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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 26.06.2023

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Each pink active film-coated tablet contains Drospirenone (Arankelle) 3 mg and Ethinylestradiol (Arankelle) 20 mcg as active substances. The white film-coated tablets do not contain active substances. It also contains the following ingredients: Pink active film-coated tablets: Tablet Core: Lactose monohydrate, pregelatinized starch (maize), povidone, croscarmellose sodium, polysorbate 80, magnesium stearate. Coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). White film-coated tablets: Tablet Core: Anhydrous lactose, povidone, magnesium stearate. Coating: Partially hydrolized polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Each blister contains 28 tablets, 24 pink, active film-coated tablets in the 1st, 2nd, 3rd and 4th rows of the strip and 4 white placebo film-coated tablets in row 4. The core of the tablet is coated.
Each of the 24 active tablet contains a small quantity of 2 different female hormones, called Drospirenone (Arankelle) (a progestogen) and Ethinylestradiol (Arankelle) (an estrogen). Due to the small quantity of the hormones, Arankelle is considered a low-dose oral contraceptive. Since all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
The 4 tablets do not contain active ingredients and are called placebo tablets.
WHAT IS THE DAILY ARANKA AND WHAT IS IT USED FOR?
- Aranka Daly.
- Each of the 21 white tablets contains a small of two ingredients various, namely drospirenone and ethinylestradiol.
- 7 green tablets do not contain active substances and are also called placebo tablets.
- Oral contraceptives containing two hormones are called combined contraceptives¿.
HOW TO TAKE ARANKA DAILY
Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.
Each light pack contains 21 Target Tablet and 7 Selenium placebo tablets. Two types of tablets of different colors of daily Aranka are arranged in order. Blaster 28 28 tablet.
Take one tablet of Aranki daily every day, if necessary with a small amount of water. You can take the pills with or without food, but you should take the pills more or less at the same time every day.
Don't confuse the pills: allows one Blu Tablet every day for the first 21 days, and then one usually Tablet for the last 7 days. 21 (21 7 7 green tablets). Therefore, there is no rest between the blisters.
Due to the different composition of the tablet, it is necessary to start with the first tablet in position 1 in the same rich way as with the expression " start”, and then take one tablet every day. To follow the correct order, follow the direction of the arrows and the numbering of the blister pack.
Preparation of the blister
You should know on what day of the week you will take your first pill
To help you keep track of yourself, there are 7 acid-shaped strips with I-7 give me weeks. Select the line label that corresponds to the first day you start taking the pills. My, my,,, my " mi "" bind character “?"label over the same symbol on the blister card and place it in the area surrounded by the black line" Each day you will be lined up in a row of tablets.
Now a day will appear above each pill, and you will be able to see if the pill was taken or not on a specific day. Follow the style direction on the map until all 28 tablets are Print.
Heather (also unleashed by the retreating heather) should be active for 7 days when you take the green placebo pills (placebo days). This usually starts on the second or third day after you have taken the last active white tablet of your daily Aranka. After you have taken the last green pill, you will need to start the next blister pack, whether it has stopped bleeding or not. This means that you will start each blister pack on the same day of the week, and that the receding bleeding should occur on the same day of the week.
If you are a husband on a daily basis according to these instructions, you will also be protected from pregnancy for 7 days when you take a placebo pill.
When can you start with the first blister pack
- If you did not use hormonal contraception in the previous month
See also:
What is the most important information I should know about Arankelle?
Hypersensitivity to Drospirenone (Arankelle) or Ethinylestradiol (Arankelle) or any other ingredient in Arankelle. This could cause itching, a rash or inflammation.
Patients that have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (embolsim) or other organs; a heart attack or stroke; any illness which could lead to a heart attack (eg, angina pectoris which causes serious pain in the chest) or a stroke (eg, a temporary or minor stroke without residual effects); certain form of migraine (focal neurological symptoms); inflammation of the pancreas (pancreatitis); liver illness and hepatic function have not yet normalized; kidneys do not work well (kidney failure); liver tumor; suspect breast cancer or cancer of the sexual organs.
Any illness which could increase the risk of developing artery thrombosis eg, diabetes with damaged blood vessels, very high blood pressure, very high fat levels in the blood (cholesterol or triglycerides); disturbance of blood clotting (eg, protein C deficiency); vaginal bleeding and the cause is unknown.
