Package Leaflet: Information for the User

Triciclor Coated Tablets

Levonorgestrel/Ethinylestradiol

1. What Triciclor is and what it is used for

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

3. How to take Triciclor

4. Possible side effects

5. Storage of Triciclor

6. Contents of the pack and additional information

Triciclor is an oral contraceptive medication.

Triciclor is prescribed for the following indications: oral hormonal 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 alterations of the breasts and reproductive organs.

Do not takeTriciclor:

• If you are allergic to the active ingredients (levonorgestrel, ethinylestradiol) or any of the other components of this medication (including those 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 during pregnancy.
• If you have or have had heart problems or blood vessel problems, particularly:
• • heart attack (myocardial infarction), heart rhythm disorder, or heart valve disorder
  • blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or brain (stroke), mini-stroke, or a tendency to form blood clots (venous or arterial thrombosis)
  • chest pain caused by angina.
• If you have or have had breast tumors, cervical, uterine, or vaginal tumors, 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 blood vessel disorders in the brain or heart.
• If you have heart valve disorders (valvulopathies).
• If you have heart rhythm disorders (arrhythmias) with a risk of forming blood clots.
• If you have inherited or acquired disorders that predispose you to blood clot formation (thrombophilias).
• If you have migraines associated with symptoms such as weakness or numbness of a part of the body, or visual disturbances (aura).
• If you have uncontrolled high blood pressure.
• If you have unexplained vaginal bleeding.
• If you have untreated endometrial hyperplasia.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Triciclor").

Warnings and precautions

Consult your doctor before starting to take Triciclor. You will need to visit your doctor for a physical examination. It is essential to 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 closely.

• Heart disease (chest pain, certain types of heart rhythm disorders, heart disease).
• Family or personal history of high levels of fat (triglycerides) in the blood.
• Have had or a close relative (parents, siblings, or children) has had a disease with a tendency to develop blood clots in the blood (in the legs, lungs, or any other part of the body) or has had heart attacks or strokes.
• Have varicose veins or have had inflammation in the superficial veins of the legs.
• Have high blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• Develop migraines (migraines) for the first time or worsen an existing migraine (becomes more intense and frequent) or is associated with visual disturbances (aura).
• Diabetes.
• Obesity.
• Depression or history of depression, as it may worsen or recur when using hormonal contraceptives. If you experience severe depression, you should discontinue the medication and use an alternative contraceptive method. Women with a history of depression should be monitored.
• Epilepsy.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Jacqueline (icterus) or liver, pancreas, or kidney function disorders.
• Have gallstones, liver disorders, or problems caused by bile duct blockage (cholestasis) – may cause intense itching.
• Rashes, red spots, or blisters (herpes gestational) especially if they have occurred during a previous pregnancy or when taking another contraceptive pill.
• Permanent brown spots on the skin of the face (melasma), especially if you have had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., tanning beds).
• Have a disorder that affects your immune system (systemic lupus erythematosus).
• Have a disease known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• Have had a blood disorder associated with kidney disease (hemolytic-uremic syndrome).
• Have had a blood disorder called porphyria.
• 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 may cause or worsen symptoms of hereditary and acquired angioedema.

Mental health disorders:

Some women who use hormonal contraceptives like Triciclor have reported depression or a depressed mood. Depression can be severe and sometimes may lead to 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 severe heart and blood vessel reactions 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 old.

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

Severe diseases:

Blood clots:

The use of combined medications, including Triciclor, may increase the risk of women developing blood clots (blood clot formation). This risk is higher during the first year of using oral contraceptives. Blood clots can block or obstruct major blood vessels and may cause:

• pulmonary embolism, myocardial infarction, angina, cerebral thrombosis, etc.

If you notice any of the following signs, inform your doctor immediately or visit the nearest hospital emergency department, as they may be indicative of blood clots:

• Pain and swelling in a leg.
• Severe chest pain that may also affect the left arm.
• Difficulty breathing or sudden shortness of breath.
• Unusual cough, and no apparent cause.
• Severe headache, unusual, severe, or prolonged, or more frequent and severe migraines.
• Visual disturbances (partial or complete loss of vision, double vision).
• Difficulty speaking clearly.
• Dizziness or fainting.
• Convulsions.
• Dizziness.
• Weakness, numbness, or tingling affecting a part of the body.
• Difficulty walking or holding objects.
• Severe stomach pain.
• 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 and obese.
• If you are a smoker and 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 recently given birth or had a second-trimester abortion. Women have an increased risk of forming blood clots, so you should consult your doctor about when you can start taking oral contraceptives after childbirth or abortion.
• If you have been immobilized for an extended period (e.g., with one or both legs in a cast or splint), are undergoing or have undergone major surgery, any type of surgery on the legs, or a significant trauma. In these situations, it is best to stop taking Triciclor (if the surgery is planned, stop at least four weeks before) and not start again until two weeks after you can stand up.
• If you have high levels of fat in the blood (cholesterol or triglycerides).
• 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 (heart valve disorders, heart rhythm disorders).

