TRICICLOR Coated Tablets

Introduction

Package Leaflet: Information for the User

Triciclor Coated Tablets

Levonorgestrel/Ethinylestradiol

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

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

Contents of the pack

1. What is Triciclor and what is it used for
2. What you need to know before you start taking Triciclor
3. How to take Triciclor
4. Possible side effects
5. Storing Triciclor
6. Contents of the pack and other information

1. What is Triciclor and what is it used for

Triciclor is an oral contraceptive medicine.

Triciclor is prescribed for the following indications: hormonal oral contraception, menstrual cycle disorders, and ovarian rest.

In addition, the use of oral contraceptives may have beneficial effects on conditions such as dysmenorrhea (menstrual pain) and to reduce the incidence of some breast and reproductive organ disorders.

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

Do not takeTriciclor:

• If you are allergic to the active substances (levonorgestrel, ethinylestradiol) or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you have or have had severe liver function disorders with or without yellowing of the skin (jaundice) or persistent itching of the skin during pregnancy.
• If you have or have had heart or blood vessel problems, in particular:
• • heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders
  • blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) or rupture of blood vessels in the brain (stroke), mini-stroke, or general tendency to form blood clots (venous or arterial thrombosis)
  • chest pain caused by angina pectoris.
• If you have or have had breast tumors, cervical, uterine, or vaginal cancer, or a type of cancer that is sensitive to female hormones.
• If you have or have had liver tumors.
• If you have diabetes mellitus associated with blood vessel problems.
• If you have disorders of the arteries of the brain or heart.
• If you have valve disorders of the heart (valvulopathies).
• If you have heart rhythm disorders (arrhythmias) with the possibility of forming blood clots.
• If you have inherited or acquired disorders that predispose to the formation of blood clots (thrombophilia).
• If you have migraines (migraines) associated with symptoms such as loss of strength or sensitivity in a part of the body, or vision disturbances (aura).
• If you have uncontrolled high blood pressure.
• If you have vaginal bleeding of unknown cause.
• Untreated endometrial hyperplasia (increased size of the uterus)
• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Triciclor").

Warnings and precautions

Consult your doctor before starting to take Triciclor. You will need to go to your doctor for a physical examination. It is essential that you inform your doctor if you have or have had any of the diseases listed below. If so, your doctor may need to monitor you more frequently.

• Heart disease (chest pain, certain types of heart rhythm disorders, heart diseases).
• Family or personal history of high fat levels (triglycerides) in the blood.
• You or a close relative have had a disease with a tendency to develop blood clots (in the legs, lungs, or anywhere else in the body) or have a history of heart attacks or strokes.
• You have varicose veins or have had inflammation in the superficial veins of the legs.
• High blood pressure, particularly if it worsens or does not improve with anti-hypertensive medication.
• You develop migraines (migraines) for the first time or worsen an existing migraine (becomes more intense and repetitive) or is associated with vision disturbances (aura).
• Diabetes.
• Obesity.
• Depression or history of depression, as it may worsen or reappear when using hormonal contraceptives. If a severe depressive episode occurs, the medication should be discontinued and an alternative contraceptive method should be used. Women with a history of depression should be monitored.
• Epilepsy.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Jaundice (yellowing of the whites of the eyes and skin) or liver, pancreas, or kidney function disorders.
• You have gallstones, gallbladder disorders, or problems caused by bile duct blockage (cholestasis) - may cause intense itching.
• Itching, red spots, or blisters (herpes gestationalis) especially if they occurred during a previous pregnancy or when taking another contraceptive pill.
• Brown spots on the skin of the face (chloasma), especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., sunlamp).
• You have a disorder that affects your immune system (systemic lupus erythematosus).
• You have a disease known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• You have had a blood disease associated with kidney disease (hemolytic uremic syndrome).
• You have had a blood disease called porphyria.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

Some women who use hormonal contraceptives like Triciclor 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.

Smoking cigarettes increases the risk of serious adverse reactions in the heart and blood vessels due to the use of oral contraceptives. This risk increases with age and the amount of tobacco and is quite relevant in women over 35 years of age.

