RINGO 0.120 MG/0.015 MG EVERY 24 HOURS, VAGINAL DELIVERY SYSTEM

Always inform your doctor about what medications or herbal remedies you are taking. Also, inform any doctor or dentist (or pharmacist) who prescribes you another medication that you are using Ringo. They will be able to inform you if you need to take any additional contraceptive measures (for example, the use of male condoms) and if so, for how long, or if you should modify the use of the other medication.

Some medications

• may have an influence on the levels of Ringo in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (for example, rifampicin);
• HIV infection (for example, ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (for example, boceprevir, telaprevir);
• other infectious diseases (for example, griseofulvin);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive mood states (the herbal remedy St. John's Wort).

If you are taking medications or herbal remedies that could make Ringo less effective, you should also use a barrier contraceptive method (for example, a male condom). Since the effect of another medication on Ringo can last up to 28 days after stopping the medication, during that time it is necessary to use an additional barrier contraceptive method. Note: Do not use Ringo with a diaphragm, a cervical cap, or a female condom.

Ringo may influence the effect of other medications, for example:

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

Do not use Ringo if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as increases in liver test results (increase in liver enzyme ALT) may occur.

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

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

Consult your doctor or pharmacist before taking any medication.

Tampons can be used while using Ringo. First, put in Ringo and then the tampon. Be especially careful when removing the tampon so that the ring is not accidentally expelled. In case it is expelled, simply wash the ring with cold or warm water and put it back in immediately.

The ring can break 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 breaks”). The use of spermicides or products for vaginal fungi does not reduce the contraceptive efficacy of Ringo.

Laboratory tests

If you have blood or urine tests, inform your doctor that you use Ringo, as it may affect the result of some tests.

1. Pregnancy and breastfeeding

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

If you want to stop using Ringo because you want to become pregnant, see section 3.5 “If you want to stop using Ringo”.

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

1. Driving and using machines

Ringo is unlikely to affect your ability to drive or use machines.

3. How to Use Ringo

You can put in and remove Ringo 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. Regularly check that Ringo is in your vagina (e.g., before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove Ringo and take a 1-week break. You will normally have your menstrual period or bleeding during this ring-free break.

While using Ringo, you should not use certain female barrier contraceptive methods, such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptive methods should not be used as a backup method of birth control because Ringo 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 in and Remove Ringo

1. Before putting in the ring, check that it is not expired (see section 5 "Storage of Ringo").
2. Wash your hands before putting in or removing the ring.
3. Choose a position that is most comfortable for you to insert it, such as standing with one leg raised, squatting, or lying down.
4. Remove Ringo from its packaging.
5. Hold the ring between your index and thumb fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4). When Ringo is in place, you should not feel anything. If you feel uncomfortable, gently change the position of Ringo (e.g., push the ring a bit further into the vagina) until you feel comfortable. The exact position of the ring inside the vagina is not important.
6. After 3 weeks, remove Ringo from the vagina. You can do this by hooking the ring with your index finger or holding 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.
7. Dispose of the used ring with your normal household trash, preferably in its packaging. Do not flush Ringo down the toilet.

3.2 Three Weeks In, One Week Out

1. The vaginal ring should remain in the vagina from the day you put it in for 3 consecutive weeks, without interruption.
2. After 3 weeks, remove the ring on the same day of the week that you put it in and at approximately the same time. For example, if you put it in on a Wednesday at approximately 10:00 PM, you should remove it 3 weeks later, on Wednesday, at approximately 10:00 PM.
3. Once you have removed the ring, do not use it for 1 week. During this week, vaginal bleeding should occur. It usually starts 2-3 days after removing Ringo.
4. Put in a new ring exactly after the 1-week break (again on the same day of the week and at approximately the same time), even if you are still bleeding.
5. If you put in the 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 in a New Ring After the Ring-Free Break".

If you use Ringo as described above, your bleeding will take place 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 in Ringo on the first day of your natural cycle (i.e., the first day of your menstruation). Ringo starts working immediately. You do not need to take other contraceptive measures.

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

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

Start using Ringo no later than the day after the break with your current pill. If the packaging of your pill also contains inactive tablets, start Ringo no later than the day after the last inactive tablet. If you are unsure which tablet it is, consult your doctor or pharmacist. Never extend the break days of your current pill beyond what is recommended.

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

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

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

If you have used the patch continuously and correctly and are sure you are not pregnant, you can also remove the patch on any day and start with Ringo 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 Ringo the next day at the same time. However, make sure to also use a complementary contraceptive method (such as a male condom) during the first 7 days of using the ring.

• If you were using an injectable, implant, or Hormonal Intrauterine System (IUS) in the previous month

Start using Ringo when you would have received the next injection or the day the implant or IUS is removed. However, make sure to use a complementary contraceptive method (such as a 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 period appears before starting with Ringo. Sometimes it is possible to start earlier; your doctor will advise you on how to do so. If you are breastfeeding and want to use Ringo, you should consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to Do If...

The Ring is Accidentally Expelled from the Vagina

Ringo can be accidentally expelled from the vagina, for example, if it is 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 regularly check if the ring is in your vagina (e.g., before and after sexual intercourse).

