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

Patient Information Leaflet

Introduction

Patient Information Leaflet

dolna 0,120 mg/0,015 mg per 24 hours,

vaginal delivery system EFG

etonogestrel/ethinylestradiol

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read this entire leaflet carefully before starting to use dolna, as it contains important information for you.

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

Contents of this leaflet

1. What dolna is and what it is used for
2. What you need to know before using dolna

2.1 When you must not 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 use of machines

3. How to use dolna

3.1 How to insert and remove 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 accidentally expelled from the vagina

Your ring has been out of the vagina temporarily

The ring opens

You have inserted more than one ring

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

If you forget to remove the ring

If your period does not occur

If you have unexpected bleeding

If you wish to change the day your period starts

If you wish to delay your period

3.5 If you wish to stop using dolna

4. Possible side effects
5. How to store dolna
6. Contents of the pack and other information

Composition of dolna

Appearance of dolna and contents of the pack

Marketing Authorization Holder and Manufacturer

1. What dolna is and what it is used for

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 slowly releases these hormones into the bloodstream. Because of 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 works like the combined oral contraceptive pill (the "Pill"), but instead of taking a pill every day, the ring is used continuously for 3 weeks. dolna releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, pregnancy cannot occur.

2. What you need to know before you start using dolna

General considerations

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

This leaflet describes various situations in which you should stop using dolna, or when dolna may be less effective. In these situations, you should not have sexual intercourse, or you should use additional non-hormonal contraceptive methods, such as a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because dolna alters the monthly changes in body temperature and cervical mucus.

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

2.1 When you must not use dolna

Do 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 which other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or if you are immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a clot in the 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 had inflammation of the pancreas (pancreatitis), associated with high levels of fats 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 tumour.

• If you have, have had, or may have breast cancer or cancer of the genital organs.

• If you have any vaginal bleeding of unknown origin.

• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medicine (listed in section 6).

If any of these conditions occur for the first time while you are using dolna, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use dolna if you have hepatitis C or are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir or pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.4 “Other medicines and dolna”).

2.2 Warnings and precautions

When should you consult your doctor?

Seek urgent medical help

• If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see “Blood clots” section below).

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

Inform your doctor if you have any of the following conditions.

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

• If a close relative has or has ever had breast cancer.

• If you have epilepsy (see section 2.4 “Other medicines and dolna”).

• If you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones).

• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).

• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).

• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you have sickle cell anaemia (an inherited red blood cell disorder).

• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you need surgery or are immobile for a long time (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 using dolna after childbirth.

• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If you have any condition that first appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [skin rash with blisters during pregnancy], or Sydenham’s chorea [a nervous disorder causing involuntary movements]).

• If you have or have ever had chloasma (yellowish-brown patches on the skin, known as “pregnancy mask”, particularly on the face); if so, avoid excessive exposure to sunlight or ultraviolet rays.

• If you have conditions that make the use of dolna difficult, for example, if you suffer from constipation, uterine prolapse (descent of the uterus or cervix), or pain during sexual intercourse.

• If you experience urgent, frequent, burning, and/or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of dolna into the urinary bladder.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with difficulty breathing, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as dolna increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects or, very rarely, they may be fatal.

It is important 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 help if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticed when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., becoming pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms—such as cough or shortness of breath—may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision difficulty in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same 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 developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with dolna is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as dolna, between about 6 and 12 women will develop a blood clot within one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill/patch/ring and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 in 10,000 women
Women who use dolna	About 6-12 in 10,000 women

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

The risk of having a blood clot with dolna is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury, illness, or if your leg is in a cast. You may need to stop using dolna several weeks before surgery or while you are less mobile. 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 of age).
• If you have given birth less than a few weeks ago.

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

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you need to stop using dolna.

If any of the above conditions change while you are using dolna—for example, a close relative experiences a thrombosis without a known cause or you gain a significant amount of weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke from using dolna is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as dolna, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using dolna—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Cancer

The following information comes from studies with combined oral contraceptives and could be applicable to dolna. There is no information available on the vaginal administration of contraceptive hormones (such as dolna).

