Clormadinona/etinilestradiol stadafarma 2 mg/0,03 mg comprimidos recubiertos con pelicula efg
Introduction
Package Leaflet: Information for the User
Clormadinona/Etinilestradiol Stadafarma 2 mg/0.03 mg Film-Coated Tablets
Clormadinona, acetate/ethinylestradiol
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you experience. The final part of section 4 includes information on how to report side effects.
Important information about combined hormonal contraceptives (CHCs):
- They are one of the most reliable reversible contraceptive methods if used correctly.
- They slightly increase the risk of suffering a blood clot in veins and arteries, especially in the first year or when restarting use of 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 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 further questions, ask your doctor or pharmacist.
-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
-If you experience side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.
1.What is Clormadinona/Etinilestradiol Stadafarma and what it is used for
2.What you need to know before you start taking Clormadinona/Etinilestradiol Stadafarma
3.How to take Clormadinona/Etinilestradiol Stadafarma
4.Possible side effects
5.Storage of Clormadinona/Etinilestradiol Stadafarma
6.Contents of the pack and additional information
1. What is Clormadinona/Etinilestradiol Stadafarma and what is it used for
Clormadinona/Etinilestradiol Stadafarma is a hormonal contraceptive taken orally. If this type of hormonal contraceptive contains two hormones such as clormadinona/etinilestradiol, they are also known as "combined hormonal contraceptives" (CHCs). The 21 tablets in the blister pack for a cycle contain the same amount of both hormones, so clormadinona/etinilestradiol is also known as "monophasic preparation".
Hormonal contraceptives like clormadinona/etinilestradiol will not protect you against HIV (AIDS) infection or other sexually transmitted diseases. Only condoms can help protect you against these.
2. What you need to know before starting Clormadinona/Etinilestradiol Stadafarma
General Considerations
Before starting to use clormadinone/ethinylestradiol, 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 clormadinone/ethinylestradiol, your doctor will perform a general examination and a gynecological examination, rule out pregnancy, and, taking into account the contraindications and precautions, decide if clormadinone/ethinylestradiol is suitable for you. These medical examinations must be performed annually while taking clormadinone/ethinylestradiol.
Do not take Clormadinone/Ethinylestradiol Stadafarma
You should 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 what other form of contraception would be more suitable.
-If you are allergic to ethinylestradiol or chloradinone acetate or to any of the other components of this medication (including in section 6).
-If you have (or have had at any time) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
-If you present the initial symptoms of thrombosis, inflammation of the veins or embolism, such as the appearance of a brief stabbing pain, chest pain or oppression in the chest.
-If you know that you have a disorder that affects blood coagulation - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
-If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
-If you have diabetes and present significant fluctuations in blood sugar levels.
-If you have uncontrolled high blood pressure or that increases significantly (constantly above 140/90 mmHg).
-If you have had a heart attack or a stroke.
-If you have (or have had at any time) 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, symptoms of a stroke).
-If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
-Severe diabetes with vascular 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 had at any time) 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 have bile flow alterations and especially during a previous pregnancy or during hormone treatment.
-If your bilirubin (a product of blood pigment degradation) in the blood is increased, for example, due to a congenital excretion disorder (Dubin-Johnson syndrome or Rotor syndrome).
-If you have or have had liver cancer.
-If you have intense stomach pain, liver enlargement or signs of bleeding in the abdomen.
-If you have porphyria (a disorder of blood pigment metabolism), whether or not it is the first time.
-If you have or have had or are suspected to have any malignant tumor that depends on hormone action, e.g., breast cancer or uterine cancer.
- If you have meningioma or have ever been diagnosed with meningioma (a generally benign tumor of the tissue layer between the brain and the skull).
-If you have severe lipid metabolism disorders.
-If you have pancreatitis (inflammation of the pancreas) or a history of the same, in the case of being associated with severe hypertriglyceridemia (very high levels of triglycerides in the blood).
-If you have frequent or persistent severe unusual headaches.
