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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Levonorgestrel / Ethinylestradiol

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

• Do not use Keriette Diario
• Special warnings and precautions for use
• Keriette Diario and thrombosis
• Keriette Diario and cancer
• Bleeding between periods
• What to do if no bleeding occurs during the placebo week
• Use of other medicines
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and use of machines
• Important information about some of the ingredients of Keriette Diario

1. How to take Keriette Diario

• When you may start the first blister pack
• If you take more Keriette Diario than you should
• If you forget to take Keriette Diario
• What to do in case of vomiting or severe diarrhoea
• Delayed menstrual period: what you should know
• Change in the first day of your menstrual period: what you should know
• If you wish to stop taking Keriette Diario

1. Possible side effects
2. How to store Keriette Diario
3. Contents of the pack and other information

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

• Keriette Diario is 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 containing two hormones are known as "combined pills".

2. What you need to know before starting Keriette Diario

General considerations

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

This leaflet describes several situations in which you must stop using Keriette Diario or in which the reliability of Keriette Diario may be reduced. In these situations, you should not have sexual intercourse or, otherwise, must use additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because Keriette Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not use Keriette Diario

• 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 could predict a heart attack (e.g., angina pectoris, which causes severe chest pain) or a stroke (e.g., a transient ischemic attack without residual effects)
• If you have a disease that could increase the risk of arterial thrombosis. These warnings apply in the following situations:
  • diabetes with blood vessel 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 specific type of migraine (with so-called neurological focal symptoms)
• If you have (or have had) inflammation of the pancreas (pancreatitis)
• If you have or have had liver disease and 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 suspicion of breast cancer or cancer of the genital organs
• If you have vaginal bleeding of unknown cause
• 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 Diario. This allergy may manifest as itching, skin rash, or swelling.
• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Use of Keriette Diario with other medicines").

Warnings and precautions

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

• If a close relative has or has had breast cancer
• If you have liver or gallbladder disease
• If you suffer from diabetes
• If you have depression
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease)
• If you have HUS (hemolytic uremic syndrome), a blood disorder causing kidney damage
• If you have sickle cell anemia (a hereditary disease of the blood's red blood cells)
• If you have epilepsy
• If you have SLE (systemic lupus erythematosus, an immune system disorder)
• If you have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash occurring during pregnancy], Sydenham's chorea [a nerve disorder causing sudden body movements])
• If you have or have ever had chloasma (golden-brown pigmented spots known as "pregnancy mask," 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 hives with possible breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Keriette Diario and venous thrombosis

The use of any combined oral contraceptive pill, including Keriette Diario, increases a woman's risk of 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 overweight,
• If a close relative has had a blood clot (thrombosis) in the leg, lung, or another organ at a young age,
• If you are undergoing surgery, prolonged immobilization, or have suffered a serious accident. It is important to inform your doctor that you are using Keriette Diario, as you may need to interrupt treatment. Your doctor will advise you when to restart Keriette Diario. Usually, this will be within two weeks after recovery.

Keriette Diario and arterial thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (blockage of an artery), for example, in 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 using Keriette Diario , 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 a close relative 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 cardiac arrhythmia)

Stop taking Keriette Diario and contact your doctor immediately if you notice possible signs of thrombosis, such as:

• Severe pain or swelling in one of your legs
• Sudden, severe chest pain, possibly radiating to the left arm
• Sudden shortness of breath
• Sudden cough without an obvious cause
• Unusual, severe, or prolonged headache, or worsening of migraine
• Partial or complete blindness, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, unusual sensation, or numbness in any part of the body

Keriette Diario and cancer

A slightly higher frequency of breast cancer has been observed in women taking oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined by their doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you notice any lumps.

Ovarian cancer occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogen alone or with a combination of estrogen-progestogen 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 to 54 years who do not use HRT, about 2 cases of ovarian cancer occur per 2,000 women over a 5-year period. In women receiving HRT for 5 years, about 3 cases per 2,000 women are observed (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 oral contraceptives. Contact your doctor if you experience unusual, severe abdominal pain.

Bleeding between periods

During the first months of treatment with Keriette Diario, you may experience unexpected bleeding (bleeding outside the placebo week). If this bleeding lasts for more than a few months, or if it starts after several 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 or had severe diarrhoea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If the expected withdrawal bleeding does not occur in two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start taking tablets from the next blister pack until you have confirmed that you are not pregnant.

