Package Leaflet: Information for the user

Keriette Diary 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, 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 to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

• Do not useKeriette Diary
• Be particularly careful withKeriette Diary
• Keriette Diaryand thrombosis
• Keriette Diary andcancer
• Bleeding between periods
• What to do if there is no bleeding in the placebo week
• Use of other medicines
• Diagnostic tests
• Pregnancy
• Breastfeeding
• Driving and operating machines
• Important information about some of the components ofKeriette Diary

1. How to takeKeriette Diary

• When you can start with the first pack
• If you take moreKeriette Diarythan you should
• If you forget to takeKeriette Diary
• What to do in case of severe vomiting or diarrhoea
• Delayed 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 Diary

1. Possible side effects

5. Storage ofKeriette Diary

6. Contents of the pack and additional information

• Keriette Diarioa contraceptive pill used to prevent pregnancy.

• Each pink tablet contains a small amount of two different female hormones, known as 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".

General Considerations

Before you can start takingKeriette Diario, 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 situation, may perform other tests.

This prospectus describes several situations in which you should stop usingKeriette Diarioor in which the reliability ofKeriette Diariomay 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 becauseKeriette Diarioalters the monthly changes in body temperature and cervical mucus.

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

Do not useKeriette Diario

• If you have (or have had in the past) a blood clot (thrombosis) in a leg vein, the 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 a 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 concentrations 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 or have had a liver tumor
• If you have (or have had) breast cancer or cancer in the reproductive 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 ethinyl estradiol, or to any of the other components ofKeriette Diario. This allergy can be recognized by the appearance of itching, 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 Diario with other medications).

Warnings and Precautions

In some situations, you will need to take special precautions when usingKeriette Diarioor 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 useKeriette Diario. You should also consult your doctor if any of the following situations occur or worsen while you are usingKeriette Diario:

• 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, gestational herpes, Sydenham's chorea)
• If you have or have had melasma (brown or gray 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 Diario and Thrombosis

Deep Vein Thrombosis

The use of any combined pill, includingKeriette Diario, 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 any of your relatives have had a blood clot (thrombosis) in the leg, lung, or other organ at a young age
• If you are to undergo surgery (operation), prolonged immobilization, or have had a serious accident. It is essential to inform your doctor that you are usingKeriette Diario, as you may need to stop treatment. Your doctor will tell you when to start takingKeriette Diarioagain. This is usually within two weeks of 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 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 Diario, especially if you are over 35 years old
• If you have high concentrations 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 takingKeriette Diarioand contact your doctor immediately if you notice possible signs of 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
• Sudden cough without an apparent cause
• 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 Diario 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 detected more frequently in women taking combined pills because they are reviewed by their doctor more frequently. The appearance 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.

Ovarian cancer is less common 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, approximately 2 cases of ovarian cancer per 2,000 women have been observed over a 5-year period. In women taking HRT for 5 years, approximately 3 cases per 2,000 patients have been observed (i.e., approximately 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 Diario, you may experience unexpected bleeding (bleeding outside the placebo week). If this bleeding lasts for more than a few months or starts after some months, your doctor should investigate the cause.

What to Do If There Is No Bleeding in the Placebo Week

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

If the expected bleeding does not appear for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start taking the next packuntil you are sure you are not pregnant.

Keriette Diario and Psychiatric Disorders

Some women who use hormonal contraceptives like Keriette Diario 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 Diario with Other Medications

Always consult your doctor who prescribedKeriette Diarioabout other medications or herbal supplements you are already using. Additionally, inform any other doctor or dentist who prescribes other medications (or the pharmacist who dispenses them) that you are usingKeriette Diario. 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 ofKeriette Diarioin 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 Diario, you should consult your doctor first.

Keriette Diarioreduces 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 Diario 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.

Consult your doctor or pharmacist before using any medication.

Blood Tests

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

Pregnancy

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

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to useKeriette Diariowhile 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 ofKeriette Diarioaffects your ability to drive or operate machinery.

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

If you were taking another contraceptive before starting to takeKeriette Diario, you will already know that most contraceptives contain 21 tablets. With these contraceptives, you take a tablet for 21 days and then there is a week in which you do not take any tablets (medication-free interval).

The system to follow when usingKeriette Diariois different. After taking the 21 colored tablets, you must continue and take the 7 placebo tablets, that is, there is no medication-free interval but there is a week of "placebo" (the week in which you take the placebo tablets from row 4). Since you have to take a tablet every day and there is no medication-free interval between two packs, taking the tablets will become a routine and, as a result, the risk of forgetting a tablet is lower.

The two different types of colored tablets inKeriette Diarioare placed in order. One pack contains 28 tablets.

