Keriette 0.1 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Keriette 0.1 mg/0.02 mg film-coated tablets EFG

Levonorgestrel/Ethinylestradiol

Read all of 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 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. 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.

Contents of the leaflet

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

• Do not use Keriette
• Take special care with Keriette
• Keriette and thrombosis
• Keriette and cancer
• Bleeding between periods
• What to do if there is no bleeding during the tablet-free week
• Use of other medicines
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and use of machines
• Important information about some of the ingredients of Keriette

1. How to take Keriette

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

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

1. What Keriette is and what it is used for

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

2. What you need to know before starting to take 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. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests.

This leaflet describes several situations in which you must stop using Keriette or in which the effectiveness of Keriette 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 alters the monthly changes in body temperature and cervical mucus.

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

Do not use Keriette

• 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 a 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 may increase the risk of arterial thrombosis. These warnings apply to 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 certain type of migraine (with so-called neurological focal symptoms).
• If you have (or have had) inflammation of the pancreas (pancreatitis).
• If you currently have or have previously 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) or if there is 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 components of Keriette. This allergy may manifest as itching, 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 with other medicines").

Warnings and precautions

In certain situations, you must take special precautions when using Keriette or any other combined hormonal contraceptive, and you may need to see your doctor regularly. If you are in any of the following situations, you must inform your doctor before starting Keriette. You should also consult your doctor if any of the following conditions appear or worsen while you are 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 HUS (hemolytic uremic syndrome), a blood disorder causing kidney damage.
• If you have sickle cell anemia (a hereditary disease of the red blood cells).
• If you have epilepsy.
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have or have previously had a condition that first appeared during pregnancy or 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 jerky 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 and thrombosis

Venous thrombosis

The use of any combined oral contraceptive pill, including Keriette, increases a woman's risk of developing venous thrombosis (formation of a blood clot in a blood 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, as you may need to discontinue treatment. Your doctor will advise you when to restart Keriette. Usually, this will be within two weeks after recovery.

Arterial thrombosis

The use of combined oral contraceptives 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 while using Keriette, especially if you are over 35 years of age.
• 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 an abnormal heart rhythm).

Stop taking Keriette and contact your doctor immediately if you notice signs of possible 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 a 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 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, it may be that more tumors are detected in women taking combined pills because they are examined more frequently by their doctor. The occurrence of breast tumors has gradually decreased after stopping the use of combined hormonal contraceptives. It is important to regularly examine 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 estrogen alone or with estrogen-progestogen combinations 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 are not on HRT, about 2 cases of ovarian cancer are observed 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, you may experience unexpected bleeding (bleeding outside the week without treatment). 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 treatment-free week

If you have taken all the 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 bleeding does not occur on two consecutive occasions, you may be pregnant. Contact your doctor immediately. Do not start taking tablets from the next blister pack until you are certain that you are not pregnant.

Keriette and psychiatric disorders

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

Use of Keriette with other medicines

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

Some medicines may reduce the effectiveness of Keriette 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), drugs 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, you must first consult your doctor.

Keriette 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 if you have hepatitis C and are taking medications 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 starting treatment with these medicines.

Keriette can be restarted approximately 2 weeks after completion of such treatment. See the section “Do not use Keriette”.

Consult your doctor or pharmacist before using any medicine.

Laboratory tests

If you require 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**. If you become pregnant while taking** Keriette**, you must stop taking it immediately and contact your doctor.**

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

In general, Keriette 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 medicine.

Driving and use of machines

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

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

3. How to take

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

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

During these 7 tablet-free days (known as the break or treatment-free week), you will experience 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 Keriette tablet (i.e., after the seven-day treatment-free period), start the next blister pack, even if the bleeding has not stopped.

This means 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.

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

When to start the first blister pack

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

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

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

You may start taking Keriette the day after the tablet-free interval of the previous pill pack ends (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, progestogen 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, switch on the day of its removal; if you were receiving progestogen by injection, switch on the date the next injection would have been due). However, in all cases, you must use additional contraceptive precautions (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 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 Keriette use.

If you have had sexual intercourse after giving birth and before starting Keriette, you must first confirm that 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 taking Keriette again after giving birth

Please read the section on “Breastfeeding”

If you take more Keriette than you should

There are no reports of harmful effects from taking too many Levonorgestrel/Ethinylestradiol 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 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 or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Keriette

• If less than 12 hours have passed since you missed the tablet, your protection against pregnancy remains intact. You can still take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.

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

The risk of incomplete protection against pregnancy is higher if you miss a tablet at the beginning or end of a blister pack.

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

• More than 1 tablet missed from the 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., a condom). If you had sexual intercourse in the week before the missed tablet, or if you forgot to start a new 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. Your protection against pregnancy 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. Then continue taking the tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately.

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

2. Alternatively, you may stop taking tablets from the current pack and go directly to the 7-day tablet-free interval (note the day you missed your tablet). If you wish to start a new pack on a specific day, shorten the tablet-free interval to less than 7 days.

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

• If you missed any tablets in a pack and do not have bleeding during the first tablet-free interval, this could mean you are pregnant. You should contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking a tablet or 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 a reserve blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible, or if more than 12 hours have passed, follow the advice given under “If you forget to take Keriette.”

Delaying your 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 continuing directly with a new Keriette blister pack instead of taking the tablet-free interval, continuing until the end of the second pack rather than starting the usual 7-day break. You may experience spotting (drops or spots of blood) or breakthrough bleeding while using the second pack. After the usual 7-day tablet-free interval, 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 tablet-free week. If you wish to change this day, do so by shortening the tablet-free interval (but never extending it). For example, if your tablet-free interval starts on a Friday and you wish to change it to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. If you shorten the tablet-free interval significantly (e.g., to 3 days or less), you may not have any bleeding during this interval. 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

You may stop taking Keriette 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 can have 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 and thrombosis" and "Keriette and cancer". Please read these paragraphs for further 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 sexual desire, breast enlargement, hives.

• Rare side effects (may affect up to 1 in 1,000 women): eye irritation when wearing contact lenses, hypersensitivity, weight loss, breast discharge, vaginal discharge, increased libido, erythema nodosum (nodules in 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 hives with possible breathing difficulty (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 adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Keriette

Keep out of the sight and reach of children.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, 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

The active substances are levonorgestrel and ethinylestradiol.

Each 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), iron oxide red (E172), and blue aluminium lake (E1329)].

Appearance of the product and contents of the pack

• Each film-coated tablet is round and pink in colour.

• Keriette is marketed in blisters of 21 tablets.

• Pack sizes are 1, 3 or 6 blisters, each blister containing 21 tablets. Only certain pack sizes may be commercially available.

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 most recent revision of this leaflet: November 2022

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