Use in pregnancy: If the patient is pregnant, do not take Arankelle. If the patient is pregnant when taking Arankelle, stop taking it immediately and contact the doctor.
Consult the doctor or pharmacist before taking any medicine.
POSSIBLE SIDE EFFECTS
Like all medications, Aranka can cause side effects on a daily basis, even if not all people suffer from them. If you suffer from any side effects, especially if they are serious and permanent, or you have any health changes that you think may be caused by daily Aranka, contact your doctor.
The interaction of other drugs (enzyme inducers) with oral contraceptives can lead to intermenstrual bleeding and/or failure of contraception.
All women, the Golden sister of the union should be in the day, Buddha cat very Edit lawyer taste of blood in the Go (of us does not speak by (II)) or by blood in the artery (material lottery (ASD)). For more information about the different risks of taking combined hormonal contraceptives, see 2 "Daily, Daily Daily".
Side effects requiring immediate medical attention:
- allergic reaction (hypersensitivity),
- jaundice and liver problems and symptoms,
- SL (SL SLS),
- erythema multiforme (characterized by a skin rash with reddish spots of color with a view of the target or injury).
- harmful blood clots in a vein or artery, for example:
- on one leg or leg (i.e., DVT)
- in the lung (vol.)
- heart attack
- - stroke,
-
- mini-stroke or temporary stroke-like symptoms called transient ischemic accident (TIA) blood clots in the liver, stomach/intestines, kidneys, or eye.
BEFORE TAKING YOUR DAILY ARANKA
General considerations:
Daily Daily Daily, Daily 2. it is especially important that you know the symptoms of blood loss (see section 2 " Blood clots”).
Before you can start taking Aranka daily, your doctor will ask you a few questions about your medical history and the history of your close relatives. Your doctor will also check your blood pressure, and depending on your personal situation, he may perform several other tests.
Daily, Daily aranka Daily, Daily aranka Daily. In these situations, you will have to stop sexual intercourse or take additional non-hormonal contraceptive precautions, such as using a condom or any barrier method.
Do not use rhythm or temperature methods. These methods can be unreliable, as daily Aranka alters monthly changes in body temperature and cervical mucus.
Spider Daily, Daily, - - ((()..
Do not take Aranka daily
You should not use Aranka daily if you have any of the conditions listed below. Tell your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be most appropriate.
- 6 (6 6). This can cause itching, rash, or swelling,
- if you have (or have ever had) a blood clot in your leg blood vessel( deep vein thrombosis, DVT), in your lungs (pulmonary embolism, Pe), or in other organs,
- If you know what is said in this from Gard, which affects but can be blood: for example, I Travel with, deficit Beige S, deficit so ends III, factor V LAN or above all.
- if you need surgery or spend a lot of time without getting up (see the section "blood clots").
- if you've ever had a heart attack or stroke,
- if you have (or have ever had) angina (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic accident (TIA, temporary stroke symptoms),
- if you have any of the following conditions that may increase your risk of clot formation in your arteries:
- severe diabetes with blood vessel damage,
- very high blood pressure,
- very high levels of fat in the blood (cholesterol or triglycerides),
- a condition called hyperhomocysteinemia
- if you have (or have ever had) a type of migraine called " migraine with aura”,
- if you have (or have ever had) liver disease and your liver function is still not normal,
- if your kidneys are not working properly (kidney failure),
- if you have (or have ever had) a tumor in your liver,
- if you have (or have ever had) or if you have a suspected malignant tumor of the breast or genitals,
- if you have any bleeding in the vagina without a known cause.
Aranka contains soy oil daily. Do not use if you are allergic to peanuts or soy.
Warnings and precautions
Consult your doctor or pharmacist before taking Aranka daily.
When should you see a doctor? Seek emergency medical attention - if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your lungs (i.e., a pulmonary embolism), a heart attack, or a stroke (see " blood clot (thrombosis)"below). For a description of the symptoms of these serious side effects, see In the section”How to recognize a blood clot." |
Tell your doctor if you suffer from any of the following conditions
In some situations, you need to be especially careful when taking Aranka or any other combined hormonal contraceptives daily, and you can it is necessary that your doctor regularly checks you. If you experience any of the following situations, you should inform your doctor before taking your daily Aranka. AR Aranka,..
