you notice possible signs of a blood clot, which may mean 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 clot (thrombosis)” below).

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

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

If you smoke, as smoking increases the risk of serious side effects on the heart and blood vessels with the use of combined hormonal contraceptives. This risk increases with age and the amount smoked. It particularly affects women over 35 years of age. Women over 35 who smoke should use other contraceptive methods.

If any of these conditions develop or worsen while using clormadinone/ethinylestradiol, you should also inform your doctor.

if you have hypertension, abnormally high levels of lipids in the blood, overweight, or diabetes (see also section 2). In this case, the risk of serious side effects associated with combined hormonal contraceptives (such as myocardial infarction, embolism, stroke, or liver tumors) increases.
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 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).
if you require surgery or remain immobile for long periods (see section 2 “Blood clots”).
if you have recently given birth, you are at higher risk of blood clots. You should ask your doctor when you can start taking clormadinone/ethinylestradiol after childbirth.
if you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
if you have varicose veins.
if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as clormadinone/ethinylestradiol 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, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to clormadinone/ethinylestradiol is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be experiencing?
swelling in one leg or foot or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking. increased warmth in the affected leg. change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
sudden shortness of breath without known cause or rapid breathing. sudden cough without clear cause, possibly bringing up blood. sharp chest pain that may worsen when taking a deep breath. severe dizziness or lightheadedness. rapid or irregular heartbeat. severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
pain, discomfort, pressure, heaviness in the chest. feeling of tightness or fullness in the chest, arm, or beneath the breastbone. sensation of fullness, indigestion, or suffocation. upper body discomfort spreading to the back, jaw, throat, arm, or stomach. sweating, nausea, vomiting, or dizziness. extreme weakness, anxiety, or shortness of breath. rapid or irregular heartbeat.	Heart attack.
sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. sudden confusion, difficulty speaking or understanding speech. sudden difficulty seeing in one or both eyes. sudden difficulty walking, dizziness, loss of balance or coordination. sudden, severe, or prolonged headache without known cause. loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and slight bluish discoloration of a limb. severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

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 of 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 blood clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

The risk of developing 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 restart 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 somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking chlormadinone/ethinylestradiol, 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 on 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 chlormadinone/ethinylestradiol 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 to 7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing chlormadinone, such as chlormadinone/ethinylestradiol, between 6 and 9 will develop a blood clot in one year.
Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot within one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use cyproterone/ethinylestradiol	About 6–9 out of 10,000 women

If you notice an increase in the frequency or intensity of migraine attacks while taking clormadinone/ethinylestradiol (which may indicate impaired blood supply to the brain), consult your doctor as soon as possible, who may advise you to stop taking clormadinone/ethinylestradiol immediately.

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

The risk of developing a blood clot with clormadinone/ethinylestradiol is small, but certain conditions increase this risk. Your risk is higher:

if you are overweight (body mass index or BMI above 30 kg/m²).
if a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you may have an inherited blood clotting disorder.
if you require surgery or will be immobile for a long time due to injury, illness, or having a leg in a cast. You may need to stop taking clormadinone/ethinylestradiol several weeks before surgery or during periods of reduced mobility. If you need to interrupt the use of clormadinone/ethinylestradiol, ask your doctor when you can start taking it again.
as you get older (especially over approximately 35 years of age).
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 (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

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 need to stop using clormadinone/ethinylestradiol.

If any of the above conditions change while you are using clormadinone/ethinylestradiol—for example, a close relative experiences 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?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it may cause 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 with the use of clormadinone/ethinylestradiol is very small, but it may increase:

with age (especially over approximately 35 years).
if you smoke. When using a combined hormonal contraceptive such as clormadinone/ethinylestradiol, you are advised to stop smoking. If you are unable to quit 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 disorder called atrial fibrillation).
if you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may 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 thrombosis without a known cause, or you gain significant weight—inform your doctor.

Tumors

Some studies have observed an increased risk of cervical cancer in women infected with a sexually transmitted virus (human papillomavirus) who have been taking the pill for a long time. However, it is unclear 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 currently taking combined hormonal contraceptives. During the 10 years after stopping use, this risk gradually returns to the baseline 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 CHCs is small in relation to the overall risk of breast cancer.