Genital bleeding:

You may not have your "period" during the week of rest. If you have taken the contraceptive pill correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor, as you should rule out pregnancy before starting the next package.

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

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

When you stop using this medication, you may experience irregular, light, or no bleeding, especially in the first 3 months and especially if your periods were irregular before starting hormone treatment.

Triciclor with other medications:

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

You should never take another medication on your own initiative without your doctor's recommendation, as medications can interfere with each other.

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

Remember that these instructions may also apply to medications you have used before or may need to use.

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

• Viruses and HIV (ritonavir, nevirapina).
• Infections (rifampicin, rifabutin, griseofulvin, and troleandomycin).
• Epilepsy (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Gout (phenylbutazone) or inflammation (dexamethasone).
• Acid reflux (antacids).
• Constipation (laxatives or purgatives).
• Sleep disturbances (modafinil).
• The medicinal herb St. John's Wort (Hypericum perforatum), used to treat certain types of depression.

It is recommended that you use another reliable contraceptive method if you take any of the medications that may make oral contraceptives less effective. Generally, women taking the medications described above should use a non-hormonal contraceptive method during antibiotic treatment and for 7 days after its discontinuation. If you need to continue taking these medications after completing your current package, do not skip the week of rest and start a new package immediately.

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

Triciclor may also interact with the following medications. Some of these medications cause an increase in Triciclor levels, while in other cases, Triciclor may increase or decrease the effect of these medications:

• Medications that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Pain relievers (paracetamol and salicylates).
• Anti-retrovirals (indinavir)
• Antibiotics (troleandomycin). Taking this medication with Triciclor may increase the risk of intrahepatic cholestasis (bile retention in the liver) during treatment.
• Oral anticoagulants (acenocoumarol).
• Oral antidiabetic medications and insulin.
• Lamotrigine (for epilepsy and certain psychiatric disorders)β-Blockers like metoprolol (for high blood pressure).
• Theophylline (for asthma).
• Corticosteroids (such as prednisolone).
• Ciclosporin (immunosuppressant), increasing the risk of liver toxicity.
• Flunarizine (for migraine prevention). Taking this medication with Triciclor may increase the risk of galactorrhea. This is a condition where the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not take TRICICLOR if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and 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.

TRICICLOR can be used again approximately 2 weeks after completing 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 instructed to undergo any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

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

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

This medication should not be used until you have completed 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 menstruation (menarche).

Older adults:

It is not indicated in postmenopausal women.

Driving and operating machinery:

No effects have been observed on the ability to drive or operate machinery with Triciclor.

Triciclor contains lactose and saccharose:

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

This medication contains saccharose. If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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 at the same time every day, until the package is finished. After that, 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 not be taking tablets, you will have a bleeding similar to the period (menstruation). This bleeding usually starts after 2 or 3 days, and may not have ended before starting the next package of tablets.

After those 7 days when you will not be 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 marked on the blister.

If it is the first time you take this medication or you have not used any hormonal contraceptive the previous month

The treatment starts on the first day of the menstrual cycle (that is, the first day of bleeding).

The contraceptive protection begins on the first day of treatment and also remains during the 7 days when you will not be taking tablets.

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

If you were taking another contraceptive and you change it toTriciclor

If your previous contraceptive was a 21-tablet package:

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

If your previous contraceptive was a 28-tablet package:

If your previous contraceptive contained inactive tablets (placebo), do not take these tablets. Start taking Triciclor immediately the day after taking the last active tablet of your previous contraceptive.

If you change from a contraceptive that only contained a progestogen (mini-pill, implant, intrauterine device (IUD), or injection)to Triciclor.

Mini-pill (progestogen-only pill)

You can stop taking the mini-pill (progestogen-only pill) 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 it is time for your next injection.

Implant or intrauterine device

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

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

Starting Triciclor after a first-trimester abortion

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

Starting Triciclor after childbirth or after a second-trimester abortion

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

You should not take Triciclor until 28 days after childbirth (if you are not breastfeeding) or after a second-trimester abortion.

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

However, if you have already had sexbefore those 28 days, you must assume that you may be pregnant before taking the contraceptive or wait for your next menstrual period.

What to do if bleeding appears during the 21 days of taking covered tablets

The appearance of bleeding during the 3 weeks of taking covered tablets is not a reason to interrupt treatment. Light bleeding usually resolves on its own. If bleeding reaches a intensity similar to normal menstruation and lasts for more than 3 cycles, you should consult your doctor.

