Dolna 0,120 mg/0,015 mg cada 24 horas sistema de liberacion vaginal efg

Label: Information for the user

0.120 mg/0.015 mg of etonogestrel/etinilestradiol every 24 hours,

vaginal delivery system EFG

etonogestrel/etinilestradiol

Important information 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 blood clots in veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a 4-week or longer break.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this label carefully before starting to use Dolna, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4

1. What is Dolna and how is it used

2. What you need to know before starting to use Dolna.

2.1 When not to use Dolna

2.2 Warnings and precautions

Blood clots

Cancer

2.3 Children and adolescents

2.4 Other medicines and Dolna

Laboratory tests

2.5 Pregnancy and breastfeeding

2.6 Driving and operating machines

3. How to use Dolna

3.1 How to put on and take off Dolna

3.2 Three weeks in, one week out

3.3 When to start with the first ring

3.4 What to do if…

Your ring is expelled accidentally from the vagina

Your ring has been temporarily removed from the vagina

The ring is open

More than one ring has been put on

If you forget to put on a new ring after the ring-free interval

If you forget to remove the ring

If your period or menstrual flow does not appear

If you experience unexpected bleeding

If you want to change the day your period or menstrual flow starts

If you want to delay your period or menstrual flow

3.5 If you want to stop using Dolna

4. Possible side effects

5. Storage of Dolna

6. Contents of the package and additional information

Composition of Dolna

Appearance of Dolna and contents of the package

Marketing Authorization Holder and Responsible Manufacturer

Dolna is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones, etonogestrel and ethinylestradiol. The ring releases these hormones slowly into the bloodstream. Given the small amount of hormones released, Dolna is a low-dose hormonal contraceptive.

Since Dolna releases two different types of hormones, it is a combined hormonal contraceptive.

Dolna acts like the combined oral contraceptive pill (the “Pill”), but instead of taking a pill every day, the ring is used for 3 consecutive weeks. Dolna releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, you cannot become pregnant.

General Considerations

Before starting to use Dolna, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

In this leaflet, various situations are described in which you should stop using Dolna, or in which Dolna may be less reliable. In these situations, you should not have sexual intercourse, or you should take additional non-hormonal contraceptive measures, such as a condom or another barrier method.Nouse the rhythm or temperature method. These methods may not be reliable since Dolna alters the monthly body temperature changes and cervical mucus.

Dolna, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

2.1 When Not to Use Dolna

You should not use Dolna 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 have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary 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 ever had) a type of migraine called “migraine with aura”.
• If you have or have had pancreatitis (inflammation of the pancreas) associated with high levels of fat in your blood.
• If you have or have had a serious liver disease and your liver is not functioning normally.
• If you have or have had a benign or malignant liver tumor.
• If you have, have had, or may have breast cancer or genital organ cancer.
• If you have unexplained vaginal bleeding.
• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medicine (including in section 6).

If any of these circumstances occur for the first time while using Dolna, remove the ring immediately and consult your doctor. Meanwhile, use non-hormonal contraceptive measures.

You should not use Dolna if you have hepatitis C or are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.4 “Other Medicines and Dolna”).

2.2 Warnings and Precautions

Inform Your Doctor If You Suffer Any of the Following Conditions.

If the condition develops or worsens while using Dolna, you should also inform your doctor.

• If any of your close relatives have had breast cancer.
• If you suffer from epilepsy (see section 2.4. “Other Medicines and Dolna”).
• If you have a liver disease (for example, jaundice) or gallbladder disease (for example, gallstones).
• If you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• 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 causes 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 need an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at greater risk of blood clots after childbirth. You should ask your doctor when you can start taking Dolna again after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have a disease that appeared for the first time or worsened during pregnancy or previous use of sex hormones (for example, hearing loss, porphyria [a blood disorder], herpes of pregnancy [skin rash with blisters during pregnancy], or Sydenham’s chorea [a nervous disease that causes involuntary movements]).