A slightly increased frequency of breast tumors has been observed in women using contraceptive pills, but it is unknown whether this is due to the treatment. For example, it could be that more tumors are detected in women using contraceptive pills because they visit their doctor more frequently. This increased frequency gradually decreases after stopping treatment.

It is important to examine your breasts regularly and inform your doctor if you notice any lumps. Inform your doctor if any close relatives have or have had breast cancer (see section 2.2 "Warnings and precautions").

Rarely, benign liver tumors have been reported, and even more rarely, malignant liver tumors, in women using the contraceptive pill. Contact your doctor if you experience a strong and unusual pain in your abdomen.

Women using combined oral contraceptives have been observed to develop endometrial (lining of the uterus) or ovarian cancer less frequently. This may also be the case with dolna, but it has not been confirmed.

Psychiatric disorders

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

2.3 Children and adolescents

The safety and efficacy of dolna in adolescents under 18 years of age has 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 or dentist (or pharmacist) who prescribes another medicine that you are using dolna. They can advise you whether you need to take additional contraceptive measures (for example, use of male condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines:

• may affect the levels of dolna in the blood.
• may make it less effective in preventing pregnancy.
• may cause unexpected bleeding.

These include medicines used to treat:

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

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

dolna may influence the effect of other medicines, for example:

• medicines containing cyclosporine.
• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Do not use dolna if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function test results (increase in liver enzyme ALT).

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

dolna can be used again approximately 2 weeks after completion of this treatment. See section 2.1 “When not to use dolna”.

Consult your doctor or pharmacist before taking any medicine.

Tampons can be used while using dolna. Insert dolna first, then the tampon. Take special care when removing the tampon to avoid accidentally expelling the ring. If the ring is expelled, simply wash it with cool or warm water and reinsert it immediately.

The ring may open when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 "What to do if… The ring opens"). The use of spermicides or vaginal antifungal products does not reduce the contraceptive effectiveness of dolna.

Laboratory tests

If you undergo blood or urine tests, inform your doctor that you are using dolna, as it may affect the results of certain tests.

2.5 Pregnancy and breastfeeding

dolna must not be used by pregnant women or by women who suspect they may be pregnant. If you become pregnant while using dolna, remove the ring and consult your doctor.

If you wish to stop using dolna because you want to become pregnant, see section 3.5 "If you want to stop using dolna".

In general, the use of dolna is not recommended while breastfeeding. If you wish to use dolna while breastfeeding, consult your doctor.

2.6 Driving and use of machines

It is unlikely that dolna will affect your ability to drive or use machines.

3. How to use dolna

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

You can insert and remove dolna yourself. Your doctor will tell you when to start using it for the first time. The vaginal ring must be inserted on the correct day of your monthly cycle (see section 3.3 "When to start with the first ring") and remain in the vagina for 3 consecutive weeks. Check regularly whether 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 take a one-week break. You will usually have your monthly period during this ring-free week.

While using dolna, you should not use certain female barrier contraceptive methods, such as vaginal diaphragm, cervical cap, or female condom. These barrier methods should not be used as an additional contraceptive method, as dolna may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove dolna

1. Before inserting the ring, check that it is not expired (see section 5 "Storage of dolna").
2. Wash your hands before inserting or removing the ring.
3. Choose the position that is most comfortable for you to insert it, for example standing with one leg raised, squatting, or lying down.
4. Remove dolna from its pouch. Keep the pouch for later use.

Hold the ring between your index finger and thumb, press opposite sides together, 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 discomfort, gently push dolna further 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 your index finger under the ring or by grasping it with your fingers and pulling it out (see Figure 5). If you are unable to remove the ring despite having located it, contact your doctor.
3. Dispose of the used ring with household waste, preferably inside its pouch. Do not flush dolna down the toilet.

Figure 1

Remove dolna from its pouch

Figure 2

Press the ring

Figure 3

Choose a comfortable position to insert the ring

Figure 4A Figure 4B

Figure 4C

Insert the ring into the vagina with one hand (Figure 4A), and if necessary, separate the labia with the other hand. Push the ring into the vagina until it feels 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 the index finger or by grasping it between the index and middle fingers and pulling it out.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day you insert it for 3 consecutive weeks, uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week and at approximately the same time as you inserted it. For example, if you inserted it on a Wednesday at approximately 10:00 PM, you should remove it 3 weeks later on a Wednesday at approximately 10:00 PM.
3. Once you have removed the ring, do not use it for one week. During this week, vaginal bleeding should occur. It usually starts 2–3 days after removing dolna.
4. Insert a new ring exactly after the 1-week interval (again on the same day of the week and at approximately the same time), even if you are still bleeding.