-If you have sudden changes in perception (vision or hearing).
-If you present sudden changes in movement (particularly signs of paralysis).
-If you observe worsening of 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 amenorrhea (absence of menstruation) due to an unknown cause.
-If you have an abnormal thickening of the uterine mucous membranes (endometrial hyperplasia).
-If you have any reason to appear unjustified vaginal bleeding.
- if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 2 “Other Medications and Clormadinone/Ethinylestradiol Stadafarma”).
If you develop any of these disorders during the administration of clormadinone/ethinylestradiol, you should stop taking clormadinone/ethinylestradiol immediately.
You should not take clormadinone/ethinylestradiol or should stop taking it immediately if you have a high-risk factor or multiple risk factors for blood clot 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 assistance
-If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section “Blood Clots” below).
To obtain 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 tobacco increases the risk of serious cardiovascular side effects with the use of combined hormonal contraceptives. This risk increases with age and with tobacco consumption. It affects especially women over 35 years old. Smoking women over 35 years old should use other methods of contraception.
If the condition develops or worsens while using clormadinone/ethinylestradiol, you should also inform your doctor.
- if you have hypertension, abnormally high levels of lipids in the blood, obesity 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 that affects your natural defense system).
- if you have hemolytic uremic syndrome (HUS, a blood clot disorder that causes kidney insufficiency).
- if you have sickle cell anemia (a hereditary disorder of red blood cells).
- if you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
- if you need surgery or spend a lot of time without standing up (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 delivery.
- if you have superficial vein inflammation that is under the skin (superficial thrombophlebitis).
- if you have varicose veins.
- if you experience angioedema symptoms such as facial swelling, tongue and/or throat swelling and/or difficulty swallowing or urticaria with difficulty breathing, contact a doctor immediately. Estrogen-containing products can cause or worsen symptoms of hereditary and acquired angioedema.
BLOOD CLOTS
The use of a combined hormonal contraceptive like clormadinone/ethinylestradiol increases your risk of suffering 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 veins (which is called “venous thrombosis”, “venous thromboembolism” or VTE).
-In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).
The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.
It is essential 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 assistanceif you notice any of the following signs or symptoms.
Do you experience any of these signs? | What could you be suffering from? |
| Deep vein thrombosis |
If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a less severe condition like a common cold. (e.g., a “common cold”). | Pulmonary embolism |
Symptoms that occur more frequently in one eye:
| Retinal vein thrombosis (blood clot in the eye). |
| Heart attack. |
Sometimes the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek urgent medical assistance as you may be at risk of another stroke. | Stroke |
| Blood clots that block 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 in the first year of use of a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
- If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
- In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).
When is the risk of a blood clot in a vein higher?
The risk of a blood clot in a vein is higher during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher also if you start taking a combined hormonal contraceptive again (the same medication or a different medication) 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 clormadinone/ethinylestradiol, your risk of a blood clot returns to normal in a few weeks.
What is the risk of 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 a blood clot in the leg or lung (DVT or PE) with clormadinone/ethinylestradiol is small.
-Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
-Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
-Of every 10,000 women who use a combined hormonal contraceptive that contains clormadinone, such as clormadinone/ethinylestradiol, between 6 and 9 will develop a blood clot in a year.
-The risk of 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 in a year in a year | |
Women whodo not usea combined hormonal contraceptive and who are not pregnant hormonal contraceptive | Approximately 2 of every 10,000 women |
Women who use a combined hormonal contraceptive that contains levonorgestrel, noretisterone or norgestimato | Approximately 5-7 of every 10,000 women |
Women who use clormadinone/ethinylestradiol | Approximately 6 – 9 of every 10,000 women |
If you notice an increase in the frequency or intensity of migraine attacks during the administration of clormadinone/ethinylestradiol (which may indicate a change in 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
Your risk of a blood clot with clormadinone/ethinylestradiol is small, but some conditions increase the risk. Your risk is higher:
-if you are overweight (body mass index (BMI) greater than 30 kg/m2).
