Package Insert: Information for the User

OVOPLEX 0.15 mg/0.03 mg Coated Tablets

Levonorgestrel and Ethinyl Estradiol

1. What is Ovoplex and for what it is used

2. What you need to know before taking Ovoplex

3. How to take Ovoplex

4. Possible adverse effects

5. Storage of Ovoplex

6. Contents of the package and additional information

Ovoplex is an oral contraceptive medication.

It 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 certain alterations of the breasts and reproductive organs.

Do not takeOvoplex

• If you are allergic to levonorgestrel, ethinyl estradiol, or any of the other components of this medication (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you have severe liver function disorders.
• If you have had blood clots in the lower limbs that have broken loose and affected other parts of the body, even if it happened a long time ago.
• If you have had tumors in the breasts, liver, cervix, uterus, or vagina.
• If you have diabetes associated with heart problems or circulatory problems.
• If you have disorders of the brain's arteries or heart.
• If you have any heart valve diseases (valvulopathies).
• If you have disorders of the heart rhythm (arrhythmias) that may cause blood clots to form.
• If you have inherited or acquired conditions that predispose you to blood clots (thrombophilias).
• If you have migraines (migraines) associated with symptoms such as weakness or numbness in a part of the body, or visual disturbances (aura).
• If you have high blood pressure.
• If you have unexplained vaginal bleeding.
• If you have pancreatitis (inflammation of the pancreas) due to a severe increase in triglycerides.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Ovoplex").

Warnings and precautions

Before taking Ovoplex, 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. You should also visit your doctor if any of these diseases worsen or appear while using this medication:

• Heart disease (chest pain, certain types of heart rhythm disorders, heart diseases).
• Family or personal history of high levels of fat (triglycerides) in the blood.
• High blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• Migraines (migraines) that are intense and repetitive or associated with visual disturbances (aura).
• Diabetes.
• Depression or history of depression, as it may worsen or recur when using hormonal contraceptives.
• Epilepsy.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Icterus (yellowing of the whites of the eyes and skin) or liver function disorders.
• Hives, especially if they occurred during a previous pregnancy.
• Permanent brown spots on the skin of the face, especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., tanning beds).
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Mental health disorders:

Some women who use hormonal contraceptives like Ovoplex have reported depression or a depressed mood. Depression can be severe and sometimes leads to suicidal thoughts. If you experience mood disturbances and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Contact your doctor if you think you may be pregnant.

Severe diseases:

Thrombosis (blood clots)

The use of contraceptive medications can increase the risk of thrombosis (blood clots). This risk is higher during the first year of using oral contraceptives.

Blood clots can block major blood vessels and may cause: pulmonary embolism, myocardial infarction, angina pectoris, cerebral thrombosis, etc.

If you notice any of the following signs, inform your doctor as they may be forming blood clots:

• Pain and swelling in a leg.
• Severe chest pain and sometimes arm pain.
• Sudden shortness of breath.
• Abrupt coughing.
• Severe headache.
• Visual disturbances (loss of vision, double vision).
• Difficulty speaking clearly.
• Dizziness.
• Convulsions.
• Weakness or numbness affecting a part of the body.
• Difficulty walking or holding objects.
• Severe stomach pain.

The following conditions can increase the risk of blood clots in the blood, so inform your doctor if you have any of them:

• Obesity.
• If you are a smoker and over 35 years old.
• If you have had a severe injury to your legs or hips.
• If you have recently given birth or had a miscarriage in the second trimester of pregnancy.
• If you need to stay in bed for many days. In these cases, if possible, treatment should be suspended.
• If you are undergoing or will undergo a major surgical procedure. In these cases, treatment should be suspended whenever possible for four weeks before and two weeks after the procedure.
• Advanced age.

Do not start treatment with oral contraceptives until 28 days after delivery, unless you are breastfeeding or had a miscarriage in the second trimester, as the risk of venous thromboembolism increases immediately after delivery.

Blood pressure

If you have high blood pressure or have a disease related to high blood pressure (including certain kidney diseases), it is recommended to use other contraceptive methods. If you decide to use oral contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medications, you should discontinue treatment.

Tumors

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to treatment. For example, it may be that tumors are detected more frequently in women using oral contraceptives because they visit their doctor more often. This increased frequency decreases gradually after discontinuing treatment. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

Similarly, cervical tumors (cervix) occur more frequently in women using oral contraceptives. However, the appearance of this tumor is associated with increased sexual activity and sexually transmitted diseases, so it is unclear whether oral contraceptives play a direct role in this risk.

Rarely, cases of liver tumors have been reported in women using oral contraceptives. In these cases, internal bleeding may occur, leading to severe abdominal pain. If this happens, contact your doctor immediately.