If you insert the new ring more than 3 hours late, contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 "What to do if you forget to insert a new ring after the ring-free break".

If you use dolna as described above, your 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

Insert 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 use any other contraceptive measures.

You may also start dolna between day 2 and day 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). This recommendation applies only when using dolna for the first time.

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

Start using dolna no later than the day after the break from your current pill. If your pill pack also contains inactive tablets, start dolna no later than the day after the last inactive tablet. If you are unsure which tablet is inactive, consult your doctor or pharmacist. Never extend the break period 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 may also stop taking the pill on any day of your current cycle and start using dolna immediately.

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

Start using dolna no later than the day after the patch-free break. Do not extend the patch-free break beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you may also remove the patch on any day and start using dolna immediately.

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

You may stop taking your progestogen-only pill on any day and start using dolna the next day at the same time. However, make sure to also 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 a hormonal intrauterine system [IUS] (progestogen) in the previous month

Start using dolna at the time you would receive your next injection or on the day your 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 recently given birth, your doctor may advise you to wait until your first normal period appears before starting dolna. Sometimes it may be possible to start earlier; your doctor will advise you accordingly. If you are breastfeeding and wish to use dolna, you should consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is accidentally expelled from the vagina

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

Your ring has been temporarily outside the vagina

dolna may still protect you from pregnancy, but this depends on how long it has been outside your vagina.

If the ring has been outside the vagina for

• less than 3 hours, it will still protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it into the vagina as soon as possible—but only if it has been outside the vagina for less than 3 hours.

• more than 3 hours during the 1st or 2nd week, it may not protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it 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 these 7 days. If you are in the first week and have had sexual intercourse in the previous 7 days, there is a possibility you may be pregnant. In this case, consult your doctor.

• more than 3 hours during the 3rd week, it may not protect you from pregnancy. You must remove the ring and choose one of the following two options:

1. Insert a new ring immediately.

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

1. Do not insert a new ring. Allow the intermenstrual bleeding to occur and insert a new ring no later than 7 days after the previous ring was removed or expelled.

Choose this option only if you have used dolna continuously for the previous 7 days.

• If dolna has been outside the vagina for an unknown period of time, you may not be protected against pregnancy. A pregnancy test should be performed and you should consult your doctor before inserting a new ring.

The ring opens

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

You have inserted more than one ring

There are no reports of serious harm due to overdose of the hormones in dolna. If you have accidentally inserted more than one ring, 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 may also call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount used.

If you forget to insert a new ring after the ring-free break

Your ring-free break has lasted more than 7 days. Insert a new ring into the vagina as soon as you remember. Use additional contraceptive measures (such as a male condom) if you have sexual intercourse during the next 7 days. If you had sexual intercourse during this ring-free break, there is a possibility you may have become pregnant. In this case, inform your doctor immediately. The longer the ring-free break, the higher the risk of pregnancy.

If you forget to remove the ring

• If the ring has been in the vagina between 3 and 4 weeks, it will still protect you from pregnancy. Proceed with the one-week ring-free break and then insert a new ring.
• If the ring has been in the vagina for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before starting a new ring.

If your period or menstrual bleeding does not occur

• You have used dolna according to the instructions.

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

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

If your usual bleeding does not occur during the one-week ring-free break and you have deviated from the recommended regimen, there is a possibility you may be pregnant, so you should contact your doctor before inserting a new ring.

If you have unexpected bleeding

In some women, unexpected vaginal bleeding may occur between menstrual periods during the use of dolna. You may need hygiene 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 wish to change the day your period or menstruation starts

If you use dolna as instructed, your menstrual period (withdrawal bleeding) will begin during the ring-free week. If you wish to change the day it starts, you must shorten (but never extend) the ring-free break.