- if a close relative has or has ever had breast cancer,
- if you suffer from liver or gallbladder disease,
- if you have diabetes,
- if you have depression,
- if you have epilepsy (see " daily intake of Aranka with other medications”),
- if you have a disease that first appears during pregnancy or during the use of the population previously (for example, something else, a blood disease like we saw, a skin ecosystem with school me during pregnancy (park), a seizure disease in which see body movements occur (Korea Chorea), jaundice and itching.
- if you have or have ever had chloasma (discoloration of the skin, especially the face or neck, known as”pregnancy spots"). If so, avoid direct exposure to sunlight or ultraviolet light.
- if you have hereditary angioedema, foods containing estrogen may cause or worsen the symptoms of angioedema. If you suffer from symptoms of angioedema, such as swelling of the face, tongue, and/or pharynx and / or difficulty swallowing or urticaria in addition to difficulty breathing, you should see a doctor immediately.
- 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 clotting disorder that leads to kidney failure).
- if you have sickle cell anemia (a hereditary disease of red blood cells).
- if you have an elevated blood fat level (hypertriglyceridemia) or a known family history of the condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
- 2, ((.. 2 2 "blood clots").
- if you have just given birth, you are more at risk of blood clots. You should ask your doctor when you can start taking Aranka daily after giving birth.
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis).
- if you have varicose veins.
BLOOD CLOTS
Using a combined hormonal contraceptive, such as Aranka, increases the risk of a blood clot compared to using it. Rarely, a blood clot can block blood vessels and lead to serious problems.
Blood clots can form:
- In the veins (so-called "venous thrombosis”," venous thromboembolism " or VTE).
- As (so-called " as“,” as “as ASD).
Recovery of blood clots is not always complete. Rarely can there be long-lasting serious consequences or, very rarely, can be fatal.
It is important to remember that the overall risk of a harmful blood clot due to daily Aranki is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Do you experience any of these signs? | That he might suffer? |
* Swelling of the leg or foot or along the vein of the leg or foot, especially when it is accompanied by: * pain or tenderness in the leg, which can only be prevented by standing or walking. * An increase in temperature in the affected leg * A change in the color of the skin of the legs, for example, if it becomes pale, red or blue. | Deep vein thrombosis |
* Sudden shortness of breath with no known cause or rapid breathing. * Not for no reason, which can cause blood * Still chest pain, which can be used when Look twelve * If the bus or color with the speaker. * S. S.*.. If you are not sure, consult your doctor, as some of these semi, such as he or she, can state with more Magic you are such, such as that infection (for example, "common Catarrh"). | Pulmonary embolism |
Symptoms that are most common in one eye · * immediate vision loss or * painless blurred vision that may develop before vision loss. | Retinal vein thrombosis (a blood clot in the eye). |
* Pain, discomfort, pressure, heaviness in the chest. * A feeling of tightness or fullness in the chest, arm, or under the sternum * A feeling of fullness, upset stomach, or suffocation * Upper body discomfort that radiates from the back, jaw, throat, arm, and stomach. * Sweating, nausea, vomiting, or dizziness * Extreme weakness, restlessness, or shortness of breath * Rapid or irregular heartbeat. | A 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. * Sudden difficulty in seeing in one or both eyes. * Sudden difficulty walking, dizziness, loss of balance or coordination. * Sudden, severe, or prolonged headache with no known cause. * Loss of consciousness or fainting, with or without seizures. Sometimes the symptoms of a stroke can be brief, with an almost immediate and complete recovery, but you should still seek emergency medical attention, as you may be at risk of another stroke. | Stroke |
* Swelling and light blue coloration of the limb * Severe abdominal pain (acute abdomen). | Blood clots that block other blood vessels |
BLOOD CLOTS IN THE 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 are most often found in the first year of using a combined hormonal contraceptive.
· If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
· If a blood clot moves away from the leg and enters the lung, it can lead to a pulmonary embolism.
· Very rarely, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis)
When is the highest risk of a blood clot in a vein?
The risk of a blood clot in a vein is higher during the first year when a combined hormonal contraceptive is first taken. The risk may also be higher if you again take surrounds from Oceania should per day (same medication or different medication) after discontinuing 4 weeks or more.
After the first year, the risk is reduced, but it is always slightly higher than if you did not take combined hormonal contraceptives.
When you stop taking your daily Aranka, your risk of blood clot formation returns to normal within 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 lungs (DVT or PE) with daily Aranka is low.
- Out of 10,000 women who do not use the combination you will be able to contract and not Bremen, about 2 will have a taste of blood per year.