• If you have or have had melasma (yellow-brown skin patches, particularly on the face); if this is the case, avoid excessive exposure to the sun or ultraviolet rays.
• If you have disorders that make it difficult to use Dolna, for example, if you have constipation, uterine prolapse (uterine or cervical descent), or experience pain during sexual intercourse.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with difficulty breathing, contact your doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Dolna 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 “deep vein 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 Dolna is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

What Can Happen If a Blood Clot Forms in a Vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in 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 Greater?

The risk of a blood clot in a vein is greater during the first year of taking a combined hormonal contraceptive for the first time. The risk may be greater if you restart taking a combined hormonal contraceptive (the same medicine or a different medicine) 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 using Dolna, 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 Dolna is small.

• Of every 10,000 women who are not using a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women using a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women using a combined hormonal contraceptive containing norelgestromin, or etonogestrel like Dolna, about 6-12 women 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).

Factors That Increase Your Risk of a Blood Clot in a Vein

The risk of having a blood clot with Dolna is small, but some conditions increase the risk. Your risk is greater:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have an inherited blood clotting disorder.
• 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 using Dolna for several weeks before the operation or while you have limited mobility. If you need to stop using Dolna, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

The risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Dolna.

If any of the conditions listed above change while you are using Dolna, 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 Dolna is very small, but it may increase:

• With age (over about 35 years).
• If you smoke.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at greater risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased even further.

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

CANCER

The following information has been obtained from studies with combined oral contraceptives and may be applicable to Dolna. There is no information on the administration of vaginal hormones (such as Dolna).

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to treatment. For example, it may be that more tumors are found in women using oral contraceptives because they attend medical check-ups more frequently. This increased frequency decreases gradually after stopping treatment.

It is essential to examine your breasts regularly and inform your doctor if you notice any lumps. Inform your doctor if any of your close relatives have had breast cancer (see section 2.2 “Warnings and Precautions”).

Rarely, cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the combined oral contraceptive. Contact your doctor if you have severe and unusual abdominal pain.

In users of the combined oral contraceptive, it has been observed that breast cancer, endometrial cancer, and ovarian cancer are less frequent. This may also be the case with Dolna, but it has not been confirmed.

PSYCHIATRIC DISORDERS

Some women who use hormonal contraceptives like Dolna 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.

2.3 Children and Adolescents

The safety and efficacy of Dolna in adolescents under 18 years have not been established.

2.4 Other Medicines and Dolna

Always inform your doctor about any medicines or herbal remedies you are taking. Also, inform any doctor, dentist, or pharmacist (or pharmacist) who prescribes another medicine that you are using Dolna. They can inform you if you need to take additional contraceptive measures (for example, use a male condom) and, if necessary, for how long, or if you need to modify the use of the other medicine.

Some medicines

• may affect the levels of Dolna in the blood.
• may makeit less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (for example, rifampicin);
• HIV infection (for example, ritonavir, nelfinavir, nevirapina, efavirenz);
• hepatitis C infection (for example, boceprevir, telaprevir);
• other infectious diseases (for example, griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• mood disorders (the herbal remedy St. John’s Wort).

If you are taking medicines or herbal remedies that may make Dolna less effective, you should also use a barrier contraceptive method (for example, a male condom). Since the effect of another medicine on Dolna may last for up to 28 days after stopping the medicine, you will need to use a barrier contraceptive method during that time. Note: Do not use Dolna with a diaphragm, cervical cap, or female condom.

Dolna may affect the effect of other medicines, for example:

• medicines containing ciclosporin
• the antiepileptic lamotrigine (this may increase the frequency of seizures)

You should not use Dolna if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir may cause increases in liver test results (elevated ALT levels).

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

Dolna can be used again approximately 2 weeks after the end of this treatment. See section 2.1 “When Not to Use Dolna”.

Consult your doctor or pharmacist before taking any medicine.

