KERIETTE 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Keriette 0.1 mg/0.02 mg film-coated tablets EFG

Levonorgestrel/Ethinylestradiol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Kerietteand what is it used for
2. What you need to know before you start taking Keriette

• Do not use Keriette
• Special warnings and precautions for use of Keriette
• Kerietteand thrombosis
• Kerietteand cancer
• Bleeding between periods
• What to do if you do not have bleeding during the treatment-free week
• Using other medicines
• Lab tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• Important information about some of the ingredients of Keriette

1. How to take Keriette

• When can you start with the first blister
• If you take more Keriettethan you should
• If you forget to take Keriette
• What to do in case of vomiting or severe diarrhea
• Delayed menstrual period: what you should know
• Change of the first day of your menstrual period: what you should know
• If you want to stop taking Keriette

1. Possible side effects
2. Storage of Keriette
3. Contents of the pack and other information

1. What is Keriette and what is it used for

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

2. What you need to know before you start taking Keriette

General considerations

Before you can start taking Keriette, your doctor will ask you some questions about your medical history and that of your close relatives. He/She will also measure your blood pressure and, depending on your personal situation, may perform other tests.

This leaflet describes several situations in which you should stop using Kerietteor in which the reliability of Keriettemay be decreased. In such situations, you should either not have sex or take extra non-hormonal precautions, such as using a condom or another barrier method. Do not use the rhythm or temperature methods. These methods can be unreliable because Keriettealters the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, Keriettedoes not protect against HIV infection (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 of the leg, lungs (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 severe chest pain) or a stroke (e.g. a small, temporary stroke 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 damage to blood vessels
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
• If you have a blood coagulation disorder (e.g. protein C deficiency).
• If you have (or have had) a certain type of migraine (with so-called focal neurological symptoms).
• If you have (or have had) pancreatitis (inflammation of the pancreas).
• If you have or have had liver disease in the past and if your liver function is still not normal.
• If you have or have had a liver tumor.
• If you have (or have had) or if there is a suspicion of breast cancer or cancer of 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 ingredients of Keriette. This allergy may be recognized by the appearance of itching, rash or inflammation.
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Using Keriette with other medicines").

Special warnings and precautions

In some situations, you will need to take special precautions when using Kerietteor any other combined hormonal contraceptive, and sometimes you will need to see your doctor regularly. If you are in any of the following situations, you should inform your doctor before starting to use Keriette. You should also consult your doctor if any of the following conditions appear or worsen while using Keriette:

• If a close relative has or has had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (an inherited disease of the red blood cells).
• If you have epilepsy.
• If you have systemic lupus erythematosus (SLE, an immune system disorder).
• If you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g. loss of hearing, porphyria [a blood disorder], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden movements of the body occur]).
• If you have or have had chloasma (brownish-yellow pigmented 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 swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Keriette and thrombosis

Venous thrombosis

The use of any combined pill, including Keriette, increases the risk of a woman developing a venous thrombosis (formation of a blood clot in a vein) compared to a woman who does not take any contraceptive pill.

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

• With age,
• If you are overweight,
• If any of your close relatives have had a blood clot (thrombosis) in the leg, lung or other organ at a young age,
• If you need to undergo surgery (surgery), a prolonged period of immobilization or if you have had a serious accident. It is important that you discuss with your doctor that you are using Keriette, as you may need to interrupt treatment. Your doctor will tell you when you can start taking Kerietteagain. This is usually within 2 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 stop 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 overweight.
• If any of your close relatives have 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 (a valve disorder or a heart rhythm disorder).

Stop taking Kerietteand contact your doctor immediately if you notice any signs of a possible thrombosis, such as:

• Severe pain or swelling of one leg
• Sudden severe chest pain, which may radiate to the left arm
• Sudden shortness of breath
• Sudden cough without an obvious cause
• An unusual, severe or prolonged headache, or worsening of a migraine
• Partial or complete blindness, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, feeling or numbness in any part of the body

Keriette and cancer

There have been reports of breast cancer with a slightly higher frequency in women taking contraceptive pills, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors has been gradually lower after stopping the use of combined hormonal contraceptives. It is important to regularly check your breasts, and you should contact your doctor if you notice any lump.

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

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

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

Bleeding between periods

During the first months of treatment with Keriette, you may have unexpected bleeding (bleeding outside of the treatment-free week). If this bleeding lasts for more than a few months, or if it starts after some months, your doctor should investigate the cause.

What to do if you do not have bleeding during the treatment-free week

If you have taken all the tablets correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medicines, 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 blister 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 medicines

Always consult the doctor who prescribed Kerietteabout other medicines or herbal remedies you are already using. Also, inform any other doctor or dentist who prescribes you other medicines (or the pharmacist who dispenses them) that you are using Keriette. They may tell you if you need to use additional contraceptive measures (e.g. condoms) and, if so, for how long.

Some medicines reduce the effectiveness of Keriettein preventing pregnancy, or may cause unexpected bleeding.