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

The use of chlormadinone 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 over a prolonged period (several years). If you are diagnosed with meningioma, your doctor will discontinue your treatment (see section “Do not take Clormadinone/Ethinylestradiol 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 must inform your doctor immediately.

Other diseases

Psychiatric disorders

Some women using hormonal contraceptives such as clormadinone/ethinylestradiol have reported depression or 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 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 significantly while taking clormadinone/ethinylestradiol, you should consult your doctor, who may advise discontinuation of treatment and prescribe medication to lower your blood pressure. Use of clormadinone/ethinylestradiol may be resumed once blood pressure returns to normal values.

If you previously experienced gestational herpes during pregnancy, it may reappear during the use of hormonal contraceptives.

If you have lipid metabolism abnormalities (hypertriglyceridemia) or a family history of such, there is an increased risk of pancreatitis. In cases of acute or chronic liver function disorders, your doctor may advise interrupting treatment with clormadinone/ethinylestradiol until liver function values return to normal. If you previously experienced jaundice during pregnancy or while using a hormonal contraceptive, and it reappears, your doctor will advise you to stop taking clormadinone/ethinylestradiol.

If you are diabetic and your blood sugar level is controlled while taking clormadinone/ethinylestradiol, your doctor will monitor you closely. Your diabetes treatment may need to be adjusted.

Brown patches on the skin (chloasma) may occasionally appear, especially if they occurred during a previous pregnancy. If you know you are predisposed to this, you should avoid prolonged exposure to sunlight or ultraviolet radiation while taking clormadinone/ethinylestradiol.

Conditions that may be negatively affected

You will also require special medical supervision:

if you have epilepsy;
if you have multiple sclerosis;
if you have severe muscle cramps (tetany);
if you have migraine (see also section 2);
if you have asthma;
if you have heart or kidney disease (see also section 2);
if you have Sydenham's chorea (chorea minor);
if you have diabetes (see also section 2);
if you have liver disease (see also section 2);
if you have lipid metabolism disorders (see also section 2);
if you have immune system disorders (including systemic lupus erythematosus);
if you have excessive overweight;
if you have high blood pressure (see also section 2);
if you have endometriosis (the tissue lining the uterine cavity, called endometrium, is located outside this lining) (see also section 2);
if you have varicose veins or venous inflammation (see also section 2);
if you have blood clotting disorders (see also section 2);
if you have been diagnosed with benign uterine tumors (fibroids);
if you have a breast condition (mastopathy);
if you had blisters (gestational herpes) in a previous pregnancy;
if you suffer from depression;
if you have chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

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

Effectiveness

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

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

Irregular bleeding

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

Spotting may also indicate reduced contraceptive effect. In such cases, withdrawal bleeding may not occur after taking clormadinone/ethinylestradiol for 21 days. If you have taken clormadinone/ethinylestradiol as instructed in section 3 below, it is unlikely that you are pregnant. If you have not taken clormadinone/ethinylestradiol as instructed before the first absence of withdrawal bleeding, pregnancy should be ruled out before continuing use.

Other medicines and Clormadinone/Ethinylestradiol Stadafarma

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

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 measuring liver function (elevated liver enzyme ALT).

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

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

Some medicines may affect blood levels of clormadinone/ethinylestradiol, making it less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:

epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclon, 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 pulmonary blood vessels (bosentan),
herbal preparations containing St. John's wort (Hypericum perforatum). If you need to take St. John's wort preparations while taking clormadinone/ethinylestradiol, you should consult your doctor first.

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

During treatment with these medicines, you should use additional barrier contraceptive methods (e.g., condoms). These additional barrier methods should be used throughout the duration of concomitant treatment and for 28 days after its completion. If concomitant treatment with another medicine extends beyond the days covered by the combined hormonal contraceptive blister pack, you should start the next pack of clormadinone/ethinylestradiol without the usual break.

If you require prolonged treatment with the above-mentioned active substances, you should use non-hormonal contraceptive methods. Consult your doctor or pharmacist.

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

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

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

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

Read the package leaflet of any other prescribed medicines.

Inform your doctor if you are taking insulin or other medicines to lower blood sugar. The dosage of these medicines may need to be adjusted.

