KERIETTE DIARIO 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Prospectus: Information for the user

Keriette Daily 0.1 mg/0.02 mg film-coated tablets EFG

Levonorgestrel / Ethinylestradiol

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What Keriette Dailyis and what it is used for
2. What you need to know before starting to take Keriette Daily

• Do not use Keriette Daily
• Be careful with Keriette Daily
• Keriette Dailyand thrombosis
• Keriette Dailyand cancer
• Bleeding between periods
• What to do if there is no bleeding during the placebo week
• Use of other medications
• Laboratory tests
• Pregnancy
• Breastfeeding
• Driving and using machines
• Important information about some of the components of Keriette Daily

1. How to take Keriette Daily

• When you can start with the first blister pack
• If you take more Keriette Dailythan you should
• If you forget to take Keriette Daily
• 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 Daily

1. Possible side effects

1. Storage of Keriette Daily
2. Package contents and additional information

1. What is Keriette Daily and what is it used for

• Keriette Dailyis a contraceptive pill used to prevent pregnancy.

• Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.

• The white tablets do not contain active ingredients and are also known as placebo tablets.

Contraceptive pills that contain two hormones are known as "combined pills".

2. What you need to know before starting to take Keriette Daily

General considerations

Before you can start taking Keriette Daily, your doctor will ask you some questions about your medical history and that of your close relatives. He 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 using Keriette Dailyor in which the reliability of Keriette Dailymay be reduced. In these situations, you should not have sexual intercourse or, if you do, you should take other non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable, as Keriette Dailyalters the monthly changes in body temperature and cervical mucus.

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

Do not useKeriette Daily

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel in 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 transient stroke without residual effects)
• If you have a disease that could 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 tumor in the liver
• If you have (or have had) or if there is suspicion of breast cancer or cancer in the genital organs
• If you have unexplained vaginal bleeding
• If you have not had your period for several months without a known cause
• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of Keriette Daily. This allergy can be recognized by the appearance of itching, 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 the use of Keriette Daily with other medications).

Warnings and precautions

In some situations, you will need to take special precautions when using Keriette Dailyor any other combined hormonal contraceptive, and sometimes you will need to visit your doctor periodically. If you are in any of the following situations, you must inform your doctor before starting to use Keriette Daily. Additionally, you will need to consult your doctor if any of the following situations appear or worsen while using Keriette Daily:

• If a close relative has or has had breast cancer
• If you have a 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 (a hereditary disease of red blood cells)
• If you have epilepsy
• If you have systemic lupus erythematosus (SLE, an immune system disorder)
• 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 disease], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden body movements occur])
• If you have or have had chloasma (brownish spots that are known as "pregnancy spots", 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 can cause or worsen symptoms of hereditary and acquired angioedema.

Keriette Dailyand thrombosis

Venous thrombosis

The use of any combined pill, including Keriette Daily, increases the risk of a woman developing venous thrombosis (formation of a blood clot in a vessel) 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 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 period of prolonged immobilization, or if you have suffered a serious accident. It is essential that you discuss with your doctor that you are using Keriette Daily, as you may need to interrupt treatment. Your doctor will tell you when you can start taking Keriette Dailyagain. Normally, it will be within two weeks after your recovery.

Arterial thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (obstruction 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 Dailyand 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 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 (a valvular disorder or a heart rhythm disorder)

Stop taking Keriette Dailyand contact your doctor immediately if you observe possible signs of thrombosis, such as:

• Severe pain or swelling in one of your legs
• Sudden severe chest pain, which may radiate to the left arm
• Sudden shortness of breath
• Sudden cough, without an apparent 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, strange sensation, or numbness in any part of the body

Keriette Dailyand cancer

There have been cases of breast cancer with a slightly higher frequency in women taking contraceptive pills, but it is not known if 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 essential 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 higher 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 follow HRT, there have been approximately 2 cases of ovarian cancer per 2,000 women in a period of 5 years. In women treated with HRT for 5 years, there have been approximately 3 cases per 2,000 patients (i.e., approximately 1 additional case).

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

Bleeding between periods

During the first few months of treatment with Keriette Daily, you may experience unexpected bleeding (bleeding outside of the placebo week). If this bleeding lasts 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 placebo week

If you have taken all the active pink tablets 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 blister pack until you are sure you are not pregnant.

Keriette Daily and psychiatric disorders

Some women who use hormonal contraceptives like Keriette Daily have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Use ofKeriette Daily withother medications

Always consult with the doctor who prescribed Keriette Dailyabout other medications or herbal remedies you are already using. Additionally, inform any other doctor or dentist who prescribes you other medications (or the pharmacist who dispenses them) that you are using Keriette Daily. They may tell you if you need to add other contraceptive measures (e.g., condoms) and, if so, for how long.

Some medications reduce the effectiveness of Keriette Dailyin preventing pregnancy or may cause unexpected bleeding.

These include medications used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine) and tuberculosis (e.g., rifampicin) or HIV infections (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 that contain hypericum while taking Keriette Daily, you should consult your doctor first.

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

Do not take Keriette Daily 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 produce increases in liver test results (increase in liver enzyme ALT).

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

Consult your doctor or pharmacist before using any medication.

Laboratory 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, you should not take Keriette Daily. If you become pregnant while taking Keriette Daily, you should stop using it immediately and contact your doctor.

Consult your doctor or pharmacist before using any medication.

Breastfeeding

In general, it is not recommended to use Keriette Dailywhen 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 using machines

There is no information that indicates that the use of Keriette Dailyaffects the ability to drive or use machines.

