Package Leaflet: Information for the User

Keriette 0.1 mg/0.02 mg Film-Coated Tablets EFG

Levonorgestrel/Ethinylestradiol

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

• Do not useKeriette
• Be particularly careful withKeriette
• Kerietteand thrombosis
• Kerietteand cancer
• Spotting between periods
• What to do if there is no bleeding in the week without treatment
• Use of other medicines
• Diagnostic tests
• Pregnancy
• Breastfeeding
• Driving and operating machinery
• Important information about some of the components ofKeriette

1. How to takeKeriette

• When you can start with the first pack
• If you take moreKeriettethan you should
• If you forget to takeKeriette
• What to do in case of severe vomiting or diarrhea
• Delay in menstrual period: what you should know
• Change in the first day of your menstrual period: what you should know
• If you want to stop takingKeriette

1. Possible side effects
2. Storage ofKeriette
3. Contents of the pack and additional information

• Kerietteis a contraceptive pill used to prevent pregnancy.
• Each pink tablet contains a small amount of two different female hormones, known as levonorgestrel and ethinylestradiol.
• Contraceptive pills that contain two hormones are known as "combined pills".

General Considerations

Before you can start takingKeriette, your doctor will ask you some questions about your medical history and your close relatives. They will also measure your blood pressure and, depending on your personal situation, may perform other tests.

This prospectus describes several situations in which you should stop usingKerietteor in which the reliability ofKeriettemay be reduced. In these situations, you should not have sexual intercourse or, if you do, you should use non-hormonal contraceptive precautions, such as a condom or other barrier method. Do not use the rhythm or temperature methods. These methods are unreliable becauseKeriettealters the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives,Keriettedoes not protect against HIV (AIDS) or any other sexually transmitted disease.

Do not useKeriette

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel in the leg, lungs (pulmonary embolism), or other organs.
• If you have (or have had in the past) a heart attack or stroke.
• If you have (or have had in the past) a disease that may predict a heart attack (e.g., angina pectoris, which causes intense chest pain) or stroke (e.g., a small transient ischemic attack without residual effects).
• If you have a disease that may increase the risk of thrombosis in the arteries. These warnings apply to the following situations:
• • diabetes with vascular damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
• If you have a blood clotting disorder (e.g., protein C deficiency).
• If you have (or have had) a certain type of migraine (with focal neurological symptoms).
• If you have (or have had) pancreatitis (inflammation of the pancreas).
• If you have or have had liver disease and your liver function is not yet normal.
• If you have a liver tumor.
• If you have (or have had) breast cancer or cancer in the genital organs.
• If you have unexplained vaginal bleeding.
• If you have not had a period for several months without a known cause.
• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components ofKeriette. This allergy can be recognized by the appearance of pruritus, skin rash, or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section on using Keriette with other medications).

Warnings and Precautions

In some situations, you will need to take special precautions when usingKerietteor any other combined hormonal contraceptive, and sometimes you will need to see your doctor periodically. If you are in any of the following situations, you should inform your doctor before starting to useKeriette. In addition, you should consult with your doctor if any of the following situations occur or worsen while usingKeriette:

• If a close relative has or has had breast cancer.
• If you have liver disease or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have hemolytic-uremic syndrome (a blood disorder that causes kidney damage).
• If you have sickle cell anemia (a genetic disorder of red blood cells).
• If you have epilepsy.
• If you have systemic lupus erythematosus (a disorder of the immune system).
• If you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nervous disorder that causes sudden movements of the body]).
• If you have or have had melasma (brownish patches on the skin, especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Keriette and Thrombosis

Deep Vein Thrombosis

The use of any combined pill, includingKeriette, increases the risk of a woman developing deep vein thrombosis (formation of a blood clot in a vein) compared to a woman who takes no contraceptive pill.