-if one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have a hereditary disorder of blood coagulation.
-if you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking clormadinone/ethinylestradiol for several weeks before the surgical procedure or while you have less mobility. If you need to stop taking clormadinone/ethinylestradiol, ask your doctor when you can start taking it again.
-with increasing age (especially over about 35 years).
-if you have given birth recently.
Your risk of a blood clot increases the more conditions you have.
Long flights (over 4 hours) may temporarily increase your 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 conditions above, even if you are unsure. Your doctor may decide to stop taking clormadinone/ethinylestradiol.
If any of the conditions above change while you are using clormadinone/ethinylestradiol, for example, a close relative experiences a blood clot 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 blood 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 clormadinone/ethinylestradiol is very small, but it may increase:
-with age (over about 35 years).
-if you smoke.When using a combined hormonal contraceptive like clormadinone/ethinylestradiol, you are advised to quit 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 contraception.
-if you are overweight.
-if you have high blood pressure.
-if one of your close relatives has 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 a heart attack or stroke.
-if you 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, rhythm disorder called atrial fibrillation).
-if you have diabetes.
Your risk of a blood clot may be increased even more if you have one or more of these conditions or if any of them are particularly severe.
If any of the conditions above change while you are using clormadinone/ethinylestradiol, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.
Tumors
In some studies, a risk factor for cervical cancer (cervix) has been observed in women infected with a sexually transmitted virus (human papillomavirus) and who have been taking the pill for a long period of 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 the interruption of use, this risk returns gradually to the age-related risk. Since breast cancer is rare in women under 40 years of age, the number of excess diagnoses of breast cancer in current and recent users of CHC is small compared to the overall risk of breast cancer.
In rare cases, benign liver tumors and, more rarely, malignant liver tumors have been reported with hormone treatment. These can cause a life-threatening internal hemorrhage. If you experience severe abdominal pain in the stomach that does not subside spontaneously, you should consult your doctor.
The use of chloradinone 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 meningioma, your doctor will stop your treatment with (see section “Do not take Clormadinone/Ethinylestradiol Stadafarma”). If you notice symptoms such as changes in vision (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in arms or legs, you should immediately inform your doctor.
Other diseases
Psychiatric disorders
Some women who use combined 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 combined hormonal contraceptives. If blood pressure increases significantly while taking clormadinone/ethinylestradiol, you should consult your doctor, who will advise you to stop treatment and prescribe a medication to reduce blood pressure. Clormadinone/ethinylestradiol use can be resumed once blood pressure returns to normal.
If you have had herpes gestational in a previous pregnancy, it may recur during the use of combined hormonal contraceptives.
If you have lipid metabolism disorders (hypertriglyceridemia) or have a family history of this condition, there is a higher risk of pancreatitis. In cases of acute or chronic liver function disorders, your doctor may advise you to stop treatment with clormadinone/ethinylestradiol until liver function values return to normal. If you have had jaundice during a previous pregnancy or during hormone treatment, and it recurs, your doctor will advise you to stop taking clormadinone/ethinylestradiol.
If you are diabetic and your blood sugar levels are controlled, your doctor will monitor you closely while you are taking clormadinone/ethinylestradiol. You may need to modify your diabetes treatment.
With rare frequency, brown spots may appear on the skin (chloasma), especially if they appeared during a previous pregnancy. If you know you are prone to it, you should avoid long periods of exposure to the sun or ultraviolet radiation while taking clormadinone/ethinylestradiol.
Diseases that may be negatively affected
You will also need special medical supervision:
-if you have epilepsy;
-if you have multiple sclerosis;
-if you have severe muscle cramps (tetany);
-if you have migraines (see also section 2);
-if you have asthma;
-if you have heart or kidney disease (see also section 2);
-if you have Saint Vitus' dance (corea 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 are severely overweight;
-if you have high blood pressure (see also section 2);
-if you have endometriosis (the tissue that covers the uterine cavity, called endometrium, is found outside of this layer of covering) (see also section 2);
-if you have varicose veins or vein inflammation (see also section 2);
-if you have blood clotting disorders (see also section 2);
-if you have benign tumors in the uterus (myoma);
-if you have breast disease (mastopathy);
-if you had herpes gestational in a previous pregnancy;
-if you have 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 conditions mentioned or if they occur during the administration of clormadinone/ethinylestradiol.