Take a tablet ofKeriette Diarioevery 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 a pink tablet once a day for the first 21 days, and then take a white tablet every day for the last 7 days. After that, you should start a new pack (21 pink tablets and 7 white tablets). As a result, there is no medication-free interval between packs.

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

Along with the blisters, adhesive labels with the days of the week are attached. Take the label of the day you start taking the pill. Put thelabel on the blister over the words "Stick the label with the day here". Each day will align with a row of tablets. It is important that you take your pill every day.And take the first tablet from the first row where it says "START".

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

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

You should start taking the next blister on the same day of the week, and withdrawal bleeding should appear on the same days every month.

When can you start with the first blister

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

You can start withKeriette Diarioon the first day of the cycle (which is the first day of your menstruation). If you start takingKeriette Diarioon the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of the cycle, but in that case, you must use extra protection measures (e.g. a condom) for the first 7 days.

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

You can start takingKeriette Diariothe 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 IUD releasing progestogen)

You can switch any day from the pill that contains only progestogen (if you used an implant or IUD, on the day of its removal, and if you received progestogen by injection, on the date of the next scheduled injection), but in all cases, you must apply additional protection measures (e.g. a condom) for the first 7 days while taking the new pills.

• After an abortion or fetal loss

Follow your doctor's instructions.

• After giving birth

After giving birth,You can start takingKeriette Diariobetween 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g. a condom) for the first 7 days of use ofKeriette Diario.

If after giving birth you have had sex again before starting to takeKeriette Diario(again), you must first check if you are 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 Diario (again) after giving birth

Read the section on "Breastfeeding".

If you take moreKeriette Diariothan you should

There are no reports on the harmful effects of taking too manyKeriette Diariotablets. If you take several tablets at once, you may experience nausea and vomiting symptoms. Young girls may experience vaginal bleeding.

If you have taken too manyKeriette Diariotablets, 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 Diario

The tablets in thefourthrow of the pack are placebo tablets. If you forgot to take one of those pills, it will not affect the effect ofKeriette Diario. You should throw away the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness ofKeriette Diario.

If you forgot to take a tablet from rows1, 2 or 3, you should follow the following instructions:

• 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 time.

• 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 forget to take a tablet at the beginning of a pack (1st row) or at the end of week 3 (3rd row of the pack).

Therefore, you should observe the following rules (see also the diagram, later):

• More than 1 tablet forgotten from the 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 next tablets at the usual time and takeextra precautionsfor the next 7 days, for example, use a condom. If you have had sex in the week before the mistake, or if you forgot to start a new 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 next tablets at the usual time. 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.

Instead of taking the 7 white placebo tablets, go directly to the next pack.

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

1. You can also leave taking the active tablets, the pink 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 pack. If you want to start a new pack on a specific day, take the placebo tablets for 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 a pack and you do not have bleeding in the placebo week, it could mean that you are pregnant. You should contact your doctor before continuing with the next pack.

What to do in case of vomiting or intense diarrhea

If you vomit in the 3-4 hours after taking the active pink 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 diarrhea, you should take another tablet from the reserve 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 Diario."

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 pack ifyou do not take the white placebo tablets and start taking a second pack ofKeriette Diario. You may have spotting (drops or spots of blood) or intercurrent bleeding while using the next pack. After the 7 days of taking the placebo tablets from the second pack,continue with the next pack.

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

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

If you take the tablets as instructed, your menstrual period or withdrawal bleeding will start in the week of the placebo tablets. If you need to change this day, do it by shortening the placebo period, that is, 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 pack 3 days earlier than usual. If you shorten the placebo period too much (e.g. 3 days or less), it is possible that you will not have any bleeding during this placebo period. Then, you may have 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 Diario

You can stop takingKeriette Diariowhen 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 may 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 Diarioand thrombosis” and “Keriette Diarioand 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, painful breasts, breast tenderness, weight gain, skin rash.

• Infrequent 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 discharge, vaginal discharge, increased libido, erythema nodosum (nodules on the 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 swelling, 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 a side effect that does not appear 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 useKeriette Diarioafter the expiration date shown on the outer packaging and 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 yourlocalpharmacy's SIGRE collection point. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofKeriette Diario

The active principles are levonorgestrel and etinilestradiol.

Keriette Diariofilm-coated tablets contain tablets of two colors:

• The pink 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)].

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

Appearance of the product and content of the container

• Each active film-coated tablet is a round pink tablet.
• Each placebo film-coated tablet is a round white tablet.
• Keriette Diariois marketed in blisters of 28 tablets: 21 active pink tablets and 7 white placebo tablets.
• The container sizes are 1, 3, or 6 blisters, and each blister contains 28 tablets.Only some container sizes may be marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

C/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 of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/