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

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

Pregnancy and breastfeeding

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

Clormadinone/ethinylestradiol is not indicated during pregnancy.

If you become pregnant while taking clormadinone/ethinylestradiol, you must stop taking it immediately. However, previous use of clormadinone/ethinylestradiol does not justify terminating the pregnancy.

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

Driving and using machines

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

This medicine 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 Clormadinone/Ethinylestradiol Stadafarma

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

Method of administration

Take orally.

How and when should you take clormadinone/ethinylestradiol?

Remove the first tablet, choosing the one marked with the correct day of the week (e.g., "Sun" for Sunday) and swallow it without chewing. Then take one tablet daily, following the direction of the arrow, preferably at the same time each day, ideally in the evening. The interval between tablet intakes should always be 24 hours whenever possible. The days printed on the cycle blister allow you to check each day whether you have already taken that day's tablet.

Take one tablet daily for 21 consecutive days. This is followed by a 7-day break. Withdrawal bleeding, equivalent to a menstrual period, usually begins 2–4 days after taking the last tablet. After the 7-day break, continue with the tablets from the next cycle blister of clormadinone/ethinylestradiol, regardless of whether bleeding has stopped or not.

When can you start taking clormadinone/ethinylestradiol?

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

Take your first tablet of clormadinone/ethinylestradiol on the first day of your next menstrual cycle.

Contraceptive protection starts on the first day of intake 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 bleeding has stopped. However, in this case, you must use additional barrier contraceptive methods during the first 7 days of intake (seven-day rule).

If your period started more than five days ago, please wait until your next period to start taking clormadinone/ethinylestradiol.

If you previously took another combined hormonal contraceptive:

Take all tablets from the old blister pack according to the usual instructions. Start taking clormadinone/ethinylestradiol the day after the usual break between tablet intakes or the day after finishing the placebo tablets of your previous combined hormonal contraceptive.

If you previously took a progestogen-only hormonal contraceptive:

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

If you previously used hormonal contraceptive injections or contraceptive implants:

Take the first tablet of clormadinone/ethinylestradiol on the same day the implant is removed or on the day corresponding to the next scheduled injection. In this case, you must use additional contraceptive measures during the first seven days.

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

After a spontaneous or induced abortion, you may start taking clormadinone/ethinylestradiol immediately. In this case, no additional contraceptive method is required.

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

If you are not breastfeeding, you may start taking clormadinone/ethinylestradiol 21–28 days after delivery. You do not need to use any additional barrier contraceptive method.

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

If you have already had sexual intercourse, pregnancy must be ruled out or you must wait for your next period before starting clormadinone/ethinylestradiol.

Remember that you must not take clormadinone/ethinylestradiol if you are breastfeeding (see section "Pregnancy and breastfeeding").

How long can you take clormadinone/ethinylestradiol?

You may take clormadinone/ethinylestradiol for as long as desired, provided there are no health risks (see section 2). Once you stop taking clormadinone/ethinylestradiol, the start of your next cycle may be delayed by about one week.

What should you do if you experience vomiting or diarrhea while taking clormadinone/ethinylestradiol?

If vomiting or diarrhea occurs within 4 hours after taking the tablets, absorption of the active ingredients in clormadinone/ethinylestradiol may be incomplete. This situation is similar to missing a tablet, and you should immediately take a new tablet from a new blister pack. Whenever possible, take the new tablet within 12 hours of taking the last tablet, then continue taking clormadinone/ethinylestradiol as usual. If this is not possible or more than 12 hours have passed, follow the instructions in section 3 “If you forget to take Clormadinone/Ethinylestradiol Stadafarma” or contact your doctor.

If you take more Clormadinone/Ethinylestradiol Stadafarma than you should

There is no evidence of severe toxicity symptoms after ingesting a large number of tablets in a single dose. Symptoms such as nausea, vomiting, and, particularly in girls, slight vaginal bleeding may occur. In such cases, consult your doctor. If necessary, your doctor will monitor electrolytes and fluid balance, and liver function.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.