The Ring has been Out of the Vagina Temporarily

Ringo may still protect you from 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 from 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 from 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 previous 7 days, there is a possibility that you may be pregnant. In this case, consult your doctor.
• more than 3 hours in the 3rd week, it may not protect you from pregnancy. Remove the ring and choose one of the following two options:

1. Put in a new ring immediately.

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

1. Do not put in a new ring. Wait for the intermenstrual bleeding to stop and put in 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 Ringo consecutively for the previous 7 days.

• a period of unknown time may not protect you from pregnancy. Perform a pregnancy test and consult your doctor before putting in a new ring.

The Ring Opens

In very rare cases, the Ringo ring can open. Vaginal injury associated with ring breakage has been reported. If you notice that Ringo has opened, remove the ring and put in a new one as soon as possible. Take complementary contraceptive precautions (e.g., a male condom) for the following 7 days. If you have had sexual intercourse before noticing that the ring had opened, consult your doctor.

More than One Ring is Inserted

There are no reports of serious harm due to an overdose of Ringo's hormones. 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 disappear. 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 in a New Ring After the Ring-Free Break

Your ring-free breakhas lasted more than 7 days. Put in a new ring in the vagina as soon as you remember. Take additional contraceptive measures (such as a male condom) if you have sexual intercourse during the following 7 days. If you have had sexual intercourse during this ring-free break, there is a possibility that you may be 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 for 3 to 4 weeks, it will still protect you from pregnancy. Wait for the ring-free week and then put in 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 with a new ring.

If Your Period or Menstrual Bleeding Does Not Occur

• You have used Ringo according to the instructions.

If your period does not occur, but you have used Ringo according to the instructions and have not taken other medications, it is very unlikely that you are pregnant. Continue using Ringo as usual. However, if you have two consecutive missed periods, you may be pregnant, so you should inform your doctor immediately. Do not put in the next Ringo until your doctor has checked that you are not pregnant.

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

If your usual bleeding does not occur during the 1-week break without a ring and you have deviated from the recommended regimen, there is a possibility that you may be pregnant, so you should contact your doctor before putting in a new ring.

If You Experience Unexpected Bleeding

In some women, during the use of Ringo, unexpected vaginal bleeding may occur between menstrual periods. You may need hygienic protection. Nevertheless, 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 Your Period or Menstrual Bleeding Starts

If you use Ringo according to the instructions, your menstrual period (withdrawal bleeding) will start during the ring-free week. If you want to change the day it starts, you must shorten (never lengthen!) the ring-free break.

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

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 spots of blood) or intermenstrual bleeding during the use of the next ring.

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

If You Want to Delay Your Period or Menstrual Bleeding

Although it is not the recommended regimen, you can delay your period (withdrawal bleeding) by putting in a new ring immediately after removing the current ring, without taking the break between rings. You can leave the new ring in 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. Take the normal 1-week break without a ring and then put in a new ring.

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

3.5 If You Want to Stop Using Ringo

You can stop using Ringo at any time you wish. If you do not want to become pregnant, consult your doctor about other contraceptive methods.

If you stop using Ringo because you want 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 the due date.

4. Possible Adverse Effects

Like all medications, Ringo can produce adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you believe may be due to Ringo, consult your doctor.

All women who take 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 Ringo".

If you are allergic to any of the components of Ringo (hypersensitivity), you may have the following symptoms (frequency not known): angioedema [swelling of the face, tongue, or throat, difficulty swallowing] or urticaria, along with breathing difficulties. If this occurs, remove Ringo and contact your doctor immediately.

Ringo users have reported the following adverse effects:

Frequent:may affect up to 1 in 10 women.

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

Uncommon:may affect up to 1 in 100 women.

• vision changes, dizziness
• bloating, vomiting, diarrhea, or constipation
• feeling tired, irritable, or moody, mood changes, changes in mood
• fluid retention in the body (edema)
• urinary tract infection or bladder infection
• difficulty, pain when urinating; urgency to urinate. Need to urinate more frequently
• problems with sexual intercourse 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
• decreased skin sensitivity
• breast tension or pain, or increased size; fibrocystic breast disease (breast cysts that can become swollen or painful)
• cervical inflammation, polyps growing 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 disappearing), 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 flushing
• 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
• mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA)
• 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

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

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

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

In very rare cases, the Ringo ring may open. For more information, see section 3.4 What to do if… The ring opens.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ringo

Keep this medication out of sight and reach of children.

If you discover that a child has been exposed to Ringo's hormones, ask your doctor for advice.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box and on each pouch after "EXP". The expiration date is the last day of the month indicated.

Do not use this medication if you notice changes in the color of the ring or any visible sign of deterioration.

Dispose of the used ring with normal household waste, preferably inside its pouch with a closure. This medication should not be thrown down the toilet. As with other medications, do not throw unused or expired rings down the drain or in the trash.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Ringo Composition

• The active ingredients are etonogestrel and ethinylestradiol. Each ring contains 11.7 mg of etonogestrel and 2.7 mg of ethinylestradiol.
• The other components are: vinyl acetate and ethylene copolymer (28% and 9% vinyl acetate) (a type of plastic that does not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the ring in a ratio of 0.120 mg/day and 0.015 mg/day, respectively, for three weeks.

Appearance of Ringo and Package Contents

Ringo is a flexible, transparent, and almost colorless ring, measuring approximately 54 mm in width.

Each ring is packaged in a laminated aluminum pouch that can be reclosed. The pouch is presented in a cardboard box along with this prospectus. Each box contains 1 or 3 rings.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this prospectus: November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)