Women who have had cholestasis (obstruction of bile flow) during oral contraceptive treatment in the past or during pregnancy are more prone to developing it again if they use oral contraceptives. These women should be monitored, and if cholestasis appears, treatment with oral contraceptives should be discontinued.

Cases of severe liver damage have been reported with the use of oral contraceptives. If your doctor determines that you develop severe liver damage while taking oral contraceptives, they will discontinue treatment and recommend the use of non-hormonal contraceptives.

Migraines

The onset or worsening of a migraine (migraine), or the appearance of a migraine with different characteristics than usual, recurrent, persistent, or intense, requires suspending treatment with oral contraceptives and evaluating the cause of the symptoms.

Women with migraines (particularly those associated with symptoms such as weakness or numbness in a part of the body, or visual disturbances (aura)) who take oral contraceptives may be at increased risk of cerebral infarction.

Immune system

The use of oral contraceptives can exacerbate symptoms of angioedema (inflammation similar to urticaria, but occurring under the skin instead of on the surface) particularly in women with hereditary angioedema (a problem of the immune system that is inherited from parents to children).

Genital bleeding

You may not have your "period" during the week of rest. If you have taken the oral contraceptive correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor as a pregnancy should be ruled out. If you have not taken the oral contraceptive as instructed in the section "3. How to take Ovoplex" and have a missed period, you should discontinue treatment and use a non-hormonal contraceptive method until a pregnancy has been ruled out.

This medication can cause vaginal bleeding or spotting between periods. If this happens, continue treatment and if bleeding continues after three cycles, consult your doctor immediately. 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 three months and especially if your periods were irregular before starting hormone treatment.

Effects on carbohydrates and lipids

Cases of glucose intolerance have been reported in women taking oral contraceptives. Women with glucose intolerance or diabetes mellitus should be closely monitored.

A small proportion of women taking oral contraceptives may experience changes in their lipid profile (analysis of fat content in the blood). They should consider using non-hormonal contraceptive methods if they have uncontrolled lipid disorders. A small proportion of women taking oral contraceptives may experience persistent hypertriglyceridemia (increased triglycerides in the blood). A significant increase in plasma triglycerides can lead to pancreatitis and other complications.

Women who have been treated for hyperlipidemia (increased cholesterol and/or triglycerides) should be monitored if they decide to take oral contraceptives.

Eye lesions

Cases of retinal vascular thrombosis have been reported with the use of oral contraceptives, which can lead to partial or complete loss of vision. If you experience visual disturbances, proptosis (bulging eyes), diplopia (double vision), papilledema (inflammation of the eye), or retinal vascular lesions, treatment with oral contraceptives should be discontinued and the cause should be evaluated immediately.

Depression

If a severe depression occurs, treatment should be discontinued and an alternative contraceptive method should be used.

Women with a history of depression should be closely monitored.

Other

Oral contraceptives do not protect against HIV (AIDS) or any other sexually transmitted disease (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). Condoms should be used to protect against these diseases.

Other medications and Ovoplex

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

These instructions may also apply to medications you have taken or used before or may take or use after.

The medications listed below may prevent hormonal contraceptives from working properly and, if so, you may become pregnant:

• Some treatments for viral infections and HIV (ritonavir, indinavir).
• Some antibiotics (rifampicin, rifabutina, griseofulvina, and troleandomycin).
• Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Some anti-inflammatory agents (phenylbutazone, dexamethasone).
• Antacids.
• Laxatives.
• Some mood-enhancing substances (modafinil).
• Medications that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Analgesics (paracetamol).

The medicinal herb St. John's Wort (Hypericum perforatum),also reduces the effect of oral contraceptives and cases of pregnancy have been reported in women taking both the oral contraceptive and St. John's Wort at the same time. The decrease in contraceptive effect lasts for up to two weeks after stopping St. John's Wort.

It is recommended to use another reliable contraceptive method if you take any of the medications that may make oral contraceptives less effective. Women taking antibiotics should use a non-hormonal contraceptive method during antibiotic use and for 7 days after discontinuation (except rifampicin and griseofulvina, which should be used for 28 days after discontinuation, as well as medications that induce liver enzymes: antiepileptics).

If the treatment with the medication lasts longer than the number of tablets in the package of AOC, the next package of AOC should be started without the usual break.

There are other substances that may increase etinyl estradiol levels:

• Medications that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Analgesics (paracetamol).

Troleandomycin may increase the risk of intrahepatic cholestasis.

Ovoplex may reduce the effect of other medications, such as:

- Oral anticoagulants (acenocoumarol).

- Analgesics (such as paracetamol and salicylates).

- Oral antidiabetic agents and insulin.

- Lamotrigine (for epilepsy and certain psychiatric disorders).

Ovoplex may also increase the effect of other medications, such as:

- Beta-blockers like metoprolol (for high blood pressure).