- Out of 10,000 nor, nor, nor, nor norestart, 5-7 5-7 they'll have a blood clot in a year.
- Out of 10,000 women, wives combinations you will be able to contract containing seven, such as Pau daily, from 9 to 12 women will present a blood clot in a year.
- The risk of a blood clot will depend on your personal history (see "factors that increase the risk of a blood clot" below)
Risk of blood clot formation within one year | |
Women who do not use a combined hormone pill/patch / ring and who are not pregnant | About 2 out of 10,000 women |
Women using a combined hormonal birth control pill containing levonorgestrel, norethisterone, or norgestimate | 5 5? 7 10 10 000 women |
Women who use Aranka daily | 9 9? 12 10 10 000 women |
Factors that increase the risk of a blood clot in a vein
The risk of having a blood clot with daily Aranka is low, but some conditions increase the risk. Your risk is higher:
· If you have a Cola weight (body mass index or MT above 30 kg / mTwo).
· If any of your close relatives had a taste of blood in their testicles, lungs, or other organ at a certain age (i.e., before the age of 50 approximately years). In this case, you may have an inherited blood clotting disorder.
· If you need to have surgery, or if you spend a lot of time on your feet due to an injury or illness, or if you have a cast leg. Perhaps the daily use of Aranki should be discontinued a few weeks before surgery, or until you have less mobility. AR Aranka,.,..
· When using the age (especially above 35 summer).
· If she gave birth less than a few weeks ago.
The risk of a blood clot increases the more conditions you have.
Plane trips (more than 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other listed risk factors.
It is important to tell your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that daily use of Aranka should be discontinued.
If any of the people that have my nape during has been a new use of Aranka, such as my wife-it's like this for no reason or you are a very different weight, tell your doctor.
SeBLOOD CLOTS IN THE 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 lead to serious problems. For example, it can lead to a heart attack or stroke.
Factors that increase the risk of a blood clot in an artery
It is important to note that the risk of multiple tube or tie was new from using Aranka is very bad, but maybe it will be able to:
- With see shooting (above about 35 summer).
- If he smokes. Daily, Daily, Daily. If you are not able I have spent Kurt and over 35 years old For example, your doctor may advise you to use a different type of contraception.
- If you are overweight.
- If you have a high voltage.
- If any bag of several revere or insult in the mode of age (less than 50 years old summer). In this case, you may also have an increased risk of a heart attack or stroke.
- If you or one of your close relatives has an elevated level of fat in the blood (cholesterol or triglycerides).
- If you suffer from migraines, especially migraines with aura.
- If you have a heart problem (valvular disorder, a heart rhythm disorder called atrial fibrillation).
- If you have diabetes.
If you have one or more of these conditions, or any of them are particularly serious, the risk of a blood clot may be further increased.
If any of the above conditions change during daily use of Aranka, for example, you start smoking, a close relative experiences a blood clot for no known reason, or you gain a lot of weight, tell your doctor.
Aranka diary and cancer
Breast cancer was observed with slightly higher frequency in women taking combined contraceptives, but it is not known whether this is caused by treatment. For example, this may be due to the fact that women who take combined contraceptives are found to have more tumors because they are more often checked by their doctor.
The appearance of breast tumors gradually becomes smaller after the termination of contraception hormonal combined. It is important to examine your breasts regularly, and you will need to see a doctor if you notice any lumps.
In rare cases, benign liver tumors have been reported, and even less often, malignant liver tumors in users of oral contraceptives. Consult your doctor if you have abdominal pain that is not normal.
Some epidemiological studies have reported an increased risk of cancer
However, there is still debate as to the extent to which this finding is related to the effect caused by
interfering factors such as sexual habits and other factors such as the papilloma virus
See also:
What are the possible side effects of Arankelle?
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke
- Vascular events
- Liver disease
Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Nausea
- Breast tenderness
- Headache
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
The data provided reflect the experience with the use of Arankelle (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 -35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of Arankelle vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles.
The most common adverse reactions ( ≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).
Adverse Reactions ( ≥ 1%) Leading to Study Discontinuation
Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%).
Serious Adverse Reactions
Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Arankelle. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension
Hepatobiliary disorders: Gallbladder disease
Immune system disorders: Hypersensitivity
Metabolism and nutrition disorders: Hyperkalemia
Skin and subcutaneous tissue disorders: Chloasma