If you forget to take Clormadinone/Ethinylestradiol Stadafarma

If you forget to take a tablet at the usual time, take it as soon as possible within 12 hours. In this case, no additional contraceptive methods are needed, and you may continue taking the tablets as usual.
If the interval is more than 12 hours, the contraceptive effect of clormadinone/ethinylestradiol is not guaranteed. In this case, take the missed tablet immediately and continue taking clormadinone/ethinylestradiol as usual. This may mean taking two tablets on the same day. In this case, you must use additional contraceptive methods (e.g., condoms) for the next seven days. If during these seven days you finish the current blister pack, immediately start taking tablets from the next blister pack of clormadinone/ethinylestradiol, i.e., there should be no break between blister packs (“seven-day rule”). Withdrawal bleeding (period) will probably not occur until after finishing the next blister pack. However, you may experience intermenstrual bleeding or spotting while taking tablets from the new blister pack.

The more tablets you miss, the greater the risk that pregnancy protection may be reduced. If you missed one or more tablets during the first week and had sexual intercourse in the week prior to missing the tablets, you should be aware that there is a risk of pregnancy. The same applies if you missed one or more tablets and did not have bleeding during the following break period. In such cases, consult your doctor.

If you wish to delay your menstrual period

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister pack by starting a second blister pack of clormadinone/ethinylestradiol instead of taking the usual break between tablet intakes. You may experience spotting (drops or stains of blood) or intermenstrual bleeding during use of the second blister pack. After the 7-day break between tablet intakes, continue with the next blister pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your menstrual period/withdrawal bleeding will occur during the tablet-free week. If you need to change this day, you may do so by shortening (but never extending) the tablet-free interval. For example, if your tablet-free interval starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you make the tablet-free interval very short (e.g., 3 days or less), bleeding may not occur during this period. You may then experience spotting (drops or stains of blood) or intermenstrual bleeding.

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

If you stop treatment with Clormadinone/Ethinylestradiol Stadafarma

When you stop taking clormadinone/ethinylestradiol, ovarian function will quickly return completely, and you may become pregnant.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can 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 clormadinone/ethinylestradiol, 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 about the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting Clormadinone/Ethinylestradiol Stadafarma”.

Serious 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 hives potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

The frequencies at 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 it),
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 connective tissue,
hypersensitivity to the medicine including skin allergic reactions,
changes in blood lipids including increased triglycerides,
decreased libido,
stomach pain,
intestinal noises,
diarrhea,
pigmentation disorders,
brown spots on the face,
hair loss,
dry skin,
tendency to sweat,
back pain,
muscle disorders,
breast discharge.

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

vaginal inflammation,
increased appetite,
conjunctivitis,
discomfort when wearing contact lenses,
deafness,
tinnitus,
hypertension,
hypotension,
circulatory blockage,
varicose veins,
hives,
eczema,
skin inflammation,
pruritus,
worsening of psoriasis,
excessive body or facial hair,
breast enlargement,
prolongation and/or increase in menstruation,
premenstrual syndrome (physical and emotional disturbances before menstruation begins),
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 other conditions that increase this risk (see section 2 for more information about 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 with the active substances ethinylestradiol and clormadinone in post-marketing experience: weakness and allergic reactions including swelling 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 adverse effects:

risk of venous and arterial thrombosis (see section 2),
risk of biliary tract diseases (see section 2),
risk of tumours (e.g. liver tumours, which in isolated cases have caused potentially life-threatening bleeding into the abdominal cavity, cancer of the cervix or breast (see section 2)),
worsening of chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis, see section 2).

Please read carefully the information provided in section 2 and, if necessary, consult your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clomadinone/Ethinylestradiol Stadafarma

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

Do not use this medicine after the expiry date stated on the carton and on the blister pack (cycle pack) after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clormadinona/Etinilestradiol Stadafarma

The active substances are clormadinone acetate and ethinylestradiol.

Each film-coated tablet contains 0.03 mg of ethinylestradiol and 2.0 mg of clormadinone acetate.

The other components are:

Tablet core: monohydrate lactose, corn starch, povidone K 30, magnesium stearate (Ph.Eur.)

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

Appearance of the medicine and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera,

La Vallina s/n, Villaquilambre 24193 (León)

Spain

This medicine is authorised 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 latest revision of this leaflet: May 2024

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