The risk of deep vein thrombosis increases in users of combined pills:

• With age,
• With obesity,
• If one of your relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age,
• If you need to undergo surgery (operation), prolonged immobilization, or have had a serious accident. It is essential to inform your doctor that you are usingKeriette, as you may need to stop treatment. Your doctor will tell you when to start takingKerietteagain. This is usually two weeks after your recovery.

Arterial Thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (blockage of an artery), for example, in the blood vessels of the heart (heart attack) or brain (stroke).

The risk of arterial thrombosis increases in users of combined pills:

• If you smoke. You are strongly advised to quit smoking when usingKeriette, especially if you are over 35 years old.
• If you have high levels of fat in your blood (cholesterol or triglycerides).
• If you are obese.
• If one of your close relatives has had a heart attack or stroke at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have heart problems (valvular disorder or arrhythmia).

Stop takingKerietteand contact your doctor immediately if you notice signs of possible thrombosis, such as:

• Intense pain or swelling in one of your legs
• Sudden intense chest pain that may radiate to the left arm
• Sudden shortness of breath
• Unusual, sudden, or prolonged cough
• Unusual, intense, or prolonged headache, or worsening of a migraine
• Partial or complete blindness, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, strange sensation, or numbness in any part of the body

Keriette and Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking contraceptive pills, but it is unknown whether this is due to treatment. For example, tumors may be more likely to be detected in women taking combined pills because they are reviewed by their doctor more frequently. The incidence of breast tumors has gradually decreased after stopping the use of combined hormonal contraceptives. It is essential to have regular breast checks, and you should contact your doctor if you notice any lump.

Cancer of the ovaries occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogens alone or in combination with progestogens has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not use HRT, about 2 cases of ovarian cancer per 2,000 women have been observed over a 5-year period. In women taking HRT for 5 years, about 3 cases per 2,000 patients have been observed (i.e., about 1 additional case).

In rare cases, benign liver tumors and even more rare malignant liver tumors have been described in users of contraceptive pills. Contact your doctor if you notice unusual abdominal pain.

Spotting between periods

During the first few months of treatment withKeriette, you may experience unexpected bleeding (bleeding outside the pill-free week). If this bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if there is no bleeding during the pill-free week

If you have taken all the pills correctly, have not vomited, and have not had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If the expected bleeding does not occur in two consecutive instances, you may be pregnant. Contact your doctor immediately. Do not start taking the next pack until you are sure you are not pregnant.

Keriette and Psychiatric Disorders

Some women who use hormonal contraceptives like Keriette 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.

Using Keriette with Other Medications

Always consult with the doctor who prescribedKerietteabout other medications or herbal supplements you are already using. In addition, inform any other doctor or dentist who prescribes other medications (or the pharmacist who dispenses them) that you are usingKeriette. They can tell you if you need to add other contraceptive measures (e.g., condoms) and, if so, for how long.

Some medications reduce the effectiveness ofKeriettein preventing pregnancy or may cause unexpected bleeding.

Examples include medications used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine) and tuberculosis (e.g., rifampicin) or HIV (ritonavir) or other infectious diseases (such as griseofulvin, ampicillin, or tetracycline), which increase intestinal motility (such as metoclopramide) and the medicinal herb St. John's Wort.

If you want to use herbal supplements containing St. John's Wort while takingKeriette, you should consult your doctor first.

Keriettereduces the effectiveness of other medications, such as those containing ciclosporin, or the antiepileptic lamotrigine (which may increase the frequency of seizures).

Do not take Keriette if you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme test results (elevated ALT levels).

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

Keriette can be used again approximately 2 weeks after completing this treatment. See the section “Do not use Keriette”.

Consult your doctor or pharmacist before using any medication.

Blood Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking the pill, as hormonal contraceptives affect the results of some tests.

Pregnancy

If you are pregnant, do not takeKeriette. If you become pregnant while takingKeriette, stop using it immediately and contact your doctor.

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to useKeriettewhile breastfeeding. You should consult your doctor if you want to take the pill while breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machinery

There is no information to indicate that the use ofKerietteaffects your ability to drive or operate machinery.