Efficacy
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's effectiveness may be affected. In very rare cases, metabolic disorders may affect the contraceptive's efficacy.
Even when taking the contraceptives correctly, they do not guarantee that you will not become pregnant.
Irregular bleeding
Particularly in the first months of use of combined hormonal contraceptives, irregular vaginal bleeding (intermenstrual bleeding or spotting) may occur. If the bleeding persists or occurs for 3 months, or recurs after several consecutive cycles, consult your doctor.
Spotting may also be a sign of reduced contraceptive effectiveness. In these cases, menstruation may not occur after taking clormadinone/ethinylestradiol for 21 days. If you have taken clormadinone/ethinylestradiol following the instructions described 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 menstruation, you should rule out pregnancy before continuing with its use.
Other medications and Clormadinone/Ethinylestradiol Stadafarma
Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.
Do not use clormadinone/ethinylestradiol if you have hepatitis C and are taking medications that contain ombitas Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Administration mode Take by mouth. How and when should you take clormadinona/etinilestradiol? Remove the first tablet, choosing the one marked with the correct day of the week (e.g., "Dom" 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 at night. If possible, the interval between the intake of the tablets should always be 24 hours. The printed days on the blister 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. Then, a break of seven days follows. Normally, the bleeding due to deprivation, equivalent to the menstrual period, will begin 2-4 days after taking the last tablet. After the seven-day break, continue taking the tablets from the next blister of the clormadinona/etinilestradiol cycle, whether or not the bleeding has stopped. When can you start taking clormadinona/etinilestradiol? If you have not taken any hormonal contraceptives 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 contraceptives 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 taken a previous combined hormonal contraceptive Take all the tablets from the old blister following the usual schedule. You must start taking clormadinona/etinilestradiol the day after the usual break between tablet intake or the day after the last tablet of your previous combined hormonal contraceptive. If you have taken a hormonal contraceptive that only contains progestogens If you are taking a hormonal contraceptive that only contains progesterone, you may not have bleeding due to deprivation, 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 use additional contraceptive measures during the first 7 days. If you have previously used injectable hormonal contraceptives or implants Take the first clormadinona/etinilestradiol tablet on the same day as the removal of the implant or the day corresponding to the next injection. In this case, you must use 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 measures. 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 can start taking clormadinona/etinilestradiol 21-28 days after delivery. You do not need to use any additional barrier contraceptive measures. However, if more than 28 days have passed since delivery, you must use additional barrier contraceptive measures during the first 7 days. If you have already had sex, you must rule out pregnancy or wait until the 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 risks to your health (see section 2). Once you stop taking clormadinona/etinilestradiol, the start of your next cycle may be delayed by about a week. What should you do if you vomit or have diarrhea while taking clormadinona/etinilestradiol? If vomiting or diarrhea occurs within 4 hours of taking the tablets, it is possible that the absorption of the active principles of clormadinona/etinilestradiol may be incomplete. This situation is similar to what happens if you forget to take a tablet and have to take a new tablet from a new blister immediately. If possible, take the new tablet within 12 hours of taking the last tablet and continue taking clormadinona/etinilestradiol following your usual schedule. If 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 severe toxicity symptoms after ingesting a large number of tablets in a single dose. You may experience symptoms such as nausea, vomiting, and, particularly in girls, light vaginal bleeding. In these cases, consult your doctor. If necessary, they will check your electrolytes and fluid balance, and liver function. Consult your doctor or pharmacist immediately in case of overdose or accidental ingestion, or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested. If you forgot to take Clormadinona/Etinilestradiol Stadafarma The more tablets you forget, the greater the risk that the protection against pregnancy may be reduced. If you forgot one or more tablets in the first week and had sex in the week before forgetting the tablets, you must know that there is a risk of pregnancy. The same applies if you forgot one or more tablets and did not have bleeding in the next break period. In these cases, consult your doctor. If you want to delay your menstrual period Although not recommended, it is possible to delay your menstrual period (bleeding due to deprivation) until the end of a new blister if you start taking a second blister of clormadinona/etinilestradiol instead of continuing with the break between tablet intake. You may experience spotting (light bleeding) or intermenstrual bleeding during the use of the second blister. After the break between tablet intake of 7 days, continue with the next blister. 