You should also contact your doctor if you think you may be pregnant.

Potentially serious diseases:

Thrombosis (blood clots)

The use of combined contraceptive medicines, including Triciclor, may increase the risk of women developing thrombosis (blood clot formation). This risk is higher during the first year of use of oral contraceptives. Blood clots can block or obstruct major blood vessels and can cause: pulmonary embolism, myocardial infarction, angina pectoris, cerebral thrombosis, etc.

If you notice the appearance of any of the following signs, inform your doctor immediately or go to the emergency department of the nearest hospital, as they may be indicative of thrombosis:

• Pain and swelling in one leg.
• Severe chest pain that may also spread to the left arm.
• Difficulty breathing or sudden shortness of breath.
• Sudden onset cough, without apparent cause.
• Severe, unusual, or prolonged headache, or more frequent or severe migraines.
• Vision problems (partial or complete loss of vision, double vision).
• Difficulty speaking clearly.
• Dizziness or fainting.
• Seizures.
• Dizziness.
• Weakness, unusual sensitivity, or numbness affecting one part of the body.
• Difficulty walking or holding things.
• Severe stomach pain.
• Sudden changes in hearing, sense of smell, or taste.
• Increased blood pressure.

The following conditions may increase the risk of blood clot formation, so you should inform your doctor if you have any of them:

• If you are overweight or obese.
• If you are a smoker and are over 35 years old. It is strongly recommended to quit smoking when taking Triciclor, especially if you are over 35 years old.
• If you have just given birth or have had an abortion in the second trimester of pregnancy. Women have an increased risk of forming blood clots, so you should consult your doctor about when you can start taking the oral contraceptive after childbirth or abortion.
• If you have been prescribed prolonged immobilization (e.g., with one or both legs in a cast), are going to undergo or have undergone major surgery, any type of leg surgery, or significant trauma. In these situations, it is best to stop taking Triciclor (if surgery is planned, you should stop taking it at least 4 weeks before) and not start again until 2 weeks after you can stand up again.
• If you have an increased level of fat in the blood (cholesterol or triglycerides).
• 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 (valve disorders, heart rhythm disorders).

Genital bleeding

It may happen that you do not have your "period" during the week of rest. If the contraceptive pill has been taken correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor, as pregnancy should be ruled out before starting the next pack.

If you have not taken the contraceptive pill according to the instructions indicated in section 3 of this leaflet "How to take Triciclor" and you have a missed period, you should interrupt treatment and use a non-hormonal contraceptive method until pregnancy is ruled out.

During the first few months of taking this medicine, you may have unexpected bleeding or vaginal spotting outside of the 7 days when you should not take tablets. If this happens, continue treatment, and if the bleeding continues after the first three cycles, consult your doctor immediately, as it will be necessary to investigate the cause. Errors in the use of the pill can also cause spotting and light bleeding.

When you stop using this medicine, you may experience irregular, scant, or no bleeding, especially in the first 3 months, and especially if your periods were already irregular before starting hormone therapy.

Taking Triciclor with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including those obtained without a prescription.

Never take another medicine on your own initiative without your doctor's recommendation, as medicines can interfere with each other.

If you are receiving treatment from another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are taking Triciclor as a contraceptive. They may indicate that you need to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medicines with Triciclor.

Note that these instructions may also apply to medicines you have used before or may need to use.

The following medicines may make Triciclor less effective in preventing pregnancy or may cause unexpected bleeding. They include medicines used to treat:

• Viral infections and HIV (ritonavir, nevirapine).
• Infections (rifampicin, rifabutin, griseofulvin, and troleandomycin).
• Epilepsy (topiramate, barbiturics (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Gout (phenylbutazone) or inflammation (dexamethasone).
• Acidity of the stomach (antacids).
• Constipation (purgatives or laxatives).
• Sleep disorders (modafinil).
• The herbal medicine St. John's Wort (Hypericum perforatum), which is used to treat certain types of depression.