Keriette contains lactose.If your doctor has told you that you have a certain intolerance to certain sugars, consult them before taking this medication.

Take one tablet ofKerietteeach day, if necessary with a small amount of water. You should take the tablets every day, more or less at the same hour.

The blister pack contains 21 tablets, each marked with a day of the week. You should start by taking the tablet marked with the correct day of the week. Follow the direction of the arrows inthe blister pack. Take one tablet each day until you have finished the 21 tablets. After that, do not take any more tablets for 7 days.

During those 7 days without tablets (which is known as interruption or week without treatment) you should start bleeding. This is called "withdrawal bleeding" and it starts on the 2nd or 3rderday of the week.

On the 8th day after taking the last tablet ofKeriette(that is, after the week of 7 days without treatment), start taking the next blister pack, even if the bleeding has not stopped.

This means that you should start taking the next blister pack on the same day of the week, and the withdrawal bleeding should appear on the same days every month.

If you useKeriettein this way, you will also be protected against pregnancy during the 7 days when you are not taking the tablets.

When can you start with the first blister pack

• If you have not used a hormonal contraceptive in the previous month.

Start withKerietteon the first day of your cycle (which is the first day of your menstruation). If you start takingKerietteon the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but in that case, you should use extra protection (e.g. a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive or a vaginal ring or a combined contraceptive patch

You can start takingKeriettethe day after the pill-free period of the pill you just finished (or after the last inactive tablet of your previous pill).

When switching from a vaginal ring or a combined contraceptive patch, follow your doctor's advice.

• Switching from a method that contains only progestogen (pill or progestogen injection, implant or progestogen-releasing IUD)

You can switch any day from the pill that contains only progestogen (if you used an implant or IUD, on the day of your reblisterda, and if you received progestogen by injection, on the date that would correspond to the next injection), but in all cases, you should apply additional protection (e.g. a condom) during the first 7 days when you take the new pills.

• After an abortion or fetal loss

Follow your doctor's instructions.

• After having a child

After having a child,you can start takingKeriettebetween 21 and 28 days later.If you start after day 28, you should use a barrier method (e.g. a condom) during the first 7 days of use ofKeriette.

If after having a child you have had sex again before starting to takeKeriette(again), you should first check if you are not pregnant or wait until your next menstrual bleeding.

Ask your doctor for advice if you are not sure when to start.

• If you are breastfeeding and want to start takingKeriette(again) after having a child.

Read the section on "Lactation"

If you take moreKeriette than you should

There are no publications on the harmful effects of taking too many tablets of Levonorgestrel/Ethinylestradiol. If you take several tablets at once, you may have nausea and vomiting symptoms. Young girls may have vaginal bleeding.

If you have taken too many tablets ofKeriette, or if you discover that your child has taken some, consult your doctor or pharmacist.

For overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Keriette

• If you makeless than 12 hoursof the forgotten tablet, the protection against pregnancy is not altered. You can still take the tablet as soon as you remember and then take the next tablets at the usual hour.

• If you makemore than 12 hoursof the forgotten tablet, the protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk of reduced protection against pregnancy.

The risk of incomplete protection against pregnancy is greater if you forgot to take a tablet at the beginning or end of a blister pack.

Therefore, you should follow the rules below (see also the diagram, later):

• More than 1 tablet forgotten from the blister pack

Consult your doctor.

• One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time.Take the tablets afterwards at the usual hour and takeextra precautionsin the following 7 days, for example, a condom.If you have had sex in the week before the oversight, or if you forgot to start a new blister pack after the pill-free period, you should be aware that there is a risk of pregnancy.In that case, consult your doctor.

• One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time.Take the tablets afterwards at the usual hour.The protection against pregnancy is not reduced and you will not need to take extra precautions.

• One tablet forgotten in week 3

You can choose between 2 options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time.

Take the tablets afterwards at the usual hour.Instead of the pill-free period, start directly with the next blister pack.