- Theophylline (for asthma treatment).

- Corticosteroids (such as prednisolone).

- Cyclosporine (immunosuppressant), increasing the risk of liver toxicity.

- Flunarizine (for migraine treatment), increasing the risk of lactation.

Do not take OVOPLEX 150/30 if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme test results (ALT).

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

OVOPLEX 150/30 can be used again approximately 2 weeks after completing this treatment. See the section "Do not take OVOPLEX 150/30".

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.

Do not use this medication if you are pregnant or think you may be pregnant (for information on using Ovoplex after pregnancy, see section "3. How to take Ovoplex").

If you become pregnant, discontinue treatment immediately and consult your doctor.

This medication should not be used until the end of the breastfeeding period.

Children and adolescents

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 (menstruation).

Older adults

It is not indicated for use in postmenopausal women.

Driving and operating machinery

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

Ovoplex contains lactose and saccharose

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

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

Follow exactly the administration instructions for Ovoplex 150/30 indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication is for oral administration.

Remember to take your medication, as forgetting Ovoplex 150/30 may reduce the effectiveness of the preparation.

Before starting treatment with this medication, your doctor must perform a detailed medical history and a thorough medical examination, including blood pressure, and rule out the existence of pregnancy. They must also perform an examination of the breasts, liver, limbs, and pelvic organs (urinary bladder, vagina, uterus, and final part of the large intestine). Your doctor may also need to perform a cervical cytology (a painless scraping of the cervix to take cells for analysis). Your doctor will repeat this examination 3 months after starting treatment, and then annually.

See the section “2. Before taking Ovoplex.”.

Instructions for correct medication administration

You must take the tablets orally, in the order indicated on the blister pack, approximately at the same time, every day, with some liquid if necessary. You must take one tablet daily for 21 consecutive days and then be without tablets for 7 days. Each subsequent pack will start after the 7-day period without tablets, during which a hemorrhage usually occurs. This hemorrhage, similar to menstruation, usually begins between days 2 and 3 after taking the last tablet, and may not have ended before starting the next pack.

Your doctor will indicate the duration of your treatment with this medication.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Start of the first pack of Ovoplex

• When no hormonal contraceptive has been used the previous month

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

For example, if bleeding occurs on a Monday, you should start taking the first tablet on the same day, with the tablet marked “Lu”, and follow the arrow indicator for the subsequent tablets.

You can also start on days 2-7 of the menstrual cycle, in which case it is recommended to use a non-hormonal contraceptive method for birth control (e.g., condoms or spermicides) during the first 7 days of tablet taking.

• When switching from another contraceptive and changing to Ovoplex

You can start taking Ovoplex the day after taking the last active tablet from your current pack of pills (this means there is no break in tablets). If your current pack of pills also contains inactive tablets, you can start taking Ovoplex the day after taking the last active tablet. Never delay beyond the next day after finishing the usual interval without tablets or the interval of inactive tablets from your previous contraceptive.

• When switching from a method that only contains a progestogen (mini-pill, implant, intrauterine device (IUD), or injection)

You can stop taking the progestogen-only pill (mini-pill) on any day and start taking Ovoplex the next day, at the same time.

Start using this medication when it is due for your next injection or the day your implant or IUD is removed.

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

• 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.

• Postpartum

If you are breastfeeding, you should not take this medication. See the section “Pregnancy, breastfeeding, and fertility.”.

Use of the tablets starts 28 days after delivery in women who are not breastfeeding or who have had a second-trimester abortion. If you start later, you must use an additional barrier method during the first 7 days of tablet taking. However, if you have already had sex, you must rule out the possibility of pregnancy before taking the contraceptive or wait for your next menstrual period.

Subsequent cycles

After the 7-day break, continue with a new pack of Ovoplex, starting on the same day of the week as the first pack.

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

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 level similar to normal menstruation and lasts for more than 3 cycles, you should consult your doctor.

Absence of bleeding

If bleeding does not occur during the break, it is recommended to consult your doctor immediately to rule out the possibility of pregnancy if the covered tablets have not been taken regularly or if you have had vomiting or diarrhea during the cycle.

What to do if you forget to take Ovoplex

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 some tablets, the effectiveness of the pill is maintained. Take it as soon as you remember and take the next tablets at your usual time.

• If you have delayedmore than 12 hoursin taking some tablets, the effectiveness of the contraceptive may be reduced.

• Take the last forgotten 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 use an additional barrier method (e.g., condoms or spermicides) during the next 7 days.
• • If you take the last tablet before the 7 days required for using an additional barrier method have ended, start another pack immediately without leaving a break between them. You will not have your period until the end of the new pack, although you may experience spotting or bleeding during the days you take the tablets.
  • If you do not have your period at the end of the new pack, contact your doctor, who must check that you are not pregnant before starting the next pack.