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 as instructed, your menstrual period/bleeding due to deprivation will begin during the break between tablet intake. If you need to change that day, you can do so by shortening (but not lengthening) the break between tablet intake. For example, if your break between tablet intake begins on Friday, and you want to change it to Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. If you shorten the break between tablet intake too much (e.g., 3 days or less), you may not experience bleeding during this period. You may then experience spotting (light bleeding) 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 questions about the use of this medication, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due to clormadinone/ethinylestradiol, consult your doctor. All women taking 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 starting to take Clormadinone/Ethinylestradiol Stadafarma”. Severe side effects Seek medical attention immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially difficulty breathing (see also the section “Warnings and precautions”). The frequencies with which side effects have been reported are defined as follows: Very common: May affect more than 1 in 10 people. Common:May affect up to 1 in 10 people. Uncommon:May affect up to 1 in 100 people. Rare:May affect up to 1 in 1,000 people. -In a leg or foot (i.e. DVT). -In a lung (i.e. PE). -Heart attack. -Stroke. -Transient ischemic attack (TIA). -Blood clots in the liver, stomach/intestine, kidneys, or eye. The risk 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. In addition, the following adverse reactions associated with the active ingredients ethinylestradiol and clormadinone have been reported in post-marketing experience: weakness and allergic reactions including deep skin inflammation (angioedema). Combined hormonal contraceptives have also been associated with an increased risk of the following diseases and severe adverse 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 potentially fatal bleeding in the abdominal cavity, cervical cancer or breast cancer(see section 2), -Worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis,see section 2). Read the information presented in section 2 carefully and consult your doctor immediately if necessary. 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 System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine. Keep this medication out of the sight and reach of children. Do not use this medication after the expiration date that appears on the box and on the blister (cycle packaging) after “CAD". The expiration date is the last day of the month indicated. This medication does not require special storage conditions. Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment. Composition of Clormadinone/Ethinylestradiol Stadafarma -The active principles are chloradinone acetate and ethinylestradiol. Each coated tablet contains 0.03 mg of ethinylestradiol and 2.0 mg of chloradinone acetate. -The other components are: Tablet core: lactose monohydrate, cornstarch, povidone K 30, magnesium stearate (Ph.Eur.) Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide red (E 172). Appearance of the product and content of the container Clormadinone/Ethinylestradiol Stadafarma is available in calendar blisters that contain 1x21, 3x21 and 6x21 coated tablets, pink, round and biconvex. Only some container sizes may be marketed. Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization: STADA Laboratory, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain Responsible for manufacturing: León Farma Laboratories, S.A. La Vallina s/n, Industrial Estate Navatejera, Villaquilambre 24008 (León) Spain This medicine is authorized in the member states of the European Economic Area with the following names: GermanyBonita AL 0.03 mg/2 mg Filmtabletten SlovakiaEthinylestradiolu/Chlormadinónacetátu STADA 0.03 mg/2 mg filmom obalené tablety SpainClormadinone/Ethinylestradiol Stadafarma 2 mg/0.03 mg coated tablets EFG Date of the last review of this leaflet:May 2024 Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/3. How to Take Clormadinona/Ethinylestradiol Stadafarma
4. Possible Adverse Effects
5. Conservation of Clormadinona/Ethinylestradiol Stadafarma
6. Content of the container and additional information
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