You can use tampons while using Dolna. First, put on Dolna, and then the tampon. Be especially careful when removing the tampon so that the ring is not accidentally expelled. If it is expelled, simply wash the ring with cold or lukewarm water and put it back on immediately.

The ring may open when using a vaginal product such as a lubricant or a treatment for an infection (see section 3.4 “What to Do If… The Ring Opens”). The use of spermicides or vaginal antifungal products does not reduce the effectiveness of Dolna as a contraceptive.

Laboratory Tests

If you have blood or urine tests, inform your doctor that you are using Dolna, as it may affect the results of some tests.

2.5 Pregnancy and Breastfeeding

Women who are pregnant or suspect they may be pregnant should not use Dolna. If you become pregnant while using Dolna, remove the ring and consult your doctor.

If you want to stop using Dolna because you want to become pregnant, see section 3.5 “If You Want to Stop Using Dolna”.

In general, it is not recommended to use Dolna while breastfeeding. If you want to use Dolna while breastfeeding, consult your doctor.

2.6 Driving and Operating Machines

Dolna is unlikely to affect your ability to drive or operate machines

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

You can put and take Dolna yourself. Your doctor will tell you when to start using it for the first time. The vaginal ring should be inserted on the correct day of your menstrual cycle (see section 3.3 “When to start with the first ring”) and remain in the vagina for 3 consecutive weeks. Check regularly if the ring is still in your vagina (for example, before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove Dolna and leave a 1-week break. Normally, you will have your menstrual period or bleeding during this pause without a ring.

While using Dolna, do not use some barrier female contraceptives, such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptives should not be used as a backup method of birth control since Dolna may interfere with the correct placement and position of the diaphragm, cervical cap, or female condom. However, you can use a male condom as an additional barrier contraceptive method.

3.1 How to put on and take off Dolna

1. Before putting on the ring, check that it is not expired (see section 5 “Storage of Dolna”).
2. Wash your hands before putting on or taking off the ring.
3. Choose a comfortable position for you to insert it, for example, standing with one leg raised, squatting, or lying down.
4. Remove Dolna from its package. Keep the package for future use.

Hold the ring between your index and middle fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4).

1. When Dolna is in place, you should not feel anything. If you feel uncomfortable, gently push Dolna into the vagina. The exact position of the ring inside the vagina is not important.
2. After 3 weeks, remove Dolna from the vagina. You can do this by hooking the ring with your index finger or holding it with your fingers and stretching it out (see figure 5). If you cannot remove the ring despite locating it, contact your doctor.
3. Dispose of the used ring in the regular household trash, preferably in its package. Do not flush Dolna down the toilet.

Figure 1

Remove Dolna from its package

Figure 2

Press the ring

Figure 3

Choose a comfortable position to put on the ring

Figure 4AFigure 4B

Figure 4C

Put the ring in the vagina with one hand (Figure 4A), if necessary, separate the vaginal lips with the other hand. Push the ring into the vagina until you feel comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5:

Dolna can be removed by hooking the ring with your index finger or holding it with your index and middle fingers and stretching it out.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day you put it in for 3 consecutive weeks, uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week and at the same time as you put it in. For example, if you put it in on a Wednesday around 22:00, remove it 3 weeks later on a Wednesday around 22:00.
3. Once you have removed the ring, do not use it for 1 week. During this week, you should experience menstrual bleeding. Normally, it starts 2-3 days after removing Dolna.
4. Put a new ring exactly 1 week after the break (again on the same day of the week and approximately at the same time), even if you have not stopped bleeding yet.

If you put a new ring more than 3 hours late, the contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 “What to do if you forget to put on a new ring after the break without a ring.”

If you use Dolna as described above, your menstrual bleeding will occur approximately on the same days each month.