Keriette Diario and psychiatric disorders

Some women who use hormonal contraceptives such as Keriette Diario have reported depression or a depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for medical advice as soon as possible.

Use ofKeriette Diario withother medicines

Always consult the doctor who prescribed Keriette Diario about any other medicines or herbal remedies you are currently using. Additionally, inform any other doctor or dentist who prescribes you new medicines (or the pharmacist dispensing them) that you are taking Keriette Diario. They will advise you whether you need to use additional contraceptive methods (e.g., condoms), and if so, for how long.

Some medicines reduce the effectiveness of Keriette Diario in preventing pregnancy or may cause unexpected bleeding.

These include medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine), tuberculosis (e.g., rifampicin), HIV infections (ritonavir), or other infectious diseases (such as griseofulvin, ampicillin, or tetracyclines), those that increase intestinal motility (such as metoclopramide), and the herbal remedy St. John’s wort (Hypericum perforatum).

If you wish to use herbal remedies containing St. John’s wort while taking Keriette Diario, you must first consult your doctor.

Keriette Diario may reduce the effectiveness of other medicines, such as those containing cyclosporine, or the antiepileptic lamotrigine (which could increase the frequency of seizures).

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

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

Consult your doctor or pharmacist before using any medicine.

Analytical tests

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

Pregnancy

If you are pregnant, you must 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.

Breast-feeding

In general, the use of Keriette Daily is not recommended while 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 medication.

Driving and using machines

There is no information indicating that the use of Keriette Daily affects the ability to drive or operate machinery.

Keriette Daily contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Keriette Diario

If you were previously taking another contraceptive before starting Keriette Diario, you are already aware that most contraceptives contain 21 tablets. With those contraceptives, you take one pill for 21 days, followed by a week without any tablets (a drug-free interval).

The regimen for using Keriette Diario is different. After taking the 21 colored tablets, you must continue with the 7 placebo tablets—there is no drug-free interval, but rather a week of "placebo" (the week during which you take the white tablets from row 4). Since you must take a tablet every day and there is no drug-free interval between packs, taking the pills becomes a routine habit, thereby reducing the risk of missing a dose.

The two different types of colored tablets in Keriette Diario are arranged in order. One pack contains 28 tablets.

Take one Keriette Diario tablet every day, with a small amount of water if necessary. You must take the tablets daily, approximately at the same time each day.

Do not confuse the tablets: take one pink tablet daily for the first 21 days, then one white tablet daily for the last 7 days. After that, start a new pack (21 pink tablets and 7 white tablets). Therefore, there is no drug-free interval between packs.

The blister pack contains 28 tablets. Taking one tablet daily for 28 consecutive days is essential to maintain contraceptive effectiveness.

Adhesive labels with the days of the week are provided alongside the blister packs. Select the label corresponding to the day you start taking the pill. Apply the label to the blister over the words “Pegar aquí la etiqueta con el día” (“Apply label with day here”). Each day will then align with a row of tablets. It is important that you take your pill every day. Take the first tablet from the first row where the word “INICIO” (“START”) is indicated.

Follow the direction of the arrow shown on the blister: take the pink tablets first for 21 days, then the white tablets for 7 days, until all 28 tablets are taken. After that, start the next blister pack. This means there is no drug-free interval between packs.

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

You should start the next blister pack on the same day of the week, and withdrawal bleeding should occur on the same days each month.

When to start the first blister pack

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

Start Keriette Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Keriette Diario on the first day of your period, you are immediately protected against pregnancy. You may also start on days 2–5 of the cycle, but in that case, you must use additional contraceptive protection (e.g., a condom) for the first 7 days.

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

You may start taking Keriette Diario the day after the tablet-free interval of the pill you just finished (or the day 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 may switch on any day from the progestogen-only pill (if you were using an implant or IUD, on the day of its removal; if you were receiving progestogen by injection, on the date the next injection would have been due), but in all cases, you must use additional contraceptive protection (e.g., a condom) for the first 7 days of taking the new pills.

• After an abortion or miscarriage

Follow your doctor’s instructions.

• After giving birth

After giving birth, you may start taking Keriette Diario between 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g., a condom) for the first seven days of using Keriette Diario.