Advice in case of vomiting and/or diarrhea

If you experience vomiting or diarrhea within 4 hours of 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 must take the additional tablets needed from another pack.

How to delay a period

To delay a period, you must start a new pack immediately after finishing the current pack, without any break.The periods may be delayed for as long as you want, but not beyond the end of the second pack.You may experience bleeding or spotting during this time.Subsequently, regular tablet taking resumes after the usual 7-day break without tablets.

What to do if you take more Ovoplex than you should

You may experience nausea, vomiting, drowsiness, breast tenderness, dizziness, and vaginal bleeding; treatment will consist of suspending administration of this medication. Contact your doctor or pharmacist as soon as possible.

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

If you have any other questions about using this product, ask your doctor or pharmacist.

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 difficulty (also see "Warnings and Precautions" section).

Like all medications, Ovoplex may cause adverse effects, although not everyone will experience them.

The use of oral contraceptives has been associated with an increased risk of:

• Thrombotic and arterial episodes, as well as thromboembolic episodes, including cerebral infarction, transient ischemic attack, myocardial infarction, venous thrombosis, and pulmonary embolism (see Warnings and Precautions).
• Cervical intraepithelial neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (cervical cancer).
• Diagnosis of breast cancer (see Warnings and Precautions).
• Benign liver tumors (e.g., nodular focal hyperplasia, hepatic adenomas).

Adverse effects are listed below, classified by frequency according to the following criterion:

Very Frequent Adverse Effects (more than 1 in 10 patients)

?Unexpected vaginal bleeding or spotting

?Headache, including migraines (headaches)

Frequent Adverse Effects (at least 1 in 100 patients)are:

?Vaginitis (vaginal inflammation), including candidiasis (vaginal fungal infection)

• Changes in mood, including depression; changes in libido (sex drive)
• Nervousness, dizziness
• Nausea, vomiting, abdominal pain
• Acne
• Chest pain or tightness, breast swelling, nipple discharge, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal discharge, and cervical ectopia (abnormal mucosa of the cervix), amenorrhea (absence of menstruation)
• Fluid retention, edema (swelling)
• Changes in weight (increase or decrease)

Frequent Adverse Effects (at least 1 in 1,000 patients)are:

• Changes in appetite, increase or decrease
• Colic, sensation of swelling, diarrhea
• Rash (skin eruption), melasma (skin discoloration) that may persist, hirsutism (excessive hair growth), alopecia (hair loss)
• Increased blood pressure; changes in lipid levels in the blood, including hypertriglyceridemia (high levels of fatty acids in the blood)

Rare Adverse Effects (at least 1 in 10,000 patients)are:

• Intolerance to contact lenses
• Allergic reactions such as urticaria (hives), angioedema (facial, lip, and/or mouth swelling, and in rare cases, difficulty breathing, dizziness, and loss of consciousness)

?Glucose intolerance

• Thrombotic episodes in veins (blood clots in veins)
• Jaundice (yellowing of the skin and eyes due to bile stasis)
• Erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs)
• Vaginal discharge
• Decreased folate levels in the blood

Very Rare Adverse Effects (less than 1 in 10,000 patients)are:

• Hepatocellular carcinomas (malignant liver tumors)
• Worsening of systemic lupus erythematosus (autoimmune disease)
• Worsening of porphyria (familial metabolic disorder)
• Worsening of chorea (involuntary movements)
• Eye abnormalities and visual disorders
• Worsening of varicose veins
• Pancreatitis (inflammation of the pancreas); ischemic colitis (certain types of colon inflammation)
• Biliary tract disorders, including gallstones
• Erythema multiforme (a type of skin inflammation)
• Sickle cell disease (renal disease with blood abnormalities)

Adverse effects ofunknown frequencyare:

• Inflammatory bowel disease (Crohn's disease, ulcerative colitis) (certain types of intestinal inflammation)

Do not be alarmed by these adverse effects, as it is very likely that none of them will occur.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 to the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Do not store above 86°F (30°C).

Keep out of the reach and sight of children.

Do not use OVOPLEX 150/30 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 Ovoplex Coated Tablets

The active principles of Ovoplex are: 0.15 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other components (excipients) are: sucrose, lactose, cornstarch, povidone K-25, magnesium stearate, povidone K-90, macrogol 6,000, calcium carbonate, talc, white wax, carnauba wax, and purified water.

Appearance of the Product and Contents of the Package

It is presented in a calendar pack containing 1 blister with 21 coated tablets.

The blister is packaged in an aluminum bag that contains a sachet with desiccant (silica gel).

After opening the aluminum bag, the desiccant can be removed.

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 informationof this medication is available on the websiteof the Spanish Agency for Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/