3.3 When to start with the first ring

• If you have not used hormonal contraception in the previous month

Put Dolna on the first day of your natural cycle (i.e., the first day of your menstruation). Dolna starts working immediately. You do not need to take any other contraceptive measures.

You can also start with Dolna between days 2 and 5 of your cycle, but if you have sexual intercourse during the first 7 days of using Dolna, make sure to use an additional contraceptive method (male condom). You should only follow this recommendation when using Dolna for the first time.

• If you were using a combined pill in the previous month

Start using Dolna as late as the day after the break with your current pill. If the package of your pill also contains inactive tablets, start Dolna as late as the day after the last inactive tablet. If you are unsure which tablet is which, consult your doctor or pharmacist. Do not extend the break days of your current pill beyond what is recommended.

If you have taken your current pill correctly and continuously and are sure you are not pregnant, you can stop taking the pill on any day of your cycle and start Dolna immediately.

• If you were using a transdermal patch in the previous month

Start using Dolna as late as the day after the break without a patch. Do not extend the break days without a patch beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you can stop using the patch on any day and start Dolna immediately.

• If you were using a progestin-only pill in the previous month

You can stop taking your progestin-only pill on any day and start Dolna the next day at the same time. However, make sure to use an additional contraceptive method (male condom) during the first 7 days of using the ring.

• If you were using an injectable, an implant, or an Intrauterine System (IUS) with hormonal load (progestin) in the previous month

Start using Dolna at the time you should receive the next injection or the day the implant or IUS is removed. However, make sure to use an additional contraceptive method (male condom) during the first 7 days of using the ring.

• After childbirth

If you have just given birth, your doctor may advise you to wait until your first normal menstrual period before starting Dolna. Sometimes, it is possible to start earlier; your doctor will advise you on how to do it. If you are breastfeeding and want to use Dolna, consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is expelled accidentally from the vagina

Dolna can be expelled accidentally from the vagina, for example, if it was not inserted correctly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse (uterine descent). Therefore, you should check regularly if the ring is in your vagina (for example, before and after sexual intercourse).

Your ring has been out of the vagina temporarily

Dolna may still protect you against pregnancy, but this will depend on how long it has been out of your vagina.

If the ring has been out of the vagina for

• less than 3 hours, it will still protect you against pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and put the ring back in the vagina as soon as possible but only if the ring has been out of the vagina for less than 3 hours.

• more than 3 hours in the 1st or 2nd week, it may not protect you against pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and put the ring back in the vagina as soon as you remember. Leave it in the vagina for at least 7 consecutive days. Use a male condom if you have sexual intercourse during those 7 days. If you are in the first week and have had sexual intercourse in the 7 days prior, there is a possibility that you may be pregnant. In that case, consult your doctor.
• more than 3 hours in the 3rd week, it may not protect you against pregnancy. Remove the ring and choose one of the two options below:

1. Put a new ring in the vagina immediately.

By putting a new ring, you will start a new 3-week cycle of use. You may not experience your period. However, you may experience intermenstrual bleeding or spotting during that cycle.

1. Do not put a new ring. Let the intermenstrual bleeding pass and put a new ring no later than 7 days from the time the previous ring was removed or expelled.

Choose this option only if you have used Dolna consecutively for the 7 days prior.

• If Dolna has been out of the vagina for an unknown period, you may not be protected against pregnancy. You should perform a pregnancy test and consult your doctor before inserting a new ring.

The ring has opened

Dolna can open. Vaginal injury associated with ring rupture has been reported. If you notice that Dolna has opened, remove the ring and put a new one as soon as possible. Take additional contraceptive precautions (e.g., male condom) for 7 days. If you had sexual intercourse before noticing that the ring had opened, consult your doctor.