If you had intercourse after giving birth before starting (or restarting) Keriette Diario, you must first confirm you are not pregnant or wait until your next menstrual bleeding.

Consult your doctor if you are unsure about when to start.

• If you are breastfeeding and wish to start (or restart) taking Keriette Diario after giving birth

Please read the section on “Breastfeeding”.

If you take more Keriette Diario than you should

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

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Keriette Diario

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these placebo tablets, it will not affect the effectiveness of Keriette Diario. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of Keriette Diario.

If you forget to take a tablet from rows 1, 2, or 3, follow the instructions below:

• If less than 12 hours have passed since you missed the tablet, contraceptive protection is not compromised. You can still take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

• If more than 12 hours have passed since you missed the tablet, contraceptive protection may be reduced. The more tablets you miss, the greater the risk of reduced protection against pregnancy.

The risk of incomplete contraceptive protection is higher if you miss a tablet at the beginning of a blister pack (1st row) or at the end of week 3 (3rd row of the blister).

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

• More than 1 tablet missed from the blister pack

Consult your doctor.

• One tablet missed in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional precautions for the next 7 days (e.g., use a condom). If you had intercourse in the week before the missed tablet, or if you forgot to start a new blister pack after the tablet-free interval, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• One tablet missed in week 3

You have two options:

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

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

You will most likely experience menstruation (withdrawal bleeding) at the end of the second blister pack, but you may also experience spotting or breakthrough bleeding during the second blister pack.

2. Alternatively, you may stop taking the active pink tablets and immediately start taking the 7 white placebo tablets (note the day you missed the tablet). Then continue with the next blister pack. If you wish to start a new blister pack on a specific day, take fewer than 7 placebo tablets.

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

• If you missed one or more tablets from a blister pack and do not have bleeding during the placebo week, this could indicate pregnancy. Contact your doctor before starting 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 tablet or if you have severe diarrhea, there is a risk that the active ingredients may not be fully absorbed into your body. This situation is similar to missing a tablet. After vomiting or experiencing diarrhea, take another tablet from your reserve blister pack as soon as possible. If possible, take it within 12 hours of when you would normally take your tablet. If this is not possible, or if more than 12 hours have passed, follow the advice under “If you forget to take Keriette 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 by skipping the white placebo tablets and starting a second pack of Keriette Diario. You may experience spotting (drops or blood spots) or breakthrough bleeding while using the second blister pack. After the 7 days of taking the placebo tablets from the second blister pack, continue with the next blister pack.

You may need to consult your doctor before deciding to delay your menstrual cycle.

Changing 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 occur during the placebo tablet week. If you wish to change this day, shorten the placebo interval—that is, reduce the number of days you take the white placebo tablets (but never extend it). For example, if your placebo week starts on a Friday and you wish to change it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If you shorten the placebo interval significantly (e.g., 3 days or fewer), you may not have any bleeding during this placebo period. Afterwards, you may experience spotting or breakthrough bleeding.

If you are unsure what to do, consult your doctor.

If you wish to stop taking Keriette Diario

You may stop taking Keriette Diario at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Several side effects related to the use of the pill are described in the sections "Keriette Diario and thrombosis" and "Keriette Diario and cancer". Please read these sections for further information and consult your doctor immediately if necessary.

• Common side effects (may affect up to 1 in 10 women): headache, changes in mood (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 sexual desire, breast enlargement, urticaria.

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

Serious adverse 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 urticaria with possible breathing difficulties (see also section "Warnings and precautions").

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Keriette Diario

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Keriette Diario after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Keriette Diario

The active substances are levonorgestrel and ethinylestradiol.

Keriette Diario film-coated tablets contain tablets of 2 colours:

• Each pink 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, red aluminium lake (E129), lecithin (E322), red iron oxide (E172) and blue aluminium lake (E1329)].

• Each white tablet (inactive tablets or placebo tablets) contains only excipients (no active substances), 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 contents of the pack

• Each active film-coated tablet is round and pink in colour.
• Each placebo film-coated tablet is round and white in colour.
• Keriette Diario is available in blister packs of 28 tablets: 21 active pink tablets and 7 white placebo tablets.
• Pack sizes are 1, 3 or 6 blisters, each blister containing 28 tablets. Only certain pack sizes may be marketed.

Marketing Authorisation 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 most recent revision of this leaflet: November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http:// www.aemps.gob.es/