It is advisable to use another reliable contraceptive method if you take any of the medicines that may make oral contraceptives less effective. In general, women being treated with the aforementioned medicines should use a non-hormonal contraceptive method during antibiotic use and up to 7 days after discontinuation. If you need to continue taking these medicines after finishing your current pack, do not leave the week without taking tablets and start a new pack immediately.

In the case of rifampicin, griseofulvin, or medicines to treat epilepsy (antiepileptics), you should continue using non-hormonal contraceptives for at least 28 days after discontinuing treatment with these medicines.

Triciclor may also interfere with the following medicines. Some of these medicines may increase the levels of Triciclor, and in other cases, Triciclor may increase or decrease the effect of these medicines:

• Medicines that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Pain relievers (paracetamol and salicylates).
• Antiretrovirals (indinavir)
• Antibiotics (troleandomycin). Taking this medicine with Triciclor may increase the risk of intrahepatic cholestasis (bile retention in the liver) during treatment.
• Oral anticoagulants (acenocoumarol).
• Oral antidiabetics and insulin.
• Lamotrigine (for treating epilepsy and some psychiatric disorders) β-blockers such as metoprolol (for treating high blood pressure).
• Theophylline (for treating asthma).
• Corticosteroids (such as prednisolone).
• Cyclosporine (immunosuppressant), increasing the risk of liver toxicity.
• Flunarizine (for preventing migraines). Taking this medicine with Triciclor may increase the risk of galactorrhea. This is a disorder in which the breasts secrete milk spontaneously without breastfeeding or having had a baby recently.

Do not take TRICICLOR if you have Hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver test results (increase in liver enzyme ALT).

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

TRICICLOR can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take TRICICLOR".

Laboratory tests

The use of oral contraceptives may affect the results of certain laboratory tests. If you are indicated to perform any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, do not use this medicine and consult your doctor.

If you think you may have become pregnant during treatment with Triciclor, you should stop taking the medicine immediately and consult your doctor.

This medicine should not be used until you have finished breastfeeding.

Use in children

The efficacy and safety of oral contraceptives have been established in women of childbearing age.

It is not indicated for use before the first menarche (menstruation).

Elderly

It is not indicated for use in postmenopausal women.

Driving and using machines

No effects on the ability to drive or use machines have been observed with Triciclor.

Triciclor contains lactose and sucrose

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to Take Triciclor

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor again.

This medication is for oral administration. You should take one tablet every day, with a little liquid if necessary, and approximately always at the same time every day, until the package is finished. Then you will have to be 7 days without taking any tablets (these 7 days are also called "rest period"). During those 7 days when you will be without taking tablets, you will have a bleeding similar to your period. This bleeding usually starts after two or three days, and it may not have ended before starting the next package of tablets.

After those 7 days without taking tablets, you should start with the next package.

It is very important that you remember to take the tablets following the order and numbering that appears marked on the blister.

If this is the first time you are taking this medication or you have not used any hormonal contraceptive in the previous month

Treatment starts on the first day of the menstrual cycle (i.e., the first day of bleeding).

Contraceptive protection begins on the first day of treatment and is also maintained during the 7 days when you will be without taking tablets.

If you start after the first day of the menstrual cycle (days 2 to 7 of the cycle), you must also use a barrier contraceptive method (e.g., condoms) for birth control during the first 7 days.

If you were taking another contraceptive and you switch to Triciclor

If your contraceptive was 21 tablets:

You can start taking Triciclor the day after finishing your current contraceptive, without waiting for the 7-day "rest" period (days when you do not take tablets).

If your contraceptive was 28 tablets:

If your current contraceptive contains inactive tablets (placebo), do not take these tablets. Start taking Triciclor immediately the day after taking the last activetablet of your contraceptive.

If you switch from a contraceptive method that only contained a progestogen (minipill, implant, intrauterine device (IUD), or injection) to Triciclor.

Progestogen pill (minipill)

You can stop taking the progestogen pill (minipill) at any time during the menstrual cycle (any day) and start taking Triciclor the next day, at the same time.

Injectable contraceptive

Start using this medication when your next injection is due.

Implant or intrauterine device

Start using this medication the day after your implant or intrauterine device (IUD) is removed.