More than one ring has been put on

No severe side effects have been reported due to overdose of Dolna's hormones. If you accidentally put more than one ring on, you may feel unwell (nausea), vomit, or experience vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not go away. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to put on a new ring after the break without a ring

Yourbreak without a ringhas lastedmore than 7 days. Put a new ring in the vagina as soon as you remember. Take additional contraceptive measures (e.g., male condom) if you have sexual intercourse during the following 7 days.If you have had sexual intercourse during this break without a ring, there is a possibility that you may be pregnant. In that case, inform your doctor immediately. The longer the break without a ring, the higher the risk of pregnancy.

If you have forgotten to remove the ring

• If the ring has been in the vagina for3 to 4 weeks, it will still protect you against pregnancy. Leave the break without a ring and then put a new ring.
• If the ring has been in the vagina formore than 4 weeks, there is a possibility that you may be pregnant. Contact your doctor before starting with a new ring.

If your period or menstrual bleeding does not appear

• You have used Dolna as instructed.

If your period does not appear, but you have used Dolna as instructed and have not taken any other medications, it is very unlikely that you are pregnant. Continue using Dolna as usual. However, if you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not put the next Dolna until your doctor has confirmed that you are not pregnant.

• If you have deviated from the recommended use of Dolna.

If your menstrual bleeding does not appear during the break without a ring and you have deviated from the recommended regimen, there is a possibility that you may be pregnant, so contact your doctor before putting a new ring.

If you experience unexpected bleeding

During the use of Dolna, some women may experience unexpected vaginal bleeding between their menstrual periods. You may need sanitary protection. However, continue using the ring as usual, do not remove it. If the bleeding continues, becomes heavier, or starts again, consult your doctor.

If you want to change the day when your period or menstrual bleeding starts

If you use Dolna as instructed, your menstrual bleeding will start during the break without a ring. If you want to change the day when your period starts, you must shorten (never extend!) the break without a ring.

For example, if your period usually starts on a Friday, you can change it to a Tuesday, i.e., 3 days earlier from the next month. Simply put the next ring 3 days earlier than usual.

If the break is made very short (e.g., 3 days or less), you may not experience your usual menstrual bleeding. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the next ring.

If you are unsure how to do it, consult your doctor.

If you want to delay your period or menstrual bleeding

Although this is not the recommended regimen, you can delay your menstrual bleeding by putting a new ring immediately after removing the current ring, without leaving the break between rings. You can keep the new ring in place for a maximum of 3 weeks. During the use of the new ring, you may experience spotting (drops or spots of blood) or irregular bleeding. When you want your period to start, simply remove the ring. Leave the usual break without a ring and put a new ring afterwards.

You can consult your doctor before deciding to delay your menstrual period.

3.5 If you want to stop using Dolna

You can stop using Dolna at any time you want.

If you do not want to become pregnant, consult your doctor about other contraceptive methods.

If you stop using Dolna because you want to become pregnant, it is recommended to wait until you have had your first natural menstrual period before trying to conceive. This will help you calculate the due date.

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 changes that you think may be due to Dolna, 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 use Dolna”.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially difficulty breathing (see also the section “Warnings and precautions”).

Users of the etonogestrel/ethinylestradiol-containing ring have reported the following side effects:

Frequent:can affect up to 1 in 10 women.

• abdominal pain, discomfort (nausea)
• infection of the vagina by yeast (similar to oral candidiasis), vaginal discomfort due to the ring, genital itching, vaginal discharge
• headache or migraine, depressive mood, decreased libido
• breast pain, pelvic pain, painful menstruation
• acne
• weight gain
• expulsion of the ring

Infrequent:can affect up to 1 in 100 women.