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

If you want to use herbal remedies containing hypericum while taking Keriette, you should first consult your doctor.

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

Do not take Kerietteif you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increased liver test results (increase in liver enzyme ALT).

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

Keriettecan be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Keriette".

Consult your doctor or pharmacist before using any medicine.

Lab tests

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

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

It is generally not recommended to useKeriettewhile breast-feeding. You should consult your doctor if you wish to take the pill while breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no information to suggest that the use of Kerietteaffects the ability to drive or use machines.

Keriette contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to Take

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

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 on the blister pack. Take one tablet every day until you have finished all 21 tablets. After that, do not take any more tablets for 7 days.

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

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

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

If you use Keriettein 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 with Kerietteon the first day of your cycle (which is the first day of your menstruation). If you start taking Kerietteon 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 must use extra protective measures (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 taking Keriettethe day after the tablet-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 progestin-only method (progestin-only pill or injection, implant, or IUD that releases progestin).

You can switch any day from the progestin-only pill (if you used an implant or IUD, on the day of its replacement, and if you received the progestin by injection, on the date of the next injection), but in all cases, you must apply additional protective measures (e.g., a condom) during the first 7 days you take the new pills.

• After an abortion or miscarriage.

Follow your doctor's instructions.

• After having a child.

After having a child, you can start taking Keriettebetween 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using Keriette.

If you have had sexual intercourse after having a child before starting to take Kerietteagain, you must first check that you are not pregnant or wait until your next menstrual period.

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

• If you are breastfeeding and want to start taking Kerietteagain after having a child.

Read the section on "Breastfeeding"

If you take more Keriettethan you should

There are no reports of harmful effects from taking too many Keriettetablets. If you take several tablets at once, you may experience nausea and vomiting. Young girls may experience vaginal bleeding.

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

In case of 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 forget to take Keriette

• If it has been less than 12 hourssince you forgot to take the tablet, your protection against pregnancy will not be affected. You can still take the tablet as soon as you remember and then take the following tablets at the usual time.

• If it has been more than 12 hourssince you forgot to take the tablet, your protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk that your protection against pregnancy will be reduced.

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

Therefore, you must follow these rules (see also the diagram below):

• More than 1 forgotten tablet in the blister pack

Consult your doctor.

• 1 forgotten tablet 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 following tablets at the usual time and take extra precautionsfor the next 7 days, for example, a condom. If you have had sexual intercourse in the week before the forgotten tablet, or if you forgot to start a new blister pack after the tablet-free period, you should be aware that there is a risk of pregnancy. In that case, consult your doctor.

• 1 forgotten tablet 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 following tablets at the usual time. Your protection against pregnancy will not be reduced, and you will not need to take extra precautions.

• 1 forgotten tablet 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 following tablets at the usual time. Instead of the tablet-free period, start the next blister pack directly.

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

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

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

• If you forget to take any of the tablets in a blister pack and do not have bleeding during the first tablet-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 severe diarrhea

If you vomit within 3-4 hours after taking the tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed into 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 it within 12 hoursof the time you would normally take your tablet. If it is not possible, or if more than 12 hours have passed, you should follow the advice included in "If you forget to take Keriette."

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you continue taking a new Kerietteblister pack directly instead of the tablet-free period, until the end of the second blister pack instead of starting the rest period. You may experience spotting (drops or spots of blood) or intercurrent bleeding while using the second blister pack. After the usual 7-day tablet-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.

Changing 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 during the tablet-free week. If you need to change this day, do so by shortening the tablet-free period (but never lengthening it). For example, if your tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you shorten the tablet-free period significantly (e.g., to 3 days or less), you may not have any bleeding during this period. Afterward, you may experience spotting (drops or spots of blood) or intercurrent bleeding.If you are not sure what to do, ask your doctor for advice.

If you want to stop taking Keriette

You can stop taking Keriettewhenever you want. If you do not want to become 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

• Uncommon side effects (may affect up to 1 in 100 women): vomiting, diarrhea, fluid retention or edema, migraine, loss of libido, breast enlargement, hives.

• Rare side effects (may affect up to 1 in 1,000 women): eye irritation with contact lens use, hypersensitivity, weight loss, breast secretion, vaginal discharge, increased libido, erythema nodosum (nodules on the legs), erythema multiforme (skin lesions).

Serious side effects

Contact a 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 with possible difficulty breathing (see also the section "Warnings and precautions").

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Keriette

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use Kerietteafter the expiration date stated 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 via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Keriette composition

The active ingredients are levonorgestrel and ethinylestradiol.

Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other ingredients (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, aluminum lake red (E129), lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

Appearance of the product and package contents

• Each film-coated tablet is pink and round.

• Kerietteis marketed in blister packs of 21 tablets.

• The package sizes are 1, 3, or 6 blisters, and each blister pack contains 21 tablets. Not all package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

C/La Vallina s/n;

24193 - Villaquilambre, León

Spain

Date of the last revision of this leaflet: November 2022

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