In all the situations described above, make sure to also use an additional barrier method when having sexual intercourse (e.g., condoms) during the first 7 days of taking Triciclor.

Taking Triciclor after an abortion in the first trimester

You can start taking the tablets immediately. If you do so, you do not need to take other contraceptive measures.

Taking Triciclor after childbirth or after an abortion during the second trimester

If you are breastfeeding, you should not take this medication until you have finished breastfeeding, see the section "Pregnancy and breastfeeding".

Do not take Triciclor until 28 days after childbirth (provided the woman is not breastfeeding) or after an abortion in the second trimester.

If you start later, you must use an additional barrier method during the first 7 days of treatment with Triciclor.

However, if you have had sexual intercourse before those 28 days, you must rule out the possibility of pregnancy before taking the contraceptive or wait for your next menstrual period.

What to do if bleeding occurs during the 21 days of taking coated tablets

The appearance of bleeding during the 3 weeks of taking the coated tablets is not a reason to interrupt treatment. A light bleeding usually disappears on its own. If the bleeding reaches an intensity similar to that of a normal menstruation, and lasts for more than 3 cycles, it is necessary to consult a doctor.

Absence of bleeding

If you have not taken Triciclor regularly, or have had vomiting or diarrhea during the cycle and do not experience vaginal bleeding during the rest period, it is advisable to consult your doctor and rule out the possibility of pregnancy. Read the sections "If you forgot to take Triciclor" and "Tips in case of vomiting and/or diarrhea" below.

If you forgot to take Triciclor

The protection of the contraceptive may be reduced if you forget to take tablets. In particular, if the forgetfulness is in the first week of treatment and you had sexual intercourse in the previous week, there may be a possibility of becoming pregnant.

? If you have delayed less than 12 hoursin taking a tablet, the efficacy of Triciclor is maintained. Take the tablet as soon as you remember and take the following tablets at your usual time.

? If you have delayed more than 12 hoursin taking a tablet, the efficacy of Triciclor may be reduced. Always take the last forgotten tablet as soon as you remember, even if it means taking two tablets in one day. Continue taking the following tablets at your usual time, but remember that you must use an additional barrier method (e.g., condoms) during the next 7 days.

If you take the last tablet of the package before the 7 days of using an additional contraceptive method have ended, start another package immediately without leaving a rest period between them. You will not have your menstruation until you finish the new package, although you may stain or have bleeding on the days you take the tablets.

If you do not have your menstruation at the end of the new package, contact your doctor, as it is necessary to rule out pregnancy before starting with the next package.

Tips in case of vomiting and/or diarrhea

If vomiting or diarrhea occurs within 4 hours after taking a tablet, you should follow the tips regarding forgetting to take a tablet. If you do not want to change your usual tablet-taking schedule, you must take the additional tablets needed from another package, and this package must always be the same color as the tablet you are taking.

If possible, take it within the next 12 hours or when you usually take your tablet. If it is not possible or more than 12 hours have passed, you should follow the guidelines described for these cases in the section "If you forgot to take Triciclor".

If episodes of severe vomiting or diarrhea are repeated over several days, you must use a barrier contraceptive method (e.g., condoms) until the start of the next package. Consult your doctor in case of doubt.

How to delay a period

To delay a period, you must start a new package immediately after finishing the current package, i.e., without respecting the 7-day rest period. You may have some staining or bleeding while taking the second package, but you do not need to worry about this. You should have a normal bleeding after finishing the second package, and respect the usual interval of 7 days without taking tablets before you can start with a new package.

If you take more Triciclor than you should

You may experience nausea, vomiting, drowsiness, dizziness, breast pain, dizziness, and vaginal bleeding. The treatment is symptomatic. However, these symptoms will naturally decrease as your body will handle the excess hormones.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

4. Possible side effects

Severe 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 urticaria with possible difficulty breathing (see also section "Warnings and precautions").

Like all medications, this medication can cause side effects, although not everyone experiences them. If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this prospectus.

Side effects are listed below, classified by frequency.