• vision changes, dizziness
• swollen abdomen, vomiting, diarrhea, or constipation
• feeling tired, uncomfortable, or irritable, mood changes, changes in mood
• fluid retention in the body (edema)
• urinary tract infection or bladder infection
• difficulty, pain, or urgency while urinating; frequent need to urinate
• sexual problems such as pain, bleeding, or the partner noticing the ring
• increased blood pressure
• increased appetite

• back pain, muscle cramps, pain in the legs or arms
• reduced sensitivity in the skin
• tension or pain in the breasts or enlargement; breast fibrocystic disease (quists in the breasts that can become swollen or painful)
• inflammation of the cervix, polyps that grow on the cervix, displacement of tissue from the inside of the cervix to the outside (ectropion)
• changes in menstrual period (more intense, longer, irregular, or absent), pelvic discomfort, premenstrual syndrome, uterine cramps
• vaginal infection (by fungi or bacteria), burning, odor, pain, discomfort, or dryness of the vagina or vulva
• hair loss, eczema, itching, rash, or hot flashes
• urticaria

Rare:can affect up to 1 in 1,000 women.

• 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
• transient ischemic attack (TIA) or mild stroke symptoms
• blood clots in the liver, stomach/intestine, kidneys, or eye

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• breast secretion

Unknown frequency:(cannot be estimated from available data).

• melasma (yellow-brown skin patches, particularly on the face)
• partner's genital discomfort (irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to its adherence to the vaginal wall)
• vaginal laceration associated with ring rupture.

Cases of breast cancer and liver tumors have been reported in women using combined hormonal contraceptives. For more information, see section 2.2 “Warnings and precautions, Cancer.”

Dolna may open. For more information, see section 3.4 “What to do if… The ring opens.”

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 to the Spanish System for the Pharmacovigilance of Medicines 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.

If you discover that a child has been exposed to the hormones of Dolna, ask your doctor for advice.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Dolna should be inserted at least one month before its expiration date that appears on the box and on each package after CAD. The expiration date is the last day of the month indicated.

Do not use Dolna if you observe changes in the color of the ring or any visible sign of deterioration.

This medication may pose a risk to the environment. Once removed, Dolna should be returned to its package and closed properly. The closed package should be disposed of with household waste or returned to the pharmacy for proper destruction in accordance with local regulations.

Do not dispose of it through the toilet. Like other medications, do not dispose of unused or expired rings through the drains or in the trash.

Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Dolna

• The active principles are etonogestrel and ethinylestradiol.

Dolna contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol in an amount of 0.120 mg and 0.015 mg, respectively, over 24 hours for a period of 3 weeks.

• The other components are: a copolymer of vinyl acetate and ethylene 28% of vinyl acetate and polyurethane (a type of plastic that does not dissolve in the body).

Appearance of Dolna and contents of the package

Vaginal delivery system.

Dolna is a flexible, transparent, colorless, or almost colorless ring, measuring 54 mm in diameter and 4 mm in thickness.

Each ring is packaged in an aluminum pouch. The pouch is presented in a cardboard box along with this leaflet and stickers to help you remember when to insert or remove the ring.

Each box contains 1, 3, or 6 rings.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing:

León Farma Laboratories, S.A.

Calle La Vallina s/n, Industrial Estate Navatejera

24193- Villaquilambre, León

Spain

This medication is authorized in the member states of the European Economic Area with the following name:

NL: Etonogestrel/ Ethinylestradiol Leon Farma 0.120 mg /0.015 mg per 24 hours, vaginal aid

BE: Etonogestrel/ Ethinylestradiol Laboratorios Leon Farma 0.120 mg /0.015 mg per 24 hours vaginal aid / 24 hours, vaginal delivery system / 24 stunden vaginal aid

AT: FemLoop – Vaginal ring

ES: Dolna 0.120 mg /0.015 mg every 24 hours, vaginal delivery system EFG

DE: VeRi-Aristo

FR: ETORING 15 micrograms/120 micrograms/24 hours, vaginal delivery system

IT: Vagan

LU: Etonogestrel/ Ethinylestradiol Leon Farma 0.120 /0.015 mg per 24 hours vaginal delivery system

NO: Etonogestrel/ Ethinylestradiol Leon Farma

PL: PolaRing

PT: Anette 0.120 /0.015 mg per 24 hours vaginal delivery system

Last review date of this leaflet:December 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)