Keriette Dailycontains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

3. How to Take Keriette Daily

If you were taking another contraceptive before starting to take Keriette Daily, you will already know that most contraceptives contain 21 tablets. With those contraceptives, you take a pill for 21 days and then there is a week when you do not take any tablets (medication-free interval).

The system to follow when using Keriette Dailyis different. After taking the 21 colored tablets, you must continue and take the 7 placebo tablets, i.e., there is no medication-free interval but rather a week of "placebo" (the week when you take the placebo tablets from row 4). Since you have to take one tablet every day and there is no medication-free interval between two packages, taking the tablets will become routine and, consequently, the risk of forgetting a tablet is lower.

The two distinct classes of colored tablets of Keriette Dailyare placed in order. One package contains 28 tablets.

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

Do not confuse the tablets: take one pink-colored tablet once a day for the first 21 days, and then one white-colored tablet every day for the last 7 days. After that, you will have to start a new package (21 pink-colored tablets and 7 white-colored tablets). Consequently, there is no medication-free interval between packages.

The blister pack contains 28 tablets. Daily intake for 28 consecutive days is important to maintain the contraceptive effect.

Along with the blister packs, adhesive labels with the days of the week are attached. Take the label for the day you start taking the pill. Place the label on the blister pack over the words "Stick the label with the day here". Each day will align with a row of tablets. It is essential that you take your pill every day. And take the first tablet from the first row where the word "START" is indicated.

Follow the direction of the arrow indicated on the blister pack, take the pink-colored tablets first for 21 days and then the white-colored tablets for 7 days, until you have taken all 28 tablets. After that, you will have to start taking the next blister pack. This means that there is no medication-free interval between packages.

During the 7 days of white tablets, you should start bleeding (normally on the 2nd or 3rd day). This is what is known as withdrawal bleeding and may continue when you start with the next blister pack.

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.

When can you start with the first blister pack

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

Start with Keriette Dailyon the first day of your cycle (which is the first day of your menstruation). If you start taking Keriette Dailyon 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 protection 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 Keriette Dailythe 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 progestogen-only method (progestogen-only pill or injection, implant, or progestogen-releasing IUD)

You can switch any day from the progestogen-only pill (if you used an implant or IUD, on the day of its removal, and if you received the progestogen by injection, on the date the next injection was due), but in all cases, you must apply additional protection measures (e.g., a condom) during the first 7 days of taking 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 Keriette Dailybetween 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 Daily.

If after having a child you have had sexual intercourse before starting to take Keriette Dailyagain, 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 Keriette Daily again after having a child

Read the section on "Breastfeeding".

If you take moreKeriette Dailythan you should

There are no reports of harmful effects from taking too many Keriette Dailytablets. 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 Keriette Dailytablets, 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 forgot to takeKeriette Daily

The tablets in the fourthrow of the package are placebo tablets. If you forgot to take one of those tablets, it will not affect the effect of Keriette Daily. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of Keriette Daily.

If you forgot to take a tablet from rows 1, 2, or 3, you should follow these instructions:

• If it has been less than 12 hourssince you forgot the tablet, the protection against pregnancy is not altered. 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 the tablet, the protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk that the 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 of a blister pack (1st row) or at the end of week 3 (3rd row of the blister pack).

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

• More than 1 forgotten tablet from 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 tablets afterwards at the usual time and take extra precautionsfor the next 7 days, for example, use a condom. If you have had sexual intercourse in the week before the missed 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 tablets afterwards at the usual time. The protection against pregnancy is not 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.

Instead of taking the 7 white placebo tablets, go directly to 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 experience spotting or intercurrent bleeding when taking the second blister pack.

1. You can also stop taking the active tablets, the pink-colored ones, and go directly to taking the 7 white placebo tablets (note the day you forgot to take the tablet). Then, continue with the next blister pack. If you want to start a new blister pack on a specific day, take the placebo tablets for less than 7 days.

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

• If you forgot to take any of the tablets from a blister pack and do not have bleeding during the placebo week, 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 active pink-colored tablet or if you have significant 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 12 hours have already passed, you should follow the advice included in "If you forgot to take Keriette Daily".

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 package if you do not take the white placebo tablets and start taking a second package of Keriette Daily. You may experience spotting (drops or spots of blood) or intercurrent bleeding while using the next blister pack. After 7 days of taking the placebo tablets from the second blister pack, 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 period: what you should know

If you take the tablets according to the instructions, your menstrual period or withdrawal bleeding will begin in the week of the placebo tablets. If you need to change this day, do so by shortening the placebo period, i.e., when you take the white placebo tablets (but never lengthening it). For example, if your placebo 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 placebo interval too much (e.g., 3 days or less), you may not have any bleeding during this placebo period. After that, 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 takingKeriette Daily

You can stop taking Keriette Dailywhenever 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 "Keriette Dailyand thrombosis" and "Keriette Dailyand 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 Medicines Monitoring System for human use, website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Keriette Daily

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use Keriette Dailyafter the expiration date stated on the outer packaging and on the blister pack after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofKeriette Daily

The active ingredients are levonorgestrel and ethinylestradiol.

Keriette Dailyfilm-coated tablets contain tablets of 2 colors:

• Each pink-colored tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. 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, aluminum lake red (E129), lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

• Each white-colored tablet (inactive or placebo tablet) contains only excipients (without active ingredients), which are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572), and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), and polyethylene glycol 3350].

Appearance of the product and package contents

• Each active film-coated tablet is round and pink-colored.
• Each placebo film-coated tablet is round and white-colored.
• Keriette Dailyis marketed in blister packs of 28 tablets: 21 active pink-colored tablets and 7 white-colored placebo tablets.
• Package sizes are 1, 3, or 6 blister packs, and each blister pack contains 28 tablets. Not all package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

C/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/