The side effectsvery common (may affect more than 1 in 10 people)are:

• unexpected vaginal bleeding or staining
• headache, including migraines

The side effectscommon (may affect up to 1 in 10 people)are:

• vaginitis (vaginal inflammation), including candidiasis (fungal infection in the vagina)
• mood changes, including depression; changes in libido (sexual desire)
• nervousness, dizziness
• nausea, vomiting, abdominal pain
• acne
• breast pain, breast pain after palpation, breast enlargement, breast secretion, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal secretion and cervical mucus, amenorrhea (absence of menstruation)
• fluid retention, edema (swelling)
• weight changes (increase or decrease)

The side effectsuncommon (may affect up to 1 in 100 people)are:

• changes in appetite, increase or decrease
• colic, bloating, diarrhea
• rash (rash), chloasma (skin spots) that may persist, hirsutism (excessive hair growth), alopecia (hair loss)
• increased blood pressure; changes in blood lipid levels, including hypertriglyceridemia (high levels of fatty acids in the blood)

The side effectsrare (may affect up to 1 in 1,000 people)are:

• intolerance to contact lenses
• allergic reactions such as urticaria (itching), accompanied by angioedema (swelling of the face, lips, mouth, and in very rare cases accompanied by difficulty breathing, dizziness, and even loss of consciousness) and severe respiratory and circulatory reactions
• glucose intolerance
• venous thrombotic episodes (blood clots in veins)
• cholestatic jaundice (yellowing of the whites of the eyes and skin due to bile stagnation)
• erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs), erythema multiforme (a type of skin lesions due to a reaction to the medication)
• vaginal discharge
• decrease in blood folate levels

The side effectsvery rare (may affect up to 1 in 10,000 people)are:

• hepatocellular carcinomas (malignant liver tumors)
• worsening of systemic lupus erythematosus (autoimmune disease)
• worsening of porphyria (blood disorder)
• worsening of chorea (involuntary movements)
• eye abnormalities and visual disturbances
• worsening of varices
• pancreatitis (inflammation of the pancreas); ischemic colitis (certain types of colon inflammation)
• cholecystopathy (bile duct disorders) including gallstones
• hemolytic uremic syndrome (kidney disease with blood alterations)

The side effects ofunknown frequencyare:

• inflammatory bowel disease (Crohn's disease, ulcerative colitis) (certain types of intestinal inflammation)
• liver damage such as hepatitis (liver inflammation) or alteration of its normal functioning

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Triciclor

It does not require special storage conditions.

Keep out of sight and reach of children.

Do not use Triciclor after the expiration date that appears on the package. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Triciclor

Each brown-colored coated tablet contains 50 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol. The other components (excipients) are: sucrose, lactose monohydrate, cornstarch, povidone K-25, magnesium stearate, talc, macrogol 6000, calcium carbonate, povidone K-90, glycerol 85%, red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), wax E, and purified water.

Each white-colored coated tablet contains 75 micrograms of levonorgestrel and 40 micrograms of ethinylestradiol. The other components (excipients) are: sucrose, lactose monohydrate, cornstarch, povidone K-25, magnesium stearate, talc, macrogol 6000, calcium carbonate, povidone K-90, wax E, and purified water.

Each yellow-colored coated tablet contains 125 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol. The other components (excipients) are: sucrose, lactose monohydrate, cornstarch, povidone K-25, magnesium stearate, talc, macrogol 6000, calcium carbonate, povidone K-90, glycerol 85%, titanium dioxide (E-171), yellow iron oxide (E-172), wax E, and purified water.

Appearance of the product and package contents

Each package contains 21 coated tablets in a blister pack (PVC/Aluminum). Each blister pack is packaged in an aluminum bag containing a sachet with desiccant (silica gel).

The desiccant is not part of the medication and should not be ingested.

Marketing authorization holder

WYETH FARMA, S.A.

Ctra. Burgos, Km 23. Desvío Algete, Km 1.

San Sebastián de los Reyes – Madrid

Spain

Manufacturer

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge

Co. Kildare

W12 HX57

Ireland

Local representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Date of the last revision of this prospectus: November 2022

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