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

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

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

If you wish to delay your period or menstruation

Although not the recommended regimen, you may delay your period (withdrawal bleeding) by inserting a new ring immediately after removing the current one, without taking a break between rings. You may keep the new ring in place for up to 3 weeks. During use of the new ring, you may experience spotting (drops or blood stains) or irregular bleeding. When you wish your period to start, simply remove the ring. Take the usual one-week break without a ring and then insert a new ring.

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

3.5 If you wish to stop using dolna

You may stop using dolna at any time.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to dolna, consult your doctor.

All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with 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 symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

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

Common: may affect up to 1 in 10 women.

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

Uncommon: may affect up to 1 in 100 women.

• visual disturbances, dizziness

• bloated abdomen, vomiting, diarrhoea or constipation

• feeling tired, unwell or irritable, mood changes, changes in emotional state

• fluid retention in the body (oedema)

• urinary tract or bladder infection

• difficulty or pain when urinating; urgency to urinate; need to urinate more frequently

• problems during sexual intercourse such as pain, bleeding or partner noticing the ring

• increased blood pressure

• increased appetite

• back pain, muscle cramps, pain in the legs or arms

• reduced skin sensitivity

• breast tenderness, pain or increased size; fibrocystic breast disease (breast cysts that may become swollen or painful)

• cervical inflammation, polyps growing on the cervix, displacement of inner cervical tissue towards the outer part (ectropion)

• changes in menstrual period (heavier, longer, irregular or absent), pelvic discomfort, premenstrual syndrome, uterine cramps

• vaginal infection (fungal or bacterial), burning, odour, pain, discomfort or dryness of the vagina or vulva

• hair loss, eczema, itching, rash or hot flushes

• urticaria

Rare: may 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

• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys or eye

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

• breast discharge

Frequency not known (cannot be estimated from available data).

• chloasma (yellowish-brown patches on the skin, particularly on the face)
• penile discomfort in partner (irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to adherence to the vaginal wall)
• vaginal injury associated with ring rupture.

Cases of breast cancer and liver tumours have been reported in women using combined hormonal contraceptives. For further 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 adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of dolna

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

If you find that a child has been exposed to the hormones in dolna, consult your doctor.

This medicine 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 the expiry date indicated on the box and on each sachet after EXP. The expiry date refers to the last day of the month stated.

Do not use dolna if you notice any changes in the colour of the ring or any visible signs of deterioration.

This medicine may pose a risk to the environment. After removal, dolna should be placed back into its sachet and the sachet properly closed. The sealed sachet should then be disposed of with household waste or returned to the pharmacy for appropriate destruction in accordance with local regulations.

Do not flush down the toilet. As with other medicines, do not dispose of unused or expired rings via drains or in household waste.

Dispose of unused packaging and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of dolna

• The active substances are etonogestrel and ethinylestradiol.

dolna contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at a rate of 0.120 mg and 0.015 mg, respectively, over 24 hours, for a period of 3 weeks.

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

Appearance of dolna and contents of the pack

Vaginal delivery system.

dolna is a flexible, transparent, colourless or almost colourless ring, measuring 54 mm in diameter and 4 mm in cross-section.

Each ring is packaged in an aluminium sachet. The sachet is presented in a cardboard box together with this leaflet and calendar stickers to help you remember when to insert or remove the ring.

Each box contains 1, 3 or 6 rings.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

Laboratorios León Farma, S.A.

Calle La Vallina s/n, Polígono Industrial Navatejera

24193 – Villaquilambre, León

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

NL: Etonogestrel/ Ethinylestradiol Leon Farma 0,120 mg /0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik

BE: Etonogestrel/ Ethinylestradiol Laboratorios Leon Farma 0,120 mg /0,015 mg per 24 uur hulpmiddel voor vaginaal / 24 heures, système de diffusion vaginal / 24 stunden hulpmiddel voor vaginaal gebruik

AT: FemLoop – Vaginalring

ES: dolna 0,120 mg /0,015 mg cada 24 horas, sistema de liberación vaginal EFG

DE: VeRi-Aristo

FR: ETORING 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal

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

Date of the most recent review of this leaflet: December 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82175/P_82175.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82175/P_82175.html