Absence of bleeding

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

If you forgot to take Triciclor

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

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

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

If you take the last tablet of the package before the 7 days when you should use an additional barrier method, start a new package immediately without leaving a rest period between them. You will not have your period until you finish the new package, although you may experience spotting or bleeding while taking the tablets.

If you do not have your period at the end of the new package, contact your doctor, as you must rule out the possibility of pregnancy before starting the next package.

Advice in case of vomiting and/or diarrhea

If you experience vomiting or diarrhea within 4 hoursafter taking the tablet, you should follow the advice for forgetting to take the tablets. If you do not want to change your usual tablet-taking schedule, you should take the additional tablets needed from another packageand this must always be the same color as the tablet you are taking.

If possible, take it within the next 12 hours or at your usual tablet-taking time. If 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 you experience repeated episodes of severe vomiting or diarrhea over several days, you should use an additional barrier method (e.g. condoms) until the start of the next package. Consult your doctor if you are unsure.

How to delay a period

To delay a period, you should start a new package immediately after finishing the current package, that is, without respecting the 7-day rest period. You may experience spotting or bleeding while taking the second package, but do not worry about this. You should have a normal period after finishing the second package, and respect the usual 7-day rest periodbefore starting a new package.

If you take more Triciclor than you should

You may experience nausea, vomiting, numbness, drowsiness, breast tenderness, dizziness, and vaginal bleeding. Treatment is symptomatic. However, these symptoms will naturally decrease as your body adjusts to 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.

Severe Adverse Effects

Contact a doctor immediately if you experience any of the following angioedema symptoms: facial, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible breathing difficulties (also see the "Warnings and Precautions" section).

Like all medications, this medication may cause adverse effects, although not everyone will experience them. If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Adverse effects are listed below, classified by frequency.

Adverse EffectsVery Frequent (may affect more than 1 in 10 people)are:

• Unexpected vaginal bleeding or spotting
• Headache, including migraines (headaches)

Adverse EffectsFrequent (may affect up to 1 in 10 people)are:

• Vaginitis (vaginal inflammation), including candidiasis (vaginal yeast infection)
• Changes in mood, including depression; changes in libido (sex drive)
• Nervousness, dizziness
• Nausea, vomiting, abdominal pain
• Acne
• Mastalgia (breast pain), breast tenderness, breast enlargement, nipple discharge, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical mucosa (ectopic cervical), amenorrhea (absence of menstruation)
• Fluid retention, edema (swelling)
• Changes in weight (gain or loss)

Adverse EffectsRare (may affect up to 1 in 100 people)are:

• Changes in appetite, increase or decrease
• Colic, feeling of swelling, diarrhea
• Rash (skin eruption), melasma (skin discoloration) 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)

Adverse EffectsRare (may affect up to 1 in 1000 people)are:

• Lens intolerance
• Allergic reactions such as urticaria (hives), accompanied by angioedema (facial, lip, mouth swelling, and in rare cases difficulty breathing, dizziness, and even loss of consciousness) and severe respiratory and circulatory reactions
• Glucose intolerance
• Thrombotic episodes (blood clots in veins)
• Jaundice (yellowing of the whites of the eyes and skin due to bile stasis)
• 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 medication reaction)
• Vaginal discharge
• Decreased folate levels in the blood

Adverse 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 disorders
• Worsening of varicose veins
• Pancreatitis (pancreas inflammation); ischemic colitis (certain types of colon inflammation)
• Biliary colic (gallbladder disorders) including gallstones
• Hemolytic-uremic syndrome (kidney disease with blood abnormalities)

Adverse Effects ofUnknown Frequencyare:

• Inflammatory bowel disease (Crohn's disease, ulcerative colitis) (certain types of intestinal inflammation)
• Liver damage such as hepatitis (liver inflammation) or altered liver function

Reporting Adverse Effects

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

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use Triciclor after the expiration date shown on the packaging. 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 packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Triciclor

Each brown-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%, iron oxide red (E-172), iron oxide yellow (E-172), titanium dioxide (E-171), cera E, and purified water.

Each white-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, cera E, and purified water.

Each yellow-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), iron oxide yellow (E-172), cera E, and purified water.

Appearance of the product and contents of the package

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

The desiccant does not form part of the medication, and therefore should not be ingested.

Holder of the marketing authorization

WYETH FARMA, S.A.

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

San Sebastián de los Reyes – Madrid

Spain

Responsible for Manufacturing

Pfizer Ireland Pharmaceuticals

Little Connell Newbridge, Co. Kildare

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Last review date of this leaflet: November 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/