It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second blister pack, but you may also have spotting or intercurrent bleeding while taking the second blister pack.

1. You can also leave taking that blister pack and go directly to the 7-day pill-free period(note the day when you forgot to take your tablet).If you want to start a new blister pack on a specific day, shorten the pill-free period to less than 7 days.

If you follow one of these two recommendations, you will still be protected against pregnancy.

• If you forgot to take one of the tablets from ablister pack and you do not have bleeding in the first pill-free period, it could mean that you are pregnant.You should contact your doctor before continuing with the next blister pack.

What to do in case of vomiting or intense diarrhea

If you vomit in the 3-4 first hours after taking the tablet or if you have severe diarrhea, there is a risk that the active principles of the tablet will not be fully absorbed by your body.The situation is similar to when you forget to take a tablet.After vomiting or having diarrhea, you should take another tablet from the reserve blister pack as soon as possible.If possible, take itwithin 12 hoursof the time you would normally take your tablet.If not possible, or if more than 12 hours have passed, you should follow the advice included in "If you forgot to takeKeriette."

Delayed menstrual period:what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister pack if you continue to take directly a new blister pack ofKerietteinstead of the pill-free period, until the end of the second blister pack instead of starting the pill-free period.You may have spotting (drops or specks of blood) or intercurrent bleeding while using the second blister pack.After the usual 7-day pill-free period,continue with the next blister pack.

You may need to ask your doctor for advice before deciding whether to delay your menstrual cycle.

Change in the first day of your menstrual period:what you should know

If you take the tablets according to the instructions, your menstrual period or withdrawal bleeding will start in the pill-free period.If you need to change this day, do it by shortening the pill-free period (but never lengthening it).For example, if your pill-free period starts on a Friday and you want to change to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual.If you shorten the pill-free period too much (e.g. 3 days or less), it is possible that you will not have any bleeding during this pill-free period.Afterwards, you may have spotting (drops or specks of blood) or intercurrent bleeding.If you are not sure what to do, ask your doctor for advice.

If you want to stop takingKeriette

You can stop takingKeriettewhen you want. If you do not want to get pregnant, ask your doctor for advice on other reliable methods of birth control.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not all people will experience them.

Always inform your doctor if you experience any side effect, especially if the side effect is intense or persistent, or if you notice any change in your health status that you consider may be due to the pill.

Several side effects related to the use of the pill are described in the sections “ Keriette and thrombosis” and “ Keriette and cancer”. Read those paragraphs for more information and consult your doctor immediately if necessary.

• Frequent Side Effects (may affect up to 1 in 10 women): headache, changes in mood (including depression), nausea, abdominal pain, breast pain, breast tenderness, weight gain, skin rash.

• Rare Side Effects (may affect up to 1 in 100 women): vomiting, diarrhea, fluid retention or edema, migraine, loss of libido, breast enlargement, urticaria.

• Rare Side Effects (may affect up to 1 in 1,000 women): eye irritation with contact lenses, hypersensitivity, weight loss, nipple secretion, vaginal discharge, increased libido, erythema nodosum (nodules on legs), erythema multiforme (skin lesions).

Severe Adverse Effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema: facial swelling, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section “Warnings and Precautions”).

Reporting Adverse Effects

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

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not useKerietteafter the expiration date that appears on the outer packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Keriette

The active principles are levonorgestrel and etinilestradiol.

Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of etinilestradiol. The other components (excipients) are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, red aluminum lake (E129), lecithin (E322), red iron oxide (E172) and blue aluminum lake (E1329)].

Appearance of the product and content of the packaging

• Each coated tablet is round and pink in color.

• Keriette is marketed in blisters of 21 tablets.

• The packaging sizes are 1, 3 or 6 blisters, and each blister contains 21 tablets. Only some packaging sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

C/La Vallina s/n;

24193 - Villaquilambre, León

Spain

Last review date of this leaflet: November 2022

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